IMPLANTABLE SURGICAL DEVICES
ISSUES OF
PRODUCT LIABILITY
by
Robin JED Higgs
A Thesis submitted in fulfilment of the requirements for the degree of
MASTER OF LAWS (Research)
The University of New South Wales
2005 This thesis has been prepared on the basis of the law and practice as at the date of submission. The University of New South Wales
Abstract
Patients who have undergone treatment that has included the surgical implantation of a prosthetic device can become dissatisfied for many reasons. One cause for dissatisfaction is any adverse event where there is a demonstrable causal nexus with the failure of a device that is defective or at risk of being so. The magnitude of therapeutic product failure is considerable and therapeutic goods such as Vioxx, Thalidomide, silicon-gel-filled breast implants, contaminated blood products, cardiac pacemakers and valves, and orthopaedic devices are testimony to this. Many of these events have exposed a greyish area of Australian law that balances medical negligence with consumer protection and contract law. Australian product liability legislation that regulates the use of therapeutic goods is a complex amalgam of law that has at its foundations the Trade Practices Act 1974 (Cth) and the Therapeutic Goods Act 1989 (Cth). When a surgical device fails there can be exposure to liability. This thesis explores those important issues that can impact on individuals or on organisations and it is evident that where issues of product liability concern implanted surgical devices the current regulations for consumer protection may not always be the most appropriate. It is evident that there is a culture of under-reporting of adverse events to a Therapeutic Good Administration that does not have the resources to investigate the cause for failure of a surgical device. Furthermore, there is a potential for bias and conflict of interest in an environment where the regulator depends on the regulated for the funding of its existence. Other issues include the complex and often undesirable consequences of those partnerships that can evolve with the development of an implantable device and with the undertaking of clinical trials, the role of the learned intermediary, that interface between manufacturer and consumer, and the role of the expert witness, that interface between justice and injustice. These and other matters that can significantly influence any debate of implantable surgical device product liability are explored and recommendations are made that might form the basis of a Therapeutic Goods (Safe Medical Devices) Amendment Act.
Robin JED Higgs DEDICATION
This work is dedicated to Grandma JMRS and to Alex. JMRS is pronounced “Jimmers” and Alex is otherwise known as “His Nibs”. Without them both this thesis would have been completed much less enjoyably at least one year earlier. This is for both of you. The matter does not appear to me now as it appears to have appeared to me then.
Baron Bramwell in Andrews v Styrop 26 LTNS 704, 706 ACKNOWLEDGEMENTS
First and foremost I would like to thank my supervisor Professor Gail Pearson for enabling me to benefit from the opportunity to learn from a process of disciplined legal research. Without the wisdom, guidance, and encouragement and the infectious laugh of Professor Pearson this thesis could never have been completed.
I acknowledge also the assistance of “family solicitors”, particularly “B”, the incredulity of my children, the observation of a student in the Law Faculty lift who remarked “you are never too old to learn law” and the monumental efforts of Rachel in Gosford and of Aileen in Noosa who have both assisted me with the presentation of the text. CONTENTS
Chapter 1 Introduction 1.1 - 1.13
Chapter 2 The Magnitude of Therapeutic Goods Failure 2.1 - 2.33
Introduction 2.1 - 2.4 Implanted Surgical Device Failure 2.4 - 2.12 Orthopaedic Implant Device 2.12 - 2.22 Failure Case Studies 2.22 - 2.30 Conclusion 2.30 - 2.33
Chapter 3 Product Liability in Australia 3.1 - 3.86
Introduction 3.1 - 3.8 Product Liability Legislation in 3.8 - 3.21 Australia The Tort of Negligence 3.21 - 3.32 Contract Law 3.32 - 3.38 Trade Practices Act 1974 (Cth) – 3.39 - 3.50 Product Liability The Australian Competition and 3.50 - 3.52 Consumer Commission The Therapeutic Goods Act 1989 3.52 - 3.56 (Cth) The Current Regulatory System 3.57 - 3.72 The Therapeutic Goods 3.73 - 3.83 Administration Conclusion 3.83 - 3.86 Chapter 4 The Evolution of the Surgical Implant 4.1 - 4.66
Introduction 4.1 - 4.5 The Classic Case 4.5 - 4.9 Beneficence 4.9 - 4.17 Surgical Implant Development 4.17 - 4.27 Surgeon-Industry Relationships 4.27 - 4.31 Clinical Trials 4.31 - 4.45 Advertising 4.45 - 4.50 Supply and Distribution of 4.50 - 4.55 Surgically Implantable Devices The Roles and the Liabilities of 4.55 - 4.61 Surgeons & Hospitals Conclusion 4.61 - 4.66
Chapter 5 The Medical and Legal Definitions of Adverse 5.1 - 5.22 Events and Injury, and of Defective Goods and Defects, in the context of the Surgically Implanted Device
Introduction 5.1 - 5.4 Adverse Events and Injuries 5.4 - 5.13 Defects and Defective Surgically 5.13 - 5.19 Implantable Devices Conclusion 5.20 - 5.22
Chapter 6 Implantable Surgical Device Manufacturers 6.1 - 6.26 Defences’ to Liability
Introduction 6.1 - 6.6 Defences 6.6 - 6.25
The subsequent defect defence 6.7 - 6.8 Compliance with a mandatory 6.8 - 6.11 standard defence The state of the art defence 6.11 - 6.15 The component manufacturers defence 6.15 - 6.18 The contributory negligence defence 6.18 - 6.21 The learned intermediary defence 6.22 - 6.23 The intermediate examination defence 6.23 - 6.24 The bulk supplier defence 6.25
Conclusion 6.25 - 6.26 Chapter 7 The Learned Intermediary – The Delicate 7.1 - 7.28 Balance Between the Defence and the Duty to Warn and to Educate
Introduction 7.1 - 7.4 The Learned Intermediary Defence, 7.4 - 7.11 the Intermediate Examination Defence, and a Manufacturer’s Duty to Warn Informed Consent, the Voluntary 7.11 - 7.20 Assumption of Risk, and the Medical Practitioner’s Duty to Warn The Learned Intermediary’s 7.20 - 7.27 Exposure to Liability as an Educator Conclusion 7.27 - 7.28
Chapter 8 The Expert Witness 8.1 - 8.51
Introduction 8.1 - 8.6 The Role of the Expert Witness 8.7 - 8.11 Admissibility of Expert Evidence 8.11 - 8.14 Opinion Evidence 8.15 - 8.17 Bias in Expert Evidence 8.18 - 8.24 The Expert and the Miscarriage of 8.24 - 8.30 Justice Immunity of the Expert Witness 8.30 - 8.32 Reform of the Expert Witness 8.32 - 8.45 System Expert Witness Conferences 8.45 - 8.49 Conclusion 8.49 - 8.51
Chapter 9 Regulating and Reporting 9.1 - 9.28
Introduction 9.1 - 9.3 Post-Market Surveillance (PMS) 9.3 - 9.8 The Safe Medical Devices Act of 9.8 - 9.11 the United States of America Regulation 9.11 - 9.14 Reporting 9.14 - 9.19 Voluntary Reporting 9.19 - 9.22 Mandatory Reporting 9.22 - 9.24 Conclusion 9.24 - 9.28
Chapter 10 Conclusions and Recommendations 10.1- 10.11
Conclusions 10.1 - 10.7 Recommendations 10.8 - 10.11 LIST OF TABLES
Chapter 2 – The Magnitude of Therapeutic Goods Failure
Table 2.1 Implant Breakage pg 2.21 Table 2.2 Implant Wear pg 2.21 Table 2.3 Articulating Bearing Dislocation pg 2.22
Chapter 3 – Product Liability in Australia
Table 3.1 Episodes of Product Recall pg 3.3 LIST OF CASES
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Yeoman Credit Ltd v. Odgers, [1962] 1 WLR 215 TABLE OF STATUTES
COMMONWEALTH
Acts Interpretation Act 1901 Australian Research Council Act 2001 Australian Securities and Investment Commissions Act 2001 Constitution Copyright Act 1968 Corporate Law Economic Reform Program (Audit Reform and Corporate Diclosure) Act 2004 Corporations Act 2001 Criminal Code Act 1995 Customs Act 1901 Evidence Act 1995 Federal Court of Australia Act 1976 Financial Management and Accountability Act 1997 Freedom of Information Act 1982 Health Insurance Act 1973 National Health and Medical Research Council Act 1992 Patents Act 1990 Privacy Act 1988 Public Service Act 1999 Stevedoring Industry Act 1956 Stevedoring Industry Acts (Termination) Act 1997 Stevedoring Industry Finance Committee Acts 1977 Therapeutic Goods Act 1966 Therapeutic Goods Act 1989 Therapeutic Goods Amendment (Medical Devices) Act 2002 Therapeutic Goods (Charges) Amendment Act 2002 Trade Practices Act 1974 Trade Practices Amendment Act (No. 1) 2001 Treasury Legislation Amendment (Professional Standards) Act 2004
AUSTRALIAN CAPITAL TERRITORY
Fair Trading Act 1992 Freedom of Information Act 1989 Human Rights Act 2004 Sale of Goods Act 1954 NEW SOUTH WALES
Children and Young Persons (Care and Protection) Act 1998 Civil Liability Act 2002 Civil Liability Amendment Act 2003 Civil Liability Amendment (Personal Responsibility) Act 2002 Fair Trading Act 1987 Freedom of Information Act 1989 Health Care Liability Act 2001 Health Records and Information Privacy Act 2002 Law Reform Commission Act 1967 Law Reform (Miscellaneous Provisions) Act 1965 Limitation Act 1969 Medical Practices Act 1992 Privacy and Personal Information Protection Act 1998 Privacy and Personal Information Act 2002 Sale of Goods Act 1923 Sales of Goods (Vienna Convention) Act 1986 Workplace Injury Management and Workers Compensation Act 19983 NORTHERN TERRITORY
Consumer Affairs and Fair Trading Act 1990 Information Act 2000 Sale of Goods Act 1972
QUEENSLAND
Civil Liability Act 2003 Fair Trading Act 1989 Freedom of Information Act 1992 Sale of Goods Act 1896
SOUTH AUSTRALIA
Fair Trading Act 1987 Freedom of Information Act 1991 Sale of Goods Act 1895 TASMANIA
Fair Trading Act 1990 Freedom of Information Act 1991 Sale of Goods Act 1896
VICTORIA
Fair Trading Act 1985 Freedom of Information of Act 1982 Goods Act 1958 Information Privacy Act 2000 Wrongs Act 1958 Wrongs and Statute of Limitations (Insurance Reforms) Act 2003 WESTERN AUSTRALIA
Civil Liability Act 2002 Freedom of Information Act 1992 Sale of Goods Act 1895
EUROPE AND EUROPEAN ECONOMIC COMMUNITY
Active Implantable Medical Devices Directive (MDD 90/385/EEC) Declaration of Helsinki 1964 Declaration of Helsinki 1996 EEC Directive 65/65/EEC OJ 22, 9 Feb 1965, 369 EEC Directive 85/374/EEC EEC Directive 92/28/EEC, OJ-30.4.92, L 113/13 In-Vitro Diagnostic (IVD) Medical Devices Directive (MDD 98/79/EEC) Medical Devices Directive (MDD 93/42/EEC) Nuremberg Code 1949 Product Liability Directive (85/374/EEC)
NEW ZEALAND
Fair Trading Act 1986 Medicines Act 1991 Sale of Goods Act 1895 Sale of Goods Act 1908 UNITED KINGDOM
Childrens Act 1989 Companies Act 1862 (England and Scotland) Congenital Disabilities (Civil Liabilities) Act 1976 Consumer Protection Act 1987 Family Law Reform Act 1969 Human Rights Act 1998 Judicature Act 1873 Medicine Act 1968 Sale and Supply of Goods Act 1994 Sale of Goods Act 1893 Sale of Goods Act 1979
UNITED STATES OF AMERICA
Biomaterials Access Availability Act 1995 Federal Food, Drug and Cosmetic Act 1938 Food and Drug Act 1906 Medical Devices Amendment Act 1976 Medical Devices Amendment Act 1992 Safe Medical Devices Act 1990 SELECTED BIBLIOGRAPHY
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AUSTRALIA
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Australian Magistrates' Perspectives on Expert Evidence: A Comparative Study, I Freckelton, P Reddy, H Selby, Australian Institute of Judicial Administration, Melbourne 2001.
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Bill's Digest No 104, Department of the Parliamentary Library, 2001-2002.
Consumer Product Safety, National Consumer Affairs Advisory Council Report entitled the Australian Law Reform Commission Report, 1989.
Directions in Injury Prevention Report 1: Research Needs, Commonwealth Department of Health and Aged Care, 1999.
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EUROPEAN COMMUNITY
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FRANCE
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NEW ZEALAND
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SWITZERLAND
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UNITED KINGDOM
Access to Justice: Final Report to the Lord Chancellor on the Civil Justice System in England and Wales, The Right Hon The Lord Woolf, HMSO, London, 1996.
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SEMINARS
C Altenstetter, EU Policies on the Regulation of Medical Goods & Equipment, paper presented at the 29th ECPR Joint Workshops, Grenoble, France, April 6-11, 2001.
T Boland, Science v. the Law, presented at the University of Sydney (Health Law Seminar Series), 23rd July 2001.
BC Bruechle, Learning from a Failure and Musical Instruments, presented to the Institution of Engineers of Australia, Perth Division, May 2001.
CV Burton, The Burton Report, delivered to the United States Congress of Neurological Surgeons, 1997.
J Charnley, Lubrication of Animal Joints, Symposium on Biomechanics, Institution of Mechanical Engineers, London, 1959.
M Flood, Conformity Assessment Procedures, Post-Market Responsibilities and Mutual Recognition Agreement with the EU, Medical Device Seminar, Dept of Medical Physics, Royal Perth Hospital, 25th May 2004.
I Freckelton, P Reddy & H Selby, Australian Judical Perspectives on Expert Evidence: An Empirical Study, presented at Australian Institute of Judicial Administration, Melbourne, 1999.
AS Greenwald, What Can Be Done, What Should Be Done, and Who is Responsible, Industry and Federal Interactions in Developing and Applying New Technology for Orthopaedics, Section V, Surveillance Issues, American Academy of Orthopaedic Surgeons, 1998.
J Kellam & M Kearney, Product Liability – A Decade of Change, presented at the Butterworths CLE Seminar, 8th March 2001.
P McClellan J, The Recent Experience of the Land and Environment Court, paper delivered to the 22nd AIJA Annual Conference, Sydney, 18th September 2004.
MD Rockville, Managing the Risks from Medical Product Use: Creating a Risk of Management Framework, Food and Drug Administration Task Force on Risk Management, May 1999.
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Justice G Samuels, Medical Truth Legal Proof, oration to the Australian Medical Association (NSW), 1997.
R Sheridan, UK and Nordic Post-Marketing Surveillance and Vigilance, presented at the 10th Annual ABHI Conference, London, 1st July 2002.
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K Smith, Risk Management for Medical Devices, presentation to the Department of Medical Physics, Royal Perth Hospital, 25th May 2004.
Hon Justice TH Smith, Evidence Act 1995 - An Overview, paper presented at the College of Law, University of Sydney, 8th April 1995.
Y Stefani, Zirconia Femoral Head Recall –Update, paper presented at the Combined Meeting of the Australian & New Zealand Orthopaedic Associations, Queenstown, New Zealand, 11th October 2001.
W Tipton, MD Executive Vice-President of the American Academy of Orthopaedic Surgeons, address to the 8th Annual Conference on CME Provider Industry Collaboration, Florida, October 5-8, 1997.
C Weijer, The Analysis of Risks and Potential Benefits in Research, NCEHR Communiqué, Vol 9.2 & 10.1, Summer-Fall, 1999 - based on a talk at the NCEHR York University Regional Workshop, 13th March 1999.
C Whitewood & A Cop, Damage of an Oxinium Femoral Head associated with Hip Arthroplasty Dislocation, paper presented at the 33rd Scientific Meeting of the Australian Orthopaedic Association (Western Australia – Regional Branch), AGM, Perth, 11th September 2004.
Justice M Wilson, The New Expert Witness Rules, breakfast address to the Australian Insurance Law Association, 28th October 2004.
J Wood, Forensic Sciences From the Judicial Perspective, Australia and New Zealand Forensic Sciences Society International Symposium on the Forensic Sciences, 13-17 May 2002.
Justice Wood, The Expert Witness – The New Era, 8th Greek Australian International Legal and Medical Conference, June 2001. PERSONAL COMMUNICATIONS
Chapter 2 - The Magnitude of Therapeutic Goods Failure
Lisa Ingerson, Australian Orthopaedic Association National Joint Replacement Register, Adelaide, 16th October 2003.
Nepean Hospital Doctor (name withheld), 1st March 2002.
Professor E Sherry, Snr Lecturer in Orthopaedic Surgery, University of Sydney, 15th February 2003.
Professor S Graves, Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, 5th February 2003.
Waverley Hospital Doctor, (name withheld), 1st March 2002.
CHAPTER 3 – Product Liability in Australia
M Flood, Therapeutic Goods Administration, 10th November 2002.
CHAPTER 4 - The Evolution of the Surgical Implant
J Harrison, President, Australian Orthopaedic Association, Adelaide, 2nd April 2005.
T Jones, Royal Perth Hospital (Dept Biomedical Engineering and Medical Physics), Perth, 12th August 2004.
CHAPTER 6 - The Evolution of the Surgical Implant
W Turner, Orthopaedic Surgeon and Lawyer, Hobart, 12th December 2001.
CHAPTER 8 – The Expert Witness
A Edelston, Senior Paediatrician, Sir James Paget Hospital, Great Yarmouth, United Kingdom, 8th July 2005. INTERNATIONAL AND AUSTRALIAN STANDARDS
European Standards: EN 540; 1994 EC Harmonised Standard. EN/ISO 15225
International Standards: ISO 14155: 1996 International Standard. ISO 13485 Quality Management Systems - Medical Devices Systemic Requirements for Regulatory Purposes. ISO 13485:1996 and ISO 13488:1996 (Quality Management Standards) ISO 9001/2:1994 this has been revised and superseded by ISO 9001:2000.
The Australian & New Zealand Standard: AS/NZS 2817:1997
NEWSPAPER ARTICLES AND MEDIA PRESENTATIONS
258 baby deaths are to be reviewed, Weekly Telegraph (United Kingdom), January 2004.
A Conversation With Robert Fenichel: Calculating Safety in the Risky World of Drugs, New York Times (USA), 6th Marcy 2001, D1.
Arthritis Drug Linked to Thousands of Fatal Strokes and Heart Attacks, Sydney Morning Herald, 20-21 November, 2004, News 3.
Class-action Settlement Reached in InterOp Law Suit, Orthopedics Today, (Australia) July 2002.
Crawford v. Board of Governors of Charing Cross Hospital, The Times (London), 8th December 1953.
Darby & Co Ltd v. Weldon, The Times (London), 9th November 1999.
Demand for tougher rules over body implants, The Sydney Morning Herald (Sydney),18th August 2001.
Details of Implant Settlements Announced by Federal Judge, New York Times (USA), 16th April 1994, A16.
Doctors Face Tough New Licence Rules, The Age (Melbourne), 5th of April 2000.
Dow Corning Employees Fabricated Data on Breast Implants Council Concludes, Wall Street Journal (USA), 3rd of November 1992, A3, cited by Marcia Angell.
Expert Evidence and Causation, The "Hired Gun", Lawyers Weekly (NSW), 17th October 2003, 1&6. Expert Overhaul on the Horizon, Lawyers Weekly (NSW), 17th October 2003.
Faulty pacemaker leaves life on hold, The Age (Melbourne), 2 August 2000.
FDA Grants Pre-market Approval for Trident Ceramic Acetabular Insert, Orthopaedics Today, (Australia), 20th March 2003.
Feud in Implant Settlements Stir Debate Over Tatics, Washington Post (USA), 11th May 1994, D1.
GMC strikes off Meadow of “abusing position” in cot death trials, The Daily Telegraph (UK), 16th July 2005, 11.
House of Representatives, Hansard, 29th March 2001, 22261.
International Best Practice, TGA News, October 2001, Issue 36.
Jury Awards US$7.3 million in Implant Case, San Francisco Chronicle (USA), 14th December 1991, A13, cited by Marcia Angell.
“Keeping up to Date” – New Techniques, Australasian College of Surgeons Surgical News, October 2004, 7.
Maker Quits Implant Market, Boston Globe (USA) 1st March 1992, cited by Marcia Angell.
Making Science Patently Obvious, The Weekend Australian (Australia) 31st January/1st February 2004, 4.
Media Release by Alan Griffin MP, 18th August 2001.
“Medical Devices” – A New Approach to Regulation – General Information, TGA Press Release, 24th May 2002.
Miscarriages of Justice, Sevenoaks Coronet (United Kingdom) 1989, 392.
Mouths for Hire, The Sydney Morning Herald (Sydney, Australia), 6th September, 2004, 11.
No Reason to Whine – Chemists Get Secret Gifts, Daily Telegraph (Australia), 13th April 2004, 2.
Object: Prostheses Mammaires Implantables, Journal Officiel de la Republique Francaise (France), 17th May 1995.
Pacemaker alert sparks hunt for recipients, The Courier-Mail, (Brisbane), 8th June 2000.
Parents Will Not Get Their Children Back, The Weekly Telegraph (United Kingdom), January 2004, Issue 652, 2. Patients Sue over Faulty Pacemaker, The Australian Financial Review (Australia), 7th August 2000.
Press Release: Federal Parliamentary Secretary for Health (Trish Worth) 28th April 2003.
Press Release: Medical Devices – A New Approach to Regulation – General Information, Commonwealth Department of Health & Aging, Therapeutic Goods Administration, 24 May 2002.
Press Release: New Product Liability Law, Australian Product Liability Reporter, 13 May 1991.
Product Liability Law Suits raised Questions about CME vs Promotion, AM News, (USA), 12th May 1997.
Snub from mother cleared of killing sons, The Daily Mail (London), 21st November 2004, 1.
TGA recalls potentially defective replacement hips, TGA Press Release, media contact: Kay McNiece 0412 132 585, 16th August 2001.
The beat her pacemaker-maker skipped, The Sydney Morning Herald (Sydney), 5th August 2005, News 5.
The Concepts of Risk and of Serious Risk, The Australian – Weekend Health (Australia), 24th-25th January 2004.
The Health Report, Radio National (Western Australia), 6th September 2004, 8.30am.
The US$4.3bn Mistake, Wall Street Journal (USA), 17th June 1994, A14.
Tighter Rules Sought on Faulty Hip Joints, BBC News (Health Sunday), (United Kingdom), 1 July 2001, 23:02pm GMT/0002am UK.
Tricks of the Trade, Australian Doctor (Australia) 2001, 31-35.
Women’s Breast Implants Suit Started the Dominos, Idaho Statesman (USA), 14th March 1992, cited by Marcia Angell.
CHAPTER 1
INTRODUCTION INTRODUCTION
1.1 This thesis explores some of those more important issues of product liability as they relate to implantable surgical devices. The endeavour has been undertaken with an outlook that is mostly with the perspective of a surgeon who has more than a passing interest in
engineering1. The completed body of work though is presented to a University Faculty that is not Medicine, is not Engineering, but is Law. At first, the reader might identify a conundrum in this that can be cause for some bafflement if nothing else. I am confident that it is appropriate at the outset to emphasise that this body of work is concerned with matters that are both medical and engineering that present in and impact on an environment that is law. It is natural that the language of the work is very much medical, and at times engineering, but this should not detract from the major implications of the research that are, at their heart, very much matters or issues of law.
1.2 It is appropriate also at this earliest practicable opportunity to alert the reader to the circumstances and to the reasons that are the genesis for this research thesis.
1.3 The past five or six decades have witnessed a most remarkable advance with respect to the development of therapeutic drugs and devices. Though there are still many diseases and disorders that cannot be cured or at least controlled the fact should not be ignored that the number of recalcitrant diseases, disorders and post-traumatic conditions is becoming less year by year. Even a short life has seen the eradication of diseases such as smallpox and poliomyelitis and there are today only a few dysfunctional body parts that cannot be replaced by transplanted organs or by man made prosthetic implantable surgical devices. Unfortunately though, beneath all this progress that
1 The author qualified MBBS at London University in 1967. Post graduate training included training as a general surgeon and as an orthopaedic surgeon with qualifications that included Fellowship of the Royal College of Surgeons of Edinburgh (General Surgery) in 1973 and Fellowship of the Royal Australasian College of Surgeons (Orthopaedic Surgery) in 1977. Engineering studies were first commenced at the University of NSW in 1977 and a Master of Engineering (Mechanical Engineering by Research) was achieved at the University of Sydney in 1990. The award of Fellow of the Institution of Engineers of Australia
1.1 is good, there is a dark side that can be found, the nature of which can be identified by a number of rhetorical questions that include –
(a) How can it be that the arthritis drug Vioxx2 was only withdrawn from the marketplace by the manufacturers
(Merck) on 30 September 20043 when almost four years
earlier Swiss researchers4 from the University of Berne5 reported in the Lancet that the incidence of myocardial infarction (heart attack) was twice (x2) as frequent (compared to the usually expected rate) in those taking the drug? The research conducted at the University of Berne included a meta-analysis of 29 published studies where the results, known in the year 2000, demonstrated the significant risk of severe cardiovascular adverse events to the users of the drug. The authors of the
study6 concluded –
“Our findings indicate that Rofecoxib should have been withdrawn several years earlier. The reasons why the manufacturers and the drug licensing authorities did not continuously monitor and summarise the accumulated evidence needs to be clarified.”
It can be estimated that more than 80 million patients were treated with Vioxx during the period 2000-2004 and that the sales revenue to Merck was US$2.5bn during the same period of time. The editor of the
Lancet, Dr Richard Horton,7 reflected that -
was achieved in the same year. The author is currently a visiting Professor at the Graduate School of Biomedical Engineering at the University of NSW. 2 Vioxx, or Rofecoxib, is a Cox-2 inhibitor drug that is used for the treatment of painful degenerative arthritic joint condition. 3 Vioxx was withdrawn by the Therapeutic Goods Administration in Australia on 1 Oct 2004 (recall reference R2004/1226-9). 4 See P Jüni, L Nartey, S Reichenbach, R Sterchi, P Dieppe, & M Egger, “Risk of Cardiovascular Events and Refocoxib: Accumulative Meta-analysis” (2004) 364 (9449) Lancet, 4999. The article was published in the Lancet on-line edition on 5 November 2004. The article is critical of both the manufacturers and the US Food and Drug administration with respect to their conduct in this matter. 5 Institute of Social and Preventative Medicine and Rheumatology Clinic, University of Berne. Finkelhubelweg 11, CH-3012, Berne, Switzerland (Tel. 41(0)31 631 33 78). 6 See vide supra n.4. 7 See R Horton, “Vioxx, The Implosion of Merck, and Aftershocks at the FDA”, (2004) 364 (9449) Lancet, 4999. In issue 9442 [at page 1287] of the same volume of the Lancet Vioxx is described as representing “An unequal partnership between safety and efficacy.” 1.2 “The licensing [by the American Food and Drug Administration (FDA)] of Vioxx and its continuous use in the face of unambiguous evidence of harm have been public health catastrophes.”
One of the most significant issues embraced by the Vioxx recall is that it is a contemporary event and that it is second only, in magnitude, to the recall of Pan Pharmaceutical complimentary medicine products in 2003. The Therapeutic Goods Administration (TGA) recalled all batches of medicines manufactured by Pan Pharmaceuticals after 1 May 2002 and as at May 2003, 1546 products had been recalled and a further 1650 export only medicines had been cancelled from the Australian Register of Therapeutic Goods.
(b) Why did it require nearly 200,0008 women to sue AH
Robins Co, the manufacturer of the Dalkon Shield9 intra-uterine contraceptive device before the defective device was withdrawn from the marketplace? A considerable number of Dalkon Shield users suffered unacceptable events of pelvic infection, septic abortions, and a variety of other pelvic diseases that on many occasions required surgical removal of the
uterus.10
(c) How can it be that an orthopaedic hip replacement surgical implant device is not withdrawn from the marketplace until at least 17,500 patients have
8 The Sydney Law Firm Maurice Blackburn Cashman represented more than 3000 Australian claimants who had suffered significant complications following the use of the Dalkon Shield device. See also D Hensler and M Peterson, “Understanding Mass Person Litigation: A Socio-Legal Analysis”, (1993) 59 (3) Brooklyn Law Review, 961-1063. 9 Richard B Sobol, Bending The Law: The Story of the Dalkon Shield Bankruptcy (1991) 408. 10 Hysterectomy. 1.3 undergone surgical replacement of their diseased hip
joint with the device?11
(d) How can it be that an estimated 1 million to 2.5 million American women had already undergone breast augmentation surgery using silicone-gel-filled breast implants by the time the FDA Commissioner had decided, in 1992, to ban the use of the implants? Silicone-gel-filled breast implants had been withdrawn following the allegation that the implant device was cause for the development of a debilitating autoimmune
connective tissue disorder.12 One claimant, Mary
Hopkins, was awarded US$7.34m.13 The silicon-gel- filled breast implant litigation, does, even to the present time, reflect the considerable tension that exists between medical science and law. There is still no sound evidence that there is a causal nexus between the surgical implantation of silicone-gel-filled breast implants and the development of connective tissue
disorders.14
(e) What is the nature of the events that are cause for a manufacturer of a therapeutic good to be fined for
excessive hospitality to medical practitioners?15 In a legal test case, Merck Sharp & Dohme became the first pharmaceutical company in the Netherlands to be prosecuted for entertaining doctors excessively, contrary to the Dutch Marketing Code for Prescription-
11 DF Craviotto, “Dissemination of Information, among Orthopaedic Surgeons, Regarding Early Failure of Total Joint Implants”, (2001) 83A (10) JBJS, 1580-81. 12 D Kessler, “The Basis for the FDA’s Decision on Breast Implants”, (1992) 326 New Eng J Med, 1713-15. 13 Mariann Hopkins v Dow Corning Corp 33F 3d 1116 1994; see also W Carlsen, “Jury Awards US$7.3 million in Implant Case”, The San Francisco Chronicle (USA), 14 Dec 1991, A13. 14 C Coope and E Dennison, “Do Silicone Breast Implants cause Connective Tissue Disease? There is still no clear evidence that they do” (1998) 316 BMJ, 403-04: see also J Sanchez-Guerrero and MH Liang, “Silicone Breast Implants & Connective Tissue Diseases. No Association has been Convincingly Established” (1994) 309 BMJ, 822-23. 15 T Sheldon, “Drug Company Fined for Excessive Hospitality” (2001) 322 BMJ 382. The company was fined AUS$67,500 for providing excessive hospitality. When the company organised dry ski slope and go-kart contests in Holland and in Belgium and other entertainment that included shrimp fishing, dinner dances, and outings to the musical “Chicago” and the “North Sea Jazz Festival”. 1.4 Only Drugs. In a separate case, in the Netherlands, 15 medical practitioners were required to appear in court for refusing to pay fines for accepting excessive
hospitality.16
(f) How can it be possible in government funded health care services for manufacturers to be able to offer
inducements to surgeons to use their prostheses17 and for the relationship between medical practitioners and the manufacturers of therapeutic goods to be described as
being18 –
“Twisted together like a snake and a staff and tangled in a web of interaction as controversial as they are ubiquitous”
(g) What are the circumstances that make it possible for a manufacturer of therapeutic goods to prevent the publication of the results of a clinical trial that proved to
be unfavourable in relation to one of its products19 and are such circumstances nothing less than an endeavour to violate academic freedom?
(h) Why is it that a dramatic difference can be identified in the outcomes between commercially and self-funded
results regarding joint replacement procedures?20 The
Ezzet21 Report identified that 75% of all clinical hip replacement series were commercially funded in the
16 T Sheldon, “Doctors fined for Accepting Excessive Hospitality” (2002) 325 BMJ, 511. These medical practitioners were entertained by the German Pharmaceutical Company Boehringer-Ingelheim at a motor vehicle anti-skid course. 17 Z Kmietowicz, “Companies offer Surgeons incentive to use their Prostheses”, (2004) 329 (1085) BMJ, 1091. It can be calculated that in the United Kingdom (National Health Service) 10% (one in two) of consultants have accepted incentives from manufacturers of hip prostheses and two-third (2/3) of cases the offers, usually travel and training, are not properly recorded or appropriately approved. 18 R Moynihan, “Who Pays for the Pizza? Redefining the Relationship between Doctors and Drug Companies. 1: Entanglements”, (2003) 327 (7400) BMJ, 1189-92. 19 NF Olivieri et al, “The long term Safety and Effectiveness of Iron-Chelation Therapy with Deseriprone for Thalassaemia Major”, (1998) 339 (7) New Engl J Med, 417-23: see also D Spurgeon, “Report Clears Researcher Who Broke Drug Company Agreement”, (2001) 323 (1085) BMJ, 1085. Dr Olivieri was sued after she presented unfavourable results of a drug trial for which she had signed a Confidentiality Agreement. 20 KA Ezzet, et al, “The Prevalence of Commercial Funding in Adult Lower Extremity Orthopaedic Research and its Impact on the Reporting of Scientific Results”, presented at The American Academy of Orthopedic Surgeons, 70th Annual Meeting, New Orleans, Feb 2003. 21 See vide supra n.20. 1.5 USA. Among funded studies good results were reported in 96% and only 22% of the funded studies reported bad outcomes. In contrast 60% of the non funded studies had a bad or mediocre report.
(i) Where is the logic that determines that a government regulatory authority, the TGA, relies for the funding for
its existence from those that it regulates.22 Further, in the event that there is a surgically implantable device adverse event, that might be a product liability issue, why does the TGA only involve the manufacturer of the device in the post explantation examination of the
device to identify the reasons for its failure?23
1.4 All of the above (rhetorical) questions concern events and circumstances that reflect issues of product liability as they relate to therapeutic goods and particularly to implantable surgical devices. Implantable surgical devices are no less goods than patients are
consumers24 though the environment where the goods are consumed is
unique.25 These are some of the matters that are associated with any consideration of implantable surgical device product liability and the fact that such issues can be identified should be a cause for restlessness for some and even alarm for others. It is issues such as these that have stimulated the program of research that is this thesis.
1.5 This list of issues that are of considerable concern is not exhaustive. This thesis dissects these and other matters that I have considered to be important topics for inquiry in a time when consumers of therapeutic goods rightly expect, and should demand, that health care in general
22 In the post-Thalidomide era funding of the TGA was based on a method of funding that reflected the view that a government regulatory authority should be seen to be “entirely independent” of any commercial interests of the industry that it regulated and could then be seen to be able to act only behalf of the public interest. In this sentiment the TGA was initially funded from the health care budget. However from 1 July 1998 the TGA has been required by the Commonwealth Government to recover fully all operating costs for all activities that fall within the scope of the Therapeutic Goods Act 1989 (Cth) (TGAct). 23 Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014. 24 Courtney v Medtel Pty Ltd [2003] FCA 36; BC 200300120. Here for the first time patients are defined as consumers. 25 The milieu interne of the human body is unique for many reasons, not the least being for the hostile nature of the environment that is associated with the protective inflammatory response whose function is to eliminate from the body environment any living or inanimate material from the body. 1.6 and implant surgery in particular is based on safety and efficacy that is seen to stand on a sound foundation of Australian Commonwealth Government regulatory control and the altruism of all of the stakeholders concerned with the manufacturer and with the use of the implantable surgical device.
1.6 In Chapter 2, The Magnitude of Therapeutic Goods Failure, I have reviewed the [massive] dimensions of therapeutic drug and implantable surgical device failure. This chapter does concentrate on those adverse events that are associated with surgically implantable devices as distinct from therapeutic drugs. However the Thalidomide drug case is reviewed in some detail as it was this case that stimulated the considerable legal reform, particularly in the United Kingdom, of
legislation concerned with consumer protection.26
1.7 Chapter 3, Product Liability in Australia, reviews that amalgam of Australian law that is concerned not only with consumer protection but also with that legislation that relates to Tort and to Contract law. In Australia, there is in no sense a Product Liability Law but rather there is, like the dentist’s amalgam, a mix of ingredients. This chapter reviews those ingredients that include the Trade Practices Act 1967 (Cth) (TPA), and the Therapeutic Goods Act 1989 (Cth) (TGAct), and reviews the current regulatory system for Therapeutic Devices [as distinct from pharmaceutical products] and the roles of the TGA and of the Australian Competition and Consumer Commission (ACCC). In this chapter there is a particular focus on the intent of the current regulatory system and of the impact of current legislation on manufacturers and on other health care providers. This chapter also draws on the experience of recent Australian Case Law that has, in the author’s view, the potential to increase the momentum of the regulation of surgically implantable devices - notably the cases of
Courtney v Medtel Pty Ltd27 and Carey-Hazell v Getz Bros & Co (Aust)
26 In the United Kingdom The Medicines Act 1968 (UK) and The Congenital Disabilities (Civil Liability) Act 1977 (UK) were a direct consequence of the Thalidomide Case. 27 See vide supra n.24. 1.7 Pty Ltd. 28 Within the fabric of this chapter there is also the personal view that the Courtney case is a benchmark case that has the potential to influence any future surgically implantable device related debate in
a way that may be as significant as has been Donoghue v Stevenson.29
1.8 In Chapter 4, The Evolution of the Surgical Implant, will be found a general review of those steps or links that are the evolutionary process of the surgically implantable device from the time of its inception to that end point that is associated either with the failure of the device, device explantation and replacement, or with the death of the consumer (patient). This chapter also examines the Principle of Beneficence that is concerned with the balance between risk, harm and benefit and the level of risk of harm that the community will accept in return for any health care related advance that is associated with the perception of benefit and with an improved quality of life. This chapter also investigates that frequently delicate and fragile relationship that can exist between manufacturers and Medical Practitioners and Clinical Researchers. These partnerships in clinical research can have the potential to be a cause for bias and a conflict of interest in the context of the relationship between doctors and patients and it is particularly for this reason that the undertaking of clinical trials is exposed to considerable discussion.
1.9 In Chapter 5, The Medical and Legal Definitions of Adverse Events and Injury, and of Defective Goods and Defects, in the Context of the Surgically Implanted Device, there is an endeavour to clarify those definitions that are so particularly important in any consideration of any unwanted or unexpected event that can be causally considered to have a nexus with the implanted surgical device. It is apparent that in medicine and in law there is no constant theme of clarity, nor any general agreement, as to the definition of what is to be understood by
the terms adverse event or injury.30 The definition of injury is, though,
28 See vide supra n.23. 29 Donoghue v. Stevenson [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85,458. 30 In both medicine and law the term injury, when applied in the context of personal injury, is understood to be that condition that is associated with the suffering of harm that might be associated with a new pathological condition or be associated with the 1.8 a little clearer than is the definition of the adverse event. There is only marginally more concordance with regard to the definitions of that condition, or state, that can be described as being defective or as being associated with the presence of a defect. I have a view that the definition of the adverse event, injury, defective goods, and defects is a significant area for discussion as I have found no good reason to form the conclusion that the generally accepted legal [and even medical] definitions of these terms is entirely appropriate to the consideration of any issue of product liability that concerns any allegation that an implanted surgical device might be defective (or at risk of being so). This chapter also brings into focus the logic that ordains that any terminology that is acceptable should have attracted the consideration of those factors that are unique to the performance of a product in the unique milieu interne of the human body. Here the environment is
generally hostile to the presence of foreign material.31 It is this that is probably the cause for the generally accepted definitions of adverse event, injury, defective good and defect to not always be the most appropriate to each individual surgical circumstance.
1.10 Chapter 6, Implantable Surgical Device Manufacturers’ Defences to Liability, provides a general overview of those defences, both statutory and others, that can be available to the manufacturer when responding
to a claim. Though Part VA of the TPA imposes strict liability32 on
manufacturers33, that liability is not absolute. There are a number of limited defences that can be available to the manufacturers of surgical implants. These defences can lessen, or defeat the liability to compensate patients, who as consumers, have suffered injury or
damage that can be shown to have been caused by a defective34
aggravation, acceleration, exacerbation or deterioration of a pre-existing, or co-existing physical or psychological condition. The concept of personal injury requires the injury to be personal and this means that the injury must involve injury to some part of the body as distinct from injury to other persons or to property. Implicit in this definition is the understanding that the surgical procedure can, if associated with the cause of harm, be injurious. 31 This hostility is the consequence of the inflammatory response that is the body’s defence mechanism to the presence of materials, both living and non-living, that are foreign and potentially harmful. 32 Liability under Pt VA of the TPA is set out in s.75AK(1). 33 See TPA s.75B – a manufacturer also includes a deemed manufacturer by reason of s.74A(4). 34 See TPA s.75AC for the meaning of goods having a defect. See also s.75AD that provides a remedy where a person suffers injury as a result of defective goods supplied by a manufacturer. Generally though the interpretation of what is a defect is considered in ACCC v. Glendale Products Pty Ltd [1998] ATPR 41 6-32; [1999] ATPR 41-672 and in Cook v. Pasminco (2000) ATPR 41-767. The author’s interpretation of what constitutes a defect and what is considered to be defective is considered in more detail in Ch 5. 1.9 surgically implanted device. The structure of this review of those defences that are generally available to manufacturers has been tailored to be more appropriate to the concerns of surgical device manufacturers as distinct from the concerns of those manufacturers of general consumer goods.
1.11 Chapter 7, The Learned Intermediary, The Delicate Balance Between a Defence and the Duty to Warn and To Educate, recognises and discusses those three principal roles that are the sphere of influence of the learned intermediary, who, through the possession of qualifications, knowledge and experience can become the interface between manufacturers and consumers, between surgeons and consumers, and between manufacturers and surgeons. It is arguable that the concept of the learned intermediary is one of the most cardinal aspects of any debate that concerns the relationship between patients, surgeons and manufacturers when there are issues of exposure to liability that may be associated with the failure or risk of failure of the surgically implanted device. The role of the learned intermediary is one that includes among other things the learned intermediary
defence.35 I have a view that the Concept of the Learned Intermediary embraces, not only a defence for a manufacturer, but includes also a role that is pivotal to any debate of the Doctrine of Informed Consent or to any debate of the role, obligations and responsibilities of those that are concerned with the transfer of knowledge in general and with
continuing education programs in particular.36 The emphasis of this chapter is not only on the well known legal principles of the Learned Intermediary Concept, rule and defence but looks also to investigate the Doctrine of Informed Consent as it applies both to surgeons and to manufacturers and to that particularly interesting issue which concerns those organisations that undertake to transfer and to improve knowledge under the cloak of Continuing Medical Education (CME).
35 See E Beerworth, Product Liability Australia (2001) Vol 2, 36,019-36,021. The learned intermediary defence, its meaning, and the circumstances in which the defence is available is described. The learned intermediary defence has not, in Australian Courts, in contrast to North American Courts, so far been widely considered. However the learned intermediary defence is available in claims based in negligence and pursuant to strict product liability legislation.
1.10 It is very apparent that CME (and probably also Continuing Legal Education) activities are obligatory for members of the medical profession (and for the legal profession) for their personal registration to continue in the practice of their profession. Many of these activities involve seminars, conferences and workshops. Also a number of surgical specialities undertake CME activities that include trade shows. Frequently these activities are sponsored by manufacturers and on occasions the activities of learned associations are financially underwritten by manufacturers. At times CME events can appear to be overly commercial in nature. For this reason there is a potential for scientific speech to be interpreted as commercial speech and at risk of being deceptive and misleading. This is a relatively new and intriguing focus on the role of the learned intermediary and is one that has recently become apparent in that class action, in the USA, that concerned issues of product liability relating to the failure of spinal pedicle screw implant devices. In this chapter this class action is reviewed and it is permissible to form a conclusion that there is potential for such claims to have a considerable influence on the conduct of CME activities, on the enterprises of professional associations, colleges, and universities, and even on the conduct of undergraduate and postgraduate education.
1.12 In Chapter 8, The Expert Witness, there is discussion of the role of the expert witness and of the many consequences that can be created by expert witness evidence that includes not only evidence of fact but also of opinion. I have a view that the expert witness is second only to the learned intermediary with respect to the capacity to influence any debate of issues of product liability as might concern implantable surgical device related incidents. This chapter looks at the role of the expert witness in some detail and explores the considerable influence that can be turned on to the process of justice by the nature of expert opinion. There can be no doubt that the expert witness has the
36 These include paternal bodies, universities, craft groups, associations, hospitals and collegiate organisations who become concerned with continuing education activities that might also include workshops and conferences that are financially supported by manufacturers and distributors of implantable surgical devices. 1.11 potential to turn the law onto its head and the evidence for this is
littered with a multitude of cases from Chamberlain v The Queen37 in
Australia to R v. Clark38 in the United Kingdom. Though these cases do not decide product liability related issues they are relevant to any consideration of the influence of the expert witness. There is though the classic product liability case that balanced on expert witness testimony that was the silicone-gel-filled breast implant case. This case did particularly identify the tension that can exist between legal evidence and scientific fact and it does remain the case that there is still no reliable scientific evidence that can link silicone breast implants, in a causal sense, with connective tissue disease. This chapter also reviews the efforts of many that are directed towards the reform of the role of and the use of expert witnesses. It is argued that reform is particularly desirable where issues of implantable surgical device product liability are debated across the boundary between those two very different specialities, medicine and engineering, in an environment that is law.
1.13 Chapter 9, Regulation and Reporting, discusses that major identifiable weakness of the regulation of implantable surgical devices, and of the maintenance of safety and efficacy, that is in large part associated with the sometime impotence of the regulatory authority (in Australia, the TGA) and with a regulatory environment that demonstrates no satisfactory methodology for the tracking of implanted surgical devices in general, nor for the identification of device related adverse events in particular. It remains worrying that, in spite of considerable regulatory reform to the TGAct there is still no satisfactory system in place that will ensure that the reporting of adverse events will occur at the earliest opportunity after the event is recognised. The reporting of adverse surgical events in Australia remains woefully inadequate and is cause to attract a discussion of those remedial measures that might provide for significant improvements to the recognition and reporting of those
37 Chamberlain v. The Queen (1983) 72 FLR 1 and Chamberlain v. The Queen [No 2] (1984) 153 CLR 521. 38. See R v. Clark (No.1) (2000) EWCA Crim 54 and R v. Clark (No.2) (2003) EWCA Crim 1020. See also C and J Bacon, “The Case of Sally Clark” (2003) 96 (3) J Roy Soc Med, 105. 1.12 surgically implantable device related incidents that should be made known to the regulatory authority, manufacturers, medical practitioners, and to other stakeholders, including consumers. This chapter also discusses that balance between regulation and reporting that is frequently, for understandable reasons, viewed with suspicion by almost all of the stakeholders. Whether regulation should be imposed by government or be by choice and whether reporting of adverse events should be mandatory or voluntary (or a mix of both) is also debated in this chapter.
1.14 The final chapter of this thesis, Chapter 10, Conclusions and Recommendations, summarises those major conclusions that are derived from the distillation of this debate of implantable surgical device product liability issues. In the distillate there are recommendations that are presented for the consideration of any reader.
1.13 CHAPTER 2
THE MAGNITUDE
of
THERAPEUTIC GOODS FAILURE
INTRODUCTION
2.1 Drug and surgical device product liability issues have been, and will continue to be a fertile cause for debate for both Legal and Medical Practitioners. The purpose of this chapter is to draw the reader's attention to the magnitude of therapeutic device failure that is generally not so well known but should be cause for considerable concern. It can be both interesting and instructive to review and to examine some of the history of those more notable incidents of surgically implantable therapeutic device failure. An appreciation of the history permits the exposure of a burden on society that is massive by any standards. It is a burden that is both fiscal and personal.
2.2 No examination of drug and medical device product liability history should
ignore the tragedy of The Thalidomide Case.1 Though this research is primarily directed to a consideration of the failed implanted surgical device, it can be both instructive and illuminating to consider this drug-related
event, as it was Thalidomide2 the infamous product, that first alerted
consumers to the potential hazards of medical products3 and as a consequence, has both encouraged and driven the debate of the notion that companies that have researched, developed, and marketed therapeutic products, both drugs and devices, should be made accountable, and indeed,
liable for any injury that their products might cause.4 The outcome of The Thalidomide Case was that the regulatory control of medical products,
1 S & Anor v The Distillers Co (Biochemicals) Ltd; J & Anor v The Distillers Co (Biochemicals) Ltd [1969] 3 All ER 1412, [1970] 1 WLR 114. The Drug Thalidomide was first marketed in the United Kingdom in 1958 and prescribed for the treatment of morning sickness. Thalidomide was withdrawn from the marketplace in December 1961 following the identification of teratogenic abnormalities (embryo damage) if used during the 5th to 8th week period of pregnancy. Writs were issued on behalf of (approximately) 60 deformed infants and their parents. The issue of liability was settled, on the basis that the Defendant would pay 40% of the appropriate figure for damages. See also H Teff and C Munro, Thalidomide; The Legal Aftermath, (1976) 5. It is interesting that Thalidomide remains the drug of choice for the treatment of some forms of recurrent leprosy. The Therapeutic Goods Administration has recently approved the use of Thalidomide for the treatment of bone-marrow cancer, multiple myeloma and leprosy. Australia and the USA remain the only nations to re-approve the drug. In Australia about 2000 people will now be able to have Thalidomide subject to strict contraception and pregnancy rules on patients and partners. However the drug may not be included on the Pharmaceutical Benefits Schedule (PBS). For further information see Editorial, “News” (2003) 15 (20) Australian Medicine, 6. 2 For further reading see PR Ferguson, “Pharmaceutical Product Liability. Thirty Years of Law Reform?” (1993) Judicial Review, 226-241. See also Pamela R Ferguson, Drug Injuries and the Pursuit of Compensation (1996) ch 10. Pamela Ferguson is a member of the Department of Law at the University of Dundee. 3 These products include both therapeutic drugs and devices. 4 See I Dodd-Smith & M Spencer, “Product Liability for Medicinal Products” in M Powers and N Harris (eds), (2000) Clinical Negligence, 835-889. In Ch 25, “Product Liability for Medicinal Products,” Dodd-Smith and Spencer discuss in detail the Thalidomide Case and its consequences. 2.1 including drugs and (surgical) devices was broadened to embrace almost
every aspect of the manufacturing and marketing of therapeutic goods.5
2.3 The Thalidomide Case might be no less interesting but for the Australian
connection.6 Forty years ago, Sydney Gynaecologist, Dr William McBride was the first clinician researcher in the world to discover the link between Thalidomide use in mothers and birth defects in their offspring. Unfortunately Dr McBride’s celebrated career took a downturn when he was
found to have falsified data in an article on Debendox, in 1992.7
2.4 Dodd-Smith and Spencer8 have reported Pamela Ferguson's disturbing description of The Thalidomide Case and it is appropriate to review that
account9 of those events that took place. The reader's attention is particularly drawn to Ferguson's observations with respect to the marketing, in Britain, of the drug Thalidomide by the manufacturers, Distillers Co (Biochemicals) Ltd:
Pamela R Ferguson Drug Injuries and the Pursuit of Compensation
(1996)
2. Infamous Products
Some pharmaceutical products which have been marketed in Britain and/or the United States of America have become notorious. These include Thalidomide, … (my edit)
A. Thalidomide
Thalidomide, which led to “the greatest drug tragedy of our time” (‘The Thalidomide Children and the Law’) report by the Sunday Times (London, Andre Deutsch, 1973, Preface p 7) was discovered in 1953 by Ciba, a West German pharmaceutical company.
5 In the United Kingdom the Medicines Act 1968 (UK) was a direct consequence of the Thalidomide Case. Further important consequences included the establishment of the Dunlop Committee on the Safety of Medicines (established under the Medicines Act 1968 (UK)) and The Congenital Disabilities (Civil Liability) Act 1976 (UK) that extended the duty of care of manufacturers (even) to the unborn child. 6 WG McBride, “Thalidomide and Congenital Abnormalities” (1961) 2 Lancet, 1358 . 7 Debendox was withdrawn after claims by William McBride that the drug could cause deformities in the children of those women to whom it was administered An enquiry by the NSW Medical Tribunal later concluded that McBride claimed statistically significant results where none existed. McBride was found guilty of scientific fraud for falsifying data in his 1982 study. McBride has been reported as saying that he altered his data in "the long-term interests of humanity". For further reading see M Ragg, “Australia: McBride guilty of scientific fraud” (1993) 550 Lancet, 341, and N Swan, “Australian Doctor Admits Fraud” (1991) 302 BMJ, 1421. 8 See vide supra n.4, at 1595. 9 Cited by I Kennedy and A Grubb (eds), Product Liabitility (3rd ed, 2000) 1595. 2.2 Preliminary animal tests indicated that the drug had little pharmacological effect, so the company did not continue with its development. Thereafter, Chemie Gruenenthal, also a German company, marketed the drug as a sedative and allowed other companies to produce and sell Thalidomide using their own brand names. It has been estimated that over one million people in West Germany took this sedative per day. The first report of suspected damage to the foetus was published in that country in 1961. The most notorious of the injuries caused by Thalidomide are “phocomely” and “amely” (incomplete development, and absence of the limbs). A study conducted in the 1940s had found one case of shortened or missing limbs in four million births. During the 1960s Thalidomide had been taken by so many women that virtually every paediatric clinic in Germany had at least one child born in this way (Teff & Munro “Thalidomide: The Legal Aftermath”, Farnborough, Hants, Saxom House, 1976 p 5); in Hamburg alone there were 50 phocomelia births in one year.
Thalidomide was marketed in Britain by Distillers Co (Biochemicals) Ltd as a treatment for morning-sickness. Distillers advertised the drug as one which could “be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child” (my emphasis) (Dworkin, ‘Pearson: Implications for Severely – Handicapped Children and Products Liability’, Part V, Chap 3, in Allen, Bourne & Holyoak, ‘Accident Compensation after Pearson’ (1979)). In December 1961 a British doctor wrote to The Lancet, noting that there appeared to be an increasing number of limb malformations in children whose mothers have been taking Thalidomide during pregnancy (McBride, ‘Thalidomide & Congenital Abnormalities’ (1961) The Lancet, p 1358).
Of the 430 British children who were injured by Thalidomide, 62 of them attempted to sue Distillers. An out of court settlement was reached in 1968 but a second legal action was started in 1971. This resulted in a lump some of £3.5 million being offered to all the claimants by the company. Public pressure forced Distillers to increase this, ultimately to £20 million. Most of this money was placed in a trust fund. It is expected that this fund will be exhausted within the next 15 years and the Thalidomide victims, many of whom now have their own families, have recently succeeded in persuading Guinness, Distillers’ successor company, to provide more compensation.
The Thalidomide Case was legally considered and debated on the question of negligence; the question being – was the Distillers Company negligent in its researching, testing and marketing of the drug? It was necessary for the
2.3 claimants to show that Distillers knew or could have known about the side effects of Thalidomide using the standards of a reasonable manufacturer at that time, i.e. in the 1950s and the 1960s. However, there was then no requirement for formal testing of medical products. The most significant outcome of The Thalidomide Case was not the agreed settlement but rather
an outcome that caused there to be considerable legislative change.10
IMPLANTED SURGICAL DEVICE FAILURE
2.5 Probably the most well known surgical device product liability issue has
been that associated with the use of silicone-gel-filled breast implants.11
This important case will be considered in some detail.12 Many observers
view this case as a massive example of a legal and regulatory failure13 that was the consequence of the Court's and of the American Food and Drug
Administration's (FDA)14 apparent reluctance to wait for reliable scientific
evidence before making decisions.15
2.6 It remains one of the most controversial aspects of this case that the scientific evidence to support an association between implanted silicone-gel-
filled breast implants and the occurrence of connective tissue disease16 did later, subsequent to the judgement of Courts and of the FDA, demonstrate (and confirm) the considerable tension that can exist between legal and
10 Vide supra n.5. 11 The term “silicone” refers to a family of chemically related organic silicon compounds derived from silica (SiO2). Silicone implants have been used for the replacement of finger and toe joints and small quantities of Silicone can be found in artificial heart valves, infant bottle teats, intraocular lens implants, testicular implants, penile implants, cerebro-spinal fluid shunt tubing and slow release hormone implants. The major use of the silicone compound, polydimethylsiloxane, has been in breast and other soft tissue augmentation implants, eg. calf implants. There are reports of wear debris from silastic finger joints being associated with enlargement of lymph nodes and malignant lymphoma. For further information see E Benjamin, A Ahmed, AT Rashid and DH Wright, “Silicone Lymphadenopathy: A Report of Two Cases, One with Concomitant Malignant Lymphoma” (1992) 5 Diag Histopathol, 133-41, and JM Digby, “Malignant Lymphoma with Intranodal Silicone Rubber Particles following Metacarpophalangeal Joint Replacements” (1982) 14 Hand, 326-28. There is also the interesting reported case of silicone expectoration after rupture of a silicone-gel-filled calf implant, see SE James, G Tarr, MS Butterworth, J McCarthy and PE Butler, “Silicone in the Sputum after Rupture of a Calf Implant” (2001) 94 J Roy Soc Med, 133-34. 12 For further information the reader is directed to that detailed, eloquent, and accurate review of the events associated with the use of Silicone-Gel-filled breast implants that can be found in Marcia Angell, Science On Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case (1st ed, 1997) 12. 13 See “The US$4.3B Mistake”, Wall Street Journal (US) 17 June 1994, A14; and “A Conversation With Robert Fenichel: Calculating Safety in the Risky World of Drugs”, New York Times (US), 6 March 2001, D1. 14 The American Food and Drug Administration (FDA) was established in 1931. However it was not until 1976 that the FDA was given power over medical devices. It was then that the Medical Advice Amendments to the Food, Drug and Cosmetic Act 1938 sought to provide reasonable assurance of safety and effectiveness for all devices. 15 See vide supra n.12 at 90-132. 16 Connective tissue disorders are those pathological conditions that affect tissues mostly comprised of the protein, collagen, e.g. skin and the tissue that binds the component parts of many organs together. The connective tissue disorders are inflammatory in nature and though their aetiology remains ill-understood they are thought to be autoimmune disorders. The autoimmune disorders are characterised by a reaction of the body's inflammatory defences to itself. 2.4 scientific evidence. I will elaborate on this aspect in more detail later in this Chapter.
2.7 Silicone-gel-filled breast implants were developed in 1962 and the devices were mostly used (80%) for cosmetic breast augmentation and also for the therapeutic reconstruction of the breast following the undertaking of surgical
mastectomy for the treatment of breast cancer.17 The use of the implants was subsequently recognised to be associated with a number of adverse events
that were mostly of an inflammatory18 nature.
2.8 The FDA scrutinized the use of silicone-gel-filled breast implants19 and by
the time the FDA Commissioner, David Kessler20, had decided, in 1992, to ban implants, an estimated 1 million to 2.5 million American women had
already undergone breast augmentation surgery using the implants.21
2.9 In his article, published in the New England Journal of Medicine,22 Kessler provided an explanation for his reasons for the ban. Kessler's article disclosed what was clearly an enormous public health problem. Unfortunately, in too many cases, in spite of Kessler's assurances that removal of the implants was unnecessary, women rushed to have the devices
removed.23
17 For a summary of the use of silicone-gel-filled breast implants see Editorial Report, “Silicone-Gel-Filled Breast Implants” (1992) 147 Canadian Medical Association Journal, 1141-46. 18 CSA Van Noonen et al., “Post Mammoplasty Connective Tissue Disease” (1982) 25 (6) Arthritis and Rheumatism, 694-97. In this article an Australian physician reported the occurrence of connective tissue disease in three women who had undergone implantation of silicone-gel-filled implants. See also J Sanchez-Guerrero, PH Schur, JS Sergent and MH Liang, “Silicone Breast Implants and Rheumatic Disease” (1994) 37 Arthritis and Rheumatism, 158-68. 19 Breast implant devices had been under the surveillance of the FDA only since 1976. This is of interest as the first report of a connective tissue disease after direct injection of silicone into the breast dates from 1964 - see K Miyoshi, T Miyaoka, Y Kobayashi, T Itahura, K Nishijo, M Higashitara, et at, “Hypergammaglobulinaemia by Prolonged Adjuvanticity in Man: Disorders developed after Augmentation Mammoplasty”, (1964) IJISHIMPO, 21-22 and 9-14. It was not until 1982 that the FDA proposed acquiring pre-marketing approval requiring that manufacturers would be obligated to supply evidence of the safety of implants. A comprehensive general chronology of the regulatory history of breast implants is provided by R Stombler, “Breast Implants in the FDA: Past, Present and Future” (1993) American College of Surgeons Bulletin, 11-15. 20 David Kessler was appointed as Commissioner of the FDA in November 1990 by President George Bush (Sr). Interestingly Kessler had obtained a Medical Degree from Harvard and a Law Degree from the University of Chicago. In 1988 the FDA requested evidence of safety and effectiveness of the silicone-gel-filled implant devices from manufacturers and the manufacturers were (by law) permitted at least 30 months to gather data. When Kessler took over the FDA in 1991, the manufacturers had not yet responded to the FDA’s 1988 order to present data on safety and effectiveness. On April 10, 1991 Kessler notified the manufacturers that there was to be no more delay and the manufacturers were given 90 days to file their pre-marketing applications. For a full chronology of the regulatory process see also Marcia Angell, vide supra n.12 at 52. 21 DA Kessler, “The Basis for the FDA’s Decision on Breast Implants” (1992) 326 New Eng J Med, 1713-15. Estimates of the number of women with silicone breast implants varies from study to study, but the FDA, in “Background Information on the Possible Health Risks of Silicone Breast Implants” December 18, 1990, (revised February 8, 1991), concluded that two million women in the United States of America “presently have” implants. 22 See vide supra n.21. 23 One woman who could not afford the fee for the removal of the device, in desperation, attempted to remove her own implants with a razor blade. Cited by Marcia Angell, see vide supra n.12 at 20. 2.5 2.10 The trickle of Court cases that began in the late 1970s24 rapidly became a
flood.25 One successful case, in 1984, concerned Maria Stern of Boise, Idaho. Maria Stern developed an autoimmune disorder that was associated with joint pain and with chronic fatigue. The jury award to Stern was almost
US$2 million26 in punitive damages against Dow Corning27 the manufacturer. As time progressed the awards became astronomic. On 13 December 1991
another claimant, Mary Hopkins28, was awarded US$7.34 million.29 Mary Hopkins suffered a painful arthritic-like condition that was described as a "mixed connective tissue disease". The significance of this case was that the
jury30 found that the plaintiff had contracted the mixed connective tissue disease as a result of her silicone breast implants, and that the manufacturing company had misrepresented the safety of the product. This finding created
a considerable increase in the public awareness of the issue.31
2.11 In November 1991, the FDA convened an advisory panel meeting which
engendered heated debate and attracted much publicity.32 The panel concluded that the manufacturers had failed to provide reasonable assurances of the safety and effectiveness of silicone-gel-filled breast implants and the lack of data was described as appalling. The advisory panel did recommend that silicone-gel-filled breast implants be removed from the market with the exception that devices could be used for the
treatment of those suffering from breast cancer.33 After two independent
24 The first case against a breast implant manufacturer occurred in 1977. The plaintiff achieved a settlement (US$170,000) for "pain and suffering" allegedly caused by rupture of the implant. 25 The explosion of breast implant cases in the Courts was detailed in the following articles: “Feud in Implant Settlements Stirs Debate over Tactics”, Washington Post (USA), 11 May 1994, D1 and “Details of Implant Settlements Announced by Federal Judge”, New York Times (USA)¸ 16 April 1994, A16. 26 The Stern verdict went out on the GPI wire on November 5, 1984. It was not widely reported in the general press. The case was revisited in 1992 by U Thomas, “Women’s Breast Implants Suit Started the Dominos”, Idaho Statesmen (USA), 14 March 1992, cited by Marcia Angell, see vide supra n.12 at 52. 27 Dow Corning Inc was found fraudulent having misrepresented the results of animal studies. 28 See Mariann Hopkins v Dow Corning Corp 33 F 3d 1116 1994 and decision of the United States Court Circuit of Appeals for the 9th Circuit, August 26, 1994. It is also of interest to observe that the cases of Maria Stern and Mary Hopkins were both conducted by the same law firm, Hersch & Hersch. 29 See W Carlsen, “Jury Awards US$7.3 million in Implant Case”, San Francisco Chronicle (USA), 14 December 1991, A13, cited by Marcia Angell, see vide supra n.12 at 55. 30 The Jury found that the implants were defective and that Dow Corning was guilty of fraud. Mary Hopkins' case was the more tragic as the implants had been inserted following a previously performed double mastectomy. For further information see Anatomy of a Crisis, The Breast Implant Imbroglio, online at www.register.com. 31 See T M Burton, Dow Corning Employees Fabricated Data on Breast Implants Counsel Concludes, Wall Street Journal, p.A3, November 3, 1992 cited by Marcia Angell, see vide supra n.12, at 60. 32 Observation by Marcia Angell, see vide supra n. 12 at 55. 33 The panel’s recommendations was accepted by Kessler on 16 April 1992. The panel’s recommendations are detailed in RE Strombler, “Breast Implants and the FDA: Past, Present and Future” (1993) American College of Surgeons Bulletin, 11-15, see also 2.6 advisory panels, the FDA requested a moratorium on the use of breast implants other than within approved clinical trials. This almost complete ban on the use of silicone-gel-filled breast implants occurred in April 1992, almost thirty years after the introduction of the device, almost seventeen months after Kessler’s appointment as Commissioner of the FDA, and eight years after the Maria Stern case.
2.12 The FDA ban was followed by a tidal wave of litigation.34 Lawsuits increased from approximately 200 at the end of 1991 to 10,000 by the end of
1992.35 In one case, the plaintiff was awarded $US5 million in economic
and emotional damages, and $US20 million in punitive damages.36 This contrasted to the net worth of Dow Corning Inc that was estimated then to
have been in excess of $US948 million.37 Interestingly, in March 1992, Dow Corning Inc ceased their involvement in the breast implant manufacturing
business,38 and on 15 May 1995, the company filed for Chapter XI
bankruptcy protection.39 It is also of interest to observe that in this and many other cases any opportunity for a claim for compensation for many claimants
may have been defeated by bankruptcy.40
2.13 I have already referred to the tension that can exist between legal and scientific evidence and it remains the case that one major contentious issue of the entire silicone-gel-filled breast implant saga is that raised by the question – do silicone-gel-filled breast implants cause connective tissue disease? The answer to this question is not a matter of medical opinion or a consequence of legal argument. It is a matter of biological fact that these
DA Kessler, “The Basis for the FDA’s Decision on Breast Implants” (1992) 326 New Eng J Med, 1713-15 in this article Kessler explained the decision and the FDA’s rationale for that decision. 34 See Marcia Angell, vide supra n.12 at 69. 35 Barie S. Carmichael, Dow Corning Corporate Vice-President and Executive Director of Corporate Communications, cited this increase in an interview in the June 1995 issue of TJFR Health News Report, a monthly newsletter for health-care public relations specialists published in Ridgewood, NJ. 36 See “Record $25 million Awarded in Silicone Gel Implants Case”, New York Times (USA), 24 December 1992, A13, cited by Marcia Angell, vide supra n.12 at 73. 37 The jury was informed of Dow Corning’s value ($US948 million) and instructed to keep it in mind when awarding punitive damages in the Hopkins case, according to Dow Corning’s Application for a Writ of Certiorari (Note 4 pp.7-8). 38 See E. Neuffer, “Maker Quits Implant Market”, Boston Globe (USA), March 1992, 1, cited by Marcia Angell, vide supra n.12 at 16. 39 Chapter XI bankruptcy protection permitted Dow Corning to be protected from dealing with creditors in countless jurisdictions as the company was then subject to a coherent plan of one Court. 40 In June 1970 the A H Robins Company, manufacturers of pharmaceuticals, acquired rights to a new intra-uterine contraceptive device for women, the Dalkon Shield. A defect in the Dalkon Shield resulted in serious injury to a considerable number of its users. In June 1974 A H Robins suspended distribution of the Dalkon Shield in the USA but stopped short of recalling the device. Eleven
2.7 implants either cause connective tissue disease, either alone or in association
with other factors – or they do not.41
2.14 It remains the case that there continues to be much doubt as to the nature of any association, if any, between silicone-gel-filled breast implants and
connective tissue disorders.42 The FDA ban on silicone-gel-filled breast
implants has only recently ended,43 despite the fact that many attempts to identify an association with systemic disease, of any sort, have been
unsuccessful.44 The debate continues and there does remain opinion that
continues to question the supposed safety of breast implants.45 Their use remains a matter for controversy.
2.15 Coope & Dennison46 have summarised the medico-legal debate better than most. They concluded –
years later the A H Robins Company faced bankruptcy following 6000 claims filed in U.S. Courts. See Richard B Sobol, Bending The Law: The Story of The Dalkon Shield Bankruptcy (1991) 408. 41 See vide supra n.12 at 90. 42 See C Coope and E Dennison, “Do Silicone Breast Implants cause connective tissue disease? There is still no clear evidence that they do” (1998) 316 BMJ, 403-04 and J Sanchez-Guerrero, MH Liang, “Silicone Breast Implants & Connective Tissue Diseases. No association has been convincingly established” (1994) 309 BMJ, 822-23. 43 The FDA's Advisory Panel on Plastic Surgery has voted to end the ten-year moratorium on silicone implants for breast enlargement, though safety concerns saw the Panel split, with a vote of 9-6 in favour. The Advisory Panel had considered the results of the first three years of the planned ten-year open label study involving 940 women of all age groups using an implant made by the California-based company INAMED. The study found that at three years 1:5 patients (20%) had already undergone repeat surgery, 6% had breast pain, 3% had experienced a change in nipple sensation and 1% had experienced a rupture. Dr Sidney Wolfe, Director of the Public Citizen's Health and Research Group, argued before the Panel that the study's results underestimated safety concerns. Using five-year data from previous studies Dr Wolfe demonstrated that 27% of women had repeat surgery, 27% had breast pain, 17% lost nipple sensation and 4% had rupture of the implant. For further information see R Moynihan, “Safety Concerns About Breast Implants Persist” (2003) 327 (7241) BMJ, 947. 44 See S Gabriel et al, “Risk of Connective-Tissue Diseases and Other Disorders after Breast Implantation” (1994) 330 New Engl J of Med, 1697-1702. See also Marcia Angell, vide supra n.11 at 90. Marcia Angell quotes Dr S Gabriel who on June 16, 1994 stated "We found no association between Breast Implants and Connective Tissues Disease and the other diseases we studied." It was not until 1994 that the first reliable evidence regarding there being no association between breast implants and connective tissue disease was published. Gabriel's article was published more than two years after the FDA ban of Silicone-gel-filled breast implants. Gabriel's conclusion was that a group of women had received silicone-gel-filled breast implants (n.749) were no more likely to develop connective tissue disease than the group without implants. This study did cast enormous doubt on any concept with their being a causal link between the implants and the occurrence of connective tissue disorders. Furthermore, another large Retrospective Cohort Study published in the New England Journal of Medicine in June 1995, could find no association between silicone-gel-filled breast implants and connective tissue disease in almost 90,000 Nurses, of whom, 1,183 had undergone breast implantation. This study was undertaken by J Sanchez-Guerrero et al and reported in the New England Journal of Medicine, (1995) Vol 332, 1666-70. See also S Gabriel, W O'Fallon, L Kurland, C Beard, J Woods and L Melton, “Risk of Connective-Tissue Diseases and Other Disorders after Breast Implantation” (1994) 330 New Engl J Med, 1697-702; O Nyren, L Yin, S Josefsson, J McLaughlin, W Blot, M Engqvist et al, “Risk of Connective Tissue Disease & Related Disorders among Women with Breast Implants: A Nation-wide Retrospective Cohort Study in Sweden” (1998) 316 BMJ, 417-22; HJ Englert and P Stockbrooks, “Scleroderma and Augmentation Mammoplasty - A Causal Relationship?” (1994) 24 Australia & New Zealand Medical Journal, 74-80. Scleroderma is that condition associated with the thickening and induration of the skin which is associated with abnormal collagen formation. The condition can affect many tissues including skin, heart, kidney, lung or oesophagus. Scleroderma can remain localised or spread widely throughout the body. The condition can be fatal. Scleroderma is one of the collagen diseases that are sometimes called connective-tissue disease. The disorder can be widespread throughout the body owing to the fact that the disease affects any tissue that is formed from the principle component of connective tissue, the protein collagen. 45 D Zuckerman, “Are Breast Implants Safe?” (2001) Medicine General Medicine, accessed on www.medscape.com. Whilst not claiming to have evidence that breast implants are unsafe, Dr Zuckerman appears keen to inform the growing number of women requesting breast implants that long-term information about safety is still not yet available. Also see Editorial, “Are Breast Implants Safe?” (2002) 8 (1) Health Reader, 12. 46 C Coope and E Dennison, “Do Silicone Breast Implants cause connective tissue disease? There is still no clear evidence that they do” (1998) 316 BMJ, 403-04. 2.8 “It is difficult to see how epidemiological studies will shed more light on this vexed issue. Some of those concerned in prolonged legal disputes are clearly unshakable in their belief that the association exists, and the public reputation of silicone breast implants may have been irrevocably tarnished”.
Coope & Dennison continued to conclude that –
“… perhaps the medical community’s most appropriate response would be to endorse the American College of Rheumatology’s plea that greater reliance should be placed on the quality of evidence during the early appraisal of health issues such as this.”
2.16 Other countries have responded quite differently to the unfolding evidence about breast implants. Spain, for example, followed the lead of the FDA and banned breast implants in 1992, but lifted the ban later the same year after
reviewing the data.47 France followed the FDA advice and recalled breast implants from the market in 1992 but as epidemiologic evidence accumulated a re-evaluation of the situation caused the ban to be lifted in
January 1995.48 Later the same year the ban was reinstituted.49 In the United Kingdom, the FDA recommendation was not implemented and the British Department of Health issued a report in 1993 stating that they found no
reason for a moratorium.50 In 1994 the British Department of Health issued
a further statement51 to the effect that:
“The conclusions … remain unchanged, in that there remains no scientific evidence from the literature of any increased risk of connective tissue disease associated with silicone-gel breast implants.”
47 See C. Vanchieri, “European Surgeons Call for Independence from U.S. Food and Drug Administration” (1993) 85 Journal of the National Cancer Institute¸ 353-54. 48 French Ministry of Social Affairs Press Release of January 24, 1995; “Object: Protheses Mammaires Implantables” cited in Journal Officiel de la Republique Francaise, 17 May 1995. 49 The French Government announced the reinstated ban in May 1995. See Journal Officiel de la Republique Francaise, 17 May 1995. 50 See JJB Tinkler et al, “Evidence for an Association between the Implantation of Silicones and Connective-Tissue Disease”, in Department of Health, Medical Devices Directorate, Bulletin (1993). 51 See DM Gott and JJB Tinkler, “Silicone Implants and Connective Tissue Disease” in Medical Devices Agency Bulletin (1994). SA Braley, “The Use of Silicone in Plastic Surgery: A Retrospective Review” (1973) 51 (3) Plastic and Reconstructive Surgery, 280-288; JP Lalardie, R Mouly, “History in Mammoplasty” (1978) 2 (2) Aesthetic Plastic Surgery, 167-176; SA Van Nunen, et al., “Post Mammoplasty Connective Tissue Disease” (1982) 25 (6) Arthritis and Rheumatism,694-697. This last paper reported the identification of connective tissue disease in three women who had undergone implantation of silicone-gel-filled breast implants. 2.9 2.17 In Australia, silicone-gel-filled breast implants were withdrawn from the marketplace in 1992 due to safety fears. Until 2001 the implants have only been supplied on a case by case basis for use in special circumstances, e.g. treatment after mastectomy. Approval for the general use of the implants
was reinstated in 2001.52
2.18 The two therapeutic product related events reviewed so far, the Thalidomide case and the Silicone-gel-filled breast implant case, are generally accepted to be the most well known of those events that have been associated with medical and surgical product failure and with the exposure to liability of manufacturers that can be inherent in such events. However, with the exception of those who hold a special interest in the subject, it is not so well known that surgical device failure, of a great variety of other surgical products, has also, too often, been cause for potentially serious and life threatening adverse events. No surgical specialty has a mortgage on surgically implantable device failure. There are many examples. For those
with an interest in the subject, the names Bjork Shile53, Dalkon Shield54, St
Jude55 and Medtel56 are as well known as snails in bottles57 and sulphites in
long johns58. For those that are not so familiar with these cases it can be instructive to briefly review some aspects of the history relating to these products.
2.19 Heart valves and other endovascular59 prostheses are life-saving devices. In the early 1950s large-diameter vascular grafts did for the first time enable surgeons to replace arteries that had become defective. Since then the
52 Dr Graham Maynard, TGA Chief Committal Adviser, Medical Devices, advised "Large-scale studies in the past five years had resolved concerns that silicone implants might cause systemic complications such as autoimmune disorders and Connective-Tissue disease…there is now sufficient data to show that the risk of these diseases in women with Silicone implants is no higher than the risk in women without Silicone implants." Dr Maynard's statement was quoted by Megan Howe, in “Implant Approved with Warning” (2001) Australian Doctor, 3. For further information see online at www.health.gov.au/tga/docs/html/breasti.htm. 53 Heart valve replacement device. 54 Intra-uterine contraceptive device. 55 The St Jude Medical Corporation has for almost half a century produced products to augment and to improve heart function. Interestingly, Mr Griffin (then Opposition Parliamentary Secretary for Health) in House of Representatives in Hansard, 6 August 2001, points out that “St Jude is the Patron Saint of Desperate Cases”, at p.29178. See also Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014. 56 Courtney v Medtel Pty Ltd [2003] FCA 36; BC 200300120. 57 See Donoghue v. Stevenson [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85, 458. 58 See Grant v. Australian Knitting Mills Ltd (1935) 54 CLR 49: 9 ALJ 351; [1935] ALR 493; [1936] AC 85; revg (1935) 50 CLR 387. 59 Endovascular prostheses are devices that are used within the arterial system to maintain patency and blood flow. The devices are particularly used in the event that there has been arterial narrowing, blockage and aneurysm formation. 2.10 emotional aspect of heart (and arterial) surgery has cast a shadow over the less emotive but then already routine use of orthopaedic replacement devices for the treatment of disorders of joints.
2.20 It has not been uncommon for endovascular prostheses to be found
defective.60 Device failure has been associated with leakage from graft holes, due to excess porosity of the devices, and in association with weave separation. Graft migration, stent frame fracture, and separation of the stent
frame from the implant have also been cause for device failure.61 Heart valve devices, such as the Bjork Shile heart valve device, have been used in vast numbers and it has been estimated that 40,000 implantations of the device were undertaken in the USA alone, and that a total of (no less than) 86,000 implantations were undertaken worldwide. Fatigue fracture of these
devices has not been uncommon.62
2.21 Implantable cardiac pacemaker devices are also conspicuous by the
frequency of incidents of device failure.63 Pacemaker device failure has been
associated with failure of assembly64 and with fracture of electrical leads.65
Pacemaker failure can be associated with rapid death.66
60 A statistically significant high rate of para-valvular leakage which might be associated with causing a prosthetic heart valve to fail by a mechanism of loosening and explantation was cause for the worldwide (voluntary) recall, on 24 January 2000, of the St Jude Heart Valves and Silizone® coated angioplasty rings. 61 In January 2002, the Medical Devices Agency (UK) issued a safety notice with regard to the unacceptable high rate of device failure associated with endovascular prostheses used for the treatment of abdominal and thoracic aortic aneurysms. Eight commercial types of endovascular prostheses were used and in each case all had attained a CE Mark. In these cases the CE Mark was no protection from product failure. For the nature and definition of the CE Mark see Appendix A. 62 Fatigue fracture of heart valve devices can be cause for death. The precise mortality figures are impossible to access but there is anecdotal evidence that if there was only a 1% mortality rate then it can be predicted that heart valve device failure can be associated with (approximately) 860 fatalities. 63 See also “Pacemaker alert sparks hunt for recipients”, The Courier-Mail, 8 June 2000; “Patients sue over faulty pacemaker”, The Australian Financial Review, 7 August 2000; “Faulty pacemaker leaves life on hold”, The Age, 2 August 2000; “Demand for tougher rules over body implants”, The Sydney Morning Herald, 18 August 2001. In June 2000 the TGA issued a hazard alert warning that pacemakers distributed in Australia by the respondent had an increased risk of malfunction. Doctors were advised to review approximately 1,048 patients who had received the pacemakers. See also Courtney v. Medtel Pty Ltd [2003] FCA 36. 64 The St Jude Tempo Pacemaker device suffered assembly problems. In the USA approximately 3,500 of these devices had been implanted. In Australia it has been estimated that 992 devices were implanted. 65 The Teletronic Pacemaker device suffered failure from lead fracture and failure. The Medtel Pacemaker suffered battery power failure as a consequence of dendrite formation following the use of faulty solder material. 66 It is not unknown for the fractured lead of a pacemaker to penetrate the (polyurethane) insulation of a pacemaker device and to be causal for puncture of the myocardium and for there to be cardiac tampanade. The myocardium is the middle of the three layers forming the wall of the heart. It is composed of a very specialised form of muscle (cardiac muscle) and forms the greater part of the heart wall. Cardiac tamponade is that event associated with the penetration of cardiac muscle that will allow blood to pass from within the heart to enter that space between the heart and its lining, the pericardium or sac, which surrounds the heart. The increasing pressure caused will gradually prevent the heart from beating normally, and this condition of tamponade, unless urgently treated, will cause death. 2.11 2.22 A particularly uncomfortable episode of device failure was that associated
with the use of the Dalkon Shield intra-uterine contraceptive device67. The Dalkon Shield intra-uterine contraceptive device was recalled by the manufacturers, A H Robins Co after nearly 200,000 women sued the
company.68 The Dalkon Shield device was cause for an unacceptable incidence of pelvic infection, septic abortions and for a variety of other pelvic diseases and on many occasions the salvage surgery required the
patient to undergo a hysterectomy.69
ORTHOPAEDIC IMPLANT DEVICE FAILURE
2.23 During the past two decades the failure of orthopaedic surgically implanted devices has attracted considerable attention. As we shall see many of these events of product failure have been associated with defects that have occurred in the process of manufacture. Probably the most well known case
is that generally known as the Sulzer Case.70
2.24 On or about 5 December 2000 the Sulzer organisation recalled 40,000 Inter-
Op Acetabular (hip) implants.71 The product recall was initiated in the USA following the identification of an abnormally high rate of implant loosening. The loosening of the implant had been identified to have been causally associated with the contamination of the surface of the implant by an oil that
67 It is alleged that, in addition to a defect in the Dalkon Shield product, there was also a disregard for cautionary medical advice – see Richard B Sobol, Bending The Law: The Story of the Dalkon Shield Bankruptcy (1991) 408. See also online www.lawyersandjudges.com. Sobol describes how A H Robins Co used Federal Bankruptcy Law to halt 6,000 law suits in US Courts, as well as to secure decisions limiting, not only the pool of women eligible to claim compensation, but also the company’s responsibility to compensate the claimants. The A H Robbins Bankruptcy is important for a number of reasons if not only for the precedent that it created for other situations in which manufacturers of dangerous products could seek refuge in bankruptcy. 68 For a history of the Dalkon Shield litigation see D Jensler and M Peterson, “Understanding Mass Personal Litigation: A Socio- Legal Analysis” (1993) 59 (3) Brooklyn Law Review, 961-1063. The Sydney Law Firm Maurice Blackburn Cashman represented more than 3,000 Australian claimants who had suffered significant complications following the use of the Dalkon Shield. 69 Hysterectomy is that surgical procedure for removal of the uterus. 70 Sulzer Orthopaedics Inc. was a leading global designer, manufacturer and distributor of orthopaedic implants for hips, knees, shoulders and elbows. The company, in conjunction with Sulzer Orthopaedics Ltd in Switzerland, was the fourth largest supplier of orthopaedic implants in the world and comprised the orthopaedic division of Sulzer Medica, a global network of medical device companies. Sulzer Orthopaedic Inc was a subsidiary of Sulzer Medica. The Sulzer Medica headquarters was in Winterthur, Switzerland. Business operations in America remain based in Austin, Texas. The company now trades as Centerpulse Orthopaedics whose place of performance is Baar in Switzerland. Recently, on 7 October 2003 the Centerpulse organisation was purchased by Zimmer Inc, 345 East Main Street, Warsaw, IN 580, USA. Zimmer purchased Centerpulse for US$3.2 billion. Zimmer's acquistion of Centerpulse creates the world's #1 pure-play orthopaedic company - personal communication - Richard Fritschi, President, Europe/Australasia, Australian regional headquarters, Unit 1/1, Skyline Place, Frenchs Forest NSW 2086.
2.12 was used during the manufacturer's cleaning process.72 The Inter-Op device had also been used in Australia. A personal review has identified that it probably was the case that only (approximately) 53 Inter-Op Acetabular devices were implanted by Australian surgeons. The Australian Experience however, was the more interesting for other reasons that will be discussed later in this chapter.
2.25 The North American experience was, in the context of the world market, by far the most overwhelming in numbers and it has been estimated that the need for revision arthroplasty (salvage surgery), causally associated with
Inter-Op device contamination and failure, has exceeded 2,800 patients.73
2.26 On 21 May 2000 Sulzer advised the FDA of a similar contamination of
porous coated tibial (knee replacement) base plate implants74. A recall was then initiated that included tibial (knee) implant devices manufactured during the period July to December of the Year 2000. It was then estimated
that 1,485 tibial devices had been implanted in the United States.75
2.27 The spectacle of Sulzer resulted in the “mass tort defense du jour … say you’re sorry, gather sympathy, plead poverty, threaten bankruptcy, hire a Plaintiff’s attorney for settlement, get defence ready, select friendly class counsel, propose a settlement that provides inadequate relief, isolate
71 At the time of the product recall Sulzer was estimated to have an 11% share of the North American market and the Inter-Op Acetabular implant device had been implanted in 17,500 patients worldwide. Ninety percent (90%) of the devices had been implanted in the USA. 72 Sulzer has stated that it produced implants which had an unacceptable level of mineral oil-based lubricant on the product. Specifically, oil was found on the exterior porous surface of certain Sulzer Inter-Op tm hip shells. On 1 June 2001, a spokesperson for Sulzer stated that there was an abundance of mineral oil left on hip implants. Sulzer used five different types of lubricating oil in the manufacture and process for the hip cup. The oils were all produced by Mobil and for each of these oils Mobil produced Material Data Safety Sheets. None of these oils were intended to be ingested or placed inside the body. While Sulzer did not open its manufacturing facilities to an independent public examination there does appear to be little disagreement that the problem resulted from a faulty manufacturing process. The oil was intended to be used solely to lubricate the tooling machines that produced the cup implant. However, the oil became improperly mixed with coolant that was sprayed onto the shell. The tooling machine was lubricated with Mobil oil, some of which seeped into the coolant that was sprayed onto the cup. The defect dates back as far as 1997 with some Sulzer hip implants. 73 See DF Craviotto, “Dissemination of Information, Among Orthopaedic Surgeons, regarding early failure of total joint implants” (2001) 83A (10) JBJS, 1580-81 - Craviotto reported that between October 1999 and December 2000 he implanted 30 (affected) Inter-Op Acetabular shells and noted complaints of groin pain at two to four months after surgery in some patients. At the time of the publication, 15 of 30 devices had required revision. The main thrust of Craviotto's paper was a recommendation for improved reporting of implant device failure. 74 On 20 October 2001, O’Malley J., US District Court in Cleveland, Ohio, conditionally certified a Class of Sulzer knee patients and granted preliminary approval to a revised Settlement Agreement that added persons who received defective Sulzer tibial base plates to the recipients of its defective hip implant. K M O’Malley J was appointed by the Judicial Panel on Multidistrict Litigation, on 19/6/2001 to preside over all cases filed against Sulzer in the US Federal Court for the purposes of pre-trial discovery. 75 It is interesting to observe that surgeons in the USA were not advised of the tibial implant device defect until 17 May 2001. By March of that year (approximately) 600 revision arthroplasties had been undertaken. 2.13 corporate parents, expose a small division, call opposing lawyers ‘greedy’, get an injunction against the State litigation, and get all the plaintiffs into
one class …”.76 Then accept the settlement agreement, which will cost the
company US$725 million.77
2.28 Though the Sulzer case in general, and the North American experience in particular, are now well known to Orthopaedic Surgeons there has been little public information in regard to the use of the Sulzer Inter-Op device in Australia. It can be estimated that (approximately) 53 Sulzer Inter-Op
Acetabular prosthetic devices78 were implanted in Australia during the year 2000 and it can be confirmed that 18 or 19 surgical device implantations
were performed in Victoria79 and that 27 implantations were performed in
New South Wales.80
2.29 A major concern with regard to the use of the Sulzer Inter-Op device in Australia was not so much the magnitude of the event, but more with respect to the questions that can be asked - were the patients adequately informed of the nature of potential consequences of the product defect, were their needs addressed, and what arrangements were made for any financial settlement (if determined to be necessary)? Credible information provided by two
Orthopaedic Surgeons has confirmed that a financial settlement81 was agreed
76 GM Fleming, Fleming & Associates quoted in Emerging Drugs & Devices, (2001) 6 (20), 13. See also GM Fleming and A Perrira, “The Proposed Sulzer Class Action Settlement: An Example of the Mass Tort Defense Du Jour” (2001) 6 (19) Emerging Drugs & Devices, 25-31. 77 Scott Kober, “Class-action Settlement Reached in InterOp Law Suit” (2002) OrthopedicsToday. Kober views the settlement agreement that was effected on 31 May 2002. 78 The Sulzer organisation in Sydney have advised that the total number of Inter-Op devices implanted was approximately 50. Conversations with Mr B Shannon, Sulzer, Sydney on 13/2/2002 (1120h-1135h) and on 3/3/2002 (1130h-1135h). Mr Shannon did admit that there had been approximately 50 implants undertaken with the Sulzer Device. Mr Shannon initially estimated the number to be 20 odd, then 30 odd. For reasons unknown Mr Shannon did not appear to be keen that this information was made public – don’t mention the numbers please. Conversations with Mr B Shannon, Sulzer, Sydney on 13/2/2002 (1120h-1135h) and on 3/3/2002 (1130h-1135h). Mr Shannon did admit that there had been approximately 50 implants undertaken with the Sulzer Device. Mr Shannon initially estimated the number to be 20 odd, then 30 odd. For reasons unknown Mr Shannon did not appear to be keen that this information was made public – don’t mention the numbers please. See TGA urgent medical device recall (hospital level) notice reference R2000/332, dated 19/12/00. (Sponsor: Sulzer Australia P/L), recall letters dispatched Friday 15/12/00. Surgeons operating at five Victorian Hospitals and three NSW Hospitals were advised to monitor patients for signs of implant loosening or instability. Surgeons were further advised that prophylactic removal is not being recommended. The TGA further described the product recall as being deemed safety-related. 79 At the Waverley Hospital, Melbourne, Victoria. 80 At the Nepean Hospital, NSW. 81 On 1/3/2002 (1100-1120h) a Waverley Hospital Doctor (name withheld) advised me that the company had been very professional and that they had paid them (potential claimants) off reasonably. The Nepean Hospital Doctor (name withheld) advised me on 1/3/2002 (1250h-1305h) that a sum of A$3,000.00 had been paid to each patient (potential claimant) and that arrangements had been effected for the funding of any revision or salvage surgery that might become necessary as a consequence of device failure. It should be recalled that each claimant in North America received approximately US$250,000. TGA representatives were unable to provide any further useful information with the exception of confirming that a formal recall of the Sulzer Device had been effected on 19/12/2000, Reference R2000/332. 2.14 between Sulzer Australia and the potential claimants, as an alternative to any other form of redress that might have involved a lengthy process of litigation.
2.30 In recent times a number of other orthopaedic device failure incidents have occurred outside Australia that have been the subject of hazard notices and product recalls. On 19 February 1998, the Medical Devices Agency (MDA)
in the United Kingdom issued a Hazard Notice82 in respect of the 3M Capital Hip System. The Hazard Notice was issued following the finding that, at some hospitals, as many as 1:5 (21%) of the 3M Capital Hip Systems
implanted had failed at 5 years after surgery83. The reasons for implant
failure were identified to have been associated with osteolysis84, and implant loosening, that was causally associated with the titanium material that had
been used for the fabrication of the implant.85
2.31 The 3M Capital Hip System failure was a significant event in the United Kingdom and one that was instrumental for the United Kingdom Government initiative that caused the formation of the National Joint
Registry.86 It is interesting to observe that, back in July of 1972, Sir John
82 Medical Devices Agency. Hazard Notice, London, MDA, 1998 (MDA 9801). 83 J Warden, “Warning Issued Over Hip Implants” (1998) 316 BMJ, 650. J Warden is the Parliamentary Correspondent for the British Medical Journal. Here it is reported that a total of 4,700 implants had been supplied in the United Kingdom between 1 August 1991 and 31 March 1997 when the device was discontinued. This number corresponds to less than 2% of the 250,000 hip replacement operations that took place during this period. 84 Osteolysis – this condition is associated with a dissolution of bone which is associated with a severe and florid inflammatory process. The condition can occur in association with infection and impairment of blood supply. The condition though frequently is associated with an inflammatory response to particulate debris which is generated from a surface of implant devices and from polymethylmethacrylate bone cement that might have been used for fixation of the device. Loosening of an implant can be associated with a process of fretting which causes particulate debris to be generated at the surface of a prosthetic implant material. The small (micron sized) particulate debris can cause there to be an intense inflammatory reaction which is associated with a loss of bone substance. This is the process of osteolysis that further aggravates the condition of loosening and can ultimately, if not treated, be associated with implant failure and with severe weakening and loss of bone. 85 See also DIS Sweetnam, J Lavelle, W Muirhead-Allwood and B Cohen, “Poor Results of the Ribbed System for Cementless Replacements” (1995) 77B JBJS, 366-68; CJ Bulstrode, DW Murray, AJ Carr, PB Pynsent and SR Carter, “Designer Hips” (1993) 306 BMJ, 732-33; SK Muirhead-Allwood, “Lessons of a Hip Failure – If We Want Improved Prostheses We Must Regulate Their Use” (1998) 316 BMJ, 644. 86 Probably the most significant outcome of the 3M Capital Hip System device failure was the formation of the United Kingdom National Joint Registry. This device failure incident identified that only the orthopaedic surgeons who carried out the operations had any knowledge of the identity of those patients that had been treated using the 3M Capital implant. A National Joint Registry was identified as necessary and Lord Philip Hunt announced, on 2 July 2001, that the United Kingdom Department of Health was to establish a National Joint Registry for hip and knee replacements – see Department of Health Press Release: Reference 2001/0298. Lord Hunt said “Establishing this Registry will lead to earlier review of patients with joint replacements, regular monitoring of performance of these new joints, and faster identification of those joint replacements that performed badly”. See BBC News, Health Sunday, “Tighter Rules Sought on Faulty Hip Joints”, London, 1 July 2001, 2302pm GMT/0002am UK. Recently a sobering note of caution is contained in the report of the Public Accounts Committee (UK). The contents of the report are cited by Zosia Kmietowicz “Companies Offer Surgeons Incentives to Use their Prostheses”(2004) 328 (1085) BMJ, 1091. The report warns that the future of the National Joint Registry, set up in April 2003 to monitor the performance of joint implants, may be in jeopardy. After six months the Register has records on only one-half of the hip and knee replacements done in the UK NHS, where it needs information from nearly all consultants and trusts to be of value. It is further reported that if compliance with the Registry does not improve, the Registry will be unable to answer how the volume of the surgeons' work affects clinical outcomes in patients. Further 2.15 Charnley, in Internal Publication No. 39 from The Wrightington Hospital,
wrote87:
“…serious consideration should be given to establishing a Central Register to keep a finger on the pulse of total implant surgery on a nation-wide basis. Surgeons should not be permitted to perform total hip implant work unless prepared to have weekly returns made of the operations as they are performed, and hereafter to have patients questioned annually by circular from the Registry”.
The United Kingdom Government initiative was clearly nothing new, but
something that had taken, after John Charnley’s88 recommendation, approximately 20 years to become reality. A further response to the 3M Hip
System failure was Muirhead-Allwood's observation89 that
"…only tested designs (of hip implants) should be used (and that) if we want improved prostheses we must regulate their use, …such as the Charnley prosthesis."
2.32 The incidence of orthopaedic device failure in Australia is reportedly an infrequent event. Though the number of individual patients affected may have been small, it has been my conclusion that the incidence of orthopaedic surgical device failure in Australia is a more frequent event than has been reported by both the manufacturers and by the medical profession. In recent years there have been a variety of major orthopaedic product liability events and some of these have been cause for TGA involvement. A recent and well
known product liability issue concerned the need to recall90 problematic
information is available online at www.parliament.uk/parliamentary_committees/committee_of_public_accounts.cfm. The information in this report contrasts with that reported by Dr Paul Fisher following his review of the activities of the National Joint Registry. Dr Fisher's review can be found in Bone, The Journal of the British Orthopaedic Association, Issue 29, p.14, Spring 2004. Dr Fisher reports that "now approaching one full year since its launch, the NJR is receiving total hip and total knee replacement data from more than half of all orthopaedic units in England and Wales. This success has been significantly aided by the commitment and support of orthopaedic surgeons and is reflected by the valuable issues and suggested improvements that have been raised over the last ten months. 87 Quotation cited by Frank Horan, Editor, JBJS. See Editorial “The National Joint Registry for England and Wales” (2003) 85B (1) JBJS, 1. 88 See also Ch 4. 89 See SK Muirhead-Allwood, “Lessons of a Hip Failure, If we want improved prostheses we must regulate their use” (1998) 316 BMJ, 644. The 3M Capital Hip incident also prompted the observation that a "fashion trade" exists in joint replacement that not only costs the UK NHS many millions of pounds each year, but more importantly causes patients unnecessary pain and distress through early failure of unproved implants. This observation was made by CJ Bulstrode, DW Murray, AJ Carr et al, “Designer Hips” (1993) 306 BMJ, 732-33. 90 TGA received initial notification about problems with the Zirconia product from the French Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSPS) in July 2001 through a vigilance report exchange program. 2.16 Zirconia91 (Prozyr®) femoral heads which had been observed to be
associated with an unacceptable incidence of failure by fracture.92
2.33 Since 1998, approximately 9,000 Zirconia femoral heads have been implanted in Australia and in New Zealand 60% (3 in 5) of all total hip replacement implants utilised a femoral head component that was fabricated from Zirconia. Investigations have strongly indicated that the nature of the problem with Zirconia is that the device (and material) failure probably was
associated with the process of manufacture. 93 The TGA announced the Zirconia product recall on two occasions, on 28 May 2001 and on 16 August 2001 by means of personal communication with interested parties and with a
press release.94 Following consultation with the Therapeutic Device Evaluation Committee (TDEC) Expert Orthopaedic Panel, the TGA recommended:
x The immediate recall of all unimplanted Zirconia Femoral Head prostheses manufactured by Saint Gobain Céramiques Advancés Desmarquest.
x That orthopaedic surgeons inform all patients implanted with a Saint Gobain Céramiques Advancés Desmarquest Zirconia Femoral Head prosthesis that they should seek urgent medical attention should they be concerned that there is a sudden change in their replaced hip (my emphasis).
2.34 On 14 September 2000, Saint Gobain Céramiques Advancés Desmarquest conducted a worldwide recall of 9 batches of the suspect Zirconia (Prozyr®)
91 Zirconia – this ceramic metal oxide is found in abundance in Australia. The use of the material for implant fabrication was pioneered by Professor M Swaine (Ceramic Engineer) in Sydney (unreported). 92 The potentially defective Zirconia hip prosthetic components had been distributed by more than 51 companies worldwide and were manufactured since early 1998. The Zirconia femoral heads, manufactured by Saint Gobain Céramiques Advancés Desmarquest were supplied by eight companies in the USA, six companies in Australia, and by four companies in New Zealand. Worldwide, the implant was distributed by 51 companies. It has been estimated that the Zirconia femoral head components have been implanted in 5% to 6% of all total hip replacements undertaken worldwide. The femoral heads are manufactured by two separate processes. One of these, the Tunnel Furnace Sintering Process has caused French health officials to ban the sale or exportation of Zirconia femoral heads manufactured by this process. The decision followed a year long investigation into high fracture rates associated with this product and an FDA warning relating to Good Manufacturing Practice (GMP) violation. In August 2001 the TGA issued a Hazard Alert and cancelled defective products from the ARTG. In September 2001, the manufacturer conducted a worldwide recall and 9 batches of the products that had experienced higher than normal fracture rates. The TGA Hazard Alert on this issue may be accessed at http://www.tga.gov.au/docs/html/hazard/htm. For further information see also TGA News Issue 39 (November 2002) and the GMP Newsletter, FDA News, Issue 271, p.3, August 2002. 93 Y Stefani, “Zirconia Femoral Head Recall – Update”, Combined Meeting of the Australian & New Zealand Orthopaedic Associations, Queenstown, New Zealand. 11th October 2001. 94 Media Release by TGA (Media contact: Kay McNiece 0412 132 585), TGA recalls potentially defective replacement hips, 16 August 2001. This Media Release reported a failure rate as high as 8.8% and described the failure of the affected Zirconia Heads as being sudden and without warning. The public were further informed that There are no screening techniques to detect likelihood of failure. Once the component fails, total and immediate revision (reoperation and replacement) is required, with the patient immobilised until revision can be performed. See also Media Release by Alan Griffin MP, 18 August 2001. 2.17 femoral heads. At first it was estimated by the manufacturer that the problem might involve as many as 200,000 total hip replacement implants
worldwide.95 Fortunately this has proven not to be the case. To date it can be estimated that only one episode of Zirconia femoral head fracture has occurred in Australia.
2.35 A number of other orthopaedic products have reportedly been associated with episodes of implant breakage. The information regarding these events is not widely known as the incidents have remained only a concern for those surgeons and patients involved and for those manufacturers of the device.
There are reports of device failures concerning knee replacement implants96
Intramedullary97 fracture fixation devices98, of Ceramic Acetabular implants99
and of Femoral Modular Revision hip stems.100
2.36 There is no doubt, and in previous paragraphs we have discussed many examples, that incidents of implantable surgical device failure are frequently, if not usually, characterised by the considerable number of claimants and the vast number of devices that can be associated with any individual product adverse event or recall. Though the numerics of the events are substantial, each single incident has the potential to be a very disturbing event for the patient concerned. Each event can also be an
95 The femoral heads recalled were those manufactured after January of 1998 and it has been confidently estimated that 9,051 Zirconia femoral heads, from the nine manufacturing batches are suspect. The suspect femoral heads have all been identified to have been manufactured using a tunnel furnace technique as distinct from the batch manufacturing technique. The defect is confined to two lots, TH93038 (n-216) and TH2957 (n-58). The worldwide recall was initiated after the identification of an unacceptably high rate of implant breakage which had been demonstrated to occur approximately 19 months to 28 months following surgery. In one manufacturing batch the fracture rate was identified to be 8.8%. The manufacturers have advised, and there is little consolation in the information, that they have not identified any fracture to have occurred in the other 41,764 femoral heads. Minerva, “Orthopaedic Surgeons at the Henri Mondor Hospital in Crèteil, France, stopped using Zirconia implants” (1999) 199 (319) BMJ, 1278. Here is is reported that a retrospective review had demonstrated that more than one third of implants had failed within 8 years of implantation. See also Editorial, (1999) 81B JBJS, 835-42. 96 E Swarts, SJ Miller, CV Keogh, G Lim and RJ Beaver, “Fractured Whiteside Ortholoc II Knee Components” (2001) 16 (7) J Arthrop, 927-34. This paper reported a comprehensive failure analysis which was performed on six femoral components and one tibial component that had fractured in service. All components were Whiteside Ortholoc II Total Knee Arthroplasty Components, manufactured from cast cobalt–chromium–molybdenum alloy and porous coated. Fracture surface analysis reviewed fatigue- induced failure in all cases. The authors recommended that limitations of cast cobalt-chromium-molybdenum alloy in weight- bearing applications must be emphasized, particularly when important determinants, such as design, metallurgy and specific clinical factors, are less than optimal (my emphasis). This study was undertaken in 2000 at the Department of Medical Physics, Royal Perth Hospital, Western Australia. 97 Intramedullary refers to the internal cavity of a long bone. This cavity is popularly known as the “marrow cavity”. Fractures of long bones can be stabilised by the fixation that is achieved by the introduction of a fracture fixation intramedullary nail into this cavity. 98 Personal Communication, Professor E Sherry, Senior Lecturer in Orthopaedic Surgery, The University of Sydney, 15 February 2003. 99 TGA Device Incident Report (DRI) 13749. In March 2002 Zimmer Australia Pty Ltd issued a Hazard Alert following the reported incidence of fracture of Alumina Acetabular Cup Articulating Liners.
2.18 extremely emotional and physically traumatic experience for both the patient and the surgeon.
2.37 Other product liability issues may become dominant that can be cause for
bankruptcy in the surgical implant manufacturing industry101, and be cause also for a critical shortage of raw materials that are necessary for the
fabrication of many implantable devices.102 Suppliers of raw materials, and those that undertake research, have found that although they are not manufacturers of devices using their products, they can be named as
defendants103 in law suits brought by people claiming to be harmed by the
devices.104 Another consequence is that if exposure to liability can be traced back to a company that has provided the raw materials used in the fabrication of a device it can be that the consequences may include the deterrence of research and development to a point where advancement and innovation can be seriously diminished.
2.38 In the early 1980’s a Temporo-Mandibular Joint Interpositional Implant
(Vitek), 105 was made available to the world market. Vitek was manufactured
from the material known by its commercial name as Proplast106, (or Polytetrafluorethylene). The Proplast Temporo-Mandibular Joint Interpositional Implant was later identified to be associated with unacceptable jaw pain, jaw noise, stiffness of jaw movement, and
100 In March 2002 Zimmer Australia Pty Ltd also issued a Safety Alert following the occurrence of a fracture of a Femoral Modular Revision hip stem prosthetic device. Zimmer International has received 21 reports of FMR stem failure by fracture. To date only one failure has been reported in Australia out of 254 units implanted. 101 In June 1970 the A H Robins Company, manufacturers of pharmaceuticals, acquired rights to a new intra-uterine contraceptive device for women, the Dalkon Shield. A defect in the Dalkon Shield resulted in serious injury to a considerable number of its users. In June 1974 A H Robins suspended distribution of the Dalkon Shield in the USA but stopped short of recalling the device. Eleven years later the A H Robins Company faced bankruptcy following 6000 claims filed in U.S. Courts. 102 Montell North America Inc - one of only two raw material suppliers of Ultra High Molecular Weight Poly-Ethylene (UHMWPE) has informed medical device manufacturers that they will no longer supply UHMWPE material for use in surgical implants. Citing fears of product liability litigation, the decision pushes the long-predicted problem of availability of biomaterials closer to the shortage stage and to a possible crisis. This leaves Hoechst Celanese Corp (German-based) as the sole supplier of UHMWPE. 103 See Artiglio v Corning Inc. 18 CAL 4th 604 (1998) - Here was an attempt to hold Dow Chemical responsible in the situation when Dow Corning had become bankrupt. Dow Chemical never manufactured or sold anything. However they were responsible for toxicological testing which was undertaken on behalf of Dow Corning. The lessons of Artiglio are that non-manufacturers can be liable to consumers for negligent testing of products providing the plaintiff can demonstrate the essential element of negligent undertaking, including a sufficient connection between the services rendered and the plaintiff's injuries. If no connection exists, then of course liability will not attach. 104 In the USA legislation to end this problem has languished in Congress - The Biomaterials Access Availability Act 1995 (US) is part of product liability Bills that were approved in the House (HR 956) in March 1995 and the Senate (S 565) in May. For further information see Editorial, “Biomaterials Supply Line Shrinks” (1996) 44 (1) American Academy of Orthopaedic Surgeons Bulletin. 105 The temporo-mandibular joint is the jaw joint. 106 Proplast is a polymer material. Polymers are materials generally known as plastics. 2.19 osteolysis.107 The Du Pont organisation supplied the Proplast for the Vitek implant. Du Pont was forced to spend (approximately) US$8 million per year defending the Temporo-Mandibular Joint litigation that followed. Because of this experience Du Pont refuses to sell biomaterials to the
medical device industry.108
2.39 In contrast to the information that is publicly available in regard to orthopaedic product related episodes of failure, it is illuminating to review the most recent edition of the Australian Orthopaedic Association National
Joint Replacement Registry109 (AOANJRR) where the reported statistics support a view that there is a significant orthopaedic product liability issue in Australia that is not generally recognised.
2.40 The 4th Annual Report (2003) of the AOANJRR lends credence to a conclusion that the breakage or wearing out of surgically implanted orthopaedic devices have been more frequent events than has otherwise th been reported.110 The 4 Report of the AOANJRR was prepared using data collected during the period 1 September 1999 to 31 December 2002 th inclusive.111 Further, the 4 Annual Report of the AOANJRR, on page 5, records that 52,788 hip and knee arthroplasty (replacement) procedures were undertaken in Australia during the period 1 July 2001 and 30 June 2002. This included 26,689 hip replacement procedures, and 26,089 knee replacement procedures.
2.41 The AOANJRR reviewed the indications for revision hip replacement and for revision knee replacement on pages 21 (Table H8) and 58 (Table K10)
107 The FDA issued a Safety Alert in December 1990, approximately eight months after Vitek issued a safety alert (in March 1990). Customer notification did not take place until June of 1992. See also Editorial, “Temporo-Mandibular Joint (TMJ) Implants products liability litigation” (1996) 8th Cir CCH Product Liability Reporter. 108 For further reading see A Hallab, JJ Jacobs, J Black and MJ Iverson, “Biomaterials Crisis Looms” (1997) 45 (1) American Academy of Orthopaedic Surgeons Bulletin; Editorial, “An Impending Crisis Involving Biomaterials” (1994) 58 Ann Thorac Surg, 1571. Hoechst and Celanese are other manufacturing organisations that have withdrawn polyacetyl resin (Delrin) from the medical device industry. Delrin has previously been used for the fabrication of prosthetic hip replacement devices. 109 Australian Orthopaedic Association National Joint Replacement Registry, 4th Annual Report, 2003, hereafter called “the Australian Registry”. See also SE Graves, D Davidson, L Ingerson, P Ryan, EC Griffith, FJ McDermott, HJ McElroy and NL Pratt, “The Australian Orthopaedic Association National Joint Replacement Registry” (2004) 180 MJA, 31-34. 110 The incidence of orthopaedic implant device failure in Australia is not dissimilar to that identified overseas. In the United Kingdom, the Trent Knee Arthroplasty Register identified that of 949 revision knee arthroplasties performed between 1992 and 1999, the indication for salvage surgery in 8% of cases, i.e. 76 implants, was device failure, as distinct from biological causes such as infection. For further information see CN Esler and WM Harper, “Trent Arthroplasty Audit Group” (2003) 85B (1) JBJS. The Trent Arthroplasty Audit Group is based at the University of Leicester, Groby Road, Leicester, LE3 9QP. 111 The Australian Registry now provides statistical information that is contributed to by 296 hospitals across the nation. 2.20 respectively. These are operations performed for the salvage of the failed surgically implanted prosthetic joint replacement. During the period of review, 7,216 revision hip replacement procedures, and 4,859 revision knee replacement procedures were undertaken. A total of 12,075 revision hip and knee arthroplasty procedures were performed during the observation period. The pre-operative indication for revision arthroplasty was Implant Breakage in 417 cases (3.5%) and Implant Wear in 865 cases (7.2%). Device breakage and material wear were recorded as causal for 1,282, or 10.6% of all revision hip and knee procedures. A further 1,097 (9.1%) revision hip and knee procedures were recorded as being required for Articulating
Bearing Dislocation,112 (See Tables 1.1, 1.2 and 1.3).
Table 2.1 Implant Breakage Hips n-7216 Knees n-4859 Total n-12075 Number % Total Hip Replacement – Acetabulum 90 0.8 Total Hip Replacement – Femoral Stem 50 0.4 Total Hip Replacement – Femoral Head 9 0.1 Total Knee Replacement – Tibial component 148 1.2 Total Knee Replacement – Patella component 85 0.7 Total Knee Replacement – Femoral component 35 0.3 TOTAL 417 3.5
Table 2.2 Implant Wear Hips n-7216 Knees n-4859 Total n-12075 Number % Total Hip Replacement – Acetabulum 245 2.0 Total Knee Replacement – Tibial component 525 4.4 Total Knee Replacement – Patella component 95 0.8 TOTAL 865 7.2
112 The cause for Prosthetic Articulating Bearing Dislocation are legion and do not necessarily reflect matters such as poor design and unfitness for purposes. The details of these statistics are tabulated in Tables 2.1, 2.2 & 2.3. 2.21 Table 2.3 Articulating Bearing Dislocation Hips n-7216 Knees n-4859 Total n-12075 Number % Total Hip Replacement 1065 8.8 Total Knee Replacement 32 0.3 TOTAL 1097 9.1
The AOANJRR statistics demonstrate that orthopaedic implant breakage113 is less a cause for the need for device explantation and revision arthroplasty (of the hip and knee joints) than has been the wearing out of the material used for fabrication of the implant articulating surfaces.
CASE STUDIES
2.42 The statistics so far presented in this chapter should leave the reader with little doubt that implanted surgical devices are too frequently associated with adverse events. There are clearly a great many potential causes for the failure of any implanted device and it is not the purpose of this discussion to become concerned with such biological causes as infection and thrombosis.
Though serious events114, they are not relevant to our argument. The important issue here is to focus on those potential causes for product failure
that can be associated with the use of the non-standard115 or defective
product.116
113 Personal Communications – (1) Ms Lisa Ingerson, Co-ordinator of the Australian Registry advised me on 16 October 2003 that the collected data would not permit the identification of the type of implants that had suffered failure as it remains the case that most of the implants were inserted prior to the commencement of the Register and it is for this reason that the exact description of the failed implant, and of the manufacturer, can not be determined. (2) Professor Stephen Graves, Project Director, Australian Orthopaedic Association National Joint Replacement Registry, dated 5 February 2003. Prof Graves has advised that the AOA NJRR has taken every care to ensure the data supply are accurate but does not warrant that the data are error-free and does not accept any liability for errors or omissions in the data. The additional information provided by Prof Graves in this communication included details relating to the breakage of knee implant components. The information provided by Prof Graves did not include any reference to failure of any Whiteside Ortholoc II knee components. Vide supra n.95. 114 See S Mayor, Editorial, “Medical Injuries in US Hospitals cause more than 30,000 deaths each year” (2003) 327 (7420) BMJ. Mayor cites a recent article in the JAMA (2003) Vol 290,1868-74, reporting that post-operative sepsis - recorded in 2,595 patients, had the biggest impact resulting in hospital stays of almost eleven days longer than inpatients without this complication. This single complication for surgery increased charges by US$57,727 (A$82,467; £34,700; €49,000) per patient and the risk of death after surgery by 21.9%. These findings permit the estimation that approximately 3,000 Americans died each year due to post-operative sepsis. 115 See Burton's J Definition of Defective Product in A & Anors v National Blood Authority & Anors (2001) 3 All ER 289. See also Ch 5. 116 TPA s.75AC defines the term "defect" for the purpose of this section. Goods are defective if their level of safety is not such that persons are generally entitled to expect: s.75AC(1). See also Ch 5. 2.22 2.43 It is appropriate now to consider a number of case studies that can, like hypotheticals serve to stimulate debate of matters such as causation and exposure to liability. I am an Orthopaedic Surgeon and, for that reason alone, discussion here will be restricted to those matters relating to defects in orthopaedic implant design, manufacturing or presentation, such as size and shape of the device for a particular patient or purpose, to failure of the implant material of fabrication by fracture, wear or disassembly, and to the role of manufacturers, sponsors, healthcare institutions and providers.
2.44 In each event of orthopaedic device failure there is an exposure to liability. Frequently, allegations can be sustained that it becomes appropriate for exposure to liability to be shared by more than one person or organisation. The previous discussion has been delivered in general terms. It can be instructive to move from generalities to a consideration of the individual, and often isolated, product-related event. This can allow there to be a dissection with the medico-legal scalpel to expose where there might be found a need for accountability. Let us consider 3 separate scenarios. It is possible in each to recognise one or more persons or organisations - from inventor, through research department, to manufacturer (and sponsor), clinical investigator, hospital, surgeon and patient - where exposure to liability might become a concern.
Case 1 - Inappropriate Assembly of Hip Implant Components.
This case concerns the inappropriate assembly of components of a Modular
Implant - a device of many parts.117
117 The modular design of orthopaedic implant devices permits the interchange of components. The modular design of the Acetabular Hip Implant devices permits the interchange of an articulating liner component in those cases where a new bearing surface is required, e.g. after liner wear or fracture. Modularity permits the articulation liner to be replaced without the disturbance of a well-fixed acetabular shell. However, the modular component is susceptible to a number of problems which are associated with modularity itself. These problems include, backside wear of polyethylene liner against the inner surface of the metal shell. For further information see OL Huk, M Bansal, M Betts, SM Rimnac, JR Lieberman, MH Huo and EA Salvati, “Polyethylene Metal Debris Generated by Non-Articulating Surfaces of Modular Acetabular Components” (1994) 76B JBJS 568-74. For further information see RL Barrack, DW Burke, SD Cook, HB Skinner and WH Harris, “Complications Related to Modularity of Total Hip Components” (1993) 75B JBJS, 688-92; WWBrien, EA Salvati, TM Wright, CL Nelson, DS Hungerford and DL Gilliam, “Dissociation of Acetabular Components after Total Hip Arthroplasty. Report of Four Cases.” (1990) 72A JBJS, 1548-50; RF O'Brien and D Chess, “Late Disassembly of a Modular Acetabular Component. A Case Report” (1992) 7 J Arthroplasty, 453-55 and MJ Star, CW Colwell, WF Donaldson and RH Walker, “Dissociation of Modular Hip Arthroplasty Components after Dislocation. A Report of Three Cases at Differing Dissociation Levels” (1992) 278 Clin Orthop, 111-15. 2.23 Progressive disabling arthritis of the hip joint caused a patient to require a total hip replacement procedure to be undertaken. The operation was undertaken in a suburban Sydney hospital, seemingly without complication, by a previous teacher, colleague and friend. Post-operatively an adverse event was recognised following radiographic evaluation. The x-rays taken post-operatively demonstrate that the device articulation consists of a small 32mm femoral ball that is contained within and articulating with a larger 38mm cup device. The diametric combination of the two prosthetic components is not compatible with any normal function. Major revision
salvage surgery was required and that surgery was successful.118
The exposure to liability in this case does at first appear to be apparent. However the chain of events preceding the assembly of the surgical device by the surgeon are complicated by the fact that the modular implant devices used had been repackaged by the Australian distributors of the product and by the hospital.
Case 2 - Ceramic Component Fracture
This case concerns the breakage of a ceramic acetabular hip implant device.
A physically fit and active lady underwent a total hip replacement procedure when aged in her mid-60s.
The surgical procedure and the lady's post-operative progress were uncomplicated. Six months after the surgery the patient was able to climb the Sydney Harbour Bridge. The patient's continuing progress was uneventful until, almost one year after the operation, she bent forwards and to the left, to retrieve a book from the floor. A popping sensation in the groin region was experienced and thereafter a slight squeak was sensed when walking. These events went largely ignored by the patient until she was routinely reviewed approximately five weeks after the incident. The patient
118 The major revision surgery included replacement of the acetabular (cup) device and insertion of a new ceramic femoral head component. The patient was my mother and I performed the revision surgical procedure. 2.24 was observed to walk with an audible squeak but otherwise her gait and hip joint movements were normal. However, a routine x-ray confirmed that the ceramic articulation liner of the acetabular implant device had fractured and that fragments of the ceramic material were present within the joint cavity.
Explantation of the device and revision surgery were indicated and successfully undertaken.
A Device Incident Report was sent to the TGA in February 2001.119 The TGA response to this Incident Report was received ten months later. Broken fragments of the implant were not examined by the TGA but their report does cite the identification of a similar report, dated 3 January 2001, which related to a component from another lot. The TGA report continued -
"…there appears to be only two reported cases of an Alumina Acetabular Liner fracture worldwide (including this one) and the liners came from separate lots. This suggests that the fractures were not caused by batch- related problems and that neither remedial, nor regulatory action is indicated at this stage. No further investigation will occur at this time, however the TGA will continue to monitor the rate and pattern of occurrence and may reopen the file as appropriate."
It is interesting to observe that, prior to seeing the TGA report, I was able to identify two other similar incidents. In reality there have been 4 device fracture incidents, each involving implants marketed by two separate
corporations.120 The first conclusion might be that there may be no more than coincidence linking these events. However, within the fabric of this case there is a common thread. It is evident that one manufacturer is based in the United States and that the second manufacturer is based in Italy. Both manufacturers assemble their acetabular implants using ceramic liners that
119 TGA DIR 12501. 120 Implex Corp, 80 Commerce Drive, Allendale, New Jersey, NJ 07401-1600, USA and Lima-Lto Spa Medical Systems, via Nazionale 36, 33030 Villanova, San Danieledel, Friuli, (Udine, Italy). 2.25 are manufactured by a third organisation in Germany.121 In the event all four
ceramic liners were manufactured by the same manufacturer.122
The concept of coincidence with respect to causation can in this event be considered to be less persuasive and sustainable. It is evident that failure of this particular orthopaedic device has been more common than has previously been acknowledged. This conclusion can be further reinforced by the fact that the Zimmer Corporation in Australia has recalled the implant device following the occurrence of two further fracture incidents in
Australia123 and four fractures in the United States.
All of these reports permit the conclusion that there have been at least 10 episodes of failure of this surgically implantable device. The cause for the ceramic material failure has not been confirmed and it remains a matter for speculation as to whether the implants have failed because of technical (surgeon-related) reasons or as a result of device failure that can be
associated with a product defect that is associated with a design defect.124
121 CeramTec AG, Medical Applications Division, Fabrikstrase 23-29, D-73207, Plochingen, Stuttgart, Germany. 122 The breakage of modular acetabular liner components has been the subject of many publications. See M Goossens, “The Transcend Alumina Ceramic Hip Articulation System. Surgical Technique - Preliminary Results of 51 Cases” in Laurent Sedel and Gerd Willmann (eds) Reliability and Long-Term Results of Ceramics in Orthopaedics (1999) 29-32; R Alessandrini, G Ghidoni, E Tinelli, G Giaretta, “Long-Term Experience with the GSP & Anca Fit System” I Laurent Sedel and Gerd Willmann (eds), Reliability and Long-Term Results of Ceramics in Orthopaedics (1999) 33-34; and N Bergman and DA Young, “The Rationale, Short-Term Outcome and Early Complications of a Ceramic Cup in Total Hip Arthroplasty” in Laurent Sedel and Gerd Willmann (eds), Reliability and Long-Term Results of Ceramics and Orthopaedics (1999) 52-56. The three reports cited here were all scientific presentations given by invited speakers at a Seminar sponsored by the CeramTec AG organisation, the manufacturer of the products. These three reports appear to suggest that ceramic device breakage is more a technical failure (surgeon-related) than an implant failure (product defect-related). 123 Zimmer Australia is the domestic corporation representing Zimmer Inc, 345 East Main Street, Warsaw, IN46580 USA. The Zimmer organisation now distributes the acetabular implant manufactured by Osteonics Inc, New Jersey, USA. A personal communication dated 31 July 2003 from Mr Schaffer (Zimmer Australia Hip Product Manager) confirms that Zimmer Australia has issued a Hazard Alert (DIR13749) following consultation with the TGA. For further information see TGA News Issue 40, March 2003 and TGA News Issue 41, July 2003. 124 A persuasive hypothesis, though not proven can be constructed to support a view that a design defect is causal for the failure of this implant. There is not the scope in this Thesis to describe in detail the engineering basis for the hypothesis. In summary though the implant is fabricated from three different materials, ultra high molecular weight polyethylene (UHMWE) tantalum, and alumina ceramic, and there is a significant modulus mismatch between these materials that varies from a Young's Modulus (E) of 2.5 to 400. The cyclic loading and unloading environment associated with walking is cause for there to be a significant alternating environment of load that is applied to the implant. In the circumstances associated with the design and use of the implant it is permissible to form a conclusion that the high modulus ceramic liner may be unable to always structurally cope with the deflections associated with the cyclic nature of the gait pattern. Alumina ceramic material is a very brittle material that is well known to function poorly in conditions associated with a deflection or bending load environment. This is in contrast to the significant defamation that is permitted by the much less stiff (more elastic) materials UHMWPE and tantalum. 2.26 Case 3 - Orthopaedic Implant Packaging Defects
In 1997 a female patient underwent a total hip replacement procedure using
an implant device manufactured by the Osteo AG organisation.125
The operation proceeded in a routine fashion and the patient's femur (thigh bone) was prepared for the implantation of the prosthetic femoral stem device. The surgical preparation of the patient's femur confirmed that the size of the implant was as predicted during the pre-operative planning
procedure126 The appropriate implant was chosen and the package containing the device was opened. On inspection the packaging was correctly labelled
as containing a Prophor® Titanium Hip Stem.127
However further inspection confirmed that at each end of the box the
labelling included different catalogue numbers.128
Closer observation confirmed that one of the seals had been broken129 and replaced in a manner creating a double seal - as if the container had been resealed.
125 Osteo AG is a manufacturer of joint reconstruction products that is based in Selzach, Switzerland - Bohnackerweg 1, Ch-2545 Selzach, Switzerland. 126 The size of the implanted orthopaedic device can generally be predicted pre-operatively using specially designed templates that are superimposed over the standard pre-operative x-rays. The process of pre-operative templating does more often than not accurately predict the size of the implant that will be required. 127 Size 150mm long/Morse taper cone 12/14. 128 The label at one end of the box details the catalogue number as 213150 and at the other end of the box details the catalogue number as being 280025. The lot number is described as being 1013. 129 In April and May of 2003 the TGA commenced a review of the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods. It is proposed that compliance with the Code of Practice for Tamper-Evident Packaging (TEP) of Therapeutic Goods will be mandatory under Therapeutic Goods Legislation and that there will be a one-year transition period during which sponsors will need to ensure compliance. The Code of Practice establishes a national requirement for TEP for Therapeutic Goods. This requirement will improve the security of Therapeutic Goods supplied in Australia and will increase the likelihood that consumers will discover if a product has been tampered with. This Code of Practice is underpinned in Legislation as a standard made under the TGAct and as such sponsors have a legal obligation to comply with this provision. TEP means that packaging has an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible or audible evidence to consumers that tampering may have occurred. For further reading see Improving Tamper-Evident Packaging (1992), Jack L Rosette, Technomic Publishing Co. Pennsylvania USA; Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002); ISO 13485 Quality Management Systems - Medical Devices - Systemic Requirements for Regulatory Purposes. The Code of Practice for the TEP of Therapeutic Goods (Ed 1, June 2003) has been developed under the direction of the Industry Government Crisis Management Committee (IGCMC), through its Sub-committee on Tamper-Evident Packaging. The Code of Practice is published by the TGA on behalf of the IGCMC. The document is based on the guideline for the Tamper-Evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices which was adopted on a voluntary basis by industry associations in December 2000. This guideline was implemented with a three-year transition period with the intention that compliance would become mandatory under the TGAct at the end of the three-year period. On the recommendation of the Therapeutic Goods Committee the Code of Practice became mandatory under Therapeutic Goods Legislation as of 01/01/04 with a one-year transition period during which sponsors will need to ensure full compliance. The IGCMC was established by the TGA to develop strategies aimed at preventing, or minimising the effect of, tampering of Therapeutic Goods. The IGCMC provides guidelines for the industry that set out the requirements for TEP. The IGCMC Guidelines have been adopted on a voluntary basis
2.27 When the box was opened it became evident that the contents of the sterile inner packaging was not a femoral stem device but was, in contrast, a
prosthetic stem device used for insertion into the humerus130 during the undertaking of a total shoulder replacement procedure! In the event the appropriate implant for completion of the operation was not available and there was then no other alternative but to adjust the preparation of the patient's femur to permit the implantation of an alternative device that was necessarily one size larger than had previously been determined to be the best fit. This is a difficult surgical undertaking that can be associated with undesirable complications that can particularly be associated with fracture of the femur and with adverse events that can be associated with prolongation of both the surgical procedure and the anaesthetic. The operation concluded successfully though the outcome could have been very different.
On 7 November 1997 a second adverse event occurred that was associated
with a packaging defect.131 On this occasion a Concord Modular Shoulder Replacement procedure was being performed. The patient's humerus (upper arm bone) had been appropriately prepared for the implantation of a humeral
stem prosthetic device.132
The outer container of the packaging was correctly labelled.133 After opening of the outer packaging it was evident that the inner packaging containing the sterile implant was found to have a split along the side wall of the plastic
container.134
by the Australian Self-Medication Industry (ASMI), the Complementary Healthcare Council (CHC) and the Medical Industry Association of Australia (MIAA) (in December 2000). 130 For Total Shoulder Replacement. The humerus is the bone of the upper arm and the proximal regions of the humerus, the humeral head, articulates with the glenoid surface of the scapula (shoulder-blade) to form the gleno-humeral (shoulder) joint. 131 This event is subject of a TGA device incident report, DIR 10528. 132 Pre-operative templating and surgical preparation confirmed the size of the device to be 150mm long/diameter 12mm. 133 Concord Shoulder Humeral Shaft - 150mm 812, Catalogue No 280020, Lot 1016. 134 The inner container is of a design characterised by there being two plastic blister packages, one within the other. A blister packaging means a package in which one or more dosage, units or devices are enclosed between a pre-formed tray with individual pockets and a lid of material which maybe flat or shaped. The material of the tray is usually different from that of the lid. It must be cut or torn in order to access the contents. The Australian Standard, AS 3872 1991 (identical to and reproduced from ISO 6018; 1987) prescribes the general requirements of packaging (para 5.1 - 5.4) and the labelling (para 6A-6I) and the Standard contains a number of definitions. Sterile: In practice the condition of a product that has been subjected to a validated sterilisation process and maintained in this state by a suitable protection; Unit pack - This is a pack containing a single unit or kit and when containing sterile devices is intended to maintain the sterility of the contents; and The sterile pack comprises an inner and outer container. The inner container is in direct contact with the implant and the outer container envelops the inner container such that sterility and the integrity of the contents are maintained. The inner and the outer container may be described as "blister" packs. 2.28 It was evident that both inner plastic blister containers were split at identical locations. Furthermore, inspection of the implant, following its removal from the inner container, revealed that there was an area of staining, with the appearances of corrosion, at the proximal regions of the device. In the event the implant device could not be inserted and it was necessary to adjust the preparation of the humeral shaft to accommodate an implant that was necessarily one size larger than predicted.
This device incident was reported to the TGA and following their recommendation the defective packaging and implant were sent to the
manufacturers135 for their examination and for analysis.
Three months later, on 27 February 1998, a report was received.136 The damage to the two inner plastic blister packages was described as thought to be -
"…due to an unfortunate sequence of impacts on the box during transportation."
The “sequence of impacts” must be events that rarely occur and should be regarded as unusual as by its very nature a blister package is one that consists of a pre-formed tray that is designed to protect the contained device from movement and from damage.
The abnormal appearance of staining at the proximal regions of the humeral
stem implant was examined using Auger Electron Spectroscopy (AES).137 This was undertaken at the Swiss Federal Laboratories for Materials Testing
The Australian & New Zealand Standard, AS/NZS 2817:1997 sets out the procedures for handling orthopaedic implants from receipt at the Healthcare facility until they are implanted or discarded. The document is a guidance on the care and handling of orthopaedic implants and is technically equivalent to and reproduced from ISO 8828:1988. With regards to sterile implants, para 3.1.2 states that "The packaging of pre-sterilised implants shall be left intact until the time of use. The packaging should be inspected for damage. If damage is found, the implant should be considered unsterile. The implant then should either be returned to the supplier for reprocessing, or, if appropriate, be repackaged and resterilised in the operating area." Para 3.7 refers to the appearance of the implant and determines that "Implants that show signs of surface or configuration damage shall be discarded. 135 See vide supra n.133. 136 Report provided by Erhard E J Hüsler, Projects/Regulatory Affairs, report date 27/02/98 - Osteo AG, Bohnackerweg 1, CH-2545, Selzach, Switzerland. 137 Auger Electron Spectroscopy (AES) is an analytical method to determine the elemental constitution of the first nanometer of a surface with a lateral resolution of less than a micron. 2.29 and Research. The AES analysis concluded that it was "uncertain" of the
cause for the appearance.138
These two incidents represent events that are characterised by defects of packaging and presentation. The unique circumstances associated with the undertaking of major surgical procedures can permit such events to have the potential to cause an outcome that can be associated with significant morbidity and even mortality. The reasons for the packaging and presentation defects, in both incidents, remains unknown but it is permissible, with the bias of hindsight, to speculate as to the causes and to ask the questions - were the packaging defects present at the time of supply or had the packages been exposed to tampering?
CONCLUSION
2.45 It is clear, and the statistics permit no other conclusion, that the failure of surgically implanted devices, is by any standard, not an uncommon event. The magnitude of some of these events have been extreme both in terms of the cost to society, the number of claimants, and the individual suffering that, in each case, is almost an obligatory outcome. The suffering of individuals has attracted far less attention than have massive class actions.
The individual event though is no less important.139 It is a worrying conclusion that the incident of implantable surgical device failure is probably more frequent than is reported. Implanted device product failure and the need for explantation and for revision (salvage), surgical intervention are both serious adverse events. The former is product liability and the latter is injury.
2.46 Whilst there can be some comfort derived from the fact that in Australia there are, at the present time, a number of voluntary implant tracking
138 The AES Report was provided by Drs R Hanert & M Roth of EMPA, Überlandstrasse 129, CH-8600, Dübendorf, Switzerland. The Report identified there to be increased carbon density at the site of implant staining with no evidence of any increase of oxygen level nor evidence of any organic residues. The Report concluded "as for the origin of the carbon stain we remain uncertain for the causes". 139 See Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014. 2.30 registries140 there remains no evidence of any satisfactory two-way communication between the various data collecting organisations and the
regulatory authority, the TGA.141 It remains the case that the many organisations concerned with the monitoring of surgically implantable devices are not compelled to communicate any information to any stakeholder and there does continue to be a lack of the necessary regulatory
authority for this to be the case142. Adverse events associated with the failure of surgically implanted devices do, for the most part, remain only a concern that is a cause for individual or craft group interest. In spite of recent reforms to the regulatory system this attitude is permitted to persist.
2.47 The regulation of implantable surgical devices in Australia and the identification and reporting of adverse device related events continues to reflect the delicate balance that exists between an environment of self regulation and the adoption of a mechanism for the reporting of adverse events that can be both mandatory and without risk of exposure to liability to the individual reporter or reporting organisation. It is permissible to form a conclusion that there should be a National Register of Implanted Surgical Devices that requires the reporting of all episodes of surgical device implantation and the mandatory reporting of all surgical device-related incidents as they become known. It should be the case that every
stakeholder, including the patient as consumer143, be required to notify the National Register of any event that might be interpreted as adverse or associated with unrealised expectations. That the patient should have the right to report to the National Register finds support in the experience of the United Kingdom Medicines and Health Care Products Regulatory Agency (MHRA) where patients are able to report their own adverse drug reactions (ADRs). Though patient reporting of ADRs to the MHRA concerns only
140 Australian Orthopaedic Association National Joint Replacement Registry, The Joint Replacement Assessment Clinic (JRAC) at the Royal Perth Hospital, the Cardiac Surgery Register, the Australian & New Zealand Heart Valve Registry, the Australian Corneal Graft Registry, the NSW Breast Implant Registry, and the Australian Safety & Efficacy Register of New Interventional Procedures– Surgical (ASERNIPS) of the Royal Australasian College of Surgeons. 141 The Annual Report of the Australian Registry is sent to the TGA - Personal communication Lisa Ingerson, Registry Co-ordinator, 16/10/03. 142 Ian MacFarlane, House of Representatives Hansard, 6 August 2001, at 29189. 143 Following an initiative of the Australian Council for Safety and Quality in Health Care consumer reporting of adverse drug reactions is a reality in Australia. The Adverse Medical Event (AME) telephone hotline has been operated by Clinical Pharmacists at the Mater Health Service in Brisbane, Queensland since October 2003. The Adverse Drug Reactions Advisory Committee
2.31 pharmaceutical products the experience in Holland144 and other countries does support a view that patients should be involved in any national register undertaking.
2.48 This review of the magnitude of the problem is cause for the author to reflect
on the far-reaching observations of Marcia Angell145 and others.146 Many important scientific and legal questions are raised in all of the events that have been described and these concern:
(a) The place of regulation in our society by competent authorities such as the TGA that have the responsibility to regulate the safety of therapeutic surgical devices that are for the most part relatively safe;
(b) The impact of tort law that predominantly compensates
victims and only secondarily encourages safety147;
(c) The sometimes marginal and ambiguous role of scientific evidence in our society and the impact of science in the Court room where scientific evidence leads to conclusions and where an Expert's conclusions become legal evidence. The answer though in each case can be very different;
(d) The impact of product liability litigation on the value of
manufacturing corporations148 and for the potential for there to be a pervasive effect of the profit motive over some aspect of treatment where that treatment involves the implantation of surgical devices;
(ADRAC) has concluded that consumer reports are received more quickly and that a better account of the event is provided. See Editorial, (2004) 27 (2) Australian Prescriber, 38. Further information is available online at www.safetyandquality.org.au 144 TCG Egberts, M Smulders, FHP De Koning et al, “Can Adverse Drug Reactions be Detected Earlier? A Comparison of Reports by Patients and Professionals” (1996) 313 BMJ, 530-1; see also K Van Grootheest, L De Graff, De Jong Van Den, LTW Berg, “Consumer Adverse Drug Reporting: A New Step in Pharmaco Vigilance?” (2003) 26 Drug Safety, 211-17. 145 See Marcia Angell, vide supra n. 12, 24-30. 146 See PH Rubin, “Are Pharmaceutical Advertisements Deceptive?” (1994) 49 (1) Food and Drug Law Journal, 7-21; PH Rubin and D Prince, “The Effects of Product Liability Litigation on the Value of Firms” (2000) Emory University Department of Economics - Working Paper No 00-08. Paul H Rubin is the Samuel Candle Dobbs Professor of Economics and Law at Emery University in Atlanta, Georgia, USA. Professor Rubin's writings on the fiscal damage to manufacturers are very relevant to any consideration of the collateral fiscal damage that might be suffered by the manufacturers of surgical devices that can be associated with product liability litigation. 147 See PH Rubin, “Why Regulate Consumer Product Safety” (1991) 14 (4) Regulation, 58-63. 148 See vide supra n.145. 2.32 (e) The potential for surgical product liability litigation to deter research and development and also innovation, and to impact on the supply of materials to the manufacturing industry; and
(f) The need to institute a Register of Implanted Surgical Devices and the construction of a system that will improve safety and quality of care that will include an effective method for the reporting of adverse events that engenders compliance, that promotes openness and accuracy, that is non-punitive, that will identify trends at an early stage, and that also will provide the opportunity for consumers to report their own individual adverse or unexpected experiences.
2.49 As we have seen, it has unfortunately been the case, and it remains so, that it is only the catastrophic (in numerical terms) failure of a surgical implant device that raises concern and causes alarm bells to ring. The isolated report of an implanted surgical device failure is probably no less important than is the more general catastrophe. Furthermore there is no doubt that the method of reporting of adverse events, and the usage of the information, has historically been associated with too many deficiencies and remains for this reason very much open to criticism. In recognising that the lack of any timely dissemination of information is a major problem, we have to ask ourselves the question as to how it can be done better. It is the author's view that the fundamental answer to this question is the establishment of a
National Register of Implanted Surgical Devices.149
149 See The Beat Her Pacemaker-Maker Skipped, The Sydney Morning Herald (Sydney), 5th August 2005, News 5. This article concerns Mavis Maurer who learned that her heart pacemaker might be faulty after her son found a reference on the internet. Mrs Maurer is among 500 Australian patients who need to have there pacemaker devices checked, and possibly replaced, after a recent medical device hazard alert (20th July 2005) was issued by the TGA. A hazard alert is the issuing of procautionary information about an implanted device where it has been proven that there is no stock to be recalled and where all effected devices have already been implanted. Unfortunately there is no record of who or where the devices are as there is no central registry of the implanted pacemaker devices. This contemporary case illustrates so well the potential benefits of a National Register of Implanted Surgical Devices. For further information see www.tga.gov.au/recalls/2005/guidant.htm. 2.33 CHAPTER 3
PRODUCT LIABILITY
in
AUSTRALIA INTRODUCTION
3.1. The Australian community expects that all consumer1 products in general,
and that medicines and implantable surgical devices2 in particular, are safe and of a high quality, and are manufactured to a standard that is at least equal to that of comparable countries. The regulation of therapeutic goods and medical devices in Australia has always been, and is particularly now,
of great public concern.3 That concern is especially evident following the
recall of Pan Pharmaceutical products4 and the recent recall of the arthritis
drug Vioxx.5 The significance of the Pan Pharmaceutical and the Vioxx recalls is that they are contemporary events and that they are the two largest recalls of any therapeutic goods in the world.
3.2. Notwithstanding the recall of Pan Pharmaceutical products and Vioxx it remains the case that product-related injuries in Australia have, and continue to be, too frequently associated with unintentional injuries. The
Directions in Injury Report6 states that product-related injuries are causally associated with 70% of all unintentional injuries that require medical treatment. Of these consumer product-related injuries that require medical attention, 21% are directly related to a design failure or product
1 The concept of a consumer is not defined, as such, in the Trade Practices Act 1974 (Cth)(TPA). However, s 4B(1)(a) and (b) provide that a person shall be taken to have acquired goods or services as a consumer if: (i) the price of the goods or services was under $40,000; and (ii) the goods or services were ordinarily acquired for personal, domestic or household use or consumption and in the case of goods, they were not acquired for resupply or for being used up or transformed in business. The Sale of Goods Acts of the States and Territories define consumer contracts with a reference to private use and there is a monetary limit for goods in Victoria ($20,000) and South Australia ($40,000) but no limit in New South Wales or the Northern Territory. With respect to the consideration of patients as consumers see Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. Also “a person” is defined in s.22(a) of the Acts Interpretation Act 1901-1973 (Cth) to include a “body politic or corporate as well as an individual”. 2 Medical devices range from a tongue depressor to orthopaedic prosthetic artificial joints and heart pacemakers. Orthopaedic devices are not generally lifesaving but devices such as heart pacemakers are. The technology must be associated with public safety and for this reason all surgically implantable devices are subject to Therapeutic Goods Administration enquiry and approval. Medical devices are defined in s.41BD of the Therapeutic Goods Act 1989 (Cth) (TGAct). 3 Statement by Allan Griffin MP, then Opposition Parliamentary Secretary for Health, House of Representatives Hansard, 6 August 2001, p.29177, 22 August 2001, p.30038. 4 For further reading on the Pan Pharmaceutical recall see J Kellam, “Australia braces for fallout from complementary medicines recall” (2003) 14 (4) Australian Product Liability Reporter, 49-51. See also TGA Website: www.tga.gov.au. 5 Vioxx was recalled by the TGA on 1 October 2004 (R 2004/1226-9). The arthritis drug Vioxx may have been causally associated with 139,000 heart attacks, strokes and deaths. Dr David Graham, Associate Director for Science and Medicine at the US Food and Drug Administration described the incident as …"what may be the greatest drug safety catastrophe in the history of [the USA] or the history of the world.". Kay McNiece, TGA spokesperson, said "There had been 20 deaths in Australia that could have been attributed to even small doses of Vioxx – see, “Arthritis Drug Linked to Thousands of Fatal Strokes and Heart Attacks”, Sydney Morning Herald, 20-21 November 2004, New 3. 6 Source: Directions in Injury Prevention Report 1: Research Needs, 1999. This Report is produced by the National Injury Prevention Advisory Council and the Commonwealth Department of Health and Aged Care. 3.1 malfunction.7 This accounts for over 650,000 treated cases annually, of which (approximately) 42,000 (6.46%) result in hospitalisation and 490 (0.08%) result in death. Whilst it is acknowledged that these statistics do not relate directly to episodes of surgical implant device failure, the figures do reflect the fact that product failure and product-related injury are matters that are justifiably cause for considerable public attention. No less a cause for attention is the incidence of morbidity and mortality that is
associated with the failure of surgically implanted products. Defective8 implanted surgical devices can be a significant cause for morbidity and mortality and the statistics of this are presented in more detail in Chapter 2, The Magnitude of Therapeutic Goods Failure.
3.3. Therapeutic9 goods have been far more likely to be the subject of a product
recall10 than have most other consumer goods (See Table 3.1).11
7 The statistic lends support to the assumption that the remaining 79% of injuries are associated with misuse of the product by the operator and/or are associated with Acts of God. 8 TPA s.75AC defines goods as having a defect if their safety is not such as persons are generally entitled to expect and s.75AK sets out a number of specific defences available to manufacturers. The definition of defective can be unclear.One popular definition is that a product is defective in the event that it fails to live up to the reasonable expectation of the user. For a detailed discussion of the definition of defective see Ch 5. The issue for the purpose of Pt VA of the TPA is that which is considered “standard” may be “defective” if it is not as safe as persons generally are entitled to expect. The concept is that a product can be defective in the event that it fails to live up to the reasonable expectation of the user. The concept of the defective product as being a "non-standard" product can be identified in A & Anors v. National Blood Authority & Anors [2001] EWHC QB 446 and it is interesting to compare the attitude of Burton J with the judgement in Graham Barclay Oysters Pty Ltd v. Ryan (2002) 194 ALR 337; BC200207277; [2002] HCA 54, Ryan v. Great Lakes Council (1999) ATPR 46 191, E v. Australia Red Cross Society (1991) 27 FCR 310; (1991) ATPR 41-085; on appeal (1991) 31 FCR 299; (1992) ATPR 41 156, and Regal Pearl Pty Ltd v. Stewart [2002] NSWCA 291. It can also be instructive to hypothesise as to the consequences of the contamination of blood or blood products by the variant Creutzfeldt- Jakob contaminate by the organism causing Creutzfeldt-Jakob Disease (vCJD) where the issues faced are more parlous than for HIV-AIDS. As yet there is no blood test for vCJD and no cure. It is clear that people who have received blood or blood products that are highly at risk for vCJD will now need to be managed as if vCJD had been diagnosed. In the United Kingdom there has already been one death. The first victim of vCJD died after being transfused blood (in 1996) donated by a donor who had been incubating vCJD. See also MS Bird, “Recipients of Blood or Blood Products ‘at vCJD Risk’” (2004) 326 (7432) BMJ, 1118-19. 9 “Therapeutic” is interpreted to mean “to prevent, diagnose, cure, or alleviate a disease, defect of/or injury in person or animals, or to influence, inhibit or modify a physiological process in person or animals. The Therapeutic Goods Administration (TGA) adopts the policy that if it looks like, acts like or is claimed to be a therapeutic good then it is a therapeutic good. 10 The TPA does not provide a definition of the term "recall". The Competition and Consumer Policy Division of the Treasury has taken the view the if a supplier voluntarily ask consumers or other suppliers to carefully dispose of or return defective goods for a refund or replacement or some form of modification to the goods, and the defect is safety related, then that action will be viewed as constituting a product safety recall. Voluntary safety-related recalls are primarily the responsibility of the supplier though the Parliamentary Secretary to the Treasurer does have the power to order a compulsory recall of a product, under s65F(1), if it is a good that will or may cause injury to a person and it appears to the Parliamentary Secretary that the supplier has not taken satisfactory action to prevent the goods causing injury to any person. Suppliers conducting a safety-related recall are required by the TPA to notify the Parliamentary Secretary to the Treasurer within two days of taking recall action: s65R(1). The product recall notifications that must be provided to the Parliamentary Secretary to the Treasurer can be addressed to the Parliamentary Secretary care of the Competition and Consumer Policy Division of the Treasury. Other organisations who should be notified are State and Territory Consumer Affairs Authorities and the TGA with regard to that responsibility for therapeutic goods. The extent of Ministerial power and the manner in which it is to be exercised is set out in s65E of the Act. Within the TGA there is the Medical Device Incident Report Investigations Scheme (IRIS). IRIS has operated for approximately thirteen years. This organization's Mission Statement includes (to) actively gather and investigate reports of adverse events or potential problems with medical devices (and) to assist in the protection of the health and safety of patients, users and others by taking action and disseminating information on the outcomes of investigations which may reduce the likelihood of, or prevent repetition of, adverse events, or alleviate consequences of such repetition. The TGA has powers in relation to therapeutic product recalls - see ss.30, 30A & 30B of the TGAct. For further information see online at www.health.gov.au/tga. 11 Source of statistics Product Recalls Australia 2002 . The data is based on publicly available information supplied by the company undertaking the recall in newspaper advertisements or other forms of announcements, and on official notification to the Parliamentary Secretary to the Treasurer, under the requirements of Section 65R of the TPA. 3.2 Table 3.1 Episodes of Product Recall Nature of Jan 98 – July 98 – July 99 – July 00 – July 01 – Good June 98 June 99 June 00 June 01 June 02 Total Therapeutic 62 164 141 172 265 804 Goods Motor 28 128 88 115 95 454 Vehicles Food 10 38 55 36 71 210 Agricultural & Veterinary 000246 Chemicals Consumer 48 76 95 111 209 539 Goods
Total 148 406 379 436 644 2013
It is evident that the statistics can support a view that, though there has been increased vigilance and regulation by the TGA, there is no indication that the incidence of product recalls in relation to therapeutic goods is decreasing. In general, consumer product recalls have risen by a factor of 2.75 over the four financial years intervening between 1998 and 2002. The recall of therapeutic goods, in the financial year July 2001 - June 2002, was 61.6% higher than was the case in the financial year July 1998 - June 1999. The recall statistics for the first six months of the year 2003 (not shown in Table 3.1) exceeded the entire number of therapeutic product recalls for the period January 1998 - June 2002. This was a direct consequence of
the Pan Pharmaceuticals recall incident.12
3.4. The Pan Pharmaceuticals recall is the largest recall of any
complementary medical therapeutic good in the history of Australia.13
12 The significance of the Pan Pharmaceutical recall is that it is reportedly the largest complementary medicines recall in the world. Following a TGA Audit that was begun in January 2003, after 87 people reported reactions to a travel sickness tablet Travacalm, the TGA suspended the activities of Pan Pharmaceuticals Ltd of Sydney for a period of six months with effect from 28 April 2003. The TGA was concerned about the quality and safety of products manufactured by the company. The TGA audits of Pan Pharmaceuticals Manufacturing premises exposed a number of problems with regard to manufacturing and quality control procedures and the deliberate manipulation of quality control test data. The TGA recalled all batches of medicines manufactured by Pan Pharmaceuticals after 1 May 2002. As at May 2003, 1546 products had been recalled and a further 1650 export only medicines had been cancelled from the Register. For further reading see J Kellam, “Australia braces for fallout from complementary medicines recall” (2003) 14 (4) Australian Product Liability Reporter, 49-51. See also TGA Website: www.tga.gov.au. 13 The Pan Pharmaceutical recall incident reflects the enormous potential for pharmaceutical products to cause harm that has long been recognised overseas. As long ago as 1747 a Select Committee of the House of Commons in the United Kingdom had evidence of a poor quality of products, incompetence of Pharmacists and the lack of power of the Authorities to order drugs which were found to have been adulterated to be destroyed. For further information see the report from the Parliamentary Select Committee on the Examination of Drugs to Prevent Adulteration (1747) Journals (HC) 25,592. See J Kellam & C Newman, “Panic and 3.3 The event caused the Federal Government, on 28 April 2003, through
the Federal Parliamentary Secretary for Health, Trish Worth14 to observe:
"While the TGA has been able to act on the evidence from its audits in the case of Pan Pharmaceuticals, I will move to amend the Therapeutic Goods Act 1989 (Cth) to ensure that those who potentially put lives at risk by bad manufacturing practices face the full weight of the law.
Consumers should be reassured that the regulator, the TGA, is keeping a watchful eye on companies that manufacture medicines and medical devices, to weed out substandard practices to protect the health and safety of the Australian public".
3.5. On 13 May 2003, the Federal Government, again through the Federal Parliamentary Secretary for Health, Trish Worth, announced a package of measures that are intended to strengthen Australia's
regulatory system for therapeutic goods.15 The package was actually introduced in October 2002, seven months before the Pan Pharmaceutical affair. In reality, it was Senator Tate who announced, on 12 March 1991, that new laws would be introduced into Australia, as part of the Federal Government's Industry Statement, that would be based on the European Community Product
Liability Directive.16 The new legislative requirements that have been instituted in relation to medical devices included: The Therapeutics Goods Amendment (Medical Devices) Act 2002, The Therapeutic Goods (Charges) Amendment Act 2002 and wholly new regulations, The Therapeutic Goods (Medical Devices) Regulations 2002 (The Regulations). In contrast to the statements made by the Federal Parliamentary Secretary for Health, Trish Worth, on 13 May
Pandemonium and the Largest Recall in the World: the Australian Pan Pharmaceuticals Crisis” (2004) 15 (1) Australian Product Liability Reporter, 1-7. 14 Trish Worth, Federal Parliamentary Secretary for Health, press release, 28 April 2003. 15 On 13 May 2003 the Parliamentary Secretary for Health, Trish Worth, advised the public, "that overall, this package of amendments represents a sensible response by the Federal Government to the Pan Pharmaceuticals incident. Legislative amendments will provide the TGA with an even better range of regulatory tools to protect the public health and safety." 16 "Press Release: New Product Liability Law 13 May 1991" (1991) 2 Australian Product Liability Reporter, 18. 3.4 2003, the current regulatory system is not so much a consequence only of the Pan Pharmaceuticals incident but is rather more the result
of the prolonged efforts of the TGA17 and of the Global Harmonising
Task Force (GHTF)18 that has resulted with the Mutual Recognition
Agreement (MRA) with the European Union.19
3.6. The TGA is also pursuing an MRA with Canada in relation to Medical Device Conformity Assessment procedures. Closer to home, the Trans-Tasman MRA has led to the signing of a Treaty between the Australian and New Zealand Governments to establish a single bi-national agency to regulate therapeutic products. A single Trans-Tasman Therapeutic Goods Agency will replace the TGA and the New Zealand Medicines and Medical Devices Safety Authority
17 In October 1995, more than seven years before the Pan Pharmaceuticals incident, the Australian Therapeutic Device Bulletin of the Therapeutic Goods Administration indicated that "Australia is looking to adopt the EU requirements into legislation…discussions are underway with all interested parties to try to achieve this within two years", (pp.4-5). 18 The GHTF, established in 1992, includes Australia, the USA, Canada, the European Economic Community, and Japan. The GHTF is a voluntary international consortium of public health officials and representatives from the regulated industry. The objectives are to harmonize the regulatory environment, reduce global regulatory differences, increase international post-market vigilance, and to foster international co-operation. The lengthy process of reassessing product liability law in Europe, which began in the 1970s, culminated in the European Directive on Product Liability of 1985 (Directive 85/374/EEC). The preamble to the Directive expressed concern that divergences between the laws of Member States can distort competition and result in differential protection of consumers. It also asserted that the imposition of liability without fault on producers was the fairest method of apportioning risk. Accordingly with a view to harmonizing national laws, the Directive required all members of the European Community to introduce a strict liability regime for defective products. Harmonization is the process of aligning two or more countries' regulatory systems so that they are more alike. Changes do not need to occur in both countries. A single country may harmonize with another simply by adopting the other country's standards and styles of regulatory control. This is in contrast to mutual recognition where two or more countries recognise a correspondence between certain types of regulatory decisions made by each other and formally agree to treat corresponding decisions as being equivalent to their own decisions. Mutual Recognition Agreements and unilateral recognition can eliminate a regulatory obligation from manufacturers and products to be re-assessed when manufacturers can provide documentation that they or their products have already met essentially the same requirements in another country. Negotiations regarding the Mutual Recognition Agreement, relating to medical devices, began in early 1994. The GHTF is charged with the standardization of product liability law in those nations signatory to the Task Force. Harmonisation with the European Union Regulatory System will enable mutual recognition agreements to be signed between nations without compromising product safety. The harmonising of regulations with European Community Directives is symptomatic of a change of regulatory focus in those nations committed to the harmonising group. The regulation of therapeutic goods in Australia reflects and in a sense gives force to virtually all of the European Directives. The effect of any new Legislation is to ensure that Australia remains instep with those attitudes of regulation that are in force in those major trading nations. The Therapeutic Goods Administration believes that there are a number of benefits to Australia from harmonization both in regard to community protection and cost efficiency for the industry. It is regarded that harmonization will provide: (a) improved scrutiny of all medical devices at a level commensurate with the risk to the user thus greater protection for the community; (b) ongoing review (five yearly) of devices being supplied; (c) avoidance of duplication of work by recognizing overseas approvals; (d) with mutual recognition agreements - easier entry to Europe and other markets for Australian manufactured devices; (e) facilitation of availability of new technology; (f) mandatory post-market surveillance; (g) self-assessment of low risk devices; (h) alignment with New Zealand's stated intentions for regulation; and (i) facilitation of exports to markets with similar regulation. It can be noted also that New Zealand is negotiating its own Mutual Recognition Agreement on conformance assessment with the EU. In addition, under the Trans-Tasman Mutual Recognition Arrangement between Australia and New Zealand medical device regulators of both countries are working co-operatively toward addressing differences in each others regulatory approach.
3.5 (MEDSAFE).20 The MRA with the European Union has permitted Australian medical device regulations to become harmonised, or,
instep, with the European Community Directives.21 The European Community Directives were devised and implemented to ensure uniformity of standards throughout the European Economic Community and to ensure that products are sufficiently well designed and constructed so that they will be fit for the purpose for which they are acquired, and to ensure that reasonable precautions have been taken to protect the user against injury while the product is being used. The Directives also place obligations on manufacturers which govern their conduct once a product has been placed on the market. These obligations include providing consumers with information about any inherent risks associated with products where such risks are not immediately obvious to the consumer. The package of measures that is the current regulatory system will be discussed in more detail later in this Chapter. The amendments to the TGAct are Government's response to a medical product issue that is not just a matter for the concern of the complementary medicine industry but
19 Australia signed the Mutual Recognition Agreement (MRA) with the European Community in June 1998; see also the statement of the Hon Peter McGauran MP, Minister for the Arts and the Centenary of Federation, Second Reading on the Therapeutic Goods Amendment (Medical Devices) Bill 2001.House of Representatives Hansard, 29 March 2001, p.22261. 20 After several years of policy development and negotiations, the Australian and New Zealand Governments have agreed to establish a single Trans-Tasman Therapeutic Products Agency to regulate medicines and medical devices. From 1 July 2005 the joint agency will replace the Australian TGA and the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE). The new agency will be accountable to the Australian and New Zealand Governments, have its ongoing funding costs recovered from industry (sponsors), and will safeguard public health and safety through regulation of the quality, safety and efficacy of therapeutic products. 21 Three European Directives provide for a more comprehensive statutory system that will eventually cover all medical devices. A Directive is a piece of Legislation which has been approved by a majority in the EU Council of Ministers or the European Parliament. Directives can be interpreted into existing nation laws by the passage of necessary statutes and decrees. The First Specific Medical Devices Directive was The Active Implantable Medical Devices Directive (90/385/EEC 20 June 1990), which covers all powered medical devices implanted and left in the human body. The draft of this Directive was released in 1991. The Second of the Medical Devices Directive, was simply (but confusingly) called The Medical Devices Directive (MDD93/42/EEC 14 June 1993). This Directive regulates most other medical devices - from bandages to diagnostic X-ray machines. The Third Medical Devices Directive is The In-Vitro Diagnostic (IVD) Medical Devices Directive (MDD 98/79/EEC) that covers any item to be used for the examination of substances derived from the human body. This Directive was fully implemented in 1998. The European Community Regulations apply to all medical devices marketed on or after 14 June 1998, unless they are custom-made devices for individual patients or intended only for an authorized clinical investigation, or are labelled as such, or are in-vitro diagnostics. The term in-vitro relates to investigations and research activities that are undertaken outside of the human body. The new regulatory system imposes requirements for safety and product performance and there is also a vigilance system that obliges manufacturers to report adverse incidents or events. The Second Directive, The Medical Devices Directive (MDD93/42/EEC 14 June 1993) has been amended by Directives 2000/70/EC and 2001/104/EC which bring medical devices containing stable derivatives of human blood or plasma within its scope. The Product Liability Directives were introduced by the European Commission as an internal market measure under Article 100 of the Treaty Establishing the European Community (the EC Treaty). The drafter of the Directive, Professor Taschner, has on many occasions subsequently spoken of his firm belief that the measure is an internal market and not a consumer protection measure. These directives have been implemented into United Kingdom Legislation by the Medical Devices Regulations 2002, which consolidates all existing Medical Devices Regulations into a single piece of legislation which came into force on 13/7/2002. In Europe the European Directives concerning medical devices replace any existing National Systems in member States and include provisions for mandatory CE marking of products within their scope, except for certain specific
3.6 reflects previously known fundamental weaknesses of the entire
system of regulation of therapeutic goods in Australia.22 A view can be taken though, in fairness to the TGA, that the organisation has lacked the resources to thoroughly track what is a huge industry that is constantly developing ever more technologically advanced surgically implantable devices. Criticism of therapeutic goods Regulatory Authorities is not confined to Australia. In 1976, a
Congressional Committee chaired by Republican Peter Fountain23 strongly criticized the United States FDA for being "lenient" toward industry and allowing the potential for a "conflict of interest" to exist on Advisory Panels. In the United Kingdom, the former Medicines Control Agency (MCA) has also been criticized for its "lack of dynamism" in improving public health and for its "non-existent" public profile, which makes it difficult for it to function as a provider of safety information. The House of Commons Committee of Public
Accounts report24 Safety, Quality, Efficacy: Regulating Medicines in the UK was critical of the poor quality of information, leaflets and labels, designed to alert patients and doctors to potential risks of medication, and of the low level of reporting of adverse reactions to medicines by doctors.
exclusions. For further reading see G Howells, “Maximal Harmonisation Under the Product Liability Directive” (2004) 14 (10) Australian Product Liability Reporter, 145-47. See also vide supra n.18. 22 A conclusion that there are weaknesses in the system of regulation of therapeutic goods in Australia is supported by the fact that Alan Griffin M P, Shadow Minister for Consumer Protection and Consumer Health requested that the Australian National Audit Office (ANAO) should undertake an audit of the TGA. The Shadow Minister has said that he "Welcomes the Auditor-General's enquiry as an opportunity to get to the bottom of what really is happening at the TGA." On 05 August 2003 the Auditor-General confirmed that the ANAO will undertake an audit of the TGA. Brian Toohey, in The Sun-Herald, p 24, May 4, 2003 described the Pan Pharmaceuticals incident as representing "A particularly ugly cocktail of regulatory failure and corporate malfeasance…Pan has given Australians yet another reason to reject soft touch regulators who are far too slow to crack down on companies that cut corners while they try to keep their share price up…although it had good reason to keep a close eye on the company, the TGA took a remarkedly relaxed approach until 19 people were hospitalised, in January (2003) after taking Travalcalm, one of Pan's products." A number of serious allegations of TGA's activities have recently been reported in the Australian Product Liability Reporter. See “News Update” (2002) 14 (7) Australian Product Liability Reporter, 108. Those allegations included - (i) Companies were engaged in spring-cleaning before audit; (ii) there was a standing joke at the TGA that auditors "were allergic to fresh paint" as a result of last minute clean-ups; (iii) auditors were moved from particular manufacturers when phone-calls were made to a senior TGA official; (iv) some auditors were believed to be "incredibly soft, incredibly weak"; and (v) these allegations have been described as being "very serious and (to) have cast real doubts on the operation of the TGA". 23 For further information see C Burton, “Balance Between Regulation and Freedom” (1977) 1 (30) Neurosurgery, 322-3. 24 The House of Commons Committee of Public Accounts Report (26th Report of Session 2002-3) is available online at www.gov.uk. See also D Singh, “Medicines Control Agency slated by Commons Committee”, (2003) 327 (7405) BMJ, 10. 3.7 3.7. The amendments to the TGAct are intended to strengthen the TGA's ability to deter, and to penalise for, substandard manufacturing practices, and to more quickly be able to recall and to ensure the
removal of defective25, or non-standard26 products from the marketplace.
3.8. Though potentially not as tragic in terms of morbidity27 as was the use of Thalidomide the Pan Pharmaceutical issue may be seen to have an impact on society, and on Australian law as it relates to matters of consumer protection that may be no less significant than
was the impact caused by Thalidomide.28 It was the injuries caused by Thalidomide that first alerted the medical profession and consumers to the potential hazards of medicinal products and gave rise to the Medicines Act (1968) in the United Kingdom. It also provided cause and great impetus for the debate of the basis upon which companies that research and market products should be liable for any injury that they cause. It can be agreed that in the circumstances of the Pan Pharmaceutical and Vioxx recall events the
recent regulatory changes29 in Australia are timely though long overdue.
PRODUCT LIABILITY LEGLISLATION IN AUSTRALIA
3.9. In the context of legal history, it was not until the early part of the 19th Century, when the industrial revolution in England provided the
25 See vide supra n.8. See also Ch 5 ¶ 5.21-5.32. 26 See Burton J, in reference to defective products, in A & Anors v. National Blood Authority & Anors,[2001] EWHC QB 446 at 36 and Ch 5 ¶ 5.21-5.32. 27 The teratological consequences of Thalidomide included amelia (absence of a limb)and phocomelia (absence of part of a limb). These conditions are, for the sufferers and for their families, by any standard, tragic. 28 It was the Thalidomide Tragedy that stimulated the formation of the Sainsbury Committee, the enactment of the Congenital Disabilities (Civil Liabilities) Act 1976 (UK), and the formation of the Dunlop Committee whose task was to thoroughly investigate the circumstances of the events. The Sainsbury Committee was established to consider the relationship between the UK National Health Service and the Pharmaceutical Industry (See Report of the Committee of Enquiry into the relationship of the Pharmaceutical Industry with the National Health Service, 1965-1967, London HMSO 1967). This Committee considered that only about two-thirds of all drugs which were on the market at the time were therapeutically effective. The remaining one-third was described as undesirable. The Congenital Disabilities (Civil Liabilities) Act 1976 (UK) was that direct response to the Thalidomide event that confirmed that a person (or organisation) such as a manufacturer of Pharmaceutical products owes a duty of care even to the unborn child. For further reading see I Kennedy and A Grubb (eds), “Action Arising from Birth” in Principles of Medical Law (1998) 671. The Dunlop Committee later became part of the United Kingdom Committee on the Safety of Medicines that was established under the Medicine Act of 1968 (UK).
3.8 opportunity for the mass production of consumer goods that legal
principles were established to hold manufacturers30 legally liable to the ultimate consumer for the quality and for the safety of their
products.31 Since then, with regard to product liability, the legal system has evolved into a complex web of legislation that serves to
look after the person who is injured by a manufactured product.32
3.10. We now face an enormously complex legal environment that is increasingly litigious. Sometimes this situation is aggravated by an overlapping set of laws which make it extremely difficult to ascertain just exactly who is legally responsible for what and for why. Australia's legislation that relates to product liability issues is not so much a body of law but rather it is an amalgam of different Commonwealth and State/Territory law. I have the view that it is for this reason, that the nature of the legislation is, for the most part, cause for the complexity that can frequently be associated with any overlap of different bodies of law. Consumers of unsafe or defective therapeutic goods and devices are particularly exposed to this legal
29 Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth), the Therapeutic Goods (Charges) Amendment Act 2002 (Cth) and the Therapeutics Goods (Medical Devices) Regulations 2002. 30 A manufacturer is identified in s.74A(3)-(8) of Pt V of the TPA. Accordingly a corporation will be deemed to be the manufacturer of goods where a manufacturer will include also those that provide component parts. Pursuant to s.74A(1) the term "manufactured" includes grown, extracted, produced, processed and assembled.: (a) The corporation actually manufactures the goods (s.74A(3)(a)); (b) the corporation holds itself out to the public as the manufacturer of the goods (s.74A(3)(a)); (c) the corporation applies its name or brand to the goods (s.74A(3)(b)); (d) the corporation permits someone to promote the goods as those of the corporation (s.74A(3)(c)); or (e) the corporation is the importer of the goods in circumstances where the actual manufacturer does not have presence in Australia (s.74A(4),(7)), where, in the event, the importers would have an exposure to liability. Where a person who suffers loss or injury is uncertain who manufactured the goods (the unidentified manufacturer), then s.75AJ states that the person may serve a notice on each known supplier of the goods requiring those known suppliers to identify - (a) The corporation which actually manufactured the goods; or (b) the person who supplied the goods to the supplier. If these known suppliers do not provide that information within thirty days of the notice, they will be deemed to have been the manufacturer of the goods for the purposes of a compensation action under Pt VA. In contrast in s.41BG(3) of the TPA a person who assembles a product is not the manufacturer. This section provides that a person is not the manufacturer of a medical device if - (a) The person assembles or adapts the device for an individual patient; (b) the device has already been supplied by another person; and (c) the assembly or adaptation does not change the purpose intended for the device. In the context of the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) the term "manufacturer" means the person who is responsible for the design, manufacture, or packaging and labelling of a device before it is placed on the market under his name regardless of whether these operations are carried out by the person himself or on his behalf by a third party. 31 Paul Latimer, Australian Business Law 2001 (first published 1981, 20th ed 2000), [7-206]. 32 For a concise description of Product Liability in the Asia/Pacific region see Jocelyn Kellam (ed), Product Liability in the Asia- Pacific (first published 1995, 2nd ed, 1999) 13-37 in Ch 1, pp 30-37, Stewart Clark and Jocelyn Kellam describe product liability law in Australia. 3.9 dilemma. E v. Australian Red Cross Society33 and the more recent
case of Courtney v. Medtel 34 are especially good examples that demonstrate a complexity, and overlapping nature of consumer protection legislation.
3.11. The law that concerns issues of product liability is applicable to the sellers of defective goods and to consumers, and the legislation has in many ways derived from inadequacies inherent in Contract and in
Tort law.35 Historically the boundaries of liability for injurious
products have largely derived from the law of sales warranties.36 It remains the case, though they have inherent imperfections, that the Law of Tort, and the Law of Contract are the foundations and the
cornerstones of Australian product liability legislation.37. Australian
33 (1991) 27 FCR 310; (1991) ATPR 41-085; on appeal (1991) 31 FCR 299; (1992) ATPR 42-034. This case concerned "E" who developed AIDS following the transfusion of HIV contaminated blood. The transfusion was undertaken at the Royal Prince Alfred Hospital. The Australian Red Cross Society was responsible for the collection and for the distribution of blood and blood products to the hospital. "E" claimed damages from the Red Cross Society and other respondents on several grounds. The second defendant was the NSW Division of the Australian Red Cross Society and the third defendant was the successor to the management of the Royal Prince Alfred Hospital. This case is particularly interesting as it demonstrates the strength and weaknesses of parallel remedies that are centred around the argument as to whether or not any of the defendants were "trading corporations" engaged in "trade or commerce", whether the conduct of any was misleading or deceptive (s.52), whether the conduct was misleading in relation to services (s.55A), whether there had been a breach of ss.71 & 74 (implied terms - these could not operate in the absence of a contract), whether blood products are "materials" (s.74(2) - this was rejected), whether a blood transfusion qualified as a "service" (s.74 - this failed under the 1984 definition), whether there was a breach of s.19 of the SGA 1923 (NSW) (this could not operate as there was no contract), and whether any of the defendants had been negligent in any way that might amount to actionable negligence or to there being any negligent misrepresentation. The claimant failed on these last two accounts. For a detailed commentary of this case the reader is referred to Gail Pearson and Simon Fisher, Commercial Law - Commentary and Materials, (1st ed, 1999) 718-22. See ch 9, The Regulatory Regimes, Pt 4 Misleading and Unconscionable Dealing, 9.6 Misleading and Deceptive Conduct. See also Paul Latimer, Australian Business Law 2001, (1st published 1981, 20th ed, 2000) [7-206]. 34 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. In June 2000 the TGA issued a Hazard Alert warning that pacemakers distributed in Australia by Medtel Pty Ltd were at risk of dysfunction due to a premature failure of the battery that was associated with the creation of short circuits that were associated with dendrite formation. The cause for this was established to be associated with the solder used in the construction of the device. Class action proceedings were commenced under the Federal Court of Australia 1976 (Cth) Part IV(a) alleging loss or damage as the pacemakers were not of merchantable quality as required by the TPA s.74D. It was evident that not all pacemakers would fail and it was determined that a faulty, or potentially faulty pacemaker would only be identified following surgical explantation of the device. In the event the claimant's pacemaker was, after surgical removal, found to be functioning normally. Notwithstanding this the Court held that the device was not of merchantable quality as it was less fit for its purpose as a pacemaker than was reasonable to expect, given its risk of premature failure. A significant consequence of this case is that goods may not be of merchantable quality in the event that it is found that there is a risk of being defective after the device has been implanted into the human body though ultimately the device may be found to be free of any defect. The Court held that the claimant was entitled to compensation under TPA s.74D for pain and suffering and for other losses resulting from the surgical removal. The implications for manufacturers may then be that they have a legal responsibility for goods which are actually defective, or are actually below expected standard, and also for goods where there is only a risk of a defect. This exposure to liability will be present even though the risk does not eventuate. 35 It is interesting to observe that the French for the adjective wrong is faux, and the French for the noun wrong is tort. It might be though only an anecdote, that the derivation of tort may have followed the genesis of wring, as to wring the truth, into wrong, where the French for wring is tordre. 36 See Gail Pearson and Simon Fisher, Commercial Law Commentary and Materials (1st ed 1999) 728. The reader is referred to Pt IV, Misleading and Unconscionable Dealing, Ch 9, The Regulatory Regimes. Here it is described that “the Law of Warranty is older by a century than special assumpsit”. Assumpsit was a general contractual remedy arising from a promise and was abolished by the Judicature Act 1873 (UK). The Law of Sales Warranties guaranteed that the quality of goods is as stated by the person giving the Warranty. If there is a breach the purchaser has the right to claim damages. In the Sale of Goods Act 1894 the implied terms include Warranties that the goods are of merchantable quality and fit for the purpose for which they are supplied. 37 For a concise review see Ellen Beerworth, Product Liability Australia, (2001) Vol 1, 4953-7951. See also Jocelyn Kellam (ed), Product Liability in the Asia-Pacific (1st published 1995, 2nd ed 1999) 13-37. See also Paul Latimer, Australian Business Law 2001 3.10 product liability legislation has been, and remains, a complex blend of civil and criminal law, with ingredients of both common law and
statutory law.38 In the mix there is a sometimes contradictory overlap
of statutory legislation.39.
3.12. It is evident that, in the event that a surgical product fails, or is unreasonably unsafe, there are opportunities for claimants in
negligence40, in contract41, pursuant to the manufacturer’s liability and/or the product liability provisions of the TPA, based upon the
strict liability regime42, the Sale of Goods Act 189343 or in some State
Fair Trading Legislation44, for a defective product.
(1st published 1981, 20th ed, 2001) [7-206] and [7-215]. See also Gail Pearson and Simon Fisher, Commercial Law Commentary and Materials, (1st ed, 1999) 3-66. 38 See RC Travers, “A Proposal to Reform Australian Product Liability Law” (1995) 69 ALJ, 1006. 39 The definition of manufacturer as provided by the TPA and the TGAct is quite different and at tension when the assembly of a product is considered. Surgeons frequently assemble implant devices, from modular components, at the time of surgery. In s.41BG(3) of the TGAct a person who assembles a product is not the manufacturer. s.41BG(3) provides that a person is not the manufacturer of a medical device if (a) the person assembles or adapts the device for an individual patient; and (b) The device has already been supplied by another person; and (c) The assembly or adaptation does not change the purpose intended for the device. In the context of the Therapeutic Goods Amendment (Medical Devices) Act 2002 the manufacturer means the person who is responsible for the design, manufacture, or packaging and the labelling of a device before it is placed on the market under his name regardless of whether these operations are carried out by the person himself or on his behalf by a third party. This is in contrast to the TPA definition of a manufacturer where pursuant to s 74A(1) the term "manufactured" includes grown, extracted, produced, processed and assembled. The extended definition of "manufacturer" provided for in s 74 of Div 2A of Pt B applies equally to Pt VA (s.75AB) of the TPA. 40 With regard to negligence and to strict liability claims the major, and sometimes most significant, hurdle for the claimant is the proving of causation. See Loveday v. Renton & Wellcome Foundation Ltd [1990] 1 Med LR 117 where it was found that the claimant had failed to demonstrate a causal link between the use of whooping cough (pertussis) vaccine and brain damage in young children. This problem for the claimant finds a number of examples in case law relating to alleged drug-related adverse events. Proving of causation has not yet been an issue with respect to surgically implantable devices. However the problem of proving causation can support an argument that product liability for therapeutic devices is for many reasons unique and that the law of tort and contracts are not the most appropriate, and in this debate there can be found support for a no fault system. 41 Generally there is no contract between the surgical implant manufacturer and the consumer. Certainly promotional material that may be made available by a manufacturer does not in itself ensure a collateral contractual remedy based on an implied warranty that the statements were true, see Lambert v. Lewis [1978] 1 Lloyd's Rep 610 at 628. Liability for defective products under the Sale of Goods Legislation only arises between persons in a contractual relationship. However, in the event that goods supplied under contract are found to be defective, through poor quality or unfitness for a purpose, the seller cannot rely on a defence that is based upon an argument that all reasonable care in the supply of the goods has been exercised. It is the existence of, and not the discoverability of a defect that renders the seller liable. See Frost v. Aylesbury Dairy Company Ltd [1905] 1 KB 608, CA. 42 See Part VA of the TPA - the strict liability regime is only available in relation to loss or injuries that arise out of goods that were supplied after 9 July 1992. 43 The Sale of Goods Act 1893 (UK) became effective Federal-wide on 1st January 1894. The 1893 Act was set against the background of the general law of contract and personal property law and codified the rights and obligations of sellers and buyers. The Act applies to every sale of goods transaction. The original English Sale of Goods Act 1893 codified existing common law rules as form the basis for sale of goods (and services) legislation. In Australia, Sales of Goods law is a complex mixture of common law, State and Federal Legislation. Until 1894 contracts for the sale of goods were governed entirely by the Common Law. The Bill drafted by Sir Mackenzie Chalmers, and presented to Parliament in 1888, was, after considerable alteration, finally passed by the UK Parliament on 1 January 1894 as the Sale of Goods Act 1893. This Act was adopted by all Australian States before the end of the century with the exception of NSW where the Act was not adopted until 1924. For further information see Sale of Goods (Vienna Convention) Act 1986; Sale of Goods Act 1923 (NSW); Sale of Goods Act 1896 (Qld); Sale of Goods Act 1895 (SA); Sale of Goods Act 1895 (WA); Sale of Goods Act 1896 (Tas); Sale of Goods Act 1954 (ACT); Sale of Goods Act 1972 (NT) and Goods Act 1958 (Vic). 44 Fair Trading Acts exist in each State and Territory, ACT (1990), NSW (1987), QLD (1989), SA (1987), TAS (1990), VIC (1985), WA (1987), and the Consumer Affairs and Fair Trading Act 1990 (NT). The provision of the State Acts mirror the unfair conduct provisions of the TPA but are without the constitutional limitations on the States with the reference "persons" rather than "corporations". In 1983 Commonwealth and State Ministers agreed to the enactment of uniform fair trading laws throughout Australia. 3.11 3.13. Any product liability litigation will usually be commenced in either the Federal Court of Australia or the Supreme Court in one of the
States or Territories.45 There are also opportunities for claimants to
be found in the TGAct.46
3.14. Unlike tort law and contract law, the law that relates to product liability demonstrates a focus on the product itself rather than at the behaviour of the individual or organisation concerned with the manufacture of the product, or on the contractual promise. A successful product liability claim requires proof that the product was defective regardless of whether or not the sponsor or manufacturer exercised all necessary (or reasonable) care. This focus on the product facilitates the identification of any exposure to liability of manufacturers and sellers to compensate consumers for any damage or injury that might be suffered because of defects in the goods
acquired. This is very evident in Courtney v. Medtel Pty Ltd47 - the only successful case so far taken to judgement on liability in
Australia. against a commercial manufacturer of a surgically implanted device. Throughout this thesis there are a great many references to Courtney v. Medtel Pty Ltd and I have a view that the Courtney case is a landmark case that has the potential to stand out as a benchmark that will influence the consideration of matters relating to implanted surgical device product liability as Donoghue v.
Stevenson48 has, for other reasons, though not entirely unrelated, continued to be a significant influence on issues of product liability in general. It is for all of these reasons that it is appropriate here to
45 Cross Vesting Legislation, (excluding that concerning representative or class actions) enacted in 1987 by Federal, State and Territory Parliaments, provides that the Federal Court and the Courts of each State and Territory are invested with the jurisdiction of the others. 46 The TGAct came into effect on 15/02/91. In Australia, Medical Device Regulation followed the development of Pharmaceutical Regulation. It was not until August 1984 that the Commonwealth Government commenced a medical device program, by establishing a National Register of Medical Devices sold in Australia. Initially, registration did not involve evaluation or approval for sale. In February 1987 the Medical Devices and Dental Products Branch of the Department of Health began to require pre- market evaluation for a small number of critical devices. The Commonwealth Government introduced a comprehensive framework for the regulation of medical devices by passing the TGAct which repealed the Therapeutic Goods Act 1966 (Cth). 47 [2003] FCA 36; BC 200300120. 48 [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85, 458. 3.12 review, in some detail, the main events of the Courtney case and that
analysis of the case by Freilich et al.49
Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120
Mr K Courtney suffered a cardio-vascular condition and in 1999 his surgeon recommended that he undergo a carotid endarterectomy procedure. It was also recommended that a pacemaker should be implanted prior to that surgical undertaking so as to reduce the risks associated with the carotid endarterectomy.
The cardiac pacemaker monitors the heart rate and rhythm and produces electrical impulses when the patient's own heart does not. The device is designed to ensure restoration of a proper heart rate in the event of arrhythmias. The device is implanted and connected to the heart by leads that transmit a generated pulse. The pacemaker device is powered by a battery.
The pacemaker device implanted into Mr Courtney was of a type manufactured by Pacesetter Inc in the United States, the Tempo pacemaker, and distributed in Australia by Medtel Pty Ltd. By July 1999 the manufacturers had become aware of a potential malfunction associated with the premature depletion of the battery that was found to be causally associated with the use of an ionic contaminated yellow spool solder that caused dendrite growth.
49 For an analysis of the Courtney case see A Freilich, P Baron & R Carroll, “Perfect - but Still Unmerchantable: An Analysis of Medtel v. Courtney” (2004) 15 (1) Australian Product Liability Reporter, 11-16. 3.13 The potentially defective Tempo pacemakers were manufactured during the period 1997 to 1998. The TGA issued a hazard alert on 5 June, 1999. The alert concerned pacemakers inserted into 1,048 patients. Mr Courtney was informed that his pacemaker would be recalled though the device had been found to be working normally. On 1 September, 2000, Mr Courtney underwent further surgery that included explantation of his pacemaker and replacement with another pacemaker. The results of subsequent tests confirmed that Mr Courtney's pacemaker would not have ceased to have functioned prematurely for the reasons associated with dendrite formation and battery depletion.
Mr Courtney instituted proceedings in the Federal Court against the manufacturer (Pacesetter Inc) and the Australian distributor (Medtel Pty Ltd) of the Tempo pacemaker. Mr Courtney sought damages and compensation under several sections of the TPA.
At the first instance decision, Sackville J determined that the cardiac pacemakers that were sold in Australia were not of merchantable quality nor fit for the purpose for which they were sold. This decision was challenged and Medtel appealed. (Medtel v. Courtney (2003) 198 ALR 630).
Medtel was not the manufacturer of the pacemakers though it was deemed to be so according to s.74A(3) of the TPA because it had permitted a name by which it carried on business to be applied to the goods. Medtel was also deemed to be the manufacturer
3.14 according to s.74A(4) as it was an importer of goods where the manufacturer had no place of business in Australia. Medtel was the deemed manufacturer that had supplied the devices to hospitals and to doctors for the purpose of resupply to patients and this activity was undertaken in the course of business. The application of Pt V Div 2A (of which s.74D is a provision) was satisfied.
The value of the pacemakers was less than $5,000 each. The devices had not been acquired by patients for the purpose of resupply. The patients were therefore determined to be consumers in accordance with ss.4B(2) (a) and (d). Oddly, both the Court and the pleadings omitted mention of the requirement under Pt V Div 2A that the goods must be of a kind that are ordinarily required for personal, domestic or household use.
Sackville J had found that Mr Courtney's pacemaker was not of merchantable quality, though in the event the device had functioned normally at all times. There was no evidence that the device would cease to function prematurely. However the device had been fabricated using yellow spool solder. An increased risk of premature battery depletion had been created. When the pacemaker was acquired, Courtney had a reasonable expectation that the device would fulfil its function with regard to correcting arrhythmias and that in doing so there would not be a super-added risk of premature failure.
3.15 The Appeal to the Full Court of the Federal Court was heard by Moore, Branson and Jacobson JJ. The central argument of the Appeal was that the primary judge had erred in categorising the pacemaker as unmerchantable because it belonged to a class of pacemakers which had a physical characteristic that might lead to premature failure. Courtney's pacemaker was free of dendritic growth at the time the device was acquired and the statistical super-added risk had not materialised in Mr Courtney's case. Herein is the paradox that Courtney's pacemaker was "not fit for the purpose" for which pacemakers are acquired and, therefore not of merchantable quality, yet it served its purpose prior to explantation and would probably have continued to serve that purpose had it not been explanted. Both elements of the paradox were sustained by facts later known, but unknown at the time of acquisition of the device - namely the device was manufactured with a yellow spool solder and had the super-added risk of premature failure. Whether or not goods are of merchantable quality is judged at the time of the sale. The fact that Courtney's pacemaker had operated in a manner consistent with its purpose did not compel the conclusion that it was not, or was, of merchantable quality when it was acquired. Courtney's pacemaker was supplied and acquired with characteristics which could cause premature failure. The risk was more than acceptable and the device was not fit for the purpose for which goods of that kind are generally acquired, and therefore not of merchantable quality. There were doubts about the reliability of the pacemakers and it could not be predicted as to whether a particular pacemaker would or would not fail. This
3.16 is what made the device unmerchantable - a risk of
failure.50 The Courtney case finds parallel, with respect to the discoverability of latent defects in a number of other cases that include Graham Barclay Oysters v. Ryan51, A & Anors v. National Blood Authority & Anors52, and Grant v. Australian Knitting Mills Ltd.53
Consideration of the Courtney case has permitted the identification of 5 significant conclusions that can be drawn from the decisions. These are:
(i) that patients, including those who have undergone
implantation of surgical devices, are consumers54; (ii) that even where goods are functioning normally, they can still be held to be unmerchantable if, when they were acquired, they were not fit for the purpose that could reasonably have been
expected55; (iii) that goods can be found to have a risk of being defective after they have been surgically implanted; (iv) that manufacturers have a legal responsibility for goods which are actually defective, are substandard or are non-standard, and they may
50 Branson J focused on the problem of how much after acquired knowledge should be brought into account in determining whether goods are of merchantable quality or not. Hardwick Game Farm v. The Suffolk Agricultural Poultry Producers Association [1969] 2 AC 31 provided some guidance concerning latent defects in goods, i.e. defects that were not apparent at the time of acquisition. In Hardwick the majority was of the view that all after-acquired knowledge should be brought into account. 51 [2000] 109 LGERA 1; BC 200004491; [2000] FCA 1099; [2002] 102 FCR 307; 102 LGERA 123; 177 ALR 18; ATPR Digest 46- 207. Ryan contracted hepatitis when he consumed oysters which were contaminated with a virus. At the time of sale there was no way that it could be determined that the oysters were contaminated. To have identified the virus would have required the destruction of the oyster. Consumers generally expect oysters to be free of contamination. As this was not the case, the oysters were unmerchantable at the time of the sale. 52 [2001] 3 All ER 289; [2001] EWHC QB 446. This case concerned contaminated blood products. The contamination was caused by the hepatitis C virus that was, at the time of the case, referred to as the cause for non-A non-B viral hepatitis. The hepatitis C virus had note been isolated and there was no test available to permit its isolation. This case, in part, revolved around the discoverability of defects and the state of the art, in scientific terms, that was in existence at the time. 53 (1935) 54 CLR 49; 9 ALJ 351; [1935] ALR 493; [1936] AC 85; revg (1933) 50 CLR 387. This case is the classic case concerning the doctrine of merchantable quality that has always been recognised as available in cases of "latent" defects in goods. This case also demonstrates the overlap that has always been between s.74B and s.74D of the TPA. 54 The implied terms provisions of the TPA protect only consumers. The concept of a "consumer" is not defined in the Act. See vide supra n.1.
3.17 also be exposed to liability when there is even a superadded risk of a defect. Furthermore this will be the case even if the risk does not eventuate. Although the doctrine of merchantable quality has always been recognised as available in cases of "latent defect" in goods (as in Grant v. Australian Knitting Mills Ltd [1935] 54 CLR 49), Courtney v. Medtel has extended the doctrine to goods that are only potentially, i.e. at risk, and not actually defective. Mr Courtney was found to have suffered loss or damage because of the risk of malfunction of his perfectly functioning pacemaker according to s.74D(1) of the TPA; and (v) the importer of a product is the deemed manufacturer of the product in the event that the
name of the organisation is applied to the goods56 and in the event that the manufacturer has no place
of business in Australia.57
3.15. The unique58 nature of implantable surgical devices, and the distinctly hostile environment of the human body's milieu interne are cause, even in optimal circumstances, for implantable devices to pose a significant risk to the body. The hostile nature of the environment,
though it is associated with a protective inflammatory59 response to anything that is foreign to the body environment, can be a cause for device failure and for risks that are associated with biological effects and with the degradation of those materials that have been used for the fabrication of the implanted device. Here is the conundrum that begs the questions as to how we judge what is the purpose of an implantable surgical device and how we define what is fit for that
55 TPA s.74D (unmerchantable quality) and s.74B (fitness for purpose). 56 TPA s.74A(3). 57 TPA s.74A(4). 58 In a generic sense. 59 The inflammatory response is that biological event whose function is for the purpose of removing any substance, living or otherwise, that is foreign to the environment of the human body. 3.18 purpose within the hostile environment of the human body. It is in part for these reasons that the law as it relates to product liability in general, may not always be the most appropriate legislation for issues of surgical device product liability. In the debate some have argued that product liability for medicinal products, and, though not specifically debated, for surgically implantable devices, might be
better based on a no fault compensation scheme.60 Though not concerned with issues of product liability a system of no fault compensation, as an alternative to negligence actions, presently exists
in New Zealand, Sweden and Germany.61 The experience has presented one argument against any no fault compensation scheme that embraces the view that the present system of compensation is based upon the deterrent value of the law. It is reasonable to take the view that to remove the threat of litigation in a product liability issue might adversely affect those principles implicit in a duty to exercise all due care and skill and to ensure that goods supplied will be fit for
their purpose.62 There are those63 that also do not entirely discount
60 AL Diamond and DR Laurence, Product Liability in Respect of Drugs in PF D'Arcy and JP Griffin (eds) Iatrogenic Diseases (3rd ed, 1986) 117-23. 61 The New Zealand Scheme is discussed by J Fleming, The Law of Torts (7th ed, 1987) 375; see also, S A McLean “Liability Without Fault - the New Zealand Experience” (1985) J Soc Welfare Law, 125. Also see A Pesce & P Burton, Dispelling Some Myths- the New Zealand Accident Compensation Scheme” (2003) 15 (22) Aust Medicine, 22. Also for further information see New Zealand Accident Compensation Commission (ACC) Website at www.acc.nz. For information regarding the Swedish no fault system see Oldertz “The Swedish Patient Insurance System - Eight Years of Experience” (1984) 52 Med Leg J, 43. For the German No Fault Scheme see D Giesen, “German No Fault Scheme” (1988) International Medical Malpractice Law, 529. The no fault scheme has operated in New Zealand since 1972. Criticism of the scheme has included those of unacceptably low levels of compensation, high cost to the taxpayer and the removal of deterrents to safety practice in the workplace. On the last of these see A Lewis, “No-fault Liability - Thirty Years of Experience in New Zealand” (1996) 15 J Med & Law, 425). In the New System the Claimant must still establish causation and foreseeability which is at times difficult in consideration of the normal process of disease progress and where there is mere misadventure. With regard to medical misadventure see K Oliphant, “Defining Medical Misadventure: Lessons from New Zealand” (1996) 4 J Med Law Rev 1. 62 PM Danzon, Medical Malpractice Theory, Evidence and Public Policy (1st ed, 1985) 1 - in Chapter 1 - the author argues that it certainly is the case in the USA that successful litigation provokes greater care – this is different from the legal concept of duty of care. 63 See the remarks of Christine Forster, UNSW Senior Law Lecturer, cited by IE Roed, “No-fault Under Scrutiny” (2003) Australian Doctor, 43-45. Forster is quoted as saying that "no-fault compensation schemes have many advantages that include - (a) expediency in dealing with a claim through a Statutory Body; (b) no need to prove fault, which creates more equitable access to funds for ongoing care; (c) lifetime care is guaranteed for those who need it regardless of the circumstances of the injury and their social situation; (d) frees up other funds in the welfare system to provide a high level of benefit for general disability; (e) removes the difficulty families have in managing a large lump sum. Compensation pay- outs under Common Law are usually used up within an average of 17 years, with most people ending up on welfare; (f) doctors are spared the stress of dealing with malicious claims; (g) reduces the practice of defensive medicine; (h) reduces or abolishes Medical Indemnity Insurance premiums and therefore keeps patient fees down; (i) creates a more secure environment in which to practice; 3.19 compensation schemes that include both no-fault and common law
arrangements where the injured may choose one or other avenue64.
3.16. In October 2002, the TGAct65 was amended to incorporate new legislative requirements in relation to medical devices, and the regulations relating to those devices are contained within the framework of the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth). The concepts of this new legislation are broad and include new definitions, new offences, and new regulations and, in contrast to previous therapeutic goods legislation, there is a broader
definition of what is meant by manufacturer66, and by the supply67 of
medical devices.68 A more detailed review of the new regulatory system follows later in this chapter.
3.17. As Federal, State and Territory Governments have looked to formulate a solution to the nation's medical indemnity and public
liability crises69 there has evolved a process of reformation70, that may
(j) removes the small number of claims that make up a large proportion of medical insurer's costs; and (k) insured patients do not have to pay lawyer's fees. However Forster does identify a number of disadvantages with any no-fault compensation scheme these are reported to include - (j) some universal schemes discriminate in the level of compensation for wage-earners compared with the unemployed or non-earners; (k) cuts to funding and tightening of eligibility criteria may occur to make the scheme most cost- efficient; (l) negligent doctors may not be held accountable for their actions; (m) the bureaucracy can be difficult for patients to negotiate, especially if their needs change and a different level of benefit is required; and (n) the monopolistic insurer may dictate what services doctors can provide. 64 In the event it is implied that the consumer should not be permitted to double dip. 65 See also Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) and the Therapeutic Goods (Charges) Amendment Act 2002 (Cth). 66 See vide supra n.39. 67 Supply is defined in s.3 of the TGAct to include - (a) supply by way of sale, exchange, gift, lease, loan or hire-purchase; (b) supply, whether free of charge or otherwise, by way of sample or advertisement; (c) supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons or animals; and (d) supply by way of administration to, or application in the treatment of, a person or animal. s.3 of the Therapeutic Goods Amendment (Medical Devices) 2002 (Cth). A more detailed review of the Regulatory System for therapeutic devices follows later in this Chapter. 68 In the context of the Therapeutic Goods (Medical Devices) Act 2002 (Cth) a medical device is taken to mean an instrument, apparatus, plant, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, the diagnosis, monitoring, treatment, alleviation of all compensation for an injury or handicap, or for the investigation, replacement or modification of anatomy or of a physiological process, or control of conception; and does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, even if it is assisted in its function by such means. 69 The Medical Indemnity Policy Review Panel handed down its final report on the Indemnity crisis, dated 10 December 2003, to the Federal Government. The Government has largely adopted the recommendations made by the Panel. The report of the Panel can be accessed at www.health.gov.au. The recommendations of the Panel have stimulated considerable reform to New South Wales tort 3.20 impact on issues of product liability, that is mostly based upon the
recommendations embraced by the Ipp Report.71 Though the dominant direction of reform has been that which relates to common law actions for negligence, the Ipp Report has addressed all forms of actions for recovery of damages whether they be in tort, contract or
statute.72
THE TORT OF NEGLIGENCE
3.18. Negligence is the tort which has come to dominate 20th century tort law following its classic formulation in the successful test case of
Donoghue v. Stevenson73 in 1932 that concerned a claimant's gastroenteritis suffered after consuming soft drink from a bottle that contained a snail. Negligence is part of the law of torts. It is
frequently referred to as “the tort of negligence”.74 The tort of
negligence75 is concerned with the protection of persons, property and economic interests from damages caused by another person's failure to take reasonable care and the law provides legal remedies for
injuries [caused by negligence] as understood in Heaven v. Pender76 at p.507:
law particularly with respect to personal injury compensation legislation. Unfortunately the legislation has not had the desired effect of reducing insurance premiums and as a consequence many individuals and community organisation have not been advantaged by the reforms. It is evident that the insurance companies have made massive profits following the reforms. Insurance company profits in 2004 were $5bn (up by 50%). Reported in Lawyers Weekly (NSW), 6th May 2005, Issue 239, 3. 70 Major legal reform in NSW includes the Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW). This NSW Legislation follows the Health Care Liability Act 2001 (NSW) and the Civil Liability Act 2002 (NSW). The new Act also amends the Limitation Act 1969 (NSW) in respect to limitation provisions for claims for injury or death (other than for motor vehicle claims) that are brought in tort, in contract or under statute. While the Act is intended to apply to all claims for negligence, whether the claim is brought in tort, contract or under statute, some of the provisions only apply to actions for personal injury. In Queensland reform includes the introduction of the Civil Liability Act 2003 (Qld) and in Victoria the Wrongs and Statute of Limitations (Insurance Reforms) Act 2000 (Vic). Like most other Governments throughout Australia, this was Victoria's response to the much debated insurance and public liability reform agenda. Commonwealth reform has included the insertion, in July 2004, of a new Pt V1B into the TPA to place restrictions on limitation periods and damages for personal injury and death claims. For further reading see Bill Madden, “Recent Case Law and the Civil Liability Acts” (2004) 12 (4) Australian Health Law Bulletin, 41-49. 71 Review of the Law of Negligence, report 30 September 2002. The full Ipp report can be accessed on the Federal Treasury website at http://revofneg.treasury.gov.au. The Ipp Report is a consequence of Federal and State Government co-operation that resulted in the establishment of an eminent person's committee that was chaired by D Ipp J. For a discussion of the Ipp Report see K Chambers & R Krikorian, “Review of the Final Ipp Report and its Impact on Health Claims” (2003) 11(4) HLB, 37. For a detailed discussion of the Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW) see S Clark & C Harris, “Civil Liability in NSW – a New Dawn for Manufacturers?” (2003) 14 (1) Australian Product Liability Reporter, 118-24. 72 See the Ipp Report, paras 1.28, 2.3, Recommendation 2. 73 [1932] AC 562. 74 See JG Fleming, The Law of Torts (9th ed, 1998) – Professor Fleming puts forward the view that negligence is a basis of liability rather than a discrete tort. 75 Harold Luntz and David Hambly, Torts Cases and Commentaries (1st published 1980, 4th ed, 1995) 117-516. 76 (1883) 11 QBD 503 at p.507 - though this is a pre-negligence case it is the author's view that the reference is relevant to any issue of implantable surgical device product liability as there is a focus on that duty to observe due care and skill that is now implicit in s74 of the TPA. This case was the first judgement to articulate clearly the concept of duty of care. 3.21 "Actionable negligence consists in the neglect of the use of ordinary care or skill towards a person to whom the Defendant owes the duty observing ordinary care and skill, by which neglect the Claimant, without contributory negligence on his (her) part has suffered injury to his (her) personal property." (My edit and emphasis).
Much has changed since 1883 and the claimant may now be contributory to the negligence. Lord Wright, in Lochgelly Iron &
Coal Co v. McMullan77, five decades later described negligence as:
"…negligence means more than heedless or careless conduct, whether in omission or commission: It properly connotes the complex concept of duty, breach, and damage thereby suffered by the person to whom the duty was owing."
In New South Wales the Civil Liability Amendment (Personal
Responsibility) Act 2002 (NSW)78 inserts a new Part 1A into the Civil Liability Act 2002 (NSW). Here, at s5, negligence is defined as:
"Failure to exercise reasonable care and skill."
3.19. Certain negligent situations79 that are concerned with issues of product liability and consumer protection can also be litigated under consumer legislation such as is contained in the TPA. As we have already observed in paragraph 3.14 there is a fundamental difference between claims in negligence and claims under the TPA. The former focuses on the behaviour and actions of those who created the product, or enabled the placement of the product with the consumer, whereas the primary focus of the latter is on the product itself, that is allegedly unreasonably unsafe.
77 [1934] AC 1 (HL). 78 K Chambers & R Krikorian, “Review of the Final Ipp Report and Its Impact on Health Claims” (2002/03) 11 (4) Australian Health Law Bulletin, 37-44. 79 These include negligent manufacture or design, non-compliance with Government and Industry Standards, and inadequate testing. 3.22 3.20. Any product liability claim that is based in negligence must include those four (4) essential elements that, in seeking a successful remedy, with respect to the liability of a manufacturer of a defective or unsafe surgical product, are necessary for a claimant to succeed. The claimant must be able to demonstrate that:
(i) A duty of care was owed by the alleged tortfeasor(s) to a class of persons which included
the claimant; 80
(ii) the defendant has breached81 that duty of care through the supply of a product containing a manufacturing, design, or an informational
defect82;
80 Donoghue v. Stevenson [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85 458. 81 The exercise of reasonable care is a defence to a claim in negligence though the following of common practice is not now, in Australia, necessarily a basis for defence following the reversal of The Bolam Test (Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582) in the judgement in Rogers v. Whitaker (1992) 175 CLR 479; 109 ALR 625 HCA. The Bolam test has long been regarded with caution by lawyers and others conscious of patient's rights and the threat of medical paternalism. Bolam ensured that any medical treatment that accorded with a body of responsible professional opinion cannot be negligent. Bolam confirmed the traditionally held view that the medical profession is the most regulated of the professions. See also Bolitho v. City & Hackney Health Authority [1997] 4 All ER 77. Here Bolam is revisited and to a degree reinstated in the United Kingdom. Bolitho v. City & Hackney Health Authority arose from a failure on the part of a hospital doctor to examine and intubate a child experiencing respiratory distress. Expert evidence was led by the Claimant to the effect that a reasonably competent doctor would have intubated in such circumstances. The Defendant, however, had her own Expert Witnesses prepared to say that non-intubation was a clinically justifiable response. The important issue in the Bolitho Case was the Court's departing from the certainties of Bolam. Under Bolam, a doctor will not be negligent if what he has done would be accepted by a reasonably body of medical opinion. According to Lord Browne-Wilkinson the Court must be satisfied that the body of opinion in question rests on the logical basis – “In particular, in cases involving, as they so often do, the weighing of risks against benefits, the Judge before accepting a body of opinion as being responsible, reasonable or respectable, will need to be satisfied that, in forming their views, the Experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter”. This appears to be a clear rejection of the Bolam rule but it must be read in the light of the strong caveat which Lord Browne-Wilkinson attached – “ In the vast majority of cases the fact that distinguished Experts in the field of a particular opinion will demonstrate the reasonableness of that opinion…but if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the Judge is entitled to hold that the body of opinion is not reasonable or responsible… I emphasise, in my view, it will very seldom be right for a Judge to reach the conclusion that views genuinely held by a competent medical Expert are unreasonable”. Bolitho undoubtedly removed the trump card which Bolam presented to the doctor but it is arguably undesirable to undermine the latter test beyond a certain point. Bolam provides some protection for the innovative or minority opinion. If this protection is removed, then the opinion which the cautious practitioner will wish to follow will be that which involves least risk. This may have an inhibiting effect on medical progress. After all many advances in medicine have been made by those who have pursued an unconventional line of therapy. Thus doctors may quite easily be regarded as negligent by a Judge given to favouring conventional medical opinion. This is an important conclusion and the reader is referred to the summary of this case that is provided by JK Mason and RA McCall-Smith (with additional material by GT Laurie), Law in Medical Ethics (5th ed, 1999) 225-26. The exercise of reasonable care is a defence to a claim in negligence though the following of common practice is not necessarily always a basis for defence. The test remains whether the defendant has acted reasonably. The defendant may be held liable notwithstanding the following of general practice. The concept of common practice enshrined in Bolam may not always be a sufficient precaution to avoid foreseeable risk. Interestingly though the Civil Liability Act 2002 (NSW) has at s.5O reintroduced the Bolam Principle for all “professionals” with some modifications to the common law. Here the standard of care for “professionals” is that which is widely accepted by peer professional opinion as competent. Peer professional opinion cannot though be relied upon if the opinion is irrational. See also Morris v. West Hartley Pool Steam Navigation Co Ltd [1956] AC 552, [1956] 1 All ER 385 HL wherein is the concept that a danger is forseeable and has been considered and that precaution should be taken (Reid L). The test remains whether the defendant has acted reasonably; it may be held liable notwithstanding that it followed the general practice. See also Cavanagh v. Ulster Weaving Co Ltd [1960] AC 145, [1959] 2 All ER 745 HL, the Defendant may escape liability notwithstanding the failure to adopt a common safeguard. In the absence of a duty to take care, harm caused by careless, imprudent or unreasonable conduct will be damnum absque injuriai – loss without wrong or without legal remedy. 82 See Ch 5 for a discussion of the terms defect and defective. 3.23 (iii) as a result of that breach the claimant suffered
foreseeable loss or damage83; and (iv) that there is a significant connection between the breach and the loss suffered such that causation
can be established.84
3.21. It is the case then that manufacturers of surgical devices can have exposure to liability on the basis of negligence where it can be demonstrated that the device was negligently manufactured or
designed, or there was non-compliance with industry standards85, or that it was inadequately tested before it was placed for sale in the marketplace. Furthermore manufacturers of surgical devices have an obligation to warn consumers of any danger associated with the use or misuse of a product and liability can arise from the negligent failure to warn. In every case all 4 elements for negligence must be found for the claimant to be successful. The House of Lords in
Wilshire v. Essex Area Health Authority86 established that causation must be demonstrated in each case. Proving causation though, on a balance of probabilities, is frequently a major problem for the
claimant.87 A further obstacle to proof in negligence in surgical
83 Damage is frequently described as Harm which is defined to include personal injury or death, property damage and economic loss. The Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW) inserts a new Pt 1A into the Civil Liability Act 2002 (NSW) which applies to claims for damages for any type of harm resulting from negligence. Pt 1A applies to any claims regardless of whether the claim is brought in tort, in contract, or under statute. 84 It might at first appear to be logical reasoning that where it is known that a product can be causally associated with the injury that has been suffered, and that the manufacturer was negligent in being aware of the fact, then it should be that the defendant be required to demonstrate that some other factor was just as, or more, likely to have caused the injury suffered. Such reasoning should assist claimants in Product Liability Litigation. However the reasoning was rejected by the House of Lords upholding that the burden of proof remains with the claimant to demonstrate that but for exposure to the product the injury would not have occurred. Any detailed consideration of the (but for causa sine qua non) test is beyond the scope of this discussion. There is much written of the test and the reader is referred to March v. E & M H Stramare Pty Ltd (1991) 171 CLR 506; 99 ALR 423 HCA where the majority view acknowledged the usefulness of the test, in all but rare circumstances, for the elimination of matters that could not be causes for the Claimant's harm. See also Wilsher v. Essex Area Health Authority [1988] AC 1974. It is also interesting to review Lord Wilberforce’s judgment in McGhee v. National Coal Board [1972] 3 AL ER 1008 (HL). 85 Compliance with industry standards or with custom, though prima facie evidence of reasonable prudence on the part of a manufacturer, cannot be regarded as dispositive, - see Morris v. Hartleypool Navigation Co [1956] AC 552 and Cavanagh v. Ulster Weaving Co Ltd [1960] AC 145. It is important that companies need to remain aware that all standards or customs are by definition minimum standards and customs, and that standards and customs represent a consensus of thought. This is not to say that any standard or custom is either adequate or inadequate. However most standards and customs have been based upon a thorough risk- benefit analysis. Consensus within the industry is useful and manufacturers should take care not to ignore standards and customs by creating their own internal standards and customs. This is no less important as the creation of standards and customs is bound with an ability to defend those standards and customs. 86 Wilshire v. Essex Area Health Authority [1987] QB 730; [1986] 3 All ER 801 CA. See also Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853 - though this case was taken to litigation under the TPA the demonstration of causation was the major hurdle for the claimant. 87 See Richardson v. LRC Products Ltd [2000] Lloyds Rep Med 280 - in this case there was no recovery against a manufacturer under the Consumer Protection Act 1987 (UK) for the consequences of pregnancy following the failure of a condom because the claimant could reasonably have obtained the morning after pill and therefore avoided pregnancy. The claimant alleged that the 3.24 product related litigation is that which counts as knowledge can be complicated by the fact that scientists and medical researchers can legitimately hold conflicting views. The evidence of experts frequently demonstrates that grey area that exists between
speculation, hypothesis and information88, on the one hand, and sound
scientific evidence on the other hand.89
3.22. It may be impossible for a claimant to identify the precise act or omission which was a breach of the duty of care. In relation to surgical products, to establish that a breach has occurred may be very difficult due to the conflicting views of experts. To establish that a breach was the cause of injury may be also be a major hurdle for the claimant. In the event though a Court may draw an inference of
negligence on the part of the defendant90 that is otherwise known as
res ipsa loquitur.91 It is the case that neither Pt VA of the TPA nor
condom was defective because either it had been damaged at the factory or the fracture in itself made it so. The defendant relied upon the development risk defence s.41(e). Kennedy J held that it was unlikely that the condom had been damaged at the factory and also that the condom was not defective under s.3 because it was as safe as "persons are generally entitled to expect". Causation was not established by the claimant. See Loveday v. Renton & Wellcome Foundation Ltd [1990] 1 Med LR 117 - the claimants were found to have failed to establish a causal link between the use of pertussis (Whooping Cough) vaccine and brain damage in children. For further reading see Andrew Grubb and Judith Laing (eds), “Causation and Defences”, Principles of Medical Law, (2nd ed, 3rd Cumulative Supplement, 2004) 58. Also for a re-affirmation that the Claimant bears the legal burden of proof see Bickford v. Imperial Chemicals Industries [1998] 1 WLR 1189 (HL) and Brown v. Lewisham & North Southark Health Authority [1999] Lloyd's Rep Med 110 (CA). 88 See R v. Clark (No. 1) (2000) EWCA Crim 54 (Henry L J, Bracewell & Richards J J) and R v. Clark (No. 2) (2003) EWCA Crim 1020 (Kay L J, Holland & Hallett J J). A major issue which assumed prominence in this case, and on Appeal, was the use of statistics and the opinions of Expert testimony. Many of the issues raised by the Sally Clark case have been the subject of consideration by the Australian Academy of Forensic Sciences. For further information see P Johnson, “The Sally Clark Case: Another Collision Between Science and the Criminal Law” 36 (1) Aust J For Sci, 11-33 and RW Byard, “Lessons to be Learnt from the Sally Clark Case” 36 (1) Aust J For Sci, 3-10. See also John Batt, “A Mother's Fight for Justice: Stolen Innocence - The Story of Sally Clark” (1st ed, 2004) 1-329. See also O Dyer, “Dr Charged with Misconduct over Murder Claim” (2004) 328 (7453) BMJ, 1393. 89 It has been suggested that the negligence based system has become out of control and it has been suggested that a radical solution that places far greater importance on the decision-making authority of the patient would see the removal of negligence as a cause of action for injury resulting from elective, or planned, as distinct from emergency, treatment and its replacement with Contract Law. This is the view of Professor Julian Morris, Visiting Professor in the Department of International Studies at the University of Birmingham, UK as recorded in Policies Spring (Sept-Nov) 2002. Professor Morris' view can be accessed online at www.cis.org.au/policies/springs02/polspring02-2.htm. Dr T Smyth a partner in the health practice of Phillips Fox Lawyers in Sydney retains the alternative view that it may be that any contracts with an exclusion clause that removes negligence as a cause for action may not be enforceable by the surgeon as the Contract may be regarded as unfair and contrary to public policy. Dr Smyth is also a registered Medical Practitioner and it is just a matter of personal interest that Dr Smyth was my Intern in 1977, at the University of NSW. See also Chapter 8. 90 Grant v. Australian Knitting Mills Ltd (1935) 54 CLR 49; 9 ALJ 351; [1935] ALR 493; [1936] AC 85; revg (1935) 50 CLR 387. 91 Res ipsa loquitur, "the thing speaks for itself": a claimant may invoke this rule if three things can be shown. First that there has been an injury and that there is no explanation for the cause of the injury. Secondly, that the injury occurred in circumstances in which such an injury would not normally occur. Thirdly, that the defendant was in control of the situation in the context that the injury occurred. Res ipsa loquitur has the effect of reversing the burden of proof and the defendant must then prove that he was not negligent. Another view is that once res ipsa loquitur is pleaded it is for the defendant to explain what has taken place and to bring forward evidence to rebut the allegation. For further reading see M Jones, Medical Negligence, (2nd ed, 1996) 3.114-3.119. The requirements for a successful plea to res ipsa loquitur were established in the case Mahony v. Osborne [1939] 2 KB 14 - this case concerned a swab that was left in the patient post-operatively. However not every injury or incidence is in itself sufficient to make a plea of res ipsa loquitur successful. In Fish v. Kapur [1948] 2 All ER 176 the patient's jaw was fractured during the extraction of a tooth, but the plea of self-evident negligence was refused. In this case the claimant was unable to get expert evidence that a broken 3.25 the European Product Liability Directives provide for a Court to draw an inference that a product was defective. It therefore remains unclear as to whether or not claimants in Australia will benefit from the doctrine of res ipsa loquitur in order to establish a product's
defectiveness, or to establish causation.92
3.23. With the exception of Courtney v. Medtel 93 and Carey-Hazell v. Getz
Bros & Co (Aust) Pty Ltd94 the relationship between a manufacturer of a surgically implanted device and a patient has not been adjudicated in any Australian jurisdiction. Notwithstanding this, there can be room for an opportunity in tort as a duty of care can exist between the two. The nature and scope of any duty of care that is owed to a claimant by a defendant manufacturer, is prescribed in
the neighbour concept of Donoghue v. Stevenson.95 Donoghue represents the eventual adoption of clear rulings for liability for negligence in the distribution of products and establishes that it is the duty of every person in the chain of supply of a product to take reasonable care to avoid causing injury to a consumer by a careless act or omission. In each case the level of care involved must have
regard to the seriousness of the consequences of any failure.96 Donoghue v. Stevenson is particularly interesting for a variety of reasons, not the least being that it represents a re-statement of what,
jaw does not occur in the absence of negligence. See also Hooper v. Young [1998] Lloyd's Rep Med 61 (CA) and Ratcliffe v. Plymouth & Torbay Health Authority [1998] Lloyd's Rep Med 162 (CA), Brooke L J at 172-3. 92 Jocelyn Kellam, Product Liability (2002) [24-270]. The Editorial Commentary by CCH Editorial Staff in consultation with (and updated by) Dr Jocelyn Kellam refer to the Trade Practices Amendment Bill (No 2) 1991 that includes the provision whereby the Court is obliged to "draw an inference that a defect in the goods caused the loss where it is reasonable in all the circumstances of the case to do so". The Explanatory Memorandum to this Bill stated that this provision was drafted in light of the doctrine in negligence of res ipsa loquitur. This provision was omitted from the final draft of the Trade Practices Amendment Act 1992 indicating a legislative intention against allowing the use of the doctrine. Kellam cites Halsbauer v. Nominal Defendant (1967) 117 CLR 448 at p.452 per Barwick CJ. In Australia the doctrine does not result in a shifting of the onus of proof onto the defendant. Res ipsa loquitur merely allows the Court to draw an inference of negligence - it does oblige it to make a presumption of negligence. 93 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120 - see ¶3.14. 94 Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014 - see ¶3.93. 95 [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85, 458. 96 Paris v. Stepney Borough Council [1951] AC 367, [1951] 1 All ER 42, HL. The claimant, who was blind in one eye, following a war injury, suffered an injury to his good eye. The injury was suffered when the claimant struck a rusty bolt with a steel hammer and a metal chip from the bolt struck the good eye causing complete blindness. The nature of the claimant's war injury was known to his employer and it was alleged that the employer was negligent in failing to supply the claimant with protective goggles against a foreseeable risk. The trial judge gave judgement in favour of the claimant as the defendant had special knowledge of the risk. A defendant with special knowledge of the risk will be expected to take greater measures than a defendant without such knowledge. The Court of Appeal unanimously reversed that judgement. The decision was based on two conclusions, (i) The defendant had no duty to provide protective goggles for the two-eyed worker, and (ii) there was therefore no duty on the defendant in respect of the claimant because, though the consequences were more serious, the risk of the injury occurring was no greater in his case than for the two-eyed worker. 3.26 following George v. Skivington97 in 1869, became known as the
neighbour principle.98
3.24. In accordance with the principle enunciated in Donoghue v. Stevenson, a manufacturer of surgical devices, owes a duty of care to the purchaser, and to the user or consumer of those surgical devices. Implicit in this duty of care is the manufacturer's duty to provide adequate warnings and directions for the use of the product and a duty to inform the surgeon of all risks and benefits. However in
these circumstances the concept of the learned intermediary defence99 may be available to the manufacturer, i.e. the duty imposed on the manufacturer is to warn the medical practitioner rather than the patient in the event that there is no opportunity for any warning to be
communicated100 by the manufacturer directly to the consumer.
3.25. It is generally accepted that in considerations of negligence the distributor of the product, or the surgeon implanting a device, should not be expected to test or to inspect products that have been delivered by the manufacturer in sealed containers where the intention is that the packaging should not normally be opened until the time when the
product will be used, or in the case of a sterile101 surgical device, implanted into the patient, (ie the consumer). In such cases there may be no opportunity for an intermediate inspection of a surgically
97 See George v. Skivington [1869] LR 5 Ex 1; in George v. Skivington, it was held that a chemist who had been careless in compounding a hair wash was liable in negligence for injuries caused by the wash to the claimant’s wife. This finding was presumably determined on the basis of the chemist’s actual knowledge of the user - the origins of the neighbour principle. George v. Skivington also recognised that a manufacturer’s exposure to liability was to known users, the knowledge of a class. See also Heaven v. Pender (1883) 11 QBD 503 – in this case a dock owner had erected staging next to a ship, and a painter was injured when a rope supporting the staging broke. The painter was a person who the supplier could reasonably contemplate (was of a class that) would use the product without opportunity to discover a defect. The knowledge of a class concept is also to be found in Elliott v. Hall (1885) 15 QBD 315. 98 The concept of the neighbour principle embraces the concepts of proximity and reasonable foreseeability of harm. 99 The concept of and the defence associated with a learned intermediary is discussed in more detail in Ch 7. 100 See JM Drazen, “The Consumer and the Learned Intermediary in Health Care” (2002) 346 (7) N Engl J Med, 498-505. 101 Almost all surgical implants are provided in a sterile state. The procedure of sterilisation is undertaken by the manufacturer and with respect to surgical devices the sterilisation is frequently undertaken using gamma irradiation. This method of sterilisation is safe for almost all prosthetic implant materials. Hospitals do not have the facilities to use this method of sterilisation and it is for this reason that almost all surgical implant devices are supplied pre-packaged and in a sterile condition. This may not be the case with smaller devices such as screws and plates that can be distributed in bulk and effectively sterilized by a method of autoclaving. This is a method using high temperatures in conditions of high pressure. These implant devices continue to be supplied in an unsterile state, and prior to their implantation these devices are necessarily packaged and sterilized by Hospital Central Sterile Supply Departments (CSSD). The CSSD is that area of a hospital that is designated and set aside for the purpose of the cleaning, packaging, and sterilisation of all items necessarily required for a surgical procedure. 3.27 implantable device and necessarily there must be complete reliance on the manufacturer.
3.26. Relevantly, Donoghue v. Stevenson102 held that a manufacturer has a duty of care to the ultimate consumer, and that this duty will apply particularly when there is no reasonable possibility of an intermediate
examination.103 The possibility of intermediate examination of a surgical device might assist a manufacturer's defence if it can reasonably have been anticipated that the examination of the device would be conducted by an intermediary who is a learned intermediary, and that the defect would be discoverable and therefore
revealed.104 Where such an examination is anticipated a manufacturer's duty of care may arise if it can reasonably be expected that the intermediate examination would not have identified the
defect.105 It is common practice or custom that in some surgical specialties, e.g. orthopaedic surgery, prior to the implantation of any surgical device there is a visual inspection of the product prior to its insertion into the patient. A visual inspection can permit only the identification of external imperfections such as, for example, scratches, cracks, corrosion or a shape abnormality.
3.27. It is an imperative that the visual inspection of a surgical device should permit the identification of any imperfections and in the event it is only then that the manufacturer can be allowed the defence that a duty of care does not arise, or at least, will give force to the severing
102 [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85, 458. 103 In Donoghue v. Stevenson [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85, 458 at [599] Lord Atkin described the manufacturer's liability for a defective product as contingent on there being no reasonable possibilityof intermediate examination of the product before it reaches the ultimate consumer. In fact this requirement is simply an aspect of reasonable foreseeability, there being no liability unless the manufacturer could reasonably have anticipated that an examination by an intermediary would be of such a type as to reveal the defect. There must be a reasonable probability of examination if the manufacturer is to avoid liability. 104 The principle of reasonable reliance on information that is provided by others is established. See Wilkinson v. Katies Fashions (Australia) Pty Ltd (1986) 11 FCR 390. See also Hurley v. Dyke [1979] RTR 265, HL - here it is held that where reliance on another to prevent the harm was found to be reasonable so that a warning was held to be sufficient to discharge the duty of care. This case concerned a dangerous car sold with all faults. For further reading see the judgement of Browne L J, in the Court of Appeal, at 294-5. See also Griffiths v. Arch Engineering Co (Newport) Ltd & Anor [1968] 3 All ER 217. See also Holmes v. Ashford [1950] 2 All ER 76, 94 Sol J 357. See also Chapters 6 and 7. 105 Defects that generally cannot be identified by visual examination are those that arise from formulation. Such an example might be the presence of stearates in orthopaedic polymers such as ultra-high molecular weight polyethylene a material used for the fabrication of the articulating surfaces of prostheses. 3.28 of any causal link between the defect and any subsequent injury. In contrast a defect that is not identifiable by the surgeon will not
necessarily protect the manufacturer from exposure to liability.106
3.28. At every step in research and marketing the manufacturer of a surgically implantable device has an obligation to take such care as the reasonably skillful manufacturer would take, and the manufacturer's conduct will always be measured against the prevailing state of scientific and technical knowledge - the state of
the art.107 The failure to exercise reasonable care, in research and design, in the manufacture, or in the labelling and warning through
product information, can lead to liability in negligence.108
3.29. The liability and the potential for negligence of public bodies such as licensing, regulatory, or planning authorities, has been examined in a
number of cases in the United Kingdom.109 There is a large body of Australian law relating to public authorities that recognises that Australia has not followed the English approach and the leading case
is that of Crimmins v. Stevedoring Industry Finance Company110
106 GM Fleming, Fleming & Associates: Quoted in Emerging Drugs & Devices, (2001) 6 (20), 13. The substance of this report concerned the device recall of hip (and knee) implants, manufactured by the Sulzer organisation and sold principally in the United States after October of 1999. The device recall concerned approximately 25,000 products, that included about 17,500 hip implants already in patients. The porous coating on these orthopaedic devices was found to be contaminated with oil that had been used in the cleaning process. The oil was not evident to visual inspection. The defect was not discoverable at the time of surgical implantation of the device. The contaminant was later found to be causally associated with failure of the implants to bond with the skeleton (osseointegrate). The failure of osseointegration caused the devices to become loose and to require salvage by revision surgery. 107 Whether or not the Defendant's conduct is deemed to be negligent the index of reference is in regard to the prevailing state of scientific and technical knowledge. See Stokes v. Guest Keen & Nettlefold (Bolts & Nuts) Ltd [1968] 1 WLR 1776 at 1783 applied in White v. Holbrook Precision Castings [1995] IRLR 215 CA, Smith v. P & O Bulk Shipping (1998) 2 Lloyd's Rep 81 - Where he has in fact greater than average knowledge of the risks, the defendant may be thereby obliged to take more than average or standard precautions. 108 ACCC v. The Glendale Chemical Products Pty Ltd [1998] ATPR 41 6-32; [1999] ATPR 41-672. 109 Hill v. Chief Constable of West Yorkshire [1989] AC 53; [1988] 2 4 ER 238, HL - during the period 1975 to 1980 the Yorkshire Ripper committed a number of horrifying murders and attempted murders on young women. Following the last murder, Peter Sutcliffe was convicted of the murders, including that of the last victim. The last victim's mother on behalf of the victim's estate, brought an action against the police for damages for negligence. The defendant successfully applied to have the Statement of Claim struck out and the claimant appealed unsuccessfully to the Court of Appeal. The claimant then appealed to the House of Lords. She maintained that the defendant, having decided to investigate the murders, owed (potential) future victims a duty to do so with reasonable care. The foundation of the duty of care was said to be reasonable foreseeability of harm to (potential) future victims if Sutcliffe was not apprehended. It was held that foreseeability of likely harm was not in itself a sufficient test of liability and negligence. Other circumstances are for there to be proximity of relationship between claimant and defendant that needs to be established whether that other fact is present. The potential ambiguity of proximity when used in the context of the law of negligence has long been recognised - See Grant v. Australian Knitting Mills Ltd [1936] AC 85 at 103-4. The interested reader is further referred to the judgement of Wilberforce L, in Anns v. Merton, London Borough Council [1978] AC 728 at 751-2. The approach in Anns has not been followed in Australia as it is regarded to be inappropriate to those cases where that which is alleged is a negligent omission or failure to act. Also see Dorset Yacht Co Ltd v. Home Office [1969] AC 1004 2 QB 412. 110 (1999) 200 CLR 1. Crimmins died following the development of a mesothelioma (lung cancer) that was causally associated with working activities where there was exposure to asbestos dust. The action against the respondent contended that the Stevedoring Authority had a duty of care to protect Crimmins from the harmful consequences of asbestos dust and that there had been a breach 3.29 Notwithstanding the experience in other jurisdictions such as the United Kingdom it may be that the TGA will not be immune from exposure to liability. The cases involving statutory authorities have fallen broadly into two general categories:
(i) The public body has affected the Claimant directly
through its alleged wrong,111 or (ii) the public body is alleged to have been negligent in the regulation of, licensing of, or approval of the act of a third party and has caused damage to be
suffered to the claimant.112
3.30. In regard to surgical devices the (so far untested) liability of the TGA to an individual consumer would more likely fall into the second category. When determining the justice and fairness of imposing a duty of care on a public body, such as a regulatory authority, a Court examines inter alia the statutory purpose for which the regulatory body derives its authority. The underlying basis is that the law will generally not allow the recovery of damages for lawful administrative action. In Australia the courts have demonstrated a very much less restricted attitude to imposing a duty of care on public bodies than has been the case in the United Kingdom. The probable and logical reason for this is that Australian Courts have not found it to be undesirable for a public body, in the exercise of its public interest functions, to be found liable to a member of the public for
failing to regulate wrongful acts of a third party.113
of this duty of care. Crimmins had been a Waterside Worker at the Port of Melbourne during the period 1961 to 1965 inclusive. He had been concerned with the unloading of asbestos cargo and had been exposed to asbestos dust. In 1997 Crimmins was diagnosed as suffering from the fatal condition of mesothelioma. For further information as to the common law duties of care that are owed by Statutory Authorities see Halsbury's Laws of Australia, vol 19, NEGLIGENCE [300-40]. See also Stevedoring Industry Act 1956 (Cth) ss.8,17,18,28,33 & 36; Stevedoring Industry Acts (Termination) Act 1997 (Cth) (The Termination Act) and the Stevedoring Industry Finance Committee Act 1977 (Cth); Presland v. Hunter Area Health Service [2003] NSW SC 754 and BC 200304853; Longo v. Sydney Water Corp [2003] NSWDDT 6 and (2003) 25 NSWCCR 125; Sutherland Shire Council v. Heyman (1985) 157 CLR 424 and 60 ACR 1. 111 Vide supra see n.109 and n.110. 112 See the so-called Statutory Purpose Test in Dutton v. Bognor Regis UDC, [1972] 1 QB 373. The test is a consideration of the Statute by which the Authority derives its duties and powers. The basis is that common law will not allow the recovery of damages for lawful administrative action. 113 Vide supra see n.109 and n.110. 3.30 3.31. Compliance by a manufacturer with a Government regulation may not provide that manufacturer with a defence to a claim by a consumer in negligence. In contrast though, non-compliance with Government regulation may be unlikely to be held consistent with the exercise of proper care. Compliance with Government regulations, though it is persuasive evidence, should not be regarded as conclusive. Courts may hold that compliance with statutory regulations does not take precedence over a manufacturers general duty to take whatever care is appropriate in particular circumstances. Whilst compliance should not be regarded as decisive, the licensing
of a product by a competent authority114 such as the TGA, and the manufacturer's compliance with all prescribed regulations, may
constitute a significant obstacle for any claimant.115 Whilst it has not
114 In the United Kingdom a Competent Authority is that Government appointed organisation, the Medical Devices Agency (MDA) that is responsible for the regulatory oversight of medical devices. The competent authority designates, certifies, and monitors the conformity assessment requirement and bodies within its jurisdiction. Assessment bodies are also known as Notified Bodies that are appointed to oversee particular aspects of conformity assessment. Notified Bodies perform conformity assessments of medium and high risk surgical devices. Notified Bodies can only provide services for which they are designated (by the TGA in Australia). With regard to the undertaking of conformity assessment procedures manufacturers can choose which Notified Body they wish to use - as long as a Notified Body has been designated to perform the required specific task. Some essential requirements a Notified Body must satisfy relate to independence, impartiality, technical competence, graduate facilities, confidentiality, liability insurance, ensuring the performance of sub-contractors to essential requirements, and the use of quality systems in the performance of their duties. The Notified Body may expect to be monitored through surveillance audits at intervals determined by the Competent Authority. If the Notified Body fails to meet the criteria the Competent Authority is compelled to withdraw designation. In Australia, the Competent Authority is the TGA. The TGA is charged by the Government to administer the Therapeutic Goods Act 1989 (Cth). In the USA and the UK the competent authority is the Food & Drug Administration (FDA) and the Medical Devices Agency (MDA) respectively. The FDA was established in 1931 but it was not until 1976 that the FDA was given power over medical devices following the Medical Device Amendments to the Food, Drug and Cosmetic Act 1938 (US). The FDA has been part of the Department of Health and Human Services since 1979. The FDA regulates products that account for over one-quarter of consumer spending in North America. The FDA protects the public from unsafe foods to drugs and from medical devices to cosmetics. The FDA also protects the rights and safety of patients in clinical trials of new medical products and monitors the promotional activities of the manufacturers of drugs and devices. The FDA regulates also the labelling of packaged foods and the safety of the American blood supply. In the USA the Food, Drug, and Cosmetic Act 1938 (US) regulates cosmetic and therapeutic devices. The MDA in the UK fulfils its role by operating an Adverse Incident Centre (AIC- the Vigilance System), by providing a medical device evaluation service, and by the very fact that it is the European competent authority. The AIC receives more than 8,500 device-related adverse incident reports each year. With regard to the evaluation of medical devices the MDA commissions 23 Evaluation Centres located in the NHS or in Universities. Devices are tested for performance and safety in both clinical and laboratory settings. More than 100 evaluation reports are published annually and these are made available free of charge to the NHS. For further information see S Ludgate, “Medical Equipment Safety: Not Left to its Own Devices” (2003) 19 (1) Journal of the Medical Defence Union, 14-15. The European Union Medical Device Directives requires each Competent Authority to withdraw CE-marked devices from the market if it finds that the device may compromise patients' health or safety. The competent authority must immediately inform the European Commission of the actions and reasons for withdrawal. This should also be a task for the TGA. On 1 April 2003 the MDA merged with the Medicines Control Agency (MCA) and as a consequence the new Medicines and Healthcare Products Regulatory Agency (MHRA) came into existence. The merged body does not have new powers, the existing statutory bases and regulations remain unchanged. The systems of licensing of medicines and the control of medical devices continues as before but the merger is seen by the Department of Health as strengthening public protection in the context of the emergence of a growing number of Healthcare products that cross the borderline between medicines and devices. These are products that are derived from human tissue engineered technologies, that combine human tissue or cells with synthetic biomaterials. These are a diverse group of products that are, at this time, finding application for the replacement of skin, and articular cartilage, and for the repair of bone. For further information see A Faulkener, I Geesink, J Kent & D Fitzpatrick, “Human Tissue Engineered Products - Drugs or Devices? Tackling the Regulatory Vacuum” (2003) 326 BMJ, 1159-60. See also www.medical-devices.gov.uk. 115 Bux v. Slough Metals Ltd [1974] 1 All ER 262, [1973] 1 WLR 1358, CA. The Courts are clearly loath to impose a standard of care that effectively penalises compliance with specific statutorily prescribed standards and are reluctant to hold a manufacturer negligent in the event that the manufacturer had been granted a licence for the device after having disclosed to the competent or regulatory authority all of the information required by that authority. 3.31 been tested judicially, it is more likely that failure to comply with statutory requirements will not assist the defendant.
3.32. The manufacturer has 3 available defences to a claim in negligence in the event that it is alleged that a surgically implanted device is defective or at risk of being defective:
(i) Volenti non fit injuria116;
(ii) contributory negligence117; and
(iii) the learned intermediary defence118
CONTRACT LAW
3.33. The Australian law of contract had its origins in the contractual principles of 19th Century England and in the English Sale of Goods
Act 1893119 that codified sale of goods law. Any legal action in contract has always been governed by the doctrine, or rule, of privity. Under the Doctrine of Privity the seller of a defective product is only
liable contractually to the buyer.120 Redress remains the concern only of the parties to the contract. For this reason, actions concerning product liability based in contract between patients and manufacturers, are unusual as there is only rarely privity between the
116 The untested question here is whether signed informed consent to surgery is a cloak of willingness. There can be no injury to the willing. Voluntary assumption of risk is extremely difficult to prove and requires that the defendant does show that the claimant not only perceived the existence of danger, but also fully appreciated it and voluntarily accepted the risk(s). See Insurance Commissioner v. Joyce (1948) 77 CLR 39; [1948] ALR 356. This case concerned the legal issues and the legal position of a person who allows him/herself to be driven in a motor vehicle by an obviously drunken driver as a guest passenger. See also Rootes v. Shelton (1967) 116 CLR 383: [1968] ALR 33, here participation in a sport was found to be implicit in there being a voluntary assumption of risk of injury through another participant’s act or omission. 117 Implicit in this defence is that the claimant contributed to any injury, by omission or misuse. Contributory negligence is not a complete defence with damages apportioned to each party’s degree of fault. See March v. E & MH Stramare Pty Ltd (1991) 171 CLR 506; 99 ALR 423. Here, the defendants, wholesale fruit and vegetable stall owners, had parked their truck, in the early hours of the morning, in the middle of a six-lane road outside the market. The street lighting was adequate and it was common for the driver to park in this manner for the purpose of unloading produce from the truck. The truck’s hazard lights had been activated by the driver. The claimant, impaired by alcohol, and driving at excessive speed, collided into the defendants’ truck. At the trial the claimant and the defendants were both held to have been negligent and responsibility for the claimant’s injuries was attributed as to 30% to the defendant and as to 70% to the claimant. On appeal to the Full Court of South Australia, a majority held that responsibility for the collision should have been attributed to the claimant’s conduct alone. The defendants were exonerated. The claimant appealed. The appeal was allowed and the trial judge’s apportionment restored. 118 See Ch 6 and Ch 7. See also Ellen Beerworth, Product Liability Australia (2001) Vol 2, 36,019–36,021. 119 See vide supra n.43. 120 Medical device manufacturers only rarely have a contractual relationship with the consumer for the supply of goods unless they are private patients buying medical products direct from the manufacturer. A doctor or hospital supplying medical devices privately might be contractually liable. Transactions are subject to the implied terms of the Sale of Goods Act 1923 (NSW). By virtue of the Doctrine of Privity the consumer-purchaser of a therapeutic product will not normally have a contractual right of action against the manufacturer unless there is a collateral contract between them. Only rarely have the Courts so construed agreements arising from the manufacturer's representations and their products, see Shanklin Pier Ltd v. Detel Products Ltd [1951] 2 KB 854. 3.32 two parties. Any surgically implanted device product liability action based in contract will more usually be a matter of concern for the manufacturer, (or the retailer or distributor), and for the hospital. Though hospital consent forms, that set out treatment agreed to by the patient and the surgeon, may have overtones of a contractual
agreement121 it has been rare, in contract, for a surgeon122 to be a defendant. Product liability litigation, in the environment of the Australian Medicare system is unlikely to focus on contractual
remedies.123 This is the case in any nationalized health service and there is only anecdotal and unreported reference to patients, and/or their estate, seeking redress in contract for the consequences of
adverse events associated with a surgical procedure.124
3.34. An action based on a breach of contract may be an appropriate opportunity for a claimant in the event that treatment has been provided as a private patient, i.e. where a fee has been directly
charged.125 For example, a private patient who suffers injury through
121 See C McDonald, “Contract of Care” (2003) Australian Doctor, 45 – here Cheryl McDonald, Medico-Legal Manager of the Medical Defence Association of South Australia observed that some consent forms that set out the treatment that has been agreed to by the patient and the doctor may have overtones of a contractual agreement. Cheryl McDonald then continues - "some people say Consent Forms aren't worth the paper they're written on - that's not true…They may be used…(my edit)… as a source document in legal proceedings as they're evidence that the doctor has imparted the information to the patient. However, neither a consent form nor a contract negates the need for the doctor to explain advice about management and to document that in the patient's medical records." 122 See vide supra n.121. In “Contract of Care” it is further stressed that unwritten contracts are ubiquitous in everyday life and that unwritten contracts do exist between those providing treatment and those receiving treatment. Furthermore these unwritten contracts usually contain implied terms rather than express terms. 123 In the United Kingdom (National Health Service) it certainly remains the case that the supply of a therapeutic product, whether it be a drug or a surgical device, is not pursuant to a contract between the patient and the healthcare professional. See Pfizer Corp v. Ministry of Health [1965] AC 512, [1965] 1 All ER 450 HL and Appleby v. Sleep [1968] 2 All ER 265, [1968] 1 WLR 948 DC. Here there was found to be no contract as the supplying health care professional was statutorily obligated to provide this service on presentation of a prescription and in the event that there was payment of a fixed Government fee for the dispensing of a drug. In contrast, exposure to liability in contract following injury that has been caused by drugs (and possibly devices) provided to a private fee paying patient, is another matter. 124 This subject was discussed at The Royal Society of Medicine on 10/09/02 by Mr Keith Parsons (Urologist), in Medicine for Lawyers, in an analysis of Urological Surgical Mishaps in the United Kingdom. Mr Parsons described one case that concerned an elderly male patient who presented for nephrectomy (removal of the kidney) for the management of a non-functioning kidney. Unfortunately the wrong (the functioning) kidney was removed. Seventeen separate errors were identified to have contributed to the adverse event. Notwithstanding dialysis, the patient deceased from multiple organ failure. Action against the surgeon was undertaken on a number of fronts and the points of law included action in contract. See O Dyer, “Surgeons Cleared of Manslaughter after Removing Wrong Kidney” (2002) 325 BMJ, 6. Dyer described the trial for manslaughter as having collapsed because the Pathologist "could not be sure" that the nephrectomy had caused the death. At a later Hearing before the General Medical Council the two surgeons involved were accused of "abject, needless and inexcusable" negligence. Both have denied serious professional misconduct and the Hearing continues. See ‘Wrong Kidney Surgeons Showed Abject Negligence’, The Weekly Telegraph (UK) 13 January 2004, 10. 125 No fee nor any other consideration passes directly between a Medicare patient and a treating surgeon or hospital and there is therefore no legally enforceable contract. The situation in Australia, though not tested, should be no different to that in the National Health Service in the United Kingdom. See Reynolds v. The Health First Medical Group [2000] Lloyd's Rep Med 240. Here the claimant endeavoured to avoid satisfying the conditions required for negligence. It was argued that a contractual obligation existed between a General Practitioner and a patient, the NHS capitation fee being a consideration. The claim was unsuccessful as the 3.33 an adverse event may have an action based in breach of contract
against a supplier of services, that may include the surgeon126 and/or
the hospital127, but not necessarily the manufacturer128. An extremely rare exception to this might be associated with a program of research, that included the trial of a surgical implant device, where a manufacturer had a contract with the volunteers participating in the research. In the event that there is a contract for private surgical treatment, the agreement is almost always exclusively considered to be a contract for the provision of services and under the TPA, provided that the relevant section is applicable, there is an implied term that the manufacturer should carry out the services with reasonable care and skill and that the materials supplied must be fit
for the purpose intended. 129 At common law, the surgeon who has not been negligent will not normally be liable for a product (device)
relationship between the doctor and the patient is statutory – see Margaret Branthwaite and Nigel Beresford, Law for Doctors, Principles and Practicalities (2nd ed, 2002) 7-12. 126 When a surgeon implants a surgical device into a private patient it may not be clear whether the contract is primarily for the provision of services or for the supply of goods. Even when devices are implanted, the surgeon's professional role in diagnosis, advice, and/or treatment will commonly be regarded as the dominant feature of the transaction, so that it may not be viewed as comparable to a contract of sale. Generally there is an implied term that a surgeon will exercise all reasonable skill and care when treating a patient but any representation as to the nature of the outcome of the treatment (e.g. surgical procedure) does not necessarily constitute a warranty or a guarantee. The Courts have generally found this to be the case in the event that the (surgical) treatment has been provided for therapeutic indications as distinct from cosmetic reasons. For example, an adverse event associated with scarring following a cosmetic nose reduction procedure was found to be a breach of a contractual term of express or implied collateral warranty in La Fleur v. Cornelis (1979) 28 NBR (2d) 569 (NBSC). In this Canadian case the cosmetic surgeon had failed to advise the patient of a 10% risk of scarring. In contrast an alternate decision was the outcome in Eyre v. Measday [1986] 1 All ER 488 (CA) and Thake v. Maurice [1986] QB 644, [1986] 1 All ER 497 (CA). These two cases concerned the sterilization of a female and the undertaking of a vasectomy procedure respectively. In Eyre v. Measday the surgeon advised that the sterilization procedure would lead to the patient becoming absolutely sterile and incapable of bearing further children. In Thake v. Maurice the representation was that the vasectomy operation was irreversible but there was a failure to warn of a minute risk of the procedure being unsuccessful. In both of these cases the patients subsequently proved able to produce further children. In both cases, on Appeal, the decision was reversed and it was determined that there had been a breach of a contractual term of express or implied collateral warranty to render the individuals irreversibly sterile. In contrast, a claim in contract has potential for success when the contract also includes the supply of goods, such as an implantable device, in the event that it can be shown that the product is not of merchantable quality or is not fit for its intended purpose. In these circumstances it is not necessary to establish fault on the part of the manufacturer or sponsor. For further information see L Nathan, Medical Negligence (1st ed 1957) 10-11 & 19. 127 In sales between non-consumers the chain of liability may be broken by a reasonable exemption clause, see Lambert v. Lewis [1980] 2 WLR 299 CA. See s74 TPA. See also Lockett v. A & M Charles Ltd [1938] 4 All ER 170. Furthermore all hospitals supplying implantable devices privately can be contractually liable and liability can in principle move back up the chain of supply via third-party proceedings and successive indemnities. 128 See Brenda Brandt v. Boston Scientific Corp et al.:No. 93982 Chicago Illinois Supreme Court - the hospital and the manufacturer, but not the doctor were sued, applying the Warranty of Merchantability following the failure of a pubo-vaginal bladder suspension device that had been used to treat incontinence. The device was manufactured by the Boston Scientific Corp and voluntarily recalled (approximately) one month after the adverse event. Jarman J found that the hospital's provision of a defective device was "predominantly a transaction for services" rather than goods, so that no implied Warranty of Merchantability claim was available. 129 TPA s.74 - There is an implied term in a contract for work that a contractor will use reasonable care and skill and do the work in a workman-like manner and that any materials supplied must also be fit for the purpose intended.- see Dodd v. Wilson [1946] 2 All ER 691. In the TPA s.74(3) defines services and s.74(1) formulates the duty of the provider as expressed in Mutual Life and Citizens Insurance Co Ltd v. Evatt [1977] AC 793. Where a professional is held to be a specialist there is a higher standard that is consistent with those who specialise in the same field. s.74(c) provides that where a corporation (as distinct from a professional) supplies services there is an implied warranty that the services supplied, and the materials used, will achieve the desired result and be fit for that purpose providing the consumer has made it known to the provider the desired outcome. s.74 of the TPA is therefore appropriate to those circumstances where a surgeon provides services (operates) through the vehicle of a service company. s.74 requires that the services supplied are supplied by a corporation to a consumer in the course of a business. 3.34 related injury130 though in the rare event that a surgeon supplies surgical devices to a private patient, it is arguable that it may not be absolutely clear whether the contract is primarily for a provision of services or for the supply of goods (or both). Even though surgical devices are supplies, the surgeon's professional role with regard to the procedural matters will usually be regarded as the predominant feature in the transaction that may not be viewed as comparable to a
contract of sale.131
3.35. The supplier of a surgically implantable device can be held liable to the consumer if the goods sold do not correspond with their
description132, or do not meet the quality conditions, either because
they are not of merchantable133 quality or not fit for their particular
purpose.134 Liability for breach of the implied terms, implicit in the TPA and the Sale of Goods Act 1923 (NSW) is strict. There is no
need to prove fault or negligence on the part of the seller.135 Where a surgical device is deemed to be defective, or where there is a
superadded risk136 of a defect, there may be a breach of the implied
term137 that the goods are of merchantable quality.138 In the event, the
130 L Nathan, Medical Negligence (1957) 10-11 & 19. 131 Bejamin's Sale of Goods (4th ed, 1992) [1-046[. See also L Nathan, Medical Negligence (1st ed 1957) 19. 132 TPA s.74C - provides a consumer with a right of action where goods do not correspond with their description, and Sale of Goods Act 1923 (NSW) s.18. 133 In New Zealand the term is "acceptable quality". In 1995 the then Federal Bureau of Consumer Affairs in Getting What You Pay For proposed changes to the TPA to introduce a concept of acceptable quality similar to the New Zealand legislation. For further reading see Gail Pearson and Simon Fisher, Commercial Law Commentary and Materials (1st ed. 1999) 958-60. 134 The purpose may be made known directly or through a person involved in antecedent negotiations. Such negotiations are defined in TPA ss.66(1)(c). 135 Frost v. Aylesbury Dairy Co. Ltd [1905] 1 KB 608, [1904-7] AL ER Rep 132, 74 LJKB 386, 53 WR 354, 49 Sol Jo, 312, 92 LT 527, 21 TLR, 300, CA. Here it was the existence of, and not the discoverability of or reason for the defect, that renders the seller liable for damage caused. The milk was found to contain typhoid germs. In order to imply the relevant term the buyer must explicitly or implicitly make known to the seller the purpose for which the goods are required. The buyer here did not need to tell the milk vendor that the milk was for human consumption. The seller was liable for breach of the implied term. 136 See Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. See also vide supra n.34. 137 A defective surgical product that causes injury through not being safe for its intended use can constitute a breach of warranty. Almost every orthopaedic product that is sold is accompanied by a representation that the device is safe and fit for the use for which it was intended. These are referred to as implied warranties. Orthopaedic products though rarely (if ever) have express warranties, i.e. a written statement indicating that defects are covered and what responsibilities the manufacture assumes in the event that the product fails to comply with the express warranty. Such warranties are sometimes referred to as limited warranties. Breach of implied or express warranties can sustain a claim for injury suffered by defective products. Disclaimers are frequently provided by orthopaedic device manufacturers to limit liability for adverse events. Courts have however generally found that manufacturer's disclaimers are invalid and unconscionable. It is interesting to observe that the warranty provided by the Centerpulse Orthopedics (formerly Sulzer Corporation) "warrants that [the] products are free from defects in materials and workmanship for a period of twelve months from the date the products are dispatched for shipment." The "benefits and risks relating to the [Centerpulse Orthopedics] products applies to the purchaser at the time the products are dispatched for shipment". It is also stated that "Benefits and risks relating to the [Centerpulse Orthopedics] products pass to the purchaser at the time the products are dispatched for shipment." It is the author's view that these general terms and conditions of business are inconsistent with the consumer’s reasonable expectations of that purpose that is associated with the use of a reconstructive joint replacement device that should be characterized by efficacy and acceptable performance for at least 10 years. For further information see Centerpulse Orthopedics Product Catalogue, 2003, General Terms and Conditions of Business, pp.5-6. 3.35 supplier of a defective surgically implantable device can find no defence in the argument that all reasonable care in the supply of the goods has been exercised.
3.36. The implied term, fitness for purpose139, indicates that a manufacturer, a retailer or distributor, or hospital or surgeon, will have been on notice for the purpose for which the consumer (in this case a patient) will use the goods, even though that purpose may never have been,
expressly communicated to the seller of the product.140 Merchantable
or satisfactory quality141, implies into contracts of sale (for all sellers) that the condition of the goods will be fit for a purpose for which goods of that kind are commonly bought, taking into account their description and price.
3.37. It may be the case that a beneficiary of a contract, to which he or she is not a party, and this may be the patient, is entitled to enforce a
contract that was made for his or her benefit.142 Though there may be no contract between the patient and the manufacturer, it may be the case that a manufacturer can be held liable if there can be seen to
have been a collateral contract143, where the consideration is the making of some other contract. The complex relationships that exist between patients, surgeons, hospitals and manufacturers (or their
138TPA ss.71(1) & 74D(3) & SGA 1923 (NSW) s.19(2). Within s.74D(3) of the TPA goods of any kind are of merchantable quality within the meaning of this section if they are as fit for the purpose or purposes for which goods of that kind are commonly bought as it is reasonable to expect having regard to: (a) any description applied to the goods by the corporation; (b) the price received by the corporation for the goods (if relevant); and (c) all the other relevant circumstances. The Full Court of the Federal Court held in Medtel v. Courtney (2003) 198 ALR 630; BC 200303598; [2003] FCAFC 151 that even though goods conformed to the highest standard that any buyer could expect, they were nevertheless unmerchantable even though at the time of sale the defect was not known nor discoverable, there being only a superadded risk that the goods were defective. 139TPA s.71(2) and s.74B and SGA 1923 (NSW) s.19(1). The use of the implied terms fitness for purpose is to imply the concept of adequate and appropriate for the purpose of performing a particular function. ss.71(2) and 74B TPA & SGA 1923 (NSW) s.19(1). 140 See vide supra n.143. 141 The question of what is merchantable quality has been approached in a number of ways and the reader is referred to G Pearson & S Fisher, Commercial Law -Commentary and Materials, (1st ed 1999), Part V Liability for Goods and Services, Ch 14, 958-9. Implicit in the definition of merchantable quality are the concepts of satisfactory quality and acceptable quality. 142 See Trident General Insurance Co. Ltd v. McNiece Bros Pty Ltd (1988) 165 CLR 107, here the High Court refused to apply the doctrine of privity of contract (confined to insurance) though the reasons given in the different judgments raise doubt as to the general application of the decision. 143 Shanklin Pier Ltd v. Detel Products Limited [1951] 2 KB 854; [1951] 2 All ER 471. In this case a paint manufacturer had assured a consumer that paint would last for at least seven years. The consumer purchased paint from a retailer but the paint lasted for only three months before it rapidly deteriorated. The warranty given by the defendant was held enforceable notwithstanding that the main contract was subsequently entered into between the claimant and a third party. The consumer recovered from the manufacturer in contract for economic loss for breach of express warranty. See also Andrews v. Hopkinson [1957] 1 QB 229; Yeoman Credit Ltd v.Odgers [1962] 1 WLR 215; Brown v. Sheen & Richmond Car Sales Ltd [1950] 1 AL ER 1102. 3.36 agents) may include collateral contracts. This hypothesis remains untested.
3.38. Manufacturers of surgical devices produce volumes of promotional material that are intended to serve both as advertising material and as a source of information for health care professionals. Much of the information is available online and can become readily available to patients as consumers. In the event it does remain the case that the statements contained in much of this promotional material is unlikely to vest the ultimate recipient or user of the device with a remedy that might be based on an implied warranty that the statements made were
true.144 Furthermore, any (pre-contractual) misrepresentation by a
manufacturer which is regarded to be only a mere puff145 or sales talk
is not actionable.146 In contrast misleading or deceptive advertising147
is. It should be noted that as a result of the Ipp Report148 it is recommended that s.52 of the TPA should no longer be available as a
cause of action in personal injury claims.149
3.39. In the preceding paragraphs those aspects of contract law that impact upon issues associated with implantable surgical device product liability have been reviewed. Within Australia's Public Hospital System and under the umbrella of Medicare, opportunities for patients in contract are, as in any nationalised health care system,
144 Lambert v. Lewis [1978] 1 Lloyd's Rep EP 610 at 628. 145 The law does not prevent the use of humour or of grandiose statements when any exaggeration is self evident. A certain amount of puffery is tolerated. However where a claim is a factual representation that can be scientifically, or otherwise objectively, determined, the protection permitted by a mere puff will not apply. See Byers v. Dorotea Pty Ltd (1986) 69 ALR 715 and (1987) ATPR 40 760. Here the claim that "our" units "are bigger and better" was a representation that could be measured against other properties in the same location and therefore the claim was not a mere puff. 146 Union Carbide Australia Ltd v. Duracell Australia Pty Ltd (1987) ATPR 45359 481, drawing in general terms unfavourable comparisons between the advertiser's products and the products of rivals can lead to liability under s.52 TPA. This case concerns the claim that Duracell Batteries lasted up to six times longer than other batteries. 147TPA s.52 - This section of the TPA has become one of the most litigated sections of the Act. It was originally intended as a form of protection to consumers that simply states "(1)A Corporations shall not in trade or commerce engage in conduct that is misleading or deceptive or likely to mislead or deceive; and (2) Nothing in the succeeding provisions of this division shall be taken as limiting by implication the generality of sub-section (1)." Section 52 does create liability and does provide a code of conduct for manufacturers and their sponsors or agents. Whether conduct is actually misleading or deceptive depends on the circumstances of each case. It remains a question of fact as to whether conduct can be misleading when it is inconsistent with the truth or when it leads or is likely to lead the person to whom it is directed into error. See also Tobacco Institute of Australia Ltd v. Australian Federation of Consumer Organisations Inc (No 2) (1993) 41 FCR 89; 113 ALR 257 and Parkdale Custom Built Furniture Pty Ltd v. Puxu Pty Ltd (1982) 149 CLR (HCA). 148 See vide supra n.69. 149 For further reading see A Morrison, “NPLA News” (2003) 14 (9) Australian Product Liability Reporter, 140. 3.37 extremely limited150 as there is generally no contract between the
patient, as a consumer, and the manufacturer (or its sponsor151). It is principally only in the context of the provision of private treatment that actions for breach of contract might feature and in the event these will usually only be of concern for a hospital and/or a surgeon and only rarely be a matter for the concern of a manufacturer (or
sponsor)152. It remains the case that, in Australia, product liability issues in respect of the implantation of surgical devices have not focused on a contractual remedy against a manufacturer.
3.40. Were a patient to be successful in an action for breach of contract, in the event of an adverse surgical device incident, then remedies may
be available in damages153, in restitution154 or in specific
performance.155 Damages are by far away the most common award for loss that must be shown to be directly associated, without
remoteness,156 to the defendant's breach. In the event that goods have been supplied under contract and are found to be defective it is no defence for the seller to argue that all reasonable care had been exercised in the supply of the goods. This reasoning would apply also in the event that there has been inadequate product containment,
labelling, or instructions for use.157
150 See Ian Kennedy and Andrew Grubb, Medical Law (3rd ed, 2000) 1612-14. See also Pfizer Corp v. Ministry of Health [1965] AC 512, [1965] 1 All ER 450 HL and Appleby v. Sleep [1968] 2 All ER 265, [1968] 1 WLR 948 DC. Here there is no contract as the supplying health care professional is statutorily obligated to provide the service that in both cases require the presentation of a form of prescription and the payment of a fixed Government charge. Liability in contract for injury caused by privately prescribed medicines, and possibly also surgical devices, may be another matter. 151 Sponsor is defined in ss.3(1) of the TGAct as - (a) a person who exports, or arranges the exportation of, the goods from Australia; or (b) a person who imports, or arranges the importation of, the goods into Australia; or (c) a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who - (d) exports, imports or manufactures the goods; or (e) arranges the exportation, importation or manufacture of the goods; (f) on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia. 152 Except in those rare circumstances when in a program of research there is a contractual arrangement between the manufacturer and the volunteers participating in that research. 153 Damages are a Court-awarded sum of money. 154 A remedy whereby the claimant is restored to his/her original position, i.e. before the loss of injury. 155 An obligation to perform and satisfy the terms of a contract. 156 Remoteness is to contract as reasonable foreseeability is to tort. 157 See Wormell v. RHM Agriculture (East) Ltd [1986] 1 All ER 769, [1986] 1 WLR 336. Though this case concerned the use of a pesticide, and the instructions for that use, it is relevant to extrapolate the findings to permit the suggestion that the mere facts that a surgical device is potentially harmful is no defence if it is safe when used according to instructions. 3.38 THE TRADE PRACTICES ACT 1974 (Cth) – PRODUCT LIABILITY
3.41. The TPA applies, in general terms, only to the activities of corporations, as distinct from the activities of individuals or
partners.158 The TPA has modified transactions for the supply of goods to consumers and provides for the liability of manufacturers
for goods that are found to be defective, at risk of being defective159 or are unsafe and where there is what would otherwise be a breach of an implied term. The TPA also regulates misleading and deceptive
conduct160, other unfair practices161, and unconscionable162 conduct in
trade and commerce.163
3.42. The statutory objective of the TPA is to enhance the welfare of the Australian community through the promotion of competition and fair-trading and the provision of consumer protection. The TPA is also concerned with certain anti-competitive conduct and with unfair
trading practices.164 The TPA is administered by the Australian Competition and Consumer Commission (ACCC). The roles of the ACCC are briefly reviewed in paragraphs 3.55 to 3.59 of this chapter.
3.43. During the early 1970s through to the early 1990s, Australian
Product Liability Law was exposed to a thorough review165 and, as a consequence, there have been many significant changes to the TPA
158 Whether or not hospitals (or indeed medical practitioners) can satisfy the Constitutional requirement for the definition of a corporation has been clarified in E v. Australian Red Cross Society (1992) ATPR 41 156. In this case the Australian Red Cross Society and the NSW Division of that Society were held to be trading corporations within s.51 of the Australian Constitution. The third defendant, the Royal Prince Alfred Hospital, was also confirmed to be a trading corporation. 159 See vide supra ¶3.14, Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. 160TPA s.52. 161TPA s.51A (future representations) and s.53 (false representations). 162 In 1986, the TPA was amended to include s.52A which prohibited the corporation from engaging in unconscionable conduct. In 1992, the TPA was again amended to repeal s.52A and to include a new Pt IVA containing ss.51AA and 51AB which prohibit unconscionable conduct. 163 The Fair Trading Act 1987 (NSW) and the Australian Securities and Investments Commissions Act 2001 (Cth) provides some similar provisions. 164 See TPA Part IV. 165 The TPA has been the subject of no less than 15 separate reviews since 1974. It is the most scrutinized piece of Legislation in Australia. See also the National Consumer Affairs Advisory Council Report of 1987 entitled Consumer Product Safety, the Australian Law Reform Commission Report of 1989, and the Industry Commission Report, Product Liability, of 1990. 3.39 and to legal procedure166. The process of reform of the TPA has included -
(a) inclusion of Pt V Div 2A167; (b) recommendations of the National Consumer
Affairs Advisory Council in 1987168; (c) recommendations of the Australian Law Reform
Commission (ALRC) in 1989169; (d) the recommendations of the Industry Commission
in 1990170; (e) the Commonwealth Government decision to base reform on the 1985 European Community Product
Liability Directive171; (f) the introduction of the Trade Practices Amendment
Bill (No. 2) 1991 which proposed a new Pt VA172; (g) the introduction of the Trade Practices Amendment Bill 1992 which replaced the Trade Practices
Amendment Bill (No. 2) 1991173; and (h) the commencement of the Trade Practices
Amendment Act 1992.174
The reforms continue and further amendments to the TPA, have, as a result of the insurance (medical indemnity) crisis, been introduced
into the Act.175
166 In May 1991 the Federal Minister for Justice and Consumer Affairs announced that the Federal Government would implement product liability reform based on the 1985 European Community Product Liability Directive and in December 1991 the Trade Practices Amendment Bill (No. 2) 1991 was introduced in the Senate (see Senate Hansard, 26 May 1992, p.2661). This Bill proposed a new Pt VA of the TPA. 167 This followed the review of the Swanson Committee in 1976 and 1977. 168 This report concerned those difficulties associated with proving negligence against manufacturers and the restriction inherent in the then existing TPA with respect to remedies for purchasers and owners of defective goods. 169 The 1989 ALRC Report Product Liability recommended that manufacturers and suppliers of goods should be liable for any loss associated with defective goods. 170 The 1990 Report Product Liability recommended that the ALRC proposals should not be implemented. 171 This decision was announced by the Federal Minister for Justice and Consumer Affairs in May 1991. 172 This Bill was introduced into the Senate in December 1991. 173 The Trade Practices Amendment Bill 1992 was introduced into Federal Parliament in May 1992. 174 The Trade Practices Amendment Act 1992 (Cth) was passed on 24 June 1992 and received assent on 9 July 1992. 175 TPA Pt V1B. See also Trade Practices Amendment (Personal Injuries and Death) Bill (No 1) 2003 and Trade Practices Amendment (Personal Injuries and Death) Bill (No 2) 2004. 3.40 3.44. Prior to the introduction of Part VA176 of the TPA in 1992, provision for a product liability claim against manufacturers was provided for
in s.52 (misleading and deceptive conduct)177 and Part V Div 2A178. (actions against manufacturers and importers of goods). These provisions have been retained with the introduction of the strict liability regime. Part V Div 2A was enacted in 1978. The aim of this
legislation is to provide consumers179 with a remedy in the event that the consumer suffers loss or damage as a consequence of a product failing to correspond with description, being unfit for purpose, or being of unmerchantable quality. Any claim is restricted to consumers who have suffered loss or damage as a consequence of their use or consumption of consumer goods.
3.45. In 1992 the TPA was amended by the addition of Part VA (Liability
for Defective Goods)180. Part VA of the TPA includes provisions for
liability for defective goods181, and defines the nature of defective
goods182, and those matters relating to liability and to defences.183 Pt VA introduced both additional statutory remedies and a strict liability
176TPA s.75AA to s.75AQ provide a statutory right to compensation which does not depend on contract or tort law, but on whether injury or loss has occurred as a result of a product having a defect. TPA Pt VA also establishes a number of defences to a product liability action. 177TPA s.52 has become one of the most litigated sections of the TPA. s.52 was intended to protect consumers by defining a norm of conduct for traders and manufacturers as distinct from creating liability. See Tobacco Institute of Australia v. Australian Federation of Consumer Organisations Inc. (1988) 19 FCR 469, at 473-4. 178 The inclusion of Pt V Div 2A of the TPA followed the recommendation of the Swanson Committee which reviewed the TPA in 1976 and in 1977. Part V Div 2A imposes liabilities on manufacturers for: (a) goods which do not correspond with their description (s.74C); (b) goods of unmerchantable quality (s.74D); (c) goods which do not conform to sample(s.74E); (d) goods unfit for a stated purpose made known either expressly or by implication (s.74B); and (e) non-compliance with express warranties (s.74A(1), definition & s.74G, non-compliance). 179 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120 established that patients who have undergone surgery that is associated with the implantation of a device, in this case a heart pacemaker, are consumers. See also vide supra ¶3.14. 180 Pt VA TPA or the Strict Liability Regime has been based upon the European Product Liability Directives 1985. 181 TPA ss.75AD-75AG. s.75AD provides (that if):
(a) a corporation, in trade or commerce, supplies goods manufactured by: and (b) they have a defect; and (c) because of the defect, an individual suffers injuries; then: (d) the corporation is liable to compensate the individual for the amount of the individual’s loss suffered as a result of the injuries; and (e) the individual may recover that amount by action against the corporation; and (f) if the individual dies because of the injuries – the law of the State or Territory about liability in respect of the death of individuals applies as if: the action were an action under the law of the State or Territory for damages in respect of the injuries; the defect was the corporation’s wrongful act, neglect or default. 182 See vide supra n 8. 183 TPA s.75AK. 3.41 regime184 that does not require the claimant to prove any knowledge of or fault on the part of the manufacturer.
3.46. Under a regime of strict liability, surgical device manufacturers can be held responsible for any harm (includes injury and death) that is caused to the individual patient, or secondarily to other persons, by defective products, regardless of any precautions that may have been taken. An action commenced under Part VA of the TPA is defined in s 75AA to include an action under s75AD (personal injury to the individual) and under s75AE (injury suffered by another because of the injury or death of the individual). It is not relevant that the manufacturer or supplier has exercised due care. It is only necessary to show that the product was sold or distributed by a defendant and that the product was not as safe as persons generally are entitled to expect at the time that it left the defendant's hands.
3.47. An action based on strict liability can be brought against any party concerned with the manufacture, design, selling or supply of a product, and the consumer need only show that the product was
184 There is a trend towards strict liability throughout the world through the widespread adoption of the EC Directives – see vide supra n.21. For further information see J Kellam & SA Knutson, “A Corporation’s Worse Nightmare: Product Liability Claims around the World – Part 2” (2003) 14 Australian Product Liability Reporter, 25-32. This article discusses the Lex Causae (applicable law) and the doctrine of Lex Loci Delecti (law of the place of wrong). The article is extremely relevant in today's environment, and particularly in Australia, where the manufacturer and the supplier of surgical devices can become associated with a loss or with damage that will have (allegedly) been suffered in a place that is very different to the place of the manufacturer. The applicable law, described by Kaye, Choice of Law in Tort and Product Liability (1991) Private International Law of Torts and Product Liability, and discussed by Posh, Product Liability Law and its Reform in Europe in Campbell, International Product Liability (1993), 16-20, may be the law of the Forum: (a) Place of the wrong, i.e. that place where the event occurred. For example, in the United Kingdom, The Private International Law (Miscellaneous Provisions) Act 1996 (UK) includes a general rule that the applicable law [of tort] is the place where [the event] occurs. Where relevant events occur in two or more countries the wrong is deemed to have occurred in the country where the claimant was injured, where property was damaged or where the most significant elements in the sequence of events occurred. The general rule is not applicable if it is seen to be substantially more appropriate for the law of another jurisdiction to apply; (b) Place; Where the injury occurred. Pearson J. formulated the relevant question as to Where in substance did the cause of action arise? in Castree v. E R Squibb & Sons Ltd (1980) 1 WLR 1248-9 See also Distillers Co (Bio-chemicals) Ltd v. Thompson (1971) 1 NSW LR 83. Kellam & Knutson emphasised that the Lex Loci Delecti can give rise to a number of possible laws. For example, where a failure to warn claimants, the place of the wrong has sometimes been construed to be in the place where the product was purchased and where a warning should have been given; or (c) Jurisdiction; that is where there is the greatest connection with the specific issue raised in the litigation. In the event that there is an allegation of defective manufacturing then the place of manufacturing may constitute the place of the wrong. See D'Ath v. TNT Australia Pty Ltd (1992) 1 QD R 369; Lewis Constr Co Pty Ltd v. Tiachauer S A [1966] VR 341 and Buttigeig v. Universal Terminal and Stevedoring Corp [1972] VR 626. 3.42 defective185 and that the product caused injury. Part VA provides for a right to compensation against a manufacturer, in the event where injury or damage is the result of a defective product. In effect, as soon as goods are found to be defective, the manufacturer must compensate those who suffer injury or damage that is causally found
to be associated with the use of the defective goods186. In the event, neither negligence, nor the existence of any contractual relationship,
need be established187. The strict liability regime has been based upon
the European Community Product Liability Directives188 and applies
only to goods that were supplied after 9 July 1992.189
3.48. Strict liability does still require the claimant to demonstrate a basis
for the defendant's liability190 and it may be the case that the proving of the presence of a defect will be no less difficult than can be the
demonstration of fault191 on the part of the defendant.192
185 See vide supra n.8. 186 See Ch 5. 187 See vide supra n.69. It is evident though from the Ipp Report that tort law reforms could have had an alternative outcome. If manufacturers were relieved of the full force of common law negligence principles the suggested reforms might impose more exacting standards on manufacturers as a consequence of the more demanding standards of strict liability. The Report recommended that tort law reforms relating to limitation of damages and liabilities should be applied to Div 2A of Part V and Part VA of the TPA. In the event a new Pt V1B was inserted into the TPA. 188 See Medical Devices Agency (1995) Medical Devices Agency Directives Bulletin EC & EFTA Member States, the EEC Agreement and the EC Medical Devices Directives, No. 11, January 1995 & Medical Devices Agency (1994), Medical Devices Agency Directives Bulletin Information about the EC Medical Devices Directives, No. 8, October 1994. See also vide supra n.18 and n.21. 189 The first product liability case brought before the European Court, C203/99, Henning Veedfald v. R Zaella Hus Regional Authority concerned a Danish kidney transplant patient. Fluid used to preserve the donor kidney contained microscopic crystals that, had the kidney been implanted, would have caused the organ to be unviable. In the event the kidney could not be implanted. The patient filed a claim against the Renal Authority responsible for both the manufacture of the fluid and the harvesting of the kidney from the donor. The case turned on questions relating to Article 7(a)(c). Article 7(c) of the Directive can be construed as meaning that a publicly owned hospital is free from liability under the directive of products produced and used by that hospital in the course of providing the specifically public financed service to the person suffering injury and in respect of which that person has not paid any consideration. In regard to this, the judgment of the Court interpreted 7(c) as meaning that the exemption from liability where an activity has no economic or business purpose does not extend to the case of a defective product, which has been manufactured and used in the course of a specific medical service where that service is financed entirely from public funds and for which the patient is not required to pay any consideration. 190 The manufacturer is liable for damage caused by the defect in his product and the injured person must prove the damage, the defect and the causal relationship between the defect and the damage. To demonstrate that injury is caused by the product or as a result of the defective nature of the product, or the defective nature of the product contributed to the injury, is an imperative. In the context of strict liability, the definition of a product includes also those component parts or raw materials that may have been used in the fabrication of the final device. Further, a manufacturer's exposure to liability will be no less even in the event that the surgical device may have been given away as a sample, or have been directed for use in a clinical surgical research program. There are statutory defences in the TPA s.75AK. 191 Some have argued that product liability for medicinal products, and perhaps also, though not specifically debated, for surgically implantable devices should be based on a no fault compensation scheme. See AL Diamond and DR Laurence, “Product Liability in Respect of Drugs” in PF D'Arcy and JP Griffin (eds), Iatrogenic Diseases (3rd Ed, 1986), 117-23. 192 This is particularly so in a rapidly advancing modern implant technological environment. It is all but impossible for claimants to become learned and this can allow the exposure of inadequacies of the traditional remedies available in contract and in tort. It is for this reason that the principles of strict liability, that are based on there being liability without fault on the part of the device manufacturer should be maintained. This view is in harmony with the European Community Directives. For further information see the preamble to EC Directive 851374 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States concerning liability for defective products OJL 210/29. 3.43 3.49. The other significant change, in 1992, was that which concerned the
introduction of a representative or class action procedure.193
3.50. The statutory causes of action available within Part V Div 2A and Part VA are broad and it is, in the context of surgically implantable devices, appropriate to consider the causes of action included in
s.75AD194 of Pt VA and in ss.74B to 74G195 of Pt V Div 2A. Sec.75AD of the TPA requires corporations who supply goods manufactured by the corporation to compensate individuals where the
goods have a defect196, and the defect causes injury to the individual. There is some tension between the TPA and the TGAct with regard to the definition of manufacturer. There is no apparent uniformity between s.41BG(2) of the Therapeutic Goods Amendment (Medical
193 Prior to the 1992 amendments to the Federal Court of Australia Act 1976 (Cth) which established representative (or class) actions such actions were uncommon. See Supreme Court Rules, Pt 8r13. Class actions commenced under Federal Legislation can only be commenced in the Federal Court. 194 TPA s.75AD imposes liability on a manufacturer of goods, (a corporation), which have a defect if because of that defect any individual suffers death or injury. Where an individual dies because of the injuries, the law of the relevant State or Territory shall apply to the claim: The term individual is used rather than person. Only natural persons can be compensated under this section. 195 In Part V of the TPA Div 2A, s.74B provides consumers with a right of action against a manufacturer for goods which are not fit for the purpose for which they were acquired, s.74C provides consumers with a right of action against a manufacturer of goods which have been purchased by description and those goods do not correspond with the description, s.74D provides consumers with a right of action against a manufacturer of goods which are not of merchantable quality, s.74E provides consumers with the right of action against a manufacturer of goods which do not correspond with samples provided by the manufacturer, s.74F provides consumers with the right of action against manufacturers who fail to provide repair facilities and spare parts in respect of consumer goods and s.74G provides consumers with the right of action against manufacturers for non-compliance with express warranties. A manufacturer is liable to compensate a consumer, or that other person, for any loss or damage. Losses (including damages) are defined in s.75AA of Part VA as a “liability action” to mean an action under ss.75AD, 75AE, 75AF or 75AG. 196TPA s.75AC(1) - here it is stated that goods have a defect if there safety is not such as persons generally are entitled to expect. The essence of a defective product is lack of safety which can be determined objectively by reference to a consumer expectation test. Whilst not in accord with the plain meaning of the language of s.75AC(1) a view can be held that the purposes of the consumer expectation test may include an intention that, with respect to the surgical implantation of a surgical device, the surgeon, rather than the patient, should be deemed to be the consumer. It can be argued that this approach is consistent with the traditional notion associated with the learned intermediary doctrine. Safety is tested against the expectations of persons generally (as persons generally are entitled to expect) rather than against the expectations of the particular consumer. See Houdrich v. Howmedica Inc 169 Ill 2d 525, 215 Ill Dec 108 662 NE2d 1248 (1996). Here the claimant sought recovery on a strict liability theory against the manufacturer of a total knee prosthetic device that had failed prematurely and had caused injury. The evidence was conflicting as to whether the device failed because of a design defect, a manufacturing defect, or both. In the event, the Court held that the evidence was sufficient to support a finding that the claimant was injured by an unreasonably dangerous condition of the knee replacement device. The Court stated: Sufficient evidence was presented to support a finding that the device failed to perform in a manner reasonably expected in light of its nature and intended function and subjected the Claimant to an unreasonable risk of harm beyond that contemplated by an ordinary person. Although the Court was not presented with the argument that the contemplation of the doctors, rather than the patient, should be controlling, the case clearly used the ordinary person standard in applying the consumer expectation test. Under the principles of strict liability if the defect arises from a deficiency of a component part or raw material then the producer of that material part or component will be liable jointly with the producer of the finished product. In the event it can be a defence to demonstrate that the defect was attributable to the design of the finished product. Under s.75AC of the TPA, goods are considered to have a defect if their safety is not such as persons generally are entitled to expect, taking into account all relevant circumstances, including: (a) the manner in which, and the purposes for which, they have been marketed; (b) their packaging; (c) the use of any mark in relation to them; (d) any instructions for, or warnings with respect to, doing, or refraining from doing, anything with or in relation to them; (e) what might reasonably be expected to be done with or in relation to them; and (f) the time when they were supplied by the manufacturer. 3.44 Devices) Act 2002 (Cth) and s.74A(1) of the TPA. As we have seen
earlier, the definition of manufacturer as provided by the TPA197 includes that person concerned with the assembly of a product. Many surgical implantable devices are produced in a modular form that is not unlike a kit consisting of separate modular components that will permit a device to be assembled so that the surgical requirements identified can be addressed more accurately in terms of size and shape of implant components. In this way a surgically implantable device can be assembled to more adequately fit the
anatomy of a particular patient.198 In contrast to the definition of manufacturer that is provided in the TPA, a surgeon is not considered to be a manufacturer within the definition that is provided in the
TGAct.199
3.51. Pt VA of the TPA also adopts the extended definition of
manufacturer.200 A corporation will be deemed to be the manufacturer of goods for the purposes of the strict liability regime, not only where it actually does so, but also where it is concerned with the importation of the goods or allows its name to be used in association
with the goods.201
197 TPA s.74A(1). 198 It can be considered that the assembled implant has been customised for the patient as distinct from having been custom made. There is a subtle difference between customised and custom made and therein can be found an hypothesis that might explain the apparent tension between the TPA and the TGAct with regard to the definition of manufacturer. 199 TGAct s.41BG(2) (applies when s.41BG(1) does not apply) of the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) defines the manufacturer of a medical device as "the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not, it is the person or another person acting on the person's behalf, who carries out those operations." Further s.41BG(3) describes a person who is not the manufacturer of a medical device if (a) the person assembles to adapts the device for an individual patient; and (b) the device has already been supplied by another person; and (c) the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following: (i) the labelling on the device; (ii) the instructions for use of the device; and (iii) any advertising material relating to the device. Pursuant to s.74A(1) of the TPA the term manufacturer includes grown, extracted, produced, processed and assembled. The corporation will be regarded as being the manufacturer of particular goods for the purpose of Div 2A where the corporation actually manufactures the goods, holds itself out to the public as the manufacturer (s.74A(3)(a)) or uses its own brand name in relation to goods, (s.74A(3)(b)). This will be the case even where the label on the product states the corporation was not the manufacturer of the goods.- See ACCC v. Glendale Capital Products (1998) 40 IPR 619; 41 ATPR 632. There is that subtle variation in the definition of manufacturer between the TPA and the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) that concerns product assembly. Almost all orthopaedic prosthetic joint replacement devices are assembled by the surgeon in the operating theatre prior to their implantation. There is therefore a tension between the definition of manufacturer in the two Acts. 200TPA s.75AJ requires, in the event that a manufacturer cannot be identified by a claimant, that the supplier should identify the manufacturer within 30 days of a request, and where, in the event, there is no compliance with the request, then the supplier(s) is deemed to be the manufacturer of the goods for the purposes of the claim. 201 The same liability is implicit in Part V Div 2A of the TPA. The definition of (deemed) manufacturer was further clarified in Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120 and in Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014. 3.45 3.52. On 26 July 2004 amendments to the TPA, concerning proportionate
liability202, came into force.203 A new Part, Pt V1A, was inserted into the TPA by the Corporate Law Economic Reform Program (Audit Reform and Corporate Disclosure) Act 2004 (Cth). The new Part, consisting of s.87CB to s.87CI, provides for proportionate liability in respect of damages for economic loss arising from misleading and
deceptive conduct.204 The liability of a concurrent wrongdoer will be for the proportion of the claim that reflects that person’s responsibility or damage (s.87CD). Proportionate liability replaces the current system of joint and several liability in some cases. This area of the law is concerned with situations in which the same damage is caused by negligence, or other legal wrong, on the part of more than one person. Where it is impossible to determine the identity of a concurrent wrongdoer or to determine which manufacturer caused the harm, under traditional tort liability theories, claimants will have to rely on a collective liability theory for recovery. Collective liability have frequently been tested in the United States of America. Any potential impact of collective liability theories in Australian Jurisdictions remains to be seen. The collective liability theories include –
x Alternate liability.205 Here the burden of proof and the identity of the actual tortfeasor rests with the defendant.
202 See Civil Liability Act 2002 (NSW), Pt 4 (Proportionate Liability) ss.34-39 (as at 8 December 2004). See also G Williams & R McInnes, “Guidance Needed in Proportionate Liability” (2004) 15 (8) Australian Product Liability Reporter, 113-116. See also J McLean, “Proportionate Liability - the Wait is Over” (2004) 2.8 Australian Legal Business, 18. 203 The amendments introduced are to the TPA and to the Corporations Act 2001 (Cth). See also Corporate Law Economic Reform Program (Audit Reform & Corporate Disclosure Act 2004 (Cth)). The amendments follow similar legislation in Victoria, Wrongs Act 2002 (Vic) Pt IVAA, which commenced on 1 January 2004 and legislation in NSW Civil Liability Act 2002 (NSW) Pt 4, Civil Liability Act 2003 (Qld) Ch 2, Pt.2, and Western Australia, Civil Liability Act 2002 (WA). 204 The Amendments to the TPA provide for proportionate liability in respect of damages for economic loss for misleading and deceptive conduct. Amendments to s.82 are contained in Schedule 3 of the Corporate Law Economic Reform (Audit Reform and Corporate Disclosure) Act 2004 (Cth) (commenced 26 July 2004). The application of principals of proportionate liability to certain damages claims is just one aspect of the recent wide-ranging legislative reforms to civil liability laws. The new legislation includes, among other things, thresholds and caps on damages awards in personal injury claims, limited ability of criminals to recover damages and a revision of the standard of care that is required of professionals. The issues of proportionate liability will be of concern to claimants and respondents alike and to insurers, insur eds and intermediaries. 205 See Summers v. Tice et al, 33 Cal. 2d 80 194 P 2d 1 [1948]. 3.46 x Enterprise liability.206 This is a form of collective liability that is based upon wrongdoing by an entire industry that is viewed as a single enterprise.
x Concert of actions liability.207 Here the plaintiff must demonstrate that the defendant engaged in a common plan or scheme to commit to a tort.
x Market share liability.208 Market share theory is a portion liability according to a particular defendant’s share of the market.
In contrast with “solidary liability” under a regime of proportionate liability, liability for any harm caused, whether joint or concurrently, by the multiple wrongdoers, is apportioned between them according
to their respective shares of responsibility.209 Any recovery from any particular wrongdoer is only that proportion of the total damages awarded for which that wrongdoer is held liable that is assessed by reference to the wrongdoers’ comparative degree of responsibility. The legislation applies to claims for economic loss and property only, and does not apply to personal injury claims.
3.53. The TPA continues to be the focus of Commonwealth Reform that has been driven by the response to the Ipp Report - Review of the
Law of Negligence - that was published in 2002.210 In tandem with Commonwealth reform there has been, and there continues to be , far reaching reform of tort law in the States and Territories. In NSW the Civil Liability Amendment (Personal Responsibility) Act 2002
(NSW)211 has introduced significant changes212 that can be a template
206 See Hall v. E.I. DuPont Nemours & Co., Inc, 345 F. Supp. 353 (E.D.N.Y. 1972). 207 See Bichler v. Eli Lilly & Co., 55 NY2d 571, 450 NYS2d 776, 436 NE2d 182 (1982). 208 See Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 163 Cal. Rptr. 132, 607 P.2d 924 (1980). 209 Previously it was the case that if a person (or organization) partially caused the loss, he or she may have been liable for the whole of the loss. 210 See vide supra n 69. 211 The Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW), the amending Act, received Royal Assent on 28/11/02 and commenced on 06/12/02. This Act amends the Civil Liability Act 2002 (NSW). The Act also amends the Limitation Act (NSW) in respect to limitation provisions for claims for injury or death (other than for motor vehicle claims) that are brought in tort, in contract and under statute. 212 For a detailed discussion of the Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW) see S Clark & C Harris, “Civil Liability in NSW – A New Dawn for Manufacturers?” (2003) 14 (1) Australian Product Liability Reporter, 118-124. 3.47 for legislative reform in the other States and Territories.213 In NSW this Act amended the Civil Liability Act (2002) (NSW) and is legislation of a most reformist nature that has addressed and implemented many of the recommendations of the Ipp Report. The long term effect(s) that this Act will have on personal injury claims in general, and on product liability claims in particular, remains to be seen, though it is recognised that, given the limits to civil liability that is a consequence of this State Legislation, claimants in New South Wales may think to rely on Federal causes of action to pursue
their claims.214 The Ipp Report had already recognised that one consequence of any State and Territory reform would be to make it more difficult for claimants to succeed in claims based in negligence. Another conclusion of the Ipp Report was that the TPA might provide an opportunity for claimants to circumvent and to
undermine215 reforms to tort law such as are embraced by the Civil Liability Amendment (Personal Responsibility) Act (2002) (NSW), and other similar Acts, as there is the potential for claimants to be
encouraged, in NSW and elsewhere216 to turn to Federal causes of action in pursuit of their claims that might become framed as actions
under the TPA.217 As a consequence, and to frustrate this, a new Pt
V1 B was inserted into the TPA in July 2004218 which sets restrictions
on limitation periods219 and on damages220 that can be awarded in personal injury and death claims. This reform is a response that can assist with a consistent Federal approach that applies to claims for a personal injury and death under Pt 1VA (Unconscionable Conduct),
213 T Smyth, “Tort Law Reform – New NSW Act – Likely to be a Model for Other States and Territories” (2002) 11 (4) Australian Health Law Bulletin, 45-46 214 See vide supra n.212. 215 To ensure that State/Territory reform would not be undermined the Ipp Report recommended amendments to the TPA. These reforms have included the Trade Practices Amendment (Personal Injuries and Death) Bill (No.1) and the Trade Practices Amendment (Personal Injuries and Death) Bill (No.2) 2004. 216 M McGarvie, “Where to for Product Liability in Victoria?” (2003) 14 (8) Australian Product Liability Reporter, 109. 217 See vide supra n 212. 218 See Trade Practices Amendment (Person Injuries and Death) Bill (No.2) 2004, schl s.9, introducing Pt V1 B Div 2 of the TPA. Pt V1 B received Royal Assent on 13/07/04 and commenced on 13/07/04. 219 The limitation period is the earlier of three years from the discoverability of the personal injury or death, or 12 years following the act or omission alleged to have caused the death or injury (the “long stop” period). 220 The maximum amount of damages for non-economic loss will be $250m and indexed for future years (TPA ss.87M & 87N). See ss.87L & 87M - the maximum award for damages will only be in a most extreme case (s.87P). No award will be made if the non-economic loss is less than 15% of a most extreme case (s.87S). For further reading see R McInnes, “Amendments to the Trade Practices Act - Supporting Short Law Reform (2004) 15 (5) Australian Product Liability Reporter, 65-7. 3.48 Div 1A of Pt V (Contravention of Product Safety and Information Provisions), Div 2A of Pt V (Supply by a Manufacturer or Importer of Unmerchantable Goods) and Pt VA (Supply by a Manufacturer or Importer of Defective Goods). These reforms include also that the Australian Competition and Consumer Commission (ACCC) be prevented from commencing representative actions for damages for personal injury or death resulting from a contravention of Pt V Div 1 of the TPA (Consumer Protection – Unfair Practice). Included in
these reforms are s.52 and s.53221 which prohibit misleading or
deceptive conduct by corporations in trade and commerce.222
3.54. The TPA also, in s.52 and s.53, establishes a normal standard of conduct that is appropriate to all aspects of corporate activity including matters relating to consumer protection. In s.52 there is provision that a corporation shall not, in trade or commerce, engage in conduct that is misleading or deceptive, or is likely to mislead or deceive. It is only necessary to demonstrate that conduct was or had the potential to be false or misleading. It is not necessary to prove that anyone was actually misled or that any misrepresentation was
relied upon.223 The Treasury Legislation Amendment (Professional Standards) Act 2004 (Cth), which came into force on 13 July 2004 has introduced a new limit on liability for misleading or deceptive conduct under s.52 of the TPA. A professional standard law of a State or Territory will apply by virtue of s.87AB to limit occupational liability relating to an action under s.52 in the same way as it limits
occupational liability arising under a law of the State or Territory.224
221 TPA s.52 prohibits conduct that involves a misrepresentation which may be made expressly, by implication, or which may include silence. The Ipp Report recommends also that s.52 of the TPA should no longer be available as a cause of action in personal injury claims. ss.53-53C are criminal offences that include forms of conduct and representations that are false and the ACCC has power under s.79 of the TPA to institute prosecution proceedings in the event of breach of these sections. 222 The Explanatory Memorandum, Trade Practices Amendment (Personal Injuries and Death) Bill (No.2) 2004 states that the legislative reform will have the additional benefit of putting pressure on the States and Territories to enact nationally consistent reforms. See also A Morrison, “Tort Reform is now Applied to Product Liability Claims” (2004) 15 (6) Australian Product Liability Reporter, 81-2. 223 See Taco Co of Australia Inc v. Taco Bell Ltd (1982) 42 ALR 177; (1982) ATPR 40-303 (Taco Bell). The third of the four steps of Taco Bell confirm that evidence of actual erroneous conclusions is not necessary. 224 Corresponding amendments were also made to the Australian Securities and Investments Commission Act 2001 (Cth) in respect of misleading or deceptive conduct arising for consideration under that Act. 3.49 3.55. A number of defences225 are available to manufacturers alleged to have supplied defective goods. A general overview and consideration of those defences available to manufacturers is presented in chapter 6.
3.56. The limitation period for action brought under s.52, Part V Div 2A, and Part VA of the TPA, previously provided that a person had three
years to commence a course of action226. In 2002, the Trade Practices
Amendment Act (No.1) 2001 (Cth)227 extended the limitation period under the TPA from three years to six years. As we have seen, a new Pt V1 B will further restrict the limitation periods for personal injury and death claims.
THE AUSTRALIAN COMPETITION AND CONSUMER COMMISSION
3.57. The Australian Competition and Consumer Commission (ACCC) is Australia’s national trade practices and consumer protection law enforcement body. It is an independent statutory authority that was formed on 6 November 1995 by the merger of the Trades Practices Commission and the Prices Surveillance Authority. The ACCC administers the TPA and the Prices Surveillance Act 1983 (Cth).
3.58. With respect to the TPA, the ACCC has both an enforcement role and an advocacy role. The ACCC is charged with the enforcement of
all mandatory standards and bans under the TPA228 and is responsible for enforcing the consumer protection provisions
contained in Part V229 of the TPA. The ACCC also enforces mandatory recalls under the TPA. Under Section 65R of the TPA
225 TPA s.75AK of Pt VA sets out a number of specific defences available to manufacturers. TPA s.85(1) also establishes a number of defences to prosecution. 226 For s.52 see s.82(2); for Part V 2A see s.74J(1); for Part VA see s.75AO – of the TPA, 227 The Trade Practices Amendment Act (No. 1) 2001 (Cth) commenced on 26/07/01. 228 Prior to 1995, mandatory standards were enforced by the Department of State, responsible for the TPA (then the Attorney- General's Department). Consistent with a general move across Government to separate policy and enforcement functions, the ACCC became responsible for enforcing standards and bans. 229 Importantly the enforcement of s.52 that is contained in Pt V of the TPA. TPA s.80A empowers the ACCC to seek an order for corrective advertising for an established contravention of a provision of Pt V. This was the approach in Glendale. The ACCC can take action under the TPA against suppliers of goods who do not comply with consumer product safety, with information standards, and with bans. The ACCC can seek orders in the Federal Court for companies to recall unsafe goods. 3.50 suppliers who initiate any voluntary safety related recall action are
required to notify the Minister230 (responsible for Consumer Affairs) within two days of taking such action. In many cases suppliers are also required to notify other parties which include the TGA.
3.59. As we have seen, in 1992, the TPA was amended by Part VA to include product liability provisions that make the manufacturer or importer of goods liable to pay compensation if a product is found to be defective and causes injury, death or damage to property. Under the TPA these provisions serve as a strong incentive for industry to ensure that their products are safe to use and are adequately labelled. Under these provisions consumers can take legal action on their own behalf. The ACCC also has the power to sue a manufacturer of defective goods on behalf of one or more persons who have suffered
loss.231 This is an advocacy role of the ACCC that is covered by
s.75AQ.232 The ACCC is able to initiate representative action (class action) in the Federal Court if the parties (claimants) give their
written consent.233
3.60. The ACCC also has the power234 to institute prosecution for proceedings in the event of there being a breach of Part VC of the TPA. These breaches are criminal in nature and include forms of conduct or representation which are false.
230 If the goods create an imminent risk of death, serious illness or injury, the Minister can publish an immediate compulsory recall order under s.65L of the TPA in the Australian Government Gazette. If there is no immediate risk to the public the Minister must first publish a notice inviting suppliers to request a conference before the ACCC. After the conference has been held the ACCC then recommends that the Minister publish the compulsory recall order, or an amended version, or not publish the order. The Minister is required to have regard to the ACCC recommendation, but is not obliged to implement it. If he does decide to disregard the recommendations of the ACCC the Minister must then publish a Statement of Reasons in the Australian Government Gazette. 231 The Ipp Report Review of the Law of Negligence 2002, chaired by Justice Ipp, recommends that the power of the ACCC to commence representative actions for damages for personal injury resulting from contraventions of Pt V Div 1 (TPA) be removed. The Ipp Report also recommends that individuals be prevented from bringing action for damages for personal injury and death under Pt V Div 1 and that the TPA (and equivalent legislation) be amended to provide that the provisions of the Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW) that concern limitation periods and any quantum of damages, those provisions that limit liability should also apply to any claim got negligently caused personal injury or death brought under Pt V, Divs 1A and 2A or Pt VA. The Ipp Report rejected the ACCC's opposition to reducing the level of consumer protection provided by the TPA. 232 If the ACCC commences a representative action under s.75AQ TPA it is only able to seek compensation for consumers. It cannot seek injunctions or other form of orders. 233 See Clarke v. Pacific Dunlop Pty Ltd (1989) ATPR 40-983. Pacific Dunlop Ltd manufactures and sells rubber gloves (Latex). The ACCC initiated representative proceedings against Pacific Dunlop Ltd based on a claim that the rubber gloves were the cause for a serious Latex allergy. The ACCC alleged that, when the product was originally sold, there was no warning label advising of the risk of Latex allergy. 234 Part VC of the TPA was introduced to make the criminal offence provisions consistent with The Criminal Code Act 1995 (Cth). 3.51 3.61. Other functions of the ACCC include the stated goals:
(i) to secure compliance with the TPA by responding to complaints and enquiries and by observing market conduct and initiating action when required; (ii) to improve market conduct; (iii) to enhance competition in our regulatory activities; (iv) to inform the community at large about the TPA and its specific implications for business and for consumers; and (v) to use resources efficiently and effectively.
It is also the case that the ACCC has a major function that is educative. This includes the supply of information and advice to suppliers and consumers with regard to the requirements of mandatory product standards.
THE THERAPEUTIC GOODS ACT 1989 (Cth)
3.62. The TGAct provides the legislative basis for the uniform national control of goods used in the prevention, diagnosis, curing, or
alleviation of a disease, ailment, defect or injury.235 The TGAct is in addition to any other legislation that may relate to therapeutic
235 Medicines have been regulated since the 1930s and dental products since World War II. There has only been a limited control of high risk medical devices since 1987. Prior to 1991 the control of drugs and devices was shared by Commonwealth and State Territory Governments. The TGAct and Regulations came into effect on 15/02/91. Non-compliance with the Therapeutic Goods Act 1989 (Cth) is an offence. Controls are enforced by the TGA through: (a) the determination of standards; (b) the restriction of the supply of therapeutic goods; (c) controls for the experimental use of therapeutic goods; (d) a requirement that goods be manufactured according to a suitable and accepted standard of manufacture; (e) a requirement that data be evaluated as part of registration and listing; (f) the imposition of evaluation time and fees; (g) the enforcement of conditions on registrations and listing; and (h) the continuing monitoring of compliance with the Act. 3.52 goods236. The promotion of therapeutic goods is also subject to the general provisions of State/Territory Fair Trading legislation and the Federal TPA. The objective of the TGAct, is to provide a national
framework for the regulation of therapeutic goods237 in Australia. The regulation of drugs and devices in Australia, is different, but
each has at its centre a national competent authority238, the TGA, as the regulator. In October 2002, amendments were made to the
TGAct239 instituting new legislative requirements in relation to medical devices: The Therapeutic Goods Amendment (Medical Devices) Act 2002 and the Therapeutic Goods (Charges) Amendment Act 2002. The regulations relating to medical devices are wholly
new: The Therapeutic Goods (Medical Devices) Regulations 2002240, (The Regulations). These recent reforms to the TGAct are intended to strengthen the role of the TGA as the regulator of the supply of medical devices and to ensure the harmonisation of Australian medical device legislation with that of the EC and the Global
Harmonising Task Force (GHTF)241. The regulatory objectives can be summarised as including:
(i) the regulation of manufacturers by the imposition of statutory and regulatory requirements for
medical devices242 and by ensuring the introduction
of quality management systems (QMS)243 by manufacturers; (ii) that there is compliance with legislation specifically with regard to the essential
236 The State Poisons Legislations, Standards for the Uniform Scheduling of Drugs and Poisons, the Customs Act 1901, and the Customs (Prohibited Imports) Regulations. 237 Goods can be classified as therapeutic, cosmetic or food. However, once a therapeutic claim is made, or implied, then the goods become therapeutic and become subject to the requirements of the TGAct. Therapeutic goods are defined in TGAct s.3(1). 238 See vide supra n.114. 239 The TGAct as amended by the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) is now divided into eight chapters. See pages 6-11 of TGA Australian Medical Devices Guidelines, An Overview of the New Medical Devices Regulatory System, Guidance document No.1 Version 1.5, 2003. The document can be accessed on line at www.tga.gov.au. 240 The Therapeutic Goods Regulations, 1989 has been constantly under review and frequently amended to make allowances for new definitions and/or classes of therapeutic goods and the manner of their control. The Therapeutic Goods (Medical Devices) Regulations 2002 reflects the most recent amendment and is directed at medical devices as distinct from other therapeutic goods. 241 See vide supra n.18. 242 TGAct s.41 BA. 243 The enforcement of QMS should ensure safety, efficiency and compliance with regulations. 3.53 principles244, device standards245 and conformity
assessment procedures246; (iii) the undertaking of risk management procedures to reduce hazard, to eliminate harm, and to ensure
that the benefits exceed side effects247; (iv) that medical device products are traceable through their inclusion on the Australian Register of Therapeutic Goods (ARTG); (v) the maintenance of post-market vigilance programs and of a system of adverse event
reporting248 that is mandatory (only) for Manufacturers and Sponsors; and
(vi) the TGA's obligation to enforce249 penalties.250
3.63. In summary the TGAct provides the basis for the controls while the Therapeutic Goods Regulations 1989, and the Therapeutic Goods (Medical Devices) Regulations 2002 indicate how those controls are to be enforced by the TGA.
3.64. The TGAct provides for the establishment and maintenance of a national
system of control of the quality, safety, efficacy and timely availability251 of
therapeutic goods, including both drugs and medical devices252, that are
244 TGAct s.41 CA. 245 TGAct s.41 CB. 246 TGAct s.41DA (procedures) and s.41E (certificates). See also s.41BH (compliance with essential principles) and s.41MA (non- compliance with essential principles). 247 There are 53 references to risk in the Therapeutic Goods (Medical Devices) Regulations 2002. 248 TGAct ss.41MP & MQ. 249 TGAct s.41BC. 250 TGAct ss.41JH & 41JI. 251 The goal of timely availability was added to the TGAct following the Baume Report (1991) on the future of Drug Evaluation in Australia. 252 A Medical Device is defined in the TGAct in s.41BD(1)(a) and s.41BD(1)(b). The definition includes any instrument, apparatus, appliance, material or other article (whether for use alone or in combination), together with any accessories or software required for its proper functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means that may be assisted in its function by such means, but the expression does not include therapeutic goods declared by the Secretary, by order published in the Gazette, not to be therapeutic devices. An accessory to a medical device is an article or articles intended specifically by its manufacturer to be used together with the medical device to enable the medical device to be used as intended by its manufacturer. In s.41BD(1)(a) it is further stated that a medical device is intended by the person under whose name it is supplied, to be used for human beings for the purpose of one or more of the following;
(i) diagnosis, prevention, monitoring, treatment, or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; (iii) investigation, replacement or modification of the anatomy or of a physiological process; or the 3.54 used in Australia, or are manufactured and exported from Australia. The TGAct controls:
, (i) The standard of all ingredients253 used in manufacture;
(ii) the presentation254, the advertising and label255 claims for products;
(iii) the registration of product(s) on the ARTG256; and
(iv) the Good Manufacturing257 and Packaging
conditions and controls.258
3.65. Advertising and the provision of generic information about therapeutic goods that is directed to the public must comply with the provisions of the
(iv) control of conception.
253 The TGA has designated the appropriate monographs to which the ingredients must comply. Most ingredients for drugs are expected to meet BP93 Standards. The materials used for the fabrication of orthopaedic devices must conform to International Standards and Australian Standards are in harmony with the Geneva ISO Standards. 254 Among the main requirements are that active ingredients must be declared on the main label. The batch number and expiry date must be clearly evident. Storage directions of an approved nature must be clear. There should be directions for use. The Australian sponsor’s name and address must appear on the label. 255 The advertising of therapeutic goods is regulated in Australia under a Co-regulatory arrangement that involves the TGA, the Therapeutic Goods Industry, Health Care Professionals, Consumers, the Advertising Industry, Retailers, the ACCC, Medsafe in New Zealand and the media. An advertisement is defined in the Act as "any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly to promote the use of or supply of the goods." Advertisements for therapeutic goods, including devices, directed to consumers are required to comply with the Act, Part II of the Therapeutic Good Regulations (Medical Devices) Regulations 2002 and the Therapeutic Goods Advertising Code (TGAC). The object of the TGAC is "to ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer. The TGAC provides a list of words and claims that are unacceptable for use on therapeutic goods. For further information see Australian Medical Devices Guidelines, Advertising Medical Devices, Guidance Document No 8, Version 1.5 (TGA). See also CA Davies, “Keeping Advertisers Honest - an Overview of the Regulation of the Advertising of Medicines and Medical Devices in Australia” (2004) 27 (5) Australian Prescriber, 124-27. 256 The ARTG is a Register of all therapeutic goods supplied in Australia. The ARTG is a public record. The ARTG continues to be the central point of control before the legal supply of therapeutic goods in Australia. The ARTG is the Register of Information about therapeutic goods for human use that may be imported, supplied in, or exported from Australia. The recently enacted Amendments to the TGAct permit devices registered as at 04.10.02 to remain valid with respect to registration to 04.10.07. All goods entered on the ARTG must display their registration (AUST R) or listing (AUST L) number on the front panel of the outer label. The ARTG currently includes 400-600,000 catalogue items that include 36,000 different devices of which more than 85% are imported and just a little less than 10% could be classified as high risk. - Personal Communication M Flood, Therapeutic Goods Administration, Canberra, November 2002. For a device to be included on the ARTG, Sponsors submit evidence for compliance and conformity (s.41 FD). The TGA is also authorised to accept overseas evidence (Reg 3.5). Automatic inclusion onto the ARTG is permitted for Class I, IIA and IIB devices that have a CE Mark. The ARTG should not be confused with Schedule 5 - Benefits Payable in Respect of Surgically Implanted Prostheses, Human Tissue Items and Other Medical Devices List. The Schedule 5 arrangements followed round table discussions in June 1999 between the Commonwealth and other stakeholders, including Health Funds, Private Hospitals, Manufacturers/Suppliers, Medical Practitioners, and Consumers. The arrangements derived from these discussions became effective in February 2001. Appendix A of Schedule 5 concerns the benefits payable by Health Funds for surgically implanted prostheses and inclusion in Appendix A is determined by the Commonwealth Department of Health and Ageing. Appendix C is concerned with "Other Medical Devices" and is overseen by the Private Health Industry Medical Devices Expert Committee (PHIMDEC). The Committee complements the work of the TGA. Members of PHIMDEC are appointed by the Minister for Health and Ageing and include as the Consumer Representative Ms Karen Carey-Hazell (see Carey-Hazell v. Getz Bros & Co Pty Ltd [2004] FCA 853). Ms Carey-Hazell is also a member of the Health Consumer's Council of Western Australia Inc. 257 All therapeutic goods must be manufactured according to an approved standard and if manufactured overseas according to a recognised therapeutic licence eg. CE Mark. See also Chapter 4 ¶4.50. 258 The manufacturing and packaging conditions detailed in the Australian Code of Good Manufacturing Practice for Therapeutic Goods (Medicinal Products) 1990, is usually referred to as the GMP. 3.55 TGAct, with the Therapeutic Goods Regulations 1990 and also with the Therapeutic Goods Advertising Code (TGAC) (The Code). The Code was originally developed by the first Therapeutic Goods Advertising Code Council that had been established in the 1970’s by the Media Council of
Australia (MCA).259
3.66. In summary, the TGAct, the Amendments and the Regulations control medical devices (and drugs) in regard to their supply and with regard to standards of development, manufacture and marketing and the TGAct
provides that it is an offence260 to import, export, manufacture or supply a therapeutic device in Australia unless it is listed by the TGA on the ARTG.
3.67. The identification of manufacturer and supplier can, though not always, find the two to be different individuals or organisations. The recently enacted amendments to the TGAct have been described as having
introduced a tension261 with regard to establishing the identity, and with respect to the understanding of, the concepts of manufacturer and supplier. With regard to the surgically implantable device, in the event that there is a product liability claim, one significant issue is the identification of the manufacturer for the purposes of Part V Div 2A s 74A(3) and s 74A(4) that
must have regard to the intention262 of that individual or organisation under
whose name or trade mark the implant was supplied.263
259 The MCA administered the operations of the TGAC as well as the revision and maintenance of the Code. The Code was authorised by the Trade Practices Tribunal during 1988 with a degree of legal underpinning from February 1991 when various parts of the Code were included in the TGAct. The MCA ceased operation in late 1996. There followed a Collegiate which was formed by the Proprietary Medicines Association of Australia (now the Australian Self-Medication Industry) and the Nutritional Foods Association of Australia (now the Complementary Health Care Council). This Collegiate was to take over the administration of the Code Council and have the Code authorised by the ACCC. The Collegiate enabled a system that was applicable to all through a number of amendments (amendment 400A) to the TGAct and Regulations in December 1997. Amendment 400 provided for the establishment of the Therapeutic Goods Advertising Code Council, a complaints resolution panel and the formal approval of mainstream print advertisements for therapeutic goods. A review of advertising arrangements was undertaken in 1999. This resulted in the development of a principles-based code and the expansion of the approval and complaints processes to include other forms of therapeutic goods advertising. Generic information about therapeutic goods was also included. 260 See TGAct ss.20, 21, 22 and 22(a) for offences relating to importation, exportation, manufacture and supply of therapeutic goods, for offences relating to wholesale supply, for general offences relating to Part III Div 1 and for matters relating to full statements in Applications for Registration. 261 E Ruschena, “The Medical Device Amendments to the Therapeutic Goods Act: Do They Apply to Me?” (2003) 11 (9) Australian Health Law Bulletin, 98-100. 262 TGAct s.41BD(2) defines the purpose of the device use that can be identified in labelling, instructions, and through advertisements. 263 Supply is defined s.3 of the TGAct. 3.56 THE CURRENT REGULATORY SYSTEM
3.68. The current regulatory system264 has been established by the TGAct265 and
those amendments instituting new legislative requirements266 in relation to medical devices: the Therapeutic Goods Amendment (Medical Devices) Act, 2002, and the Therapeutic Goods (Charges) Amendment Act, 2002. As we have seen the regulations relating to medical devices are wholly new and there are now new definitions, new offences and new regulations: the Therapeutic Goods (Medical Devices) Regulations 2002.
3.69. The Therapeutic Goods Amendments (Medical Devices) Act 2002 does
form the legislative basis267 for product requirements and brings Australia
into line with international best practice268 by implementing the principles
of the Global Harmonization Task Force (GHTF).269. Under the new system Australia will move away from a prescriptive regulatory system
that has always recognised unique standards270 as the default standard. Instead, manufacturers will be able to use TGA gazetted standards, that are based on international standards, to demonstrate that technical requirements have been met. The level of regulatory control will be proportional to the degree of risk associated with the use of a particular surgical device. Notwithstanding all of this, the question that remains is not whether a new regulatory system should have been introduced, or was indeed necessary, but whether the new system has been appropriately designed and will be appropriately operated and enforced. Surgical device
264 See Press Release, Medical Devices – A New Approach to Regulation – General Information, Commonwealth Department of Health & Aging, Therapeutic Goods Administration, 24 May 2002. See also Bill's Digest No 104 2001-2002, Department of the Parliamentary Library. The new regulatory system is embraced by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 that was passed by Parliament on 21 March 2002, and received Royal Assent on 5 April 2002. 265 Pt 4-3 of the TGAct imposes significantly more onerous obligations on the manufacturers of medical devices. Conformity assessment procedures have been introduced that are obligatory and must be met by Australian and overseas manufacturers before a sponsor (or a manufacturer) is permitted to supply a medical device product in Australia. 266 These were passed by Parliament on 4 March 2002 and the Regulations were effective from 4 October 2002. It is expected that all therapeutic devices will be subject to the new legislation from 4 October 2007. 267 TGAct s.41BA refers to the requirements for medical devices that include 14 essential principles that concern the safety and performance characteristics of medical devices. 268 TGA News (October 2001) Issue 36. The official newsletter of the Therapeutic Goods Administration. 269 See vide supra n.18. 270 These unique standards are in the form of Therapeutic Goods Orders and those requirements as contained in the British Pharmacopoeia. British Pharmacopoeia means the edition of the book of that name, including any additions or amendments, that was in effect for the purposes of the Therapeutic Goods Act 1966 (Cth) immediately before the commencement of Section 3 of the TGAct and if additions or amendments of that book are published after that commencement, includes those additions or amendments, or those new additions, from a day specified by the Minister by order published in the Gazette - see Cir 3(1) of the TGAct. 3.57 use should be regulated by a system that involves extensive pre-market clinical trials, a licensing process and a transparent and rigorous post-
market surveillance program.271 There is a growing realization that the safety and effectiveness of medical devices cannot be demonstrated using the same scientific and regulatory conditions as for drugs. The recent reforms to the TGAct reflect what I believe to be a long overdue realization that therapeutic devices are very different to drugs and as such, former legislation is no longer appropriate to the regulation of medical devices in general and to the regulation of surgically implantable devices
in particular.272.
3.70. The Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth)
introduces a more complex definition of the term medical device.273. The definition is in harmony with European Community Medical Device Directives and focuses on the purpose for which the device is intended to be used, that is identified on the device label, in the instructions for its use,
or from advertising.274. The amendments to the TGAct include a new classification system for medical devices that is, in my view, long overdue.
The classification system is based upon the manufacturer’s275 intended use for the device, the degree of risk associated with the use of the device, the level of invasiveness, the expected duration of the use for the device, and any contact of the device with the cardiovascular (circulatory) or
neurologic systems.276 The standardised international device nomenclature system known as the Global Medical Devices Nomenclature code (GMDN) is now used to categorise medical devices included on the
ARTG.277 The new classification system more appropriately addresses
271 See SK Muirhead-Allwood, “Lessons of a Hip Fracture – If we want Improved Prostheses we must Regulate their Use” (1998) 316 (644) BMJ, 644. 272 See The Hon Peter McGauran MP, Minister for the Arts and the Centenary of Federation, Second Reading Speech on the Therapeutic Goods Amendment (Medical Devices) Bill 2001, House of Representatives, Hansard¸ 29/3/01, at p.22261. 273 See vide supra n.252. 274 TGAct ss.42 BD(2) and 41 BD(1)(a). 275 TGAct s.41 BG(1) advises that the manufacturer of a medical device is the individual or organisation that is responsible for the design, production, packaging and labelling of the device before it is supplied under a name regardless of whether the name is of the person responsible for the undertaking of those activities. 276 Schedule 2 of the Regulations. 277 Work on the GMDN commenced in 1993 and was, in 2001, published as EN/ISO 15225. For further information see www.GMD.org. There is a Guidance Document, one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that includes the Australian Medical Devices Guidelines, the Declaration of Conformity, Guidance Document No. 5. Can be accessed on line at www.tga.gov.au. The ARTG is a public record. 3.58 those risks associated with new and emerging technologies and should provide better coverage and scrutiny, of these important, often highly
invasive medical devices.278 This is in contrast to the former legislation that distinguished and grouped medical devices into two classes,
registrable and listable,279 where new and emerging technologies are not
always easily classified.280 Some products, that were previously regulated
as therapeutic devices, are not now covered by the new legislation.281 Those products will now be known as Other Therapeutic Goods.
3.71. Medical devices are now grouped into five classes282 and the
classification283 of a device284 determines the conformity assessment
procedures required of the manufacturer.285 Higher class devices undergo a mandatory and a more stringent form of conformity assessment than do lower class devices. The responsibility for conformity assessment rests with the manufacturer of the device. The TGA is responsible for the issue of certification after confirmation that conformity assessment procedures
have been appropriate and have been applied. The 5 classes of devices286 are:
278 See vide supra n.272. 279 In contrast to registration a listing does not specifically require submission of efficacy or stability of data. However, the TGA reserves the right to call for this data from the sponsor at any time without notice. Therapeutic goods are listed as distinct from registered, if they do not contain scheduled poisons and are known to be relatively safe when used as directed. It is the case that listed devices have not been a subject of formal evaluation by the TGA. Under the TGAct listed goods underwent only an administrative review that was often based on the assessment of GMP certification and compliance with the advertising provisions in the Therapeutic Goods Regulations 1990. In regard to registered devices the TGA does recognise that registered medical devices may have previously undergone an evaluation of clinical safety and efficacy. Clinical data and corresponding evaluation remains valid to support an application for an inclusion in the ARTG under the new system. However, it is likely that the safety data now required about a registered medical device will be greater than at the time of any previous or initial registration. The revised Medical Device Legislation requires that appropriate conformity assessment procedures be undertaken for the device, including a clinical evaluation, and clinical expert report, prior to its inclusion in the ARTG. A previously listed device in the ARTG will need full evidence of conformity with the essential principles and conformity assessment procedures to support an application for inclusion in the ARTG. 280 The Industry Submission 1996, Medical & Scientific Equipment Industries Report, commissioned by the manufacturers of implantable devices, Industry Inquiry, Report No. 56, 20 December 1996, reported that "…devices [are] dealt with by the Therapeutic Goods Administration on a product by product basis, according to pre-determined classifications specified by regulations. New and changing technology or circumstances often require changes to the Act and/or regulations as a new product or problem emerges." 281 Examples of products not meeting the new definition of a medical device are tampons and hospital, household and commercial grade disinfectants. 282 The five classes are based on a device's risk, degree of invasiveness, and length of time the device is likely to remain in contact with the body. 283 Classification rules are defined in Schedule 2 of the Medical Device Regulations. 284 The medical device can be the same kind of device as another device if it has the same manufacturer, sponsor, classification, and GMDN Code. 285 Pt 3 Div 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 sets out the conformity assessment procedures that apply to each class of device. S.41FD of the TGAct requires a sponsor or applicant to certify that the appropriate conformity assessment procedure has been applied to the device. 286 See TGA Guidance document on the Classification of Medical Devices on line at www.tga.gov.au. 3.59 x Class I287 - low risk devices which are non-invasive288 and only for transient use.
x Class II(a)289 - intermediate risk medical devices, including devices which are invasive and for short term use.
x Class II(b)290 - intermediate risk medical devices, including some invasive or implantable devices.
x Class III291 - high risk devices including surgically invasive devices and animal-derived products.
x Active Implantable Medical Devices (AIMD)292 – these are high risk active working devices.
3.72. The new classification system though is not without anomalies. Orthopaedic surgical implants are classified as Class II(b) devices. This is in contrast to the classification of other, equally invasive devices, such as
breast implants and vascular prostheses that are in Class III.293. The absorbable suture, a relatively harmless low-risk device, is also in Class III. In Europe, medical device experts are considering the reclassification of orthopaedic implant devices, such as total hip replacement prosthetic implants, as high risk devices, into Class III. I am in agreement with this move but do question why hip implant devices should be isolated from other joint replacement devices. The logic is questionable as knee, elbow, shoulder and ankle replacement implants are just as invasive and (statistically) perform less well than do hip replacement devices when the
287 Class I – includes as hospital beds, cervical collars, walking aids, wheelchairs, simple surgical and dental instruments such as scalpels, saws, and manual drills, gloves, gauze dressings and stethoscopes. 288 Invasive can include to mean implantation through a body orifice that can include a natural opening (including the external surface of the eye) or a permanent artificial opening e.g. stoma. In contrast the term surgically invasive is to be used in the context of a surgical procedure where there is a breach of a dermal or epithelial layer and not through a body orifice. 289 Class II(a) - includes as hearing aids, dental filling materials, ECG machines, hospital grade disinfectants, devices for storage and transport of organs, cornea, sperm and embryos, external bone growth stimulators, single use catheters and X-ray film. 290 Class II(b) – includes baby incubators, external defibrillators and pacemakers, surgical lasers, ventilators, haemodialisers, condoms, contraceptive diaphragms, blood bags, blood warmers, blood pumps, wound dressings, contact lens care products, instrument grade disinfectants, penile implants, and orthopaedic implants. 291 Class III - includes absorbable sutures, heart valves, vascular prostheses and stents, condoms with spermicides, IUDs and breast implants. This category also includes devices that incorporate medicinal products, such as bone-cement containing an antibiotic. 292 AIMD – includes implantable pulse generators, implantable electrodes and implantable drug infusion devices. With regard to Class III and AIMD devices Reg 1.6 requires that these devices have a unique product identifier that is given by the manufacturer to identify the device and any variant of the device. A variant is a device where there is a variation in design (e.g. shape, size, length or diameter) that is provided to accommodate different patient 's anatomy. 293 The major difference between Class II (b) and Class III is that Class III implant design dossier must be examined and approved before a product can be sold, while such examination is not carried out systematically for Class II (b) devices. 3.60 incidence of adverse events294 is considered. The improvement to the
quality of life295 that is associated with hip replacement surgery has
exceeded that which is associated with the replacement of other joints.296 Whatever is the motive for the reclassification, the request has been made
by both the French297 and the United Kingdom Medical Devices
Agencies.298 A contrary view has been taken that upward classification of orthopaedic (hip) replacement devices could falsely raise expectations of
safer devices entering the marketplace.299
3.73. An important aspect of the new regulatory system is that manufacturers
and their sponsors300 must demonstrate compliance with measures to ensure
294 JN Weinstein and JD Birkmeyer, The Dartmouth Atlas of Musculo-Skeletal Health Care (2000). 295 One of the most commonly used measures of health utility in the medical literature is the quality-adjusted life-year (QALY). The basis concept of quality-adjusted life years is that the QALY represents a trade-off between quality and quantity of life and thus can be used to measure the net health effects of programs or activities. QALYs represent an attempt to bring the two dimensions of length of life and quality of life into a single framework of evaluation. (See D Eddy, “Cost-Effectiveness Analysis: Is it up to the Task?” (1992) 167 JAMA, 3344.) Among their various functions QALYs can be used to monitor the effects of treatment of patients in clinical practice or in clinical trials, to determine what to recommend to patients, and to provide information to patients about the effects of different treatments. See Beauchamp and JF Childrers, Beneficence in Principles of Biomedical Ethics (4th ed, 1994) 309. The QALY combines a quantitative measure (i.e. life-years gain) with a qualitative measure (i.e. quality of life) to provide a single reference, or value-weighted number, that summarizes a patient's health-related quality of life. In contrast, the disability-adjusted life-year (DALY) is another measure of health utility, which was devised to assess the global burden of disease. Disability-adjusted life-years are calculated by adjusting age-specific life expectancy for loss of health life due to disability. The value of the year of life at each age is weighted, as are decrements to health due to disability from the specified diseases and injuries. For further reading see MR Gold, JE Siegel, LV Russell and MC Weinstein, Cost-Effectiveness in Health and Medicine (1996). It is interesting also to compare the cost per QALY of different treatments. A Maynard, “Developing the Health Care Market” (1991) 101 Economic J, 1277-86, provides the following data that is correct as of August 1990 - Pacemaker Implantation £ 1,100 QALY Total Hip Replacement £ 1,180 " Aortic Valve Replacement £ 1,140 " Advice to stop smoking £ 270 " Heart Transplantation £ 7,840 " Home Haemodialysis £ 17,260 " Neurosurgical intervention for malignant £107,780 " intracranial tumours In a widely noted study, British Health Economist Alan Williams examined the cost-effectiveness of coronary artery bypass grafting in terms of QALYS. According to his analysis, bypass grafting compares favourably with the use of pacemakers for the treatment of heart block. Coronary artery bypass is superior to heart transplantation and the treatment of endstage renal failure, but it appears to be less cost-effective that hip replacement. For further interest see A Williams, “Economics of Coronary Artery Bypass Grafting” (1985) 291 BMJ, 326-29. See also MC Weinstein & WB Stason, “Cost-effectiveness of Coronary Artery Bypass Surgery” (1982) 66 (5) Circulation, 2. 296 A Loupaci, R Bourne, C Rorabek, D Feeney, C Wong, P Tugwell, K Leslie, R Bullas, “The Effect of Elective Total Hip Replacement on Health-Related Quality of Life”, (1993) 75A J Bone Joint Surg, 619-26. See also WR Oblewski, “15-21 Year Results of Charnley Low Friction Arthroplasty” (1986) 211 Clin Orthop, 30-35. 297 Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSS-APS). 298 The MDA is now part of the United Kingdom's Medicines and Health Care Products Regulatory Agency (MHRA). The MHRA is that new Executive Agency established through the merger, on 1 April 2003 of the Medicines Control Agency (MCA) and The Medical Devices Agency (MDA). The new agency is responsible for the regulation of both medicines and health care products. Further information is on line at http://www.mhra.gov.uk. 299 MS Rapp, “European Medical Device Group Seeks to Reclassify Hip Implants” (2003) 6 (3) Orthopaedics International, 28&37. The European Medical Technology Agency (EUCOMED) is of the view that reclassification might also increase product costs, reduce design innovation and therapeutic options without necessarily increasing device safety. 300 The sponsor is that person or organisation trading in Australia that initiated and was responsible for TGA approval for inclusion of a device on to the ARTG. The sponsor is responsible for submitting the manufacturer's evidence that is necessary for inclusion on to the ARTG and for payment of any application fee. The sponsor who is responsible for a therapeutic device in Australia (including matters relating to product recall) can be an Australian manufacturer or can represent an Australian or overseas manufacturer. s.3 of the Therapeutic Goods Amendment (Medical Devices) Act (2002) (Cth) includes a definition of a person who is considered to be the sponsor of a medical device. The sponsor is: (a) a person who exports, or arranges the exportation of, the goods; or (b) a person who imports, or arranges the importation of, the goods; or 3.61 that safety and quality control provisions are adhered to. These measures also include that sponsors must maintain sufficient documentation to demonstrate compliance with, and the undertaking of conformity
assessment procedures.301 Additionally, manufacturers must produce the documented information that is evidence that can demonstrate that all of the pre-market regulatory requirements and investigations have been undertaken in a manner that is not only scientifically adequate but also commensurate with the scientific and manufacturing standards of the time. The TGA also has the power to require manufacturers to provide information or documentation in relation to the supply, handling, monitoring of and also of the results of the supply of kinds of medical
devices which are exempt from inclusion on the ARTG.302 In the past the TGA has, too often, relied upon an honour system among manufacturers (and sponsors) for the provision of product information and even for the reporting of problems.
(c) a person who manufactures the goods, or arranges for another person to manufacture the goods for supply; but does not include a person who: (d) exports, imports or manufactures the goods; or (e) arranges the exportation, importation or manufacture of the goods on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in Australia. The “sponsor” may be the manufacturer, but may not be. 301 Conformity assessment routes in the European Union Medical Devices Directive that manufacturers can choose are summarised in the United States Government's General Accounting Office (GAO 1996a, pp.32-3) comparative review of the European and American Regulatory Systems. The routes to conformity assessment are found in the Annexes to the EU's First Medical Devices Directive. They are: (1) Full Quality Assurance System Review which examines every aspect of the manufacturer's Quality Assurance system, covering every phase of the manufacture of a device, from design through to shipping. A manufacturer choosing the full Quality Assurance system route for a class III device is also required to submit a design dossier for the Notified Body's review. If the Notified Body certifies the manufacturer's Quality Assurance system, that certification covers the related devices. This practice allows the manufacturer to place a CE mark on, and mark it all off, the related devices without going through any additional conformity assessment review; (2) Type Examination which is a procedure which the Notified Body ascertains and certifies that a representative sample of the device being reviewed conforms to the essential requirements. The Notified Body physically tests a prototype of the device to determine whether it meets certain standards; (3) Declaration of Conformity, which is a procedure that is available only for devices in Class I and II(a). A manufacturer "declares" that a device conforms to the essential requirements. The Notified Body reviews only aspects of the devices relating to sterility or measuring function. Notified Body's are those organisations appointed by the Competent Authority to evaluate devices. In Australia the Competent Authority is the TGA. The TGA is also the Notified Body. It is clear that manufacturers have a choice of a number of ways by which Essential Requirements may be met. It is to be noted that the European Directives do not specify mandatory standards: rather it is the Essential Requirements of the Directives which are mandatory. See also vide supra n.18 and n.21. 302 TGAct ss.41JD, 41JE and 41JF. Here compare sections 31A and 31B of the TGAct. It is an offence to fail to provide information as and when required by the TGA, see ss.41JB(3), 41JG(3) and 41JG(4). It is a defence to a charge of providing false or misleading documents if the document is accompanied by a statement setting out the particulars in which the information is false or misleading. See ss.41JI(2). Compare also ss.31E(3) of the TGAct. See also sections 31D and 31E of the TGAct. This defence applies only to the provision of documents and not to the provision of information. A person cannot refuse to provide information or documents on the ground of potential self-incrimination. However, any information provided cannot be used against the person in any criminal proceedings, except for the offence of providing false or misleading information – see ss.41JC and 41JJ TGAct. Compare also s.31F of the TGAct. See also sub s.41FN(3). 3.62 3.74. The Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth)
includes those conformity assessment procedures303 that are required of manufacturers or sponsors of a medical device. It is necessary for manufacturers to demonstrate that appropriate quality management
procedures or systems304 have been applied during the manufacture of a
medical device before it can be included on the ARTG.305
3.75. The Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) ensures that the auditing of Sponsors’ and Manufacturers’ applications for inclusion of a device on to the ARTG will be mandatory and will be undertaken by the TGA for those kinds of medical devices as prescribed in the Regulations. Furthermore, the TGA has a discretionary power to audit
applications in all other cases.306 The Government has indicated that a quality systems audit will be mandatory prior to inclusion on the ARTG of
any Class III or AIMD medical device,307 and some form of production audit or sample examination will be required for the inclusion of Class II
(b) devices on the ARTG.308 If the TGA is satisfied on all aspects of the
audit, the medical device must be included in the ARTG.309 The formal requirements of a satisfactory audit must be satisfied and be factually
correct. In regard to the auditing of applications it is perhaps remiss that it remains uncertain as to what is represented by a quality systems audit. Furthermore there is no clarity as to the nature of events that would cause a
discretionary audit to be undertaken.310 These non-mandatory audits are
303 The TGA has (TGAct s.41FN(3)) power to suspend a conformity assessment certificate for up to six months if it is satisfied that there are likely to be grounds for revoking the certificate – see also s.41EM. Unless suspension is immediately necessary to prevent imminent risk of death, serious illness or serious injury, the TGA must provide written notice of the reasons for the proposed suspension and give the person a reasonable opportunity to make submissions, s.41EN. If the ground on which the issue was ordered no longer applies and there is no other ground for suspension then the suspension must be revoked, s.41EP. 304 The system must be of a kind such that its application will ensure that each medical device to which the system is applied complies with the appropriate provisions of the essential principles, the classification rules, and those conformity assessment procedures, that are required at each stage, from the design of the device until its final inspection before being supplied. 305 TGAct s.41FD(f). For devices entered into the ARTG prior to 4 October 2002 there is a 5-year transition period. During this transition period those devices can continue to be supplied, but, if the sponsor wishes to supply the device after 4 October 2007 an application has to be made to include those devices on the ARTG. See also Australian Medical Device Requirements under the TGAct, Version 4, May 1998; s.25(1) in the TGAct. 306 TGAct ss.41FH, 41FI, 41FJ & 41FK. These sections of the TGAct (in Subdivision C – Auditing of Applications) define the selection of applications for auditing (s.41FH), auditing (s.41FI), procedures to be taken following audits (s.41FJ) and when an application lapses (s.41FK). 307 These are high-risk category devices. 308 See vide supra n.272. 309 TGAct s.41FI(2). 310 The presently accepted approach is based on risk and a degree of random sampling. See Industry Commission 1996, Medical & Scientific Equipment Industries Report, Industry Inquiry Report No. 56, 20 December 1996, at p 57. It has been claimed that there are numerous examples of high-risk technologies that are not subject to comprehensive pre-market assessment. See also vide supra n.272. 3.63 random311 and it is intended that a 20% audit rate (1:5 of manufacturers) should be achieved by the TGA. At present, the TGA does not conduct pre-market audits.
3.76. Compliance with applicable medical device standards312 permits the
establishment of compliance313 with the essential principles314 of safety and performance that apply to (all surgically implantable) devices. The
essential principles include both general principles315 for safety and
principles of design and construction316 that impact on safety. A presumption of conformance with the relevant essential principles is
implicit with the use of a medical device standard317 (or a number of
medical device standards).318
3.77. In the event that matters of compliance and conformity are under scrutiny, the TGA, when undertaking an audit, will not only be able to cause a
311 TGA audits (s.41FH TGAct) can be random (1:5 manufacturers per year is the target), non-mandatory (superficial audits) or mandatory (in-depth audits). 312TGAct s.41CB - medical device standards. 313 Compliance with the essential principles is an obligation on the manufacturer to use an appropriate conformity assessment procedure. 314 The 14 essential principles are detailed in Schedule 1 of The Therapeutic Goods (Medical Devices) Regulations, 2002. See TGAct s.41CA - the Regulations set out requirements for medical devices and these requirements are to be known as Essential Principles. See also s.41BH that defines the meaning of compliance with essential principles - a medical device complies…with the essential principles if and only if it does not contravene any of the essential principles. The medical device is also taken to comply with the essential principles if the medical device complies with one or more medical device standards that apply to it. The essential principles relate to safety and performance and are applicable to all devices independent of the risk class. The essential principles are important regulatory product requirements that are intended to ensure that the use of a device does not compromise health and safety and that any risk associated with the use of the device are considered to be clinically acceptable risk to the patient given the anticipated benefits. Compliance with the essential principles can include the support of clinical evidence and by the undertaking of risk analysis and risk management activities (with the guidance of ISO 14971:2000 (2004). 315 General Principles are that: (a) the use of a medical device must not compromise health and safety; (b) the design and construction of a medical device must conform with safety principles. (A published literature review should be able to prove clinical performance and safety of the device in question. For an overview of performance data to construct a hierarchy of evidence see National Health & Medical Research Council (NHMRC) Quality of Health Care and Outcomes Committee, 2000); (c) medical devices are to be suitable for the intended purpose; (d) long term safety of medical devices is fundamental for their supply; (e) medical devices are not adversely affected by transport or storage; and (f) the benefits of medical devices are to outweigh any side effects. 316 Principles of Design and Construction that impact on safety include: (a) biocompatible chemical, physical and biological properties; (b) the exclusion of infection and microbial contamination.; (c) safe construction and environmental properties; (d) medical devices with a measuring function; (e) protection of the host environment against radiation; (f) the safe operation of medical devices connected to or equipped with an energy source; (g) that adequate and comprehensive information be provided with medical devices; and (h) that clinical evidence should be a basis for the principles of design and construction. 317 A medical device standard is one way of showing compliance with the essential principles (or a number of medical device standards) and conformity must be supported by clinical evidence and by risk analysis and management. 318 Medical Device Standards will be identified by orders in the Commonwealth Gazette. 3.64 sponsor to produce documents319 within twenty (20) working days of a
request, but will also have the power to undertake random320 inspections
and sampling of medical devices.321 The existing powers of entry, search and seizure that have always applied to matters relating to therapeutic goods will also now apply to medical devices, whether these be included in
the ARTG, or remain exempt from inclusion.322
3.78. It is fundamental that any risk of there being an adverse event323 associated with the use of a surgical device must be outweighed by the benefits that
are expected to be gained from the use of the device.324 Implicit in the requirements of the Therapeutic Goods Amendment (Medical Devices) Act
2002 (Cth) is that manufacturers and sponsors325 report any incident of any
adverse event.326 In the Act, an adverse event (or incident) is described as any event that resulted, or could have led to death or to a serious deterioration in the health of a patient or user of the device. It is further stated that a medical device adverse event is an incident that is associated (caused or partially attributable) with the use (or misuse) of a medical
device.327 It is the author's view that, in consideration of surgically implantable devices, this definition of an adverse event is too broad and
too simplistic.328 The definition also ignores that event associated with a device that has previously been approved for use, but has subsequently been found to be inappropriate to that use.
319 TGAct s.41FN(1)(b) - documents will include Quality Management System records, documented evidence of compliance with essential principles, details of changes to the system or to the product, a declaration of conformity, details of post-production monitoring and of any certificates, reports, or correspondence issued by the TGA. Records must be kept for at least five years after the manufacture of the last device to which the records relate. ISO 13485 requires two years, or the lifetime of the device distribution records for Class III, AIMD's and implantable Class IIB must be kept for ten years. 320 Where the TGA has issued a Conformity Assessment Certification there can be routine short notice and unannounced surveillance, or random inspection, to ensure that the manufacturer is continuing to apply the approved quality systems required. Audit cycles are expected to be at intervals approximately 12-18 months. 321 TGAct s.41FN. 322 Part 6-2 of the TGAct. 323 See Ch 4, ¶4.19-4.28. 324 This benefit risk analysis balances the anticipated benefit of any surgical device, the advantages of its early availability, against the devices potential for harm. Marginally more effective devices or materials may be inherently less safe than are presently available alternatives. See Ch 4, ¶4.19-4.28. 325See vide supra n.300. 326 TGAct ss.41MP(2) & 41MQ. 327 M Flood, “Conformity Assessment Procedures, Post-Market Responsibilities and Mutual Recognition Agreement with the EU” Medical Device Seminar, Dept of Medical Physics, Royal Perth Hospital, Western Australia, 25th May 2004. 328 The reader is referred to that alternative definition that is described in Ch 5. 3.65 3.79. In the past the TGA has operated a voluntary adverse event reporting system under which those that have used, or have in any way been concerned with a device, report any problems for investigation by TGA staff. The effect of the European Directives and the new legislation has
been to shift the emphasis from voluntary to mandatory329 reporting by the
manufacturer and the sponsor. 330 Only manufacturers (and sponsors) are required to take into account the nature and risks of their products and to put procedures into place to enable the systematic review of the performance of devices in the post-market phase, and to take corrective
action as and when needed.331 It is mandatory, not only for legal reasons, but also for ethical reasons and for reasons of patients' safety, that the reporting of any information regarding an adverse incident should be undertaken as soon as the information is known, and in the event the manufacturer (or sponsor) may recall a particular device, and must report
the technical and medical reasons for that recall332 without delays.333 There is a legal requirement to report any malfunction or deterioration in the
characteristics or performance334 of a device that might lead, or might have led, to the death of a patient, or user, or to a serious deterioration in
health.335
329 The debate as to whether reporting should be voluntary or mandatory is complex and continues. See Ch 9 for a more detailed discussion of the need for an effective system of reporting of adverse surgical events and outcomes. 330 Sponsors who are not manufacturers are required to report any adverse event to the manufacturer of the device and both the manufacturer and the sponsor are required to notify the TGA. Further information regarding sponsors can be found in Regulation 10.2. 331 Manufacturers and sponsors must notify the TGA after becoming aware of any information relating to any malfunction or to a deterioration in the characteristics or performance of a device, any inadequacy of design, production labelling or instructions for use, any inadequacy in advertising material, any use in accordance with, or contrary to, the use intended by the manufacturer that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health or information relating to any technical or medical reason for a malfunction or deterioration that has led the manufacturer (or sponsor) to take steps to recover devices that have been distributed. 332 TGAct ss 41MP(1) & 41MP(2). 333 For further information refer to the TGA post-market guidance document that can be accessed online at www.health.gov.au/tga. It is now an offence for manufacturers and sponsors only, not to notify the TGA of any adverse matters within the period specified in TGAct s.41MQ. The Government has indicated that the proposed maximum time allowed before providing an initial report will be ten days after the manufacturer first became aware of a serious problem. 334 Deterioration in the characteristics or performance includes any inadequacies in labelling or with regard to the instructions that might have or have had such an effect. 335 Failure to comply with these provisions is a criminal offence. The TGA also has the discretion to cancel an entry of a device from the ARTG (without first suspending it) on a number of grounds which include, amongst others, those circumstances constituting an adverse event. See TGAct ss.41GL and 41MP. 3.66 3.80. The mandatory system of reporting of an adverse event has been based on the recommendations of the GHTF study group of Vigilance and
Surveillance336 that includes and implements:
(i) Penalties and timeframes; (ii) recall and seizure provisions;
(iii) voluntary reporting provisions337 for medical device users; (iv) international information exchange between conformity assessment bodies; and (v) information exchange between intergovernmental
agencies within Australia.338
3.81. As we have seen, a major feature of the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) is that the TGA has the power to cancel an entry in the ARTG and to revoke the conformity assessment certificate
applying to the device concerned339. With respect to the administrative monitoring and enforcement provisions, and the powers to suspend or cancel the inclusion of a medical device from the ARTG, the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) contains a range of
criminal and other offence340 provisions341 that attract a monetary penalty.342
336 In the United Kingdom, the Medical Devices Directive of the Medical Devices Agency (MDA), in its interpretation of the Medical Device’s Directive requires that the manufacturers of medical devices notify Competent Authorities of certain adverse events. This is euphemistically known as the Vigilance System. The purpose of the Vigilance System is outlined in Section 3 of the European Commission Guidelines on a Medical Device Vigilance System, March 1998 – rev 3., ECG MDVS. It is intended that the Vigilance System requires manufacturers (and sponsors) to have procedures in place to systematically review experience that has been gained from the use of devices in the post-production phase. 337 The Department of Health & Aged Care is responsible for ensuring data systems are developed in consultation with key stakeholders – the data collected will allow the identification of the role of products in the causation of injury. The key stakeholders described included Monash University National Centre for Coronial Information (MUNCCI) and the National Injuries Surveillance Unit (NISU), of Flinders University, South Australia. 338 These include the Health Care Complaints Commission, and Coronial Inquests. 339 TGAct ss.41GK. 340 Offences attract penalties. One Penalty Point is equivalent to A$110 (or x 5 for incorporated bodies). Examples of penalties include - (i) 60 points ($6,660/$33,300); General breaches of conditions (s.41MN); Misrepresentations (s.41ML); Device misuse (s.41 MO) (ii) 60-240 points ($6600/$33300-$26,640/$133,200 ARTG Offences e.g. no registration (ss.41MI, 41MJ, 41MK, 41MM) (iii) 240 points ($26,640/$133,200) Non-compliance with essential principles (s.41MA) Conformity assessment defences (ss.41ME, 41MF) 3.67 The majority of offences343 replicate existing offences relating to therapeutic goods, although there are now offences that relate to those new
requirements, such as the essential principles344 and conformity assessment
procedures.345 Other offences include the misuse of medical devices that
have been exempted for special or for experimental uses346, and the failure
to notify the TGA of any tampering347 with medical devices. As we have seen in paragraph 3.49 matters relating to misleading and deceptive
advertising is subject to the TPA.348
3.82. The TGAct defines a number of other offences, such as offences for importing, exporting, supplying or manufacturing a medical device or for the wholesale supply of a medical device, if the device is not registered on
the ARTG.349
3.83. The TGA also has the power to require the public notification of adverse
events350 and/or recall of devices351 that have been supplied when they did
(iv) 400 points ($44,400/$222,000) False statements (s.41MH) Adverse event reporting offences (ss.41MP, 41MQ) Criminal Offences may attract a jail sentence.
341TGAct s.41BK. Offences include those for importing, exporting, supplying or manufacturing a medical device or for the wholesale supply of a medical device, if the device is not registered on the ARTG. See also ss.41MI and ss.41MK. 342 Strict Liability applies and fines for non-compliance are up to $24,000.00 for individuals and $120,000.00 for corporations. 343 The Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) - Pt.4-11 concerns offenses relating to medical devices. 344 A person is guilty of an offence of non-compliance with essential principles if (a) the person imports, supplies or exports a medical device and (b) the medical device does not comply with the essential principles or (c) the Secretary has not consented to the importation, supply or export. The maximum penalty is 240 points. See s.41MA 345 TGAct ss.41ME (manufacturers) and 41MF (sponsors). See also s.41DA that sets out the requirements for manufacturers and sponsors relating to obligations and requirements that are known as Conformity Assessment Procedures. The Conformity Assessment Procedures set out the requirements relating to the application of Quality Management Systems for medical devices and other requirements imposed on manufacturers - maximum penalty 240 points. 346 TGAct s.41MO - maximum penalty 60 points. 347 There is a requirement for the mandatory reporting of product tampering or implied tampering. Mandatory recall powers exist in cases of prior tampering and/or where sponsors refuse to recall goods. In the event of suspected tampering the release of information by the Commonwealth should be to Commonwealth, State/Territory, and overseas authorities with responsibilities for therapeutic goods and with suspected acts of terrorism. These measures follow the product tampering that involved the Paracetamol products of two large pharmaceutical companies, Herron Pharmaceutical and SmithKline Beecham. Federal Government has introduced tough new laws to safeguard the integrity of pharmaceutical products and to minimise the risk to public health that is associated with Product Tampering. Tough penalties will apply to companies and to individuals who fail to comply with the new Legislation regarding tampering. A company or individual who fails to notify the TGA within 24 hours of becoming aware of a substantial risk of tampering can be fined up to $44,000.00 for an individual or $220,000.00 for a company. Also individuals or companies that fail to report an extortion demand within 24 hours, fail to comply with a requirement for TGA to disclose tampering to the public, or to report products that may have been tampered with, or continues to supply goods that are subject to a TGA recall requirement, can be fined up to $26,400.00 for individuals, and $132,000.00 for companies. See also Pt IV C - Product Tampering ss.42T, 42U, 42V, & 42W of the Therapeutic Goods Amendment Act (No3) 2000 (Cth). 348 TPA s.52 and s.53. 349 TGAct s.41MI, maximum penalty 240 points. 350 This is achieved by the issue of an Alert, Hazard or Recall Notice. There are prescribed time-frames for notification. Information concerning an event that represents a serious threat to public health must be reported within 48 hours of the event. Information of an event causing death or serious deterioration of health should be notified within 10 days. Any event that might have caused death or serious deterioration of health must be notified within 30 days of the event. The descriptive serious 3.68 not comply with the requirements of the Therapeutic Goods Amendment
(Medical Devices) Act 2002 (Cth).352 Failure to comply with this
requirement is punishable by a fine of up to $66,000.00.353 The penalty is not particularly onerous, and the necessary incentive to report and to
comply with legislative provisions354 may not be achieved as a consequence of this.
3.84. There are a number of reasons for there to be a disincentive for a manufacturer or sponsor to report an adverse event. It can be that a report of an adverse event might be considered as an admission of liability for the
event and for any consequences.355. Furthermore the maximum penalty for
failure to notify the TGA of adverse events is only $44,000356 for individuals - the retail cost of just four hip or knee joint prostheses! The equivalent position in the USA provides for a penalty of US$15,000 per violation and US$1m for all violations adjudicated in a single
proceeding.357 It is the case that there is a greater financial inducement or incentive to report adverse events in the USA than might be the case in Australia. The maximum penalty for providing false and misleading
information or documents358 is $44,000 for an individual, or $220,000 for a corporation. This is less onerous than the previously available penalty that
included also a possible 12 months jail sentence.359
deterioration includes life-threatening incidents that are cause for permanent impairment of function, cause for anatomic damage, or require medical and/or surgical intervention. 351 There are specific provisions which apply to the recall of drugs and medical devices. These provisions are set out in the Uniform Recall Procedure for Therapeutic Goods (the Procedure) published by the TGA. The Procedure establishes a comprehensive protocol that must be followed by manufacturers and sponsors of drugs and medical devices in Australia when conducting a recall of a drug or medical device. The protocol is the result of an agreement between the industry and Federal and State/Territory Health Authorities. A drug or medical device recall must be conducted under the supervision of a co-ordinator, or competent authority, appointed by the Federal and State/Territory health authorities. Generally, in Australia, the competent authority is the TGA. Recall letters, advertisements and media releases must be approved by the competent authority before being despatched or published. In addition the Procedure prescribes the responsibility of sponsors in respect of the maintenance of records, the establishment of recall procedures and the provision of information to the relevant competent authority. 352 TGAct s.41KA. 353 TGAct s.41KC. 354 See generally RD Cooter and TS Ulen, Law and Economics, (3rd ed, 2000) Ch 8; RA Posner, Tort Law in Economic Analysis of Law (1992) Ch 6, and AW Katz, Foundations of the Economic Approach to Law (1998). 355 C Altenstetter, “EU Policies on the Regulation of Medical Goods & Equipment” (2001) paper presented at the 29th ECPR Joint Workshops, Grenoble, France. 356 TGAct s.41 MP. 357 See United States Statute No 104 US. Stat. at 4526-28. The Food & Drug Administration (FDA) of USA is able to impose penalties for all violations of the Act up to US$15,000 per violation and US$1m for all violations adjudicated in a single proceeding. See also Editorial, “Infusaid Assessed US$290,000 Civil Penalty for Unapproved Modifications” (1993) Medical Devices, Diagnostics & Instrumentation, 4. The FDA levied a US$1.58m civil penalty on a small company, Lexicor, and its founder, Michael Hickey in September 1993. 358TGAct s.41MH - false statements in declarations is 400 penalty points ($44,400 for an individual, or x 5 for incorporated bodies). 359 TGAct s.22A. See also ss.41JH and 41JI of the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth). 3.69 3.85. The major amendments made to the TGAct in October 2002 introduced new legislative requirements in relation to medical devices: the Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) and the Therapeutic Goods (Charges) Amendment Act 2002 (Cth). The Regulations that now relate to therapeutic devices, as distinct from drugs, and the Therapeutic Goods (Medical Devices) Regulations 2002, represent long overdue but important changes to the legislation. In summary, the framework, and the major initiatives, of the current regulatory system includes:
(a) Regulatory features that replicate the provisions of the TGAct that are applicable to therapeutic goods, including therapeutic devices; (b) a fit and proper person test in the provisions for granting a licence to manufacture; (c) appropriate regulatory controls for the manufacturing processes of medical devices; (d) new statutory conditions to ensure compliance with good manufacturing principles and powers to cancel a licence to manufacture;
(e) the introduction of the essential principles360 for safety and performance, and the conformity assessment procedures for demonstrating quality management, both of which must be complied with before a medical device may be included on the ARTG; (f) new penalties that are intended to deter poor manufacturing practices that endanger public health and safety and amendments which should deter non-compliance with regulatory requirements;
360 Although the essential principles contained in the new regulations are expressed in broad and general terms, more detailed requirements for particular kinds of medical devices may be specified in the medical device standards. 3.70 (g) an obligation for manufacturers and sponsors to make therapeutic goods available for inspection and in the event that they are not, the TGA has the power to cancel the inclusion of the therapeutic goods on the ARTG; (h) an obligation for sponsors to maintain records of all manufacturers involved in the manufacture of each batch of therapeutic goods; (i) new offences for falsifying or destroying documents and records relating to the manufacture, testing, or evaluation of therapeutic goods and devices; (j) maximum penalties for existing offences that are increased to include maximum fines $220,000.00 for individuals, $1.5m for companies, and a jail term of five years; (k) the continued use of the ARTG as the central point of control for the legal supply of all medical devices in Australia; (l) new regulations to enhance the TGA’s power to audit applications for inclusion on the ARTG, and
to require a conformity assessment certificate361, and hence to undertake its own compliance checks prior to inclusion of medical devices on the
ARTG362; (m) a device classification scheme that is based on different levels of risk for each class of device; (n) the mandatory reporting of known adverse events
by manufacturers and sponsors363;
361 The new regulations currently prescribe no situation in which either of these procedures will be mandatory. 362 These are useful powers but it remains to be seen whether these changes will result in any comprehensive and effective pre- market assessment for all high-risk devices. Any improvement on the previous system will depend on the circumstances in which the TGA decides to exercise its powers. 363 It is a common theme throughout this thesis that a view can be taken that the mechanism for adverse event reporting has hardly been improved. The post-market surveillance and adverse incident reporting program continues only to require manufacturers and sponsors to report adverse events to the TGA. 3.71 (o) product labelling must now include manufacturer's and/or sponsor's details. The intent is that therapeutic goods should be better identified in the event of a recall and it should follow that recall powers will be more effective; and (p) new legislation that provides for the TGA to be enabled with additional enforcement powers in relation to medical devices which it does not possess in relation to therapeutic goods in general. These include the power to refuse the registration of goods, to cancel registration, or to suspend a medical device from the ARTG prior to
cancellation364, and the power to require public notification and recall of medical devices to penalise non-compliance with the essential principles and the conformity assessment procedures.
3.86. The introduction of minimum enforceable standards for the efficacy and safety of medical devices is an improvement on the previous regulatory regime, pursuant to which many medical devices were not required to comply with any quality or safety standard. However, it remains the case that the reporting of adverse events is a weakness of the current regulation of implantable surgical devices. The reporting of adverse events continues to be a voluntary undertaking for all stakeholders other than for the manufacturer and sponsor. There continues to be no mechanism, nor indeed any legislation, that requires adverse events to be reported by the other major stakeholders that include healthcare workers, hospitals, and paternal organisations or collegiate bodies such as the Royal College of Surgeons, the Australian Orthopaedic Association, and others.
364 It is already the case that a medical device may be cancelled from the ARTG for a variety of reasons that are already grounds for the cancellation of the registration or listing of a therapeutic good. There are also some additional grounds for cancellation, including where a conformity assessment certificate relating to a medical device has been revoked, or where a medical device has been suspended and the defect warranting suspension has not been rectified during the period of this suspension. 3.72 THE THERAPEUTIC GOODS ADMINISTRATION
3.87. The TGA was established in 1991365 as a direct result of the TGAct. The functions of the TGA have evolved with the years though there was a
significant reorganisation following the Baume Report of 1991.366 Following its formation, the TGA has operated under the control of various government departments. The TGA is now a Division of the Commonwealth Department of Health & Ageing. The Commonwealth Department of Health & Aged Care has a major role to play in injury prevention but it has only limited statutory powers to address product related injuries. It is for this reason that Health Authorities have, in the
past, relied for consumer protection on the powers provided by the TPA.367
3.88. The TGA administers the TGAct.368 Additionally, the TGA can mandate
and regulate369 product standards and those approved manufacturing principles for health care products under the Act and regulations. Three statutory committees have been established to provide advice on the regulation of therapeutic goods. They are:
(i) The Medical Devices Evaluation Committee
(MDEC)370;
(ii) the Therapeutic Goods Committee (TGC)371; and
365 In 1991 the Proprietary Medicines Advisory Committee’s functions were transferred from the Victorian Government to the Federal Government where the Committee formed part of the Therapeutic Goods Administration (TGA). 366 P Baume, “A Question of Balance: Report on the future of drug evaluation in Australia” (1991) Australian Government Publishing Service. The Baume Report was commissioned because of perceived dissatisfaction with the performance of Australia’s drug evaluation system. The Baume Report was released on 3/7/91 - A 232 page report on the future of drug evaluation in Australia. The Federal Government gave immediate acceptance to all of the Baume recommendations. Professor Peter Baume has been Professor of Community Medicine at the University of NSW and a former Federal Health Minister. 367 In 1994 all health authorities agreed that there should be a legal requirement for warning labels on tobacco products. However, they were not able to introduce these through their own regulations and consequently the requirements were introduced as an information standard under the TPA, that is, the Trade Practices (Consumer Products Information Standards) Tobacco Regulations 1994. (There is a Memorandum of Understanding between The Department of Health & Aged Care and the ACCC). 368 TGAct s.6 - The Jurisdictions of the Act. 369 Regulate is used in reference to the testing and approval of medicines, medical devices, chemicals and radiation sources, and the development and implementation of national policies and controls for these goods. 370 MDEC advises the Minister on issues relating to the safety, quality, performance and timely availability of medical devices and also provides advice on the policies, procedures and priorities that should be applied to the administration of the medical devices legislation. 371 The TGC advises the Minister on standards relating to therapeutic goods, raw materials, manufacturing processes and testing procedures. 3.73 (iii) the National Coordinating Committee on
Therapeutic Goods (NCCTG).372
3.89. The role of the TGA in Australia remains very similar to that of the Medical Devices Agency (MDA) in the United Kingdom and to that of the Food and Drug Administration (FDA) in the USA. The TGA can be
considered to be the competent authority373 that is delegated by the Federal Government to ensure that there is consumer safety with respect to
therapeutic goods. The primary task of the TGA, like that of the MDA374 and of the FDA, is to safeguard public health by working with users,
manufacturers and legislators375 to ensure that medical devices meet appropriate accepted standards of safety, quality and efficacy
(performance)376 and that they comply with the TGAct, amendments and other regulations, and that the legislation is in harmony with those relevant
Directives of the European Union.377 As we have already observed the TGA maintains the ARTG and controls access to unregistered goods. The TGA is also responsible for the licensing of manufacturers and to ensure
that post-market378 surveillance and vigilance programs are in place to enable the audit of product performance and to facilitate device tracking.
3.90. The major responsibility of the TGA is to ensure that all therapeutic
devices marketed in Australia are registered on the ARTG.379 Following
the amendments to the TGAct380, an additional part was created in the
372 The NCCTG includes representatives from the States, Territories and the Commonwealth and is concerned with many aspects of the regulation of therapeutic goods (including medical devices). 373 See vide supra n.114. 374 See Medical Devices Agency Mission Statement that can be accessed on line at www.mda.uk. 375 TGA has a duty to continue to explore changes in current regulations and new technological development in order to make the entire surgical device industry more effective whilst maintaining the safety of the community. The TGA's concern is to regulate the marketing and labelling of surgical devices whilst not intruding upon the practice of surgery or indeed influencing or redefining the doctrine of informed consent. Surgeons should continue to have the right, exercising reasonable clinical judgement, to use surgical devices for the purpose that they are intended and also for off label purposes provided that the TGA has approved the device for some other purpose. 376 In terms of performance the TGA oversees a therapeutic goods market that is a little more than A$9B and includes exports worth approximately A$2B and that they comply with the Act, the Amendments, and with other regulations. 377 See vide supra n.21. 378 Post-market activities include the control of advertising, GMP audit, adverse event monitoring, the recall of unsafe products, and law enforcement through surveillance and risk-based product testing. 379 There are some prescribed exemptions. See Therapeutic Goods Regulations – Exempt Goods, Schedule 5, sub-regulation 12(1) and Schedule 5(a), sub-regulation 12(1a). See also extracts relevant to therapeutic devices incorporating amendments 2 December 1997. 380 Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth), s.BD(1)(a). 3.74 ARTG for medical devices.381 The purpose of this is that a medical device should perform safely and achieve its intended function during normal conditions of use and that the known and foreseeable risks, and any undesirable side-effects should be minimised and acceptable when weighed against the benefits of the intended function of the device. It is recognised that a flexible, case-by-case approach should be adopted so that clinical data requirements are commensurate with the intended purpose of
the device.382
3.91. Manufacturers and sponsors are responsible for the initiation of any
application for a medical device to be included in the ARTG.383 The role of the TGA is considered to be that of a gatekeeper that regulates supply as distinct from use. Currently there are more than 1,800 sponsors and the number of products included on the ARTG increases significantly each year. In 1995 there were approximately 48,000 products included on the ARTG. That total included approximately 21,000 devices and 27,000
drugs.384 In 2002 there were between 400,000 and 600,000 catalogued
items that included more than 36,000 different devices.385 Less than 5% of medical devices that are used in Australia are manufactured in Australia. More than 95% of these devices are imported and just a little less than 10%
can be classified as high risk.386 In an international perspective Australia represents no more than 2% of the world market
3.92. The TGA was initially funded from the Health Care Budget. The reasoning behind the creation of the TGA in the post-Thalidomide era and
381 The clinical evidence requirements for inclusion of medical devices in the ARTG is provided in Guidance Document No. 4, Version 1.5, TGA, Commonwealth of Australia, 2002. The Guide defines the results to be attained or the risks and hazards to be addressed during product development but does not specify the technical solutions for doing so. 382 The clinical data may include data generated during a clinical investigation program (for the device) and/or data obtained from a review of the literature, that may include clinical experience with the same or with generically similar devices. Clinical trials in Australia are conducted under either the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) Scheme. For further details about each of these Schemes see document Access To Unapproved Therapeutic Goods – Clinical Trials in Australia, available at . See also Australian Ethical Standards which are set out in the National Health & Medical Research Council’s National Statement on Ethical Conduct in Research involving Humans, July 1999. One of the requirements is that the clinical trial protocol, and therefore conduct, must conform to ISO 14155 Clinical Investigation of Medical Devices. (Note: this Standard is being revised in combination with European Standard EN540:1993 and will form a single Standard called Clinical Investigation of Medical Devices.) 383 Sponsors are encouraged to use the Devices Electronic Application Lodgment (DEAL) System for Applications. 384 G Vaughan, “The Australian Drug Regulatory System” (1995) 18 Australian Prescriber, 69-71. 385 Personal communication, M Flood, Therapeutic Goods Administration, 10 November 2002. 386 High Risk devices include those in Group III and those included in Class Active Implantable Medical Devices (AIMD). 3.75 the method of funding was that this government regulatory authority
should be seen to be "entirely independent"387 of the commercial interests
of the industry388 that it regulated and should be seen to be able to act only on behalf of the public interest. However, from 1 July 1998 the TGA has been required by the Commonwealth Government to recover fully all operating costs for all activities that fall within the scope of the TGAct, including the regulation of the pharmaceutical and medical device industries and the TGA’s undertaking of its public health responsibilities. There is now the dubious situation where the regulated fund the existence
of the regulator. Fees389 are negotiated in consultation with industry through the TGA Industry Consultative Committee (TICC) and are charged by the TGA for all services including auditing and product
registration. These costs are recovered from sponsors.390
3.93. Another fundamental problem for the TGA is that whilst adverse incidents have steadily increased the organisation's investigative resources have
not.391 Unfortunately the TGA remains too often unable, through lack of
387 See J Abraham, “Making Regulation Responsive to Commercial Interests: Streamlining Drug Industry Watchdogs” (2002) 325 BMJ, 1164-67. Abraham's argument in this publication is that the European Drug Regulatory Community has become aligned with the commercial interests of the Pharmaceutical industry and that this might be viewed as an unhealthy state of affairs. 388 See K Godrey, “UK Government Tighten Rules for Drug Regulators” (2004) 329 (7476) BMJ, 1203 - Kathryn Godfrey reports that drug regulators will be barred from having any links to the pharmaceutical industry under new UK Government measures that were recently introduced. The Government proposals are designed to increase public confidence in the monitoring of the safety of medicines and to encourage drug companies to be more open. Norman Warner, Health Minister for England, said that the Government was aware of the criticism of the Medicines and Health Care Products Regulatory Agency which suggested that the Agency was "in the pockets of the industry." 389 There are separate fee schedules for medicines and for medical devices and new annual fees and charges apply from 1st of July each year. For medical devices the following fees apply - Application Fees Application for ARTG Entry Application for Conformity Assessment Certificate Conformity Assessment Fees Initial Assessment Surveillance Assessment Annual Charges to Maintain ARTG Entry
390 For listed and registered devices, refer to the Summary of Fees & Charges at 1st July 2003. Also see Medical Devices Application & Assessment Fees, Summary – 4 October 2002 (Medical Device Regulations Schedule 5). Annual fees for listed and registered devices vary according to class of device: Class I $ 45.00 Class I measuring function $645.00 Class I sterile $645.00 Class IIA: $645.00 Class IIB $645.00 Class III $850.00 AIMD $850.00 There are also conformity assessment charges. The initial assessment fee may be as high as $36,390 (Schedule 3, clause 1.6 – design examination).
391 Personal communication, M Flood, Therapeutic Goods Administration, 10 November 2002. 3.76 resources, both financial and scientific, to undertake any major independent evaluation of any adverse incident that is associated with the failure of a surgically implanted device. One function of the TGA might have been to become actively concerned with the testing of the quality, safety and efficacy of drugs and devices. Unfortunately it remains the case that little or no drug or device testing is undertaken by the TGA. It continues to be routine practice for the TGA, from the very outset, to involve and have the sponsor (the manufacturer) undertake to investigate the reasons for a particular surgical device [or drug] failure. All of this tempts the generation of an environment that can embrace a perceived conflict of interests and bias. It remains the case that the investigation of any incident of device failure will normally be expected to be carried out
by the manufacturer, with the TGA only monitoring392 progress of the
investigation. The recent case of Carey-Hazell393 has attracted considerable
media394 and Government395 attention to the undesirable consequences of this process. Criticism of TGA processes engendered by the Carey-Hazell case should not be ignored. For this reason I have taken the view that it is appropriate to summarise the Carey-Hazell case here.
Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd
[2004] FCA 853; (2004) ATPR 42-014
Carey-Hazell underwent the surgical implantation of a prosthetic mitral heart valve for the treatment of a mitral
valve396 prolapse. The surgery was performed on 20 June 1996 at the Sir Charles Gairdner Hospital in Perth. The prosthetic mitral valve was manufactured by St Jude
392 The TGA does only undertake a visual inspection of any failed orthopaedic device. The TGA does though monitor the documented progress of any technical inspection that is undertaken by the manufacturer. 393 [2004] FCA 853 394 Radio National, “The Health Report” 6 September 2004, 8.30am repeated 8.00pm. Program transcript accessed 16.09.04 at www.abc.net.au. 395 Hansard No 4, p.1643, 2002. 396 The mitral valve sits on the left side of the heart between the upper pumping chamber and the lower one, that is the ventricle. The valve's purpose is to ensure the blood only flows forward. It does this by means of flaps, or leaflets. When the ventricle contracts to push blood into the aorta ( the artery which carries blood around the body), the mitral valve leaflets close together to form a seal to stop any backflow of blood. 3.77 Medical Inc - "The St Jude Medical Valve"397. The place of business of the manufacturer is in Minnesota, United States of America. It does not have a place of business in Australia. The first respondent was the importer and supplier of the valve in Australia at the relevant time - Getz Bros & Co (Aust) Pty Ltd. Unfortunately Carey-Hazell subsequently developed blood clots and suffered a number of severe complications. Thrombo-embolic events caused infarcts to the spleen and to the left kidney and a stroke was suffered in March 1997. These complications caused it to be necessary for the St Jude Mitral Valve to be removed. This surgery was undertaken on 26 June 1997. The ex- planted mechanical valve was replaced with a porcine (pig) tissue valve.
At the time of explantation of the prosthetic valve it was observed that the surface of the valve was covered with a thrombus (blood clot). The ex-planted valve was returned to St Jude Medical Inc by the hospital for testing and was received on 25 July 1997. Microscopic examinations were undertaken by the Field Experience Report Analyst who received the device and later by St Jude Medical Inc's Consultant Pathologist, one Dr Titus. No abnormalities or defects were observed on the surface of the valve. In August 2001 the valve was subjected to further microscopic examination and analysis using a scanning electron microscope. The latter, but not the formerly undertaken optical microscopic examination,
397 The St Jude Mitral Valve is a mechanical valve composed of four parts: an outer ring or orifice, a sewing ring, and two leaflets which are hinged inside the outer ring. The outer ring and the leaflets are made from graphite which is covered with a layer of pyrolytic carbon. The orifice is the housing in which the left and right leaflets sit. The leaflets are semi-circular flaps which open and close to permit blood to flow through in a single direction. The sewing ring is made of fabric. It enables the valve to be sewn into the patient's heart tissue. 3.78 revealed the presence of a small chip on the left edge of the right leaflet.
It was not disputed that the blood clots most likely originated from the site of the valve as it has been generally accepted in the medical profession that prosthetic valves carry a risk of clots forming on the surface. It is generally accepted that implanted mechanical mitral heart valves carry a risk of developing thrombi, or blood clots, upon the surface of the valve because of its foreign nature. Thrombi can produce complications by obstructing vessels where they occur or by breaking off from the site where they are formed and travelling to and obstructing small vessels distant from the original thrombus. The latter is referred to as an embolism. In order to minimise the risk of thrombo- embolic complications patients with mechanical heart valves are treated with anti-coagulant drugs.
The applicant claimed that the importer of the valve was in contravention of ss.74B (fit for purpose) and 75AD (defective goods) of the TPA, and had been negligent. She claimed that the patient information booklet that had been received after implantation did not warn her of the risk of clots and she further claimed that the valve had a manufacturing defect - the chip. The Court held that there was no breach of either s.74B or s.75AD TPA, or breach of the duty of care in negligence, since the evidence pointed to the conclusion that the chip had most likely occurred after explantation, and since the known risk of [the clot] complication did not render the valve unfit for its purpose.
3.79 The Court considered that the words of s.75AD clearly require that an applicant, through the application of a commonsense approach, prove that the product was defective, that they were injured and that the product caused their injury. The applicant was not able to do this and s.75AK(1)(a) provided an absolute defence for the defendant where it can be established that the defect in the product alleged to have caused the loss did not exist "at the supply time". The intention of s.75AK(1)(a) is to ensure that a manufacturer will not be held liable for matters beyond its control occurring either later downstream in the distribution chain or caused by the injured party or another user of the product. To succeed in raising the s.75AK(1)(a) defence the manufacturer must prove on the balance of probabilities that the product was free of defect at the time the product left its control. A major hurdle in this case was in fact the determination of that time when the defect, the chip, occurred. In reality it will never be known as to whether the defect was present prior to implantation of the device, during its period of implantation, or subsequent to device explantation.
Though this case reinforces a number of principles, I have a view that the case is the more significant for reasons relating to the TGA's policy of having failed surgically implantable devices returned to the manufacturer for their examination. A review of the chronology of events does confirm that the explanted prosthetic valve was not immediately returned to the manufacturer but rather was
3.80 retained by the deemed manufacturer398 at its offices in Australia. The device was ex-planted on 26 June 1997 and was not received by St Jude Medical Inc until 25 July 1997. Furthermore, though requested to do so by the Head of Cardio-thoracic Surgery at the Sir Charles Gairdner Hospital in Perth, electron microscopic examination of the device was not performed until August 2001, approximately four years after explantation.
Carey-Hazell did provide permission for the explanted prosthetic valve to be sent for testing. However, like many people who have suffered a health care injury, there was a need for an explanation at the earliest opportunity and an assumption (or expectation) that an independent authority would undertake those tasks associated with the examination of the device. In the event this was not the case on both accounts. Carey-Hazell endeavoured to have the prosthetic device returned for independent testing. In this endeavour the lady was unsuccessful and she has
said399 that –
"We were told that the valve wouldn't be returned, we were told that the manufacturer had an obligation under the Therapeutic Goods Act to have the valve properly tested and to report, and that took precedence over my right to have the valve returned to me. That's not the truth. There is nothing in the TGA that removed the right of the owner of the valve to have the valve tested as they deemed to be appropriate."
A consideration of all of the events associated with this case does permit the conclusion that the applicant does consider that the system has failed her and in the events
398 TPA s.74A(4). 399 See vide supra n.394. 3.81 that have occurred there can be found many reasons why the TGA's present policy should be exposed to scrutiny and review.
3.94. In the preceding paragraph, I have discussed circumstances that have the undesirable potential for there to be a conflict of interest and bias to be generated by the TGA's (routine) practice of having the manufacturer of a failed surgical device to undertake the investigation to determine the reason(s) for an adverse event. The Carey-Hazell case illustrates this potential so well. Furthermore it is also the case that adverse incident reports are generally retained as confidential until the outcome of any investigation permits information, necessary to prevent further incidents, to be disseminated to healthcare providers and to those other stakeholders with a need to know. The rules of natural justice or procedural fairness cluster around two broad principles expressed as maxims: Nemo debet esse judex in propria causa and audi alteram partem. The former maxim translates as no one can be judged of his or own cause. Perhaps when it concerns the examination of a failed implanted surgical device, the maxim should read no one should be the judge of his or own cause. The second maxim translates literally as hear the other party. This second maxim does support a view that the opinion of the sponsor (the manufacturer) should not be the only voice that is heard for the reason that there might be
bias and ostensible or apparent bias.400
3.95. In summary, the TGA, through the TGAct, the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002, and those amendments to the Act of 2002, has been and remains responsible for the quality, safety, efficacy and timely availability of drugs and medical devices in Australia. The TGA is also entirely responsible for the enforcement of the current regulatory system for medical devices that
400 The principle that a decision-maker must not have an interest in the outcome of the decision or an appearance of bias (partiality). See also Address by P Mason (President of the NSW Court of Appeal) on The Bounds of Flexibility in Tribunals, 24 February 2003, NSW Chapter of Council of Australasian Tribunals. 3.82 reflects, and is a consequence of, the now accepted internationally harmonized framework for the regulation of medical devices.
CONCLUSION
3.96. It is evident that the regulatory control of surgically implantable devices in Australia includes a mosaic or amalgam of legislation that is administered by Commonwealth, State and Territory Agencies, each with its specific and frequently different product liability and consumer protection legislation. At the Federal level, the Consumer Affairs Division (CAD) of the Treasury is responsible for administering the product safety provisions of the TPA. These provisions provide the Minister responsible for Consumer Affairs, currently the Minister for Financial Services and Regulations, with the power to directly intervene in the marketplace to address any issue where there is a perceived or actual safety risk to the public. The other major Commonwealth agencies that have responsibility for the regulation of product safety include:
(i) The TGA – for medicines, therapeutic goods and devices; and (ii) the ACCC.
The TGA, a Division of the Australian Department of Health and Aged Care has as its primary task an obligation to safeguard public health by working with users, manufacturers and legislators to ensure that medical devices (and drugs) meet appropriate standards of safety, quality and performance, and that they comply with the TGAct and with those enacted amendments and regulations.
3.97. The regulation of medical devices in Australia is then a complex jigsaw of statutory law wherein there is not only conformity, but some overlap, a few
3.83 missing pieces, notably relating to deficiencies in the reporting of adverse events, and the occasional contradiction, particularly regarding the definition of "manufacturer". Notwithstanding all of this, it will have been seen that there is now a far more uniform national approach to product safety regulation in Australia, where that regulation is concerned with the regulation of medical devices, than has previously been the case. This is a direct consequence of the harmonising of Australian legislation with European Directives that has followed the activities of the Global Harmonizing Task Force. It is the case that there is now also a far more uniform national approach to medical product safety regulation in general. This is important and the overall responsibility for this lies with the
Ministerial Council on Consumer Affairs (MCCA).401
3.98. Within all of the legislation there is though a conundrum that exists with particular regard to the regulation of surgically implantable devices. Whilst Commonwealth, State and Territory Government Departments are generally funded by Government it is the case that the TGA, an organisation initially funded from the health care budget, has been required from 1st July 1998 to recover fully all of those operating costs for all activities that fall within the scope of the TGAct, and those enacted amendments and regulations, including the regulation of the pharmaceutical and medical device industries and the TGA's undertaking of its public health responsibilities. The TGA is required to be both pro- active as well as reactive with regards to its role, yet in doing so must derive its working revenue for its existence from the very industry that it
serves to regulate. 402
401 The MCCA consists of Commonwealth, State, Territory and New Zealand Ministers responsible for Fair Trading, Consumer Protection Laws, Trade Measurement and Credit Laws. The role of the MCCA is to consider Consumer Affairs and Fair Trading matters that are of strategic national significance. It can be predicted that further major changes will become effective as after several years of policy development and negotiations, the Australian and New Zealand Governments have agreed to establish a single Trans-Tasman Therapeutic Products Agency to regulate medicines and medical devices. The initiative will harmonize the regulation of therapeutic products between both countries under the Trans-Tasman mutual recognition arrangement. From 1 July 2005, the joint agency will replace the Australian TGA and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The new agency will be accountable to the Australian and New Zealand Governments, have its ongoing funding costs recovered from industry, and will safeguard public health and safety through regulation of the quality, safety and efficacy of therapeutic products. 402 Here the author suggests that there may be a conflict of interest between the TGA and the sponsors, as the TGA is 100% cost- neutral in that all income is derived from fees paid by sponsors (representing the manufacturers). 3.84 3.99. There is probably no disagreement that, in both Federal and State/Territory jurisdictions, there have been ambitious, most reformist, and expeditious efforts to improve the law that applies to personal injury and death claims whether they be based on issues of product liability or otherwise. However timely and necessary are the changes, I have the view that the legislation does remain too porous. With particular regard to implantable surgical devices there is still, in Australia, no clearly defined understanding of what constitutes a reportable adverse event, and there remains no reporting system that encourages all stakeholders, other than manufacturers and sponsors, to communicate the details of adverse events to the TGA, nor even to disseminate the information between themselves. While only manufacturers and sponsors have an obligation in law to report adverse events to the TGA it is evident that there is no great incentive for this to be the case and it is not misanthropic to suggest that, in the alternative, the present regulations can maintain an atmosphere where there is some disincentive to report adverse events.
3.100. The recent legislative changes do represent a step forward for the provision of the safe use of medical devices in general and for the safe use of implantable surgical devices in particular. Matters relating to such issues as compliance and regulation are now clearer. However, a view can be sustained that there could have been even more change to the existing regulatory system to further strengthen that system. The continuing reliance of post-market surveillance on voluntary health professional reporting systems is too flimsy for absolute public safety. Evidence suggests that a substantial number of medical device adverse events and
malfunctions are not reported to the manufacturer nor to the TGA.403 It should be possible to further encourage the implantable device industry, at least down to the hospital level, to take those steps necessary to ensure that incidents of implantable device failure will not go unreported. It is important that there is an acceptable level of adverse event reporting and
403 See vide supra n.327. 3.85 that the barriers to reporting be removed.404 Under current regulations this will not be the case. Recognising that a lack of timely dissemination of information is currently a problem, we have to ask how it can be done better. Whether the system for reporting should be voluntary or mandatory, or a mix of both, provides room for debate. This is an important unresolved issue that is discussed in more detail in Chapter 9.
3.101. An unexpected consequence of the amendments to the TGAct, and to the Regulations, is that reasons can be identified that can stimulate the consideration of the complete isolation, in a legal sense, of the regulation of surgically implantable devices from other therapeutic goods. The Regulations governing the use of surgically implantable devices might more appropriately be derived from a blending of ingredients of that legislation that regulates therapeutic goods, with ingredients of that legislation that is directed towards consumer protection and the regulation of goods and services in general. Implantable surgical devices might, by their isolation in the blend, permit a more appropriate regulation of these devices. To this must be added a workable, candid, and non-punitive procedure for the reporting of adverse events by all stakeholders. This might be achieved by the implementation of a National Register of Implanted Surgical Devices. This was also a conclusion in the previous chapter. Such a Register should require the notification of the surgical implantation of each and every therapeutic device and should require the reporting, by all stakeholders, including consumers, of any adverse event known to be associated with a surgically implanted device that might be identified in any post-implantation vigilance program or incident. Implicit in all of this it is the author's view that there might be great benefit to be derived from the introduction of a Therapeutic Goods (Safe Medical Devices) Amendment Act that would reinforce the TGAct and include the establishment of a National Register of Implanted Surgical Devices.
404 The barriers to any reporting system include matters relating to liability, feedback, burdens, recognition, and confusion that can be singularly, or in combination, associated with any perceived need to report an event. See also Ch 9. 3.86 CHAPTER 4
THE EVOLUTION
of the
SURGICAL IMPLANT INTRODUCTION
4.1 The aim of this chapter is to review the evolutionary process that is the development and marketing of any implantable surgical device. This chapter is concerned with, but not limited to, -
(a) a general overview of the process of manufacture of an implantable surgical device from conception (the idea) to surgical implantation. It is appropriate to review this subject as an understanding of the process of development of a surgically implantable product should permit a better insight into those circumstances that can be cause for there to be an exposure to liability for those involved in the many stages of device development. The manufacturing process that leads to the production of a marketable surgically implantable device includes a complex chain of events and with each link in the chain there can be individuals and/or organisations who may be at risk for one reason or another;
(b) a discussion of that important interface between the evolution of a surgically implantable device and the important concept of beneficence that is the balance between risk, harm and benefit that seeks to identify the level of risk that society is prepared to accept in return for a measurable health care gain;
(c) a consideration of the conduct of clinical trials where surgically implantable devices are tested in the marketplace in a manner that appears for the most part to be associated with little or no regulation; and
4. 1 (d) a review of the nature of those relationships that can exist between medical practitioners and manufacturers during the development and marketing of any surgical implantable device.
4.2 The process of evolution of a prosthetic device is something that I have had much experience with. As an Orthopaedic Surgeon, with more than
a passing interest in engineering1, I have been concerned with the development of 4 orthopaedic joint replacement devices.
4.3 The experience, in each case, has permitted me to benefit from a considerable insight into the process of surgical implant development. I was the sole inventor of a Modular Total Shoulder Replacement device - the Concost (formerly Concord) Modular Shoulder Replacement
System.2 This device was used worldwide during the period 1992 to 2002 when production was ceased for reasons associated with a corporate merger. In the 1980's I was a member of an international design group whose task was to design the International ITH® Femoral
Hip Stem.3 I was also one of the designers of the Prophor® Total Hip
Replacement System4 and have been retained to redesign the Isoélastique
Femoral Hip Stem5 component that had clinically performed badly as a consequence of an unacceptable incidence of loosening and fracture. Though the experience in each case was very different there was a common thread that reflected the close relationship, almost a marriage, that exists between the surgical, the engineering, the biological and the manufacturing management disciplines.
1 I have a Master's Degree (ME(Res)) awarded by the Faculty of Engineering (School of Mechanical Engineering) at the University of Sydney. 2 The Concord Modular Shoulder Replacement System was developed in association with Osteo AG of Bohnackerweg 1, Ch - 2545 Selzach, Switzerland. The name Concord was later changed to Concost in 1996 to avoid costly litigation that might have followed a French Manufacturer's claim to have registered the name Concord. 3 Manufactured by the Richards Medical Company, 1450 Brooks Road, Memphis, Tennessee, TN 38116, USA. 4 Manufactured by Osteo AG of Bohnackerweg 1, Ch - 2545 Selzach, Switzerland. 5 This device was designed by Professor J Butel, Director of Orthopaedic Surgery in Grenoble, France and was developed in France by SSFC, 89/93 Avenue Paul-Vaillant Couturier, B.B. 66-94250 Gentilly, France.
4. 2 4.4 Traditionally, and particularly since the mid-1950s, surgeons, engineers, and manufacturers have collaborated to develop new surgical devices and the time-honoured process of development usually commences with the presentation of a concept from which a prototype is made. The prototype is then reviewed and adjustments are made that parallel the generation of a device that can be further evaluated in the laboratory, with cadaver implantation, and occasionally with trials of performance in animals. As development proceeds and modifications are made an implantable device is developed that is suitable for clinical trial in humans. At the stage of the clinical trial, the approval of a regulatory
authority6 is an imperative. The clinical trial permits the evaluation of
the device in vivo7 that may identify the need for further modifications. In the event that the clinical trial has demonstrated the achievement of expectations with regard to safety and performance the device can be registered on the Australian Register of Therapeutic Goods (ARTG) by the regulatory authority, that is, in Australia, the Therapeutic Goods
Administration (TGA).8 The device can then become available for
general use in the marketplace.9
4.5 There is now a well structured and regulated step-by-step product life cycle that can be the subject of TGA scrutiny at each stage and at any
time10. The product life cycle is structured to ensure that there is a demonstrated compliance and conformity with those regulatory principles that particularly relate to product safety and performance. Throughout the cycle of development, design and construction solutions must be seen to eliminate or to minimise any risk of harm. The current regulatory environment now imposes the burden on manufacturers to carefully document the events of each stage of development and the
6 The Therapeutic Goods Agency in Australia (TGA), the Food and Drug Administration (FDA) in the USA, or the Medical Devices Agency (MDA) in the UK. For further information see also Ch 3 ¶ 3.87-3.95. 7 In-vivo is to living human as in-vitro is to the laboratory. 8 The TGA, is in Australia, the competent authority, that is responsible for the maintenance of the Australian Registry of Therapeutic Goods (ARTG). The ARTG is a public record and is the Register of all therapeutic goods supplied in Australia. It is the central point of control before therapeutic goods can be supplied and used. See Ch 3, ¶ 3.87-3.95, ¶ 3.62-3.67 and ¶ 3.68-3.86. 9 M Flood, “Conformity Assessment Procedures, Post Market Responsibilities, and Mutual Recognition Agreement with the EU”, Presentation to Department of Medical Physics, Royal Perth Hospital, 25 May 2004. 10 See Ch 3, ¶ 3.62-3.67, ¶ 3.68-3.86 and ¶ 3.87-3.95.
4. 3 regulatory task now requires that claims have to be supported by clinical
evidence at each stage.11 Furthermore the regulations also impose a duty for manufacturers to ensure that Quality Management Systems (QMS) are in place that will provide the organisation with the means to consistently manufacture medical devices that are safe, that perform as
intended, and that meet customer and regulatory requirements.12 It is also the case that there has to be documentary evidence of a commitment to QMS activities. Naturally also, post-market surveillance (PMS) vigilance activities and device adverse incident reporting also feature prominently in the current regulatory system. It is clear that all of this is very much different to that environment of surgical implant development that existed prior to the 1950s.
4.6 Prior to the 1950s the (now) traditional step by step process of evolution was not at all so well structured and at times it was the case that one single individual might have undertaken all of the roles embraced by the development process. The classic example of this is the story that concerns the English Orthopaedic Surgeon, Sir John Charnley. Sir John Charnley is as well known to Orthopaedic Surgeons as Lord Woolf is to Lawyers. The story of Charnley is of such historical significance that it
will be briefly reviewed in the second part of this chapter.13 It is a story that demonstrates so clearly that delicate balance that exists between innovation and risk of harm and brings so clearly into focus that magnitude of risk that the community will accept in return for a particular technological advance.
4.7 Today there are complex relationships that exist between all of those individuals, working groups, and scientific and commercial institutions that are concerned with any surgical implant development program. It is therefore appropriate in any consideration of issues relating to surgical
11 See Therapeutic Goods (Medical Devices) Regulations 2002, Sch 1, Pt 2 & Sch 3, Pt 8. See also TGA Medical Devices Guidance Document No 4, Clinical evidence requirements for inclusion of Medical Devices in the Australian Register of Therapeutic Goods, Version 1.6. 12 QMS standards - ISO 13485:1996 and ISO 13488:1996 have been the basis for licensing of manufacturers since 1996. ISO 9001/2:1994 has been revised and superseded by ISO 9001:2000.
4. 4 product liability that we consider those relationships as there can frequently be indirect responsibilities and liabilities, one with another, that may impact upon events in the long-term. From the moment of
invention through to the consumer14 there is necessarily a chain of events and at each stage each individual or organisation has a duty to take
reasonable care15 to prevent injury to the consumer that might be shown to be causally related to an act of carelessness or perhaps even through
some failure to act that can engender negligence.16
THE CLASSIC CASE
4.8 Sir John Charnley's contribution to the development of surgical implant technology remains legendary. Charnley is perhaps most remembered for his contribution to the treatment of degenerative disorders of human joints in general and of the hip and knee joints in particular. There is no disagreement amongst surgeons that Charnley's greatest contribution is
the prosthetic replacement17 of the hip joint that has been rendered
useless and painful by disease or injury.18
4.9 Fundamental to the development of the Charnley Hip Arthroplasty was Charnley's pioneering research work on the slipperiness of human
articular cartilage.19 Charnley's classic work on the lubrication20 of
13 See ¶ 4.8-4.18. 14 See Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120 - this case has been discussed in detail in Ch 3. In Courtney it was established that patients who have undergone the implantation of surgical devices are consumers. 15 Throughout the entire process the nature of the care, or the degree of the care must be appropriate to the seriousness of the consequences of failure. See Paris v. Stepney Borough Council [1951]AC 367; [1951] 1 All ER 42 9HL; the plaintiff already blind in one eye, following a war injury, became blind in the other eye as a consequence of a work mishap. The employer was aware of the war cause of blindness. The plaintiff suffered further injury when undertaking work associated with the repair of a motor vehicle. The plaintiff struck a rusty bolt with a steel hammer and a metal chip from the bolt penetrated the good eye causing blindness. It was alleged that the employer was negligent in failing to supply the plaintiff with protective goggles that would have prevented the injury. The Trial Judge found in favour of the plaintiff but the Court of Appeal unanimously reversed that judgement. It was found that the greater risk of injury (was) not the same thing as the risk of injury. A one-eyed man is no more likely to get a splinter or a chip in this eye than is a two-eyed man. The risk is no greater, but the damage is greater to a man already blind in one eye. See the conclusions of Lords MacDermott and Morton. 16 Donoghue v. Stevenson [1932] AC 562. 17 The term prosthetic replacement is a generic term that refers, where appropriate, to total knee replacement, total hip replacement, total shoulder replacement, etc. The phrase prosthetic replacement of a joint is interchangeable with the term arthroplasty which loosely translated from the Greek, implies the creation of a new joint. 18 J Charnley, “Arthroplasty of the Hip. A New Operation” (1961) Lancet, 1129. 19 Articular cartilage is that biological material that covers the surface of the components of human joints. It is a particularly smooth slippery surface that has an extremely low coefficient of friction.
4. 5 animal joints, financed by royalties from numerous other inventions and by donations from many grateful patients, became the foundation for his
subsequent discoveries21
4.10 Charnley's considerable contribution to the science of hip arthroplasty was completed at the Wrightington Hospital in the United Kingdom. However, it was, when still at the Manchester Royal Infirmary, that Charnley developed his (then) new procedure for the replacement of the hip joint, which included the use of polytetrafluorethylene (PTFE) or
Teflon.22 At the time this was analogous to the use of silicone to
augment breast size.23 Both were innovative and controversial.
4.11 The polymer, Teflon, was identified by Charnley to be an incredibly
slippery biocompatible material with a coefficient of friction24 close enough to that of joint cartilage for it to be the [ideal] material of choice
for the fabrication of artificial joint surfaces.25
4.12 At first, Charnley manufactured his Teflon hip prostheses in his own workshop which was located in the attic of his house in Hale. The workshop was well equipped with a workbench, with tools, and with a lathe. A monetary grant from the Manchester Regional Hospital Board
permitted also the employ of a Fitter and Turner - one Harry Craven.26 Charnley performed his hip replacement operations on Thursdays. In his workshop attic, the prosthetic devices (implants) were made on the day before surgery and Lady Charnley is recorded as having described
Wednesday night as socket night.27 The Teflon implants functioned well
20 J Charnley, “Lubrication of Animal Joints” (1959) Symposium on Biomechanics. London, Institution of Mechanical Engineers, 12-22. See also J Charnley, “The Lubrication of Animal Joints in Relation to Surgical Reconstruction or Arthroplasty” (1960) 19 Ann Rheum Dis, 10. 21 Nas S Eftekhar, “The Life & Work of John Charnley (August 29, 1911 - August 5, 1982)” (1986) 211 Clin Orth & Rel Res, 10- 22. 22 Teflon (PTFE) is a polymer (plastic) possessing a very low Coefficient of Friction. The lower is the Coefficient of Friction the less is the resistance to movement. 23 See Ch 2 ¶ 2.5-2.18. 24 The coefficient of friction is that engineering numerical index that quantifies the resistance to movement. The lower is the coefficient of friction then the less is the resistance to movement. Surfaces possessing a low coefficient of friction are slippery, less resistant to movement, and retard sticking, or loss of movement. 25 At that time the rest of the world was frying their eggs and bacon on Teflon-coated non-stick frypans. 26 See NW Nisbet and M Woodruff, “Biographical Memoirs of a Fellow of The Royal Society” (1984) 30 J Roy Soc, 119. 27 Charnley J (Lady), Personal Communication to Nas S Eftekhar in 1981. See vide supra n.21 at 13.
4. 6 for approximately 12-18 months. After this short interval of time implant failure was rapid and frequent and the clinical results became extremely poor. After approximately 300 total hip operations had been performed, Charnley chose to abandon the use of the material Teflon. The Teflon prostheses not only became loose, but they suffered extremely bad wear and the wear particles of PTFE caused the patients to suffer from a florid foreign body inflammatory reaction which was
localised to the tissues surrounding the implant.28
4.13 There was no doubting that Teflon in bulk form was extremely biocompatible and a very slippery material with a low coefficient of friction. Unfortunately though, for Charnley, and for near to 300 patients, the earlier Research and Development (R & D) did not identify that low friction was not consistent with low wear. Engineering conditions associated with low friction are not always consistent with there being low material wear. Teflon was found to wear extremely badly in the body, and in its particulate form, the material products of this wear process proved to be a biological disaster and cause for surrounding tissue necrosis and osteolysis with associated implant loosening. This experience can rightly be described as the orthopaedic surgeon's nightmare - the surgical creation of osteolysis from osteoarthritis - an experience not too dissimilar from creating connective
tissue disorders out of silicone-gel-filled breast implants.29
4.14 Charnley's clinical use of Teflon was clearly associated with the presence of a risk. There is an argument though that can support a view that Charnley was a super specialist and as such might now have been seen to have been considered to have had a licence to take that risk. The
decision in De Freitas v. O'Brien30 can provide some comfort to the so-
28 This inflammatory response to foreign material is known as Osteolysis. The process of Osteolysis is extremely damaging to bone. The loss of bone substance associated with the condition can become associated with loosening of implants and even with fracture of bone and/or implant. 29 See Ch 2 ¶ 2.5-2.18. 30 De Freitas v. O'Brien (1995) 25 BMLR 51 - In this UK case a spinal surgeon, described as being one out of only eleven such specialists in the country, claimed that surgery he performed was in line with what his fellow Spinal Surgeons would have considered clinically justified. The claimant claimed that, in fact, normal Orthopaedic Surgeons would not have operated in the
4. 7 called super specialist who may undertake procedures that others might regard as being inappropriate or even too risky.
4.15 Charnley abandoned the use of Teflon in 1961. Most of the patients, and it can be calculated that there were at least 150, but no more than 300, required revision salvage surgery to be undertaken. The experience led Charnley to the discovery of another polymer, High Density Polyethylene (HDP). His research reflected one man's perseverance that confirmed that hope can triumph over bad experience. Charnley's work also did bring into sharp focus that delicate balance that exists between innovation and risk of harm.
4.16 Charnley, the man, died on 5th August 1982, just a few weeks short of his 71st birthday. Throughout the world the tribute was unanimous - a
genius had left his work.31 Charnley, the prosthesis, continues to be used to this day, in one guise or another. The work at Wrightington continues and the Charnley Low Friction Arthroplasty is still internationally
regarded as the gold standard of implants.32
4.17 The story of Charnley might fascinate and interest different people for different reasons. For me, as an Orthopaedic Surgeon with the interests of an Engineer, there is reason to pause and cause to reflect that in the story there is little indication that innovation should ever be abandoned
completely for the sake of absolute predictability.33 The lawyer might view the story of Charnley a little differently and perhaps as presenting
circumstances. A Court of Appeal confirmed that the Bolam Test did not require that the responsible body of opinion be large, thus endorsing the acceptability of acting within limits defined by such specialisation. One criticism of the decision in De Freitas is that it licences the taking of risks. 31 J Older, “A Tribute to Sir John Charnley (1911-1982)” (1986) 211 Clin Orth & Rel Res, 23. 32 On 19 February 1998 the Medical Devices Agency in the United Kingdom issued a Hazard Notice in respect of the 3M Hip System. The Hazard Notice was issued following the finding that, as some centres, as many as 1:5 of the 3M Hip Systems implanted had failed at five years after surgery. This was a significant event in the United Kingdom and one that was instrumental for the United Kingdom Government initiative that caused the formation of the National Joint Registry. It is interesting to observe that, back in July of 1972, Sir John Charnley, in internal publication No. 39 from the Wrightington Hospital "serious consideration should be given to establishing a Central Register to keep a finger on the pulse of total implant surgery on a nationwide basis." The United Kingdom Government initiative was clearly nothing new but something that had taken, after John Charnley's recommendation, approximately 20 years to become reality. A further response to the 3M System failure was the observation of Muirhead-Allwood published in the British Medical Journal, that "…only tested designs (of hip implants) should be used (and that)…if we want improved prostheses we must regulate their use, such as the Charnley prosthesis". See SK Muirhead-Allwood, “Lessons of a Hip Failure – If we want improved prostheses we must regulate their use” (1998) 316 BMJ, 644. 33 The story of Charnley serves also to emphasise that Murphy's Law is not a law of nature - anything that can go wrong will.
4. 8 the classic scenario for a massive class action. The facts of the events, as they are known, can support a conclusion that the Teflon devices were not as safe as persons generally are entitled to expect. Furthermore there are important legal issues that concern matters of (obtaining) informed consent to risks that were probably unknown at a particular time of surgical and scientific experimentation and implant development.
4.18 The development and the use of the Charnley Low Friction Arthroplasty
was a resort to an innovative therapeutic technique34 that was also a collection of unique events. The circumstances were that almost all of the potential claimants underwent their surgery at the same institution and the surgery was performed by the same surgeon, using the same prosthesis, that he had invented and developed. The potential respondent, clearly identifiable, fulfilled almost every role in the medical market chain from inventor, to manufacturer, to surgeon and even to distributor. One point for telling the story of Charnley is that the tale describes a single individual who fulfilled a great many roles. With each role there are obligatory responsibilities and today it is usually the case that each role is undertaken by a different individual or organisation. As we have seen in chapter 3 the legal consequences of this can be complex. Another reason for telling the story is that it so clearly demonstrates that society cannot be assured of improvements to therapeutic goods technology without being prepared to accept some level of (acceptable) risk of harm. The balance between the risk of harm and benefit is a delicate one that is embraced by the concept of beneficence.
BENEFICENCE
4.19 The Principle of Beneficence is a singularly important consideration that should be at the foundation of any emerging new and innovative technology or treatment intervention. Charles Weijer, Bioethicist and
34 The descriptive innovative therapeutic technique should not be confused with that surgical technique or procedure that is undertaken when it is beyond the capacity of the clinician to perform the procedure. See Tonkins v. Bexley Area Health Authority
4. 9 Assistant Professor of Medicine, at the University of Dalhousie35 further emphasises that the "concept of risk is pivotal to the weighing of
potential benefits and risks required by the Principle of Beneficence."36 Weijer further considers the terms risk, harm, and benefit, and the phrase risk-benefit ratio. Weijer considers that the phrase risk-benefit ratio is not a “parallel production” and hence it is strictly speaking incorrect. Weijer is further of the view that it is more properly the case to speak of "harms and benefits" or of "risks and potential benefits". Risk, in the context of the implantable surgical device debate is a multi-dimensional concept that embraces both the probability and the potential magnitude
of harms37 and is a statement of the probability that harmful events will
occur. Risk is both a descriptive and an invaluable concept.38 Risks can
present in a number of forms and Levine39 has categorised the spectrum of risks into 4 groups that are -
(i) Physical risk that is associated with bodily harm that can be minor or serious, temporary or permanent, immediate or delayed;
(ii) psychological risk that includes some form of emotional suffering such as anxiety, shame or behavioural change;
(iii) economic risk40 that includes financial costs that are incurred and [maybe] related to participation [in a clinical trial]; and
[1993] 4 Med LR 235 - here a patient suffered damage to the lingual nerve when undergoing the extraction of wisdom teeth. It was alleged that the clinician performing the surgery had undertaken a procedure beyond his capacity. 35 Halifax, Nova Scotia, Canada. 36 C Weijer, “The Analysis of Risks and Potential Benefits in Research”, (1999) 9.2 and 10.1 NCEHR Communiqué - based on a talk at the NCEHR York University Regional Workshop, 13 March 1999. Professor Weijer is a Member of Council and Chair of NCEHR's Committee on Ethic of Research Design. Risk is defined as the combination of the probabilities of the occurrence of harm and the severity of that harm where harm is that physical injury or damage to the health of people, property, or the environment. 37 See vide supra n.36. 38 TL Beauchamp and JF Childress (eds), Beneficence in Principles of Biomedical Ethics, (4th ed, 1994) 292. 39 RJ Levine R J, Ethics and Regulation of Clinical Research, (2nd ed, 1988) 37-65. 40 Economic risk does have relevance to Cost Benefit Analysis (CBA) and Cost Effectiveness Analysis (CEA). In CEA the benefits are measured in non-monetary terms, such as years of life, quality-adjusted life-years, or number of cases of disease. CEA permits an estimation of “cost per year of lives saved”. CBA considers benefits and costs when measured in monetary terms. Though
4.10 (iv) social risk that may be a consequence of discrimination within society (e.g. insurance or employment discrimination) or some form of social stigmatisation.
I have little doubt that patients as consumers of new and emerging technology can experience physical, psychological or economic risk, but the suffering of social risk is probably extremely rare.
4.20 Any consideration of risk should include also an appreciation of the
concept of minimal risk. Minimal risk is defined41 as that risk of harm that could be associated with a program of research or surgical treatment that is not greater, considering probability and magnitude, than those risks that might ordinarily be encountered in daily life, during the performance of routine physical or psychological activities, or associated with the natural history of the progression of a disease process. The concept of minimal risk is probably not applicable to surgically implantable device therapeutic procedures. The implantation of any new prosthetic device may in itself be minimally risky but the surgical procedure required for that implantation can present circumstances that, in combination, might be cause for more than minimal risk. In the context of the surgically implantable device the concept of reasonable
risk42 may be one that is more appropriate. The concept of reasonable risk balances benefits (positive effects) with the potential risks (or potential harm) of use. From the perspective of the manufacturer of materials used for the fabrication of implantable surgical devices, there is also the concept of perceived risk that must be balanced against any
different, both aim to identify, measure, compare, and evaluate all relevant costs and consequences of treatment interventions and the terms are quantitative rather than qualitative. For further information see D Eddy, “Cost Effectiveness Analysis” (1992) 267 JAMA, 1669-75; D Eddy, “Cost Effectiveness Analysis” (1992) 267 JAMA, 3342-48; and D Eddy, “Cost Effectiveness Analysis” (1992) 268 JAMA, 132-36. 41 In the USA the concept of minimal risk is defined in US Federal Common Rule No 45 Cfr 46 102(g). 42 Food and Drug Administration (FDA) Task Force on Risk Management (Rockville MD) – Managing the Risks from Medical Product Use: Creating a Risk of Management Framework, FDA, May 1999.
4.11 opportunity for real risk. The magnitude of the failure of some implantable surgical devices, such as silicone-gel-filled breast implants, can present manufacturers with a challenge the basis of which is to be able to accurately identify or predict that perception of risk that is the consumer's. Perceived risks, and the risk of litigation, can be a cause for
a manufacturer to avoid43 pursuing a particular avenue of research and development and as such this can be an impediment to technological innovation.
4.21 Unlike risk, benefit is not a “probabilistic” term.44 Benefit refers only to the magnitude of a positive outcome without reference to its
probability.45 In contrast risk is comparable to harm46 in the context of
risks of harm.47 Generally, after the implantation of a surgical device, benefit should be measurable and identifiable as a positive value such as an improvement in the quality of life and health. Unfortunately, in some cases, not only may there be no evidence of benefit but surgeons may remain oblivious to the possibility of harm and it is not infrequent to hear it said that “even if an [untested] treatment is not going to do any good it
is unlikely to be harmful”.48 It is unfortunately though the case that there have been occasions where surgical interventions, that were confidently expected to be both beneficial and completely safe, have proven to be harmful. Expectations have not always been fulfilled and the classic case of Sir John Charnley's use of Teflon is a particularly good example of
this.49
4.22 Weijer50, as we have already observed, is of the view that the phrase "risk-benefit ratio" is strictly speaking incorrect and that any
43 Avoidance is an accepted risk management strategy. Adverse events associated with use of the Intra-Uterine Device (IUD), the Dalkon Shield, and the bankruptcy of the AHA H Robins Company, the manufacturer, was cause to deter other companies from entering the IUD market. For further information see R Sobol, Bending the Law: The Story of the Dalkon Shield Bankruptcy (1991). The practice of defensive medicine is closely related to the concept of avoidance as a risk management strategy. 44 See vide supra n.38 at 292-293. 45 See vide supra n.36. 46 With regard to implantable surgical devices the concept of harm is viewed to be inseparable from that of injury. 47 See vide supra n.38 at 293. 48 LG Cuervo and JK Aronson, “The Road to Health Care - Balancing Benefits and Harms of Interventions is Essential” (2004) 329 (7456) BMJ, 1-2. 49 See vide supra ¶ 4.8 to 4.18. 50 See vide supra n.36.
4.12 consideration of risks and benefits should more properly speak of "harms and benefits" or of "risks and potential benefits". In contrast, regulatory authorities such as the TGA view any analysis of risks and benefits as
contingent upon there being safety and efficacy51 (or vice versa). Regulatory authorities such as the TGA (and the FDA in the USA and the MDA in the UK) have an important role in setting minimum standards of safety and efficacy for implantable surgical devices that at times can be much in contrast with the commercial interests of
manufacturers.52 Following legislation in 1976 (Medical Device Amendments to the Food, Drug, and Cosmetic Act 1976 (USA)) manufacturers, in the United States of America, have had the burden of proof to establish that their medical devices are safe and effective before they may be distributed and used. It is also the case that many manufacturers, such as those making silicone-gel-filled breast implants, have benefited from additional time to meet the standards because their products were already on the market. With regard to breast implants the
FDA Commissioner, David Kessler53, defended a restrictive policy, rather than prohibition. He argued that for "patients with cancer and others with a need for breast reconstruction," there can be a favourable risk-benefit ratio in carefully controlled circumstances.
4.23 The extent to which regulatory bodies can predetermine acceptable risks on behalf of individuals or society is affected by the acceptance of a form
of paternalism, in which experts make such judgements.54 Notwithstanding this there is no great room for disagreement with the
conclusions of David Eddy55 that support a clinical approach to any risk- benefit analysis that includes 3 considerations –
51 See Ch 3, ¶ 3.87-3.95. 52 The controversial decision by the US Food and Drug Administration, in the 1970s, to severely restrict the use of silicone-gel-filled breast implants exemplifies the societal controversies that can be associated with any risk-benefit analysis that is undertaken in the context of health care. 53 See DA Kessler, “ Special Report: The Basis of the FDAs Decision on Breast Implants” (1992) 326 N Engl J of Med, 1713-15. 54 See vide supra n.38 at 225. 55 D Eddy, “Expert Saves Medical Practice Should be Confined to Areas with Solid Scientific Basis” (1999) Gene Therapy Weekly, 16-17.
4.13 (i) Where there is evidence of benefit the use of the intervention should be balanced against the evidence of interventions that have comparable effectiveness;
(ii) if an intervention has no effect, or is associated with harm, then the intervention should not be used; and
(iii) where evidence supporting the use of an intervention is inconclusive, then, for new technology, the evidence for use of the intervention should be examined in a research setting, and for old technology, the intervention should not be recommended for use beyond already known benefits.
4.24 Beauchamp and Childress56 describe any risk-benefit analysis as a subject that is [also] exposed to the constraints of justice. They consider 4 possible patterns of distribution of risks and benefits that include the 4 circumstances where:
(i) The risk and benefits fall on the same party. For example in most therapeutic interventions, the patient bears the major risks and stands to gain the major benefits;
(ii) one party bears the risks, while another party gains the benefit. For example, one generation may gain the benefits of technologies that will
adversely affect future generations;57
56 See vide supra n.38 at 315. 57 See Editorial, “The Legacy of Diethylstilboestrol (DES) From the 50s and 60s” (2004) 323 (3) Australian Adverse Drug Reactions Bulletin, 10. DES is a synthetic oestrogen that was used to prevent miscarriages. In 1971 an association was
4.14 (iii) both parties bear the risks, but only one party stands to benefit. For example, a nuclear- powered artificial heart would primarily benefit the user, but its risks would also be imposed on other parties in contact with the user; and
(iv) both parties gain the benefits, while only one party bears the risks. For example, persons in the vicinity of a nuclear power plant may bear significantly greater risks than other persons who also benefit from the plant.
4.25 With specific respect to implantable surgical devices any risk-benefit analysis must also take into account the imperfect environment in which the device is expected to operate. The implantation of a surgical device is generally for the purpose of treating a pre-existing disease, condition or injury. Whilst the device is intended to be associated with an improvement of the patient's condition, it can be the case that the patient will not achieve a perfect state of health, even though the patient may hold such expectations.
4.26 No discussion of risk, benefit, and the relationship between the two would be complete without reference to the concept of risk management. Risk management includes those policies and procedures that are designed to reduce risk. Many of these are derived from legislation or are introduced by manufacturers (and others) as a means of minimising the risk of subsequent litigation. In the Therapeutic Goods (Medical
Devices) Regulations 2002 there are 53 references to risk.58 Many of the essential principles of current regulations concern the identification and the litigation for risks that reflects a balance between benefits and with demonstrated between the in utero exposure to DES and the development of a rare cancer, clear cell adenocarcinoma of the vagina, in exposed daughters who were diagnosed at ages up to 22 years. 58 Here risk is defined as that combination of probabilities of the occurrence or probable rate of the occurrence of a hazard causing harm when the hazard is the potential source of harm and the harm is the physical injury and/or damage or health, property or to the environment.
4.15 what are thought to be acceptable or residual59 risks. Risk management
activities60 and the identification of risks that can be associated with the surgical implantation of devices is implicit in the TGA requirements that include those conformity assessment procedures that permit compliance with the provisions of the essential principles that are concerned with the minimisation of risk at every stage in the life cycle of product development.
4.27 It is appropriate and interesting to observe that The Explanatory Memorandum to the Trade Practices Amendment Bill of 1992 which inserted Pt VA into the TPA, states that s.75AC does not require goods
to be absolutely free of risk.61 Div 2A of Pt V and Pt VA of the TPA focus heavily on consumer expectations without any allowance for balancing the risk of harm against the social utility of a product. Commenting on s.74D of the TPA, Lindgren J in Graham Barclay Oysters v. Ryan (2000) 102 FCR 307, at [538] states that -
"it is not unreasonable for leglislature to adopt a policy requiring a manufacturer to meet the reasonable expectations of consumers as to the fitness of the manufacturer's goods for their purpose or purposes. Consistent with that policy, if the manufacturer knows that it cannot be sure to meet those expectations, it must cease manufacturing, or if possible ensure that the consumer has agreed to bear the risk."
4.28 This raises the issue as to whether a standard based upon reasonable consumer expectations is able to strike an appropriate balance between the protection of consumers and the social utility of manufacturing products. This is especially relevant to a consideration of blood products. This Thesis does not provide the scope to discuss this issue in any further detail but it is not inappropriate to form the conclusion that if society will not accept the risk that blood and blood products may be contaminated by some organism that is at this time unknown, or may not
59 Residual risks are risks that remain after protective measures have been taken that can be balanced against/with anticipated benefit. Residual risks are distinct from tolerable risks that are acceptable in a given context based on the current values of society. 60 See K Smith, “Risk Management for Medical Devices”, paper presented at Department of Medical Physics, Royal Perth Hospital, 25 May 2004 - the TGA defines risk management as including risk analysis, risk evaluation, and risk assessment. 61 See Explanatory Memorandum to the Trades Practice Amendment Bill 1992 (Senate) Notes on Clauses, para 14.
4.16 be detectable, there might be profound implications for blood transfusion
services, such as the Australian Red Cross, as we know them.62
SURGICAL IMPLANT DEVELOPMENT
4.29 It is fundamental to the development of any surgical implant that there is an idea and that there is the germination of that idea in a milieu where the risk of harm is constantly balanced against the perception of real benefit. Any conclusion that there is a need for a particular type of surgical device clearly must commence with the identification of there being a clinical requirement for the device. There has to be a disease, disorder or post-traumatic condition that can be identified to have the potential to be improved or cured by the device. It may or it may not be the case that the seed for an innovation is identified during the undertaking of some related (or rarely unrelated) research project. The clinical indication that a surgical prosthetic device can be beneficial is usually identified by a surgeon clinician, or by a group of surgeons, and occasionally by the product development department of a manufacturer. It is now almost always the case that there is, in the evolutionary process, a blend of ideas and information that follows from the interaction of surgeons, biomedical engineers, biologists, and manufacturing management. Others may become involved in the development process but these four groups represent the major stakeholders in any surgical implant development venture. Herein is the fundamental marriage of skills that we have already referred to.
4.30 The surgeon may or may not be engaged in full or part-time research and can be an employed academic surgeon, self-employed in private practice, or employed in a mix of both. It is frequently the case that the clinician will have a full or part-time appointment with an Area Health Authority, representing a particular State or Territory Health Service. The Area
62 See SM Bird, “Recipients of Blood and Blood Products - At vCJD risk” (2004) 328 (7432) BMJ, 18-19. vCJD is otherwise known as “Mad Cow Disease” – variant Creutzfeldt-Jakob Disease (vCJD).
4.17 Health Authorities do mostly appoint surgeons as independent contractors to provide services on a sessional basis. Surgeons can also be employed by an Area Health Authority as a full-time, or part-time Staff Specialist where, in the event, there is a clear employer-employee relationship. Only rarely now is there an association that can be considered as being associated with some form of honorary
commitment.63
4.31 It may be the case that the clinician is employed by a university institution or be associated, in some other way, with a university. The association between the university and the clinician generally includes the award of an academic appointment at the particular institution. That academic appointment can be of a full-time capacity that includes both academic (teaching) and clinical (treating) responsibilities and obligations. Being medical and surgical, these university appointments are mostly accommodated at individual hospitals but do also include academic teaching and research activities that might be conducted within the geographic environment of a university campus. A variety of other academic (university) associations do exist that include Adjunct, Honorary, and Clinical appointments. The tenure of these appointments generally last for only as long as the clinician is associated with the teaching activities of the institution. These university appointments do not attract a salary or any other form of consideration, there being no formal status in the nature of an employer-employee relationship. In a sense these appointments are all honorary appointments that generally reflect a university need or occasionally are a reward for past services.
4.32 Research in Australia can be funded from a number of sources. Most medical research is funded through grants such as are provided by the National Health & Medical Research Council (NHMRC). However funding for research can be provided by the individual researcher or by
63 Honorary appointments at State Hospitals (in NSW) were common until the mid-1970s. It is now extremely rare for an appointment at a State Hospital to be of an Honorary nature.
4.18 some other philanthropic individual or organisation (including venture capitalist). It can also be the case that research is funded by a surgical device manufacturing organisation that may have identified the market opportunity for a particular device or may have become aware of the inventor and his or her invention and research by some other means. There might have been a direct approach to the manufacturer by the inventor(s). The manufacturer may have become aware of the invention from reports in the literature, or indeed from corridor discussions, or the inventor, through some other clinical relationship with the manufacturer, may have been invited to serve as a consultant for purposes that might include matters relating to surgical implant research and development,
and education.64 Co-operation between researchers and industry is
inevitable and some might say even obligatory. Industry funding65 is particularly important in times when government and private funding for research is diminishing. It can also be the case that a freelance surgical product distributor may become involved with device development,
manufacturing and marketing66 serving as a conduit to bring inventor and manufacturer together.
4.33 It is clear that the inventor of an implantable surgical device can develop and sustain a number of relationships that can include relationships with academic institutions, with hospitals, with colleagues, and with surgical device manufacturers and their distributors. It is rarely the case today
that the inventor becomes the manufacturer.67 However, though rare,
64 The International Smooth Stem Hip Group (ISSHG) in Adelaide is funded by the Howmedica Corporation (USA). The Swiss Association for Orthopaedic Research (AFOR) was funded by the Osteo AG implant manufacturing organisation of Selzach (Switzerland). 65 In the United Kingdom the industry spends £3.3bn annually on research, financing about 90% of all clinical drug trials, but develop few truly innovative drugs. It is also the case that over half of all post-graduate medical education in the United Kingdom, and much of the education of nurses, is funded by the pharmaceutical industry from its annual marketing budget of £1.65bn. See RE Ferner, “The Influence of Big Pharma” (2005) 330 (7496) BMJ, 855. See also DA Henry, IH Kerridge, S Hill, et al, “Medical Specialists and Pharmaceutical Industry – Sponsored Research: a Survey of the Australian Experience” (2005) 182 (11) MJA, 557- 60. 66 The classic example is that of Mr Peter Welsh, who enabled the manufacture of the Anterior Cruciate Ligament Fixation Screw (designed by Dr L Pinczewsky), by the Australian Defence Industries organisation in Lithgow and the manufacture of the Active® (formerly Motus®) Total Knee Replacement Implant Device (designed by Dr M Cross), that is manufactured by Australian Surgical Design & Manufacture Pty Ltd (ASDM) of St Leonards (formerly Miranda), NSW and distributed by Active Orthopaedic Sales Pty Ltd in NSW. 67 The classic Australian example is that of Professor Ron Sekel, Orthopaedic Surgeon, and CEO of Portland Orthopaedics, manufacturers of the Margron® Total Hip Replacement Device. The Margron® device was conceived in 1991 and first surgically implanted in 1997. The device was developed in association with the University of NSW Department of Engineering, the Lucas Heights Atomic Research Centre, and the Commonwealth Scientific and Industrial Research Organisation (CSIRO). More than 700
4.19 there are examples of clinician entrepreneurs who have very successfully evolved, not only from inventor to manufacturer, but also from
manufacturer to distributor68.
4.34 In every case, for the seedling of an idea to fruit, there has to be a manufacturer. Generally the manufacturer will be an international organisation that possesses the experience, the infrastructure and the financial resources to undertake the R&D that is required for the production of the device and for the introduction of that device into the marketplace.
4.35 Whether the inventor works alone or as part of a group it is important, in the early phase of the evolutionary process, that inventors and those working with them are prudent. It is the case that the creator of a (surgical) device that proves to be defective, and as a result causes injury to a patient, may have exposure to liability for that patient's injury even if the creator of the device has taken all reasonable care and was not negligent. At this early stage in development it is also important to
ensure that novel ideas and designs are protected69 and that the ownership
of intellectual property is preserved.70 If the invention is in any sense novel then patents are generally sought. The patent is able to protect the nature of the intellectual property and to facilitate the commercialization of the device. Inventors holding patents make the first sale in the commercial chain when they transfer their intellectual information. This first sale occurs when a patent is assigned or licensed to a device
Margron® devices have been implanted. The manufacturing process of Portland Orthopaedics Pty Ltd are situated in Matraville, NSW. For further information see online www.margron.com . 68 See vide supra n.65 and n.66. 69 A patent offers absolute monopoly for up to 20 years over an invention to the extent that all others can be excluded from competing in the marketplace with the same or with a similar device. A patent can protect a commercial enterprise against all comers. To be patentable an invention must be new, must involve an inventive step in the sense that the development should not be obvious to a person skilled in the particular field, and it must have utility. A patent application must comply with formal requirements prescribed by the regulations: Patents Act 1990 (Cth), ss.29, 40. 70 See the Copyright Act 1968 (Cth) s.196 and the Patents Act 1990 (Cth) ss.29, 40. Under current regulations a design is validly registrable if it is "new and distinctive" when compared to existing designs. A design will be new unless it is identical to an existing design, and distinctive unless it is substantially similar in overall impression to an existing design. The Designs Bill 2002 identifies that an infringement occurs where a product embodies a design that is identical to or substantially similar in overall impression to a registered design. For further discussion see D Nicol and J Nielsen, “The Australian Medical Biotechnology Industry and Access to Intellectual Property: Issues for Patent Law Development” (2001) 347 Sydney Law Review. It is interesting to observe that Australian medical inventions now account for more than 25% of patents granted to Australians in the USA. This has increased from 10% in 1984. See “Making Science Patently Obvious”, The Weekend Australian, 31 January/1February 2004, 4.
4.20 manufacturer. Generally the manufacturing industry works hard to ensure that products receive patent protection as vast sums of money are invested in R&D. Less frequently though a patent may be a mere tool to prevent other workers, institutions and organisations from pursuing a similar line of enquiry or R&D. The patent then is an occasion that can have a potential to deter innovation and to slow the progress of scientific research. In this regard there is the classic example that is not so widely known that concerns the Australian development of the ceramic Silicone
Nitride.71 Research into the use of Silicone Nitride was concluded in Australia in 1978 when Heimke, in the United States, was granted a
patent for the medical use of the material.72 More than two decades later Silicone Nitride material has still not seen application as a material for the fabrication of an implantable surgical device that is in clinical use.
4.36 It can be the case that a team of researchers will be identified by, and become a working team for a manufacturer. These partnerships can include clinical researchers and pure researchers from a number of different disciplines, institutions and even nations. International development teams are appealing and can also be generated by manufacturers for a variety of reasons. While the motives are many, I have no doubt that the foundation for most of these relationships is motivated by profit. The International ITH® working group, already
referred to73, included clinicians from Canada, Southern Ireland, West Germany (as it was then) and from Australia. The objective for this group was, over one weekend, to identify and to provide the preliminary design parameters for a new cementable total hip replacement femoral
stem device.74 Among the parameters that were to be the cornerstone for the design was included the material of fabrication to be used, titanium
71 Silicone Nitride is an industrial ceramic material that has properties making it suitable for its use in the fabrication of prosthetic joints and skeletal replacement parts. At the University of NSW, in 1977 and 1978, Eric McCartney (formerly Professor of Ceramic Engineering at UNSW), myself and others successfully demonstrated the biocompatibility of the material when used to replace skeletal elements in animals (rabbits). 72 Professor E McCartney, (formerly Professor of Ceramic Engineering at UNSW), myself, and others, in 1978, terminated the Silicone Nitride Research program as patent protection for the use of material was granted to Heimke in the USA. 73 See ¶ 4.3 and n.3. 74 The International (ITH®) Titanium Stem Prosthesis. This device was manufactured by the Richards Medical Company, 1450 Brook's Road, Memphis, TN, 38116, USA.
4.21 alloy, and the cost. The device was to be cheap to produce, ie, keep it as simple as possible.
4.37 It can also be the case that more formalised working partnerships can be generated. University employees will, in particular, be encouraged to enter into working and financial partnerships with University business
organisations75 and with industry.76 Where the inventor is a public servant or employed by a University it is not unusual, nor inconceivable, that the employing organisation will identify some ownership of intellectual property. This ownership of intellectual property has the potential to generate revenue for the institution and can be partly regarded as some form of compensation or consideration for that time that has been consumed by the inventor employee in the expenditure of energy that has been put into research where there is also an obligation, that is remunerated by the employer-employee relationship, to perform some other function e.g. to provide clinical surgical services and undergraduate and postgraduate student teaching.
4.38 Working partnerships, with contractual agreements, can also be formed
between manufacturers77 and the individual inventor or group of
inventors.78 The considerations associated with these industry contracts can vary greatly. Remuneration can include the payment of consultancy
fees, commissions, royalties79, the provision of hospitality80, gifts81, and
75 For example the Unisearch organisation at the University of New South Wales (UNSW) and the Business Liaison Office at the University of Sydney. 76 See H Moses and JB Martin, “Academic Relationships with Industry: A New Model for Biomedical Research” (2001) 285 JAMA, 933-5. Moses and Martin report that financial relationships with industry is extremely common in the USA. It is estimated that in the Year 2000 US$55B to US$60B of industry research and development in basic biomedical discovery and clinical trials occurred within universities. This is in contrast to US$25B in total United States Federal spending and US$8B to US$10B in private foundation support for biomedical research. 77 See D Blumenthal, N Causino, E Campbell and KS Louis, “Relationships between Academic Institutions and Industry in the Life Sciences - and Industries Survey” (1996) 334 N Engl J Med, 368-73. Blumenthal et al found that 90% of companies had associations with academic institutions, that 8% retained Faculty members as consultants, that 59% supported research and that 38% provided financial support for the education of students and fellows. See also WA Rogers, PR Mansfield, J Braunack-Mayer and JN Jureidini, “The Ethics of Pharmaceutical Industry Relationships with Medical Students” (2004) 180 MJA, 411-14. Here the authors conclude the best policy is for medical students to have no contact at all with drug companies. 78 In the USA, as from February 1999, Drug Manufacturing Companies that submit licensing applications to the FDA must reveal whether researchers involved in a drug trial have any financial interest. This is not yet the case in Australia. However, in Australia failure to disclose a pecuniary interest when giving a referral or recommendation for treatment is included in the definition of unsatisfactory (s.36(1)(h)) in the Medical Practice Act 1992 (NSW) - s.36(1)(h) defines the term unsatisfactory and s.36(2) provides a detailed definition of what constitutes a pecuniary interest. 79 Royalties are usually calculated on ex-factory turnover costs and not on retail sales. Royalties generally vary from 1%-4% of ex- factory cost depending on the degree of novelty of the invention and the extent of the inventor's contribution to the development of the product.
4.22 other "kickbacks".82 Lobbying by Australia's Drug Industry Association, Medicines Australia, has persuaded the ACCC to scrap a proposal that, if effected, would have required the public disclosure of drug companys' sponsorship of doctors' travel and accommodation and other promotional benefits. The ACCC had recommended that companies disclose any planned sponsorship of events and travel for doctors, "to ensure that benefits are not provided which might effect [a] doctor's prescribing
habits."83 In the event these liaisons are common and implicit in all of the arrangements there will be secrecy and confidentiality agreements, and generally the acceptance of an undertaking to assist with the
marketing of the device, with post-marketing surveillance84 and with future product development.
4.39 Post-market surveillance and continuing development activities will generally also include an educative role for the surgeon. The educative role may frequently require a surgeon to travel widely (both domestically and internationally) for the purpose of lecturing, for product demonstration, and for the undertaking of surgical procedures. These activities and the partnerships generated between clinician and
80 See T Sheldon, “Drug Company Fined for Excessive Hospitality” (2001) 322 BMJ. Here Sheldon reports that a company was fined A$67,500 for providing excessive hospitality. In a legal test case, Merck Sharp & Dohme became the first pharmaceutical company in the Netherlands to be prosecuted for entertaining doctors excessively, contrary to the Dutch Marketing Code for Prescription-Only Drugs. The Court found that hospitality had not been kept within reasonable limits at a Scientific event and the prosecution argued that the emphasis had been on fun and entertainment and not on scientific education. The company organised dry ski slope and go-cart contests both in Holland and Belgium, for General Practitioners and Neurologists, which they called the Maxalt Grand-Prix. A weekend was also provided on the Friesian Island of Terschelling, which included shrimp fishing and dinner dances; seminars were followed by outings to the musical 'Chicago' and the 'North Sea Jazz Festival'. It was further added that speakers presented as being independent were in reality, in several cases on the (Merck Sharp & Dohme) payroll, sitting on an Advisory Board, which considered the marketing strategy for the anti-migraine drug Rizatriptan (Maxalt). The prosecution, in this case, did accept that the company might not be the only company guilty of contravening the Code. It argued that the medical world was a closed shop in which doctors have little interest in making it known that they have been on a jaunt. The company, in reply, argued that their educational and promotional activities had undergone strict internal legal and medical testing. Tony Sheldon also reported in “Doctors Fined for Accepting Hospitality” (2002) 325 BMJ, 511, that 15 doctors in the Netherlands were required to appear in Court for refusing to pay fines for accepting excess hospitality. The 15 doctors went on a car anti-skid course, offered by German Pharmaceutical Company Boehringer-Ingelheim as entertainment after an event promoting its drugs against blood pressure and rheumatism. Another 50 doctors have already paid fines of up to A$431. 81 The NSW Medical Board and the Australian Medical Association have draft Codes of Ethics regarding acceptance of gifts. The NSW Medical Board Code can be seen in full at www.smh.com.au. See also “ No Reason to Whine – Chemists get secret gifts”, Daily Telegraph (Australia), 13 April 2004, 2. The article reports that Chemists received rewards that included wine, expensive whiskey, free golf days and massive discounts - of up to 40% - on the price of drugs. 82 See JD Capozzi and JL Delsignore, “Reimbursement Incentives to Physicians” (2004) 86A (4) JBJS, 876-77. Capozzi and Delsignore stressed that "kickbacks" can undermine the decision-making capacity of a clinician to act for the good of his or her patient and that financial incentives, regardless of their dollar value, can exert tremendous influence on the prescribing patterns and treatment choices of physicians that can seriously jeopardize physician-patient relationships. See also JP Orlowski and L Wateska, “The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns. There's no such thing as a free lunch.” (1992) 102 Chest, 270-3. In the USA there is an Anti-Kickback Statute – No 42 U.S.C. § 1320-7b. 83 The ACCC's proposals drew strong criticism from Medicine Australia, and from the Australian Medical Association. For further information see Bob Burton, Editorial, (2003) 327 (7426) BMJ, 1248. 84 Post-market surveillance or PMS is frequently referred to as post-market vigilance.
4.23 manufacturer can generally benefit both. Both can clearly benefit financially. It will also be the case that the surgeon will become more exposed to the professional and lay communities and this can engender an elevation of the individual's status. I suspect though that the manufacturer benefits most.
4.40 Inherent in all of these arrangements is the opportunity for a manufacturer to be able to establish a market penetration into institutions that are generally, if not always correctly, described as Centres of Excellence. It is the case that, for the most part, the partnerships between clinicians and manufacturers are formed on a basis, and with an understanding, that is honourable. Unfortunately though the partnerships
can include considerations that are complex85, not entirely ethical, perhaps not always transparent, and which can be causal for the
occasional conflict of interest.86 The nature of the association between clinician and industry can even have a potential to influence the
surgeon/patient relationship.87
85 See Zosir Kmietowicz, “Companies offer Surgeons incentives to use their prostheses” (2004) 328 (1085) BMJ, 1091. Here Kmietowicz reports that "another worrying aspect of hip surgery is the fact that owing to incentives from manufacturers nearly half of all hospitals (in the UK) are using prostheses they would otherwise not purchase. In addition 10% (n-217 my calculation) of consultants have accepted incentives from manufacturers of hip prostheses and in two-thirds (2/3) of cases the offers, usually of travel and training, are not properly recorded or appropriately approved". The British Orthopaedic Association Handbook 2004, incorporating lists of members, and the 86th Annual Report of the BOA confirms on page 26 that there are 352 Senior Fellows and 2169 Fellows of the BOA (total 2169) - 10% is 217 surgeons. Further information can be obtained from the BOA at 35-43 Lincoln's Inn Fields, London, WC2A 3PN. The author is an overseas Fellow of the BOA. 86 See DF Thompson, “Understanding Financial Conflicts of Interest” (1993) 329 New Engl J Med, 573-6. In 1993 Thompson defined Conflict of Interest as "a set of conditions in which professional judgement concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain). For a detailed review of the potential for and the incidence of Conflict of Interest in Orthopaedic Research see JD Zuckerman, M Prasarn, EN Kubiak and J Koval, “Conflict of Interest in Orthopaedic Research” (2004) 86A (2) JBJS, 423-28. See also C Stewart and A Lynch, “Undue Influence, Consent and Medical Treatment” (2003) 96 J Roy Soc Med, 598-601. Stewart and Lynch report that in certain circumstances the law recognises that a person's free will may be so influenced by another - the doctrine of undue influence. In the past the doctrine of undue influence was confined to situations involving the transfer of property. I have been unable to find any reported reference to any situation of undue influence that involves clinicians and manufacturers but the doctrine is probably applicable. 87 I know of one surgeon (name withheld) who in 1998, was presented with a Contract for his consideration that included a proposal that, in lieu of the payment of royalties on the sale of an invention, he should receive a lump sum payment and an annual consultancy fee for a period of three years in the event that he agreed to use only surgical products that were available from that manufacturer. The nature of such arrangements are clearly unhealthy. Naturally the surgeon declined the offer. See also K Crouch, “You Scratch my Back and I'll Scratch Yours” (2002) The NSW Doctor, 3 - This article discusses the scenario where Tumour Exterminators Pty Ltd approaches you regarding their new product…and…they propose a deal whereby you prescribe a product to your patients who suffer from tumours (as long as it is appropriate in the circumstances) and in return the company will pay you a financial commission for your prescription." The hypothesis asks the question Are you able to accept it? The Medical Practice Act 1992 (NSW) divides the situation into two categories: (1) Doctors who recommend a product for profit from a company in which they have an interest; and (2) Doctors who recommend a product for benefit from a company in which they have no interest. Under the first category a doctor must determine whether the interest he or she has in the company is a pecuniary interest as defined by the Act as follows: (a) Where the doctor earns 5% or more of the shares in the public company; (b) Where the doctor has any interest in the private company; (c) Where the benefit is received from a natural person and that person is the doctor's partner; or (d) Any other circumstances prescribed by the regulations.
4.24 4.41 It is not unknown for remuneration to clinicians involved in clinical research partnerships to have frequently been calculated on a basis that is derived from a knowledge of the magnitude of the retail sales revenue that has been generated by that particular surgeon's use of that manufacturer's products. Surgeons have been graded A, B, or C according to the magnitude of their product usage, or their clinical
activities might be exposed to the 10% rule88. Such activities are
regrettable89 but not confined only to the surgical implant industry. The relationship between medical practitioners and the manufacturers of pharmaceutical goods has been described as being “twisted together like the snake and the staff” and entangled in a web of interactions as
“controversial as they are ubiquitous”.90 The dangers associated with the proximity of medical practitioners and industry are recognised in already
developed Codes of Practice.91
4.42 It is an imperative92 that any conflict of interest be disclosed to reveal any potential bias in the result of published or presented research. As have many peer review journals, the American Volume of the Journal of Bone
& Joint Surgery initiated a conflict of interest policy in 198593 that has
If a doctor does have a pecuniary interest in a company (as defined above) from which he or she receives a benefit, then the doctor may recommend the product in return for the benefit. However, this is conditional on the doctor disclosing the nature of the interest to the patient at the time of giving the recommendation. Recommending a product or a service to a patient in return for a benefit either where you have a pecuniary interest, which has not been disclosed, or where you have no interest in the company at all, may amount to unsatisfactory professional conduct. This can lead to deregistration. In March 2005 at least five major orthopaedic manufacturing companies in the United States of America received subpoenas (in a Federal investigation) for documents relating to contracts between the manufacturers and surgeons who implanted artificial hip and knee joints. All documents dating back to January 2002 are to be made available for investigations. Personal communication, J Harrison, President Australian Orthopaedic Association, 2 April 2005 (Adelaide). The closing stock prices for the five companies was, on 5 April 2005, down from between 1% and 7%. It is also the case that Medtronic, the world’s biggest manufacturer of heart pacemakers, is also facing investigation - source, Bloomberg News and Reuters, 5 April, 2005. 88 The 10% rule determines the level of funding or the value of any consideration. The value of any funding or consideration is determined by calculating 10% of 10% of retail turnover revenue that is generated by the individual surgeon’s use of the manufacturer's products, i.e. A$10,000 if retail sales are A$1m. 89 See J La Puma, CB Stocking and WD Rhoades, “Financial Ties as Part of Informed Consent to Post-marketing Research, Attitudes of American Doctors and Patients” (1995) 310 BMJ, 1660-61 – this study identified that just over one-half of patients questioned found payment to clinicians unacceptable. An even greater proportion (80%) held the view that patients should have the right to know if their doctor would be paid for enrolling them [in any program of clinical research]. 90 R Moynihan R, “Who Pays for the Pizza? Redefining the Relationships Between Doctors and Drug Companies. 1: Entanglement” (2003) 327 (7400) BMJ, 1189-92. For further reading see BMJ Theme Issue, “Time to Untangle Doctors from Drug Companies” (2003) 326 (7400) BMJ. 91 These Codes of Practice have been described as mere window dressings unless they can be explicitly and vigorously observed. For further information see S Mayer, “World Body Reviews Doctors' Links to Industry” (2003) 326 BMJ, 1165 and E Wage, “How to Dance With Porcupines: Rules and Guidelines on Doctors' Relations With Drug Companies”,(2003) 326 BMJ 1196-8. 92 See JD Zuckerman et al, cited in n.86. 93 JJ Gartland, “The Conflict of Interest Policy for the Journal of Bone & Joint Surgery” (1985) 67A JBJS, 671.
4.25 required all authors to provide the requested, and any relevant, information before an article will be published.
4.43 It is not always the case that every aspect of research and development can be accommodated by in-house resources. Manufacturers frequently benefit from relationships with other manufacturers, suppliers of raw materials and with other research organisations. The classic example of this is the sourcing of materials for artificial joint articulating surfaces.
Worldwide the sourcing of polyethylene94 and ceramic materials95 is from just 3 or 4 manufacturing organisations respectively. The business relationships and obligations between all of these organisations, and indeed also with the inventor(s) can be complex, and any exposure to any
liability can include those concepts of alternative liability96, the risk of
contribution97, the risk of concerted action98 and of market share.99
94 The three major suppliers of these materials used in medical implants are Dow Chemical, Dow Corning Corp, and Du Pont Inc. 95 Worldwide there are only four manufacturing organisations that produce surgical implants using medical grade ceramic materials. These organisations manufacture the ceramic implants for more than 150 different ceramic hip implants. 96 Alternative liability can occur when more than one manufacturer is involved and the principle behind the alternative liability theory is that manufacturers are in a better position than is a claimant to identify the negligent party or the cause of the injury. See the US case Sumners v. Tice 33 Cal 2d 80, 194, p.2d 1 (1948) - here the plaintiff was shot in the eye by one of two negligent hunters. Both hunters had fired in the direction of the plaintiff but the latter was unable to ascertain which of the two had fired the actual shot which caused his injury. The alternative liability theory places the onus on each defendant to show that he was not responsible. This principle is contained in the US Second Restatement of Torts, which states: Where the conduct of two or more actors is tortious, and is proved that harm has been caused to the plaintiff by any one of them, but there is uncertainty as to which one has caused it, the burden is upon each actor to prove that he has not caused the harm (s433 B(3)). In Australia, on 26 July 2004, a new Part, Pt V1A, consisting of s87CB to s87CI, was inserted into the TPA to provide for proportionate liability in respect of damages for economic loss for misleading and deceptive conduct. See Ch 3 ¶ 3.52. 97 The Risk Contribution theory is a theory that is a blend of the market share and the alternative liability theories. See Martin v. Abbott Laboratories 689 P 2d 368 (Wash. 1984). In this case the Court determined that the defendants could only be found liable for a percentage of the claimant's compensation, equivalent to their percentage share of the market at the time. Hence the plaintiff who sues manufacturers who are responsible for 60% of the market, will recover only 60% of the compensation that would otherwise be due. See also Ch 3 ¶ 3.52 for a discussion of proportionate liability and the liability of the concurrent wrongdoer. 98 The theory of Concerted Action simply states that where all those in concert commit an act they are equally liable for the injury that results from the incident. For further information see Prosser and Keaton (eds), On Torts (5th ed, 1985) 323. 99 The Market Share theory requires the plaintiff to demonstrate that the defendants are responsible for a substantial share of the market, and, for example, that failure to demonstrate that a particular drug of the manufacturer's is that particular drug that caused the plaintiff''s injury was not produced by the organisation, demonstrates the liability to pay a percentage of the compensation awarded to the plaintiff and that percentage is calculated on the amount of each (market) share. See Morris v. Parke Davis & Co (573 F Supp 1324 (CD Cal 1983)). See also Sindell v. Abbott Laboratories et al - Supreme Court of California. 607 PE 2d 924 - (1980). Here the plaintiff developed a malignant bladder tumour that required surgical removal. The tumour was associated with the use of diethylstilboestrol (DES) that had been prescribed for the purpose of preventing a miscarriage. The Proceedings included several drug companies as defendants who had manufactured and marketed DES until 1971 when the FDA ordered manufacturing and marketing to cease. The plaintiff was unable to identify which defendant had manufactured the drug responsible for her injuries. Approximately 200 companies may have done so. It was held that each defendant would be held liable for the proportion of the judgement represented by the share of the market, unless it was possible for the defendant to demonstrate that it could not have made the product which caused the plaintiff's injuries. The legacy of DES continues following the demonstration, in 1971, of an association between in utero exposure to DES, and the development of a rare cancer, clear cell adenocarcinoma of the vagina in exposed daughters ("DES daughters") who were diagnosed at ages up to 22 years. For further information see Editorial, “The Legacy of Diethylstilboestrol (DES) from the 50s and 60s” (2004) 23 (3) Australian Adverse Drug Reactions Bulletin, 10.
4.26 4.44 The development of any surgical device will require considerable in-
vitro100 and in-vivo101 observation of performance of design, of materials of fabrication, and of techniques for insertion and means of fixation. It is an imperative that all materials used for the fabrication of implantable surgical devices that are identified during an R & D program do satisfy the requirements of safety and efficacy and are identical to the materials of fabrication for the implant that is actually placed into the
marketplace.102 That there should be any doubt that this is not always the case may come as a surprise to the reader.
4.45 The reaction of tissues to particulate device materials and to particular shapes of implants and the quantification of such parameters as wear and friction (and others) can be evaluated in laboratories quite separate and distinct from that of the manufacturing organisation. Contractual arrangements between these organisations can also be extremely complex and become associated with the joinder of exposure to liability
in the event of there being an adverse event103.
SURGEON-INDUSTRY RELATIONSIPS
4.46 Manufacturers, and distributors of products are not just in the business of making people better. The bottom line for industry is profit and the primary business of a manufacturer is to make money. In a capitalist society there is nothing very wrong with this. Surgeons though are in the business of making people better. They also make a little money along the way. Occasionally the two, the manufacturer and the surgeon, can
100 In-vitro investigation is that which is undertaken with a program of study and investigation, usually in a laboratory environment, that does not involve the use and/or collaboration of living organisms 101 In-vivo research is research that is undertaken on or with the collaboration of living organisms. In the context of surgical research in-vivo investigation generally includes the use of living animals in research and later the collaboration of individuals who become included in a program of clinical research…the clinical trial. 102 This is not always the case. This information and copies of supporting evidence that included the microscopic appearance of the materials was provided to me by a Senior Orthopaedic Consultant who was associated with a leading North American international manufacturer of total knee replacement devices. The name of the Consultant has been withheld. 103 Artiglio v. Corning Inc 18 CAL 4th 604 (1998). The lessons of Artiglio are that even non-manufacturers could be liable to consumers for the negligent testing of products providing the plaintiff can demonstrate the essential element of negligent undertaking, including a sufficient connection between the services rendered and the plaintiff's injuries. If no connection exists then of course liability will not attract. See Ch 2 n.103.
4.27 enter into a relationship104 that can blur and distort the ethics of the business of both. The dilemma that can be created has been particularly
well summed up by Capozzi105 et al in their (somewhat rhetorical) observation –
“Do we decide to use particular drugs, medical devices, or appliances because of our relationship with the manufacturer, or because those products are truly better for our patients? What specifically do the meals, gifts, trinkets and stipends that industry representatives offer have an impact on our decision to use certain products? The medical industry has an agenda to sell products, and gift-giving, is a standard technique for marketing those products. Physicians have a responsibility to remain current in their medical educations. When those two paths cross, a potential conflict arises.”
Komesaroff and Kerridge106 emphasise the “uneasiness” that exists in the relationship between [manufacturers] and the medical profession though they do identify some “clearly” desirable effects. Komesaroff and Kerridge emphasise that the co-operative efforts of industry and medical practitioners can facilitate the endeavours of each [and of governments] to achieve the quality use of health care resources. Both groups are concerned with encouraging the effective and responsible use of therapeutic drugs and devices in treatment programs, with post market surveillance (PMS) of their use and with the undertaking of innovative research. However in all of this the two parties have different aims that focus on different stakeholders. Komesaroff and Kerridge continue to identify areas of concern that are the direct consequence of each’s focus on different stakeholders –
104 A leading UK Pharmaceutical trade magazine has actually published a detailed guide as to how drug companies can use medical opinion leaders to sell new products and one of the most striking aspects of the guide is the cynicism and the contempt in which opinion leaders appear to be held. See News Review, “Tricks of the Trade” (2001) Australian Doctor, 31-35. See also P Aitken & C Katona, “Working with the Drug Industry: Is your reputation at risk?” (2005) 13 Student BMJ, 158-59. 105 JD Capozzi, R Rhodes and JL Delsignore, “Medical Education and Corporate Sponsorship” (2003) 85A (1) JBJS, 168-70. 106 See PA Komesaroff and IH Kerridge, “Ethical Issues Concerning the Relationships between Medical Practitioners and the Pharmaceutical Industry” (2002) 176 MJA, 118-21. See also Association of the British Pharmaceutical Industry, “Code of Practice for the Pharmaceutical Industry”, (2003) ABPI. Research governance, the system of overseeing health and medical research, in Australia, is based primarily on a series of National Health and Medical Research Council (NHMRC) guidelines. These guidelines derive their authority from the NHMRC Act 1992 (Cth) which gives the Council to power to refuse to fund or to withdraw funds from research that does not comply with the guidelines.
4.28 “Doctors are interested primarily in patient care and scientific advance, while industry is interested primarily in commercial outcome. The primary stakeholder in patient care is the patient, whereas the principal stakeholder in industry is the shareholder. The similarities and differences between the participants and their interests create both a need for disclosure and the potential for conflict and less clearly ethically justifiable ones.”
The 3 main areas for concern identified by Komesaroff and Kerridge are-
(i) that associations between doctors and manufacturing companies may serve commercial objectives of industry and inquisitive interests of clinicians rather than legitimate care, educational, or research goals;
(ii) that a drug [or device] promotion will inappropriately influence the decisions of doctors; and
(iii) that there is the danger that industry involvement in research will lead to distortions of scientific evidence and frustrate the independent assessment of data.
4.47 In certain sectors of the Australian medical community there is an emerging atmosphere of discomfort that is stimulating the introduction of guidelines that set out the boundaries for those relationships between doctors and manufacturers and for the maintenance of academic freedom
for those undertaking research107. These developments are timely. There is evidence to support an argument that industrial funding has had undue
influence on the research agenda108 and there is also evidence that therapeutic goods manufacturers have endeavoured to violate academic
107 It is also the case that the Royal Australasian College of Surgeons and the Australian Orthopaedic Association have (separately) introduced guidelines that set out the ethical boundaries for relationships between their members and fellows on the one hand and manufacturers on the other hand. See also PC Gðtzsche, Editorial, “Research Integrity and Pharmaceutical Industry Sponsorship” (2005) 182 (11) MJA, 549. 108 P Dieppe, J Chard, D Tallon and M Egger, “Funding Clinical Research” (1999) 353 Lancet, 1626.
4.29 freedom by ceasing the trial of a drug and even threatening legal action if
the investigator publish “fears” about a drug109.
4.48 In the United Kingdom, the Royal College of Physicians (RCP) has introduced new guidelines that should preserve the ethical boundaries of
any relationship between [medical practitioners] and manufacturers110. The RCP Guidelines state the position of the College in regard to hospitality for meetings, gifts, grants, research, declaration of interest, and doctors acting as consultants to industries. The new recommendations of the RCP include the following –
(a) No conditions should be attached to gifts of items of equipment, or aid; (b) Individual physicians should not accept cash or objects in kind and gifts, honorariums, or hospitality received must be declared; (c) Speakers at company-funded meetings should not be chosen solely by the manufacturer; (d) The payment of a reasonable expense and honorarium is acceptable for larger and for overseas meetings, but should be administered by an independent scientific body and not paid directly to individual physicians; (e) Manufacturers should not pay for a physician’s spouse or partner;
109 In the 1990s a four year dispute at the Toronto Hospital for Sick Children centred on attempts by a drug company to prevent the publication of results of a trial that were unfavourable in relation to one of its products. The dispute began after researcher Dr Nancy Olivieri broke a confidential agreement with Apotex, a Toronto-based pharmaceutical company that was sponsoring her research. Dr Olivieri published results critical of the drug Deferiprone, which she was testing in young patients suffering from thalassaemia (a blood disorder). Dr Olivieri, former Head of the Toronto Hospital for Sick Children’s Haemoglobinopathy Program, was also removed from her Hospital post – though later reinstated. For further information see NF Olivieri et al, “Long- term Safety and Effectiveness of Iron-chelation Therapy with Deferiprone for Thalassaemia Major, (1998) 339 (7) N Engl J Med, 417-23 and D Spurgeon, “Report Clears Researcher Who Broke Drug Company Agreement” (2001) 323 (1085) BMJ, 1085. 110 The Royal College of Physicians report is set out in the College Journal, (2002) 2 Clinical Medicine, 320-2. The position statement is authored by Dr John Collins and Dr John Bennett. For further information see also N McGuaran et al, “Royal College Issues New Guidelines on Gifts from Drug Companies” (2002) 325 BMJ, 511. It is interesting also to observe those guidelines operating in other countries - x France – the doctor should not accept gifts in cash or otherwise except small gifts not exceeding Euro 30. x Spain – gifts should not exceed Euro 19. x USA – gifts of value less than US$100 are permitted if intended for patients’ benefit. x India – the Medical Council of India, in its new Code of Ethics Regulation, March 2002, does not prohibit doctors from accepting gifts or cash incentives from drug companies. x Australia – drug companies have agreed to end “the lavish wooing of doctors” with free lunches and report seminars.
4.30 (f) Manufacturers can fund scholarships and grants if the selection of the recipient remains the concern only of the academic or training institution involved; (g) All research should be approved by the appropriate Ethics Committee and all financial matters relating to research should be handled by the Finance Department of the Health Authority, University, or Institution and supervised by their financial officers; (h) Physicians must not advertise patients’ availability for use as research subjects; (i) Written agreement from the sponsoring company must be obtained for the freedom to publish results in journals chosen by the physician; (j) Doctors should only be paid as consultants to the health industry for services provided outside of working hours [associated with employee-employer relationships]; and (k) All arrangements must be clarified in advance in a business contract that is approved by the physician’s employer.
CLINICAL TRIALS
4.49 Probably the most important phase of any surgical implant (or drug) development program is that which concerns the clinical trial of the surgically implantable device in humans. It is at this stage that considerations of ethics and considerations of safety (in the context of risks and harms) are second and third to none. The ethical duties of medical practitioners involved in clinical trials are paramount, and are, in
general terms, outlined in the International Code of Medical Ethics111. The conduct of any research involving human subjects should be guided
111 As amended at Venice in 1983. The International Code of Medical Ethics describes the duties of physicians in general and those duties fall into four groups that include, maintaining the highest standards of professional conduct, the occasion to provide a competent medical service with compassion and respect for human dignity, preservation of honesty with regard to the conduct of patients and colleagues, and the complete avoidance of any motive of profit that might influence the free and independent exercise of professional judgement (my emphasis). The following practices are deemed to be unethical conduct: Self advertising unless permitted by the laws of the country and the Code of Ethics of the Craft Association, and the paying or receiving of any fee or of any other consideration solely to procure the referral of a patient for prescribing or referring the patient to any source.
4.31 by those ethical principles emphasised in the Belmont Report of 1979112
and be in accord with the NHMRC's113 National Statement on Ethical Conduct and Research Involving Humans. Also the clinical investigation of surgical devices should conform to European and other
International Standards114. Standards are particularly important if it can be appreciated that the clinical trial of any surgical innovation is no more or less than an experiment. In any trial of surgically implantable devices the subjects will undergo treatment for their pathology in what should be seen as a well organised dry run that is conducted in an environment that is generally not very different to that environment associated with the market place that is the objective of the manufacturer.
4.50 For many reasons it should be evident that, in terms of civil liability, the legal duties owed by researchers in any drug or device trial are considerable. Matters relating to the exposure of liability of researchers who undertake clinical trials have been considered in depth by Natasha Cica in her Working Paper presented to the Australian Institute of
Criminology in June 1994.115 In that presentation, Cica, emphasises that, in terms of civil liability, the legal duties owed by researchers can be classified under three headings –
(i) Liability in battery; (ii) Liability in negligence; and (iii) Liability for disclosing confidential information.
112 The Belmont Report 1979 commends that the undertaking of surgical research should be guided by those three ethical principles, respect for persons, beneficence and justice. The principle of beneficence includes the general surgical principal of do no harm and that there should be a maximisation of potential benefits that must be joined by the minimisation of risk. It is fundamental that surgical clinical research and clinical trials must be accompanied by an acceptable balance of potential benefits and risks. Respect for persons, requires there to be informed consent and confidentiality and the Principle of Justice requires that the benefits and burdens of participation in research should be distributed equitably. For further information see National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research”, (1979) OPRR Report, 1-8. 113 National Health & Medical Research Council, “National Statement on Ethical Conduct In Research Involving Humans”, NHMRC, Canberra, 1999. 114 At this time there are two standards that apply to the clinical investigation of medical devices. These are the European Standards EN540: 1994 EC Harmonised Standard and the International Standard, ISO14155: 1996, International Standard. The International Standard is not entirely adopted but it was revised in 1998 and later harmonized with a revised EN540. As a consequence ISO EN14155 will replace EN540 as the EU Harmonize Standard. There is now a more comprehensive in-depth standard with approved ethical and scientific foundations that includes updated terms and definitions, more detail with regard to responsibilities and methods, detailed guidance on literature review and detailed requirements for any clinical investigation plan. 115 Natasha Cica, “Civil Liability Issues Associated with a Heroin Trial - Feasibility of Research into the Controlled Availability of Opioids Stage II” (1994) Working Paper No 11, Australian Institute of Criminology, 1-23.
4.32 Liability in battery116 arises out of a touching of another person without that person’s legally valued consent and liability in negligence requires that a claimant must be able to demonstrate those four (4) essential
elements that have already been discussed in Chapter 3.117 Any
discussion of liability for disclosing confidential118 information centres on
the Privacy Act 1988 (Cth)119 and in NSW, the Health Records and Information Privacy Act 2002 (NSW) and the Privacy and Personal Information Protection Act 1998 (NSW).
4.51 Clinical trials of implantable surgical devices will generally include large
numbers of volunteers who should have been made very aware120 of any risks associated with the investigations. The clinical trial of surgically implantable devices must require that those who become involved do so only in the knowledge that agreement to participation is a reasonable choice that has been based upon a foundation of informed consent. It should be implicit in the ethical basis for any clinical trial that all of the participants must have an understanding of the possible benefits and of the possible risks of harm that might be exposed by the trial. Even in the event that the development of a new implantable device may be considered as just a modification of similar devices that are already in use is no less a reason for ensuring that informed consent is given and that the protection of the welfare of individual patients is maintained.
116 Battery is a form of trespass that is an intentional act that is associated with physical body interference without lawful justification or consent. Battery can be actionable per se without proof of damage – see Collins v. Wilcock [1984] 1 WLR 1172. Emergencies apart, to which the defence of necessity applies, and where there may be incapacity through intellectual disability, medical treatment that includes the direct touching of an individual’s body without that person’s consent is a battery. This includes also those cases where a different treatment is undertaken from that to which consent may have been given – see Murray v. McMurchy [1949] 2 DLR 442 (British Colombia SC) and Rogers v. Whitaker (1992) 175 CLR 479; 109 ALR 625 (HCA). 117 See ¶ 3.18-3.32. 118 Confidentiality is a different concept from privacy. Where confidentiality focuses on disclosure, privacy focuses on the collection of information. The current version of the Australian Medical Association’s Code of Ethics (2003) does acknowledge that it may be permissible for a medical practitioner to disclose personal information about a patient only “where there are overwhelming societal interests”. This is clearly a broader justification for breaching confidentiality than is permitted by the law. 119 See the Privacy Act 1988 (Cth) – the National Privacy Principles (NPPs) in Schedule 3 to the Act and the Information Privacy Principles (IPPs) in s.14 of the Act cover the collection, storage, security, use and disclosure of personal information. The NPPs apply to private organisations and individuals and the IPPs applies to Federal Government Agencies. There is also the National Health and Medical Research Council (NHMRC), National Statement on Ethical Conduct in Research Involving Humans, June 1999. See also Guidelines approved under the Privacy Act 1988 (Cth), s 95A, December 2001. 120 In Ch 7 we have discussed the doctrine of informed consent. Obtaining informed consent is now as routine for a clinical practice as it is for research. In both, the primary focus of informed consent is disclosure of risk. This is so, not only in a medical context, but also in a legal context. For further information see N Moumjid and MF Callu, “Commentary: Informed Consent and Risk Communication in France” (2003) 327 BMJ, 734-5.
4.33 True informed consent is particularly essential in the event that a new device may not be better than that which is currently used. Herein there can be a potential conflict of interest between a surgical innovator and the patient. Failure to perform a clinical trial that is designed to identify whether or not a new device actually provides benefits to patients is a
strong argument for applying the regulatory ethics paradigm.121 Ideally a randomised trial should be undertaken and the widespread use of any new device should be delayed until the indications, problems, and adverse events have been identified. Randomised trials of surgical
devices though are not common122 and in orthopaedic surgery it remains the case that novel designs of hip prostheses may still enter the market
place with only limited evaluation of their clinical performance123. Dent
et al124 maintained that –
“… follow up is commonly too short to show how often conditions relapse or late complications arise. Patients in evaluations are sometimes highly selected and the researchers are particularly skilled pioneers, limiting the results generalisability and making reporting bias a concern. Particularly important is the fact that evaluations often have too few patients to detect important but less frequent complications of the procedure.” Dent et al also observe (my edit) “that clinicians working in settings less favourable than those from which major series have been reported will have to climb the learning curve and may not even then achieve such good results. Furthermore procedures evolve and change appreciably, particularly when they are new.”
Michael Lawrence-Brown125 has further stressed the influence of any rapid development within a [surgical] speciality that causes the outcomes of interventions to be greatly dependent on the standard of the skills of
121 See Editorial, “Ethics and Innovation in Medicine” (2001) 27 J Med Ethics, 295-6. This Editorial discusses the ethical standards that are approved by an Institutional Review Board that are fundamental to protect patient welfare. The Editorial also questions as to whether or not the safeguards associated with what is described as the regulatory ethics paradigm are necessary in every case particularly in the event that the new implantable device, say a total hip replacement arthroplasty device, is considered as just a modification of similar devices that are already in use. 122 A Foulkner, LG Kennedy, K Baxter, J Donovan, M Wilkinson and G Bevan, “The Effectiveness of Hip Prostheses in Primary of Total Hip Replacement: A Critical Review of Evidence and an Economic Model” (1998) 2 Health Technol Assess, 6. 123 T Dent, S Wortley and B Campbell, “New Interventional Procedures – Unlike Drugs are Implemented Despite Paucity of Evidence” (2004) 329 (7456) BMJ, 4. 124 See vide supra n.123. 125 Cited by RACS College Media Office, “Speciality Update – Vascular Technology Spearheading Vascular, Cardiac, Interventionalist ‘Super Speciality’” (2004) 5 (9) Surgical News of the Royal Australasian College of Surgeons, 9.
4.34 the interventionalist and that “[vascular] surgeons need to match those standards from different disciplines at the intersects of management and interventions”. There is no doubt that the introduction of new technology and the undertaking of new surgical interventions can be associated with heightened obligations for surgeons [and manufacturers].
Gorton126 has drawn the attention of surgeons to these obligations in his
discussion of that recent case127 in Western Australia that highlights those problems that are specific to “new or experimental practices”. In his
dissection of Hall v. Petros128 Gorton identified a number of important issues and questions that included;
(i) “New clinical trials report regularly on advances and doctors must, in their practice, utilise the best available medical knowledge and techniques in the care of their patients. (ii) When does a new technique become accepted and expected practice? (iii) What are the obligations to explain to patients the risks of new or experimental practices, - particularly when results may be exceptionally good? (iv) [What, if any, are the consequences when there are no independent studies of a new surgical intervention particularly when the] more common gold standard procedure is different. (v) [The issue of whether or not a new surgical intervention or technology is supported by a body of evidence of] respected practitioners. (vi) [New surgical interventions and technology demand a higher standard for the warning of material risks and with regard to the warning of the] risks and benefits of alternative treatments. [Gorton emphasised that] inherent in a new procedure is a heightened obligation to inform the patient – both of the risks involved in the new procedure and the alternative procedures available. (vii) [Patients should] also be given the choice of alternative procedures, and the benefits and risks of the alternatives, with full information”.
126 M Gorton, “Keeping up to Date – New Techniques” (2004) 5 (9) Surgical News of the Royal Australasian College of Surgeons, 7. See also Nettleship v. Western [1971] 2 QB 691 – here it was demonstrated that those who are learning a skill must exercise the same standard of care as those who are already proficient in that skill. 127 Hall v. Petros (2004) WADC 87 (27 May 2004) – this case involved the use of a relatively new procedure – intra vaginal sling plasty (IVS). 128 See vide supra n. 126.
4.35 In concluding his report, Gorton identified 2 other important conclusions;
(i) [In the event that a new technique and new procedure proven to be successful then] “new techniques and new procedures should be utilised. [Gorton continued] There are even cases where it may be negligent not to adopt the new procedure or new technique even though it is not universally common practice within the medical profession. (ii) [It is important that the decision in Hall v. Petros] should not deter doctors from exploring new techniques and new procedures”.
4.52 Pre-market clinical trials and post-market surveillance (PMS) programs include the in-vivo observation of the performance of the surgically implanted device that is not only vital for marketing purposes but is also fundamental to the achievement of compliance with requirements of regulatory bodies such as the TGA. The TGAct and the ancillary regulations set out those requirements that are known as the essential
principles129 for the safety and performance characteristics of medical
devices130 and those requirements that are known as conformity
assessment procedures.131 Compliance with the requirements of competent authorities, such as the TGA, the FDA, or the MDA, is
complex.132 As is also the case with therapeutic drugs and other pharmaceuticals, safety and performance of any implantable surgical
129 See Ch 3 ¶ 3.62-3.67. There are fourteen essential principles: x 6 - general essential principles for all devices; x 6 - essential principles that are technology specific; x 1 - essential principle that refers to information provided with a device; and x 1 - essential principle that relates to previous clinical evidence. 130 See TGAct ss.41BA (Requirements for Medical Devices), 41CA (Essential Principles), 41BH (Meaning of Compliance with Essential Principles), 41CB (Medical Device Standards), and 41MA (Non-compliance with Essential Principles). 131 See TGAct s.41DA (Conformity Assessment Procedures). 132 In the past, in Australia, compliance with TGA requirements has not always been so complex nor difficult. The introduction of ceramic materials, porous coated devices, bioactive hydroxy apatite materials and such devices as Isoelastic implant devices was not preceded by any process of compliance with any regulatory requirement. The clinical experience with these implants was undertaken at a time when the devices were demonstrably not approved by the FDA, in the USA, for general use. Indeed a number of orthopaedic implant devices, designed and manufactured in the USA, and designed for insertion without the need for fixation to be provided by orthopaedic bone cement (polymethylmethacrylate cement) were clearly labelled "Not For Use Without Bone Cement", when the intention known to all surgeons using the device, was that the implant was intended to be fixed to the skeleton without the use of orthopaedic bone cement so as to permit fixation by means of osseo-integration. A classic example of this is the Tricon M® total knee replacement implant. There is little doubt in this regard that the use of uncemented implants has, worldwide, been very much a consequence of the widespread use of these implants in Australia at a time when regulatory requirements were such that there was no regulatory, legal or clinical impediment to the use of those implants in large numbers.
4.36 device must be demonstrably supported by the completion of authorised and authoritative clinical trials and PMS programs. The ultimate goal of any manufacturer is to satisfy the requirements for the mandatory CE
marking of products.133
4.53 The CE Mark indicates that a manufacturer is satisfied that the surgical device conforms with the relevant essential regulatory requirements and that the device is fit for its intended purpose. The CE Mark is further seen as evidence that the device meets all of the appropriate provisions of the relevant legislation including all those that relate to safety. As a result of the global harmonising of the regulations that relate to surgically implantable devices it is the case that the CE Mark will permit the manufacturer of a product to freely market the product in those countries that have adopted the European Community Directives as the
basis for implantable surgical device legislation and regulation.134
4.54 There is inevitably a requirement for industry, wherever possible, to fast track clinical experience in order to facilitate the early achievement of those conformity assessment requirements that might be obligatory for Australian regularity authority approval and product registration on the ARTG. For this reason clinical trials have frequently been funded by manufacturers and undertaken in a number of countries worldwide as distinct from only in the country where regulatory approval is sought. Some of these countries may be selected, as indeed may be the institution, not only for their scientific expertise but for other reasons that might enable and facilitate a speedy generation of clinical experience of great numbers. The less regulated but scientifically advanced environment will be the least complicated and best environment for the
133 The CE marking of products is mandatory, except for certain specific exclusions that include custom-made devices, devices undergoing a clinical investigation, and in-vitro diagnostic medical devices (IVDs) for performance evaluation. Although custom- made devices are exempt from carrying the CE Mark, custom-made devices and devices intended for clinical investigation must conform with all the relevant essential requirements and manufacturers are required to draw up a Statement of Compliance that is subject to the control of the National Competent Authority. For further information see the European Medical Devices Directive - 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. 134 There are three European Directives concerning medical devices and the Directives replace any existing national systems in member states of the global harmonising group. See the Active Implantable Medical Devices Directive (90/385/EEC); The Medical Devices Directive (93/42/EEC); as amended in Directives 2000/70 and 2001/104 on Medical Devices incorporating Stable Derivatives of Human Blood or Human Plasma; the In-Vitro Diagnostic Medical Devices Directive (98/79/EEC). See Ch 3 n.21.
4.37 achievement of the desired clinical experience. European and Australian locations are attractive to manufacturers of surgically implantable devices as clinical trials can be facilitated by fewer delays in approval,
easier ethical compliance and less cost.135 For a manufacturer the early penetration of the market place by a new device will permit a quicker return on investment and it may be the case that financial gain can be placed ahead of the interests of the patient. There are many examples of implants that have seen service in Australia for a considerable number of years that have only recently been granted pre-market approval by the
FDA for surgical implantation in North America136. Notwithstanding the recent legislative reform and changes to the regulatory system in
Australia137 there has so far been no great evidence that current regulations for pre-market approval, for post market surveillance (PMS), for third-party review options, for device tracking and reporting methods, and for the use of international standards and performance standards has significantly improved. There is though concern that if the TGA is more proactive, as distinct from reactive, then the burden on manufacturers (and sponsors) will be far more onerous than has been the case in the
past.138
135 America is the major manufacturer of orthopaedic implant devices and as long ago as 1995 the Wilkerson Report identified that "More than 60% of medical device companies plan to market off-shore products that are not available in the USA. More than 90% of these companies cited USA product review requirements as the reason for introducing products overseas first. These companies must generate early cash flow from European (and Australian - my edit) markets in order to fund the more costly and time- consuming approval and commercialisation requirement in the USA." See The Wilkerson Group Inc. New York, “The Wilkerson Group Forces Reshaping the Performance and Contribution of the US Medical Device Industry” (1995) 26-34. 136 Susan M Rapp, Editorial, “FDA Grants Pre-market Approval for Trident Ceramic Acetabular Insert” (2003) Orthopaedics Today. The FDA approved the pre-market approval application of Stryker Howmedica Osteonics-patented trident ceramic acetabular insert. The approval makes this ceramic-on-ceramic hip replacement system one of the first available for use in the United States. The FDA approval, which was originally expected in the Year 2001, and at subsequent time points, was delayed until inspection of the German manufacturing facilities of CeramTec AG, supplier of the ceramics used in the Trident insert, could take place. Susan Rapp further reported that ceramic-on-ceramic articulations have a long track record of use in total hip replacement (THR) systems in Europe, Australia and Canada. The Trident Ceramic Acetabular system had been available in Europe and Australia since 1998 and was only, in March 2002, approved for sale in Canada. Stryker Howmedica Osteonics is the orthopaedic implant division of the Stryker Corporation, in Kalamazoo, Michigan. In the same newsflash William N Capello, MD, described as another investigator advised that he was offering the Trident ceramic-on-ceramic bearing to younger patients and (to) those very young patients either with juvenile rheumatoid arthritis or underlying medical problems. It will improve my practice tremendously – Dr Capello is a paid consultant for Stryker Howmedica Osteonics. Dr Capello is Professor of Orthopaedic Surgery at Indianna University School of Medicine in Indianapolis. One of the lead investigators for the Trident US clinical study was Associate Professor James d’Antonio, MD. – Associate Professor of the University of Pittsburgh. 137 Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth), the Therapeutic Goods (Charges) Amendment Act 2002 (Cth) and the Therapeutic Goods (Medical Devices) Regulations 2002. See also State and Territory Tort Law Reform following the Ipp Report (2002) and Reform to the TPA that are included in the Trade Practices Amendment (Personal Injuries and Death) Bill( No 1) 2003 and Trade Practices Amendment (Personal Injuries and Death) Bill (No 2) 2004. 138 Personal communication - Trevor Jones, Royal Perth Hospital, Department of Bioengineering and Medical Physics, 12 August 2004.
4.38 4.55 The undertaking of clinical trials is gradually becoming more regulated to ensure that there is ethics committee approval, that academic freedom is preserved, that the source of funding does not engender bias or a conflict of interest, and that the rights of patients and the public interest are not compromised. There should be no valid criticism of this though a
recent editorial139 in the Journal of The Royal Society of Medicine warned that:
"The red tape involved in getting clinical trials off the ground [in the United Kingdom] might stretch from London to Helsinki, and a recent European Union Directive means that it could soon take a tour of Brussels on the way back".
4.56 In contrast to the clinical trial of a drug, the trial of a surgical device can
only rarely include the observation of control groups.140 Also with specific regard to the implantation of surgical devices, it is all but
impossible to undertake a randomised or double blind141 clinical trial. For
these reasons surgical trials are inevitably associated with risk142 and their
results can be seriously exposed to question.143
4.57 Any clinical trial can present the participants with a variety of risks. As we have already observed a view can be taken that a clinical trial is nothing more or less than a surgical experiment and it may be that the
139 Editorial, “Clinical Trials and Tribulations” (2004) 97 (3) J Roy Soc Med, 101-2 - this Editorial discussed Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials of medicinal products for human use. See office of European Communities 2001:L121:34-44. See also S Mayor, “Squeezing Academic Research into a Commercial Straitjacket” (2004) 328 (7447) BMJ, 1036. 140 Sham surgical procedures are far from ethical. See R Macklin, “The Ethical Problem with Sham Surgery in Clinical Research” (1999) 341 N Eng J Med, 992-6 and S Horng and FG Miller, “Is Placebo Surgery Ethical?” (2002) 347 N Eng J Med, 137-9. 141 At the present time there are three basic methods for the study of drug or implant performance. These include randomised clinical trials, meta-analyses, and retrospective case series. 142 The phenomenon of risk is discussed in ¶ 4.19-4.28. See also PA Clark, “Placebo Surgery for Parkinson’s Disease: Do the benefits outweigh the risks?” (2002) 30 J Law Med Ethics, 58-68. 143 See WJ Maloney, “National Joint Replacement Registries (NJRR). Has the Time Come?” (2001) 83A (10) JBJS, 1582-85. Maloney further emphasis other significant problems associated with the clinical trial of a surgical device that include: (a) The use of any new surgical device can embrace a learning curve that includes a surgical learning process that is not formalised nor necessarily policed; (b) The surgery associated with the clinical trial may be performed by the inventor and this can introduce potential for bias; (c) Centres of Excellence include the experience of sub-specialised experts that do not necessarily reflect that of the general surgical community; and (d) As prospective randomization of the clinical trial is not practical in the evaluation of surgically implantable devices it is inevitable that a degree of retrospective judgement persists with the derivation of conclusions.
4.39 research volunteer who is injured may resort to a claim for compensation in negligence, or if appropriate in contract. In the event of there being an adverse event in a clinical trial it can be difficult for a research subject, who as a volunteer, and possessed of the cloak of willingness, to prove that a manufacturer, or clinical investigator, is at fault. Causation in such cases can be extremely difficult to establish. It can be extremely difficult
for a research subject to prove fault.144 Research by its very nature examines the unknown, and adverse events, though undesirable, can
unpredictably occur even when all reasonable care has been taken145. Notwithstanding this a manufacturer sponsoring a clinical research program or trial can be exposed to liability in the event that there has been a failure to identify a discoverable risk, to communicate this information to the investigator, or to choose an individual or institution that has appropriate skills, experience and adequate resources to undertake the clinical trial in a proper manner.
4.58 In Australia, institutional ethics committees, in their review of research protocols, do require that there is significant protection for the subjects of research from product-related injury. Furthermore, and notwithstanding all of this, Ethics Committees generally will have reinforced the imperative that the healthcare professional who undertakes a clinical trial does remain aware of ethical obligations towards the patients who
participate in these studies.146
144 In the United Kingdom, the Pearson Commission concluded that there is need for some defined method of compensation as a right to those participating in research and the Commission favoured strict liability as there were insufficient grounds for introducing no-fault compensation schemes. See report of Royal Commission of Civil Liability and Compensation for Personal Injury (Cmnd 7054) at 1341, Chaired by Lord Pearson, presented January 1978. 145 Too frequently the report of results of the clinical trial of a new surgical intervention or technology are qualified in terms of an association with the “learning curve” that is the bedfellow of new therapeutic activities. The “learning curve” is a phenomenon that is associated with the reporting of improved results as the therapeutic program progresses in association with the improved modified procedure or improved skills of the provider. The phenomenon of the learning curve represents a significant risk to any participant in a clinical trial and to those that may be amongst the first to undergo any new interventional procedure. 146 Recommendations guiding physicians in biomedical research that involves human subjects is to found in the Declaration of Helsinki (Revised 1996). The original Declaration of Helsinki was introduced in 1964 and superceded the International Ethical Declarations that were drawn up in the form of the Nuremberg Code in 1949 in response to the atrocities perpetrated by the Nazi regime scientists.
4.40 4.59 The conduct147 of, and the funding148 of clinical trials has too frequently been cause for criticism of the relationship between those undertaking the research and the manufacturers of the devices under investigation.
Where Government funding for research is not available149 manufacturers can find real incentive to fund evaluations and the private support of a manufacturer of a surgical device can have the potential to influence the
research and to engender a serious conflict of interest.150 It was George
Bernard Shaw who described this potential so well151 -
"That any sane nation, having observed that you could provide for the supply of bread by giving bakers a pecuniary interest in baking for you, should go on to give a surgeon a pecuniary interest in cutting off your leg, is enough to make one despair…"
4.60 Naturally, much will depend upon how any research grant for a clinical trial is provided. In Australia, healthcare and academic institutions require full disclosure of the source of research funding and there is generally an agreement that results of research will be reported regardless of the outcome of that research. This is all very necessary if
academic freedom and scientific integrity is to be preserved.152 There is
147 See JH Tanne, “Better Standards Needed for Industry-Sponsored Clinical Trial, (2002) 325 BMJ. In this article Tanne cites three papers in the New England Journal of Medicine that highlight the problems of academic freedom and scientific integrity in agreements between Medical Schools and industry sponsors who pay for many clinical trials. Tanne further observed the partnerships between industry and academia will lead to clinical advances only if academic freedom is preserved. The case of Canadian researcher, Dr Nancy Olivieri, is reported. Dr Olivieri was sued after she presented unfavourable results of a drug trial for which she had signed a Confidentiality Agreement. 148 In May 2004 a new European Directive on clinical trials took effect with the aim of ensuring that the approval of monitoring of clinical research in different countries in Europe would be harmonised. The Directive would also require more complex monitoring of adverse reactions to study treatments and verification of data in which the sponsor's role cannot be delegated to trial investigators. The response to the new EU Regulations has not all been favourable and Professor Rory Collins, of the British Heart Foundation and Professor of Medicine and Epidemiology at the University of Oxford is reported to have observed that "the bureaucratic hurdles and extra cost will have a destructive effect on clinical trials". For further information see S Mayor, “Squeezing Academic Research into a Commercial Straitjacket” (2004) 328 (7447) BMJ, 1036. The pharmaceutical industry in the United Kingdom spends £3.3bn annually on research and finances about 90% of all clinical drug trials. See RE Ferner, “The Influence of Big Pharma” (2005) 330 (7496) BMJ, 855-56. Ferner also observes that this massive funding of clinical research by the industry permits the industry to influence the interpretation or reporting of results of trials. Negative results can be dismissed as erroneous (“failed trials”), whereas positive ones can be published repeatedly in different guises. 149 I Chalmers, C Rounding and K Lock, “Descriptive Survey on Non-commercial Randomised Controlled Trials in the United Kingdom 1980-2002” (2003) 327 BMJ, 1-4. The authors observed that clinical trials, particularly those which are not commercially funded, are fast becoming an endangered species. 150 It is for this reason that almost all reputable Peer reviewed Journals require authors of manuscripts accepted for publication to declare any Conflict of Interest. Without such a declaration the article accepted for publication will not be published. 151 GB Shaw, Preface on Doctors. The Doctors Dilemma: A Tragedy, (1913), cited by MA Rodwin, “Financial Incentives for Doctors” (2004) 328 (7452) BMJ, 1328-29. Rodwin is Professor of Law at the Suffolk University Law School, Boston, USA. Professor Rodwin's Paper identifies those main problems that are attracted by incentives. 152 See JH Tanne, “Better Standards Needed for Industry Sponsored Clinical Trials” (2002) 325 BMJ, 985 - Tanne reviewed three papers that had been reported in the New England Journal of Medicine that highlighted problems of academic freedom and scientific integrity in agreements between medical schools and industry sponsors who pay for many clinical trials. See also N Engl J of Med, (2002) 347, 1335-41.
4.41 no doubt that commercially funded research can be associated with
positive outcomes.153 In a sample of randomised clinical trials published in the British Medical Journal from January 1997 to June 2000 it was found that the author’s conclusions were positively associated with
financial competing interests.154 The growing awareness of these problems and the nervousness engendered has been causal for their to be new guidelines aimed at increasing the transparency and encouraging the
responsible and ethical reporting of industry-sponsored clinical trials.155 Clinical trials in Australia are for the most part, undertaken ethically and
with adequate scientific scrutiny and it is the exceptional case156 where it
is difficult to distinguish the good oil from the snake oil157 and the rarer
153 Seth S Leopold, MD, of the University of Washington Medical Centre in Seattle reported at a presentation at the Annual Meeting of the Academy of Orthopaedic Surgeons in Dallas, 2002, that "Receipt of funding from a commercial interest was the only study variable [we] found that was significantly associated with positive outcomes." In this study two blinded investigators reviewed 315 articles published in the American Edition of the Journal of Bone and Joint Surgery, the Journal of Arthroplasty and the American Journal of Sports Medicine over a period of one year. The investigators identified that 79% of industry-funded orthopaedic studies had positive outcomes. By comparison, only 63% of studies not commercially funded had positive outcomes. See also report by L Koury, “Commercial Funding Effects Research Outcomes” (2003) 6 (3) Orthopaedics International, 24. See also KA Ezzet, “The Prevalence of Commercial Funding in Adult Lower Extremity Orthopaedic Research and its Impact on the Reporting of Scientific Results”, presented at the American Academy of Orthopaedic Surgeons, 70th Annual Meeting, New Orleans, February, 2003. Dr Ezzet and his colleagues identified a dramatic difference in outcomes between commercially and self-funded results regarding total knee replacement procedures. They reported "There were no bad results in the clinical series on total knees among funded authors, whereas half the non-funded papers had a bad conclusion." Dr Ezzet and his colleagues reviewed all 2001 issues of the Journal of Bone and Joint Surgery (American and British Volumes) and the Journal of Arthroplasty, as well as all papers that were presented at the American Academy of Orthopedic Surgeons and at the American Association of Hip and Knee Surgeons' meetings in the same year. The data base included 603 presentations that related to adult lower extremity orthopaedic reconstruction surgical procedures. Studies were reviewed for commercial sponsorship, financial relationships, country of origin, nature of study and the conclusions. In the United States, 75% of all clinical hip replacement series were commercially funded. This compared to none in Japan and Korea. Financial relationships were also found to be prevalent in Canada and in the United Kingdom. Among funded studies on total hip replacement, good results were reported in 96% of events. Dr Ezzet observed that this was twice as often as in non-funded studies. Only 22% of the funded studies reported bad outcomes, where 60% in non-funded studies had a bad or mediocre report. In regard to in vitro laboratory studies Dr Ezzet and his colleagues also found that 93% of funded studies reported good results as against 33% of non-funded studies … "among laboratory studies of implants, 9% of non-funded studies reported good results vs. 67% of funded studies." Ezzet concluded "…I don't think that we can say that the funded doctors are simply a better group of surgeons. I think it is safe to say our current body of literature is strongly biased. Rather than banning these types of relationships, we need to foster an environment that allows more independent research to provide balance." 154 See LL Kjaergard and B Als-Neilsen, “Association between Competing Interests and Author’s Conclusions: Epidemiological Study of Randomised Clinical Trials Published in the BMJ” (2002) 325 BMJ, 249-52. 155 These guidelines have been published - see Editorial, (2003) 19 Current Medical Research and Opinion,149-54. This is a peer reviewed national journal that focuses on evidence-based clinical studies, research investigations and experimental treatment. Although not commissioned by industry itself, the article presents the first set of guidelines developed by members of the industry (as well as Journal editors and academics) for the industry itself. The "Good Publication Practice" guidelines seek greater transparency by addressing two main themes: Publication Bias and the Relationship Between Companies and Academic Investigators. However the guidelines are voluntary and aspirational rather than obligatory, and there is, at this time, no mechanism for policing the guidelines. For further reading see D Singh, “Drug Companies Advised to Publish Unfavourable Trial Results, (2003) 326 BMJ, 1163. 156 With a contrary view, Annelle Tuffs of Heidelberg, in BMJ, (2004) 328 (7438), cites a study by Arznei Telegramn (2004) 35 Drugs Bulletin, 21-3, that demonstrates that about 94% of the information sent by drug companies to General Practitioners in Germany is not supported by scientific evidence. Only 6% of the information was scientifically supported by identifiable literature. This study was undertaken by the Institute for Evidence-Based Medicine in Cologne. The study evaluated 175 brochures containing information on 520 drugs that were distributed to 43 General Practitioners. 157 “Active promotional campaigns that heralds the launch of a new drug, NPS News (National Prescribing Service Newsletter) December 2002, 25.
4.42 case when authors or speakers are judged to be purveyors of carbolic
smoke balls.158
4.61 In Australia, the potential for the generation of a conflict of interest should be considerably less than is, for example, the situation that now exists in the United States. This is in part due to the fact that surgical devices are mostly imported into Australia - in contrast to being manufactured in the USA. For example, less than 5% of surgical devices that are implanted in Australia are actually manufactured in Australia. This is though a reason for the creation of other special problems that will reflect the very different jurisdictions that might become involved
following the occurrence of any adverse event.159 It is also the case that the funding of R&D is better structured in Australia. Brief mention has already been made to the fact that there are a number of sources for the procurement of R&D funds. It certainly is the case that there are well structured opportunities for research funds to be derived from the
NHMRC160 and from the Australian Research Council (ARC).161 There are also more structured arrangements for partnership and infrastructure grants from other organisations. These arrangements permit research funds to be derived from co-operatives that include Universities,
Government and private organisations.162
158 See Carlill v. Carbolic Smoke Ball Co [1893] 1 QB 256. The defendants, the proprietors of a medical preparation called "The Carbolic Smoke Ball", issued an advertisement in The Pall Mall Gazette of November 13, 1891, in which they offered to pay a fee to any person who contracted influenza after having used one of their Smoke Balls in a specified manner and for a specified period of time. The plaintiff on the faith of the advertisement bought one of the Balls, and used it in the manner and for the period specified, but nevertheless contracted influenza. Hawkins J held that the facts established a contract by the defendants to pay the plaintiff a sum of money in the event which had happened; such contract was neither a contract by way of wagering….and that the plaintiff was entitled to recover (my edit). 159 The importer might be obligated to pay compensation to the injured party, with recovery from the overseas manufacturer or supplier, under strict liability. Where possibly, under fault liability the importer might be exposed with regard to patent defects rather than with matters relating to those aspects of device development which are concerned with ensuring the safety of the device. 160 For further information see online: www.nhmrc.gov.au. 161 The ARC has since July 2001 been a statutory agency under the Public Service Act 1999 (Cth) and a prescribed agency under the Financial Management and Accountability Act 1997 (Cth) as well as having statutory responsibilities under the Australian Research Council Act 2001 (Cth). The Chairman (announced 12/11/2002) of the ARC is Mr M A (Tim) Besley A.C. In his media release of 29/01/2002, Dr Brendan Nelson, MP, Minister for Education, Science and Training, announced the Commonwealth Government's Statement on Innovation Backing Australia's Ability, and directed the ARC to allocate at least 33% of funding in the year 2003 to four main priority areas that included Nanomaterials and Biomaterials representing good health and frontier technologies. The announcement demonstrated the Federal Government's major commitment to supporting innovation and research. The average allocation for collaborative research in 2001 was $130,879, in 2001 $163,145 and in 2003 $178,762 - an increase of 36.6% over a three year period. 162 Private organisations that fund R&D include venture capitalists, individual philanthropists, and organisations such as Rotary and Apex to mention just a few. A funding of clinical trials though is another matter. These are predominantly funded by the manufacturers of therapeutic goods and devices.
4.43 4.62 Following the satisfactory completion of R&D and clinical investigation the manufacturer, or sponsor, is then positioned to make a formal application to the TGA for the particular device to be entered on to the
ARTG.163 The approval, or otherwise, of the TGA with regard to
registration of a surgical device is discussed in detail in Chapter 3164.
4.63 I have formed the view that clinical trials are cardinal events that will permit or prevent the use of any implantable surgical device in humans. The considerable significance, and the complex nature, of clinical trials in any surgical implant development program has caused me to conclude that benefit might be derived from a statutory requirement for the
compulsory registration165 of all clinical trials. Resistance to the concept
that clinical trials should be registered is probably inevitable166 and
registration may even be regarded by some as a threat to research.167 Also I have a view that there may be occasions when the results of a clinical trial will not measure up to the expectations of the clinician and/or of the manufacturer and in such cases there can be an incentive to
avoid the reporting of results of the trial. This is a form of misconduct168
that can distort the direction of scientific endeavours. Ian Chalmers169 stressed that under-reporting can be a cause for patients to suffer harm. Chalmers stated that -
"By suppressing negative findings and exaggerating positive ones, by down playing harms and talking up benefits, health care decisions [can be] based on incomplete data and ultimately harm the patients."
163 Australian Register of Therapeutic Goods (ARTG). See Ch 3, n.251. 164 See Ch 3, ¶ 3.87-3.95. 165 The case for registering all clinical trials was first advanced more than a decade ago. The reader is referred to RJ Symes, “Publication Bias; Case for an International Registry of Clinical Trial” (1986) 4 J Clin Oncol, 1429-41. See also K Woods, “Implementing the European Clinical Trials Directive” (2004) 328 BMJ, 240-1. 166 See R Horton and R Smith, “Time to Register Randomised Trials” (1999) 319 BMJ, 865-6. In this paper it is evident that five years of industry resistance, government impotence, and public confusion followed Horton & Smith's recommendations (in 1999). 167 R Nicholson, “Another Threat to Research in the United Kingdom - Research Ethics May be Unable to Function Because of Political Control” (2004) 328 (7450) BMJ, 1212-13. 168 See John Braithwaite, Corporate Aim in the Pharmaceutical Industry (1984) 56-7. Braithwaite cites many examples where the results of trials have been concealed by drug companies and where there has been misrepresentation of dangerous effects noted by their own investigators. Braithwaite observes that most fraud in clinical trials is unlikely to even be detected (at 54). Notwithstanding this, during the period 1977-1980, the United States Food and Drug Administration identified 62 doctors who had falsified or manipulated clinical data (at 53). See also I Chalmers, “Under Reporting Research is a Scientific Misconduct” (1990) 273, 1405-8, cited by K Abasi, “Compulsory Registration of Clinical Trials” (2004) 329 (7467) BMJ, 637-38.
4.44 As we have already observed, surgical clinical trials are inevitably associated with some degree of risk and they are nothing less than experiments of new or improved surgical interventions. The undertaking of clinical trials should demand some measure of regulation that is designed to protect the well being of individual participants and the community at large and to preserve the independence and scientific integrity of those that undertake the clinical trials. In all of this there must be an endeavour to avoid any unhealthy influence that might be more pecuniary than therapeutic. It can also be argued that a register of clinical trials might permit other stakeholders to become aware of that which is good and that which may not be demonstrated to be associated with benefit, or worse still shown to be associated with a potential for harm.
ADVERTISING
4.64 Surgeons acquire knowledge from a variety of sources that include textbooks, journals, the attendance at scientific meetings and workshops, from the internet, from continuing medical education (CME) programs and from informal corridor discussions with colleagues. Surgeons also rely heavily on the information that is provided by the manufacturers and
distributors of implantable surgical devices170. Advertisements171 are frequently published for surgical products where there are claims by manufacturers of clinical and scientific fact. Unfortunately it remains the case that too frequently these advertisements are poorly supported by scientific data and there can even be found evidence of exaggeration of
the results of research and clinical trials.172 It is unfortunately also the case that much of the information provided may not have been exposed to peer review, may never have been formally evaluated, and as a result
169 See vide supra n.149. 170 MD Chapman, “Education in Orthopaedic Trauma” (1997) 339 Clin Orthop, 7-19. 171 Part IVA of the TGAct concerns advertising. In s42B there is the definition of approval number, approved advertisement, mainstream media, and publisher. TGAct s42C and s42D concern those offences relating to publication of advertisements and those offences relating to publishers respectively.
4.45 the information can have the potential to be misleading or even
deceptive.173 The lessons to be learned from all of this are that there should be greater diligence by manufacturers in substantiating their claims and greater vigilance among members of the medical profession
when reading them.174
4.65 Manufacturers produce volumes of promotional material that is intended to serve the purpose of advertising and as information for health care professionals. Though advertising is mostly directed for the attention of medical practitioners it is the case that much of the information is increasingly becoming available on-line and in the event can become readily available to consumers. In the event it is particularly important that manufacturers avoid the publication of promotional information that
might be misleading or deceptive175 as consumers can be greatly influenced by marketing material and by the representations made.
172 T Bhattacharyya, P Tornetta, WL Healy and TA Einhorn, “The Validity of Claims Made in Orthopaedic Print Advertisements” (2003) 85A (7) JBJS, 1224-28. This paper reports that approximately half of the claims made by manufacturers are not supported by sufficient data that might be useful in undertaking any clinical decision-making process. 173 R Moulds, F Bochner and L Wing, “Drug Advertising” [letter] (1986) 145 MJA, 178-79. Here it is reported that the Australasian Society for Clinical and Experimental Pharmacologists found that 31% of pharmaceutical advertisements were “misleading” or “unjustifiable”. Another 22% were described to be in “technical breach” of the code as current at that time. In Australia there is a Code of Conduct of Medicines Australia that depends on a gate-keeping process to monitor the conduct of manufacturers that relies mainly on spontaneous complaints and on voluntary compliance by manufacturers. Code of Conduct of Medicines Australia was previously the Australian Pharmaceutical Manufacturers Association. In the Medicines Australia Code of Conduct Annual Report 2003, Canberra: Medicines Australia; (2003) it was reported that there had been 48 new complaints about drug promotion. Furthermore the Editorial, “Medicines Australia Code of Conduct: Breaches” (2004) 27 (1) Australian Prescriber, 6-8, it was identified that most of the complaints originated from rival pharmaceutical companies. Some complaints were found to be merely chance events. In 2002-03 the Sanofi-Synthelabo Corporation advertised the hypnotic drug Zolpidem (Stilnox) in the Qantas Magazine of October 2002. A chance complaint occurred after the illegal advertisement may have been seen by thousands of Qantas travellers. The company was fined A$50,000 and the advertisement was not to be used again in the lay media. This case is cited by Agnes Vitry, “Is Australia Free From Direct-to-Consumer Advertising?” (2004) 27 (1) Australian Prescriber, 4-6. See s52 of the TPA prohibits conduct that involves a misrepresentation which may be made expressly, by implication, or which may include silence. In s52 there is provision that a corporation shall not, in trade or commerce, engage in conduct that is misleading or deceptive, or is likely to mislead or deceive. s53-53C are criminal offences that include forms of conduct and representation that are false and the ACCC has power under s79 of the TPA to institute prosecution procedures in the event of breach of these sections. 174 TW Loke, FC Koh and JE Ward, “Pharmaceutical Advertisement Claims in Australian Medical Publications – Is Evidence Accessible, Compelling and Communicated Comprehensively?” (2002) 177 MJA, 291-93. 175 See S Woloshin, LM Schwartz, J Tremmel and HG Welch, “Direct-to-Consumer Advertisements for Prescription Drugs: What are Americans being Sold?” (2001) 358 Lancet, 1141-6. In this paper the authors identified that 31% of all DTCA in New Zealand, including five out of six television advertisements, were in breach of the New Zealand Medicines Act 1981 (NZ). This study also demonstrated that 52% of DTCA in the USA was identified with a violation of the Food, Drug and Cosmetic Act 1938 (USA). The reader is also referred to the article “ Company Vitae”, The Guardian (United Kingdom) 4 August 2001, 19. The article describes a manufacturer’s artificial knee joint, that is “made out of zirconium, an exotic metal that is so strong that it means that people in their 50s can now have knee implants that will last them for the rest of their lives”. See also T Scott, N Stanford & D Thompson, “Killing me Softly: Myth in Pharmaceutical Advertising” (2004) 329 (7480) BMJ, 1484-87. Here the authors emphasise the concern that medical journals provide advertisers with a privileged channel of communication to medical practitioner and provide evidence that confirms that advertising influences doctors behaviour more than they might think. The authors also examine how [drug] advertisers use images to construct mythical and potentially misleading associations between diseases and products. See also R Ferner, “The Influence of Big Pharma” (2005) 330 (7496) BMJ, 855-56. At 855 Ferner indicates that “professional self delusion” [occurs where] doctors view that they are not influenced by marketing. Ferner makes the observation that this “self delusion” may force external regulation of the medical profession.
4.46 Patients will frequently rely heavily on the available information when
exercising choice176.
4.66 Direct-to-consumer advertising (DTCA) of therapeutic products continues to be an important issue that has attracted considerable debate [only] with respect to prescription medicines. The debate has so far not become concerned with matters relating to therapeutic devices in general and to implantable surgical devices in particular. However it remains the case that the issues relating to prescription medicines are very much relevant to any consideration of implantable surgical devices. It is the case that DTCA of prescription medicines to the general public is now legal only in two countries of the Organisation for Economic Co- operation and Development (OECD) – these are New Zealand and the
United States of America. DTCA is not permitted in Australia.177 The impact of DTCA on the New Zealand Health Care System was last reviewed in 2003 by academics at New Zealand’s Four Schools of
Medicine178. The conclusions of this review were that DTCA was not
favoured and it was proposed that DTCA should be banned179. The review further concluded that DTCA did not provide consumers with objective information on risks and benefits nor of other available options regarding treatment. I suspect, and this is only a personal view, that as New Zealand and Australia move closer to a mutual recognition agreement with respect to the regulation of therapeutic goods that it will be the case that DTCA will inevitably be banned in New Zealand.
176 See J Kellam and M Kearney, “Product Reliability – A Decade of Change” presented at Butterworths CLE Seminar, 8 March 2001 – here the authors emphasis that the definition given to defects in Part VA TPA, coupled with the willingness of the Courts to find manufacturers guilty of misleading and deceptive conduct or representations found to be false where there are over representations, particularly with regard to safety, efficacy, warnings and instructions for use is an important part of consumer protection in Australia. 177 The legality of DTCA in New Zealand and the USA has implications for Australia at a time when Australia and New Zealand are moving towards a common Regulatory Therapeutic Goods Agency and when Australia and USA are negotiating the Free Trade Agreement. For further information see K Lokuge and R Denniss, “Trading in our Health System? The Impact of the Australia-US Free Trade Agreement on the Pharmaceutical Benefit Scheme” (2003) Canberra, Discussion Paper 55. In 1985 the FDA reversed its longstanding policy of prohibiting DTCA, and August 1997 it liberalised its policy on such advertising. Drug companies are allowed to advertise their products directly to consumers, as long as they state the indications for the use of the drug, and disclose the major health risks and side effects associated with the drugs use. The ruling allows drug companies to refer consumers to further information that is made available on web sites, on free-off-charge telephone numbers or in printed references and recommends that patients be directed to medical practitioners for more information. Another requirement is that the advertisements must not be misleading. 178 L Toop, D Richards, T Dowell, M Tilyard, I Fraser and B Arroll, “Direct-to-Consumer Advertising of Prescription Drugs in New Zealand: For Health or for Profit?”, report to the Ministry of Health supporting the case for a ban on DTCA. New Zealand Departments of General Practice (Christchurch, Dunedin, Wellington and Auckland Schools of Medicine); 2003. 179 D Burton, “New Zealand Moves to Ban Direct Advertising of Drugs” (2004) 328 BMJ, 68.
4.47 4.67 The debate for and against DTCA is continuing and the jury is still out.
Barbara Mintzes180 argues that DTCA risks medicalising normal human conditions, with the [manufacturers] raking in increasingly healthy
profits. In contrast Sylvia N Bonaccorso and Jeffrey L Sturchio181 argue that, through advertising, [manufacturers] can enable patients to make better informed choices about their health and treatment.
4.68 Any discussion regarding the conduct of manufacturers in their efforts to advertise their products would not be complete without some reference to examples of conduct that might be interpreted as misleading, deceptive,
or even unconscionable.182 Here I refer to the way in which implantable surgical devices are promoted and to the nature of the descriptives, using such words as guarantee … unique … only … and there are others.
Consider a brochure advertising Trabecular Metal Techonology183 that describes the attributes of the metal implant material, Tantalum. Tantalum is used for the fabrication of artificial hip and knee joints, and is described by the manufacturer “as a material that flexes like bone and looks like bone”. The descriptive continues with the claim that the material is “the best thing next to bone”. A ceramic acetabular implant
material184 is described by another manufacturer as “eclipsing all others”. Here the implication might be that the ceramic material is unique. An engineer might have no major difficulty with any of these claims.
However engineers are not the target audience for the information185. The
180 B Mintzes, “Direct-to-Consumer Advertising is Medicalising Normal Human Experience” (2002) 324 BMJ, 908-9. 181 SN Bonaccorso and JL Sturchio, “Driect-to-Consumer Advertising is Medicalising Normal Human Experience” (2002) 324 BMJ, 910-11. 182 To be taken advantage of in a transaction in a way that offends the conscience is known as unconscionable conduct. TPA s51AC applies to conduct in a business context (occurring since 1 July 1998) which is “in all the circumstances, unconscionable”. TPA s51AC sets out the factors that the Court can consider in deciding when a conduct was unconscionable. TPA s51AC also builds on the more traditional concepts of unconscionable conduct under TPA s51AA that applies to all commercial situations, not just those of a buyer/seller relationship. Relief under s51AA may be found when there is unfair exploitation of a weaker parties disadvantage, in the event that the stronger party allowed the weaker party to rely on an incorrect assumption, or fails to disclose an important fact, and where the weaker party relies on a misrepresentation by the stronger party. There are other applications of TPA s51AA that are not relevant to this debate. 183 Implex & Zimmer Corporations, Zimmer Inc, 345 East Main Street, Warsaw, IN46580 USA - promotional material 2002. The Zimmer Corporation was founded in 1927 and in October, 2003, finalised its acquisition of Centerpulse AG, (formerly Sultzer). On 23/04/04 Zimmer Holdings Inc reached agreement with the Implex Corporation, manufacturers of Tantalum (Trabecular Metal Technology) to buy the company for US$108m in cash and stocks. 184 Stryker Howmedica Osteonics Corporation, 2725 Fairfield Road, Kalamazoo, MI 49002, USA – promotional material 2002. Howmedica Osteonics is the largest subsidiary of the US$3b Stryker Corporation. 185 See the four steps of Taco Bell in Taco Co of Australia Inc v Taco Bell Ltd (1982) 42 ALR 177; (1982) ATPR 40-303 (Taco Bell). The first step in Taco Bell is to identify that relevant section of the community (public) who are likely to be misled or deceived.
4.48 target group for the information are orthopaedic surgeons and it is not difficult for the orthopaedic surgeon to find some clinical evidence to permit the conclusion that the manufacturer’s claims cannot be
sustained.186
4.69 Whilst drug companies have been accused187 of misleading consumers, the claims made by surgical device manufacturers have, for reasons unknown to me, escaped any more than minor criticism. A recent advertisement by Centerpulse (formerly Sulzer) of their Alloclassic™ ZweymĦller™ Total Hip Joint Replacement Device might prove to be
the exception. 188 This advertisement depicts a middle aged male running on a beach with a young lady riding on his back. The right hip region of the young lady is highlighted with a red circle.
4.70 This advertisement for the hip replacement device has the potential to cause the reasonable observer to form a conclusion that implantation of the Alloclassic™ ZweymĦller™ Total Hip Joint Replacement implant will permit the ability for the consumer to undertake the activities portrayed. It is not unreasonable to form a conclusion that one (or perhaps both) of the individuals shown in the advertisement have undergone treatment using the surgical implant that is advertised. Richard Frischi, President Europe/Australasia, Zimmer-Centerpulse Orthopedics Division was requested to provide information as to whether or not, one or both, of the individuals portrayed in the advertisement had undergone total hip replacement using the device that has been advertised. On 9 March 2004 a reply was received from Mark Harding,
186 See www.mathysmedical.com for the comparative wear rates of different combinations of materials used for the fabrication of total hip replacement articulations (ball and socket components). The work reported relates to the annual linear wear rates various retrieved material pairs that had undergone re-operation by Professor Semlisch. The scientific evidence concluded that the wear rates of metal on metal (cobalt – chromium – molybdemon metal) and the wear rates of ceramic on ceramic (alumina) are identical – a linear wear rate of 0.003 – 0.01mm/year in each case. 187In the Drug and Therapeutics Bulletin the drug company Novartis is accused of breaching advertising regulations in its advertisement for Pimecrolimus (ELIDEL), a new cream for treating dermatitis and eczema in children. See Editorial, “Drug Company accused of Breaching Advertising Regulations” (2003) 41(5) The Drug and Therapeutics Bulletin, 33-6 – the editorial criticised the company’s advertisement published in many journals, that showed a baby who appeared younger than two years of age, implying that the cream could be used in the treatment of babies below that age. The licence for the new cream was limited to its use in patients aged two years or older. Dr Richard Chiswell, Medical Adviser to Novartis said: the boy used for the advertisement was actually 2 years and 5 months old. He admitted that the Medicine and Healthcare Products Regulatory Agency had recently drawn their attention to the fact that the boy looks younger to many people. 188 The Centerpulse advertisement of the Alloclassic™ ZweymĦller™ Total Hip Joint Replacement System was published in Journal of Bone and Joint Surgery, (2003) 85B (7). The Centerpulse Orthopedics Division (formerly Sulzer) is a subsidiary of the Zimmer Corporation.
4.49 the Marketing Director of Zimmer, Australia & New Zealand. That reply reads as follows –
“Thank you for your letter and the enclosed observation of our JBJS advertising. Neither the young lady nor the male on the beach has been implanted with the highly successfully ZweymĦller™ Alloclassic™ hip. The lucky recipient of the ZweymĦller™ Alloclassic™ is the 70-year old lady in the deck chair on the beach. Unfortunately, her deck chair is situated just outside the frame of the picture and is not visible in the shot. She is looking forward to 10+ years of trouble-free mobility. I hope this answers any questions you may have regarding the advertising of Zimmer/Centerpulse. If I can assist further please call me on ….”
There is some parallel here with the recent Federal Court finding that Cadbury-Schweppes Pty Ltd had breached the TPA by inadequately conveying that two Cottee’s cordial products did not contain the extracts
of real fruit pictorially depicted on the packaging.189 It may be that surgical device manufacturer’s advertisements in surgical journals and other publications may pose an even greater threat to the ethics and integrity of surgical practice and education than does industry funding of research.
SUPPLY AND DISTRIBUTION OF SURGICALLY IMPLANTABLE DEVICES
4.71 It necessarily follows that, whether a device be imported or not, there is the need for the generation of a sales organisation that will facilitate the sale and distribution of the device in each state and territory. The imported device may be distributed by a subsidiary of the manufacturer
189 See ACCC v Cadbury Schweppes Pty Ltd [2004] FCA 516; (2004) ATPR ¶ 42-001 - In February 2002 the ACCC instituted legal proceedings (ss52, 53(a) & 55 of the TPA) again Cadbury Schweppes, the manufacturers of Cottee’s cordial products alleging false, misleading and deceptive conduct in its labelling of Cottee’s Banana Mango flavoured cordial and Apple Kiwi flavoured cordial concentrate. The labelling on the Banana Mango cordial used the words “Banana Mango”, pictures of bananas and mangoes and a “Go Bananas” motif. The Federal Court found that the labelling would convey to some reasonable potential purchases the impression of real bananas and real mangoes. The labelling on the Apple Kiwi flavoured cordial concentrate used the words “Apple Kiwi” in the name of the product and pictures of cut Kiwi Fruit. Gray J observed that the packaging and labelling of “ …each was capable of conveying to a significant body of reasonable consumers a representation that the produce concerned contained extracts of the real fruit depicted. In each case it is likely that some reasonable consumers would be misled or deceived by the representation and influenced by it to purchase the product concerned on the basis that it contains the real fruit represented”. Cadbury Schweppes were found to have engaged in conduct that was likely to mislead or deceive and had made false representations in contravention of the TPA. Mr G Samuel, ACCC Chairman, subsequently stated that “truth in labelling is an
4.50 that is incorporated in Australia or be distributed by some other organisation chosen as a local supplier, agent or franchisee. The responsibility for the advertising of, and for the promotion of, the product is generally a responsibility that is jointly undertaken by the manufacturer and by the domestic distributor or sponsor.
4.72 The domestic supplier remains responsible for the provision of instrumentation that is necessarily required for the surgical implantation of the device, for the importation of the device, and/or for the importation of those components from which the device will be assembled by the treating surgeon. The domestic supplier of the device is also responsible for providing, to the users of the device, that information that relates to the safe use of the product. This information is usually prepared and provided by the manufacturer for distribution by the domestic supplier and the information is disseminated to surgeons in the form of correspondence and brochures that cross the desk, and by way of seminars and demonstrations that are arranged for specific purposes and needs. It has been my experience that it has only rarely been the case that a manufacturer or supplier of a surgical device will have provided information direct to the ultimate consumer, the patient. It is generally the case that the ultimate consumer will only become exposed to a manufacturer's advice, instructions for use, through
communication with a learned intermediary.190 With regard to product information it remains also the case that learned information can also be derived from corridor consultations, at clinical meetings, from continuing
medical educational activities, at seminars, and conferences191 and from
essential requirement, especially for food products”. Food manufacturers and importers should ensure consumers are sufficiently informed as to the ingredients and nature of food products they market. For further information see on-line www.ACCC.gov.au. 190 For further information see Ch 7. 191 A number of professional bodies have been involved in a morass of litigation that was the pedicle screw multi-district litigation in the USA. The pedicle screw law suit marked the first time that a medical society had been sued in a product-liability case for illegally conspiring to promote the use of a surgical device. The professional bodies involved in this litigation included the North American Spine Society, the American Academy of Orthopaedic Surgeons, the American Association of Neurological Surgeons and the Scoliosis Research Society. The multi-district litigation involved more than 2,000 Civil Actions originally filed in approximately 60 of the 94 Federal Districts in the USA. For further information see report by Tipton W, M.D.: Executive Vice- President of the American Academy of Orthopaedic Surgeons, at the 8th Annual Conference on CME Provider Industry Collaboration, Fort Lauderdale, Florida, October 5-8, 1997 and in Orthopaedic Bone Screw Products Liability Litigation, 193 F. 3d 781 (3rd Cir 1999). Also see Ch 7.
4.51 the reading of Journals.192 Many of these continuing educational activities are sponsored by a number of entities that include manufacturers, treating institutions, surgical societies and craft groups.
4.73 The supply of a surgical implant product to the ultimate consumer, the patient, can occur in a variety of ways -
(i) In the past it was not unknown for surgical devices to be supplied direct from the manufacturer or distributor to the surgeon. The device was retained by the surgeon on a consignment basis and after implantation the patient was invoiced directly by the manufacturer or by the distributor.
(ii) In rare cases the surgeon might purchase the implant device from the manufacturer or the distributor and after implantation of the device the patient would be invoiced for the cost of the device by the surgeon.
(iii) It is generally now the case that the manufacturers and distributors of surgical devices will supply their products directly to (private or public) hospitals. More often than not surgical devices are supplied to treating institutions on an as need basis that takes into account the experience of past and predicted surgical planning and follows, and requires, the dissemination by hospitals of that information to suppliers.
192 The quality of information provided by surgical device manufacturers, which is not peer-reviewed, has never been formally evaluated. However the validity of claims made in orthopaedic print advertisements has been investigated at the Boston University Medical Centre, Boston, and at the Lahey Clinic, Burlington, Massachusetts, USA by Bhattacharyya et al. This research concluded that "Orthopaedic surgeons should interpret claims made in orthopaedic print advertisements with caution." Approximately half the claims are not supported by enough data to be used in a clinical decision-making process. For further information see T Bhattacharyya, P Tornetta, WL Healy and TA Einhorn, “The Validity of Claims Made in Orthopaedic Print Advertisements” (2003) 85A (7) JBJS, 1224-28. Also see Ch 7.
4.52 (iv) In the event that a surgical device is frequently used in a particular hospital, the manufacturer or distributor may choose to maintain a consignment stock of implant devices at that institution and as products are consumed, invoices will be raised, and considerations will pass as the parties to any contract have arranged and promised.
(v) It may be the case that implant products, e.g. orthopaedic bone screws, can be supplied to a hospital in bulk form. In such cases it is then necessary for the hospital to repackage the devices
at this domestic level in the supply chain.193
Though the primary responsibility and role of surgeons and hospitals is to provide services to the ultimate consumer entrusted to their care it can be seen though that both can have a role with regard to the supply of goods. In all of these arrangements there can be complex contractual
agreements.194 It does though remain only rarely the case that there is any contract between manufacturer (and/or distributor) and the treating surgeon and even rarer is the occasion when there is a contractual arrangement between the manufacturer (and/or supplier) and the ultimate consumer, the patient.
4.74 Under the Medicare arrangement it is the case in Australia that patients who are treated in Public Hospitals are not required to pay for the cost of any surgically implanted device. In contrast, private patients, whether treated in private or public hospitals, will be responsible for the cost of the implantable device and will be invoiced (billed) either by the supplier of the device (representing the manufacturer) or by the finance
193 Orthopaedic bone screws continue to be supplied to treating institutions in bulk form as they are high volume trauma treatment products. It continues to be the case that hospitals continue to undertake the responsibility of repackaging these devices prior to their surgical implantation.
4.53 department of the private or public hospital. It is now also common practice that invoices for the goods consumed will be transmitted as part of some previously agreed arrangement directly to the patient's Private Health Fund Provider. In this way invoicing arrangements for private patients can bypass the consumer.
4.75 It is not unknown for public and private hospitals to have favoured195 customer arrangements with suppliers that cause the institution to benefit from discounted implant costs. It can be the case, and there is evidence
to support the observation,196 that discounts may not be passed on to the patient, nor indeed to a Health Fund or to the State/Territory Health Care budget. In the event the motive of public institutions for the arrangement has not been disclosed but is probably one that is for the purpose of generating revenue that can be used by the institution to assist with the funding of the day to day activities of the organisation.
4.76 With the occurrence of an adverse event it can be the case that a surgical implant, that has failed for some reason, will require explantation (removal) and replacement. For the undertaking of salvage surgery the marketing structure remains no different with the exception of there being a need for the provision of custom or customised (individual specific) implant devices, and for the provision of the instrumentation that might be needed for the revision or salvage surgical undertaking. The responsibility for the availability of any special requirements
194 See Ch 3 ¶ 3.33-3.40. 195 My descriptive. 196 In 1998, in the performance of my duties as Head of Orthopaedic Surgery at the Concord Repatriation General Hospital (CRGH) in Sydney, I undertook a review of the cost of implant devices consumed by the Department during the financial year 1997-1998. The review identified and confirmed that the institution profited from the sale of such devices as total hip replacement implants, total knee replacement implants, total shoulder replacement implants and orthopaedic bone screws. It can be calculated that approximately $95,335 revenue was raised by the institution in the undertaking of total hip replacements (n.125), total knee replacements (n.117), and total shoulder replacements (n.6). This calculation can be supported by the evidence of just three events -
Operations Charge to Total Date Surgical procedure Medical $ costHealth CRGH (n-248) Record No. to CRGH Fund Profit
(n-125) 24/02/98 Total hip replacement MRN 791* $7,341 $7,940 $ 599 (n-117) 31/03/98 Total knee replacement MRN 352* $4,857 $4,965 $ 108 (n-6) 14/04/98 Total shoulder replacement MRN 788* $3,146 $4,450 $1,304 *Last 3 digits/numbers omitted for reasons of privacy.
4.54 remains one that is almost197 entirely borne by the manufacturer and/or sponsor. That responsibility does remain one that is dependent on the timely communication to the manufacturer of information that is generated on the consumer's behalf by the treating surgeon.
THE ROLES AND THE LIABILITIES OF SURGEONS & HOSPITALS
4.77 This Chapter has so far demonstrated a major focus that has predominantly been directed onto the conduct of the manufacturer of the surgically implantable device and onto the relationships that exist between industry and those clinicians (and other researchers) that become involved in the design, research, and development of a prosthetic device.
4.78 Surgeons (and other health care professionals) and hospitals are mostly providers of services. Occasionally there is also the supply of goods with those services and as such individuals and/or organisations can
attract exposure to liability in tort, contract or under statute.198 Exposure to liability may be both in relation to the service that has been provided and occasionally also in respect to a product that may have been supplied in the course of providing the service. It is questionable whether or not a hospital can be exposed to liability in the event that implantable surgical devices, such as screws, are provided to the institution in bulk form and where the devices are necessarily repackaged and sterilised by the hospital Central Sterile Supply Department (CSSD). Though so far untested, these activities might expose the hospital to liability as a
manufacturer.199
4.79 Surgeons and/or their incorporated entity can be exposed to liability that can follow on from the failure to exercise due care and skill in the supply
197 The treating institution has an obligation to ensure that appropriate instrumentation is available to permit the surgeon to undertake the necessary surgical procedure. To be effective it is implicit that there is co-operation between the surgeon and the treating institution. 198 See E v. Australian Red Cross Society (1991) 27 FCR 310; (1991) ATPR 41-085; on appeal (1991) 31 FCR 299; (1992) ATPR 41-156.
4.55 of services. This might be derived from a failure to warn of all of the risks of the complications and of the reasonably anticipated limitations of the surgical procedure and the implanted device, or because the product(s) supplied in connection with the services may later found to be
of unmerchantable quality or not fit for the purpose that was intended.200
4.80 Issues of consumer protection apply to surgeons, as learned intermediaries, and as providers of services, just as much as they do to any other trade or profession. When a surgeon implants a prosthetic device into a patient (the consumer) there is a supply of services, that is represented by the surgical procedure, and there is also a supply of goods together with those services. The practice of surgery, and the provision of medical care in general, have been cause for debate as to whether the supply of services that occurs should be characterised as a supply of services with a product component, or whether there is a supply of goods
to which there is attached a service component.201 To complicate matters further, there is also the issue, that has so far not been tested in any Australian jurisdiction, that it might also be the case that the surgeon who assembles an implantable surgical device (at the time of surgery) from a number of components might be regarded as a manufacturer and as such attract the additional common law statutory liabilities of
manufacturers.202 This is a matter that is reflected also by the tension that exists between the definition of manufacturer that is to be found in the
TPA and in the TGAct.203
199 ACCC v Glendale Chemical Products Pty Ltd [1998] ATPR 41-632; [1999] ATPR 41-672. 200 See Ch 3 ¶ 3.33-3.40 and ¶ 3.41-3.56. See also TPA s.74 and for example Dodd v. Wilson [1946] 2 All ER 691. 201 See vide supra n. 198. 202 A manufacturer is identified in s74A(3)-(8) of Pt V of the TPA. Pursuant to s74A(1) the term “manufactured” includes (grown, extracted, produced, processed and) assembled. In contrast in s41BG(3) of the TGAct the person who assembles a product is not the manufacturer. In this section a person is not a manufacturer of a medical device if – x The person assembles or adapts the device for an individual patient; x (the device has already been supplied by another person; and x the assembly or adaption does not change the purpose intended for the device. In the context of the Therapeutic Goods (Medical Devices) Act 2002 (Cth) the term “manufacturer” means the person who is responsible for the design, manufacture, or packaging and labelling of a device before it is placed on the market under his/her name regardless of whether these operations are carried out by the person himself or on his/her behalf by a third party. 203 See vide supra n.202.
4.56 4.81 Whatever is the case, surgeons owe a general duty of care to their patients where it can be foreseen that some loss or damage may be suffered by reasons of their acts or omissions. It has been the case that surgeons have generally found exposure to liability only in negligence in the event that in the supply of a service, that is the procedure of surgical implantation, that it can be shown to have been undertaken in a manner that was regarded to have been inappropriate, performed incorrectly,
and/or undertaken without prudence204 or have been associated with a
clear failure to warn. The case law is littered with examples205. Generally the undertaking of due care and skill will be unique to the particular circumstances of the surgical procedure that is being performed though it generally is excepted that the greater the risks of the
procedure then the greater should be the standard of care and skill.206
4.82 As we have seen in chapter 3 there is generally no contractual
relationship between surgeons and patients.207 Though the hospital consent forms have the trappings of a contract there is, under the provisions of Medicare, no privity (and no promise) between surgeon and patient though the information provided to the patient by the surgeon may have been of a nature that might sometimes be construed as
containing a warranty.208 The existence of an enforceable contract is
rare.209
204 See Ch 3 ¶ 3.18-3.32. 205 See Rogers v Whitaker (1991) 175 CLR 479; 109 ALR 625 (HCA); Stennett v Handcock [1939] 2 4 ER 578. 206 See Spiers v McFarlane [1988] 46 SASR 443 – in this case a carpenter used a highly flammable adhesive to secure a Laminex top to a cupboard. The cupboard was situated close to a gas stove and there followed an ignition of a pilot light that was concealed in the stove. Considerable damage was caused to the home. It was held that the carpenter had not been negligent in the circumstances, that he was under a duty to exercise reasonable care that the inflammable adhesive would not cause damage. It was evident that the carpenter had searched for a naked flame prior to commencing the installation and use of the adhesive. It was held that the carpenter that not negligent by virtue of his failure to locate the pilot light that was concealed in the stove. It was held that the carpenter had not been negligent in the circumstances though he was under a duty to exercise reasonable care. 207 See Ch 3 ¶ 3.33-3.40. 208 See Eyre v Measday [1986] 1 All ER 488 (CA) and Thake v Maurice [1986] QB 644, [1986] 1 All ER 497 (CA). These two cases concern the sterilisation of a female and the undertaking of a vasectomy procedure respectively. In Eyre v Measday the surgeon advised that the sterilisation procedure would lead to the patient becoming absolutely sterile and incapable of bearing further children. In Thake v Maurice the represensation was that the vasectomy operation was irreversible but there was a failure to warn of a minute risk of the procedure being unsuccessful. In both of these cases the patient subsequently proved able to produce further children. In both case, on Appeal, the first decision was reversed and it was determined that there had been breach of a contractual term of express or implied collateral warranty to render the individuals irreversibly sterile. 209 See La Fleur v Cornelis (1979) 28 NBR (2d) 569 (NBSC). In this Canadian case a cosmetic surgeon had failed to advise the patient of a 10% risk of scarring. The adverse event associated with scarring following the cosmetic nose reduction procedure was found to be a breach of a contractual term of an express or implied collateral warranty.
4.57 4.83 Hospitals can be exposed to liability as trading corporations and any
argument to the contrary was put to rest in E v Australian Red Cross210. This case concerned the Royal Prince Alfred Hospital (RPAH) (representing the Central Area Health Service of Sydney – the successor to the management of the RPAH) that had provided treatment to the claimant, E, that had included the administration of plasma that had been derived from a blood donation from an HIV positive donor. The donation had been collected by the NSW Division of the Australian Red Cross Society in 1984. It was evident that the RPAH was predominantly concerned with activities that included the supply of services rather than of goods. However, the institution did both and it traded profitably. Wilcox J formed the conclusion that there was nothing in the nature of the RPAH activities to disqualify the institution as a trading corporation. Wilcox J considered it difficult, in the light of the “Tasmanian Dam”
case211 to form any other conclusion than that the RPAH was a trading corporation whose trading activities were substantial. Wilcox J acknowledged that “trading activities yielding some $18m per year can only be described as substantial”. It was concluded that the RPAH trading activities during the period 1984-1985 were of a nature that the
institution should be regarded as being a trading corporation212 within the
definition provided in the Constitution.213
4.84 In the context of a private hospital and indeed also of a public hospital, providing private services, in the event that an implantable surgical device is sold on to a patient it is the case that the distinction between the selling of goods and the provisions of services can become blurred. Whether or not a hospital is engaged in the business of selling prostheses
210 E v Australian Red Cross (1991) 27 FCR 310; (1991) ATPR 41-085; on appeal (1991) 31 FCR 299; (1992) ATPR 41-156. 211 See Commonwealth of Australia v Tasmania (Tasmanian Dam) (1983) 158 CLR 1. 212 See also Australian Beauty Trade Supplies Ltd v Conference and Exhibition Organisers Pty Ltd (1991) 29 FCR 68; 99 ALR 474 – here a trading association operating through its members’ unpaid labour organised an annual Trade Fair the purpose of which was to profit from trade. This association was held to be a trading corporation. 213 The Australian Constitution s.51.
4.58 is an issue that remains, for the purposes of strict product liability, so far
untested.214
4.85 It might be the case that hospitals215 and medical practitioners216 can be vicariously liable for the conduct of others. This is particularly so where it can be shown that there is an employer-employee relationship. The circumstances of visiting medical staff at public hospitals remains
unclear.217 In common law an employee can be vicariously liable for the torts of employees that are committed in the course of their
employment.218
214 See the US case Ira A & Rachel M Royer v Catholic Medical Centre, Hillsborough – Northern Judicial District, No 98-060, 23 November 1999 – Here the claimant underwent a total knee replacement operation at the Catholic Medical Centre in September 1991. Two years later the claimant suffered severe pain that doctors determined to be associated with a prosthetic defect. Revision surgery was undertaken in June 1993 and subsequent to that the patient sued the manufacturers, Dow Corning Corp, Dow Corning Wright Inc and Wright Medical Technology Inc. The claimant filed a further writ against the Catholic Medical Centre alleging that the institution was strictly liable and that it had sold a prosthesis with a design defect that caused the device to be unreasonably dangerous. The Catholic Medical Centre argued that the total knee replacement implant was not a “sellable good” for the purpose of strict product liability. The Court found that the Catholic Medical Centre was not engaged in the business of selling prosthetic devices and found for the defendant. This finding is in contrast to E v Australian Red Cross (1991) 27 FCR 310; (1991) ATPR 41- 085; on appeal (1991) 31 FCR 299; (1992) ATPR 41-156. See also Peter Zbras et al v St Vincent’s Medical Centre et al. CV 950323593 Sup Ct Conn, this case concerned a medical malpractice action brought by the claimants against the defendants, WT Shanley MD, his professional corporation (Fairfield Orthopaedic Associates PC) and the St Vincent’s Medical Centre. The claimant suffered a back injury in 1984 and 1987. Both injuries were work-related and in July 1993 Dr Shanley performed a spinal fusion procedure using pedicle screws. The surgery was undertaken at the St Vincent’s Medical Centre. Unfortunately the claimant suffered from continuing pain and is was alleged that this was caused by the misplacement of a pedicle screw. The case was based on the alleged vicarious liability of the St Vincent’s Medical Centre. The Court ruled that Dr Shanley was not an agent, employee and/or servant of the St Vincent’s Medical Centre and therefore St Vincent’s could not be held liable to the plaintiff under theories of vicarious liability. Dr Shanley did not receive any consideration from St Vincent’s nor was there any evidence that St Vincent’s exercised a control over the manner in which Dr Shanley practiced medicine. Furthermore there was no evidence of any contract between Dr Shanley and St Vincent’s. Dr Shanley administered his own private corporation in offices separate from the hospital. Furthermore the financial affairs of Dr Shanley were conducted by his private corporation and Dr Shanley also order the instrumentation (surgical devices) that were used for the spinal fusion procedure. The Court found that there was only an independent contractual relationship between Dr Shanley and the St Vincent’s Medical Centre and that there was no employer/employee relationship. The claimant argued that the St Vincent’s Medical Centre had sold an “adulterate medical device” and that the bill for the instrumentation was directed for the claimant’s attention. Notwithstanding this, the Court ruled that the St Vincent’s Medical Centre was not engaged in the business of selling equipment, but was engaged in the business of providing medical services. It therefore followed that the St Vincent’s Medical Centre was not subject to the Product Liability Act. In support of this decision it was held that by allowing a claim against a hospital under the Food, Drug and Cosmetic Act because the hospital billed the patient for an alleged adulterated surgical device that was ordered by a private clinician would limited and interfere with the health care practitioner’s relationship in prescribing and administering any device. 215 See Peter Zbras et al v St Vincent’s Medical Centre et al CV 950323593 Sup Ct Conn – this case is considered in n.213. In Ellis v Wallsend District Hospital (1989) Aust Torts Reports ¶ 80-259; (1989) 17 NSW LR 533(CA);[1990] 2 Med LR 103 (NSW) (CA) -Kirby P, under the heading “Liability in Negligence – Vicarious Liability” gave a brief history of the issue of the liability of hospitals (at 562-5). See also Henson v Board of Management of the Perth Hospital (1939) 41 WALR 15 for the gradual emergence of a new doctrine with regard to the employment of professional staff in hospitals. 216 See Alexander v Heise [2001] NSW SC69. The facts of this case are that on 4 March 1996 the claimant suffered a headache and later on that day an appointment was made by the claimants wife for the claimant to see Dr Heise on 11 March, seven days later. On 10 March the claimant suffered a berry aneurysm and died. The claimant alleged that the receptionist who undertook to make the appointment owed him a duty to assess his symptoms and to prioritise his treatment. It was further alleged that Dr Heise had a duty to instruct his receptionist in this matter, and an appointment should have been made as a matter of urgency. The key issues before the Court included whether the defendants, or either of them, were under a duty a care in the circumstances; and whether the defendants, or either of them breached their duty of care, if in fact one did exist. With respect to the receptionist the Court held that the receptionist owed a separate duty of care to patients but there was no breach of the duty of care in the circumstances of the case. The Court held that Dr Heise owed a duty of care to ensure that patients seeking appointments are prioritised through adequate training. However it was held that the medical practitioner did not breach this duty of care. The Court did though hold that the medical practitioner is vicariously liable for the conduct of the receptionist. The High Court maintains the view that “a person who employs others to advance his/her own economic interest should in fairness be placed under a corresponding liability for losses occurred in the course of the enterprise”. 217 See Gold v Essex County Council [1942] 2 KB 293. 218 There are three relevant issues that must be shown to exist in determining a vicarious liability. These are –
4.59 4.86 The matters relating to vicarious liability are cause for a complex issue that has not been entirely resolved, and it is one that turns on the nature of any contractual relationship that exists between a treating hospital or a medical practitioner and those who work within the environment
provided.219 In consideration of whether or not there is vicarious liability the presence of an employer-employee relationship can be persuasive and relevant to this there is little doubt that full-time and part-time,
permanent or temporary, staff are regarded as employees.220
4.87 With regards to the issue of vicarious liability it is of historical interest to observe that it was the case until the 1950s, in the United Kingdom, that all hospitals were held not to be liable for the negligence of their staff. This state of affairs existed since 1909 when a court of appeal held in
Hillyer v Governors of St Bartholomew’s Hospital221 that vicarious liability could only arise in the case of the performance of purely “ministerial” or administrative duties as distinct from clinical activities. The decision in Hillyer was probably directed towards relieving
hospitals, that were in those days charitable222 organisations, from exposure to liability for services provided that attracted no revenue.
Hillyer was rejected in 1942223 and it is the case now that almost all common law countries have rejected the Hillyer principle.
4.88 Staff specialists, whether employed full-time or part-time (fractional), are employees of Area Health Authorities. This is notwithstanding the fact
(a) A person has committed a tort; (b) The person should an employee of the institution; and (c) the tort was committed during the course of employment. For a general discussion see Clerk and Lindsell (eds), Torts, (17th ed, 1997) Ch 3. See also Harrold Luntz and David Hambly, Torts – Cases in Commentary, (1st pub 1980, 4th ed, 2000) 867-924. 219 See Ready Mixed Concrete (South East) Ltd v Minister for Pensions [1968] 2 QB 497; Lee Ting Sang v Chung Chi Leung [1990] 2 AC 374. 220 See Stokes v Guest, Keen & Nettlefold (Bolts and Nuts) Ltd [1969] 1 WLR 1776. See also Collins v Hertfordshire C C [1947] 1 KB 598 – this case recognised that both permanent and temporary full-time members of hospital staff were employed under Contracts of Service rather than under Contracts for Services as independent contractors. This particular case concerned a junior house surgeon who was employed on a temporary but full-time basis. 221 [1909] 2 KB 820. This case holds both historical and personal significance for me. St Bartholomew’s Hospital was founded by Rahere (a monk) in 1123. It is the world’s oldest working hospital and it is where I studied medicine and worked from 1962 until 1968. 222 There has been a potential, in England, since 1866, for charitable and non-profit organisations to have exposure to liability – see Mersey Docks & Harbour Board Trustees v Stock Gipps [1856] LR 1 HL 93.
4.60 that each appointment is governed by a statutory instrument, the State or Territory health service. In contrast though a surgeon in private
practice224 is regarded as a sole practitioner (defined as a Visiting Medical Officer or VMO) who is either self employed or employed through some other form of incorporation. Generally the hospital, where the VMO surgeon undertakes his or her surgical practice, has no vicarious liability. The relationship between the institution and the clinician is generally only of a contractual nature where the clinician benefits from certain privileges that include, for example, the right to use hospital facilities, such as operating theatres, laboratories, etc. The clinician is permitted to admit patients to the institution and to treat those patients using the facilities that are provided. In these arrangements there is no
sense of the clinician being an employee.225 In these circumstances though there does remain some doubt as to whether or not the treating institution owes a non-delegable duty to ensure that patients are treated
appropriately, skilfully and safely.226
CONCLUSION
4.89 This chapter has reviewed the chain of events that are concerned with the evolution or development of an implantable surgical device from its conception to its surgical implantation. The now traditional evolutionary process is very different from that which is so well demonstrated by the classic case of Sir John Charnley. Charnley's resort to an innovative therapeutic technique may have been appropriate in his time and, for certain cases, this may now still be the case. However resort to an innovative surgical technique, though appropriate in certain cases, should
223 See Gold v Essex County Council [1942] 2 KB 293. 224 For example a General Practitioner working as an Occupational Health Adviser to a company in return for an annual retainer is regarded as an independent contractor working under contract for the supply of services. Such an arrangement does not cause the company to be vicariously liable for the General Practitioner’s conduct – see Capfunde v Abbey National (1988) 45 BMLR 176 (CA). In this case the General Practitioner worked part-time for the Abbey National Building Society, an organisation not dissimilar to an Australian credit union. 225 See Ellis v Wallsend District Hospital (1989) Aust Torts Reports ¶ 80-259; (1989) 17 NSWR LR 553; [1990] 2 Med LR 103 (NSW) (CA). 226 In Ellis v Wallsend District Hospital (1989) Aust Torts Reports ¶ 80-259; (1989) 17 NSWR LR 553; [1990] 2 Med LR 103 (NSW) (CA) it was held that there is a non-delegable duty of care in the event where patients present directly to a hospital for treatment in contrast to those occasions when a patient presents directly for admission at the behest of a clinician exercising his right of private practice that included admission privileges. See also Commonwealth v Introvigne (1982) 56 ALJR 749.
4.61 only be made with caution227. It is now possible, although so far untested, that a Court might decline to endorse the use of a previously untried procedure if the patient was thereby exposed to considerable risk of harm. Other factors which might be taken into account by the Court would be the previous response of the patient to other more conventional treatment modalities, to the seriousness of the patient's condition and to the attitude of the patient towards the novelty of the procedure and the risk. Whether or not the use of any new technique for the implantation of a surgical device could amount to negligence would ultimately depend on the extent to which the use of the procedure was considered justified in the particular case in question.
4.90 It is now the case that in the cycle of manufacturing there are considerably more stakeholders than was the case that is reflected by the endeavours of Charnley. These many stakeholders clearly will have legal obligations to ensure that the entire evolutionary process of any surgically implantable device does proceed in a manner that is both ethical and transparent. The whole process though does continue to require a very close working relationship between surgeons and manufacturers. The ethical balance of these partnerships is a continuing cause for concern for the medical profession. Though rare, it is recognised that these relationships "can have trappings entwined in an embrace of avarice and excess, an embrace that distorts medical
information and patient care".228
4.91 In this chapter we have seen that there is evidence that the outcomes of research can be greatly dependent on how any research funding is provided. To avoid this most research institutions in Australia now have established guidelines to prevent the standard of research, and the outcome of research, from being influenced by a manufacturer that provides funding. Furthermore, the demand of publishers that there is a
227 See the previous discussion of Hall v. Petros (2004) WADC 87 and M Gorton, “‘Keeping up to Date’ – New Techniques” (2004) 5 (9) Surgical News of the Royal Australian College of Surgeons, 7. 228 Quotation from Editorial in the British Medical Journal, K Abbasi and R Smith (eds), “No More Free Lunches”, (2003) 326 BMJ.
4.62 full public disclosure of the source of funding, prior to any successful publication of a manuscript, is healthy. It is an ongoing imperative that policies in respect of funding must be clear to all involved and should ensure that the relationships between clinicians and those who provide
financial support for research remains ethical.229 The ethical duties of researchers, their academic freedom, the rights of patients, and the public interest should not be compromised in any way.
4.92 Those conducting research and those who manufacture surgical devices are now exposed to greater scrutiny and to regulatory control that demands considerably more attention to matters relating to consumer protection and to the minimisation of risk. The evolutionary process that is associated with the development of a surgically implantable device does necessarily include a rigorous process of R&D that will include clinical trials and post-market surveillance (PMS) of device performance. Inherent in the obligation to provide safe and effective surgical interventions it is an imperative that reliable and valid scientific and clinical evidence is available. It is acknowledged though that the interpretation of data can be particularly difficult when low levels of the
risk of adverse events are under consideration.230
4.93 It should be evident from the discussion in this chapter that drug and surgical device trials have fundamental differences. The trial of the surgical implant intervention can only rarely include control groups and randomisation is ethically open to question. The assessment of the balance between risk of harm and benefit is very much more challenging where the treatment intervention includes the surgical implantation of a device in contrast to the trial of treatment interventions involving
drugs.231 The evaluation of different implantable surgical devices such as joint replacements, heart valves and cardiac pacemakers can lack the
229 See D Spurgeon, “Report clears Researcher who broke Drug Company Agreement” (2001) 323 BMJ, 1085. 230 Professor S Shapiro, in commenting on the association between oral contraceptives and breast cancer, observed that a relative of 1-2 is "beyond the resolving power of the epidemiologic microscope" - Conference of Oral Contraceptives and Breast Cancer, Royal Society of Medicine, UK, 17 and 19 July, 1989. 231 LG Cuervo and JR Aronson, “The Road to Health Care” (2004) 329 (7456) BMJ, 1-2.
4.63 necessary control and co-ordination to permit the identification of sound
evidence that can provide valid conclusions.232 The matters relating to the trial of implantable surgical devices are clearly very complex and influenced by both desirable and undesirable factors. It is for this reason that some regulatory control of clinical trials at a national level might be beneficial and it can again be proposed that there should be a National Register of Implantable Surgical Device Trials.
4.94 In the United Kingdom the British Medical Journal has suggested233 that the criteria for a suitable registry should include –
(i) Free access, searchable, and the identification of trials with a unique number; (ii) registration of any clinical trials should be free or at minimal cost; (iii) registration information is validated; and (iv) the registered entry should include details to identify the trial and the investigator and include the status of the trial and that the registered details should also include research questions, methodology, nature of intervention, funding, and that sponsorship should be disclosed.
4.95 Any National Register of Implantable Surgical Device Trials should be simple to use, open to any general search, and should permit free access to anyone who needs to know who is studying what and where. At the present time it remains extremely difficult to identify who is studying what in Australia. For example, Orthopaedic Surgeons in different research centres, and for that matter even the TGA, can remain unaware of device trials and the results of research unless the information is published. This problem is further complicated by the fact that it is not unknown for there to have been a failure to publish negative or poor
232 Sackett D L, Wennberg J E.: Choosing the Best Research Design for Each Question. Editorial BMJ, Vol 315, No 1636, 1997. 233 K Abbasi, Editorial (2004) 329 (7467) BMJ, 638.
4.64 results that are associated with the use of new technology.234 Lieberman, in the American Journal of Bone and Joint Surgery emphasises that this can be a major problem for a number of reasons. Innovators may be tempted to “move onto to the next innovation” when it becomes evident that a device or technique does not work. Also, it may be the case that the reporting of negative results can potentially “damage an individual surgeon's reputation and financial well being”. Furthermore there can be the occasion when a surgeon will wish to “avoid conflict with the industrial partner” in the event that the manufacturer becomes reluctant to publish negative outcomes. Notwithstanding all of this, Lieberman
does also identify that it is frequently difficult to publish negative data. 235
4.96 This chapter has, once again, identified a re-emerging theme that is a constant to any debate of any surgical device product liability issue. Throughout the chain of events, with each link, that enables the evolution and the use of the surgical device, there is little obligation, on any party, other than the manufacturer or its sponsor (distributor) to notify any competent authority of the occurrence of any adverse event. PMS of already-marketed surgical devices is a vital component of the evolutionary process. The acquisition and recording of data concerning the efficacy (performance) of surgical devices is largely a voluntary undertaking that is performed by those paternal bodies and craft groups such as the Australian Orthopaedic Association, The Royal Australasian College of Surgeons, University Institutions and others. These organisations are best able to collect useful, and mostly accurate and detailed, information from their members. Unfortunately there is no working mechanism for the information that is collected by these organisations to be disseminated to other stakeholders that include, not
234 See vide supra ¶ 4.63. See also O Dyer, “GlaxoSmithKlein Faces US Law Suit Over Concealed Trial Results” (2004) 328 (7453) BMJ, 1395 - this Editorial discussed the major law suit in the USA that the British Pharmaceutical giant GlaxoSmithKlein has faced over alleged concealment of negative trial results involving its antidepressant drug, Paroxetine. One potentially beneficial consequence of this law case is that GlaxoSmithKlein will now summarise the results of all its clinical trials on its website and the data base is to be called the GSK Clinical Trial Register. The law suit was launched by New York State's Attorney General Eliot Spitzer who is reported to have accused GSK of "repeated and persistent fraud," alleging that the company suppressed data from at least four trials of the antidepressant drug. For further information see Gibson al.: “GlaxoSmithKlein to Publish Clinical Trials after US Law Suit” (2004) 328 (7455) BMJ, 1513 and O Dyer, “GlaxoSmithKlein to set up Comprehensive online Clinical Trials Register” (2004) 329 (7466) BMJ, 590-1. 235 JR Lieberman, “Ethics of Introduction of New Operative Procedures and Technology” (2003) 85A (11) JBJS, 2243-46.
4.65 only other surgeons, but also the Regulatory or Competent Authority - in Australia the TGA - and the consumer public at large.
4.97 It is evident also that whilst many innovations bring positive advantages which patients, surgeons and health care systems value, it can be the case that lack of information on their benefits and harms can be associated with unnecessary risk and may mitigate against their widespread use. In endeavouring to find a solution Dent et al have emphasised that surgeons must “better evaluate innovations and collaborate more” with colleagues
who are skilful in evaluating health technology.236 Further it is emphasised by Dent et al that manufacturers of medical devices need to do “more than the minimum required by their regulators” and to “show by research if their products change patient outcomes”. Manufacturers should also demonstrate that, if their products change patient outcomes, how the benefits and harms of any new interventional surgical procedure compares with existing treatments and even with no treatment at all.
4.98 Prosthetic implant design and manufacture continues with the expectation that each new device will be as good if not better than the existing product. Regardless of how much testing is undertaken prior to product release, it is reality that patients are the final testing ground for
any new device.237 The pursuit of integrity in research and development, the avoidance of any conflict of interest and bias, thorough post-market surveillance and the reporting of all adverse events are fundamental to the maintenance of patient safety.
236 T Dent, S Wortley and B Campbell, “New Interventional Procedures - Unlike Drugs are Implemented Despite Paucity of Evidence” (2004) 329 (7456) BMJ, 3-4. 237 WJ Maloney, “National Joint Replacement Registries: Has the Time Come?” (2001) 83A (10) JBJS, 158-85.
4.66 CHAPTER 5
THE MEDICAL and LEGAL DEFINITIONS
of
Adverse Events and Injury, and of Defective Goods and Defects, in the Context of the Surgically Implanted Device INTRODUCTION
5.1 Patients who have undergone treatment that has included the implantation of a surgical device can become dissatisfied for a great variety of reasons. The device (and the surgical procedure) can fail to live up to the consumer's expectations. The reasons for this are numerous and not all are associated with adverse events or with product defects. It must not be forgotten that the
environment of implantation is one that is hostile1 to the presence of foreign material and there can be undesirable events that are the consequence of any inflammatory response to any implantable material that has been used in the fabrication of the device. There are, though, occasions when a patient's expectations may not be achieved because of an adverse event. These are events that the medical profession have generally described as complications. The
adverse event, or the complication, may be biological in nature, e.g. infection2 or
thrombosis3, and as such these events are generally not a consequence of some imprudent action on the part of the surgeon nor necessarily related to a defect that is inherent in the implanted device. These are unwanted outcomes that can never be entirely predicted nor prevented. Also, too frequently the adverse event that complicates a patient's progress can be associated with those consequences
that may just be the normal progression of the patient's illness or disease.4
5.2 Notwithstanding the skill of even the most experienced surgeon, it remains the case that surgical history is littered with evidence and with statistics that demonstrate that no surgical undertaking can be assured of complete freedom from the unwanted outcome. Unwanted outcomes can become serious events
1 This hostility is the consequence of the inflammatory response that is the body's defence mechanism to the presence of materials, both living and innate, that are foreign and potentially harmful. 2 The infective process is caused by a microbial organism that is bacterial. 3 This condition is associated with a blood clot that can occur in deeply situated veins and be associated with small fragments of clot becoming detached. These smaller fragments are called emboli and these emboli may cause further clotting in the lungs (pulmonary embolus) that can be fatal. 4 Large randomised trials and meta-analysis of randomised controlled trials are effective in distinguishing adverse events that are caused by the underlying pathological condition from those that are related to the surgical intervention. Only proper reporting of adverse events that are associated with randomised controlled studies will permit the adequate assessment of the potential net clinical benefit of the intervention. For further information see AC Keech, SM Wonders, DI Cook & VJ Gebski, “Balancing the Outcomes: Reporting Adverse Events” (2004) 181 (4) MJA, 215-18.
5.1 and can be associated with the causation of harm to the patient.5 Entangled in
this concept of harm is the concept of injury.6 A surgical procedure that is associated with being causal for harm can be described as injurious and in the event the patient must be considered as having suffered an injury. Though adverse surgical events are mostly unintended, they are events that may have been unpreventable or, at best, potentially preventable. There is a distinction between the two that should be appreciated. The unpreventable event cannot be prevented within the current state of knowledge. In contrast the potentially preventable event [that occurs] can be the result of some identifiable substandard quantum of care or technical expertise on the part of one or more of the stakeholders concerned. Though rarely the case, a patient may suffer injury that
can be regarded as being iatrogenic in nature.7 It may be the case that the iatrogenic event - or the iatrogenic injury - can be an undesirable outcome that may be a consequence of an imprudent surgical activity or a consequence of, and causally associated with, a product defect, that can be associated with conditions
of, or with the risk of, unsafeness.8
5.3 The acceptance of the concept that a surgical procedure can be cause for injury is alien to most surgeons. Nevertheless, whatever is the attitude of individual surgeons, any hypothesis that injury can be a direct consequence of an interventional surgical procedure is an extremely important issue. The iatrogenic injury is demonstrably unwanted and undesirable and it is an event that can even be product related with respect to causation. I have a view that an iatrogenic [adverse] surgical event must stimulate and become associated with a culture of reporting that is characterised by an extremely low threshold both for the recognition and for the notification of the event.
5 The Macquarie Dictionary defines ‘harm’ as any injury, damage, or hurt, of any kind that is done or sustained. 6 In both Medicine and Law the term injury, when applied in the context of personal injury, is understood to be that condition that is associated with the suffering of harm that might be associated with a new pathological condition or be associated with the aggravation, acceleration, exacerbation or deterioration of a pre-existing, or co-existing physical or psychological condition. The concept of personal injury requires the injury to be personal and this means that the injury must involve injury to some part of the body as distinct from injury to other persons or to property. 7 See definition of iatrogenic in William AR Thomson, Black’s Medical Dictionary (23rd ed 1958). Iatric from the Greek for physician is a term meaning anything that pertains to a physician and iatrogenic is that condition, usually an undesirable disorder, that is engendered or induced by a physician. 8 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. Unsafeness, or the risk of unsafeness of the Medtel cardiac pacemaker was found to be associated with premature battery failure that was associated with the creation of short circuits that were
5.2 5.4 It is generally accepted by the medical profession that the surgical implantation of devices for the restoration or replacement of function reflects a continuing and now rapid advance of technological innovation. As we have seen in chapter 3 (n.295) cardiac pacemaker implantation and total joint replacement surgery are, and remain, the most cost effective interventions that are undertaken by surgeons of any discipline. The improvement to the quality of life that is, for example, associated with total hip and total knee replacement surgery is well
known and beyond dispute.9 Unfortunately though the failure rate that is associated with implantable device surgery is still quite high. Implanted surgical devices can and frequently do fail and the magnitude of this has already been discussed in chapter 2, The Magnitude of Therapeutic Goods Failure.
5.5 In chapter 2 there is a review of the incidence of surgical device failure in general that confirms that the failure of surgical implants is not an infrequent event. In the same chapter, in some detail, the incidence of orthopaedic surgical device failure in Australia is reported. The incidence of orthopaedic device failure in Australia is generally regarded to be an infrequent event but it can be argued that this is not a true reflection of the real circumstances. The Australian
Orthopaedic Association National Joint Replacement Register (AOANJRR)10 statistics demonstrate that device breakage and material wear was, in the financial year 2002-2003, a cause for orthopaedic device explantation in 10.6%
of all revision hip and knee surgical interventions.11 A reasonable conclusion is that one in ten of revision hip and knee surgical procedures were probably performed for the removal of a defective implanted surgical device or in circumstances associated with there being a risk of a defect.
5.6 The failure of a surgically implanted device embraces an important concept that includes the definition of failure, or of the index of failure, that is considered as that endpoint, which is identified by the need for there to be the surgical removal causally associated with dendrite formation that was established to be associated with the nature of the solder used in the construction of the device. See Ch 3 ¶ 3.14. 9 A Laupacis, R Bourne, C Rorabeck, D Feeney, C Wong, P Tugwell, K Leslie, R Bullas, “The Effect of Elective Total Hip Replacement on Health-Related Quality of Life” (1993) 75A J Bone Joint Surg, 1619-26. See also O Ethgen, O Bruyere, F Richy, C Dardennes & J Reginster, “Health-Related Quality of Life in Total Hip and Total Knee Arthroplasty” (2004) 86A (5) J Bone Joint Surg, 963-74. 10 See Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), 4th Annual Report, 2003.
5.3 (explantation) of the device and, if surgically and technically possible, the replacement with another implantable device. The nature of this surgery is for salvage and the procedures required are generally referred to as revision surgical
procedures.12 In spite of improvements in surgical technique, materials, (engineering) science, prosthetic design and methods of implant device fixation, the need for explantation of a prosthetic device is a reflection of an event that can appropriately be described as being adverse. Unfortunately for surgeons and patients alike it is an event that is associated with an incidence that is not
demonstrably declining with time.13
5.7 It can also be a conclusion that, within these introductory remarks, there is a view that, in the event of implanted surgical device failure, that is demonstrated to be causally associated with device breakage and material wear, as distinct from biological causes, the undertaking of a surgical intervention for the explantation and revision of the implanted device might reasonably be interpreted as representing nothing less than injury. Notwithstanding any success that might be associated with the revision procedure, I can find no persuasive argument that, in the event, the patient, as a consumer, has not suffered from harm that may be in some way product-related with respect to causation.
ADVERSE EVENTS AND INJURY
5.8 A view can be held that persons in general are, today, much better informed of issues relating to health care than was the case in the past and are more aware of the measurable disability of treatment associated adverse outcomes that can include death, life-threatening illness, a prolongation of hospitalisation (for
11 See Ch 2, Tables 2.1, 2.2 and 2.3. 12 The use of the term Revision is generally understood to include any surgical intervention that is undertaken for the purpose of removal and replacement of that surgical device that has failed or functioned less than optimally for whatever reasons. 13 JN Weinstein & JD Birkmeyer, The Dartmouth Atlas of Musculo-Skeletal Health Care (AHA 2000). This publication reported the revision rate for total hip replacement, in 1993, in the USA, to be 16.8% of cases and this incidence increased to 17.3% of cases in 1997. These American statistics were obtained using American Medicare data, that related to Medicare beneficiaries who are generally older than 65 years of age. It is this author's view that these statistics probably do not reflect the complete picture and it is probable that the revision (explantation) burden, when younger patients are included, is much higher than that quoted in the Dartmouth Atlas. There is no reason to believe that Australian data is any more encouraging (or accurate). The Australian Orthopaedic Association National Joint Replacement Registry (4th Annual Report) confirms (Table G1, p.6) that the revision rate for total hip and for total knee replacement devices is 13.9% and 8.8% respectively and that, with regard to both implant devices, the incidence of failure is increasing. Incidence of failure is not declining with time.
5.4 further treatment), or the occurrence of a disability that may be apparent at the
time of discharge from hospital or at some time thereafter.14 It is also the case that the reduction of the incidence of these events is a goal to which surgeons strive to achieve. On 11 June 2003 the Medico-Legal Society of NSW (Inc)
devoted its Scientific Meeting to the subject Reducing Adverse Outcomes.15 Professor Barraclough, one of two guest speakers, emphasised that -
"Reducing adverse outcomes is just one of the challenges that is facing our health system…and though we are [also] better consumers, more demanding of perfection, with greater wants, and [I] use the word wants rather than needs…adverse events are receiving considerable attention because of the age of consumerism in which we live." 16
5.9 Professor Barraclough has endeavoured to define what is meant by the term adverse event. The definition of the term has never been associated with much clarity though surgeons are frequently inclined to use the term as frequently as claimant lawyers choose to ignore its true meaning. As Professor Barraclough has so rightly stated, the definition of the term is further obscured by the public press in its convenient view that adverse events represent "doctor-error", rather than as is more frequently the case, an event that can be associated with "unintended harm". Professor Barraclough does acknowledge that "some adverse events involve negligence", though in his discussion the torchlight is directed only at the Surgeon to find a cause. Professor Barraclough is not alone in forming his conclusions and his observations are understandable as historically the torchlight of medical litigation has only rarely been focused on issues of product liability and consumer protection even when there has been
clear evidence of surgically implanted device faults17, problems and/or failure. I
14 See RM Wilson, WB Runciman, RW Gibberd, BT Harrisson, L Newby, JD Hamilton, “The Quality in Australian Health-Care Study” (1995) 163 MJA, 458-71 and C Vincent, G Neale, M Woloshynowych, “Adverse Events in British Hospitals: Preliminary Retrospective Record Review” (2001) 322 BMJ, 517-9. 15 Professor B Barraclough & M Sedgley, “Reducing Adverse Outcomes” (2003) 20 (2) Proceedings of the Medico-Legal Society of NSW (Inc), 1-12. 16 Professor Barraclough in “Reducing Adverse Outcomes”, presentation at the Scientific Meeting of the Medico-Legal Society of NSW (Inc), 11/06/03, reports that there is "…a very significant social and financial cost to adverse events. The Australian Patient Safety Foundation has suggested that about A$2 billion a year is the cost of adverse events, which is about 4% of the total spent on health across the country, an enormous amount of money, and that is when we just look at the bare basics. If we actually did those sums in the same way that we do the costings around motor vehicle accidents, we would actually come up with a number of about A$15 billion, not A$2 billion". For further reading see TA Brennan, LL Leape, N Laird, et al, “Incidents of Adverse Events and Negligence in Hospitalised Patients: Results of the Harvard Medical Practice Study I” (1991) 324 New Engl J Med, 370-76. 17 In the UK the MDA receives approximately 6,600 reported events that are variously described as adverse incidents or untoward incidents. In 1999, 6,610 reports of adverse incidents were made to the MDA. These reports showed:
5.5 sense also that the direction of the focus of attention, in the event that there are issues of medical and surgical litigation, has been driven by the fact that there is no satisfactory definition of that adverse event that is associated with the failure of a surgically implanted device. This is in contrast to those events that are associated with surgical complications in general (that may be anticipated) and with errors of technique (that can just as likely be unintended as they are imprudent) where there is a much clear understanding of that which constitutes an adverse surgical event. It is clearly important that surgical product related adverse events be more clearly defined, to permit a focus, where appropriate, onto the implanted device that may be shown to be defective, or to have a superadded risk of being defective.
5.10 There are acceptable definitions for those adverse events that occur in association with the use of pharmaceutical products and there is no general
disagreement as to the meaning of adverse drug reaction.18
5.11 The TGAct does not include any definition of that which constitutes an adverse event. Furthermore, there is no definition of defective goods, and there is no clear definition or explanation of what constitutes a defect. There is though reference to the notification of adverse events and to the notification of harmful
effects.19 The TGAct provides that the -
"…notification of any adverse event should follow the malfunction, deterioration in characteristic or performance…or following any…inadequacy with respect to design production, labelling and instruction for use or advertising…that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health…or
(a) that 37% involved manufacturing problems (design, quality control, packaging etc); (b) that 27% of device faults developed during use; (c) that 12% of device faults were associated with user error; and (d) that in 24% of cases there was no link between the adverse incident and device failure. For further information see G Roberts, Risk and Management Methods in Risk Management in Health Care (2nd ed 2002). 18 The definition of adverse events adopted by the International Conference on Harmonisation, and adopted by the TGA in Australia concerns only that untoward medical occurrence in a patient or clinical investigation subject following the administration of a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. For futher information see the TGA Guidance Notes on Good Clinical Practice (CPMP/ICH/135/95) and on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). 19 See TGAct s.41MP (notification of adverse events), s.29A (notification of adverse effects).
5.6 information20…that has led the manufacturer to take steps to recover devices of that kind that have been distributed."
With regard to the notification of harmful effects the TGAct requires notification in circumstances associated with there being …
"…unintended harmful effect…or in the event that a device…may not be as effective…as intended." (my edits).
In contrast though, there is, in the Therapeutic Goods (Medical Devices)
Regulations 200221 a definition of what is intended by the meaning of serious, and it is the author's view that the definition reflects an extremely low threshold
for the use of the descriptive.22
5.12 The definition of adverse event that is to be found in the Harvard Medical
Practice Study 1990 probably comes closer to being adequate.23 There, an adverse event is defined as -
"…an unintended injury (my emphasis) that was caused by medical management that resulted in measurable disability…"
5.13 The Harvard Study, like others that have followed,24 considered only serious adverse events that were biological with respect to causation as distinct from events that were device (or product) related. Whilst the Harvard definition of the adverse event is appropriate to, and probably nearest to acceptance in the
20 Information is to include matters of a technical and/or a medical nature. 21 Dictionary (Regulation 1.3) p.147. 22 Serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is: (a) Generally accepted as not being appropriate to be diagnosed or treated without consulting a medical practitioner, dentist or other kind of healthcare worker registered under the law of a State or Territory; or (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without supervision by a medical practitioner, dentist or other kind of healthcare worker registered under a law of a State or Territory. 23 See TA Brennan, LL Leape, NM Laird, L Hebert, AR Localio, AG Lawthers, JP Newhouse, PC Weiler & HH Hiadt, “Incidents of Adverse Events in Negligence in Hospitalised Patients: Results of the Harvard Medical Practice Study I” (1991) 324 New Eng J Med, 370-76 and LL Leape, TA Brennan, NM Laird, AG Lawthers, AR Localio, BA Barnes, L Hebert, JP Newhouse, PC Weiler & HH Hiadt, “The Nature of Adverse Events in Hospitalised Patients: Results from the Harvard Medical Practice Study II” (1991) 324 New Eng J Med, 377-84. See also Lucian L Leape, “The Preventability of Medical Injury” in MS Bogner (ed), Human Error in Medicine (1994) 13. 24 R Bellomo, D Goldsmith, S Russell & S Uchino, “Post-operative Serious Adverse Events in a Teaching Hospital: A Prospective Study” (2003) 176 MJA, 216-18.
5.7 practice of general medicine, the focus of the definition is too narrow when used to describe implantable surgical product-related events, where the incident may be more of a mechanical (device-related) than a biological event.
5.14 Surgery in general and implant surgery in particular are undertakings that are in reality not too dissimilar from those activities that we normally expect to be associated with high risk industries. Implant Surgery is, in many senses, comparable to other industries such as Public Transport, Defence and the Airline industry. I make no apology for raising this issue as in every high risk industry there is generally a systematic approach to safety that is dependent upon a clear understanding of that incident that represents an adverse event. This appreciation of the adverse event is able to generate a pro-active culture of safety and risk avoidance within which the reporting of adverse events is not only mandatory, but routine. Professor Barraclough also compared our Health
Care System with the operations of Airlines.25 He has compared Doctors with Pilots, and he has emphasised that there are many lessons that we can learn from the Aviation Industry about systems of safety, about risk management and about a safe reporting culture.
5.15 In respect of a safe reporting culture it is appropriate and instructive, to review and to consider that guidance provided for the Medical Profession by the
Medical Devices Agency (MDA)26 in the United Kingdom. The MDA in the United Kingdom has very clearly defined and enunciated those events that
require reporting as adverse device-related incidents27 and as we shall see the threshold for reporting is quite low. The MDA ensures that the Medical Devices
Directive28, through the relevant National Regulations29 will require that
manufacturers and/or sponsors notify the relevant competent authority30 in the event that:
25 See vide supra n.15 at 3. 26 The MDA in the United Kingdom is the competent authority that is the equivalent of the TGA in Australia. 27 See Guidance on the Medical Devices Vigilance System for CE Marked Joint Replacement Implants, published by the Medical Devices Agency, UK 1998. 28 93/42/EEC. 29 UK Statutory Instrument - SI 1994 No 3017.
5.8 (a) They know of any implant deterioration or malfunction, or any inadequacy in instructions for use which has led, or might lead, to the death of a patient or serious deterioration in his/her state of health; or (b) the implant has been recalled for medical or technical reasons to prevent deterioration in the state of health referred to above.
5.16 In Australia, the TGA requires that manufacturers should notify sponsors, and/or the TGA, of any adverse event and of any near event. These are events that
include31 -
(a) any malfunction or deterioration in the characteristics or performance; (b) any inadequacy in the design, production, labelling, instructions for use, advertising material; or (c) events associated with any use in accordance with, or contrary to the intended use.
It is also a requirement that manufacturers should inform the TGA of -
(a) information relating to any technical or medical reason for a malfunction or deterioration that has led the manufacturer to take steps to recover devices that have been distributed; (b) information that is related to any proposed recall action that may have been undertaken overseas prior to any recall action in Australia; (c) information that indicates that a device does not comply with the essential principles; and
30 This is also the policy of the TGA in Australia. See TGA Guidance Document Post Market Activities Australian Medical Device Guidelines, Guidance Document, No 11, version 1.7. 31 From Keith Smith, Medical Device Assessment Section, Therapeutic Goods Administration, Office of Devices, Blood & Tissues, presentation Conformity Assessment Procedures, Department of Medical Physics, Royal Perth Hospital, 25 May 2004. See also Ch 3, ¶3.68-3.95.
5.9 (d) information that indicates that a certificate (other than one issued by the TGA) has been restricted, suspended, revoked or
is no longer in effect.32
The TGA also has identified a number of exemptions to reporting requirements and these include -
(a) Problems that are noted before the use of a device; (b) adverse events that are related only to the patient's condition; (c) events that are related to the service life of a device; (d) events that have occurred when fail-safe mechanisms have functioned correctly; (e) events that are associated only with a remote likelihood of occurrence or serious injury; (f) expected and foreseeable side effects that are documented in instructions for use or labelling of the device; (g) adverse events described in an Advisory Notice (unless the severity or frequency has changed); and (h) other exemptions that may be granted by the TGA from time to time.
5.17 The guidance that has been provided by the MDA in the United Kingdom specifically considers the question as to whether or not a revision surgical incident, with or without device explantation, is reportable as an adverse event. The MDA has clearly retained the view that orthopaedic revision (salvage)
arthroplasty events are reportable33 as adverse device-related incidents, in the event that there has been;
32 These certificates may relate to compliance with the Essential Principles or Conformity Assessment Procedures. TGAct s.41BA (Requirement for Medical Devices (Parts 4-2 and 4-3)), s.41BH (Meaning of Compliance with Essential Principals), s.41BI (Meaning of Non-application of Conformity Assessment Procedures), s. 41CA (Essential Principals), s.41DA (Conformity and Assessment Procedures) and Part 4-4 (Conformity Assessment Certificates, ss41E and 41EA to 41EW). 33 My enquiry of colleagues in Australia and in the United Kingdom has caused me to suspect that there is no great general awareness amongst Orthopaedic Surgeons that there are specific orthopaedic device-related events that, in contrast to other recognised surgical complications, do, in the European Economic Community, attract an obligatory requirement that the particular device-related event be notified to a Competent Authority.
5.10 (a) Mechanical failure: Surgical (or salvage) revision procedures carried out because of mechanical failure of the implant (however long it has been implanted), are considered to be a malfunction or deterioration of the implant and are therefore reportable unless there is clear evidence that the main cause for failure was not implant related. Examples of such cases include: i. Inappropriate implant selection; ii. Misalignment/malpositioning during implantation; iii. Failure of the (bone) cement mantle in cemented implants.
(b) Aseptic loosening34: Revision procedures carried out primarily because of aseptic loosening within the expected life of the device (as specified in the information supplied with the implant by the manufacturer) are also considered to be a malfunction or deterioration of the implant and are also reportable. Where the expected life of the implant is not specified, revisions carried out because of aseptic loosening within ten years of primary implantation should be reported. (c) Reasons for revisions that are not clear: In some cases, the reason for revision may not be well defined or may involve a number of aetiological factors. Under these circumstances the incident should be reported.
5.18 It is evident that, in the United Kingdom, the definition of an adverse event, when considered in the context of the surgically implanted orthopaedic device failure incident that should be reported, is much broader than is the case in Australia. It is also the case that, in the United Kingdom, the threshold to report adverse events is considerably lower than is the case that is generally recognised
and accepted in Australia.35 Furthermore, in Australia, it is mandatory only for the manufacturer (or sponsor) to report such events to the TGA. It is also well
34 Aseptic loosening is that condition where there is a failure of fixation of an implanted device that is not associated with infection (or inflammation). In contrast, septic loosening is causally associated by infection by a bacterial organism. In general aseptic loosening is causally associated with a failure of fixation that is mechanical in its origins.
5.11 known by the TGA that there is evidence that a substantial number of medical device adverse events and malfunctions are not reported by other stakeholders to
the manufacturer nor to the TGA.36
5.19 The European Commission Guidelines require that the reporting of adverse events be undertaken without delay and it is suggested that the maximum elapsed times for determining the relevant facts in making an initial report of an
adverse event should be 10 days for incidents and 30 days for near incidents.37 For orthopaedic revision (salvage) arthroplasty procedures, which are reportable, notification of the competent authority should be undertaken within 10 days of advice that a revision procedure has taken place. My review of the Australian
Orthopaedic Registry38 has left me in no doubt as to the conclusion that it remains more usually than not the case that the orthopaedic revision (or salvage) surgical arthroplasty incident is an event that has not been considered to be an
adverse event that has required there to be a report to any competent authority39, nor to any other organisation or stakeholder for that matter.
5.20 In summary, I am conscious of the fact that adverse events are incidents that are associated with less than optimal results when measured against the expectations of patients and surgeons. It is appropriate also to observe that the adverse event recognises a surgical incident that is inevitably characterised by injury (harm) to, and/or a measurable disability, for the patient concerned. In the circumstances a satisfactory definition of adverse event might be;
35 For example, in the event of there being an adverse event following the implantation of an orthopaedic implant it remains the case that the TGA only requires that there is an adverse event report in the event of there being a need for a premature revision of the orthopaedic implant that is causally associated only with the consequences of loosening or fracture of the implant. 36 M Flood, (Application Entry and Co-ordination Office of Devices, Blood and Tissues, TGA, Canberra), “Conformity Assessment Procedures, Post Market Responsibilities, and Mutual Recognition Agreement with the EU”, Presentation to the Department of Medical Physics, Royal Perth Hospital, 25 May 2004. In regard to under-reporting Flood stated that "to err is human, but not to learn from our mistakes, and not to pass on what we learnt to others in order to prevent injury is unforgivable." 37 In the context of there being an unexpected complication following the use of an implantable surgical device, revision (salvage) arthroplasty surgery is not considered to be a near incident. The event is an incident. 38 Australian Orthopaedic Association National Joint Replacement Registry, 4th Annual Report, 2003. The 4th Annual Report, 2003, reviewed Hip and Knee Replacement procedures during the period September 1999 to December 2002. During that period of review 7,216 revision hip procedures, and 4,859 revision knee procedures were known to have been undertaken. Only 15.2% (n1095) revision hip procedures, and 24.6% (n1193) revision knee procedures were undertaken for reasons that did not fit the MDA definition of an adverse event. The Registry reported that of 12,075 revision orthopaedic surgical interventions, 9,787 interventions, or 81.1%, were undertaken for a reason where there probably was a causal nexus between the need for further surgical intervention and an implantable device product-related event. 39 As we have previously seen the Competent Authority in Australia is the TGA.
5.12 An implantable surgical device adverse event is that unintended, preventable or potentially preventable event, that is characterized by the presence of a causal nexus with the surgical implantation or explantation of a surgical device, and/or with the existence of a defect or superadded risk of a defect, that results in death, or a life threatening illness, and/or in the prolongation of the anticipated hospital stay, and/or re- operation, and/or a measurable temporary or permanent disability for the patient (the consumer).
DEFECTS AND DEFECTIVE SURGICALLY IMPLANTABLE DEVICES
5.21 For the genesis of any product liability claim it is a fundamental requirement
that a defect, or a superadded risk40 of a defect, can be shown to be a characteristic of an implantable or implanted surgical device - the defective device (product). It is just as elementary that, for there to be any successful recovery or redress for a claimant, and no less with regard to the defendant's position, that any claim will inevitably be reliant upon the nature of the defect. It naturally follows that it is cardinal to any surgical device product liability claim that the meanings of defect and defective are understood and agreed to by all concerned. The term defect is not self-defining. There is a statutory
definition but this applies only to certain causes of action.41 There is no universally accepted meaning that is suitable for every product liability issue. Courts have struggled with the problem of elucidating the meaning of defect and the struggle is characterized by the many theories that have evolved to test
whether or not a product is defective.42
40 See Courtney v. Medtel Pty Ltd [2003] FCA 36; BC200300120. 41 As we have seen in n.8 in Ch 3 the TPA s.75AC, defines goods as having a defect if their safety is not such as persons are generally entitled to expect and s.75AK sets out a number of specific defences that are available to manufacturers. 42 These theories, mostly having their origins in the United States, include the Consumer Expectation Test, the Risk-Utility Test, the Reasonably Prudent Manufacturer Test, and the Alternative Safer-Design Test. See also A & Anors v. National Blood Authority and Anors [2001] 3 All ER 289.
5.13 5.22 Black’s Law Dictionary43 defines the defective condition as follows:
"A product is in a defective condition unreasonably dangerous to the user when it has a propensity for causing physical harm beyond that which would be contemplated by the ordinary user or consumer who purchases it, with the ordinary knowledge common to the foreseeable class of users as to its characteristics. A product is not defective or unreasonably dangerous merely because it is possible to be injured while using it."
There can be no great criticism of this definition but it is permissible to suggest that the terminology unreasonably dangerous is perhaps not the most appropriate descriptive to be used in the context of the surgically implantable device. It is the author's preferred view that the defective implantable surgical device is just that because the device is unreasonably unsafe to the user when it has a propensity for causing physical harm.
5.23 Butterworth’s Concise Australian Legal Dictionary44 defines a defective product as: "A product which is flawed and therefore unfit for its intended or contemplated use or purpose, and not of merchantable quality, as a result of negligence in its design, manufacturing, or marketing."
5.24 For the purposes of the TPA defective goods are goods that are not as safe as
persons are generally entitled to expect.45 The definition does not require that goods be absolutely free from risk though the level of safety is that which the
community46 at large is entitled to expect.47
5.25 In negligence claims a defective product is considered to be a product that is imperfect and unreasonably unfit for its intended or contemplated use or
43 Black’s Law Dictionary (5th ed 1979) 377. 44 Butterworth’s Concise Australian Legal Dictionary (2nd ed 1998) 119. 45 s.75 AC(1) of the TPA does not require goods to be absolutely free from risk. Here the test is the objective knowledge and the expectations of the community, rather than the subjective knowledge and the expectations of the injured party, the individual. 46 ACCC v. Glendale Chemical Products Pty Limited; Barnes v. Glendale Chemical Products Pty Ltd [1998] ATPR ¶41-632; Glendale Chemical Products Pty Ltd v. ACCC & Anor (1999) ATPR ¶41-672. ACCC v. Glendale Chemical Products Pty Limited [1998] 40 IPR 619; ATPR 41-632 (Glendale Chemicals). See also s.75AC (1) TPA; Fair Trading Act 1987 (NSW) s.34(1) and Article 6(1) of the Medical Devices Directive 93/42/EEC 14 June 1993. 47 Fair Trading Act 1987 (NSW) s.34(1). For the purpose of NSW Consumer Protection Legislation, defective goods are those goods that do not comply with a safety standard, are the subject of a question referred to the Product Safety Committee, are the subject of a report by the Committee, or are the subject of a banning order.
5.14 purpose, and not of merchantable quality, for reasons that are the consequence of negligence on the part of the manufacturer in respect of the product design, manufacturing, or marketing (labelling and instructions for use). The defect, or imperfection, must be identifiable. This can be difficult for any consumer.
Freeman et al48 discussed the burden of having to prove defect and causation in product liability claims and emphasised that the [perceived] difficulties largely arose from
"…a lack of legal or other resources needed to investigate them properly, or to an inability to gain access to essential information…that is…particularly acute in relation to technical products, or where the alleged injuries are of a complicated nature." (My edit)
The notion of defect, in negligence, implies an imperfection, not only of the product itself, but also with regard to the conduct of the manufacturer. In this sense the issue of a defect focuses more on the manufacturer as an entity, in contrast to the focus being [only] directed at the device itself.
5.26 I have the view, that, in a generic sense, a defective surgical device is represented by that state that is associated with the device being characterised by
a deficiency, or with a lack of something that is essential to its completeness49, or alternatively to an imperfection that causes the device to be unsafe, or not as safe
as persons might generally be entitled to expect.50 In this sense the definition of defect will include that element that is introduced into, or omitted from, the product at the stage of formulating the manufacturing or processing of the
product, that might be a consequence of an error in scientific judgement.51
48 R Freeman, J Meltzer, & S Thomson, “Report on Product Liability in the European Union” (2003) 14 (5) Australian Product Liability Reporter, 65-71. The authors also report that "Producers and insurers, on the other hand, are concerned that any relaxation of the rules relating to the burden of proof might have the effect of encouraging 'spurious claims'. Indeed, some producers suggest that there should be a greater obligation on claims to substantiate claims in the early stages of proceedings." 49 Tait v. Latham & Son (1987) 66 LJQB 349. 50 TPA s.75AC(1); Fair Trading Act 1987 (NSW). 51 The use of Titanium and Titanium alloys as bearing surfaces in the fabrication of total hip and total knee replacement devices is an example of an error of scientific judgement with regard to the suitability of a material for use for the fabrication of an articulating surface. The classic example of this relates to the Miller Galante I femoral knee component replacement device manufactured by the Zimmer Corporation in the early 1990s.
5.15 5.27 In all of these conceptions, the factors that may be taken into account in determining the safety of surgical implants, or conversely lack of safety, include,
(as is the case with products in general), the design52, formulation,
manufacturing53, packaging54, or labelling55 of those products, or the provision of
that information concerning the use of the device.56 A defect can also include an
error or omission in the information57 that is presented with the device and which
can cause the use of device to be unsafe or ineffective.58 All of these factors are
determined by mandatory regulatory standards.59 Implantable surgical devices should be regarded as safe in the event that there has been compliance with all
52 Manufacturers are liable for harm caused by their failure to take reasonable care to ensure that a product has been safely designed, see Hindustan Steam Shipping Co Ltd v. Siemen's Bros & Co [1955] 1 Lloyd's Rep 167. Design defects of surgical implants attributable to negligence is elusive. However see Ch 2, Case 1 ¶2.44. Though manufacturers cannot, by definition, be liable in negligence for not knowing about undiscoverable defects, some cases have suggested that a higher standard of care is expected, especially in the research that goes into the design of intrinsically dangerous or novel products, see Vacwell Engineering Co Ltd v. BDH Chemicals Ltd [1971] QB 88, 109. The important question here is whether the manufacturer ought to have been able to foresee that the device had a potential danger that was of the nature of a defect that was probably associated with some imperfection or aberration of its design. Implicit in the question of foreseeability is the nature of the research and reasonableness of the steps that were taken by the manufacturer to identify the functional performance of the device in a mechanical environment consistent with the intended use. In this respect the conduct of the manufacturer can include a scrutiny of the in-vitro biomechanical testing that had been undertaken, actual scientific knowledge, biomechanical testing, pre-clinical work and clinical trials - actual scientific knowledge. The performance of the manufacturer will also be judged by a scrutiny of his constructive knowledge that is reported in the international literature in relation to the performance of similar classes of devices. See Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. The outcome in the Courtney v. Medtel case was similar to that in the Shiley Heart Valve Class Action Settlement, which included foreign claimants, where payments were also made despite the absence of injury - reported in The Guardian 24 March 1992 UK. 53 Where it is strongly the evidence that the defendant has a carefully regulated quality control system in the manufacturing process, the more likely it is that a particular defect will be attributed to negligence in the production process. - See Grant v. Australian Knitting Mills Ltd [1936] AC 85 101. 54 Packaging must be such that a product, if sterile, can be maintained in a sterile state, can be protected from deterioration, and protected from tampering. Notwithstanding the nature of the packaging, inappropriate storage of surgical orthopaedic implants has been causal for the poor performance of certain devices, particularly those orthopaedic devices fabricated from ultra high molecular weight polyethylene (UHMWP). This material is known to perform poorly after prolonged periods of storage that cause deterioration of the polymer chains, associated with increasing brittleness, and poor resistance to wear. 55 The inadequate labelling or instructions for use, as distinct from the inherent design of a product, can be cause for exposure to liability, see Wormell v. RHM Agriculture (East) Ltd [1986] 1 All ER 769, [1986] 1 WLR 336; applied in Amstrad PLC v. Seagate Technology Inc (1997) 86 BLR 34. See also ACCC v. The Glendale Chemical Products Pty Ltd [1998] ATPR 41 6-32; [1999] ATPR 41-672. 56 TPA s.75AC(2). Risks must not be minimised by promotional material, see Independent Broadcasting Authority v. EMI Electronics Ltd & BICC Construction Ltd (1980) 14 BILL LR, 1,HL,28 PER Lord Edmund-Davies. There can be liability from injury resulting from a reasonably foreseeable misuse which has not been warned against. Where there has been a total failure to warn there is little scope for a defence such as a contributory negligence. 57 With respect to warnings and instructions (marketing defects) it is the case that failure to warn claims are now the most common form of litigated product cases in the USA, see J Stapleton, Product Liability (1994) 252. Manufacturers are required to make available all information that will enable products to be used safely – see Holmes v Ashford [1950] 2 All ER 76 CA; and warnings must be readily intelligible and commensurate with risks – see Vacwell Engineering Ltd v. EDH Chemicals Ltd [1971] 1 QB 111 CA; [1971] 1 QB 88. See also EC Directive 92/28/EEC, OJ-30.4.92, L 113/13, as implemented by the Medicines Advertising Regulations - 1994, S1 1994/1932 and by the Medicines (Monitoring of Advertising) Regulations 1994, S1 1994/1933 directs that risks must not be minimised by promotional material. Where there has been a total failure to warn there is little scope for any defence such as contributory negligence or volenti as the user will normally have been unaware of any danger. The Court must be satisfied that the claimant would not have used the product had a proper warning been given – see H v. Royal Alexandra Hospital for Children [1990] 1 Med LR 297 SC of NSW. 58 Ultra-High Molecular Weight Polyethylene implants are thermo-plastic polymers that can seriously deteriorate if sterilised, prior to implantation, in autoclave high temperature environment. In the event that this is not made known to the user then the defect in information is in the form of a failure to warn adequately of a risk. There is also a failure to produce adequate instructions as to the safe or effective use of the device. As distinct from omission, inaccurate information can also render a device as unsafe or ineffective. 59 Mandatory standard is defined in s.75 AA of the TPA. Compliance with regulatory requirements is discussed in more detail in chapter 3.
5.16 statutory and regulatory conditions.60 Adherence to regulatory requirements or legislation should ensure a satisfactory defence for a manufacturer and there
should be no inference61 that an implant device was not safe, not fit for the intended purpose, or was unmerchantable when the device complied with a Commonwealth mandatory standard even though the standard in place may not have been the safest possible standard with regard to the latest state of scientific
or technical knowledge62 at the time when the implant was supplied by the
manufacturer.63
5.28 Whatever definitions of defective and defect are acceptable and determined to be appropriate it is implicit in the term defect that it must be possible to compare the defective device with a standard and in doing so be able to identify that the
defective product is flawed or is non-standard, or is at risk of being so.64 Burton
J, in A & Anors v. National Blood Authority & Anors65 discusses this point most
eloquently. Whilst I have already reviewed this case in Chapter 366 it is appropriate to again consider the conclusion made by Burton J. Burton J drew a distinction between "standard" and "non-standard" products. "Standard" products reflect the method of design and the standard of safety that is intended by the manufacturer. A "non-standard" product is a particular unit of the
product that does not meet that standard.67 In A & Anors v. National Blood
60 See TGAct, Therapeutic Goods Amendment (Medical Devices) Act 2002, and Therapeutic Goods (Medical Devices) Regulations 2002. See also TPA s.75AC(4)(an inference that goods have a defect is not to be made only because; (a) there was compliance with a Commonwealth mandatory standard for them; and (b) that standard was not the safest possible standard having regard to the latest state of scientific or technical knowledge when they were supplied by the manufacturer), s.75AL (this section provides that if the “mandatory standard” defence in s.75AK(1)(b) is established by the defendant, the Commonwealth shall be liable), and s.75A(1)(b). 61 Though not obviously of direct relevance, see Crimmins (as Executrix of Estate of Crimmins dec'd) The Stevedoring Industry Finance Company [1999] HCA 59 for the foundations of a contrary hypothesis. 62 See Hansen v. Baxter Health Care Corp., 2002 WL 93106 (Ill.2002) - this is an important medical device product liability case that, amongst other issues, demonstrated the very real issue of the legal dilemma that is created when a company introduces a safer product. The question is, can the new and the old products both exist in the marketplace at the same time, or does the safer produce mean that the old product is de facto defective? The technology at issue in this case was intravenous tubing whose junctions were associated with friction fit couplings and new technology that was associated with connections that included a Luer-lock. The claimant, when recovering from major surgery, suffered an ultimately fatal air embolism. The air embolism was found to be causally associated with the disconnection of a friction fit intravenous line connection. The jury rendered a general verdict for the claimant that was, on Appeal, found by the Appellate Court to justify the verdict on the basis of there being a defective-design. It was found that the friction fitting was defective because it could, and did, come apart due to patient movement. 63 TPA s.75 AC(4) (a & b), here though is left the possibility that goods could still be held to be defective considering the meaning of “only because” in s.75AK(1)(b)(the defence that the goods had a (that) defect only because there was compliance with a mandartory standard for them). 64 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. The issue for the purpose of Pt VA of the TPA is that a “standard” product may be “defective” if it is not as safe as persons generally are entitled to expect. The concept is that a product can be defective in the event that it fails to live up to the reasonable expectation of the user. 65 [2001] EWHC QB 446 (26 March 2001). See also n.25 &26, Ch 3. 66 Ch 3, n.8. 67 Burton J, in reference to defective products, in A & Anors v. National Blood Authority & Anors [2001] EWHC QB 446 at 36, observes that “…in course of Mr Forrester’s QC’s submission other more attractive or suitable descriptions (of defective products – my edit) were canvassed. I have firmly settled on what I clearly prefer, namely the “non-standard” product. Thus a standard product is one which is and performs as the producer intends, a non-standard product is one which is different, obviously because it
5.17 Authority & Anors, the Court held that infected blood products were non- standard. The Court suggested it might be easier to prove the existence of a defect where the product was non-standard, since it would fail to be compared with the standard product. The problem with this argument is that the product is only non-standard if it is defective, but whether it is defective could be affected by whether it is or is not non-standard. The Court envisaged that a non-standard product was one that was defective in a non-technical sense. Even this might be disputed.
5.29 With regard to that which makes a product defective Burton J firmly settled on terminology that he clearly preferred, namely the "non-standard" product. Burton J. continued [at 36]:
"Thus a standard product is one which is and performs as the producer intends, a non-standard product is one which is different, obviously because it is deficient or inferior in terms of safety, from the standard product: and where it is the harmful characteristic or characteristics present in the non- standard product but not in the standard products, which has or have caused the material injury or damage…namely that they are what is called in the United States 'rogue products' or 'lemons', and in Germany an 'Ausreisser' - escapees or 'off the road' products."
5.30 In any consideration of the definition of the defective surgically implantable device I have the view that the conclusions of Burton J represent the more
appropriate of all of the definitions that have been considered.68 The basis for this definition of a defective product is a lack of safety that is determined by the
is deficient or inferior in terms of safety, from the standard product: and where it is the harmful characteristic or characteristics present in the non-standard product but not in the standard product, which has or have caused the material injury or damage … namely that they are what is called in the United States “rogue products” or “lemons”, and in Germany an “Ausreisser” – escapees or “off the road” products”. It is interesting to compare the attitude of Burton J with the judgement in Graham Barclay Oysters Pty Ltd v. Ryan (2002) 194 ALR 337; BC200207277; [2002] HCA 54, Ryan v. Great Lakes Council [1999] FCA 177; BC 9900565; (1999) ATPR 46 191, E v. Australia Red Cross Society (1991) 27 FCR 310; and Regal Pearl Pty Ltd v. Stewart [2002] NSWCA 291. It can also be instructive to hypothesise as to the consequences of the contamination of blood or blood products by the variant Creutzfeldt-Jakob organism that causes Creutzfeldt-Jakob Disease (vCJD) where the issues faced are more parlous than for HIV- AIDS. As yet there is no blood test for vCJD and no cure. It is clear that people who have received blood or blood products that are highly at risk for vCJD were now to be managed as if vCJD had been diagnosed. In the United Kingdom there has already been one death from vCJD. The first victim died after being transfused blood (1996) donated by a donor who had been incubating vCJD. See also MS Bird, “Recipients of Blood or Blood Products at vCJD Risk” (2004) 326 (7432) BMJ, 1118-19. 68 It is important to appreciate that for some non surgical products goods may perform as the producer intended yet still be not a safe as persons generally expect. This is particularly the case with childrens’ toys.
5.18 consumer expectation test69 and this definition is reflected in the European
Directive.70 The definition of an implantable surgical device as being a non- standard product must include the imperative as is to enquire as to what the public generally, as distinct from the individual, can be entitled to expect of the safety that is a characteristic of the standard product.
5.31 As we have seen in Chapter 3 (¶3.41-3.56), where a surgical device is determined to be non-standard or to have a defect and to be defective then the TPA imposes strict liability upon manufacturers with respect to devices that can
be found to be unfit for their purpose or are not of merchantable quality.71
5.32 In consideration of the concepts of defect and defective it is appropriate to briefly consider and to recognise the influence of technological advance on these concepts. Undoubtedly innovative technology has the potential to render previously tried and tested devices obsolete. A question that can be asked is whether obsolescence sine qua non constitutes a precondition for unsafeness. Generally a surgical device should not be considered defective for the sole reason that a better device has subsequently entered the marketplace. Whilst it is perhaps logical to conclude that where technological evolution has permitted the introduction of a better device the fundamental issue is as to whether or not a device that was implanted, for example, ten years ago, is said to be defective should be determined by considerations of whether or not the product was defective at the time when the product was supplied or placed into general
medical market circulation.72
69 Consumer Expectation Test – the safety of a device should be tested against the expectation of persons generally rather than against the expectation of a particular consumer. All surgical devices carry risk of adverse events and any test which relies on a consumer’s expectation can present extreme difficulties by the very nature of being too restrictive. As with most aspects of medicine and surgery the risk of treatment must therefore be carefully balanced against a consideration of those anticipated benefits. 70 See Council Directive 85/374/EEC. Here defective is defined not in the context of a product's fitness for use, but rather if the product lacks the degree of safety which the public at large is entitled to expect. Safety is also assessed by excluding any misuse of the product that is not reasonable under the circumstances. This definition is different from the interpretation in the USA, where it is generally expected that products are defective only if it can be demonstrated that they were not manufactured according to the manufacturer’s specifications. Also within the European Directive a product can also be considered defective (See Article 6 of 85/374/EEC) if it can be demonstrated that the product does not provide the degree of safety that a person (the individual) is entitled to expect, taking into account those circumstances including: (a) the presentation (including instructions and warnings) of the product; (b) the use to which the product could reasonably be expected; and (c) the time when the product was put into circulation. 71 TPA, ss.74B and 74D of Div 2A Pt V. A surgical device is defective within the meaning of s.74 AC of the TPA if it is not as safe as persons are generally entitled to expect, and a device with a defect, that renders the device unsafe for use, is defective within the meaning of s.75 AC of the TPA. 72 TPA s.75 AC(3).
5.19 CONCLUSION
5.33 It is the author's preferred view that, in the context of product liability issues relating to implantable surgical devices, an adverse event should be regarded as -
…an unintended, preventable or potentially preventable event, that is characterised by the presence of a causal nexus with the surgical implantation or explantation of a surgical device, and/or with the existence of a defect or superadded risk of a defect, that results in death, or a life-threatening illness, and/or in the prolongation of the anticipated hospital stay, and/or re-operation, and/or a measurable temporary or permanent disability for the patient (the consumer).
Furthermore it is also the author's conclusion that, where an adverse event, can be shown to be causally associated with a product defect, or with a risk of a defect, then the surgical procedure associated with the implantation and/or with the explantation of the device represents an event that is nothing less than injury.
5.34 With respect to the concepts of defect and of defective surgically implantable goods it is now the case that the super added risk of a defect and the actual state of being defective are equally as much a cause for there to be an exposure to
liability.73 There is no persuasive argument to the contrary that implantable surgical goods have a defect if their safety is not such as persons generally are entitled to expect and that the defective surgical implant is a non-standard product and can be distinguished from the safe or standard implantable surgical product. With respect to the concept of risk it is also the author's preferred view that any risk should be seen to be a risk that is a reasonable or serious risk as
distinct from a minimal risk.74 It has to be accepted that some surgical products, will by their very nature, (as can the activities of daily living), present unavoidable risks to consumers. I also have the view that when considering the
73 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. 74 See Ch 4, Beneficence, ¶4.19-4.28.
5.20 concepts of defect and defectiveness, that the term dangerous is not the most appropriate descriptive when there is a consideration of implantable surgical
device safety or otherwise.75 The concepts of risk and of serious risk have been
particularly well described by Professor Runciman in addressing76 how safe our hospitals are - the converse to risk. Runciman provided what he described as a "crude analogy" -
"…if you have a puncture in your car tyre, it's not the same problem as running out of fuel. Clearly to run out of fuel is a risk but to experience a puncture in your car tyre is a serious risk."
5.35 With regard to the meaning of the term defective when the term is applied to any issue of surgically implantable device failure, I have settled on the following definition -
The implantable surgical device is defective or at risk of being defective when;
(a) there is a malfunction or deterioration of device characteristics that is causally due to inadequacy of design, and/or of manufacturing, and/or of the labelling and/or of the instructions for use; (b) it can be identified that something has been omitted from or introduced into the device that renders the device imperfect and/or unreasonably unfit for surgical implantation and for its use or contemplated use or purpose; (c) the device is not of merchantable quality; (d) the device is a non-standard product that has a propensity for causing harm because it is deficient or inferior in terms
75 Though danger is consistent with there being a risk of exposure to harm or injury the term dangerous applies also to an environment that is perilous and probably reflects negligence, rather than matters relating to product liability. 76 See Weekend Health, The Australian, 24-25 January 2004, 1. This article is authored by Professor Runciman who is President of the Australian Patient Safety Foundation.
5.21 of safety or has harmful characteristics that are not present in the standard product; or when (e) the device is unsafe, not as safe, or where safety is not as such as persons generally are entitled to expect.
5.36 In contrast an implantable surgical device is not defective or at risk of being defective in the event that -
(a) it is solely the case that there is a better product in the market; (b) there was no defect, or risk of being or becoming defective at the time the product was supplied or put into the marketplace; (c) it is merely possible to be injured whilst using the device; and (d) where the main cause for any adverse event was not surgical implant device related with the respect to causation.
5.37 In this chapter there has been an endeavour to form an interpretation of those terms, adverse event, injury, defective goods and defect that is appropriate to those (surgical) circumstances that become associated with there being a therapeutic indication for the removal (explantation) of an implanted surgical device in the event that the performance of the device has become associated with an undesirable expectation or risk of unsafeness or with the frank failure of function for one reason or another. However, the mere fact that a surgical device presents a risk to a patient does not indicate that the manufacturer has
failed to meet general safety requirements77 and although there might be a risk, the device may still be as safe as persons generally are entitled to expect.
77 The test is whether the product presents only the minimum risks compatible with the use of the device. A serious risk is any serious risk which includes those risks the effect of which are not immediate but which require rapid intervention by Regulatory Authorities.
5.22 CHAPTER 6
IMPLANTABLE SURGICAL DEVICE
MANUFACTURERS'
DEFENCES TO LIABILITY INTRODUCTION
6.1 There are a number of defences that can be available to the manufacturers1 of allegedly defective surgical implants. These defences can lessen, or defeat the liability to compensate patients, who as consumers, have suffered injury or
damage that can be shown to have been caused by a defective2 surgically implanted device.
6.2 In a concise overview of those defences to liability that are available to manufacturers, Dr Ellen Beerworth defines “defence” in the context of issues
relating to product liability 3 as:
"A ‘defence’ is a means by which a defendant may remove, in whole or in part, a claimant’s right to damages or other remedy, notwithstanding the claimant's proof of the elements of the cause of action. The availability of defences both at common law and under statutory schemes means that manufacturers and other defendants to product liability and related claims do not attract absolute liability for loss or damage associated with the use of products."
6.3 The defences available in product liability claims fall into several categories and in each case the onus of raising, establishing, and proving a defence, on the balance of probabilities, rests with the defendant. In contrast the claimant has to
show that the product was not as safe as ordinary consumers would expect,4 or
that the device was defective and the cause of the [alleged] injury,5 or that there
was a superadded risk of the device failing.6 It is necessary also for the manufacturer to demonstrate that the product was in the same condition at the
time of surgical implantation as when it left the defendant's control7 and that it
1 See TPA s.75B - A manufacturer also includes a deemed manufacturer by reason of s.74A(4). 2 See TPA s.75AC for the meaning of goods having a defect. See also s.75AD that provides a remedy where a person suffers injury as a result of defective goods supplied by a manufacturer. Generally though the interpretation of what is a defect is considered in ACCC v. Glendale Products Pty Ltd (1998) ATPR 41-632 and in Cook v. Pasminco (2000) ATPR 41-767. The author's interpretation of what constitutes a defect and what is considered to be defective is discussed in more detail in Ch 5. 3 Dr E Beerworth, “Overview of Defences to Liability” in H Budd (ed) Product Liability Australia, (2001) Vol 1 1265. 4 See TPA Pt VA s.75AC(1) and s.75AC(2). See also TPA Pt V Div 2 s.71(1) and s.71(2). It is appropriate to observe that goods may be of merchantable quality but not fit for the purpose. 5 TPA ss.75AD to 75AG – the threshold elements which a claimant much establish are that a corporation; in trade or commerce; supplied; goods; manufactured by it; with a defect; and as a result; an individual has suffered loss or damage or a type which is recognised. If these elements are satisfied the manufacturer will be liable unless it can rely on a defence provided in TPA s.75AK. 6 See Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. 7 See TPA s.75AK(1)(a).
6.1 was used in a reasonably foreseeable manner.8 This is also the case in other
jurisdictions.9 The burden of proof that is borne by the consumer continues to attract controversy. As Freeman et al have emphasised in their Report on product
liability in the European Union10 it remains the case that there is a perception on the part of consumer representatives that consumers are unfairly disadvantaged by
the burden of having to prove defect and causation11 in product liability claims.12
6.4 For the most part the defences available to a manufacturer of allegedly defective implantable surgical devices are best characterised as defences that arise out of conduct by the defendant that is considered to be reasonable in the circumstances. It may be the case that a manufacturer will not be liable to compensate a claimant
if any of the following defences can be proven13 -
(i) Consumer protection for Defective Products (TPA Pt V, Div
2A).14 x Defences for alleged unmerchantable quality (TPA
s.74D).15 These include –
8 TPA s.71(2). 9 With respect to the European Economic Community, for further information, see Art 7 of the 1985 European Community Product Liability Directive. Under Art 7 it is a defence for a manufacturer to prove that -(a) it did not put the product into circulation; (b) having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation but it or that the defect came into being afterwards; (c) the product was neither manufactured by it for sale of any form of distribution for economic purpose nor manufactured by it in the course of its business; (d) the defect was due to compliance of the product with mandatory regulations issued by the public authority; (e) the state of scientific and technical knowledge at the time when it put the product into circulation was not such as to enable the existence of the defect to be discovered; or (f) in the case of a manufacturer of a component, the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product. 10 R Freeman, J Meltzer & S Thomson, “Report on product liability in the European Union” (2003) 14 (5) Australian Product Liability Reporter, 65-71. See also Art 4 of the 1985 European Community Product Liability Directive – this clearly requires that a plaintiff bear the burden of proving his or her case. Paragraph 28 of the Explanatory Memorandam to the Trade Practice Amendment Act 1992 (Cth), which introduced Pt VA, clearly states that it is intended that Australian consumers who are injured by defective goods should be placed in the position which is not less advantagous than that enjoyed by their European counterparts in the same situation. 11 See Bright v. Femcare Ltd (2000) 175 ALR 50; FCA 742. Here Lehane J at [92] reinforced the need for any loss to be a result of an injury saying: “What appears to be necessary is that there be a clear link between particular defective goods and the ‘injury’ (not loss or damage) suffered by an individual. That may create obvious difficulties in the case of group members, at least, who did not undergo a procedure which was unsuccessful. It cannot be sufficient to plead that a group member suffered ‘loss or damage as a result of defects where such injury and loss would have been avoided in the event of the …applicator not being exposed to the risk of being out of calibration’”. (The Femcare applicator is a sterilisation system that is known as the “Filshie” system.) With reference to s.75AC(1) Lehane J noted also at [92] that “…goods have defect, for the purpose of the provisions, if their safety is not such as persons generally are entitled to expect”, not as was the plaintiff’s Statement of Claim that “doctors, hospitals or patients are generally entitled to expect”. 12 I have a view that this is in part due to those perceived difficulties, in proving claims, that can be associated with a lack of legal and other resources that are needed to investigate the claims, or with an inability to gain access to essential information. 13 The first three of these defences are defences under Pt VA, s.75AK(1) of the TPA. Here liability is strict but not absolute. 14 Under Pt V, Div 2A there are defences that are probably not appropriate to issues relating to surgical implant product liability. These defences include s.74(C) (correspond with description), s.74(E) (correspond with sample), s.74(F) (repair facilities and spare parts), and s.74(G) (non-compliance with express warranties). 15 See Ryan v. Great Lakes Council (1999) ATPR 46-19; Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120, upheld on appeal Medtel Pty Ltd v. Courtney (2003) 198 ALR 630; BC 200303598; [2003] FCAFC 151.
6.2 s.74D(2)(a)(i) – act or default of another after the product left the manufacturer’s control. s.74D(2)(a)(ii) – cause independent of human control after the product left the manufacturer’s control. s.74D(2)(b) – defect brought to the consumers attention before entry into a contract of supply. s.74D(2)(c) – consumer examined the product before entering into the contract.
x Defences to alleged unfitness for purpose (TPA
s.74B).16 These include - s.74B(1)(c) – consumer did not advise the manufacturer of the purpose. s.74B(2)(a)(i) – the device was unfit for the purpose after it left control of the manufacturer because of the default of another. s.74B(2)(a)(ii) – fitness of purpose was compromised by an act independent of human control. s.74B(2)(b) – the consumer did not rely on the skill or judgement of the manufacturer.
(ii) The Manufacturer’s liability for Defective Goods (TPA Pt VA).17 x TPA s.75AK provides a number of defences to a product liability action that go to the question as to whether or not the goods are safe. These include –
(a) The subsequent defect defence18; (b) the compliance with a mandatory standard
defence19;
16 See Rasell v. Garden City Vinyl and Carpet Centre Pty Ltd [1991] 2 Qd R 323 – this case concerned water staining on a new carpet (TPA s.74 B (2)(b)). See also (by analogy) Baldry v. Marshall [1925] 1 KB 260; [1924] All ER Rep 155. 17 The basic principal of Pt VA is that subject to the defences provided in s.75AK a manufacturer, who supplies goods that do not comply with the consumer’s expectation of safety, and cause damage, is liable to compensate the person suffering the loss. As distinct from Pt V, Div 2A, where the manufacturer’s liability is for the nature of the goods. 18 TPA s.75AK(1)(a) - The alleged defect did not exist at the time the goods left the control of the manufacturer, the supply time. See also cl 47 of the Explanatory Memorandum to the Trades Practice Amendment Bill 1992 (Cth).
6.3 (c) the “State of the Art” defence20; and
(d) the component manufacturer’s defence21; (iii) The Manufacturer’s obligations with regard to Product
Information Standards and Product Recalls (TPA Pt VC).22 Offences described in Pt VC are not mens rea offences although
strict liability is mitigated by the effect of TPA s.85(1).23 TPA
s.85(1)24 provides, subject to subsection (2), in a prosecution in relation to a contravention of a provision of Part VC, [that] it is a
defence if the defendant establishes:25 x s.85(1)(a), that the contravention in respect of which the proceedings were instituted was caused by a
reasonable26 mistake27, including a mistake of fact
19 TPA s.75AK(1)(b) - The only reason the product was defective was because it complied with a mandatory standard. See also cl 52 of the Explanatory Memorandum to the Trade Practice Amendment Bill 1992 (Cth) – compliance should be the sole cause and not the partial cause for the defect. 20 TPA s.75AK(1)(c) - The defect could not have been discovered in the light of the state of scientific and technical knowledge at the time of supply. This defence is otherwise known as the state of scientific or technical knowledge defence or the development of risk defence. See cl 55 of the Explanatory Memorandum to the Trades Practice Amendment Bill 1992 (Cth). 21 TPA s.75AK(1)(d) - The manufacturer of a component should not be liable if the finished product is defective solely due to an act or omission of the manufacturer of the finished product. The wide meaning of good in s.(4)1 includes component parts. If a defective component is incorporated in the finished goods, the finished goods will also be defective and both manufacturers will have exposure to liability. The component manufacturer has a defence under s.75AK(1)(d) in accord with Art 7(f) of the 1985 European Product Liability Directive. The term Finished Goods is not defined in the TPA. See also cl 59 of the Explanatory Memorandum to the Trades Practice Amendment Bill 1992 (Cth). TPA s.75AK(1)(d) makes it clear that a defect in a component part cannot be attributed to the component part manufacturer if the defect was due to an activity of the manufacturer of the finished product. 22 The TPA draws distinctions between conduct that is to be regarded as criminal, attracting fines (Pt VC), and conduct that attracts only civil pecuniary penalties (Pt IV). Pecuniary penalties are civil penalties imposed under TPA s.76. 23 TPA s.85(1) is also a defence to TPA Pt V, Div 1A, s.65C (Product Safety Standards and Unsafe Goods). See Pretorius v. Venture Stores (Retailers) Pty Ltd (1992) ATPR 41-166 FCA. 24 The defendant seeking to rely on a TPA s.85 defence bears the onus of establishing its defences on the civil standard; on the balance of probabilities: see Adams v. ETA Foods Limited (1987) 19 FCR 93; 78 ALR 611. This case concerned the seller of beef pies that were subsequently found to contain quantities of sheep meat. ETA Foods Ltd had obtained its pies from a reputable supplier over a four-month period and was not aware that the pies contained sheep meat. The Court accepted the defence of a reasonable mistake. The reasonable mistake defence, in this case, concerns a defence to a false representation. In this case, concerns a defence to a false representation. In the circumstances, ETA was able to establish a defence under small s.85(1)(a). The Court found also that ETA could not establish a defence under s.85(1)(c) because even though the supply of the mince was beyond the control of ETA, it had not taken reasonable precautions or exercised due diligence in avoiding the contravention. 25 A defendant bears the legal burden in relation to the matters in subsection (1) (see s.13.4 of the Criminal Code). 26 Reasonableness can be assessed by reference to both the manufacturer's technical ability and to the reasonable expectations of the industry. Standard industry practice can be, though not automatically, sufficient to protect the manufacturer. The Court in Wilkinson v. Katies Fashions (Aust) Pty Ltd (1986) 11 FCR 390 stated that reasonableness is an objective matter having regard to the individual circumstances of each case. In addition, under s.85 there is reference to the fact that reliance was placed on, or the offence was caused by another person. Another person is defined in s.85(1A) to exclude a person who was a servant or agent of the defendant or in the case of a corporate defendant, a director's servant or agent of the corporate defendant. Reasonableness is established to be an objective matter in regard to the individual circumstances of the case in question. See Greiner v. Independent Commission Against Corruption (1992) 29 NSW LR 125. 27 TPA s.85(1)(a) is an extremely difficult defence as carelessness, negligence and recklessness must be excluded. Similarly ignorance of the law nor a mistake of law is a sustainable defence; see Gilmore v. Poole-Blunden (1999) ATPR (Digest) ¶ 46-197. In Doolan v. Waltons Ltd (1981) ATPR 40-257 (FCA), the Court adopted the definition of 'mistake' in the earlier case of Vaughan v. Wright [1969] VR where the word 'mistake' was taken to include an error in conduct consisting of an unintended failure to perform correctly and effectively a task that was intended to be performed.
6.4 caused by reasonable reliance28 on information
supplied by another person; 29 or x s.85(1)(c), that (i) the contravention in respect of which the proceeding was instituted was due to the act or default of another person, to an accident or to some other cause beyond the defendant’s control; and (ii) the defendant took reasonable precautions and exercised due diligence to avoid the
contravention.30 In s.85 the TPA does provide for other defences that are not
relevant to this discussion.31 (iv) There are other defences that are available to manufacturers that include -
(a) The contributory negligence defence32;
(b) the learned intermediary defence33;
(c) the intermediate examination defence34; and
(d) the bulk supplier defence.35
28 See Waltons Stores (Interstate) Ltd v. Maher (1988) 164 CLR 387; 76 ALR 513. 29 TPA s.85 (1)(b) provides that another person, a third party, does not refer to a servant or agent of the defendant. The third party might include the surgeon who has undertaken the role of a learned intermediary. See Thorp v. C A Imports Pty Ltd (1990) ATPR 40-996. The defendant C A Imports Pty Ltd manufactured toy koala bears from material supplied from Korea and the toy bears were marketed with the label bearing the words "Made in Australia". C A Imports raised the defence of reasonable reliance on information supplied by another person provided by s.85(1)(b). The basis of this defence was the reliance placed on advice received from the Department of Trade that if more than 50% of manufacturing costs were incurred in Australia the product was entitled to be labelled "Made in Australia". See also Wilkinson v. Katies Fashions (Aust) Pty Ltd (1986) ATPR 40-721 (FCA) and ACCC v. Murray (2002) ATPR 41-899. 30 TPA s.85(1)(c)(ii) -See Adams v. ETA Foods Ltd (1987) ATPR 40 (831). ETA could not establish the defence as reasonable precautions and due diligence had not been taken even though the supply of mince was beyond ETA's control. Here beef and sheep meat included in pies was in the form of mince, not minced by ETA but supplied as "minced beef" to ETA by a third party, St George Meat Markets. See also Eva v. Mazda Motors (Sales) Pty Ltd (1977) ATPR 40-020. 31 See TPA ss.85(3) to 85(6). 32 TPA s.75AN, see also s.75AF, s.75AG, s.75AD and s.75AE. 33 The Learned Intermediary defence is discussed in more detail in Ch 7. See also cl 50 of the Explanatory Memorandum to the Trade Practices Amendment Bill 1992 (Cth) where it is indicated that the role of intermediaries may also be relevant to the defence provided by TPA s.74AK (1)(a). 34 See Griffiths v. Arch Engineering Co (Newport) Ltd [1968] 3 All ER 271. Here the concern was with the liability of subcontractors and a plant hire company. 35 See ACCC v. Glendale Products Pty Ltd (1998) ATPR 41-632. This is the only case where liability has been established under Pt VA.
6.5 6.5 There may also be an opportunity for the manufacturer to diminish liability that is
based upon the use of an exclusional disclaimer of liability or warranty.36 These are best characterised as opportunities that are based upon the claimant's and the defendant's pre-incident allocation of responsibility for any loss or damage. Any defences that are based upon limitations of actions are best characterised as defences designed to ensure that defendants are not prejudiced by a claimant
initiating a claim many years subsequent to becoming aware of a cause of action.37
6.6 In addition there is a publisher defence38 in the event that an alleged contravention arises from an advertisement in circumstances where there was no reason to suspect that the advertisement was not correct.
DEFENCES
6.7 As we have seen there are a number of defences that are available to manufacturers of implantable surgical devices. It is here appropriate to discuss, in more detail, those defences that are especially relevant to issues of product liability that concern implantable surgical devices. Those defences that have special and specific relevance include –
(a) The subsequent defect defence; (b) the compliance with mandatory standard defence; (c) the “State of the Art” defence; (d) the component manufacturer’s defence; (e) the contributory negligence defence; (f) the learned intermediary defence; (g) the intermediate examination defence; and (h) the bulk supplier defence.
36 See TPA s.75AP - the parties cannot contract out of Pt VA. 37 A respondent may read that a claim is statute barred (s.75AO(1)). See Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014. TPA Pt VIB places restrictions on limitation periods and damages for personal injury and death claims. Where it applies, Pt VIB amends limitation periods under the TPA. Where the claimant is claiming damages for personal injury or death the limitation period will be the earlier of: (a) three years from the date of discoverability of the personal injury or death; or (b) twelve years (the "long-stop period") following the act or omission alleged to have caused the death or injury. See also Sch 1 s.9, introducing Pt VIB, Div 2 of the Trade Practices Amendment (Personal Injuries and Death) Bill (No.2) 2004. 38 TPA s.85(3) - where the contravention arises from an advertisement that the defendant publisher or advertising agent received the advertisement in the ordinary course of business and neither knew nor had reason to suspect that the advertisement was incorrect.
6.6 The Subsequent Defect Defence
6.8 The manufacturing process associated with the fabrication of most surgical implants requires that there are a number of quite distinct and separate stages to
the process.39 It is frequently the case that some (or all) of these stages are undertaken by a number of different organisations prior to, and after, the final assembly or manufacture of the finished implant device. After assembly of the device many organizations, individuals, and institutions can become concerned with the sterilization, packaging and distribution of the device. In the event the manufacturer may not be liable for a defect if it can be found that the defect occurred later at some other time in the evolutionary process, or at some stage later in the distribution chain through the subsequent action(s) of a supplier, retailer, hospital or surgeon, as a result of some unforeseeable or improper use of the implant, as a consequence of tampering with the goods, or in the event that there has been theft of the goods. The unintended event may even be caused by the injured patient. The manufacturer may, in these circumstances, be able to successfully defend liability under Pt VA of the TPA, if, on the balance of probabilities, it can be shown that the alleged defect occurred at some stage later in the manufacturing, marketing or supply process. Section 75AK(1)(a) of the TPA provides the manufacturer with a defence if it can be shown that the alleged defect did not exist at the time the goods were supplied by the manufacturer, i.e.
the supply time.40 This means that the manufacturer is not liable, in principal, for matters beyond its control. It is important to this defence that the exact nature of
the defect is known41 and there must have been documented evidence, that is
discoverable, of quality management systems (QMS)42 that were undertaken by
39 The evolutionary process associated with the development of surgical implantable devices is discussed in Ch 4. 40 The supply time in relation to goods (other than for electricity) is defined in TPA s.75AK(2) as that time when goods are supplied by their actual manufacturer. The matters to be taken into account were set out at Para 49 of the Explanatory Memorandum to the Trade Practice Amendment Bill 1992. Article 7 of the 1985 European Community Product Liability Directive uses slightly different terminology, referring to the time the product was put into circulation but the intended effect of the words are the same. 41 With regard to orthopaedic surgical implants the nature of the defect is particularly important with regard to polymer (plastic) materials that are used to fabricate the articulating surface of artificial joints. These polymers include ultra high molecular weight polyethylene and it is well known that these materials can age and deteriorate during periods of shelf storage. At the time of supply there can be no defect. However after prolonged storage the materials can harden and become less than fit for the purpose that was intended. It is also the case that sterilisation using Gamma irradiation can be a cause for oxidation of polyethylene and in the circumstances it can be the case that an accelerated wear process might result from progressive oxidation. Notwithstanding this it is probable that surgical device materials should maintain a satisfactory level of safety for a reasonable period of time and be able to endure some degradation, wear and even mishandling. 42 See cl 49 of the Explanatory Memorandum to the Trade Practices Amendment Act 1992 (Cth).
6.7 the manufacturer to ensure that there had been good manufacturing process and quality control.
6.9 The subsequent defect defence embraces also the concept of contributory negligence. Matters relating to contributory negligence are discussed later in this
chapter. The role of intermediaries may also be relevant to this defence.43 In the event that full and proper information has been made available to the intermediary by the manufacturer a product may not be considered to be defective if there is a subsequent adverse event of an injurious or damaging nature that is shown to have resulted from the failure of a learned intermediary to adequately or properly inform the consumer. Matters relating to the role and to the doctrine of the
learned intermediary44 are discussed in more detail Chapter 7, The Learned Intermediary, The Delicate Balance Between a Defence and the Duty to Warn and to Educate.
6.10 The subsequent defect defence may be difficult to prove but the manufacturer will not be liable, in principle, for events that are beyond its control.
Compliance with a Mandatory Standard Defence
6.11 Compliance with standards has traditionally been evidence of “due care” and of product safety. A defence of compliance with a mandatory (statutory or
regulatory) standard45 may be successful if a manufacturer can show that the
defect in the goods has only46 occurred because of compliance with some mandatory standard(s), that has been imposed by a Commonwealth or
43 As we have previously seen cl 50 of the Explanatory Memorandum to the Trade Practice Amendment Act 1992 (Cth) indicates that the role of intermediaries may be relevant to this defence. In cl 50 it is stated that a product cannot be considered to be defective if it acts in an injurious or damaging way due to the failure of an intermediary to inform the consumer properly, provided that the proper information is provided to the intermediary by the manufacturer. 44 The “Learned Intermediary” Defence - unlike North American Courts, the Australian Courts have not so far widely considered the “learned intermediary” defence. However, the “learned intermediary” defence is available in claims based in negligence and pursuant to the strict liability of Pt VA of the TPA. ¶ 24 of the Explanatory Memorandum to the Trade Practice Amendment Act 1992 (Cth) that introduced Pt VA confirms that the role which intermediaries may play in the supply of goods may also need to be taken into account. 45 A statutory or regulatory standard is a mandatory standard and s.75AA provides that a mandatory standard is a standard for the goods or anything relating to them, which is imposed on the manufacturer by a State, Territory or Commonwealth Law, and where some civil or criminal sanction is attached to a failure to comply. The definition of a mandatory standard in s.75AA specifically excludes a standard which can be complied with by meeting a higher standard. Furthermore standards that only prescribe minimum requirements do not fall within the definition of mandatory standard. Thus, a standard which merely permits (as distinct from requires) a product to be tested, constituted, labelled, manufactured, etc. in a certain way is not a mandatory standard.
6.8 State/Territory Regulatory body.47 A Commonwealth mandatory standard48 is one
that is imposed by the Commonwealth.49 The standard imposed by the law of a State or Territory, or a standard that is voluntarily assumed by a manufacturer (such as an Australian Standard) is not a mandatory standard for the purpose of Pt VA TPA. In the event the compliance defence will not apply if the surgical device is found to be defective because of compliance with one of those
standards.50 If a surgical device fails to comply with a statutory or regulatory product safety standard then the device is per se defective. Failure to follow a
regulatory standard51 will almost always assure liability for a manufacturer, though the converse may not easily relieve the manufacturer of liability as establishing the defence can still present a complex task. It remains the case that compliance with a statutory or regulatory requirement may not always eliminate the possibility of a defect being found and there may still be exposure to
liability.52
6.12 Most Australian standards are voluntary53 and prescribe minimum requirements, and it is for this reason that it can be difficult to rely on this defence. The defence should recognise that there has been compliance with a Commonwealth
46 Cl 52 of the Explanatory Memorandum to the Trade Practice Amendment Act 1992 (Cth) states that a manufacturer is not free of liability in the event that compliance is only a partial cause for the relevant defects. 47 TPA s.75AK(1)(b) refers only to a mandatory standard and provides a defence where the manufacturer can establish that the defect in a product existed only because of compliance with a Mandatory Standard. The Explanatory Memorandum to the Trade Practices Amendment Act 1992 (Cth) emphasises that the TPA s75AK(1)(b) defence will only be available where compliance with the Standard was the sole cause of the defect, and not where compliance was merely a partial cause of the product being defective. Distinction should be drawn here between Minimum Standards and Mandatory Standards. The two Standards can be confused. A Regulatory Authority may recommend Minimum Standards for compliance and a manufacturer may exceed those standards because Minimum Standards do not equate to a Mandatory Standard. In the event that a Commonwealth Mandatory Standard is cited then the Commonwealth will be liable to the person who suffers loss or damage. The Commonwealth Mandatory Standard is defined in TPA s.75AA. Where that defence is successfully argued in relation to a Commonwealth Mandatory Standard, s.75AL provides that the Commonwealth should be liable instead of the manufacturer to compensate the claimant. Under TPA s.75AL(1), a defendant who is seeking to rely on a Commonwealth Mandatory Standard as a defence must serve a copy of its defence and a prescribed notice on the Commonwealth as soon as practicable after raising the defence. Once the notice has been served, TPA s.75AL(2) automatically makes the Commonwealth a defendant to the action. Commonwealth liability in place of the defendant’s liability is provided for in TPA s.75AL(3). Interestingly there is no equivalent provision to TPA s.75AL under the 1985 European Community Product Liability Directive. 48 TPA s.75AA provides that a standard which sets out only minimum performance requirements is not a mandatory standard for the purpose of Pt VA of the TPA. TPA s.75AC provides a meaning for the objective standard that is based upon what the public at large rather than any particular individual is entitled to expect. See Paras 6-9 of the Explanatory Memorandum to the Trade Practices Amendment Act 1992 (Cth) which introduced Pt VA. 49 TPA s.75AL provides that if the mandatory standard defence in s.75AK(1)(b) is established by the defendant the Commonwealth is liable. Commonwealth liability under TPA s.75AL applies only if the goods are defective. There is no equivalent provision to s.75AL under the 1985 European Community Product Liability Directive. See vide supra n.29. 50 See J Kellam & Kearney, Product Liability - A Decade of Change, Butterworths CLE Seminar 8 March 2001. 51 For detailed discussion of those current Regulatory Standards applicable to medical devices see Ch 3, ¶3.62-3.86. 52 See Bux v. Slough Metals Ltd [1974] 1 All ER 262; [1973] 1 WLR 1358, CA, evidence of full compliance with statutory requirements will not necessarily pre-empt a successful claim alleging negligence and will not preclude liability for negligence in common law. 53 Voluntary and mandatory standards may be viewed differently by the Courts. Mandatory standards are generally issued by Government and the Courts appear loathe to impose a standard of care that has the potential to penalise a statutory prescribed and enforced standard.
6.9 Government certification, or with some other Commonwealth regulatory requirement, and that the manufacturer has fulfilled all of its obligations with respect to the provision of a product that does provide an adequate level of
safety.54 However if a risk is foreseeable then the compliance with a mandatory standard, or the following of a common or accepted practice, may not represent a
proper precaution.55 However manufacturers of medical devices have, in the
USA, suffered a notable setback. In 1999 a Federal Appellate Court held56 that "pre-market approval" of medical devices by the FDA had no pre-emptive effect on product liability claims brought under State law. As a result of the Court's decision, manufacturers of medical devices may face continuing exposure to product liability suits, even when there has been full compliance with the requirements of the regulatory body, in this case the FDA.
6.13 Generally though compliance with a regulatory standard will assist a manufacturer's defence. Compliance with statutory or regulatory standards has traditionally been considered to be evidence that there has been a discharge of the duty to take due care and to be evidence of product safety. The Courts rightly have held that statutory regulations are no substitute for the provision of an
appropriate duty of care57 and that compliance with a recommended testing procedure is not ipso facto a defence in any given case and similarly the views of
expert official committees, though relevant, are not determinative.58 It is also the
54 The product should be as safe as persons generally are entitled to expect. 55 See Morris v. West Hartlepool Steam Navigation Co. Ltd [1956] AC 552, [1956] 1 All ER 385 (HL). See also Cavanagh v. Ulster Weaving Co. Ltd [1959] 2 All ER 745, [1960] AC 145. Treating a trade practice as evidence of the proper standard of care may not be sufficient caution to avoid foreseeable risks. Conformity with industry standards or custom, though prima facie evidence of reasonable prudence on the part of a manufacturer is not in itself a defence. 56 See Goodlin v. Medtronic Inc., No 97-5801, 1999 US App Lexis 2507 (11th Cir February 18, 1999). The claimant had undergone the surgical implantation of a cardiac pacemaker. Later the manufacturer issued a warning about the risk of defect in the lead to the Pacemaker. The claimant underwent open-heart surgery to replace the electrical lead. The surgery however revealed there to be no evidence of any defect. The claimant asserted claims against the manufacturer for negligent design and strict product liability. The District Court concluded that the FDA had found the Pacemaker to be safe and effective during the pre-market approval process. As a result, the Court found that the claimant's claims were pre-empted, and entered judgement for the manufacturer. This decision was reversed by the United States Court of Appeals for the Eleventh Circuit. The Appeal Court recognized that s.360K(a) of the Federal Food, Drug and Cosmetic Act contains an express provision that Federal law will pre-empt conflicting requirements of State law. Citing Medtronic Inc. v. Lohr, 518 US 470, 501 (1996), the Court noted that the claimant's claims could not be pre-empted unless the pre-market approval process imposes a specific Federal requirement on a "particular device". The Court recognised that during the often "rigorous" pre-market approval process, the FDA demands the "submission of detailed information regarding the safety and effectiveness of the device under review" (Goodlin at 5-6). The Court also conceded that after FDA approval, a manufacturer may not alter its labelling, product design, or manufacturing process in any way. Nevertheless, the Court of Appeals determined that the FDA's pre-market approval process imposes no "specific Federal requirement" because the process does not impose any ascertainable, substantive prerequisite for approval" (Goodlin at 29). Finding that the pre-market approval process imposes "no specific Federal requirement" on a "particular device" the Eleventh Circuit expressly rejected the Seventh Circuit's resolution of the same issue in Mitchell v. Collagen Corp, 126 F. 3d 902 (7th Cir, 1997). This case has some similarity with that of Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. 57 See vide supra n.52. 58 See Thompson v. Johnson & Johnson Pty Ltd [1992] 3 Med LR 148, 172-2 (SC of Victoria, App Div).
6.10 case that the issue of a product licence will not automatically constitute a defence
to a claim59.
6.14 It is then the case that s.75AK(1)(b) of the TPA provides a defence where the manufacturer can prove that the only reason the product was defective was because it complied with a mandatory standard and in the event compliance with that standard must have been the sole cause for the defect. A manufacturer is not freed from liability where compliance is merely a partial cause of the relevant
defect.60
6.15 It is generally the case that Courts have been reluctant to impose their own standard of care, or version of reasonableness, as this might seemingly be
interpreted to penalize compliance with a statutory regulation of Parliament.61 Though how far the TGA, as a regulatory body, can enjoy immunity from
exposure to liability when discharging statutory duties remains untested.62
The State of the Art Defence
6.16 The State of the Art Defence63 is also variously described as the Development
Risks Defence64 or the Standards of Knowledge Defence. The State of the Art Defence is based upon the premise that when the allegedly defective surgical implant was manufactured and supplied on a particular date the defect was not
59 See European Economic Community Directive 65/65EEC OJ 22, 9 Feb 1965, p. 369. 60 See ¶52 of the Explanatory Memorandum to the Trade Practices Amendment Act 1992. 61 Budden v. BP Oil Ltd (1980) 124 Sole Jo 376, CA. Evidence of compliance with a standard prescribed by legislation or by regulation which can be met by meeting a higher standard is prima facie evidence that the defendant has not been negligent. The Courts would be reluctant to hold negligent a manufacturer who had been granted a product licence for a surgical device after disclosing to the Licensing or Regulatory Authority, all of the information deemed relevant to safety: See also Donoghue v. Stevenson [1932] AC 562; Daniels and Daniels v. R. White & Sons Ltd and Tarbard [1938] 4 All ER 258. 62 See Crimmins (as Executrix of estate of Crimmins dec'd) v. Stevedoring Industry Finance Company (1999) 200 CLR 1. See also Anns v. Merton London Borough Council [1978] AC 728, 754, per Lord Wilberforce. 63 TPA s.75AK(1)(c). 64 The development risks defence, though derived from the European Directive (art 7(e) of Product Liability Directive - 85/374/EEC), has been opposed in the UK by the UK Law Commission and by The Pearson Commission (Law Commission Liability for Defective Products) Cmnd 6831 (1977) and The Pearson Commission (Civil Liability and Compensation for Personal Injury) Cmnd 7054-1 (1978), Ch 22. The European Commission has stated that the United Kingdom has implemented the development risks defence incorrectly. See European Commission v. United Kingdom [1997] All ER (EC) 481. For further information see R Freeman, J Meltzer & S Thomson, “Report on Product Liability in the European Union” (2003) 14 (5) Australian Product Liability Reporter, 66-71. Here the authors report that consumer representatives have suggested that the development risk defence be abolished. In contrast producers (and insurers) have urged that it should be retained.
6.11 discoverable. Freeman and Hibbert65 cite the results of the Fondazione Roselli
Study and Report66 that observes that this defence -
"is the result of a compromise between the need to avoid stifling innovation of products on the one hand and the need to ensure that consumer expectations about the safety of products are met on the other."
6.17 For this defence to be successful, any defect must have been neither known nor
reasonably discoverable67 by the manufacturer given the state of the scientific and
65 R Freeman & M Hibbert, “Lovells Summary - The Fondazione Roselli Study and Report” (2004) 15 (8) Australian Product Liability Reporter, 121-22. 66 Fondazione Roselli is an Italian based academic institution that undertook an empirical study of the economic impact of the Development Risks Defence during the period 2003 and 2004. The Fondazione Roselli Report was published in June 2004. The Study was undertaken in response to the 1999 Green Paper of the European Union on the Product Liability Directive 85/374/EEC. 67 See Ryan & Ors v. Great Lakes Council & Ors (1999) ATPR Digest ¶ 46-191where the defence was raised successfully. This case is important to any consideration of the State of the Art defence. Representative proceedings had been brought against a number of respondents, where oysters had been contaminated with Hepatitis A virus. More than 400 individual persons became sick as a result of consuming the contaminated oysters. Because the only test that would have detected the presence of the contamination would have destroyed the goods, Wilcox J found that the defect was not capable of being discovered. The TPA s.75AD claim failed and Wilcox J found that the respondents had a valid defence under TPA s.75AK(1)(c) namely that a manufacturer will not be held liable “if it established that … the state of scientific or technical knowledge at the time when they were supplied by their actual manufacturer was not such as to enable the defect to be discovered”. The judgement was the subject of an appeal, and Lindgren J was of the view that Wilcox J was entitled to apply the defence to the circumstances in the case. The appeal decision suggests that the defence was successful for the reason that random testing was inappropriate in the circumstances as it would have destroyed the product. This judgement contrasts greatly with that of Burton J in A v. National Blood Authority (2001) 3 All ER 289 – this case concerned 114 individuals who were infected with the Hepatitis C virus as a result of transfusions with contaminated blood and blood products. The claimants argued that the blood was defective under the Consumer Protection Act 1987 (UK). The infection with the Hepatitis C virus occurred at a time when there was no test available for the detection of the virus. However, it was known to the medical profession at that time that it probably was the case that a viral pathogen did exist that was quite distinct from the Hepatitis A and Hepatitis B viruses. The Hepatitis was then known as non-A/non-B Hepatitis. The defendants argued that the public could not “legitimately expect” that blood and blood products were completely safe, but rather, could only expect that all reasonably available tests had been carried out. Burton J disagreed, saying at [56]: "I do not consider that the legitimate expectation of the public at large is that legitimately expectable tests will have been carried out or precautions adopted. Their legitimate expectation is as to the safeness of the product (or not)." Importantly, Burton J held that the avoidability of the dangerous characteristic, the impracticality of taking alleviating measures, and the benefit or utility to society that the product provides, were not relevant in the determination of whether a product is defective. Burton J considered the case of Ryan in his judgement, and concluded that the wording of TPA s.75AK(c) more readily allowed consideration of whether the defect could be detected in the goods in question as opposed to the manufacturer’s knowledge of the risk of contamination. However, it does not appear that the claimants in Ryan argued that the defence should not apply as the risk was generally known to the manufacturer. The decision in Ryan has been subject to some criticism. Certainly the decision in A v. National Blood Authority is not easy to reconcile with the interpretation of the State of the Art Defence taken in Ryan v. Great Lakes Council. The approach in Ryan is vastly more generous to manufacturers. However, the approach in A v. National Blood Authority will almost certainly be embraced by claimants in the future and may well prove to be influential. The decision of Burton J is an example of strict liability strictly applied. The Ryan case involved, inter alia, a claim under TPA s.75AD arising out of the claimants’ contraction of the Hepatitis A virus as a result of eating contaminated oysters. The oysters had grown in the contaminated area of Wallis Lake. Wilcox J. held that as the discovery of the defect and the supply of the products were mutually exclusive (ie. the only test which could reveal the defect – flesh-testing of the oysters – would destroy the goods), the defence in TPA s.75AK(1)(c) was available. A similar approach was taken by Kennedy J in Richardson v. LRC Products Pty Ltd [2000] LLR Med 280. This case involved a condom that broke during sexual intercourse resulting in an unwanted pregnancy. Although it was found that the condom was not defective, Kennedy J. considered whether the State of the Art Defence would have been available had he found against the defendant. Kennedy J. was of the view that “I do not think that this is so unless the case had shown there was a defect of whose possible existence the leading edge of valuable scientific knowledge was ignorant. The test provided by the Statute is not what the defendants knew but what they could have known had they consulted those who might be expected to know the state of research and all available literature sources. This provision is, to my mind, not apt to protect a defendant in the case of a defect of unknown character merely because there was no test that is able to reveal its existence in every case” [at p.285]. The potential narrow application of the State of the Art defence, and with substantially different conclusions to that identified in Ryan, is to be found in A v. National Blood Authority [2001] 3 All ER 289. Burton J said at [74]: ”It would, in my judgement, be inconsistent with the purpose of the Directive if a producer, in the case of a known risk, continues to supply products simply because, and despite the fact that he is unable to identify in which, if any, of his products that defect will occur or recur, or, more relevantly, in a case such as this, where the producer is obliged to supply, continues to supply without accepting responsibility for any injuries resulting, by insurance or otherwise.” A similar approach was taken by Kennedy J in Richardson v. LRC Products Pty Ltd [2000] LLR Med 280 - this case concerned a condom that broke during sexual intercourse resulting in an unwanted pregnancy. See also Para 55 of the Explanatory Memorandum to the Trade Practices Amendment Act 1992 which states that it is the state of scientific and technical knowledge, not the subjective knowledge of the individual
6.12 technical knowledge68 at the time that the product was put into circulation69. Throughout every step concerned with the evolution of a surgical device, from its design to its supply, the manufacturer must take reasonable care, and observe a demonstrated conduct, that can, at all times, bear the scrutiny of the prevailing
state of scientific and technical knowledge. This is the State of the Art.70
manufacturer which is to be taken into account. It is interesting also to observe that in Ryan v. Great Lakes Council the Court held that the grower of the oysters was liable under TPA s.74D, as it had not warned the first applicant with the possibility of contamination. In the absence of such a warning it was reasonable for the applicant to have assumed that the oysters were of merchantable quality. On Appeal (Graham Barclay Oysters Pty Ltd v. Ryan (2002) 194 ALR 337; BC200207277; [2002] HCA 54) the Court accepted the trial Judge's conclusions with respect to TPA s.74D on the basis that that provision must be construed as a consumer protection measure. It was further concluded that if a manufacturer that it cannot be certain of meeting the reasonable expectations of consumers as to the fitness of products for a purpose or purposes, it must either cease manufacturing or ensure that consumers have agreed to bear the risk that the products may not be fit for a purpose. Note that TPA s.74D was not the subject of the Appeal to the High Court in Graham Barclay Oysters Pty Ltd v. Ryan. See also Regal Pearl Pty Ltd v. Stewart [2002] 211 CLR 240 NSWCA 291 (15 Nov 2002); BC2002068002 (Sheller, Stein & Hodgson JJA) This case highlighted the risks facing the owners of restaurants and others who sell cooked food. An important and interesting facet of the Regal Pearl case was that the importer was held to have no obligation to test produce for contamination and was entitled to rely on foreign certification processes. The restaurant has purchased prawns through a wholesale company, the third respondent. The wholesale company had purchased the prawns from an importer, the second respondent. Cooked food was sold and it was identified that the food was contaminated by Hepatitis A. The Hepatitis A was traced to prawns that were part of a shipment of approximately 10 tonnes of frozen shrimp imported from Myanmar in late February 1997. While the State of the Art defence was not specifically considered, the considerations in this case are not inconsistent with those adopted by Wilcox J in the Federal Court in Ryan v. Great Lakes Council. In Ryan the oysters were found to be defective within the meaning of Pt VA of the TPA. However the State of the Art defence was held to apply and therefore the claim based on Pt VA failed. The reason the defence was held to apply was because the only test that would have detected the contamination would have destroyed the oysters. As we have seen the approach in Ryan, followed in Regal Pearl, contrasts with the view held by Burton J in A & Anors v. National Blood Authority & Anors [2001] 3 All ER 289. Burton J held that it was not relevant that the defect could not be detected in particular blood products, as once the defect is known, the manufacturer who supplied the product did so at its own risk. As the blood authority was aware that there was something in the blood that caused a post-transfusion Hepatitis known as non-A Non-B Hepatitis, though undetectable, was not reason to gain advantage from the defence. In Regal Pearl, the wholesaler was found liable under s.19 of the SGA. On Appeal Stein JA held that the supply of contaminated prawns by the Wholesaler to the restaurant was the supply of goods of unmerchantable quality. It is interesting also to review "Heil v. Hedges [1951] 1 TLR 512 - this case concerned undercooked parasitic worm infested prawns. In the context of all the cases discussed here it is interesting also to observe that, in 1999, there occurred the death of the first probable victim of variant Creutzfeldt-Jakob Disease (vCJD) after being transfused with blood, in 1996, from a donor who had been incubating vCJD. The issues faced here are more parlous than for HIV, against which the blood supply is protected by HIV testing and surgical instruments by autoclaving. As yet there is no blood test for vCJD and there is no cure. It is the case that surgical instruments used on patients with vCJD have to be destroyed. Surgical instruments used on these patients cannot be reused. There is also a strong argument that would support a view that those highly at risk for vCJD should be ineligible for occupations that entail procedures that may expose others to the risk of small vCJD. For further reading see SM Bird, “Recipients of Blood or Blood Products ‘at vCJD risk’” (2004) 328 (7432) BMJ, 18-19 – “we need to define their rights and responsibilities and those of others”. See J Kellam & D Eastman, “Recent Decision on the 1985 EC Directive” (1996) 7 APLR 58. Here the authors discuss the German Blackberry Cake case and the Austrian Mineral Water (Coca Cola) Bottle case. In both of these cases the defence failed because the state of science and technology allowed the defects – infection with hepatitis and imperfection in the glass respectively – to be discovered. 68 To come within this defence the manufacturer must have kept up to date with advances in knowledge after it had first placed the product into circulation in the marketplace. The defence does not require the highest possible standards and it can be suggested, for example, that a manufacturer would not reasonably be expected to know of, and to act on, an obscure report in a foreign language. This is sometimes referred to as the Manchurian defence and reflects that it may not be reasonable to expect a manufacturer to have become aware of an obscure article published in such a distant and isolated territory. Manchuria consists of nine provinces of the Chinese Republic lying to the east of Mongolia. Failure to read a single article may be excusable where disregard of a series of warnings in the medical or industrial press might be evidence of negligence. See Crawford v. Board of Governors of Charing Cross Hospital (unreported, April 22, 1953) CA (judgement date: 7th December, 2953) – Times (London) 8th December, 1953. Here the claimant had developed a brachial palsy as a result of his arm being kept in a certain position during a surgical procedure. Six months prior to the surgery an article had appeared in the Lancet pointing out this danger, but the Anaesthetist, against whom negligence was alleged, had not read the article in question. The Court of Appeal eventually found in favour of the Anaesthetist, Lord Denning stating that "It would, I think we are putting too higher a burden on a medical man to say that he has to read every article appearing in the current medical press; and it would be quite wrong to suggest that a medical man is negligent because he does not at once put into operation the suggestions which some contributor or other might make in a Medical Journal. The time may come in a particular case when a new recommendation may be so well proved and so well known, and so well accepted that it should be adopted, but that was not so in this case." For further reading see also JK Mason & RA McCall-Smith (with additional material by GT Laurie), Medical Negligence, in Law of Medical Ethics, (5th ed 1999) Ch 9, 225-26. 69 See E. v. Australian Red Cross Society (1991) 31 FCR 299; 105 ALR 53. See TPA s.75AK(1)(c). 70 Stokes v. Guest, Keen & Nettlefold (Bolts & Nuts) Limited [1968] 1 WL & R 1776 at 1783; Where he has in fact a greater than average knowledge of the risks, [the employer] may be thereby obliged to take more than average or standard precautions applied in White v. Holbrook Precision Castings [1985] IRLR 215, CA and Smith v. P & O Bulk Shipping [1998] 2 Lloyd’s Rep 81.
6.13 Generally any State of the Art defence should also embrace a concept of reasonableness and/or practical technological feasibility.
6.18 The State of the Art Defence is available in claims pursuant to Part VA of the
TPA71, and in claims based in negligence, but it is not available in claims in contract. Exposure to liability in negligence can be the case when a manufacturer fails to exercise proper care in undertaking research and/or the design of a surgical implant, in the process of manufacture of the device, or in the labelling
and warning with information of possible risks.72 The exercise of proper or reasonable care, or the adherence to a common practice of the industry, can assist a defence to a claim in negligence but the converse can ensure liability for the manufacturer. The State of the Art Defence reflects what a reasonably prudent
manufacturer would have done under similar circumstances.73
6.19 Implicit in the State of the Art Defence is that at the time of the manufacture of the goods the stated scientific or technical knowledge was such that, objectively speaking, no one could have discovered that characteristic of the product that was
defective.74 However the manufacturer is not relieved from demonstrating a continuing responsibility to ensure that every measure is taken to discover any defect before a product is released into the marketplace and to remain vigilant as
71 TPA s.75AK(1)(c) provides for absolute defences to Pt VA liability. These include that the state of scientific or technical knowledge at the time the product was supplied was not such as to enable the defect to be discovered. See also Ashington Piggeries Limited v. Christopher Hill Limited [1971] 1 All ER 847. 72 See Cartwright v. GKN Sankey Limited [1972] 2 Lloyd’s Rep 242, 259, CA; Devilez v. Boots Pure Drug Co. Limited (1962) 106 SJ 552; McMullin v. ICI Australian Operations Pty Limited (1997) 72 FCR 1; ACCC v. Glendale Chemical Products Pty Limited [199] ATPR 41-672. 73 Marshall v. Lindsey County Council [1935] 1 KB 516, (CA), per Maugham LJ, “an act cannot, in my opinion, be held to be due to a want of reasonable care if it is in accordance with the general practice of mankind. What is reasonable in a world not wholly composed of wise men and women, must depend on what people presumed to be reasonable. A jury could not, in my opinion, properly hold it to be negligent in a doctor or in a midwife to perform his or her duties in a confinement without mask and gloves, even though some experts gave evidence that in their opinion that was a wise precaution. Such an omission may become negligent if, and only if, at some future date it becomes a general custom to take such a precaution among skilled practitioners”. See also Whiteford v. Hunter [1950] WN 553, per Lord Porter, “a defendant charged with negligence can clear his feet if he shows that he has acted in accordance with general and approved practice”. Subsequently, the House of Lords confirmed that a doctor, and it follows a manufacturer, would not be negligent even where there were two schools of thought, providing (he) act in accordance with one of them. See also Bolitho v. Hackney Health Authority [1997] 4 All ER 771. The important issue in the Bolitho case is the Court's departure from the certainties of Bolam (Bolam v. Friern Barnet Hospital Management Committee [1957] 1 WLR 582; [1957] 2 All ER 118 (QBD)) Under Bolam a doctor will not be negligent if what he has done would be accepted by a responsible body of medical opinion. See also Bolitho v. City & Hackney Health Authority [1998] AC 232 (HL). See also Wilsher v. Essex Area Health Authority [1988] 1 All ER 871, [1988] AC 1074, [1988] 2 WLR 557, HL. See also Rogers v. Whitaker (1992) 175 CLR 479. 74 A contemporary problem is that which concerns the discovery of vCreutzfeldt-Jakob Disease ("Mad-Cow Disease" vCJD). The problem presented concerns the discovery of vCJD contamination of blood products. At this time there is no known test to identify the cause for vCJD. For further reading see SM Bird, “Recipients of Blood and Blood Products at vCJD risk” (2004) 328 (7432) BMJ, 18-19.
6.14 to insights obtained into the product at a later date,75 or with the wisdom of hindsight. There is an obligation for manufacturers to be vigilant so as to permit the recognition of any technological or scientific advance that may affect the
safety of goods supplied76 during any period of ongoing marketing.
6.20 Manufacturers and sellers may have the opportunity to introduce the State of the Art Defence when it is alleged that a device is defective where the facts show that the surgical implant was the safest in use at the time, and was manufactured in compliance with all regulatory and industry standards. Any reference that a
device is defective77 is not to be made only because of the fact that, after the product was supplied by the manufacturer, safer devices of the same kind were put into the market.
The Component Manufacturer’s Defence
6.21 Not infrequently the manufacturer of a surgical device will recruit the co-
operation of other organizations to undertake the manufacture of components,78 to source raw materials, to provide a variety of device treatments (e.g. application of hydroxyapatite bioactive coatings and other porous ingrowth surface treatments), and to perform in-vitro and in-vivo testing that can include pre-clinical and/or clinical device implantation. As distinct from these upstream activities, that is higher up in the chain of supply, a manufacturer may also be vicariously liable in
75 See Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1 (1998). In Vassallo, the Court confirmed a US$1.1m judgement (plus costs) against the corporate successor to a silicone breast implant manufacturer in a case in which the claimant alleged a new form of autoimmune disease, "atypical connective tissue disease" was caused by silicone leaking from her breast implant, which had been implanted in 1977. The Massachusetts Supreme Judicial Court affirmed the verdict. The Court held that a manufacturer's duty to warn is limited to those risks that are reasonably foreseeable and which can be discovered by the manufacturer by reasonable testing prior to marketing of the product. The Vassallo decision is particularly important to pharmaceutical and medical device manufacturers, where the use of the product after FDA approval often reveal additional risks that were not known when the product was initially marketed, and manufacturers facing latent disease claims arising out of products sold years earlier, where there have been subsequent developments in the knowledge of risks associated with the product. For further reading see online www.mintz.com/newspubs/ProductsLiability/Advisory_Aug_1998.htm. 76 In this regard the supply time is that time when the defective good was supplied and not the time when goods of that type were first supplied. 77 TPA s.75AC(3) should ensure that implant development and surgical innovation are not jeopardised by the introduction of strict liability. 78 The wide meaning of goods in TPA s.41(1) includes component parts which are later integrated into finished goods. The manufacturers of components incorporated into finished goods will be liable to compensate injured claimants if the component goods contribute to, or cause a defect in, the finished goods. If a defective component is incorporated into the finished goods, then the finished goods will also be defective. Both a component manufacturer and the manufacturer of the finished goods will be liable to compensate the claimant. A component manufacturer should not be liable if the finished product is defective solely due to an act or omission of the manufacturer of a finished product in the event where component parts are manufactured according to specifications. Component manufacturers are provided with a defence under TPA s.75AK(1)(d). TPA s.75AK(1)(d) does not specifically include a defence that the finished product was incorrectly assembled. This is in accord with Article 7 of the 1985
6.15 negligence for the conduct of a person or organisation lower down in the chain of supply, downstream, such as a retail dealer or supplier who may have obligations with regard to the undertaking of pre-delivery inspections, modifications or
product assembly,79 or with those activities of organizations associated with the sterilization, packaging, and the provision of promotional information. Outsourcing of these upstream and downstream activities is common and is frequently undertaken to more effectively utilise resources. The question, in all of this, is that which enquires as to whether or not the manufacturer may also have exposure to liability for any injury or damage that might be causally associated with the undertakings of others. Providing proper and reasonable care is exercised in retaining the resource, then it generally has been the case that the manufacturer is not vicariously liable for the activities of those contracted where there is no employer-employee relationship. As with all rules there are exceptions and these mostly have concerned the debate as to whether a
manufacturer's duties are non-delegable80 and in regard to activities which might
be described as extra-hazardous81.
6.22 It is clear that the more a surgical device manufacturer’s conduct and activity extends beyond its own endeavours then exposure to liability can include others
and particularly for those that may have supplied components or raw materials82 for the fabrication of the implant device. There is a risk of exposure to liability for each individual and/or organization throughout the entire chain of supply. It is
therefore the case that joint and several liability can follow.83 The manufacturer and/or supplier of components or of raw materials may be successful in a defence if it can be established that the defect was the result of the defective design of the
European Community Product Liability Directive. The subsequent defect defence under TPA s.75AK(1)(a) may also be relevant to component manufacturers. 79 See Vandermark v. Ford Motor Co. 37 Cal Rptr 896 (1964) - in Vandermark the vehicle manufacturer’s authorised dealer failed to eliminate a defect in the brake master cylinder in the course of a pre-delivery inspection. See also Sabloff v. Yamaha Motor Co., 283 A 2d 321 (NJ 1971). 80 It is only rarely that a manufacturer’s duty of care has not been treated as non-delegable. See Winward v. TBR Engineering Ltd [1986] BTL & C 366, CA. 81 See Alcock v. Wraith (1991) 59 BLR 20, CA; See also D & F Estates Ltd v. Church Commissioners for England [1989] AC 177 (HL), here Their Lordships extended non-liability for loss to builders in not dissimilar circumstances. 82 Taylor v. Rover Co. Ltd [1966] 2 All ER 181 and 186. In Taylor a product was supplied and failed prematurely in a manner inconsistent with ordinary wear and tear due to faulty manufacture. Generally though, the law of negligence does not impose vicarious liability onto a person such as a manufacturer for another person’s negligent act or omission, provided the manufacturer has satisfied itself that the other person is competent and reputable and had taken all other appropriate steps to minimise the risk of loss or damage, such as by ensuring that component parts were fit for their intended purpose, and not such as to affect the safety or suitability of the finished product, See Dr E Beerworth, Product Liability Australia, (2001) 5018 [3.20]. See also Imperial Chemical Industries of Australia and New Zealand Ltd v. Murphy [1973] 47 ALJR 122.
6.16 product, i.e. it was not the component (or the raw material) itself that caused the defect but how, by the design, the part or material was incorporated into the
product by the manufacturer of the finished goods.84 A component manufacturer, or supplier of a raw material, might also find defence in those circumstances where there has been a lack of appropriate instruction that may have related to some intermediate or later stage of the manufacturing process.
6.23 In the event that a modular surgical device, that includes a number of separate parts, has been surgically implanted it might prove difficult to identify which manufacturer’s product was used, or was defective, as more than one manufacturer, or supplier of raw materials, may have been concerned with the manufacture of the device, of its component parts, or of the raw materials used in the fabrication of the finished device. It can be found that the Court might impose on each individual organization the burden of demonstrating, on the balance of
probabilities, that their product was not used.85 In the event that a manufacturer is not able, on the balance of probabilities, to demonstrate that their product was not
used, it can follow that the need to show causation may be set aside. 86
6.24 It has been the case in the USA that a defendant can be found liable in part for a percentage of a claimant’s total damages that is calculated on the basis of the
manufacturer’s market share.87 In Australia, if two or more corporations are
liable88 for the same loss, they are jointly and severally liable under s.75AM of the TPA. If the injury, loss, or damage, is caused by a defective component, then both the component manufacturer and the manufacturer of the finished product
83 See TPA s.75AM. 84 See TPA s.75AK(1)(d). 85 See Pamela R Ferguson, Drug Injuries and the Pursuit of Compensation (1996), and Schreiber & Hirssh, “Theories of Liability Applied to Overcome the Unique Identification Problem in DES Cases” (1985) 4 Medicine and Law, 337-38. See also Sindell v. Abbott Laboratories 26 Cal 3d 588; 163 Cal Rptr 132; 607 P 2d 924 (1980), cert denied. Sindell v. Abbott Laboratories 449 US 912; 101 S Ct 285; 66 L Ed 2d 140 (1980). Here, more than 300 companies manufactured the drug Diethylstilboestrol (DES). DES is a synthetic oestrogen which was prescribed for the prevention of earlier miscarriage. It was alleged that DES may have increased the occurrence of complications during pregnancy and was causally associated with the occurrence of vaginal and cervical cancer in the female offspring of those who had been prescribed the drug during pregnancy. Between three and four million women used DES in the USA and approximately 8,000 in the United Kingdom. DES was first synthesised in the United Kingdom in 1937 and subsequently used by pregnant women over a period of 20 years. It was also alleged that pharmacists frequently supplied on prescription whatever brand of DES was on their shelf. Too frequently the manufacturers of the DES used could not be identified. 86 Hymowitz v. Eli Lilly & Co (1989) 539, NE 2d 1069. Here the New York Court of Appeal imposed liability on the manufacturer even though it could show that it had not produced the drug that injured the patient. 87 See Mindy Hymowitz v. Eli Lilly & Co (1989) 541, NYS 2d 941 (NY CA). Wachtler CJ …We now resolve the issue twice expressly left open by this Court, and adopt a market share theory, using a national market, for determining liability and apportioning damages in DES cases in which identification of the manufacturer of the drug that injured the claimant is impossible. See also Brenner v. American Cyanamide Co. No 12596/93 (NY Sup Ct Erie City (25 January 1999, unreported)). 88 Under TPA s.75AD, s.75AE, s.75AF, and s.75AG.
6.17 could be joined.89 The implication of this is that companies supplying implantable surgical devices, and particularly generic products, if sourced from a variety of manufacturers, might be exposed to liability. This is a particular risk if the
organisation(s) involved do not keep adequate records90 and in the event are unable to satisfactorily demonstrate the particular circumstances of their roles and obligations in the development of the implants.
6.25 A non-manufacturer may also be liable to a consumer for other activities that
might include the negligent testing91 of a product that is later found to be defective. It can be the case that exposure to liability of other individuals and organizations, outside the chain of manufacture and distribution, may exist if it can be shown that research, which was performed negligently, led to the marketing of the product. The events of the silicone-gel-filled breast product
liability case included the lessons of Artiglio92 that demonstrate that non- manufacturers can be liable to consumers in the event that there has been negligent testing of products. The claimant must, in each case, demonstrate the essential element of negligence, and demonstrate that there has been a sufficient causal nexus between the services rendered and the claimant’s injuries.
The Contributory Negligence Defence
6.26 A defence may be based on the concept of contributory negligence93 on the part of the claimant and any alleged misuse and assumption of risk that are best
characterised as arising out of some act or omission of the claimant. 94
89 According to para 65 of the Explanatory Memorandum to the Trade Practices Amendment Act 1992 (Cth) the claimant is provided with the opportunity to institute proceedings against the party which will be best able to pay compensation. 90 See Courtney v. Medtel Pty Ltd [2003] FCA 36 BC 200300120; ATPR (Digest) 46-228 - the manufacturer of the pacemaker device, Pacesetter Inc, kept no records that would have identified the type of solder that had been used in the manufacture of each Tempo Pacemaker device, at [108]. 91 For example - the modelling of product performance by Finite Element Analysis (FEA). 92 Artiglio v. Corning Inc. 19 Cal 4th 604 (1998) – here was an attempt to hold Dow Chemicals responsible in the situation where Dow Corning had become bankrupt. Dow Chemical never manufactured or sold anything. However they were responsible for toxicological testing which was undertaken on behalf of Dow Corning. 93 The 1985 European Community Product Liability Directive is silent on the issues of contributory negligence and voluntary assumption of risk. 94 It is not unknown for individuals to be hypersensitive, or allergic, to the constituents of implantable devices. Hypersensitivity to nickel, contained in many orthopaedic metals, is rare but not unknown. In the event that the patient is aware of a particular condition of hypersensitivity, or allergy, no liability arises in respect of the consumer's unexpected sensitivity unless it has been expressly, or impliedly, made known to the seller of goods and/or services. In the same context a Pharmacist would not normally be liable if unaware of a customer's abnormal sensitivity, or allergy, to a medicinal preparation - see Griffiths v. Conway (Peter) Ltd [1939] 1 All ER 685, CA and Ingham v. Eves [1955] 2 QB 366, CA. In Griffiths v. Conway the claimant purchased a Harris Tweed coat from the defendant. The claimant developed dermatitis and initiated proceedings under s.14(1) of the SGA 1993 - "The coat was not fit for purpose". The claimant's skin was abnormally sensitive and the defendant was not aware of this. Furthermore the
6.18 Contributory negligence by the consumer may be raised as a defence by the
manufacturer or supplier.95 Dr Ellen Beerworth describes contributory negligence
as; 96
“A negligent act or omission by a claimant which is the cause of the loss or damage in the sense in which negligence on the part of the defendant may be a cause of loss or damage.”
Dr Beerworth continues to cite examples of contributory negligence and amongst those examples cited there are circumstances that are relevant to this discussion, that include the failure to read product information before use or consumption of the product, and the use of a product in a manner
that is highly likely to cause injury.97
6.27 Under certain circumstances, following the implantation of a surgical device, conduct by the consumer (the product user), that is in reality post-sale conduct, and even the conduct of others, can eliminate or reduce the exposure of manufacturers to any liability. The misuse of a surgical product, that is not reasonably foreseeable by the implant manufacturer, and that causes an adverse event, might relieve the manufacturer, sponsor, or distributor (seller) of liability. This is not only because of any contributory negligence or of aspects that impact on causation but because the manufacturer is responsible only for dangers arising
from a product's contemplated or foreseeable use.98 It is axiomatic that, if misused, a product cannot be said to be defective with regard to the purpose
intended, so there can be no breach of duty.99 Alternatively, if the misuse of the implant can be reasonably foreseeable, then it may be that this will constitute evidence that supports the need for an alternative design or be evidence of a
claimant had not made it clear to the defendant that the Harris Tweed coat was being purchased for a particular purpose. The claimant failed. For further reading see the commentary of G Pearson & S Fisher, Implied Terms, Pt V Liability for Goods and Services in Commercial Law - Commentary and Materials (1st ed 1999) Ch 4, 95-26. In contrast, as regards to fitness for purpose, the inability of the seller to detect an unforeseen side effect is not in principle a defence - see Hill (Christopher) Ltd v. Ashington Piggeries Ltd [1972] AC 441, 498 and Frost v. Aylesbury Dairy Co Ltd [1905] 1 KB 608, CA. 95 Though contributory negligence by the buyer is not a defence to an action based in contract; see Basildon District Council v J E Lesser (Properties) Ltd [1985] QB 839, [1985] 1 All ER 20. 96 See E Beerworth, Product Liability Australia (2001) Vol 1, 1265. 97 See Kelly v. Smith & Smith (1986) SASR 13. See also Griffiths v. Arch Engineering Co (Newport) Ltd [1968] 3 All ER 217. 98 TPA s.75AC(1). 99 See TPA s.75AC(2)(a),(d),(e). Also see Aswan Engineering Establishment Co v. Lupdine Ltd [1987] 1 All ER 135, 154 - this is a fit for purpose case but the matters are relevant to this discussion.
6.19 contra-indication for the implantation of the device in question. Where misuse is foreseeable, there is an obligation for the manufacturer to give a warning to avoid
the use of the product in that manner.100 It is also the case that any misuse of a product by a claimant can reduce the claimant's recovery under those rules
governing the apportioning of responsibility.101 It may also be the case that any
loss will be shared by the claimant and the respondent102 if it can be demonstrated that loss or damage was in part associated with an act or omission of the claimant,
as well as there being a defect in the goods.103
6.28 With particular reference to orthopaedic surgical implants or to the implantation of a cardiac pacemaker, any misuse of the prosthetic implant product, by a claimant, if it can be shown, presents as an interesting [untested] concept. The misuse defence to a product liability claim may be available if it can be shown that the claimant has used the product, e.g. a total hip or a total knee replacement prosthesis or a cardiac pacemaker, in a wholly unreasonable manner, that is
outside what any reasonable user would consider to be acceptable use104. It is arguable that to run a marathon after having undergone a total hip or knee replacement procedure or the insertion of a cardiac pacemaker might reasonably be seen to be a misuse of the surgically implanted device, particularly in the circumstance where a warning against undertaking such an activity can be demonstrated to have been provided by a learned intermediary. In the event that misuse can be established as a defence, based upon contributory negligence, there
100 Good-ware Treaders Ltd v. D & B Holdings Ltd (1979) 98 D.L.R. (3d) 59. 101 TPA s.75AN provides that where the loss was caused by both a defect in the action goods and an act or omission of the person who suffered injury or loss because of the defective goods, the Court will reduce the amount of compensation by an appropriate amount, taking into account all the relevant circumstances. In appropriate circumstances, the reduction can amount to a complete disallowance of the claim. See also the Explanatory Memorandum to the Trade Practices Amendment Act 1992 (Cth), ¶ 6.8. TPA s.75AN has a similar affect, therefore to the defences of contributory negligence and voluntary assumption of risk in negligence cases. 102 TPA ss.75AE, 75AF, 75AG, and 75AN. TPA s.75AN permits the manufacturer to be able to reduce the amount of compensation payable, if loss results partly from misuse, to reflect that part of the damage caused by contributory acts or omissions by the injured person. See also ACCC v. Glendale Chemical Products Pty Ltd (1998) 40 IPR 619; ATPR 41-632. This case is all the more interesting by virtue of the fact that there was no finding of contributory negligence in circumstances where the injured person had read the label twice and still did not follow the instructions provided, choosing instead to rely on the advice of an acquaintance. 103 The decision in ACCC v. Glendale Chemical Products Pty Ltd (1998) 40 IPR 619; ATPR 41-632 contrasts with that in Holmes v. Ashford [1950] 2 All ER 76; 94 SLL JO 357. Here the claimant was treated with a hair dye (Inecto) by a hairdresser. The hair dye was known to be harmful in certain circumstances. The product was supplied with a label and a brochure bearing a warning. The warning had been read but the hairdresser did not undertake those tests recommended before the application of the dye. Tests were intended to identify those that might be allergic to the product. Following application of the dye the claimant suffered from a dermatitis and claimed against both the hairdresser and the manufacturer of the dye. The hairdresser was held liable and negligent for a failure to advise the claimant as to the risks associated with the use of the dye. The manufacturer was held not to be negligent as the Court considered that the manufacturer had acted reasonably in the circumstances there being no obligation to directly warn every person that used the dye. This case also demonstrates the doctrine of the learned intermediary. 104 Decca Radar Limited v. Caserlite Limited [1961] 2 Lloyd’s Rep 301; Poole v. Crittal Metal Windows (NZ) Ltd [1964] NZLR 522. See also Beck v. State of NSW [2001] NSWSC 278; BC 200101695.
6.20 is then an absolute defence to liability.105 If contributory negligence106 can be
established then the damages are reduced under apportionment legislation.107
6.29 Generally, contributory negligence is not a defence to an action based in contract. However it can be the case that contributory negligence, on the part of a consumer may be raised in a defence that at least may have the effect of reducing
the level of compensation that is recoverable.108
6.30 The common law defence of voluntary assumption of risk,109 based on the maxim volenti non fit injuria provides for an absolute or complete defence for claims that
is characterised as a type of “plaintiff’s strict liability”110 for claims in tort and in
contract111 if the defendant can show that the claimant had knowledge of facts constituting a dangerous condition, and knew that the condition was dangerous, and appreciated the nature or extent of the risk associated with the voluntary
exposure to that danger.112 The defence based on voluntary assumption of risk is also available in claims pursuant to strict liability legislation such as can be found
in TPA Pt V, Div 2A and Pt VA.113
105 TPA s.75AN provides that compensation for loss under ss.75AD and 75AE may be reduced where the loss or damage is caused by both an act or omission of the claimant as well as by a product defect. 106 See March v. E & MH Stramare Pty Ltd (1991) 171 CLR 506; 99 ALR 423 HCA - this case concerned the claimant, who driving at excessive speed with abilities impaired by alcohol, collided into the defendant's truck that had been parked in the middle of a six lane road outside a wholesale fruit and vegetable market. The event occurred in the early hours of the morning when the street was moderately well lit and the truck's parking and hazard lights were active. At the trial the claimant and the defendant were both held to have been negligent and responsible for the claimant's injuries (70% and 30% respectively). On Appeal the full Court of South Australia held, in the majority, that responsibility for the collision should have been attributed to the claimant's conduct alone. See TPA ss.75AE, 75AF, 75AG, and 75AN where the loss or damage was caused by both an act or omission of an individual who suffers the injuries as well as the defect in the goods. The amount of the loss is to be reduced by an amount equivalent to that individual's share in causing the loss. 107 See Ch 3, ¶ 3.52 and n.203. See also the Civil Liability Act 2002 (NSW) Div 8 (Contributory Negligence) ss.5R, 5S and 5T. 108 See Astley v. Aus Trust Ltd (1999) 73 ALJR 403. 109 See Grant v. Australian Knitting Mills Ltd (1935) 54 CLR 49; [1936] AC 85. 110 E Beerworth, Product Liability Australia (2001) Vol 2, 35034 at [28.70]. 111 See Dann v. Hamilton [1939] 1 All ER 59 – at 60 per Asquith J. 112 In New South Wales the Civil Liability Act 2000 (NSW) is legislation that specifically concerns the assumption of risk. See Div 4 (Assumption of Risk), s.5F (meaning of “obvious risk”), s.5G (injured persons presumed to be aware of obvious risks), s.5H (no proactive duty to warn of obvious risks) and s.5I (no liability for materialisation of risk). See Insurance Cmr v. Joyce (1948) 77 CLR 39; [1948] ALR 356 - this case concerns the legal position of a person who allows himself to be driven in a motor car by an obviously drunken driver as a "guest passenger". Latham CJ argued that such a person is entitled to expect only the degree of care which can be achieved by a drunken driver, and that if he is injured as a result of the drunkeness of the driver he has no cause for complaint because there has been no breach of duty to him. Secondly it was suggested that such a case falls within the category of contributory negligence and thirdly that the maxim volenti non fit injuria applies. See also Rootes v. Shelton (1967) 116 CLR 383;[1968] ALR 33, - in this case the voluntary assumption of risk of injury, in a sporting activity, from another participant's act or omission, that with the knowledge of the risk involved, there is an implied consent to relieve that other participant of the legal consequences that might ordinarily follow should there have been some act or omission. 113 See TPA s.75AN.
6.21 The Learned Intermediary Defence
6.31 The role of the learned intermediary is one that includes, among other things, the
learned intermediary defence.114 I have a view that the concept of the learned intermediary embraces, not only a defence for a manufacturer, but is also a concept that is pivotal to any debate of the doctrine of Informed Consent or to any debate of the role, obligations and responsibilities of those that are concerned
with the transfer of knowledge115 in general and with continuing education programs in particular. The concept of the learned intermediary, and those other ramifications associated with the concept, are discussed in Chapter 7.
6.32 Briefly though, it is appropriate to emphasise that the effect of the learned intermediary doctrine upon a manufacturer's duty has been the subject of
considerable case law in the USA.116 The doctrine has extended both to pharmaceutical products and to medical device cases. The role of the learned intermediary can be pivotal in enabling a manufacturer to fulfill a duty of care. Detailed information is provided by manufacturers to qualified intermediaries rather than to consumers. It is expected that this information will be used to ensure that a patient is fully informed of the risks, harms and benefits that might be associated with the use of a particular therapeutic drug or device. In the event where a therapeutic product is considered to be defective and the manufacturer has provided full and adequate information, and warnings, to a learned intermediary, there will have been no failing of the manufacturer's duty to warn in those circumstances where the learned intermediary has not informed the patient.
6.33 The learned intermediary defence should be available in claims based in negligence and to issues of product liability pursuant to strict product liability
114 The learned intermediary defence, its meaning, and the circumstances in which the defence is available is described by E Beerworth, Product Liability Australia (2001) Vol 2, 36,001-36,019. The learned intermediary defence has not, in Australian Courts, in contrast to North American Courts, so far been widely considered. However the learned intermediary defence is available in claims based in negligence and pursuant to strict product liability legislation. This is evident in H v. Royal Alexandra Hospital for Children [1990] Aust Torts Reports 67, 503. See TPA s.75AC(2) & s.75AK(1)(a). See also Ch 7, ¶ 7.6-7.16. 115 These include paternal bodies, Universities, craft groups, Associations, Hospitals, and Collegiate organizations who become concerned with continuing education activities that might also include workshops and conferences that are financially supported by manufacturers and distributors of implantable surgical devices. 116 See Phelps v. Sherwood Medical Industries 836 F 2d 296 (7th Cir 1987) (Heart Catheter) and Brooks v. Medtronic Inc, 750 F 2d 1227 (4th Cir 1984) (Cardiac Pacemaker). In Australia it has been held that the duty to warn rests with the treating medical practitioner and not with the manufacturer or distributor of a product - see H v. Royal Alexandra Hospital for Children (1990) Aust Torts Reports 81-000.
6.22 legislation such as that found in Div 2A Pt V and Pt VA of the TPA.117 The
defence is not available in claims in contract.118
The Intermediate Examination Defence
6.34 The intermediate examination defence119 is available in a product liability claim in circumstances where products supplied are found to be defective or unsafe and where it can be shown that the manufacturer or supplier of the product did reasonably anticipate that another third party, eg. a learned intermediary (or perhaps even the consumer), would undertake an [intermediate] examination of
the product that might reveal any defects prior to the use or to the consumption120 of the product. In such circumstances the intermediate examination defence is
available121 so to avoid or to mitigate against loss or damage.
6.35 Where an intermediate inspection of a product is anticipated, or where a consumer is placing primary reliance on the judgement of a learned intermediary, and not the manufacturer, a warning by a manufacturer to the ultimate consumer may not be necessary. The manufacturer may satisfy its obligations to the ultimate consumer where it can be expected that an intermediate examination of a prosthetic device will be undertaken prior to the surgical implantation of the device. It is important though to keep in mind that any reliance on the intermediate examination defence and on the learned intermediary rule are merely
exceptions to the manufacturer's general duty to warn the ultimate consumer.122
6.36 Lord Atkin, in Donoghue v. Stevenson123 described the manufacture's liability for a defective product as contingent on there being no reasonable possibility of
117 See H v. Alexandra Hospital for Children [1990] Aust Tort Reports 67,503 ¶ 81-100 and Bryden v. Chief General Manager of Health Department (1987) Aust Tort Reports 80-175. 118 See E Beerworth, Product Liability Australia (2001) Vol 2, 36,019 [29.30] & [29.35]. 119 See Hindustan Steam Shipping Co Ltd v. Siemens Bros & Co Ltd [1955] 1 Lloyd's Rep 167 - though manufacturers are liable for harm caused by their failure to take reasonable care to ensure that a product has been safely designed they cannot be liable in negligence for not knowing about undiscoverable defects. 120 Hurley v. Dyke [1979] RTR 265 (HL) - here reliance on another to prevent the harm was found to be reasonable so that a warning was held to be sufficient to discharge the duty of care (dangerous cars sold "with all faults": see especially the Judgement Browne LJ, in the Court of Appeal (at 294-5). See again also Griffiths v. Arch Engineering Co (Newport) Ltd [1968] 3 All ER 217. 121 See Griffiths v. Arch Engineering Co (Newport) Ltd [1968] 3 All ER 217. 122 See I Kennedy & A Grubb (eds), Medical Law (2000) 1617. Kennedy & Grubb emphasise that the rule operates to discharge the manufacturer's duty, not to the learned intermediary, but to the ultimate consumer who has a right to full and current information about any risks inherent in the ordinary use of a product. In the event the manufacturer can only be said to have discharged its duty to the consumer when the intermediary's knowledge approximates that of the manufacturer.
6.23 intermediate examination before it reaches the ultimate consumer. This requirement is simply an aspect of reasonable foreseeability, there being no
liability124 unless the manufacturer could reasonably have anticipated that the examination conducted by the intermediary would be of such a type as to reveal
any defect125 prior to the use or consumption of the product that is associated with its surgical implantation.
6.37 The opportunity, or lack of, to undertake an intermediate examination of a surgical device is in contrast to the lack of opportunity to undertake an independent test of the device. It may be held that if there has been no opportunity to independently test the surgical device then the user (or consumer) of the device can be entitled to assume the merchantability of the device and that
the device is fit for the purpose that it was designed for.126 This assumption may not be valid if there is evidence of device failure that has been published in the peer-reviewed literature. Relevant to this, there is the question that remains unanswered, that is – are corridor conversations, between specialists, that concern device failure, to be regarded as including knowledge that is "published" and
accessible to others? This question remains untested but Burton J127 in A & Anors v. The National Blood Authority & Anors does provide some guidance.
123 See Donoghue v. Stevenson [1932] All ER Rep 1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85, 458. 124 Subject to there being any contributory negligence (TPA s.75AN & Civil Liability Act 2002 (NSW), Div 8, ss.5R & 5S) or proportionate liability (amendments to TPA s.82 contained in Sch 3 of the Corporate Law Economic Reform(Audit Reform & Corporate Disclosure) Act 2004 (Cth). 125 See Griffiths v. Arch Engineering Co (Newport) Ltd [1968] 3 All ER 217. 126 Personal communication, William Turner, Orthopaedic Surgeon and Lawyer, Royal Hobart Hospital, 12 December 2001. 127 See A & Anors v. The National Blood Authority & Anors [2001] EWHC QB 446, at [49] Burton J refers to the availability and accessibility of scientific and technical knowledge, “in the sense of the accessibility of the sum of knowledge at a given time to interested persons. It is undesirable that the circulation of information is affected by objective factors, such as, for example, its place of origin, the language in which it is given and the circulation of the journals in which it is published. Burton continues It seems to me that the right approach is to look at "accessibility" and to regard as "Manchuria" perhaps an unpublished document or unpublished research not available to the general public, retained within the laboratory or research department of a particular company. Burton J then states that in such a situation, it would be unrealistic, I would say unreasonable, to take the view that the study published in Chinese has the same chances as the other of being known to a European product manufacturer. Though, I do not consider that in such a case a producer could be held liable on the ground that at the time of which he put the product into circulation the brilliant Asian researcher had discovered the defect in it”. This contrasts with TPA s.75AK(1)(c) – the “State of the Art Defence”. Here it is the objective state of scientific and technical knowledge, not the subjective knowledge of the individual manufacturer, that is taken into account. Whilst the manufacturer must keep up to date with advances in knowledge after it first puts a product into circulation the inaccessibility of “Manchurian” knowledge (my descriptive) may provide an opportunity for defence. See also Crawford v. Board of Governors for Charing Cross Hospital (unreported, April 22, 1953) – this case demonstrated that the Courts may not find a clinician guilty of negligence where he has not read one article on a topic warning of danger. The findings in this case indicate that where there is any one article on a particular topic then a clinician might not have had the opportunity to read it. However with increased development of information technology the Courts might not take such a generous view particularly in the event where there can be found specific warnings in authoritative clinical guidelines. Failure to read a particular article will not necessarily constitute a breach of the standard of care. For further reading see JW Jones, “A Medico-Legal Review of Some Current UK Guidelines in Orthodontics; A Personal View” (1999) 26 (4) J Orthodontics, 307-324. See also Gascoine v. Ian Sheridan & Co. and Latham[1994] 5 Med LR 47.
6.24 The Bulk Supplier Defence
6.38 The manufacturer may have an opportunity to introduce that defence that can be referred to as the bulk supplier defence. This defence is probably only rarely appropriate to matters regarding surgically implantable device product liability. Implantable surgical devices are rarely supplied in bulk. However, it may be that the bulk supplier defence is available to manufacturers, and other suppliers of surgically implantable products such as hydroxyapatite and other bone graft substitute materials or fracture fixation screws, which may be supplied in bulk, where there is a reasonable expectation that the entity (the hospital) acquiring the product in bulk would repackage, label and sterilize the product and at times provide appropriate warnings and information to persons who can reasonably be
foreseen to be at risk of suffering loss or damage when using the product. 128
CONCLUSION
6.39 In this chapter, and in chapter 7, those defences that are available to manufacturers of goods in general, and to the manufacturers and distributors of surgically implantable devices in particular, have been reviewed. Notwithstanding the many defences that are available it remains the case that, for the most part, a manufacturer’s duty of care is non-delegable and the burden of proof in any defence by a manufacturer is almost always obligatory. If the necessary link (nexus) between defect and injury is established it is to be inferred that at the time of injury the defect was present unless the manufacturer can
demonstrate otherwise.129
6.40 Matters relating to those other general conditions and terms of business, such as exclusion clauses and warranties, have not been discussed in this chapter as it is only rarely the case that there is a contract between the manufacturer and the patient as a consumer. Generally a person, or organisation, that is not party to a contract, or the intended beneficiary of a contract, cannot be exposed to the
128 See ACCC v. Glendale Chemical Products Pty Ltd [1998] 40 IPR 619; ATPR 41-632. See also Forbes v. Olympic General Products (Qld) Pty Ltd (1989) Aust Torts Reports 80-301.
6.25 benefit or to the burden of any exclusion clause130. The TPA does though
provide131 that any term of a contract that excludes, restricts or modifies (or has
the effect of) the liability of a corporation for breach of a condition or warranty132 implied by a provision of Pt V Div 2 of the TPA is void.
6.41 In this chapter there is only the briefest reference to the tampering133 of goods that may have occurred outside or beyond any influence of the manufacturer, and to
the ramifications that can be associated with the consequences of the theft134 of a surgical device. In both events there can be circumstances that are beyond the control of a manufacturer or sponsor that will provide a strong foundation for a
sustainable defence.135 Unfortunately, though interesting, these are matters beyond the scope of this thesis.
129 Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014, Kiefel J at [191] - the debate here concerned the presence of a chip on a heart valve and the determination of when that defect occurred.. 130 See White v. John Warwick & Company Ltd (1953) 2 All ER 1021, 1026 per Denning L J. It is also interesting that during the 1980s and 90’s many American orthopaedic implant manufacturers, through their agents, distributed joint replacement devices in Australia that were intended, in Australia, to be implanted and fixed to the skeleton without the use of polymethylmethacrylate bone cement. Whilst these implants were knowingly distributed in Australia for use without polymethylmethacrylate bone cement the information provided with the products, and the labelling of the products, in almost every case, instructed that the implant “was only for use with bone cement”. During the 1980’s and 1990’s these same products had not been approved by the FDA for use without bone cement (in the USA) though their design was clearly such that the products were intended to achieve fixation to the skeleton through osseo-integration between the host bone and the porous ingrowth structure of the implant surface. 131 TPA ss.68 & 75AP. 132 I have rarely observed it to have been the case that an implantable surgical device comes with a warranty as to liability for defect. Interestingly though the Centerpulse Orthopedics Inc. Product Catalogue, 2003, does in Chapter 3, pp5-6, (in para 10) refer to that organization's Warranty with respect to surgically implantable orthopaedic devices. In para 10.1 Centerpulse Orthopedics warrants that the products are free from defects in materials and workmanship for a period of twelve months from the date the products are dispatched for shipment. If the purchaser fails to immediately notify Centerpulse Orthopedics of any defects, Centerpulse Orthopedics disclaims any warranty and any other liability. Further in para 10.5 Centerpulse Orthopedics' does not extend to any defect or damage caused by incorrect application and handling (for example, implantations not performed with the proper surgical skill, failure to observe the recommendations for applications, combination of Centerpulse Orthopedics products with those of other manufacturers, excessive use, loss of sterility, improper use of mechanical aids, etc.) as well as natural wear and tear of the product. Further, Centerpulse Orthopedics disclaims any warranty and liability for individual and special designs. Any liability of Centerpulse Orthopedics for auxiliary persons is excluded to the extent admissible by law. In para 15.1 the jurisdiction and applicable law is described to be for the purchaser and Centerpulse Orthopedics are with the Courts of Baar (Switzerland). Centerpulse Orthopedics reserves the right to sue the purchaser at his domicile. In para 15.2 it is stated that The relationship between purchaser and Centerpulse Orthopedics is governed by Swiss Law, excluding the United Nations Convention on Contracts for International Sale of Goods. 133 See TPA s.75AK(1)(a). See also the Therapeutic Goods Amendment Act (No. 3) 2000 (Cth), Pt 4C, Product Tampering, ss.42T, 42U, 42V, and 42W. The mandatory reporting of product tampering or of implied tampering is necessary and compliance would be persuasive. Regulation regarding tampering were strengthened following the tampering of pharmaceutical products manufactured by Herron Pharmaceutical Company and SmithKline Beecham. 134 In the event that a product is stolen the manufacturer will not have supplied the device or product and there is an opportunity for the manufacturer to benefit from a stolen product defence. 135 Mere speculation that there has been tampering is no defence. To rely on a defence in TPA s.74D(2) and s.75AK the manufacturer must prove actual third party interference after supply. See Effem Foods Ltd v. Nicholls (2004) ATPR 42-034. This case concerned the contamination of a chocolate bar by a safety pin.
6.26 CHAPTER 7
THE LEARNED INTERMEDIARY
The Delicate Balance between a Defence and the Duty to Warn and to Educate INTRODUCTION
7.1 The concept of the learned intermediary has achieved more distinction in the United States, than has been the case in Australia. In North America the concept has been reaffirmed and developed in a series of cases during the 1970s and 1980s that concerned the exposure to liability of
manufacturers of prescription drugs. 1
7.2 The concept developed as a rule, originally intended to reflect, through an equitable distribution of tort duties, the tri-partite informational
relationship between drug manufacturers2, medical practitioners and patients. The rationale for the rule is sound and is much less of a rule than it is a specific application of the long-established common law principles of intervening cause and intermediate examination that had
already been developed and enshrined in Donoghue v. Stevenson.3
7.3 It remains the case that when manufacturers place products into the marketplace a relationship is created with consumers who generally will have considerably less knowledge than does the manufacturer concerning the risks of harm, the benefits, and the balance between the two that can be associated with the surgical implantation of any prosthetic device. For patients (as consumers) to be able to make informed decisions and to be able to provide informed consent there is a duty on the part of manufacturers to provide warnings of risks and benefits, and of all other information, in a manner that will correct any imbalance of knowledge.
1 See Schenebeck v. Sterling Drug, Inc, 423 F2d 919 (8th Cir 1970); Hoffman v. Sterling Drug, Inc 485 F2d 132 (3rd Cir 1973); Dunkin v. Syntex Laboratories Inc, 443 F Supp 121 (WD Tenn 1977); Lindsay v. Ortho Pharmaceutical Corp, 637 F2d 87 (2d Cir 1980); Timm v. Upjohn Co, 624 F2d 536 (5th Cir 1980); Cert Denied 449 US 1112 (1981); Stanback v. Parke Davis & Co, 657 F2d 642 (4th Cir 1981); Walker v. Merc & Co, 648 F Supp 931 (MD Ga 1986; Affirmed 831 F2d 1069 (11th Cir 1987); Plummer v. Le derle Laboratories, 891 F2d 349 (2d Cir 1987). 2 The Learned Intermediary rule was first elaborated in Sterling Drug, Inc v. Cornish, 370 F2d 82 (8th Cir 1966). The rationale for the rule was further outlined by Wisdom J. in Reyes v. Wyeth Laboratories 498 F 2d 1264 (5th Cir CA), cert denied 419 US 1096 (1974). Wisdom J. held that: "As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of drugs inherent in patent drugs sold over the counter, in selling the prescription drugs are required to warn only prescribing physician, who acts as a learned intermediary between manufacturer and consumer."
7.1 The standard of care to be met by manufacturers to ensure that consumers are properly warned is necessarily high. This is particularly so for surgical devices that are implanted into the human body where the
risks associated with their use can be substantial4 and at times life- threatening. The capacity for implantable surgical devices to cause injury is significant. The greater is the risk of this then it follows that the warnings and information that should be provided must be more detailed
and contain all of the information that is required.5
7.4 It is rarely the case that the manufacturer of a surgically implantable device will have the opportunity to meet directly with the patient for the purpose of providing information regarding the risks and benefits associated with the use of a particular implant. In this case the surgeon, who is regarded as the learned intermediary, is the informational interface between the supplier of goods (manufacturer) and/or services and the patient as a consumer. The learned intermediary is the conduit for the transfer of information from manufacturer to patient that can fulfil the obligation implicit in a manufacturer's duty to warn. H v. Royal
Alexandra Hospital for Children6 demonstrated a restricted application, in Australia, of the concept of the learned intermediary and of the learned intermediary defence. In circumstances where the learned intermediary
3 Donoghue v. Stevenson [1932] All ER Rep.1; [1932] AC 562; 101 LJPC 119; 147 LT 281; 36 Digest (Repl) 85,458. 4 Courts in the United Kingdom have recognised that manufacturers of products that are ingested, consumed or inserted into the body are subject to a correspondingly high standard of care under the law of negligence. See I Kennedy & A Grubb, Medical Law (3rd ed, 2000) 1619. See also Shandloff v. City Dairy [1936] 4 DLR 712 and Arendale v. Canada Bread Co [1941] 2 DLR 41. 5 See Lambert v. Lastoplex Chemicals Co (1971) 25 DLR (3d) 121 - at pp.124-5, [1972] SCR 569, Laskin J imposed liability on the manufacturer of a fast-drying lacquer sealer who had failed to warn of the danger of using the highly explosive product in the vicinity of a furnace pilot light. However there were three different labels on the packaging warning of the danger of inflammability. The claimant, an engineer, had read the warnings before undertaking to lacquer his basement floor. In accordance with the warnings, the claimant turned down the thermostat to prevent his furnace from igniting. However he did not turn off the pilot light. As a consequence a fire occurred that resulted in an explosion. Laskin J found the manufacturer liable as none of the three warnings were sufficient in that they did not warn specifically against leaving pilot lights on near the working area. It is no less of a burden on manufacturers of surgically implantable devices to provide clear, complete and current information concerning the dangers inherent in the ordinary use of the devices. 6 See H v. Royal Alexandra Hospital for Children [1990] Aust Torts Reports 67, 503. This case concerned a haemophilic child who required treatment with anti-haemophilia factor (AHF). AHF is produced from human blood plasma. Following treatment the child developed the Acquired Immune Deficiency Syndrome (AIDS). The AHF was found to have been contaminated with the Human Immune Deficiency Virus (HIV). The court held that the defendants (the hospital), the Commonwealth Serum Laboratory (CSL) – the manufacturer, and the Australian Red Cross (the Blood Bank) were all aware of the risk that AHF might be contaminated with and transmit both known and unknown causes for infection. The court considered that the defendants had a duty to warn of this risk. However the court also considered that since AHF is usually administered by medical practitioners the duty was to warn doctors rather than patients themselves and that the provision of an adequate warning to doctors would discharge the manufacturer’s duty to warn. A court found that the CSL and the Blood Bank had failed to warn doctors of the risk of using AHF. However it was held that the failure to warn the treating doctors was not cause for the child to develop AIDS as the treating doctors were already well aware of the risk. See also Bryden v. Chief General Manager of the Health Dept (1987) Aust Torts Reports 80-175.
7.2 has been provided with all necessary information by the manufacturer and does not fulfil the obligation to inform the patient of all of the material risks and benefits involved in a surgical procedure, there may be an opportunity for the manufacturer to benefit from the learned
intermediary defence7 in the event that the product is found to be
defective8 and unfit for the purpose9 that was intended. It is suggested that the learned intermediary defence should be available in claims based in negligence and pursuant to strict product liability legislation, such as
Pt V Div 2A and Pt VA10 of the TPA. The defence is not available in
claims based in contract.11
7.5 The activities of the learned intermediary are far broader and more wide reaching than is the defence and I have a view that the role of
7 See Holmes v. Ashford [1950] 2 All ER 76 CA. It is not usually necessary for the relative information to be communicated directly to the consumer when a product is to be used under expert supervision. In Holmes v. Ashford [1950] 2 All ER 76 CA - the claimant was treated with a hair dye (Inecto) by a hairdresser. The hair dye was known to be harmful in certain circumstances. The product was supplied with a label and a brochure bearing a warning. The warning had been read but the hairdresser did not undertake those tests recommended before the application of the dye. The tests were intended to identify those that might be allergic to the product. Following application of the dye the claimant suffered from a dermatitis and claimed against both the hairdresser and the manufacturer of the dye. The hairdresser, the learned intermediary, was held liable and negligent for a failure to advise the claimant as to the risks associated with the use of the dye. The manufacturer was held not to be negligent as the Court considered that the manufacturer had acted reasonably in the circumstances there being no obligation to directly warn every person that used the dye. See also Griffiths v. Arch Engineering Co. (Newport) Ltd & Anor [1968] 3 All ER 217 - the claimant's employers were engaged in repair work at a dock. Welding work was sub-contracted to Arch Engineering who hired a portable grinding machine from Gwent Contractors (second defendant). Mr Edwards, a Director of Arch Engineering, arranged with Mr Smith, the Managing Director of "Gwent" to hire the machine. Mr Edwards took the machine to the docks and handed it to Mr Lambert, the Charge-Hand/Fitter. The following day the claimant asked Mr Lambert if he could use the machine as he wanted to smooth burrs off from a socket of a drill. The machine was designed to be held in both hands but there was no vice available to secure the device. There being no vice handy, the claimant could only hold the machine in one hand. It was necessary for the claimant to hold the device with the left hand and to present the socket with the right hand. As soon as the socket made contact with the machine, the grinding wheel shattered and the claimant suffered serious injuries to his right hand. The Court held that Arch Engineering and Gwent Contractors were equally liable to the claimant, because, on the facts, there was a reasonably foreseeable risk of injury against which the claimant should have been warned by Arch Engineering which, through Mr Edwards, was in de facto control of possession of the machine, and as the claimant was allowed to use it without warning of dangers which ought to have been known to Mr Edwards, as a Professional Engineer - a learned intermediary. It was also held that it was incumbent on the Managing Director of Gwent to take reasonable precautions against risk of injury to a person into whose hands the machine might foreseeably come. The claimant was held to be one-fifth liable since he was at fault in the manner of using the machine. However, see also A & Anors v. National Blood Authority & Anors [2001] 3 All ER 289, where it was held that the knowledge of an intermediary was irrelevant. This case concerned 114 patients who had become infected with Hepatitis C as a result of transfusion with contaminated blood and blood products. It was known that there was a small risk of infection from blood transfusions, however, there was no test available at the time to detect Hepatitis C. It was then regarded that the infection was caused by an agent known as non-A non-B. The blood was found to be defective within the meaning of the UK Consumer Protection Act because the general public expected blood to be 100% safe. 8 TPA s.75AC defines the term defect that is central to all of Pt VA's liability provisions. Goods are defective if their level of safety is not such that persons are generally entitled to expect: TPA s.75AC(1). In determining the safety of goods the section does not require goods to be absolutely free of risk and TPA s.75AC(2) lists those matters to be taken into account when determining whether goods are defective and unsafe (TPA s.75AC(2)(a-f)). TPA s.75AC(1)(d) specifically refers to the instructions or warnings that are company goods. See also Ch 5. 9 TPA s.71(2) and Sale of Goods Act 1923 (NSW) – s.19(1). 10 See E Beerworth, Product Liability Australia (2001) Vol 2, 36,019 [29.30]. See also Carey-Hazell v. Getz Bros & Co (Aust) Pty Ltd, [2004] FCA 853; (2004) ATPR 42-014. 11 See vide supra n.10.
7.3 intermediaries has, in the past, been very much understated.12 Furthermore, in my opinion the role of the learned intermediary embraces a much wider responsibility than is implicit in the defence. There can be found other obligations of the learned intermediary that are crucial to the carrying into effect of:
(a) the performance of a duty to warn patients (as consumers) that enables access to informed consent and the voluntary assumption of risk; and (b) the role and responsibilities of educators and learned institutions when satisfying their obligations to enabling continuing professional education.
THE LEARNED INTERMEDIARY DEFENCE, THE INTERMEDIATE
EXAMINATION DEFENCE, AND A MANUFACTURER'S DUTY TO WARN
7.6 It is the case that the principles underlying the doctrine of informed consent are equally, if not more, applicable to the relationship between manufacturers of surgical devices and consumers than they are to the surgeon-patient relationship. The doctrine of informed consent has developed as a judicial attempt to redress the inequality of the balance of information that characterises a doctor-patient relationship. In reality, this inequality or informational imbalance is probably even greater between the manufacturer and consumer. The imbalance is further aggravated because the consumer rarely has the opportunity to question the manufacturer directly. In contrast, the patient is afforded the opportunity to question the clinician at will.
7.7 As a general rule, there is a ‘duty to warn’ that is owed directly by the manufacturer to the ultimate consumer. The informational supremacy
12 See Product Liability, “Role of Intermediaries”, Australian Trade Practices Reporter, 17864 [¶24-240]. See also TPA s.75AC(2) all relevant circumstances must be taken into account in determining the safety of goods. According to para 24 of the Explanatory
7.4 enjoyed by manufacturers must impose a high standard for disclosure of information that should not be regarded as a burden. The rationale for the manufacturer's duty to warn can be traced to the neighbour principle
in Donoghue v. Stevenson.13 However, in exceptional circumstances, a manufacturer may satisfy its informational duty to the consumer by providing a warning through a qualified third party - the learned intermediary. As we have seen in paragraphs 7.3 and 7.4 manufacturers have a duty of care to patients, with respect to providing warnings, and a manufacturer can discharge this duty by warning the medical practitioner. This is generally known as the Learned Intermediary Rule
and forms the basis for the learned intermediary defence.14 The basis for this rule is for the medical practitioner to decide whether to prescribe a drug or to insert a prosthetic surgical implant and, if he or she does so, to
determine what information should be provided to the patient.15 This is an approach that may be interpreted to regard the learned intermediary as
the consumer16 and, amongst other things, requires that any surgically implantable device will meet the expectations of the learned intermediary. The learned intermediary rule will not apply, however, where there is no prospect of an expert intervening to provide an opinion of clinical judgment as to the potential outcome of a surgical procedure
for a particular patient.17
7.8 The role of the learned intermediary that includes the expectations to interpose judgment about the suitability for the use of a product, and the
Memorandum to the Trades Practices Amendment Act 1992 (Cth) which introduced Pt VA, the role which intermediaries may play in the supply of goods may also need to be taken into account. 13 Donoghue v. Stevenson [1932] All ER Rep. 1: [1932] AC 562 (HL). 14 The learned intermediary defence was first used in 1996 in Sterling Drug v. Cornish 370 F. 2d 82, 85 (8th cir 1966). The learned intermediary defence, its meaning, and the circumstances in which the defence is available is described by E Beerworth, Product Liability Australia, (2001) vol 2, 36,019-36,021. 15 Any failure to provide information, or to warn, will be the basis for a medical negligence action against the medical practitioner, rather than a product’s liability action against the manufacturer. The Learned Intermediary Rule is, of course, only applicable in those cases of drug or device prescription or provision that is undertaken by a medical practitioner. There can be no expectation of an expert intermediary where a drug or a device is available at a pharmacy. 16 This approach represents the consumer expectation test and for the purpose of the test it is contended that the health-care professional, the surgeon, rather than the patient, should be deemed the consumer. The issue of the consumer expectation test is whether a product is more dangerous than expected by the ordinary learned intermediary and this approach is more consistent with the traditional application of the Learned Intermediary Doctrine. See Shanks v. Upjohn Co., 835 P. 2d 1189 (Alaska 1992). 17 Reyes v. Wyeth Laboratories 498 F 2d 1264 (5th Cir CA), cert denied 419 US 1096 (1974) - this case concerned mass immunization. See also MacDonald v. Ortho Pharmaceuticals Corp., 475 NE 2d 65 (Mass Sup Jud Ct) (1985) - this case concerned the repeat prescriptions for contraceptive pills.
7.5 need for warnings or information to be conveyed to consumers are not
confined only to medical practitioners18 but also includes hairdressers19,
and others such as parents20, and aircraft pilots.21 In order to attract the defence, the manufacturer must prove that the information that is
provided to the learned intermediary was adequate in the circumstances22 so as to alert them to the potential risks that might be posed by the
product.23 Information such as a warning conveyed to learned intermediaries will not be considered adequate so as to give rise to the learned intermediary defence if the information is accompanied by an
expressed representation that the product is safe for use.24
7.9 The issues of the learned intermediary rule, the “post-marketing” duty to warn and causation are inseparable and have been examined by the
Canadian Supreme Court in Hollis v. Dow Corning Corp25.
18 See H v. Royal Alexandra Hospital for Children [1990] Aust Torts Reports 67, 503; Bryden v. Chief General Manager of the Health Department (1987) Aust Torts Reports 80-175. 19 See vide supra n.7. 20 See Bellotte v. Zayre Corp., 531 F 2d 1100 (1st Cir 1976). 21 See Stevens v. Cessna Aircraft Co., 115 Cal App 3d 431, 170 Cal Rptr 925 (1981). 22 Consider the case of Mary Banker, Individually as Parent and Guardian of Nicholas, an Infant v. James G. Hoehn et al and H.H.G.M., Inc., et al. (278 AD2d 720; 718 NYS 2d 438; NY App Div 2000). The claimant’s son was born in 1980 with a facial birthmark. In 1993, defendant James G Hoehn a Plastic Surgeon, undertook to remove the birth mark from the infant’s face by use of an Argon laser manufactured by the defendant HHGM Inc. Unfortunately the laser surgery was not successful and resulted in hypertrophic scarring. The claimant commenced this action, alleging medical malpractice against Hoehn and strict product liability, based on a failure to adequately warn against HHGM and the FISMA Corporation – the defendants. Following the completion the defendants sought summary judgment dismissing the complaint intending that any duty to warn with respect to the Argon laser was precluded under the doctrine of the learned intermediary and that even if the warnings were held insufficient, Hoehn’s knowledge of the risks associated with the use of the Argon laser in treating children with such facial birth defects and Hoehn’s failure to review the warnings given in the operations manual for the laser established that any failure to warn on his part did not proximately cause the injury to the infant. Believing that the defendants’ motion for summary judgment was premised only upon the learned intermediary doctrine, which, as we have seen, is centred on the assumption that proper warnings had been given, the Supreme Court denied the motion, finding that the defendants’ submissions had failed to establish the exact warnings given by the defendants prior to the surgery. 23 See vide supra n.7. 24 See Parker v. Oloxo Limited [1937] 3 All ER 524 – the claimant’s hair had been treated by her hairdresser who had described the hair dying used as harmless. A booklet supplied by the manufacturer with the product advised that the dye could be harmful if used without a skin test. However an agent of the manufacturer had also advised the hairdresser that the dye was safe to use. In the event, the claimant suffered a dermatitis of the scalp and claimed against the hairdresser and the manufacturer. The manufacturer was found liable to the claimant in negligence and the hairdresser liable in contract for breach of the implied warranty that the hair dye would be fit for the purpose. It was further held that the hairdresser was entitled to receive damages from the manufacturer equivalent to that which the hairdresser was liable to pay the claimant. 25 Hollis v. Dow Corning Corp (1995) 129 DLR (4th) 609 (Can Sup Ct) – In 1983, breast implants, manufactured by the defendant corporation, were implanted in the claimant’s breast by a Surgeon. One of the implants ruptured, requiring removal and further surgery. The literature accompanying the product warned of rupture during surgery but not of post-surgical rupture, except from abnormal squeezing or trauma. The claimant brought an action for damages against the manufacturer and the surgeon, succeeding at trial against the manufacturer on the basis of Res ipsa Loquitur. The action against the surgeon was dismissed. On appeal to the British Columbia Court of Appeal, the manufacturer’s appeal was dismissed, but on the ground that, though not negligent in the manufacture of the product, it was liable for the failure to warn since the evidence showed that, by 1983, it had received reports of about 50 cases of ruptures. The claimant’s appeal against the surgeon was allowed and a new trial ordered. On further appeal by the manufacturer, the Supreme Court of Canada held, dismissing the appeal, that the manufacturer had a duty to warn the medical profession of potential dangers, including those coming to its notice after manufacture and distribution of the product.
7.6 7.10 To allow manufacturers to claim the benefit of the learned intermediary rule, where they have not fully warned the surgeon, would undermine any basic rationale for the duty to warn, which is to ensure that the consumer is fully informed of all risks. Since the manufacturer is in the best position to know the risks associated with the use of its product and is also in the best position to ensure that the product is safe for its intended use, the primary duty to give a clear, complete and current warning must fall on its shoulders. The physical aspects of the warning must also have been adequate to alert a reasonably prudent person to any
potential risk.26 The means of conveying the warning must have been equal to the need, and any warning must have indicated the consequences
that might result from the failure to follow that warning.27
7.11 A claimant seeking to hold a manufacturer of a medical device liable for injuries under a failure to warn theory is required to establish that it was the failure to adequately warn of the potential risks and side-effects of the use of the product that was a proximate cause of the injury suffered. Under the doctrine of the learned intermediary rule, the manufacturer of the surgical device will have satisfied its duty to warn of potential adverse effects when it adequately warns medical professionals who recommend and use the device in the treatment of patients. This approach has not always been followed in the United Kingdom and the
recent case of A & Anors v. National Blood Authority28 can have the potential to be cause for some concern in Australian jurisdictions. In this case it was held that the knowledge of an intermediary was irrelevant and the decision of Burton J to exclude the role and the knowledge of the learned intermediary in determining whether a product is defective was, and remains, particularly controversial.
7.12 When a medical practitioner acts as a learned intermediary and intercedes between the manufacturer and the patient, there can be
26 See Bristol-Myers Co. v. Gonzales, 548 SW 2d 416 (1976). 27 See Sema v. Roche Laboratories, Division of Hoffman–La Roche Inc., 684 P2d 1187 (1984).
7.7 protection for the manufacturer that relieves the manufacturer of any responsibility to directly warn the patient of potential adverse side
effects29. The rule presumes that the intermediary is “learned”, that is to say, fully informed of the risks and benefits that can be associated with the use of the product. It follows that the manufacturer can only be seen to have discharged its duty to the consumer when the intermediary’s
knowledge approximates that of the manufacturer. Kennedy & Grubb30 have emphasised that the rule operates to discharge the manufacturer’s duty, not to the learned intermediary, but to the ultimate consumer, who has "a right to full and current information" about any risks inherent in the ordinary use of the product.
7.13 The duty to warn of a reasonably foreseeable danger or risk that arises out of knowledge that is known before any sale or before implantation of a product has occurred differs, for several reasons, from the duty to warn in circumstances that are influenced by knowledge that has been acquired about a product after it has been sold and implanted. For example, before the sale and the implantation of a surgical device, there is a period of time during which learned intermediaries may choose, for a variety of reasons, not to use the product; or patients may choose not to give informed consent to the implantation of the device after being advised of the risks involved. However, after a prosthetic implant has been sold, implanted and is in use, the nature of the danger, or risk of danger, is imminently more real and palpable in that the risk now co-exists with the
patient.31 Stated otherwise, before a surgical device is implanted, the learned intermediary is the gatekeeper whose role is to assesses the risk of harm and to inform the prospective patient-consumer who then must give his or her consent to the surgical implantation procedure. After surgical implantation, the learned intermediary continues to act as the gatekeeper. In the event of a device failure, or of a super added risk of
28 [2001] 3 All ER 289. 29 See JM Drazen, “The Consumer and the Learned Intermediary in Health Care” (2002) 346 (7) N Engl J Med, 523-24. 30 See I Kennedy & A Grubb, Medical Law (3rd ed, 2000) 1617. 31 This is so clearly stated in Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120; ATPR (Digest) ¶ 46-228.
7.8 failure, a patient continues to enjoy autonomy in choosing what happens to his or her body but it is the information that is provided by the learned intermediary that determines whether there is acceptance of the risk of surgical device explantation versus the risk of danger from continuing to live with the implant that may have become associated with an adverse
event e.g., device breakage, abnormal material wear, or malfunction.32
7.14 The way in which a product has been promoted to learned intermediaries may affect a Court's decision about whether the manufacturer can avail itself of the learned intermediary defence. Evidence of excessive
promotion alone is not a basis for liability33. However the growing trend to advertise and to promote drugs and devices directly to consumers has the potential to erode the protection permitted by this defence. This form of advertising, generally known as direct to consumer advertising (DTCA), can have the potential to alter the informational balance
between the medical practitioner and the patient.34 In the circumstances Courts may look for evidence that the over-promotion of drugs and devices could reasonably be said to have induced the learned intermediary to disregard or at least underestimate warnings provided by
the manufacturer.35
7.15 There can be occasions when surgeons become aware of the potential for, or the occurrence of, adverse events other than through communication with a manufacturer. These occasions include the reading of journal articles, scientific meetings, and even those corridor
consultations that frequently occur between colleagues.36 In those circumstances, where the treating surgeon becomes independently aware of the potential adverse side effects of the use of a particular device, such
32 See Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120; ATPR (Digest) ¶ 46-228 - this case concerned the Tempo Cardiac Pacemaker that was found to be defective or at risk of being defective as a consequence of dendrite formation that occurred following the use of contaminated yellow spool solder. 33 See Stevens v. Parke-Davis & Co., 101 Cal Rptr 64 (1972). 34 See Perez v. Wyeth Laboratories Inc 161 N.J. 1 (1999) - Here it is emphasised that if a company promotes a therapeutic good by DTCA then it has a non-delegable duty to warn the consumer of foreseeable risks. See also Ch 4 ¶4.64-4.70. 35 See Love v. Wolf, 38 Cal Rptr 183 (1964). 36 See Ch 6 ¶ 6.37.
7.9 knowledge may constitute an intervening event, that can relieve the manufacturer, who is not aware of the event, of any liability to a patient
under the failure to warn theory37.
7.16 Inextricably bound to the concept of the learned intermediary is the
intermediate examination defence.38 The intermediate examination
defence39 is available where it can be shown that the manufacturer or
supplier of a product did reasonably anticipate40 that another qualified party, a learned intermediary, would undertake an intermediate examination of the product to reveal any defects and in doing so avoid
loss or damage.41 Implicit in the defence is that an intermediate examination of a product is anticipated by the manufacturer and that the consumer will have placed primary reliance on the judgement of a learned intermediary, in this case the surgeon, to do this, and not on the manufacturer. The strength of the intermediate examination defence relies upon the discoverability of a defect by a learned intermediary. I have a view that this might, in the alternative, be a significant weakness of the defence as it is generally the case that only gross defects of design
or packaging can be identified at the time of surgery.42 This view finds
support in the Sulzer case43 where more than 17,000 replacement hip joint prosthetic devices were surgically implanted - each having a surface
37 This hypothesis is so far untested in Australian jurisdictions. 38 See Hindustan Steam Shipping Co Ltd v. Siemens Bros & Co Ltd [1955] 1 Lloyd's Rep 167 - Though manufacturers are liable for harm caused by their failure to take reasonable care to ensure that a product has been safely designed they cannot be liable in negligence for not knowing about undiscoverable defects. 39 There is a defence available to a manufacturer that is provided for under Div 2A of Pt V that relates to the intermediate examination. However it remains uncertain as to the consequences that will follow if an intermediate examination that should reveal the existence of a defect does not and when an intermediate examination is contemplated but does not take place. It may be though that such a situation will be covered by TPA s.75AN under Pt VA. The intermediate examination defence is not available in claims pursuant to TPA Pt VA. See Australian Ship Building Industries (WA) Pty Ltd v. Packer (1993) 9 WAR 375; Griffiths v. Arch Engineering Co. (Newport) Ltd [1968] 3 All 217. See also Ch 6, ¶ 6.34-6.38. 40 See Griffiths v. Arch Engineering Co (Newport) Ltd [1968] 3 All ER 217. The intermediate examination defence is not available on proof alone that there was an opportunity for an intermediate examination. See Grant v. Australian Knitting Mills Ltd (1935) 54 CLR 49; [1936] AC 85. 41 See case No 3 in Ch 2. In this clinical incident, the learned intermediary through intermediate examination, was able to identify a defect in packaging. 42 A number of defences are available to manufacturers under Div 2A of Pt V of the TPA. In an action under Div 2A, it may be possible to plead that the failure to detect a defect amounted to contributory negligence. However the role of contributory negligence in an action under Div 2A is uncertain. Whilst contribution to the loss may be available as an answer to a claim for damages for breach of contract, it is undecided whether that principle may be invoked in an action under Div 2A. 43 The Sulzer case is described in Ch 2 ¶2.23-2.29. This case concerned the recall of the Sulzer Inter-Op Acetabular prosthetic device that had been implanted in 17,500 patients worldwide. The implants were found to have an unacceptable level of mineral oil-base lubricant on the surface of the product. This contaminant, derived from a tooling process, caused the prosthetic devices to become prematurely loose through a failure of fixation by osseointegration. In the event the surface defect was proven to be present at the time when the devices were supplied by the manufacturer. See TPA s.75AC(2)(f).
7.10 defect that was not discovered (nor discoverable) by the surgeon at the time of surgical implantation.
INFORMED CONSENT, THE VOLUNTARY ASSUMPTION OF RISK, AND
THE MEDICAL PRACTITIONER'S DUTY TO WARN
7.17 The principle of the doctrine of informed consent44 is that patients need to be able to voluntarily give explicit and informed permission for medical and surgical treatment. The professional standard of consent to treatment has been accepted as a judicial concept since the 1767 British case Slater
v. Baker & Stapleton.45 To be able to give informed consent provides the clearest demonstration of the role of patient autonomy and reflects a partnership between the surgeon and the patient that has replaced the
traditional paternalism of the past.46 The legal significance of informed consent derives from two main areas of law; negligence and assault and battery. Touching a person, whether to perform surgery or to punch them in the face is lawful only if that person consents to the action. Valid consent legitimates forms of authority in conduct that otherwise would not be legitimate and provides access to needs that otherwise
might be unobtainable.47
7.18 The doctrine of informed consent is linked with the doctrine of "undue influence". There are circumstances where the law recognises that an
44 The term informed consent was first introduced into the judicial lexicon in 1957 in the written opinion of an Appellate Judge in California, USA in Salgo v. Leland Stanford Jnr University Board of Trustees, 154 CAL At pp. 2d 560, 317 P.2d 170 (1957). The introduction of the Human Rights Act 1988 (UK), incorporating the European Convention of Human Rights (ECHR) in October 2000 has reintroduced a focus on the process of obtaining informed consent. 45 Slater v. Baker & Stapleton (1767) 95 Eng. 860, 2 Wils. KB 359 - cited by DJ Mazur, “Inference of the Law on Risk and Informed Consent” (2003) 327 BMJ, 731-34. 46 The standard of informed consent relates to a patient's needs and not to the physician's judgement. The medical practitioner's duty of disclosure is measured by the "prudent patient" or "materiality of risk" standard. It is the disclosure of all material information that a "prudent patient" might find significant when deciding whether or not to undergo the proposed treatment that is so important. 47 There can be a fine line between battery and negligence. In Chatterton v. Gerson [1987] 1 All ER 257 it was argued that because the plaintiff had not been informed of all the risks associated with the treatment, her consent was vitiated and, the defendant doctor was liable in battery. This argument by council for the plaintiff was not accepted and it was ruled (by Bristow J) that once a patient had received information in broad terms then a claim for failure to discuss the risks and implications of a procedure was negligence and not trespass to the person, or battery. This decision was confirmed in Hills v. Potter [1983] 3 All ER 716 729 and by the Court of Appeal in Sidaway v. Bethlem Royal Hospital Governors[1985] 1 All ER 643. See TL Beauchamp & JF Childress, Principles of Biomedical Ethics, (4th ed, 1994) - cited by I Kerridge & M Lowe, “Informed Consent and Shared Decision Making” (1997) 5 BMJ, 275-77.
7.11 individual's free will may be so influenced by another that agreements made by that person should be set aside. The philosophical basis for the doctrine of "undue influence" is another demonstration of respect for the autonomy of the individual, and of the cardinal imperative to ensure that
people have freely chosen a course of action.48 The doctrine of "undue influence" has historically been confined to situations involving the transfer of property there being little concern for that environment embraced by the doctor-patient relationship that includes the provision
and the acceptance of treatment. Staughton LJ has said: 49
"…undue influence in the law of property and contract, are not, in my opinion, applicable to the different context of consent to medical or surgical treatment. The wife who guarantees her husband's debts or the widower who leaves all his property to his housekeeper, are not in the same situation as a patient faced with the need for medical treatment."
Stewart and Lynch50 emphasise that the main reason for this apparent deviation from the application of the doctrine of “undue influence” is that, in medical consent cases, the medical practitioner will not necessarily gain commercially from success in bringing influence to
bear.51 However where a surgeon has a financial (or any other commercial) interest in a product it is prudent that information of this
fact should be disclosed to the consumer.52
48 See C Stewart & A Lynch, “Undue Influence, Consent and Medical Treatment” (2003) 96 J Roy Soc Med, 598-601. 49 See Re T (Adult: Refusal of Treatment) [1992] 4 All ER 649 at 669: Here a pregnant woman had suffered injury in a motor vehicle accident. The patient's mother was a practicing Jehovah's Witness and the patient had signed a form of refusal for treatment that included a blood transfusion. It is particularly relevant to observe that the patient was not a Jehovah's Witness. After delivery of a stillborn child the patient's condition deteriorated. Later judicial approval was authorised for a blood transfusion. A Court of Appeal found that the patient's refusal for blood transfusion was invalid because of her incapacity. 50 See vide supra n.48. 51 Though informed consent is a clinical and legal requirement that follows the need to inform patients of all material risks involved in a medical procedure there are now suggestions that informed consent should also require full disclosure of the financial implications of medical and surgical treatment to patients. It has been suggested that all patients should now be fully aware of the financial implications of medical treatment, including the decision not to proceed, to defer or cancel proposed treatment or to seek alternative treatment. For further information see M Gorton, “Law Report” (2004) 25 (2) Australian Orthopaedic Association Bulletin, 115. 52 See Ch 4, n.87, - Recommending a product or a service to a patient in return for a benefit which has not been disclosed can amount to unsatisfactory professional conduct that could lead to deregistration (in NSW) by the Medical Board.
7.12 7.19 The term informed consent reflects a relatively modern concept that
received much attention in the Salgo53 case in the United States in 1957. The information that doctors are legally required to provide to patients to ensure that informed consent is obtained has continued to attract much
judicial debate in Australia. As discussed in Chapter 354 it has, until fairly recently, been practice in Australian jurisdictions to accept a standard of medical practice that has traditionally been based on the
"Bolam test" as it applies to the law of negligence.55 Australian Courts though have moved away from Bolam with the consequence that the requirements for informed consent have become more onerous for
medical practitioners. 56 In contrast in English Courts there has been a
tentative shift back toward Bolam.57 It is of interest to observe that following the recommendations of the Ipp Report, Review of the Law of Negligence, 30 September 2002, there may be a move back towards the Bolam test. Amendments to the Civil Liability Act 2002 (NSW) in the Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW) include a reintroduction of the Bolam principle for all "professionals"
with some modifications to the common law.58
7.20 There are a number of obligatory elements for consent to be informed
and legally valid59 and these include60:
(a) the patient must be competent61;
53 Salgo v. Leland Stanford JR, University Board of Trustees UBT 317 P 2d 170 CAL C Dist CT App (1957). Here the Court specified that the patient should be given enough information on the nature, consequences, harms and benefits, risks and alternatives of any treatment offered so that ordinary patients can make reasonable decisions about their treatment - the reasonable person's standard of disclosure. 54 See Ch 3, n.81. 55 Bolam v. Friern Barnet Hospital Management Committee [1957] 1 WLR 582; [1957] 2 All ER 118 (QBD). 56 Rogers v. Whittaker (1992) 175 CLR 479; 109 ALR 625 (HCA). 57 Bolitho v. City and Hackney Health Authority [1998] AC 232 (HL). 58 Civil Liability Act 2002 (NSW), Div 6, s.5O & s.5P. 59 For a thorough review of that which is defined as a legally valid consent see A Kennedy & A Grubb, Medical Law (2nd ed, 1994) 135-48. 60 For further information see KR Mitchell & TJ Lobat, Bioethics for Medical and Health Professionals (1991) (Social Science Press, Sydney). 61 The Family Law Reform Act 1969 (UK) reduced the age of majority from 21 years to 18 years of age, s.8(1). Competence is generally held to be consistent with being of an age more than 18 years and having an ability to fully understand the treatment that is recommended, including any surgical procedure, its consequences, and the consequences of not undergoing treatment. The definition of a minor is a person who is under the age of 18 years and is not a foetus in utero. Legally, however, a minor aged 16 years can consent to medical treatment. The so-called older child under the age of 16 can give valid consent for medical treatment if they demonstrate a sufficient level of maturity and are of sufficient age and understanding. They may nevertheless wish a parent to countersign the form of consent. The common law right for older children to consent to most types of treatment was recognised by
7.13 (b) the consent must be voluntary62 and free;
(c) there should have been no duress or undue influence63 that may cause any decision to be non-voluntary; (d) there must be sufficient disclosure of reliable and understandable information, and (e) the information must be understood, integrated and evaluated in terms of the patient's own values.
All of these elements are necessary for the concept of concordance that is fundamental to consensual treatment. The responsibility for concordance rests with the clinician performing the procedure, treatment or
investigation.64 Furthermore, information regarding treatment must be provided in a clear and simple manner that avoids the use of inappropriate medical terminology and technical jargon. The information provided should be in plain English and conveyed in a manner that does not cause anxiety or decrease confidence. Furthermore, in providing information, the medical practitioner cannot discharge the duty to inform simply by providing pamphlets about a proposed
procedure.65 One problem with regard to patient information inserts that provide information on contraindications, side effects, interactions etc.,
the majority judges of the High Court in Department of Health and Community Services (NT) v. JWB (Marion’s case), (1992) 175 CLR 218 at 237: 106 ALR 385 at 395 (HCA). The adoption of this principal is known as the “mature minor test” or the test of “Gillick competence”. See also Gillick v. West Norfolk AHA (Gillick’s case) [1986] AC 112 (HL) at 189 per Lord Scarman. Under the Children's Act 1989 (UK), ss.27(7) and 43(8) a child has the right to refuse to submit to medical assessment or examination. However under the Children’s Act 1989 (UK) Courts do have the power to decide what is in the best interest of the individual child. In the United Kingdom the Court’s view has been that where emergency treatment is required to save life, for example transfusion for a Jehovahs Witness, then the Courts will give consent – Re E (A Minor) (Wardship: Medical Treatment) [1993] 1 FLR 386 and Re S (A Minor) (Consent to Medical Treatment) [1994] 2 FLR 1065. This issue has not been tested in Australia. In Australia, the Children and Young Persons (Care and Protection) Act 1998 in New South Wales (NSW) permits a medical practitioner to carry out medical treatment without the consent of a child (person under the age of 16 years) or young person (person aged 16 years or above but under the age of 18 years) or the parents of a child or young person, if the medical practitioner is of the opinion that it is “necessary as a matter of urgency, to carry out the treatment of the child or young person in order to save his or her life or to prevent serious damage to his or her health”. Herein is a defence to civil or criminal actions to performing treatment without consent. Under these circumstances a minor's refusal to consent cannot overrule the consent that may be given by a Court that is at liberty to overrule the minor's wishes if it is in the best interests of the minor. The Courts in the United Kingdom also have determined that the respect for private and family life, enshrined in Article 8 of the Convention of Human Rights, does not prevent them from making a decision as to what might constitute a child's best interests. Problems arise when there is doubt as to a patient's capacity to consent. It has been held that the patient lacks the capacity to consent if there is some impairment or disturbance of mental functioning which renders them unable to make a decision. For further reading see National Health Service (UK) Litigation Authority Review, Human Rights Special Issue, “Consent to Medical Treatment”, (2004) 16 (30), 16-19, and Editorial, “The New Consent Form: Are We Performing Informed Consent?” (2003) 85 Annals of the Royal College of Surgeons of England, 354-55. 62 Voluntary is seen to be able to choose and to act freely without exposure to any manipulation by, or to experience the undue influence, of others. 63 See vide supra n.48. 64 National Health & Medical Research Council, General Guidelines for Medical Practitioners on Providing Information to Patients. Canberra: Australian Government Publishing Service, 1991. See also M Lowe & I Kerridge, “Informed Consent and Shared Decision-Making” (1997) 5 Student BMJ, 275-77.
7.14 is that the documents are frequently poorly produced, sometimes too medical or legalistic in wording, and often defensive in tone. The information provided is at risk of being discouraging and unhelpful in
determining any balance between risk and benefit.66
7.21 In Australia, there is a perceived dilemma in many doctors’ minds between providing patients with sufficient information about
complications and creating unnecessary fear in the minds of patients.67 Generally the medical profession holds the view that a doctor's duty to
disclose information is subject to a therapeutic privilege68 that can justify the withholding of information from a patient where, on reasonable judgement, it is evident that the information would be likely to harm the
patient's health.69 The majority judgement of the High Court in Rogers v.
Whitaker70 recognised therapeutic privilege though Gaudrom J was not convinced that it existed. However this therapeutic privilege does not justify withholding information that might prevent a patient from consenting to a procedure that is not urgent or is non-essential. With regard to therapeutic privilege there is some relevance to be found in the
Lord Wilberforce Test. Lord Wilberforce held that -71
65 Skene, Loane & R Smallwood, “Informed Consent: Lessons from Australia (2002) 324 BMJ, 39-41. 66 To avoid all of this many craft groups e.g. The Australian Orthopaedic Association and The Royal Australasian College of Surgeons now produce patient information kits that are procedure specific, clear, concise and peer reviewed. 67 E Ek, E Yu, J Chan & B Love, “Nerve Injuries in Orthopaedics: Is there anything more we need to tell our patients?” (2005) 75 ANZ J Surg, 132-35. See also NS Wenger & JR Lieberman, “Achieving Informed Consent when Patients appear to Lack Capacity and Surrogates (2000) 378 Clin Orthop, 78-82. 68 When obtaining informed consent the health care provider must disclose all material risks to the patient, subject to therapeutic privilege which allows clinicians to withhold some facts if there is a real possibility of psychological damage being suffered by the patient, if all the facts were to be revealed. Notwithstanding therapeutic privilege the clinician must though answer all of the patient's questions truthfully. Therapeutic privilege must not be confused with professional privilege – see Hill v. Howe (1991) 24 ALD 159 (FCA). 69 Doctors routinely discuss with patients the risks of dying on the operating table during elective cardiac surgery. Of 50 patients asked what sort of information they wanted, 42% said they wanted no risk information at all and 50% said they did not want to be advised of the risk of death, (see Editorial, (2001) 86 Heart, 626-31). It might be concluded that patients do not always want to hear the details of every potential complication. Therapeutic privilege may be seen to permit the communication of selected risk information. The important question is as to how selected risk information communication might stand in Court in the event of a legal challenge. 70 Rogers v. Whitaker 1992 175 CLR 479: 109 ALR 625 (HCA) – here the majority did not define therapeutic privilege although they did refer to therapeutic privilege as providing an opportunity for a medical practitioner to prove that he or she reasonably believed that disclosure would prove damaging to a patient (CLR at 486; ALR at 630). The existence of therapeutic privilege was acknowledged by King CJ in F v. R (1983) 33 SASR 189 at 192 (SC (SA)). 71 See Moorgate Mercantile Co Ltd v. Twitchings [1977] AC 890; [1975] RTR 528, at 905. This case concerned a Car Dealer who was offered a vehicle for sale by a vendor who had represented that the vehicle was free of all hire purchase liability when this was, in fact, not the case. Though at first the relevance of this case to this discussion may not be apparent it is the author's view that the sentiment of the Lord Wilberforce Test is very much appropriate to any consideration of the duty of care of a manufacturer of a surgical implant to a patient when the transaction and the duty are very much dependent upon the conduct of an intermediary.
7.15 "A man who knows that others rely on a particular source of information, which derives that information from him, may surely be under a duty to supply that information if he has it, even though transmission of the information makes the seeker of it less than 100 percent secure."
7.22 In Rogers v. Whitaker72 the High Court, in finding 6-0 against an Ophthalmologist (Rogers), held that it is part of the doctor's duty of care
to disclose all "material" risks. A risk is material, if -73
"In the circumstances of the particular case, a reasonable person in a patient's position, if warned of the risk would be likely to attach a significance to it or if the medical practitioner is, or should reasonably be aware, that the particular patient, if warned of the risk, would be likely to attach significance to it."
Furthermore the risk74 does not have to be only life threatening to require disclosure. Though failure to warn cases in medical negligence law
recognise that a doctor has a duty to warn75 patients of all material risks
72 Rogers v. Whitaker (1992) 175 CLR 479; 109 ALR 625 (HCA). 73 The definition of “material risk” is to be found in CLR 479 at 490. This has become known as the Rogers v. Whitaker test. See Pearce v. United Bristol Health Care NHS Trust [1998] E & WCA 2243 (20 May 1998) - Here the Court of Appeal applied a reasonable patient standard, i.e., "If there is a significant risk which would affect the judgement of the reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt." There is a similarity of this test to the Rogers v. Whitaker test that makes recent Australian experience relative to the English jurisdiction. That all material risks must be discussed has been approved in subsequent judgements of the Australian High Court – see Rosenberg v. Percival (2001) 205 CLR 434; (2001) 178 ALR 577; [2001] HCA 18. See also Chappell v. Hart (1998) 195 CLR 232. 74 The information which a patient needs to have about risks and benefits for there to be informed consent is judged by what a "prudent" patient or "reasonable person" would want to know. See Canterbury v. Spence 464 F 2d (1972) Dist Columbia. See also Sidaway v. Board of Governors of the Bethlem Royal Hospital & the Maudsley Hospital & Ors [1985] 1 AC 871 HL. Here the "prudent doctor test" was also adopted. 75 See Rogers v. Whitaker (1992) 175 CLR 479; 109 ALR 625 (HCA). Here the patient, almost blind in one eye consulted an Ophthalmic Surgeon and asked about possible complications of an operation that was to be performed but did not expressly ask whether sympathetic ophthalmoplegia might result. This is a condition associated with severe damage (and blindness) of the contralateral eye. In the circumstances here the Surgeon was under a duty to inform the patient of this slight risk. But for the Surgeon's failure to warn the patient would not have accepted the risk so that the Surgeon was held liable for the sympathetic ophthalmoplegia and resulting blindness to the contra-lateral eye which followed the operation. The decision of a State Appellate Court was upheld on Appeal by the High Court of Australia (see [1993] 4 Med LR 79). The outcome in Rogers v. Whitaker is more in line with Canadian Law (Hopp v. Lepp (1980) 112 DLR (3d) 67) where duty is in part determined by reference to the conduct of reasonable doctors and that this might allow for a range of answers from the wholly truthful to the partially truthful, to the somewhat deceptive and to the untruthful. Rogers v. Whitaker is not always in line with English Law - see Sidaway v. Board of Governors of the Bethlehem Royal Hospital and the Maudsley Hospital [1985] AC 871 at 981 - Lord Templeman said at 902: "Mrs Sidaway could have asked questions, if she had done so she could and should have been informed that there was an aggregate risk of between 1% and 2% of some damage either to the spinal cord or to a nerve root resulting in injury which might vary from irritation to paralysis. The test applied by the House of Lords in the Sidaway case is very different to that applied in Rogers v. Whitaker. See also Rosenberg v. Percival 2001, 205 CLR 434; 171 ALR 577. Here the claimant had for a number of years, suffered from a worsening condition of dental malocclusion. The condition was treated by a saggital split osteotomy, Unfortunately the claimant suffered a complication known as temporo-mandibular joint disorder. The claimant sued her surgeon for failing to warn her of the risk of this complication and argued that had she been warned of the risk of temporo-mandibular joint disorder (TJD) she would not have undergone the procedure. It was held that the risk was not a material risk and therefore did not need to be disclosed, and also, that had she been warned of the risk she would not have undergone the procedure. The Supreme Court of Western Australia over-ruled
7.16 inherent in the proposed treatment or procedure (subject to therapeutic privilege), it is the case that the claimant bears the burden of proving that the medical practitioner has failed to disclose a risk as well as the materiality of that risk.
7.23 Surgeons have a particular obligation to explain to patients the risks of
new or experimental interventional procedures.76 Gorton77 cites the
recent case in Western Australia of Hall v. Petros78 that involved the use of a relatively new procedure - intra vaginal sling plasty (IVS). One of the more determinative issues in this case was the alleged failure of the surgeon to provide the patient with sufficient information and advice, particularly with respect to the warning of material risks that were known to be inherent in the IVS procedure, and the risks and benefits of
alternative interventions.79 Gorton identifies this case80 as "more
these findings and ordered a retrial on the issue of causation. On Appeal, the High Court restored the findings. An objective factor that weighed again the claimant was that she was a Nurse with some twenty years of practical experience and a Senior Lecturer at a University. In the Court's view the claimant had better access to medical knowledge and dental knowledge than the ordinary person (per Kirby J at [125], Gummow J at [91] and McHugh J at [33]) even though the claimant claimed that she did not know the risk of TJD given her nursing background, she would have known that surgery generally carried inherent risks (per Kirby J at [164], Gummow J at [91] and McHugh J at [33]). This appeared to weigh against the claimant, particularly in light of her testimony that "if there had been any risk I would not have had the surgery" (at [28]). This case is discussed in detail by Tina Foukas, “Causation of Damage in Recent "Failure to Warn" Cases” (2002) 11 (1) AHLB, 4-11. See also Bolam v. Friern Hospital Management Committee (1957) 1 WLR 582 - the Bolam case defines medical negligence in terms where doctors are expected to perform in a manner that accorded with the practice of other doctors. There is in Rogers v. Whitaker emphasis on a standard of disclosure which varies from person to person, and is based upon the information acquired by the individual undergoing a procedure. This is the subjective person's standard of disclosure. It is held by some that the Bolam test is not so much a standard of care as a justification for mediocrity in care - from APLA Submission to the Senate, cited in APLR (2002) 13 (8), 77-84. Contributors as authors to this Submission included Dr Peter Cashman, Dr Keith Tronc, Mr Bill Madden, Mr John Gordon, and Mr Robert Davis. Recent English Case Law suggests that the Bolam test is being modified so that a Court can reject medical opinion if it is not reasonable or responsible - see Bolitho v. City & Hackney Health Authority [1998] AC 232 HL. See also Smith v. Tunbridge Wells Health Authority [1994] MLR 334 HL - here it was held that it was "neither reasonable nor responsible" for a surgeon not to mention the risk of impotence following rectal surgery, even if some doctors do not mention that risk. In PS Pearce v. United Bristol Health Care NHS Trust [1998] 48 BMLR 118 (CA) - the Court of Appeal applied a reasonable patient standard…"if there is a significant risk (of stillbirth) which would affect the judgement of the reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt." The similarity of this test and the Rogers v. Whitaker test makes recent Australian experience relevant to the English jurisdiction. See also Chapple v. Hart (1998) 72 ALJR 1344 (HCA) - for a detailed consideration of causation and non-disclosure of information. The claimant underwent surgery for a degenerative condition of her throat. She was not advised that there was a risk of mediastinitis caused by the unavoidable perforation of the oesophagus followed by infection, which could result in permanent damage to the vocal cords. The risk eventuated and the claimant suffered damage to her vocal cords that was associated with loss of voice. It was accepted that the surgical procedure had been undertaken without negligence but it was argued that the defendant had been negligent in not advising the claimant of this risk. The majority of the High Court (Gaudron, Gummow and Kirby JJ) held that as a matter of "common sense" the defendant's negligence was a cause for the claimant's injury. The coincidence of the failure to warn of the risk and materialisation of the risk was sufficient to establish a causal link. This conclusion was reached even though it was accepted that the claimant would have had the operation at some time in the future. In the event the evidence did not establish that the claimant would have suffered the injury at some future time, merely that she would have been exposed to a similar risk. For further reading see Clarke, “Causation in Chapple v. Hart: Common Sense or Coincidence?” (1999) 335 J Law & Medicine. 76 M Gorton, "Keeping up to Date” (2004) 5 (9) Royal Australasian College of Surgeons, Surgical News, Law Report, 7. 77 See vide supra n.76. 78 (2004) WADC 87. 79 One of the issues in Hall v. Petros was whether the intra vaginal sling plasty technique was supported by a body of evidence of "respected practitioners". 80 See vide supra n.76.
7.17 inherently an informed consent case, than [a] case of negligent treatment". This particular case highlights the need for surgeons to recognise that more onerous burden that can be associated with the introduction of any new or experimental interventional surgical procedure. Where this is the case, patients should be provided with sufficient information regarding alternative treatment options so that an informed choice can be made.
7.24 The communication of risk to patients is regarded by some as "the main
work of doctors".81 Many doctors are not good at communicating information about risk - yet increasingly it is one of their central tasks. Risk communication is in itself risky and medical practitioners can be predictably fallible and prone to bias in their judgement of risks and of
their use of information.82 Gigerenzer83 emphasises that the framing of risks, "both numerically and linguistically", and the perceived value that individuals may place on the various gains and losses have an effect on the choices that patients make. Furthermore choice can be derived from the patient's understanding and interpretation of the given guidance that
is used according to their own circumstances, values and references.84
7.25 The doctrine of informed consent may not require the surgeon to advise a patient of the TGA investigational status of a particular surgically
implantable device.85 It follows that a surgeon may not need to disclose the TGA's classification of a particular device to a patient in order to be sure that the patient has been fully informed. However, in the absence of any Australian authority it is not possible to predict what an Australian court might decide in these circumstances. The mere fact that the TGA has not cleared a product for a particular use does not mean that the
81 R Smith, “Communicating Risk: The Main Work of Doctors” (2003) 327 (7417) BMJ, 27. 82 W Godolphin, “The Role of Risk Communication in Shared Decision Making – First Let’s Get Two Choices” (2003) 327 (7417) BMJ, 692-93 – Godolphin cites S Plous, The Psychology of Judgement and Decision Making (1993). 83 H Thornton, “Patients’ Understanding of Risk – Enabling Understanding Must Not Lead to Manipulation” (2003) 327 (7417) BMJ 693-94 – Thornton cites G Gigerenzer, Reckoning with Risk. Learning to Live with Uncertainty (2002). 84 H Thornton, “Patients' Understanding of Risk - Enabling Understanding Must Not Lead to Manipulation”(2003) 327 (7417) BMJ, 693-94. 85 See Southard v. Temple University Hospital, 781 A2d 101, (Pa 2001). Pennsylvania Supreme Court - this case concerned the US Food & Drug Administration and the investigational status of pedicle screws used for spinal fusion surgery.
7.18 product is not in fact suitable for that purpose. It means only that the TGA has not approved the device for that purpose. The fact that the TGA has not approved a device for a particular purpose does not cause the device to be unsafe or defective. It is very evident that the TGA's role is to regulate the manufacturing, marketing and labelling of medical
devices, and not to intrude upon the practice of medicine86 by influencing a surgeons use of a device or by redefining the doctrine of informed consent.
7.26 The voluntary assumption of risk represents a common law defence of a
claim in negligence that is based on the maxim volenti non fit injuria.87 . The voluntary assumption of risk also embraces the philosophy of
contributory negligence.88 In the event that a patient voluntarily exposed himself or herself to the risk of suffering injury, the recovery for any injury incurred as a result of the defendant's conduct can be mitigated or denied. It will be a complete defence if the defendant can demonstrate that the claimant had knowledge of facts constituting a dangerous condition, knew the condition was dangerous, appreciated the nature or extent of the danger, and voluntarily exposed herself or himself to the
danger.89 I have a view that this defence might find relevance in the
86 See Buckman Co v. Claimants' Legal Com., 531 US at 350, 121 S Ct at 1018, 148 L.Ed. 2d at 862 - This case considered the "of- label" use of medical devices and accepted as a necessary corollary of the FDA's in the USA mission to regulate in this area but without directly interfering with the practice of medicine." 87 See Ch 3, ¶ 3.32. 88 See March v. E & MH Stramare Pty Ltd (1991) 171 CLR 506; 99 ALR 423 HCA. - This case concerned the claimant, who driving at excessive speed, with abilities impaired by alcohol, collided into the defendant's truck that had been parked in the middle of a six lane road outside a wholesale fruit and vegetable market. The event occurred in the early hours of the morning when the street was moderately well lit and the truck's parking and hazard lights were active. At the trial the claimant and the defendant were both held to have been negligent and responsible for the claimant's injuries (70% and 30% respectively). On Appeal the Full Court of South Australia held, in the majority, that responsibility for the collision should have been attributed to the claimant's conduct alone. See TPA ss.75AE, 75AF, 75AG, and 75AN, where the loss or damage was caused by both an act or omission of an individual who suffers the injuries as well as the defect in the goods. The amount of the loss is to be reduced by an amount equivalent to that individual's share in causing the loss. It is particularly interesting to observe in ACCC v. Glendale Chemical Products Ltd [1999] ATPR ¶41-672 (Federal Court) that a finding of contributory negligence was not made even in circumstances where the injured person had read the label twice and still did not follow the instructions, choosing in contrast to rely on the gratuitous advice of an acquaintance. The warning to use safety glasses was also ignored. In negligence a contributing cause is an additional concurrent cause without which the initial negligent act or omission would not have occurred, or would not have had the effect it did, and which is held to be partly responsible for the claimant's loss. 89 See Insurance Comr v. Joyce (1948) 77 CLR 39; [1948] ALR 356 - This case concerns the legal position of a person who allows himself to be driven in a motor car by an obviously drunken driver as a "guest passenger". Latham CJ argued that such a person is entitled to expect only the degree of care which can be achieved by a drunken driver, and that if he is injured as a result of the drunkeness of the driver he has no cause for complaint because there has been no breach of duty to him. Secondly it was suggested that such a case falls within the category of contributory negligence and thirdly that the maxim volenti non fit injuria applies. See also Rootes v. Shelton (1967) 116 CLR 383; [1968] ALR 33, in this case the voluntary assumption of injury, in a sporting activity, from another participant's act or omission that with the knowledge of the risk involved there is an implied consent to relieve that other participant of the legal consequences that might ordinarily follow should there have been some act or omission.
7.19 event that non-essential (cosmetic) implant surgery has been undertaken. Implicit in this defence though is that the defendant be in all respects learned, be in possession of all of the relevant information that is required, and be seen to have communicated all of the information regarding potential risks and benefits of the surgery to the consumer. If contributory negligence can be established then the damages are reduced
under apportionment legislation.90 With regard to matters relating to the surgically implanted device there is no evidence that this defence has been tested.
THE LEARNED INTERMEDIARY'S EXPOSURE TO LIABILITY AS AN EDUCATOR
7.27 Continuing education is increasingly becoming an obligatory requirement for most professions. It certainly is the case that Continuing Medical Education (CME) and that Continuing Legal Education (CLE) are requirements that are not only obligatory but fundamental to the maintenance of any registration to continue in the practice of medicine and law. In New South Wales the Medical Practice Act [Principal Act]
1992 (NSW)91 requires all registered medical practitioners to make an annual declaration about their participation in continuing professional development (CPD). The Medical Board in NSW expects that every registered medical practitioner will participate in CPD that is relevant to their practice of medicine and considers participation in CPD to be a good indicator of a practitioner's professionalism and commitment to maintaining an up to date body of knowledge and skill. The requirements of CME (and of CLE) include obligations that are not only
90 See Law Reform (Miscellaneous Provisions) Act 1965 (NSW) s.10(1). For proportionate liability for misleading and deceptive conduct see Pt V1A s.87CB that applies to an apportionable claim under s.82 for conduct that was done in contravention of s.52. See also the Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW) (the Amending Act) that received Royal Assent on 28 November 2002 and substantially commenced on 6 December 2002. The Amending Act effects significant reforms by amending the Civil Liability Act 2002 (NSW) (the CLA) and other legislation and introduces the concept of proportionate liability for joint tort feasors in relation to claims for a contravention of s.42 of the Fair Trading Act 1987 (NSW) (Misleading or Deceptive Conduct) and to claims involving economic loss or property damage in non-personal injury matters. While the majority of product liability cases involve claims for personal injury, some fall within the scope of apportionable claims under the amending Act. See also Johnson Tiles Pty Ltd & Anors v. Esso Australia Pty Ltd [2003] VSC 27.
7.20 the responsibility for the individual but are a requirement of and implicit in the paternalism and self regulatory environment that is inherent in the day to day undertakings of most professional institutions that include
Universities, Associations, other craft groups, and Collegiate bodies.92
7.28 CME and CLE activities are undertaken in a variety of different ways. There is not only an obligation on the individual professional to pursue a process of personal enlightenment that can be achieved by the reading of journals or by the undertaking of a particular line of research. It is also the case that the professional bodies associated with each craft group have obligations to make available and to supervise a program of continuing education that can include lectures, seminars, workshops, and conferences. These activities permit the dissemination of information that is current and appropriate to a particular specialist professional group and include the presentation of information regarding aspects of professional undertakings that can include matters relating to surgically implantable devices. The presentation of the results of post-market surveillance (vigilance) programs enables product users and potential users to evaluate the performance of devices that are already in the marketplace. Innovations are presented and frequently the information provided is of a nature that is at times indistinguishable from a recommendation or an endorsement to use the products presented. In many cases these educational activities are financially underwritten by surgical implant manufacturing organisations and/or by their sponsors and distributors. It is also the case that at many meetings, seminars and conferences there are trade exhibitions that are, at times, not unlike a "Boat Show" or a "Motor Show". Most of these activities are generally undertaken ethically and with transparency but there have been occasions
91 See Halsbury’s Laws of Australia, Medicine, LexisNexis Butterworth, Australia, [280-225] and P de Prez, “Self-Regulation and Paragons of Virtue: The Case of Fitness to Practice” (2002) 10 (1) Med Law Rev, 28. See also Mary-Anne Toy, “Doctors Face Tough New Licence Rules”, The Age, 5 April 2000, 1-2. 92 Approximately 85% of medical practitioners are involved in College CPD and CME programs. Annual certification is required for Registration as a Medical Practitioner in NSW and for Surgeons there is a tri-annual program of Continuing Education that enables the issue of an annual Certificate of Compliance with the requirements of Continuing Education. The Workers Compensation Commission, a statutory State Government body, undertakes and supervises a program of continuing medical and legal education for medical practitioners designated as Approved Medical Specialists for the purposes of the Workplace Injury Management and Workers Compensation Act 1998 (NSW).
7.21 when the activities of sponsored surgical-society meetings and other legitimate CME activities have been described as not greatly different
from "Tupperware Parties"93 that are designed to sell surgical implants, and to enrich physician-presenters, manufacturers and sponsors
(distributors).94
7.29 With regard to most CME activities it is logical and not unreasonable to form the conclusion that those organisations and individuals concerned with the administration and with the endorsement of activities, and those concerned with the presentation of scientific information, can be considered to have an informational advantage over those in the audience who attend the activities for the purpose of undergoing education. Furthermore, it is not unreasonable to hold the view that those who are concerned with the dissemination of education might be regarded as learned intermediaries. In all of this there is, the question that is so far untested in Australia -
In the event of exposure to a product liability matter, could it be the case that a treating surgeon, who has participated in CME activities, might find a need for, and an opportunity in, the learned intermediary defence in the event that the CME activity was concerned with the endorsement and promotion of the use of the product that is now at the heart of a product liability issue.
In all of this can be found a second question, that might, to some, be even more absorbing. The question is -
Will professional bodies, such as Universities, craft groups and Colleges etc., have exposure to liability and be
93 This descriptive was used in the United States case, Orthopaedic Bone Screw Pedicle Liability Litigation 193 F 3d 781 (3rd Cir. 1999). 94 See Craig de Borzo, “Product Liability Law Suits raised Questions about CME vs Promotion”, AM News (USA), 12 May 1997. Here de Borzo cites US District Judge Louis C Buchtle who did not dismiss (professional) Societies from law suits in his reference to the promotion of spinal fusion instrumentation systems.
7.22 joined in a surgical product liability matter in the event that it can be shown that a particular implantable surgical device has not only been recommended and promoted for use, but the use of the device has also been endorsed during the course of a CME activity?
7.30 If the hypothetical questions asked in the preceding paragraphs are argued successfully, then, the legal consequences might see the elimination of Associations, craft groups, and Colleges as we now know them in Australia. This is not simply pure speculation on the part of the author, as events have already occurred in the United States, that are cause for real concern. It is timely to review the circumstances of those events here.
7.31 Many patients have undergone the procedure of spinal fusion95 for the treatment of disabling and painful spinal conditions. A successful fusion, or arthrodesis, immobilises the affected spinal segments and provides relief from pain. Spinal fusion operations are frequently undertaken using bone graft to encourage new bone formation and satisfactory fusion of the segments involved. Frequently it is also the case that surgical implant devices are used to augment the fusion by permitting early stability to be achieved at the site of the bone graft. The frequently used and very popular form of implantable instrumentation is that
associated with the use of pedicle96 screw fixation. The use of pedicle screw instrumentation has been associated with a significant incidence of screw failure by breakage and in the United States pedicle screw breakage has become associated with numerically massive class actions in many different district jurisdictions. In August 1994, more than 2,000 civil actions, originally filed in approximately 60 of the 94 Federal
95 Fusion is synonymous with the term arthrodesis. Fusion or arthrodesis is that condition when two skeletal segments that were previously mobile are rendered immobile by a process of bone grafting that frequently does also include augmentation of fixation using a surgically implantable device. Diseased joints can be fused to prevent movement that is associated with relief of pain. Cervical (neck) and lumbar (low back) fusion procedures are frequently undertaken to relieve patients of pain that is associated with segmental degenerative spinal pathology. 96 Each vertebral body has two pedicles that are situated posteriorly and join the body of each vertebra to its neural arch. Within this neural arch is the spinal cord.
7.23 Districts in the United States, were consolidated in the Eastern District of
Pennsylvania.97 All of the approximately 5,000 individual claimants claimed to have suffered physical injuries that were caused by defective surgically implantable orthopaedic bone screw devices. These devices were pedicle screws that had been affixed to the pedicles of the spines during spinal fusion surgery. In most cases, claimants alleged that the devices broke after being implanted. In some instances, claimants required further surgery to have the devices removed. In some cases the
broken devices could not be removed.98
7.32 Now it is well known that the use of pedicle screw devices had been widely promoted in the United States by manufacturers both independently and in association with orthopaedic and neurosurgical
conferences, seminars and workshops. As we have already seen99 these educational events have the potential to be sales events undertaken under the mantle of CME seminars. It was, as a consequence of this that many associations were named as defendants in the pedicle screw litigation. It was alleged that these associations may have aided and abetted, in conspiracy with manufacturers, the unlawful promotion of the pedicle
screw devices.100 The pedicle screw litigation can be viewed as the turn
of the pedicle screw.101 It is the case that a number of surgical societies have had to fight to prove their innocence in the first mass tort case to hold associations liable for what they teach in seminars. Embroiled in this litigation were the North American Spine Society, the Scoliosis Research Society, the American Academy of Orthopaedic Surgeons, and the American Association of Neurosurgeons. All were accused of conspiring and acting in concert with manufacturers to promote the use of pedicle screw devices. The associations were named as defendants because they had allegedly aided and abetted the unlawful promotion of
97 Under 28 U.S.C. §1407. 98 See Orthopaedic Bone Screw Products Liability Litigation, 193 F 3d 781 (3rd Cir. 1999). 99 See vide supra ¶ 7.28. 100 This allegation is attributed to Arnold Levin, Co-Chairman of the Claimants' Legal Committee – see A Levin, Editorial, “Pedicle Screw: First Cases Naming Academy Sent to Local Courts” (1998) 26 (2) American Academy of Orthopaedic Surgeons Bulletin. 101 See vide supra n.100.
7.24 the device. Not unnaturally the Medical Associations denied that they were involved in any conspiracy and contended that they had merely held educational meetings at which scientific information was discussed.
7.33 William Tipton, Executive Vice-President of the American Academy of
Orthopaedic Surgeons102 is recorded as having said:
"We must hear about advances and future treatments in order to make the best decisions for our patients. I believe this threat, at its worst, could bankrupt our organisations and eliminate what has been the best platform for the exchange and accumulation of this information."
7.34 In the pedicle screw debate, the American Academy of Orthopaedic Surgeons moved for Summary Judgement and argued that there was no causal connection between any of the claimants' injuries and anything that the Academy had done. Furthermore it was held by the American Academy that speakers at Academy meetings, did not, by their statements, fraudulently induce physicians to implant pedicle screw devices. The Academy also held that there was nothing to show that physicians were induced to implant the pedicle screw because the speakers at a medical association seminar did not disclose their financial arrangements with manufacturers, did not disclose the FDA clearance status of the pedicle screw, and did not disclose the risks and
complications of using pedicle screw fixation devices.103
7.35 Understandably the Associations and Societies, in the United States of America, would have preferred not to have been involved in this case. In the event no conspiracy and no concert with manufacturers was proven. It is permissible though to speculate that the Associations may have been guilty of the non-disclosure allegations and that the entire case can still
102 William Tipton, M.D., Executive Vice-President of the American Academy of Orthopaedic Surgeons, at the 8th Annual Conference on CME Provider Industry Collaboration, Fort Lauderdale, Florida, October 5-8, 1997. 103 See again A Levin, Editorial, “Pedicle Screw: First Cases Naming Academy Sent to Local Courts” (1998) 26 (2) American Academy of Orthopaedic Surgeons Bulletin.
7.25 have the potential for serious long-term ramifications that may affect both undergraduate and post-graduate teaching programs as we know them. Furthermore, one particularly disturbing aspect is that Scientific Speech or Educational Speech at seminars, workshops and conferences
might become regarded as Commercial Speech104 and as such be at risk of
being false, deceptive or misleading.105 For Scientific or Educational Speech to be regarded as Commercial Speech in the United States it is probably required that three questions be answered in the affirmative. These are -
(i) Is the speech an advertisement? (ii) Does the speech refer to a specific product or service? and (iii) Does the speaker have an economic motivation for the speech?
An affirmative answer in each case is strongly persuasive that the speech
is commercial speech.106
7.36 In Australia it is frequently the case that surgeons (and other researchers) will give presentations of their experiences, and undertake demonstrations of implantable surgical devices, as advocates for those devices. It remains an issue, and it can be argued, whether statements made at such events are “in trade or commerce” and amenable to the TPA, particularly in circumstances where the presenter or the event has benefited from the financial support and sponsorship of the manufacturer (or sponsor) of the product.
7.37 The pedicle screw lawsuit in the United States represents the first time that any Medical Society or Association has been sued in a product-
104 Commercial speech is broadly defined as speech that is related to the economic interests of the speaker and its audience. Commercial speech is generally in the form of a commercial advertisement for the sale of goods and/or services. 105 See again A Levin, Editorial, “Pedicle Screw: First Cases Naming Academy Sent to Local Courts” (1998) 26 (2) American Academy of Orthopaedic Surgeons Bulletin.
7.26 liability case for illegally promoting a device. We have already posed the question that issues such as the pedicle screw case might have the potential to eliminate or to permanently change associations as we know them. One further question is - Will such lawsuits have the potential to stifle Medical Education as we know it in an environment that demands that there be greater disclosure by associations, colleges and universities when it is almost inevitable that their educational activities will influence the decision-making process of clinicians that can impact on the doctor- patient relationship?
CONCLUSION
7.38 In this chapter the three main areas of influence that are the focus of the learned intermediary have been reviewed. There are many drugs, medical devices, and a legion of surgical procedures that are known by the medical profession to have unwanted and undesirable side effects and risks. Patients as consumers, and the pharmaceutical and medical device industry properly rely upon physicians and surgeons to communicate appropriate information of the risks, side effects and potential benefits of drugs and devices. Traditionally the concept of the learned intermediary has focused on the role and obligation of those qualified professionals who intercede between manufacturers and consumers. As we have seen the learned intermediary performs a vital role in the dissemination of information when the former has no opportunity to communicate with the latter. To be able to accomplish this the learned intermediary must necessarily be qualified for the role and, in a sense is, privileged by the nature of the information that he or she has.
7.39 The learned intermediary has the qualifications and the opportunities to assist the manufacturer with many of those obligations that are normally associated with the supply of goods and services to consumers. It is in
106 See US Health-Care Inc v. Blue Cross of Greater Phila., 898 F. 2d 914, 933 (3rd Cir. 1990).
7.27 this environment that the learned intermediary has mostly been regarded as a vehicle within which a manufacturer can find some defence in a product liability matter where the issue is concerned with the duty to warn. Notwithstanding the importance of the learned intermediary defence, this is only one of three major roles that are performed by the learned intermediary. Though the duty to warn of all material risks is a requirement that is of considerable legal importance, this chapter has identified and debated two other major responsibilities for the learned intermediary that are marginally more medical than legal though no less important in the event that there is exposure to liability in a product liability related matter. These two other roles include those obligations of the learned intermediary to enable access to informed consent from patients and the responsibilities of learned bodies in the undertaking of their function as providers of continuing education. These two other important roles have been discussed in this chapter and it should be the conclusion that these are functions of the learned intermediary that are no less important than is the learned intermediary defence. This is the underlying theme of this chapter.
7.28 CHAPTER 8
The
EXPERT WITNESS INTRODUCTION
8.1 In 1782 Lord Mansfield allowed the opinion evidence of a famous engineer, one Mr Smeaton, as to whether the erection of a bank had
caused the silting up of a harbour. Lord Mansfield observed that1 -
“… in matters of science, the reasonings of men of science can only be answered by men of science … it is objected that Mr Smeaton is going to speak, not of the facts, but as to opinion. That opinion, however, is deduced from the facts which are not disputed … I cannot believe that where the question is, whether a defect arises from a natural or an artificial cause, the opinions of men of science are not to be received.”
8.2 Lawyers retain expert witnesses with the expectations that their specialist knowledge will enable them to interpret facts in ways that even well
informed members of the general public would be unable to do.2 Justice Wood, in a conference paper presented in June 2001, quoted Judge
Leonard Hand, who in 1900 observed: 3
"No one will deny that the law should in some way effectively use expert knowledge wherever it will aid in settling disputes. The only question is as to how to do it best."
I have a feeling that, more than 100 years later, matters relating to the expert witness and to expert evidence have changed very little. Judge Hand's statement and question are as appropriate now as they were in 1900.
8.3 The direction and outcome of litigation turns on the evidence before the Court. That evidence is frequently expert evidence. The expert witness,
1 See Folkes v. Chard [1782] 3 Doug KP 157 – cited by R Clemence et al in Medical Evidence – A Hand Book for Doctors, [2001], Royal Society of Medicine Press Ltd, Ch 7, 72-73. 2 See the Evidence Act 1995 (Cth) - s.79 defines the two requirements that must be satisfied for a witness to be an "expert". s.79 does though dilute the level of expertise required to give evidence in Court and status is given to those who can demonstrate only a “specialised knowledge” about the subject of the evidence. 3 Justice Wood, “The Expert Witness - The New Era” Conference Paper, 8th Greek Australian International Legal and Medical Conference, Corfu, June 2001 ¶ 1.
8.1 and the expert report, can be the rudders of many personal injury and product liability cases. Nothing is more certain than the fact that the expert witness has in his or her evidence the potential to turn the law on
its face. The support for this can be found in the Personal View4 of M C Bishop who described expert witnesses as -
"The central players are the expert witnesses. The public assumes that they are in the forefront of their specialty, giving up to date, balanced opinions that are based on their own practice - honed by continuing professional development - and a detailed knowledge of the literature on the subject, to which they are major contributors. They are also supposed to be unbiased. In a number of well publicized recent criminal cases experts have been challenged on the factual quality of their evidence and sometimes on an idée fixe, which may amount to an obsession, on which their eminence may have become established. Are these notorious cases the tip of an iceberg on unsatisfactory professional activity?"
8.4 Justice Gordon Samuels described the expert witness as tending to present the same image in legal literature as the lawyer does in
Shakespeare. Samuels J described the expert witness as5 -
"Venal grasping and fit to be hanged… and …following acrid passages of fair sample: these witnesses are usually required to speak, not to facts, but to opinions; and when this is the case, it is often quite surprising to see with what facility, and to what extent their views could be made to correspond with the wishes or the interests of the parties who call them". (My edit).
In this context Samuels is referring to the danger of a legal approach that has the potential to distort scientific evidence and to be a cause for bias. Later in this Chapter, bias, that friend of miscarriage and impediment to justice, will be discussed.
4 MC Bishop, “Personal View - The Negligence of Medical Experts” (2004) 329 (7478) BMJ, 1353. 5 G Samuels, “Medical Truth and Legal Proof - Changing Expectations of the Expert Witness” (1998) 168 (2) MJA, 84-87.
8.2 8.5 In all of this there is the burden that is the Judge's duty to ensure that those that provide evidence are not only fair, but are treated fairly and that the cross-examination of the expert witness does not get out of hand. This duty has, particularly in the United States of America, seen a shift in legal practice that has transformed the role of the Judge "from a relatively passive assessor to an active inquisitor searching for the
underlying essence of scientific knowledge of claims".6 The question
raised by Edmond & Mercer7 is as to whether or not, within the constraints of the adversarial system, this responsibility can be discharged by a Judge. It is suggested that there might be cases in which the Judge, in order to evaluate the scientific evidence, would need to seek the assistance of interim instruction, as might be provided by a medical expert chosen to sit alongside the Judge in the manner of an
inquisitor.8 The inquisitorial9 approach, with Judge and Medical Expert seated together has not attracted great support and is not a feature of Anglo-Australian jurisdictions. This is in the face of the fact that most Judges have no more medical expertise than the average intelligent lay
person and for this reason the reliance on expert opinion is a heavy one.10
8.6 The Judge's burden is clearly considerable. Justice Margaret Wilson
makes reference to "the non-expert Judge" who has the difficult task…11
"…to determine the extent to which opinions given on each side are polarized by the adversarial process [and who] needs the help of an independent expert who can assist the Court to understand the question and consequently to resolve it." (My edit).
6 G Edmond & D Mercer, “Keeping "Junk", History, Philosophy and Sociology of Science Out of the Courtroom” (1997) 20 UNSW Law J, 48-49. 7 See vide supra n.6. 8 The Inquisitorial, or Roman System, is common to many European Jurisdictions but is not part of Anglo-Australian Law. The Inquisitorial System is more prevalent in the Civil Law Systems of some European Courts than in those Common Law traditions associated with the Anglo-Australian System. The Inquisitorial System is derived from that body of Roman Jurisprudence developed during the period 510BC to 235AD and codified by the Emperor Justinian in the Corpus Juris Civilis. 9 See Peter Stein, Roman Law in European History, Cambridge, New York & Melbourne: Cambridge University Press, 1999. 10 B Mahendra, “Neutralising the Expert” (1996) New Law Journal: Expert Witness Supplement, 1997-98. 11 See Justice Margaret Wilson, “The New Expert Witness Rules,” Breakfast Address to the Australian Insurance Law Association, Brisbane Club, 28 October 2004.
8.3 In each case the due weight must be given in individual cases to advances in medical knowledge, which are prolific. Judges inevitably must form their conclusions from a consideration of mainstream medical
opinion.12 In Re: A & D (non-accidental injury: sub-dural
haematomas)13 it was evident that advances in medical knowledge required there to be much further research on the mechanism of [conditions such as] sub-dural haematomas and the degree of force required to cause them in young children and babies. Bracewell J, in
discussing non-accidental injury14, chose to highlight that, in reaching her judgement, she was faced with a very difficult exercise:
"It is undoubtedly true that the frontiers of medical science have constantly been pushed back and that the state of knowledge is increasing all the time. That is why I find that when presented with speculative theory based on an unlikely hypothetical base an expert will rarely discount it and will in effect never say never. Fanciful speculation is not an appropriate method of enquiry. What is needed and what the experts have done in this case is to piece together all the available information and look at the differential diagnosis."
Bracewell J's conclusions were that Judges are best assisted by experts who provide opinions based firmly on clinical findings and on recognised medical knowledge.
8.7 Notwithstanding this, the use of the expert witness, as an aid to the
justice system, is a significant advance on the reliance of medieval law15 upon evidence that was extracted by one form of painful ordeal or another. That the expert witness has the power to so effectively alter the course of justice is discussed later in this chapter with reference to a number of cases of the recent past where a miscarriage of justice has been built on expert evidence that has later been found to be dubious at
12 See vide supra n.10. 13 Family Law Reports 2002; 1:337. 14 See Re A (non-accidental injury: medical evidence) Family Law Reports 2001; 2:657. 15 See Henry Charles Lea, History of the Inquisition of the Middle Ages, Vol 1 (1888) [New York Press 1958] - at p.431, Medieval Law is described as the "…worst body of Jurisprudence invented by man…".
8.4 best, and even, on occasions, unsustainable and without any scientific basis.
8.8 As valuable as the expert is to the judicial process it remains the case that
the Court is not bound to accept the expert's report16 and the parties are not necessarily bound by the conclusions of the expert. This power over
the expert's evidence can be cause for conflict.17
8.9 There are strengths and weaknesses in Australia's expert witness system
and Chester Porter18 QC, a long time advocate for improvement to the system, describes a situation that so well illustrates one fundamental weakness of that system. With reference to a colleague Porter describes
a search for an expert: 19
"He had a custody dispute and was acting for the father, a difficult task in the days when all Judges were masculine with a rather enhanced view of maternal worth. He was concerned at what appeared to be a hopeless brief and I, with a brain-wave, suggested expert evidence, the wise opinion of a Psychiatrist. He rang a leading shrink forthwith.
To his delight the expert vigorously supported his client's cause on a brief telephone outline of the facts. He was certain that the child would gain enormously if the father's suit was successful. Trevor rang off seeing clear sailing ahead. Half an hour later he was rung back by the embarrassed expert. He had forgotten that he was already retained by the wife to give evidence for her, which as I remember it, he did."
16 In ACCC v. Glendale Chemical Products Pty Ltd (1998) ATPR 41-632 Emmett J was dismissive of the value of expert evidence (at 40,970) (.91) (.92). See also Minnesota Mining & Manufacturing Co. v. Beiersdorf Aust Ltd (1979-80) 144 CLR 253 at 269 and A & Anors v. National Blood Authority & Anors [2001] EWHC QB 446. 17 See Oxley v. Penwarden [2001] Lloyd's Rep Med 347 - this case concerned a patient who suffered from peripheral arterial disease that the treatment of which eventually required there to be an amputation of a limb. There was a successful appeal against an Order to instruct a single "causation" expert or to accept one appointed by the Court. A similar conclusion was reached in Sims v. Birmingham Health Authority [2001] Lloy'd Rep Med 382. 18 Chester Porter QC, longtime member of The Australian Academy of Forensic Sciences, Council Member and Queen's Advocate in some noteworthy Royal Commissions and author of Walking on Water: A Life in the Law: Hired Gun Experts, Random House Australia, 2003. Chester Porter, at the age of 21, became the youngest lawyer in Australia to be admitted to the Bar. 19 Chester Porter, “Hired Gun Experts” (2003) 35 (2) Aust J For Sci, 179-82.
8.5 8.10 It is probably the case that no area of law is immune from the weaknesses of a system that is reflected by Porter's descriptive. Certainly, the outcome of medical negligence cases can depend very much on the skills of the particular expert witness that has undertaken to explain, in Court, the scientific facts or uncertainties surrounding a particular event. It is well known that the adversarial system of law has clung onto the quaint notion that an expert is capable of assisting the Court to decide cases while divorcing themselves from the adversarial
process which affects the rest of the litigation.20 It is not rare for two very similar Court cases to derive opposite conclusions, the first preferring the evidence of the defence expert witness, and the second preferring the evidence of the claimant's expert, though in each case, the debate may have concerned two events that are as identical as medicine
will ever permit.21 It is clearly evident that experts will not always come
to a common view even when considering identical circumstances.22
8.11 This chapter will focus on a discussion of the strengths and weaknesses of the expert witness system as it currently exists in Australia and will examine those aspects of the system that the author considers to be of considerable relevance to scientific evidence, both medical and engineering, that is at the heart of any implantable surgical device product liability issue. The matters raised in the continuing pages of this chapter should not necessarily be viewed as being discussed in their order of importance as each to the other is inextricably woven into the fabric of the subject and no less important to the law in general as it is to any issue of therapeutic good product liability in particular.
20 See vide supra n.10. 21 The dependence on the skills of the expert witness in explaining the scientific facts or uncertainties, and the influence of that evidence is discussed by Minerva (2000) 10 Student BMJ, 130. See also Editorial, (2002) 8 Brit J of Surg, 134-7 where there is reference to two very similar United Kingdom Court Cases of accidental pneumothorax (puncture of the lung) that occurred after fine needle aspiration of breast lumps. In the first case the evidence of the defence’s expert witness that pneumothorax is a rare but recognised complication of the procedure, was preferred. In the second case the claimant’s evidence that pneumothorax occurs as a result of poor technique was the preferred cause. 22 Disagreement between experts can be cause for a formidable battle between the experts and the Court must choose, on the balance of probabilities, which opinion is the more convincing – see Reckitt Benckiser (Australia) Pty Ltd v. S C Johnson & Son Pty Ltd (2004) ATPR 42-026. This case concerned a contravention of TPA s.52 and s.53(c) in regard to alleged misrepresentations in relation to the packaging and advertising of an air sanitiser product.
8.6 THE ROLE OF THE EXPERT WITNESS
8.12 The duty of the expert witness is to provide an informed, balanced and impartial evidence that is uninfluenced by the law's adversarial approach. All of this takes place in a Court environment that is frequently intimidating, confrontational, and sometimes unpleasant for the expert. The Courtroom is often viewed as a "hostile environment" and "some perceive the purpose of cross-examination as being to impune their professional integrity by means of a personal attack on their
credibility."23 Mr Justice Wall24 described appearances in Court as follows:
"The idea that appearances in Court are some kind of a gladiatorial combat where the naked doctor armed only with net and trident is torn to pieces by the legal lions waving machetes whilst the Judge smilingly gives the thumbs down - these ideas ought to have gone."
8.13 The duty of the expert has been described by Samuels J25 (speaking extra-judicially) with those words of Lord President Cooper in Davey v.
Edinburgh Magistrates26 as to:
"…furnish the Judge or Jury with the necessary scientific criteria for testing the accuracy of their conclusions so as to enable the Judge or Jury to form their own independent judgement by the application of these criteria to the facts proved in evidence".
Samuels J continued, in his AMA oration, to summarise those tasks that are the function of the expert. Samuels J identified 2 tasks for the expert
and these are:27
23 E Butler-Sloss & A Hall, “Expert Witness, Courts and the Law” (2002) 95 J Roy Soc Med, 431-34. 24 Mr Justice Wall & I Hamilton, Handbook for Expert Witnesses in Children Act Cases (2000) Bristol:Jordan Publishing. 25 Justice Gordon Samuels, addressed matters relating to expert evidence in his 1997 AMA (NSW) oration “Medical Truth Legal Proof”. 26 Davey v. Edinburgh Magistrates (1953) SC 34 at 40 per Lord President Cooper. 27 See vide supra n.25.
8.7 (i) The task of collecting, examining and evaluation of case material and forming an opinion in a scientific manner to provide basic scientific evidence or technical data [that will] inform the Judge or Jury of matters about which its lack of specialised skill or experience would leave it ignorant. In this regard it is intended that knowledge substitute speculation; and (ii) to present, with clarity, the inferences, conclusions, and opinions from the facts which the Judge or Jury, for lack of specialised knowledge, cannot draw for themselves.
To be able to undertake these tasks the expert's qualifications must have included training through a professional course of study that has provided the expert with the opportunity of dissecting and interpreting the matters at issue that is not available to, and that is beyond the ability
of other people.28 Dixon, Menzies and Windeyer JJ describe the expert's qualifications as being the result of "an organised branch of knowledge"
that is relevant to the subject matter and enquiry. 29 How these commitments are undertaken, and what opinion is derived can provide the expert with the ability and opportunity to turn black into white and vice verse and in doing so be able to single handedly change the course
of justice.30
8.14 In contrast Freckelton et al31 cite Sir Richard Eggleston, who argued views, that are perhaps now outdated, that the 4 separate functions performed by the expert witness include:
28 See Clarke v. Ryan (1961) 103 CLR 486 at 491-2 per Dixon C J at 501 per Menzies J and per Windeyer J at 508. Specialized knowledge though may have been acquired from different types of training, study and experience. See also Idoport Pty Ltd v. National Australia Bank Ltd [2001] NSWSC 123 at [153] per Einstein J. 29 See vide supra n.28. 30 See vide supra n.21. 31 I Freckelton & H Selby, Expert Evidence, (1999), Loose Leaf, Sydney:The Law Book Company [7.20] at 1-1522.
8.8 "Generalising from experience, acting as librarian, acting as statistician and acting as advocate."
More relevant to the present time though are the results of Freckelton's (et al) survey, undertaken in 1999, that found that Judges, when considering the role of the expert witness, considered the most
persuasive factors to be: 32
(a) Clarity; (b) Field of experience; (c) Fact familiarity; and (d) Impartiality.
To these Boland33 adds that the ideal expert witness should be:
"…conceived of as an objective scientist, impartial and uninvolved, who brings to the Courtroom factual information and scientific conclusions untainted by prejudice, bias, or concern for the use which is to be made of his (or her) testimony in deciding the disposition of the case."
8.15 The role of the medical practitioner as an expert witness is enshrined in
Rogers v. Whitaker34 and has been revisited in Bolitho v. City & Hackney
Health Authority.35 The decision in Rogers does though seem to have shifted the emphasis away from the reliance on medical expert reports and testimony. Notwithstanding this, the role and duty of the expert
witness has been reviewed from different perspectives.36 The role
32 I Freckelton, P Reddy, H Selby, “Australian Judicial Perspectives on Expert Evidence: An Empirical Study,” (1999) Australian Institute of Judicial Administration, Melbourne. 33 T Boland, “Science v. The Law,” (2001) Health Law Seminar Series (CLE), The University of Sydney, Faculty of Law. An American study undertaken in 1994 by Shuman et al, An Empirical Examination of the Use of Expert Witnesses in the Courts - Part III - A Three City Study,” (1994) Jurimetric Journal, 193, cited in: H Selby, Tomorrow's Law, (1995) Sydney Federation Press, 58- 98, poses the suggestion that American Lawyers look for three very different qualities, these being - credentials (88%); adamancy of their support for the Lawyer's viewpoint (84%), and fee charge (75%). 34 (1992) 175 CLR 479. 35 [1997] 4 All ER 77. 36 See Peter C Bruechle, FIEAust, “Learning from a Failure and Musical Instruments,” (May 2001) a paper presented to the Institution of Engineers of Australia, Perth Division. Here Bruechle summarised the role of the expert to include: (i) the expert must behave honourably and ethically, (ii) the expert's duty is to the Court and not the client, (iii) the expert evidence should have no bias,
8.9 probably remains best summarised by Cresswell J in “The Ikarian
Reefer”.37 In “The Ikarian Reefer”, an Admiralty case, his Honour,
Cresswell J made seven points38 that represented the principles relating to the duties and to the responsibilities of the expert witnesses in civil
cases.39 Taken out of context these included the following seven obligations for the expert witness:
(i) Expert evidence presented to the Court should be, and should be seen to be, the independent product of the expert uninfluenced as to the form or
content by the exigencies of litigation;40 (ii) An expert witness should provide independent assistance to the Court by way of objective unbiased opinion in relation to matters within his
expertise.41 An expert witness in the High Court should never assume the role of an advocate; (iii) An expert witness should state the facts or assumptions upon which his or her opinion is based. The expert witness should not omit to consider material facts which could detract from
his [or her] concluded opinion;42
(iv) An expert witness should make it clear43 when a particular question appears or falls outside of his
(iv) the evidence should have a sound scientific basis, (v) the expert should have knowledge and experience in the field in which the evidence is given, (vi) the Court system is adversarial and the expert should endeavour not to become an adversary, (vii) experts should, more frequently, seek a pre-trial conference with the (other) expert, (viii) the expert should not be inflexible if the opposition produces evidence that demonstrates testimony to be incorrect, incomplete and not the most likely scenario, and, (ix) evidence should be clear and understandable. (My summary of Bruechle's Paper). See also Whitehouse v. Jordan [1980] 1 Al ER 650; [1981] 1 Al ER 267. See also Lord Woolf, “Access to Justice” (1996) HMSO, IV 14. 37 National Justice Compania Naviera SA v. Prudential Assurance Co Ltd (“The Ikarian Reefer”) [1993] 2 Lloyd's Rep 68; Approved on Appeal [1995] 1 Lloyd's Rep 455. 38 See vide supra n.37 at 81-82. 39 Cresswell J’s list of duties and responsibilities of the expert witness has been influential in causing Rules of Court to be devised. 40 See Whitehouse v. Jordan (1981) 1 WLR 246 at 256 per Lord Wilberforce. 41 See Polivitte Ltd v. Commercial Union Assurance Co PLC (1987) 1 Lloyd's Rep 379 at 286 per Mr Justice Garland and re J (1990) FCR 193 per Mr Justice Cazalet. 42 See vide supra n.34.
8.10 or her expertise. If an expert's opinion is not properly researched because he or she considers that insufficient data is available, then this must be stated with an indication that the opinion is no
more than a provisional one;44 (v) In cases where an expert witness who has prepared a report could not assert that the report contained the truth, the whole truth and nothing but the truth without qualification, that qualification should be
stated in the report;45 (vi) If after exchange of reports, an expert witness changes his view on a material matter having read the other side's expert's report or for any other reason such change of view should be communicated [through legal representatives] to the other side without delay and to the Court; and (vii) Where expert evidence refers to photographs, plans, calculations, analyses, measurements, survey reports or other similar documents, these must be provided to the opposite party at the same
time as the exchange of reports.46
ADMISSIBILITY OF EXPERT EVIDENCE
8.16 In Australia it is most commonly the case that the trier of fact is the Judge. The Judge is presumed and regarded to be alert to reliability and
relevance, and admissibility47 of evidence is not usually an issue.48 Notwithstanding this, the trial Judge does have the discretion to reject
43 The expert should not only make it clear but the expert should also avoid the temptation to address matters which are outside their area of expertise as to do so may encourage the risk of testing cross-examination. 44 See vide supra n.34. 45 See Derby & Co Ltd v. Weldon cited in the Times, 9 November 1990 per Lord Justice Stoughton. 46 There must be disclosure of all evidence used for formulating an opinion. 47 For further reading regarding the admissibility of evidence the reader is referred to Stephen Odgers, Uniform Evidence Law, 6th Ed, Ch 3, Admissibility of Evidence, pp.160-593, Thomson Law Book Co, 2004. 48 See Evidence Act 1995 (Cth) s.136; Evidence Act 1995 (NSW) s.136; R v. Hulse (1971) 1 SASR 327 at 330; Clelland v. R (1982) 151 CLR 1. See also The Hon Justice T H Smith, Evidence Act 1995 - An Overview, Paper presented at the College of Law, Sydney, 8 April 1995.
8.11 evidence even though it is admissible, and Counsel can object to opinion
evidence.49 In A & Anors v. National Blood Authority & Anors50, the decision of Burton J to exclude the role and knowledge of a learned witness in determining whether a [blood] product was defective was a decision that has the potential to be of some concern to the manufacturers and distributors of implantable surgical devices, and of other therapeutic goods, though in s.135 of the Evidence Act 1995 (Cth) there is an opportunity for exercise of discretion to exclude evidence of
an expert's opinion. 51
8.17 It is the burden of the trial Judge to ensure that the expert is qualified on the issues before the Court and that any relevant and reliable opinions are accepted from that expert. However the Judge has a broad discretion with regard to the undertaking of this duty. This is necessary as there is no threshold for the admissibility of expert evidence which takes into
account its reliability.52 Unfortunately the discretion exercised by Judges in some recent Australian trials has resulted in decisions which have
been cause for concern in the medical community.53
8.18 The appropriate test for the admissibility of expert evidence has not been satisfactorily resolved. For example, under common law, it is accepted that, to be admissible, the opinion of an expert must derive from a "field of expertise". Yet it remains the case that the test for a "field of
expertise" has never clearly been resolved by Australian law.54 The
49 See Regina v. David John McIntyre [2001] NSWSC 311. 50 See A & Anors v. National Blood Authority & Anors [2001] EWHC QB 446. 51 Or, where applicable, Evidence Act 1995(Cth), s.137. See also S Odgers & J Richardson, “Keeping Bad Science out of the Court Room - Changes in American and Australian Expert Evidence Law” (1995) 18 UNSW LJ, 108. See also G Edmond & D Mercer, “Keeping "Junk" History, Philosophy and Sociology of Science out of the Court Room: Problems with the Reception of Daubert v. Merrell Dow Pharmaceutical Inc” (1997) 20 UNSW LJ, 48. 52 For a conclusion of reliability, the ultimate test is reliability - see Idoport Pty Ltd v. National Australia Bank Ltd [1999] NSWSC 828 at [242], here Einstein J expressed the view that: "Section 79 is a direct rejection of the American Frye test". Some members of the High Court have interpreted s.79 of the Evidence Act 1995 (Cth) in such a way as to require expert testimony to meet a standard of evidentiary reliability and relevance to be admissible. See H G v. The Queen [1990] 197 CLR 414, Gaudron J at [58]. Gaudron J restated her position in Velevski v. The Queen [2002] 76 ALJR 402 at [82]. 53 These concerns have been raised by R Tjiong, formerly Chairman and Manager of the United Medical Protection (UMP) organisation in Sydney, NSW. See also RTT Tjiong, “Reforming the Law on Expert Evidence, the Process of Reform should involve the Medical Profession” (1998) 168 MJA, 53-54. 54 Whilst Australian Law has never clearly resolved the test for a "field of expertise" the "general acceptance” test has been adopted by some authorities and this formulation devised from the United States' decision of Frye v. United States 293 F 1012 (1923). See also R v. C [1993] 60 SASR 467 at 473 per King C J. Some authorities have required a Court to make an assessment of "reliability" the Casley-Smith v. Evans & Sons Pty Ltd (No 1) (1988) 49 SASR 314 (FC) at 320 and 328 per Olsson J.
8.12 question remains as to whether the test for the admissibility of expert
evidence should be the Frye test55 of "general acceptance", or that which
is generally believed by the relevant scientific authority,56 the Daubert
test57 of "reliability", that is supported by "appropriate validation"58 that has been demonstrated by an accepted scientific method. Alternatively, should the test for admissibility be the adoption of both the Frye and the
Daubert tests.59 Whilst on occasions both tests appear to have been
adopted60 the opportunity to resolve the issue has occurred but not been
taken up.61
8.19 In the United States, prior to 1975, the accepted standard for the admissibility of expert evidence was the Frye test and expert testimony
was admissible 62 if it was …
"used from a well recognised scientific principle or discovery, the thing from which the deduction is made [being] sufficiently established to have gained general acceptance in the particular field to which it belonged."
It is held by some63 that there is a close resemblance between the Frye
test and the Principles of Admissibility that are applied in Australia.64
55 See Frye v. The United States 293 Fed 1012 (1923). Here the test for admissibility depends upon whether the theory or technique on which the opinion has been based is generally accepted within the scientific community. The Frye test was based upon a "general acceptance" theory. Frye was a 1923 criminal case in which the District Court of Columbia Court of Appeals held that expert testimony based on scientific evidence is not admissible unless the technique has been generally accepted by the scientific community from which it was derived. 56 See Eagles v. Orth [1976] Qd R 313 At 320; R V Lewis (1987) 29 A Crim R 267 At 287-288 per Muirhead J. 57 Daubert v. Merrell Dow Pharmaceuticals Inc. 509 US 579 (1993). Here the test for the admissibility of expert evidence provides that scientific validity or real liability depends on matters such as falsifiability, known or potential error rate, peer review, and publication. The Daubert Case concerned Jason Daubert who was born with a rare defect. His mother had used Bendectin, a drug which counters the morning sickness of pregnancy. In Australia Dr William McBride, his scientific fraud then still concealed, despite years of efforts by whistleblowers, featured prominently among the expert witnesses who testified against Bendectin. 58 Casley-Smith v. Evans & Sons Pty Ltd (No 1) (1988) 49 SASR 314 FC At 320 & 328 per Olsson J; Ritz Hotel Ltd v. Charles of the Ritz Ltd (1988) 15 NSWLR 158; Interlego A G v. Croner Trading Pty Ltd (1991) 102 ALR 379. 59 R v. Gilmore [1997] 2 NSWLR 935 at 939 & 941; Osland v. The Queen (1998) 197 CLR, see the judgement of Gaudrin & Gummow J J at 336 and the judgement of Kirby J At 373-376. 60 See vide supra n.59. 61 H G v. The Queen [1999] HCA 2: 197 CLR 414. 62 Frye v. The United States (1923) 293 Fed 1013 at 1014. 63 See vide supra n.6. 64 See Stephen Odgers, “Admissibility of Evidence” in Uniform Evidence Law (6th ed 2004) Ch 3, 160-593. See also Makita (Aust) Pty Ltd v. Sprowles (2001) 52 NSWLR 705, Heydon J A At 743-744 summarised the applicable law in relation to the Admissibility of expert evidence as an exception to the opinion rule.
8.13 Not all commentators are in agreement with this and there are contrary
views.65
8.20 In Daubert66 the Supreme Court in the United States decided that the Frye test was superseded by the Federal Rules of Evidence that became
applicable in 1975.67 The effect of Daubert was to impose upon the Judge the task of assessing the reliability of a scientific opinion. Although of no direct authority in Australia, the principles of Daubert have the potential to have a substantial effect on the way in which Australian Courts, in the future, may assess and admit scientific
evidence.68 The Daubert test is though the more significant in that there
is an implied requirement for the Judge to become a scientist69 and the
judgement in Daubert marks the full turn of a cycle since Frye in 1923.70
In the words of David Bell,71
"The law has shown a parallel oscillation from the rigor of Frye in 1923 to the greater discipline [still] of Daubert in 1993."
OPINION EVIDENCE
65 I Freckelton, The Trial of the Expert (1987) Pub Oxford University Press, 6; S Odgers & J Richardson, “Keeping Bad Science Out of the Courtroom - Changes in American and Australian Expert Evidence Law” (1995) 18 (108) UNSW Law J, 123. 66 The Court recognised the difficulty between the quest for truth in the Courtroom as distinct from the scientific arena holding that the trial Judge must act as a gatekeeper to at times exlude novel if authentic scientific opinion. In the USA the difficulties associated with untested causal theory when presented as scientific fact caused the Supreme Court to develop the Doctrine of Daubert. The basis of the Doctrine is that expert scientific testimony is only admissible if its rests on a reliable foundation in terms of the underlying methodology and is at all times relevant to the issues at question. The liability is to be judged in part by considering matters such as peer review and acceptance in the specialist scientific community. In the USA the Supreme Court has also applied the Doctrine of Daubert to non-scientific but technical expert testimony - see Tire Co of Kuhmo v. Patrick Carmichael, case No 97 1709, (24 March 1999) unreported. 67 In 1975 the United States Congress passed the Federal Rules of Evidence which specifically addressed the admissibility of expert evidence. In particular Rule 702 provided: "If scientific, technical or other specialised knowledge would assist the trier of fact to understand the evidence or to determine a fact in issues, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise." 68 See vide supra n.5. Here Samuels stresses that the decision in Daubert that it was for the Judge to ensure that all scientific testimony in evidence "is not only relevant but reliable" (Daubert at 2795). Samuels further states that Judges have suggested four indicators for assessing "the tested reliability". These are: (i) Whether the assertion can be and has been tested (matters relating to scientific reliability); (ii) Whether the theory or technique has been subject to peer review and publication; (iii) The known or potential rate of error; and (iv) Whether there has been general acceptance within the relevant scientific community. These indicators represent a move away from the pre-existing tests that refer to mere general acceptance within a relevant scientific community. While this decision has no direct applicability in Australia, the test for reliability may be a useful model for procedural reform. For further information see G Edmond & D Mercer, “Keeping "Junk" History, Philosophy and Sociology of Science Out of the Courtroom” (1997) 20 UNSW Law J, 48-59. 69 See vide supra n.5. 70 DS Bell, “From Frye to Daubert” (2000) 32 (2) Aust J For Sci, 61-64.
8.14 8.21 It is a general rule of common law that evidence consisting of opinion72 is
not generally admissible as evidence.73 However an expert witness is permitted to offer opinions based upon matters which are relevant to the
case. This is reflected in the Evidence Act 1995 (Cth)74 that permits the use of opinion evidence from a person possessing "specialised
knowledge75 based on the person's training, study or experience"76 provided the opinion is "wholly or substantially based on that
knowledge".77 Under the common law, there has been some uncertainty
as to whether expertise can be derived from experience78, rather than from a formal course of study. Because it must be established that the opinion is wholly or substantially based on specialised knowledge, it will be necessary to show that the person "has specialised knowledge of an
identifiable kind".79 Implicit in this is the concept that ordinary persons are unlikely to have sufficient knowledge to give meaningful evidence in regard to the matters that are subject to debate. Under Common Law, the regularly cited test of expertise has been that referred to by Dixon C J in
Clark v. Ryan.80
8.22 With regard to "experience" it can be the case that an expert will have the opportunity to learn of events and to gain knowledge during the course of a corridor conversation or consultation with a [learned] colleague. The knowledge and experience derived from such a dialogue can become
71 See vide supra n.70. 72 For further reading see Pt 3.3 - Opinion, pp.255-289 in Uniform Evidence Law, 6th Ed, Stephen Odgers, Law Book Co, 2004. 73 See JJ Doyle QC, “Admissibility of Opinion Evidence”, 61 ALJ 688; P Gilles, “Opinion Evidence” 60 ALJ 597; NMiller, “Daubert & Junk Science; Have Admissibility Standards Changed?” (1994) 61 (4) Defence Counsel Journal, 501. 74 See the Evidence Act 1995 (Cth), s.76 for the Opinion Rule and s.79 for the Exceptions to the Rule. 75 This phrase is not defined in the Evidence Act 1995 (Cth). See Adler v. Australian Securities and Investments Commission [2003] NSW CA 131 at [629] - Giles J A of the NSW Court of Appeal observed that the phrase "is not restrictive: it's scope is informed by the available bases of training, study and experience". 76 The trend of authority recognises that expertise may be derived from experience. See H G v. The Queen (1999) 197 CLR 414, Gaudron J At [58]; Weal v. Bottom (1966) 40 ALJR 436. 77 The requirements of s.79 of the Evidence Act 1995 (Cth) are mandatory and it is not sufficient that an expert's opinion is given in accordance with the conventions of the expert's particular field of scolarship. Harrington-Smith on behalf.of the Wongatha People v. State of Western Australia (No 7) [2003] FCA 893 At [19] per Lindgren J. Lindgren J observed that "Lawyers should be involved in the writing of reports by experts: not, of course, in relation to the substance of the reports (in particular in arriving at the opinions to be expressed); but in relation to their form, in order to ensure that the legal tests of admissibility are addressed". 78 Where "experience" is asserted to be the basis of "specialized knowledge" this will need to be clearly demonstrated. Much will depend on the field of knowledge in question and if specialized knowledge is derived from experience, the test of "reliability" would need to be applied with some care. 79 NMFM Pty Ltd v. Citibank Ltd (No.7) (1999) 161 ALR 576 at [7] per Lindgren J. 80 See Clark v. Ryan (1960) 103 CLR 486, Dixon C J At 491. In this case the opinion evidence of the expert was inadmissible in regard to any conclusion as to the existence or non-existence of negligence. This case emphasised that such statements as "the defendant has been negligent" or "grossly negligent" or, rarely, "I can see no evidence of any negligence" should be inadmissible in the matter (regarding negligence) as it is a matter for the Court to determine for itself.
8.15 part of an opinion later tendered in evidence. In the event where some basis for an opinion is hearsay there is need for careful analysis. The
Australian Law Reform Commission (ALRC)81 considered that -
"the view should be taken that second-hand hearsay [evidence] is generally so unreliable that it should be inadmissible except where some guarantee of reliability can be shown together with a need for its admissibility".
It may be the case that evidence derived from corridor conversations and
consultations may not be caught by the hearsay rule82 providing it is -
"…possible to trace the information back to a person who may be supposed to have had personal knowledge of it."83
8.23 An expert witness should resist the opportunity to stray outside his or her
area of expertise.84 In s.79 of the Evidence Act 1995 (Cth) the words
"wholly or substantially"85 were introduced in place of the words "wholly or partly" to avoid an expert witness giving non-expert opinion
evidence.86 However it remains the case that the Courts can benefit from considerable flexibility with regard to the admission of evidence of
"expert" opinion87 as there is no definition of the word "substantially" in the Evidence Act 1995 (Cth).
8.24 Under Common Law, the admissibility of expert opinion evidence will depend on there having been proper disclosure of all evidence by all
parties and the presentation of evidence that forms the factual basis88 for
81 ALRC 26, Vol 1, ¶678. 82 See Evidence Act 1995 (Cth), s.59. 83 The ALRC explained this requirement regarding "personal knowledge" in s.69(2)(a) and (b), as defined ni s.69(5) (ALRC 26, Vol 1, ¶707). 84 Randwick City Council v. Minister for the Environment (1998) 54 ALD 682. 85 With respect to "wholly or substantially based on that knowledge" it is necessary then to show that the person "has specialized knowledge of an identifiable kind". See NMFM Pty Ltd v. Citibank Ltd [No 7] (1999) 161 ALR 576 at [7] per Lindgren J. 86 See ALRC 38, ¶ 151(a). 87 See Quick v. Stoland (1998) 87 FCR 371 per Branson J (at 374-375), Emmett J (380-381). Here is an example of disagreement with regard to the admissibility of evidence of "expert" opinion. 88 It is possible that a failure to disclose the basis for an opinion might bear on the question of relevance under s.56. If the basis for an opinion is not disclosed, or no evidence is admitted to establish the basis, it can be concluded that the opinion evidence does not satisfy the requirement of relevance because it will not be possible to assess whether it is capable of effecting the probabilities of the
8.16 the opinion. The expert must disclose the facts upon which any opinion
is based89 and the facts upon which the opinion is based must be capable
of proof by evidence that is admissible.90 Furthermore the evidence must
be admitted to prove the facts upon which the opinion has been based.91
It is not infrequent for opinions to be viewed as controversial92 and it is
frequently the case that there will be genuine disagreements93 of opinion. Any opinion required to explain the cause for an event places upon the expert the heavy burden to explain [to the Court] that which is being
advanced is nothing more than an hypothesis.94 The expert also has the burden to provide evidence to the Court as to whether or not the hypothesis is widely accepted within the profession and also to provide the Court with any evidence that might support any contradictory view of the hypothesis. In any event any opinion or hypothesis should not be seen to be a cause for concern that the expert has intentionally or unintentionally expressed an opinion that has fallen outside of their field of expertise. In the Report of the Australian Institute of Judicial
Administration, 199995 it was reported that 79% of Judges who answered the survey reported that they had encountered the failure by expert witnesses to stay within the parameters of their expertise [only] "occasionally".
BIAS IN EXPERT EVIDENCE existence of a fact in issue. See Quick v. Stoland (1998) 87 FCR 371 at 374 per Branson J. See also Hayden J A in Makita (Aust) Pty Ltd v. Sprowles (2001) 52 NSWLR 705 at [86]. 89 Arnotts Ltd v. Trade Practices Commission (1990) 24 FCR 313 at 348. 90 Ramsay v. Watson (1961) 108 CLR 642 at 649. Under Common Law, the admissibility of expert opinion evidence depends on proper disclosure and evidence of the factual basis of the opinion. The expert must disclose the facts, that may be assumed, upon which is opinion is based. See Arnotts Ltd v. Trade Practices Commission (1990) 24 FCR 313 at 348. There must be admissible evidence (Paric v. John Holland (Constructions) Pty Ltd (1995) 59 ALJR 844 at 846) and evidence must be admitted to prove the assumed facts upon which the opinion is based (see R v. Perry (1990) 49 A Crim R 243 (NSWCA)). 91 Steffen v. Ruban [1966] 2 NSWLR 623 at 626 and 630-631. 92 See ¶8.39. 93 See Editorial, (2002) 8 British J of Surg, 134-7, and Minerva in Student BMJ, (2000) Vol 10, 130, regarding the diametrical opposite opinions of two experts with respect to the causation of pneumothorax following fine needle biopsy of breast lumps. See vide supra n.21. 94 In Velevski v. The Queen (2002) 76 ALJR 402. The majority Gummo W & Callinan J J (at [154]), considered that a precondition to admissibility of expert evidence is "a valid scientific connection to the pertinent enquiry". It must be demonstrated that the reasoning or methodology underlying the testimony probably can be applied to the facts in issue.
8.17 8.25 The problems caused by bias in expert evidence has long been
recognised.96 Freckelton and others recognise that there are several reasons for expert evidence to be influenced by bias, which may, as often
as is not, be unconscious97 as it is deliberate.
8.26 Bias, particularly hindsight bias, has the potential to ensure that some reasonably acting defendants will be unfairly subjected to adverse
liability judgements.98 The question of bias in general and the issue of hindsight bias in particular, are crucial issues that should be included in any debate concerning the role of the expert witness. Nine of ten Judges
surveyed by Freckelton (et al) in 199999 said they had encountered bias in expert witnesses at some time.
8.27 Hindsight bias is a form of bias that no profession (nor indeed any individual) can escape. It is that form of bias that frequently attracts the observation "it should have been obvious". In the event such a statement is almost a guarantee for hindsight bias. Here the expert will have some knowledge of the events that have taken place and in forming his or her opinion there can be the potential for that expert to trivialise the circumstances and the management dilemmas facing the clinician at the time preceding the adverse event. In this way the too frequent uncertainties inherent in diagnosis and treatment can be conveniently
overlooked.100 Hindsight bias though, may not necessarily be deliberate,
but rather may be induced by what one researcher101 has described as a "creeping determinism" that is associated with "a process that is driven by subconscious desires on the part of the expert to appear
95 See vide supra n.32. 96 See vide supra n.32. See also B Fischoff, “Hindsight - Foresight: The Effect of Outcome Knowledge on Judgement Under Uncertainty” (1975) 1 J Exp Psychol, 288-99; SJ La Bien & G La Bien, “Determinations of Negligence and the Hindsight Bias” (1996) 20 Law Hum Behav, 501-16 and J Baron & JC Hershey, “Outcome Bias in Decision Evaluation” (1988) 54 J Pers & Soc Psychol, pp.569-79. 97 G Samuels, “Medical Truth Legal Proof - Changing Expectations of the Expert Witness (1998) 168 MJA, 84-87 - here Samuels refers to unconscious bias "which is a well known characteristic of Expert evidence". See also Miller Steamship Co Pty Ltd v. Overseas Tank Ships (UK) Ltd (1963) NSWR 737 at 753 per Walsh J. 98 K Kamin & JJ Rachlinski, “Determining the Liability in Hindsight” (1995) 19 Law Hum Behav, 89-104. 99 See vide supra n.32. 100 RI Cook & DD Woods, “Operating at the Sharp End: The Complexity of Human Error” in MS Bogner (ed), Human Error in Medicine, (1994), 255-310.
8.18 knowledgeable, intelligent and unambiguous". This form of bias is ever present and it is frequently difficult to resist.
8.28 There is considerable scientific evidence that does support a view that hindsight bias is inevitable and occurs more frequently when the
reviewing expert is aware of an adverse outcome.102 The degree of bias is also generally very much proportional to the [known] severity of the
outcome.103 Professor "Doug" Tracey has drawn the appropriate analogy
"…any drunk can find his way home…"104 Tracey further emphasises that the Court "…should recognise that it is always easier to retrace a difficult pathway than to start at the beginning."
8.29 It is the view of Boland105 that expert witness bias is not necessarily the product of dishonesty or malice, or a determination to pervert the process, but in contrast may be derived from a genuine and deeply held feeling that the cause is just and should be supported. Boland emphasises also that there can be occasions when some evidence may be withheld from the expert as this may provide a tactical advantage to the other party if they later should have the opportunity to become privy to it under disclosure of reports. In this regard, it is also evident that bias can be derived from the instructions and the assumptions that are included in the instructing brief of the solicitor, from any other evidence that is provided, and from such observations as the claimant's presentation or demeanor. Boland shows that in such circumstances, bias can be
unconscious - unconscious bias.106
101 L Berlin, “Malpractice Issues in Radiology- Hindsight Bias” (2000) 175 Am J Radiol, 597-601. 102 RA Kaplan, KL Posner & FW Cheney, “Effective Outcome on Physician Judgement of Appropriateness of Care” (1991) 265 JAMA, 1957-60 - here anaesthetists reviewed outcomes that was randomly assigned to be either bad or neutral. The reviewers were provided with cases with the same descriptive facts. The study demonstrated that the degree of bias is linked to the severity of the outcome. See also RH Brook & FA Appel, “Quality-of-Care Assessment: Choosing a Method for Peer Review” (1973) 288 New Engl J Med, 1323-29; J Barron & JC Hershey, “Outcome Bias in Decision Evaluation” (1988) 54 J Pers & Soc Psychol, 569-79. 103 TB Hugh & GD Tracy, “Hindsight Bias in Medico-Legal Expert Reports” (2002) 176 MJA, 277-78. See also SJ La Bein & G La Bien, “Determinations of Negligence and the Hindsight Bias” (1996) 20 Law Hum Behav, 501-16. This study demonstrated that with severely injured patients judgements by reviewers tended to be harsher than was the case when the outcome was less severe. 104 D Tracey, “Discovering Bias in the Expert Witness: and Understanding Medical Error - Does Hindsight Equal Foresight?” (12 November 2003) 20 (3) Proceedings of the Medico-Legal Society of NSW Inc, 1-3. 105 See vide supra n.33. 106 See vide supra n.33.
8.19 8.30 It is permissible also to take a view that unconscious bias might be engendered by any long-term relationship such as can be associated with the multiple engagement of a particular expert by a particular
organisation. Multiple engagements can generate an advocacy107 that has the potential to impact on the expert witnesses' independence and also on
his or her perception of independence.108 In these circumstances there can be a potential for what might also be described as partnership bias that is characterised by a lack of objectivity. Partnership bias can also be the consequence of a vested financial interest of the expert in the
outcome of a case.109 Herein are significant issues that reflect the tension that exists between an expert's role to provide information for the
organisation and the adversarial nature of the legal process.110
8.31 In their perspective on expert evidence, Freckelton et al discuss the aetiology of bias and observe that there are several reasons for expert
evidence to be influenced by [partnership] bias.111 These include:
(a) The inevitability that the parties will select experts who are likely to provide an opinion which favours their case. This ignores unexplored those opinions which may be more representative of the relative specialty; (b) the involvement of the expert as part of the team that includes providing assistance in the formulation of the case and the search for holes in the other side's expert
107 See vide supra n.32. The AIJA Report (Freckelton et al) suggests that the perception of the advocacy of expert witnesses for those who instruct them is held by some members of the judiciary and this is reflected by the fact that 27% of Judges surveyed considered that experts were "often biased" and that 67% considered experts to be "occasionally biased". Furthermore in 26% of cases the appearance of expert impartiality was considered important in the acceptance of the evidence. Nearly one-half of Judges admitted encountering partisanship that was a significant problem for fact finding in their Court. 108 See vide supra n.5. It is instructive also to review the Dairy Farmers Restructure that occurred in 1999 where the independent expert, Ernst & Young was required to amend its report to consider the impact of the hostile Parmalat proposal upon the Dairy Farmers Restructure. 109 Spigelman J, Chief Judge of the Supreme Court, quoted in the Sydney Morning Herald, 6th September 2004, 1-2. Here Spigelman J, with regard to the system of charging fees on a “no win-no fee” basis observed that “obviously there is concern in this that the expert then has a vested financial interest in the success of the case and is then unlikely to be impartial”. 110 The adversarial system where an expert is chosen by each side carries with it the dilemma that evidence may be viewed as having bias particularly when the testimony concerns technical issues. Like many other professionals, medical practitioners and engineers typically work in a collegial environment. The collegial process does not fit easily within the adversarial legal process – for further reading see J Foley, “The Role of the Professional Engineer in the Legal Environment” (2004) Newsletter of the Forensic Engineering Society, 2. See also the case of Makita (Aust) Pty Ltd v. Sproules (2001) 52 NSWLR 705. This was a slip and fall accident and the decision (reversed on appeal) was based on expert opinion where it was suggested that partisanship existed on the part of the involved expert. 111 See vide supra n.32.
8.20 opinion. [This can enable] the professional expert who becomes well practiced, and can "learn to adjust" his or her testimony to accommodate potential problems, and to also learn how to present an aura of confidence and persuasiveness, in a way which will be dismissive of any challenge; (c) the fact that the task attracts [mostly] retired practitioners who can be lacking in current research and clinical experience, but have impressive credentials. Those active in their specialty may be reluctant to become experts because of the disruption which it has for their work; and (d) the emergence of an economic tie between the expert witness and the engaging party or the greater potential concern of a tie arising from a commercial interest in some newly developed technology.
8.32 Unfortunately the ASIC Guidelines112 do not provide experts with much guidance in determining whether they are independent in situations where they have repeatedly been engaged by a company or where they are required to consider competing or alternate proposals. That the independence of the expert witness is fundamental to the exclusion of bias is a logical view and it may be suggested that [in each case] the
independence of experts should be tested. Latham and Morrison113 have suggested that a useful test for the independence of experts might be
112 See ASIC Practice Note 43 Valuation Reports and Profit Forecasts - whilst it is generally market practice for the vast majority of expert reports to be provided by independent experts, whether or not specifically required to be so by the Corporation's law or the Listing Rules, ASIC does consider that it is highly desirable that all experts or Valuation Reports involving the exercise of judgement or opinion should be provided by independent experts whether or not the law specifically requires that independence. The determination of whether or not an expert is independent can only be identified on a case by case basis that considers the factual circumstances existing at the time. In the past an expert who represented him or herself to shareholders as independent, but was not, may have been seen to have been engaging in conduct which could be viewed as misleading or deceptive or likely to mislead or deceive (1041H of the Corporation's Law (Cth)). In the event that an expert is not independent, ASIC has taken the view that the readers of the Report have reason to expect the expert should disclose his or her lack of independence - see para 11 of ASIC Practice Note 43. Surgical product liability issues where it may be considered that an expert witness has demonstrated conduct that might be misleading or deceptive or likely to mislead or deceive more correctly an issue that is covered by s.52 of the Trade Practices Act 1974 (Cth). 113 For further information see M Latham & M Morrison, “Is Your Expert Independent?” (June 2001) Corporate Advisory, Corrs Chambers Westgarth, Lawyers, 5-6.
8.21 based upon the US Securities Exchange Commission Ruling that includes the following hurdles:
(a) Whether the expert is capable of exercising objective and impartial judgement (or debate) on the transaction (the case at question): and (b) Whether a reasonable investor (party) knowing of the Expert's work (credentials) upon past or competing transactions would conclude that the Expert is capable of exercising objective and impartial judgement on the transaction (case in question), or in ASIC's terms whether it is likely that the report would be perceived to be biased (my edits).
8.33 It should be evident that merely warning experts of the afflictive influence of bias is not always adequate because bias is frequently present even when those making their evaluations have been warned and
advised to guard against it.114 In the event, any Barrister worth his salt, on becoming aware of any bias should be capable of exposing that bias during a cross-examination.
8.34 In this discussion of bias I have concentrated mostly on matters relating to hindsight, unconscious and partisanship bias, for these are probably
the most important and most common forms of bias. Professor Tracey115 has though described a number of other forms of bias that do have credible foundations. These include -
(a) "Commissioning Bias" - In reality this is a form of the Partnership Bias that we have already discussed in ¶8.30 and ¶8.31. Tracey intimates that this form of bias might be eliminated "…if all expert witnesses
114 V Fischoff, “Hindsight-Foresight: The Effect of Outcome Knowledge on Judgement Under Uncertainty” (1975) 1 J Exp Psychol, 288-99. 115 See vide supra n.104.
8.22 were to be called by the Court rather than by the opposing parties." (b) "Mateship Bias" - Tracey observes that this is a form of bias that is "rarely adduced in cross-examination" and exists where a small number of specialist practitioners are well known to each other. (c) "Competition Bias" - Tracey describes this form of bias as being the "exact opposite to mateship bias" and it is one that exists between different specialties who might
"lay claim" to similar areas of expertise.116 (d) "Ivory Tower Bias" - the ivory tower is described by Tracey as "that mythical place far removed from real practice". These are teaching institutions "inhabited" by academics who fail to "appreciate the difference between the classroom and the courtroom".
(e) "Second Opinon Bias" - this form of bias117 is derived from that second opinion that is provided but fails to distinguish between "reasonably competent practice and the theoretical ideal". (f) "Publication Bias" - this form of bias is associated with the expert's reference to studies that are an improvement on previous published work that "sets an apparent new standard against which an individual [surgeon] might find himself unfavourably compared in [medical] litigation".
(g) "Sympathy Bias" - this form of bias118 is not confined to the expert witness but is also, in Tracey's view, "part of Judges and Juries" especially when they are presented with an "extremely likeable claimant who has suffered some distressing injury or devastating permanent disability.
116 Examples of this are Hand Surgeons, who might be Orthopaedic Surgeons or Plastic Surgeons and Maxillo-facial Surgeons who might include Dental Surgeons. 117 This form of bias is attributed by Tracey to Stuart Boland (Surgeon) - see vide supra n.104.
8.23 THE EXPERT AND THE MISCARRIAGE OF JUSTICE
8.35 In Constructing RSI Belief and Desire, Lucire Yolande discusses the effect of judicial decisions and expert evidence on the evaluation of
science by the law. Yolande states that119 -
"Judicial decisions sometimes legitimate false causes. Judicial decisions can create new medical categories… rather than evaluate testimony, Judges and Jurys may choose to adopt the view of the expert who allows them to make the decision that they want to make, one that seems to suit society's needs, the needs of the individual claimant or what they see is the public good." (My edit).
Yolande continues with a consideration of Abalos v. The Australian
Postal Commission120 and she discusses the expert evidence of Professor Ferguson who supported a conclusion that repetitive strain injury (RSI) was a disease caused by some general aspect of working conditions. Ferguson gave evidence in this case that he was "appalled" at what he considered to be the "inhuman" production line operations in the Australian Postal Coding Room. Ferguson stated that, simply from an inspection of the work, it was quite foreseeable "that at least a portion of the operators would suffer…damage…including the generalised muscle injury called RSI". At the Court of Appeal the decision that the Australian Postal Commission had been negligent was reversed. Abalos appealed successfully and, by the time the case reached the High Court, Professor Ferguson had, according to Yolande, "effectively abandoned his beliefs" about RSI being an injury of any kind, let alone one that was
negligently caused.121
118 This form of bias is attributed by Tracey to Peter Arnold (Medical Practitioner) - see vide supra n.104. 119 See Lucire Yolande in Constructing RSI Belief and Desire (2003) Pub UNSW Press, 171-75. 120 See Abalos v. Australian Postal Commission (1990) 171 CLR 167 FC. 121 See also DA Ferguson, Editorial, “RSI: Putting the Epidemic to Rest” (1987) 147 MJA, 213-14.
8.24 8.36 In Abalos there is support for the conclusion that the evidence of experts should not be beyond dispute. That the expert can be very wrong is well known. Justice Samuels in his 1997 oration to the Australian Medical
Association (AMA) NSW Branch Medical Truth and Legal Proof122 described the error of experts as the:
"… background for considerable alarm that has been generated in recent years by a number of cases in the United Kingdom and Australia in which a miscarriage of justice (that is to say a wrong result) has occurred as a result of the admission of highly dubious scientific evidence."
In an earlier paper, delivered to the Australian Academy of Forensic
Sciences in 1991123, in elaborating the concept of the wrong result
Samuels J cites the Chamberlain case124 in Australia, the case of The
Birmingham Six in England125, and the case of McLeod-Lindsay126 as being associated with no other result than the wrong result. The role of the expert witness in all of these cases was pivotal to the outcome and
reflects a problem that has not been diminished by experience.127
122 See vide supra n.5. Justice Gordon Samuels, addressed matters relating to expert evidence in his 1997 AMA (NSW) oration Medical Truth and Legal Proof. 123 G Samuels, “Is This the Best We Can Do?” (1993) 25 Aust J For Sci, 3-9. 124 See the Report of the Commission of Enquiry into the Chamberlain Convictions, May 1987, The Morling Report, Canberra AGPS, 1987, at 324. The Royal Commission established that some of the vital evidence for the prosecution was wrong. See Chamberlain v. The Queen (1983) 72 FLR 1 and Chamberlain v. The Queen [No 2] (1984) 153 CLR 521. 125 See I Makler, “The Court of Appeal Meets its Waterloo” (1991) 16 (3) Legal Services Bull, 101; B Woffinden, “Miscarriages of Justice” (1989) The Sevenoaks Coronet (England), 392. In his Oration to the AMA, in 1997, Justice Samuels describes the scientific evidence and the methodology used to produce it as being fatally flawed in this case. 126 See Report of the Royal Commission of Enquiry into the conviction of Alexander Lindsay, The Loveday Report, July 1991, at 185. Scientific developments subsequent to this trial refuted the evidence upon which the case for the prosecution largely depended. 127 See Regina v. Veleski [1999] NSW CCA 96 and Veleski v. The Queen [2002] HCA 4. Veleski was charged with the murder of his wife and his children, twin babies aged about three months, and their sister, aged 6 years. Veleski was convicted and appealed unsuccessfully to the Court of Criminal Appeal of NSW (Grove, James & Kirby J J). Kirby J would have allowed the Appeal, the Jury's verdict, in his Honour's opinion, being unreasonable. His Honour was also of the view that there was a miscarriage of justice (at ¶351) because of what he described as an "imbalance" (at ¶305) in the medical evidence. His Honour concluded that "…as the matter developed, there was an imbalance between those who favoured the suicide hypothesis, compared to those who favoured homicide. The imbalance was not the chance expression of individual views of doctors who have become involved. It was quite deliberate…". In the High Court Appeal it was concluded (at ¶45) that "…some of the evidence adduced from the pathologists was evidence of matters of human behaviour rather than matters about which they drew on their specialist or other medical expertise." The Appellant argued "…that the Court of Criminal Appeal erred in failing to hold that a miscarriage of justice was caused by the directions to the Jury in respect to the conflicting expert evidence". In support of this ground (at ¶178) the Appellant referred to the approval by Gibbs C J & Mason J in Chamberlain v. The Queen [No 2] [1984] 153 CLR 521 of a passage (at 558, citing (1983) 72 FLR 1 At 81-82; 46 ALR 493 At 573-574) in the judgement of Jenkinson J. The passage of Jenkinson J with which their Honours agreed was as follows: "Those means of evaluating evidence which the Jury enjoys by hearing and watching witnesses, and which are denied an Appellate Tribunal could not in my opinion have enabled the Jury reasonably to have eliminated the doubt, as to whether the matter tested contained foetal haemoglobin, which a careful consideration of the transcript of evidence and the exhibits raises in the mind".
8.25 8.37 These cases and others are the background of a canvas that raises many questions and provides fewer answers. A number of issues though are patently evident. Expert witnesses must maintain the wisdom to
acknowledge the limitation of their understanding.128 Furthermore
experts should avoid providing any opinion that is a trespass129 beyond their field of expertise, and they must be able to concede errors that may have occurred during cross-examination. Furthermore statements of opinion from experts should be noted as such, and not stated as assertion
of fact.130 In 1858, Taylor, in A Treatise on the Law of Evidence,
observed, with a relevance that is no less valid now than it was then;131
"Perhaps the testimony which least deserves credit with a jury is that of skilled witnesses. These gentlemen are usually required to speak, not to facts but to opinions: and when this is the case, it is often quite surprising to see with what facility, and to what extent their views can be made to correspond with the wishes or the interests of the parties who call them."
128 CJ Bacon, “The Case of Sally Clark” (2003) 96 (3) J Roy Soc Med, 105. In discussion of the Sally Clark cases (R v. Clark, (o1) (2000) EWCA Crim 54 and R v. Clark, (No 2) (2003) EWCA Crim 1020) Bacon emphasises that failure to detect maltreatment can result in the death of another child, while unjustified prosecution can wreck a life and a family. In this case the unjustified prosecution of Sally Clark was later found to be (in part) a significant consequence of the expert witness testimony provided by Professor Sir Roy Meadow. Clare Montgomery Q.C., in her address to the British Academy of Forensic Sciences, on 18 February 2004, described the Sally Clark case as "this grotesque miscarriage of justice was the result of flawed evidence given by forensic scientists." 129 See Velevski v. The Queen [2002] HCA 4 - here Gummow & Callinan J J [at ¶ 161], found "in this case the experts may, despite s.80(b) of the Act, in some respects have gone beyond their field of expertise. Under the common law, the admissibility of expert opinion evidence depends on proper disclosure and evidence of the factual basis of the opinion. Thus, the expert must disclose the facts upon which the opinion is based, (see also Arnotts Ltd v. Trade Practices Commission (1990) 24 FCR 313 at 348). There can be no doubt that a particular opinion may be "substantially based" on specialised knowledge notwithstanding the fact that the expert witness takes into account matters of "common knowledge´in formulating his or her opinion, Gaudron J at [82]. The facts upon which the opinion is based must be capable of proof by admissible evidence (see Ramsay v. Watson (1961) 108 CLR 642 at 649) and evidence must be admitted to prove the assumed facts upon which the opinion is based. (See Steffen v. Ruban [1966] 2 NSWLR 623 at 626 and 630-631). An expert witness should not be permitted to stray outside the witness' area of expertise. The expert must stay "wholly or substantially" within the area of expertise (see Idoport Pty Ltd v. National Australia Bank Ltd [1999] NSWSC 828 at [252]-[274] per Einstein J. It is not enough that a particular opinion falls within the field within which the witness is an expert, if no "specialized knowledge" is used in reaching the opinion (see Quick v. Stolland [1998] 87 FCR 371 per Emmett J [at 380-381] and Finkelstein J [at 383]). If the issue is in respect of that opinion that is given but involves no question of specialised knowledge then the opinion cannot be regarded as based on the witness' specialized knowledge (see Cadwallader v. Bajco Pty Ltd [2001] 189 ALR 370 at [148] per Austin J. 130 The Evidence Act 1995 (Cth) s.76(1) provides that evience "of an opinion is not admissible to prove the existence of a fact about the existence of which the opinion was expressed". s.79 creates an exception to that rule in the following terms: "Exception: Opinions based on specialized knowledge, if a person has specialized knowledge based on the person's training, study or experience, the opinion rule does not apply to evidence of an opinion of that person that is wholly or substantially based on that knowledge." See Farrell v. The Queen [1998] 194 CLR 286 at 292-293 [10] per Gaudron J, 300 [28]-[29] per Kirby J in respect of knowledge or experience of ordinary persons and H G v. The Queen [1999] 197 CLR 414 at 432 [58] per Gaudron J, and adopted in R v. Makoare [2001] 1 NZLR 318 at 324 [23] per Blanchard J on behalf of the New Zealand Court of Appeal. See also Osland v. The Queen [1998] 197 CLR 316 at 336 [53] per Gaudron & Gummow J J in respect of a reliable body of knowledge or experience. See also Editorial, “The Neurologically Impaired Infant” (2001) 3 United Journal Review of the Obstetrics and Gynaecology Grand Rounds, 19. 131 From Taylor, A Treatise on the Law of Evidence, 3rd Ed, p.69, 1858, cited by Pavlakis J & Collins A, Blake Dawson Waldron, in Expert Evidence in Health Care Litigation, July 1995. See also ¶ 8.4.
8.26 8.38 There are many questions raised by any miscarriage of justice. One important question is that which seeks to identify the cause for, or the culture that permits, there to be an opportunity for bad scientific
evidence, or junk132 science, to be allowed access to the courtroom.
Samuels J133 suggests that some commentators would answer this question instantly by ascribing it to judicial incompetence, and the evasion by judges of their responsibility to properly evaluate expert
testimony.134 David S Bell135 has the alternate view that there is now an "abysmal low" in the Australian courtroom that is characterised by the situation where a Judge is able to evaluate science even only by
observing the "demeanor"136 of the scientist addressing the court. The problem of how a Judge is to choose between two expert scientific witnesses, each of whom appears to be thoroughly well qualified, yet cannot agree upon anything, is a perennial difficulty that invites a solution that is sometimes based upon a reliance on the demeanor of the
witness.137 How far the demeanor of a witness can influence the Court is
a sensitive issue.138 Samuels J concedes that here there is a problem that is complex and he makes the suggestion that "it is possible that the
132 See vide supra n.6. 133 See vide supra n.123. 134 See DS Bell, “Whose Accountability, Judges or Experts?” (1994) 26 Aust J For Sci, 74-76. 135 See DS Bell, “From Frye to Daubert” (2000) 32 (2) Aust J For Sci. 62. The low described by Bell can be found in the case of Abalos v. Australian Postal Commission (1990) 171 CLR 167 FC - where a person claiming to have suffered Repetitive Strain Injury (RSI) held that a Judge can evaluate science by observing the demeanor of the scientist addressing the Court. The Trial Judge made no reference at all to the specific testimony, much less evaluate it, in deciding for the claimant. The Appellate Court of which Gordon Samuels J happened to be the President at the time, undertook the task of weighing the evidence to find that the information provided by both adversaries gave no support to the decision. The High Court reversed the decision. It ruled that, even in the complete absence of reasons for a decision or reference to the behaviour of the expert witnesses, the Appellate Court have to assume that the Trial Judge has the advantage of witnessing their demeanor. In some inexplicable way, the demeanor of the expert witnesses, completely unknown to their Honours, dismissed the science…Abalos permitted the evaluation of science through the demeanor of the scientist. Imagine the direction science would have taken had the Court the responsibility of evaluating Einstein's ideas by pandering to the belief in demeanor. The Court has promoted a focus on the messenger rather than on the message. The principle has given authority to junk science, blatant contradiction and unreasonable prejudice. Bell concluded…We deserve better. 136 See DS Bell, book review of Journal of Law and Medicine, Vol 1, p.83-84 (commencing July 1993). See also Abalos v. Australian Postal Commission (1990) 171 CLR 167 FC and vide infra n.40 and vide supra n. 134. 137 See DeVries & Anor v. Australian National Railways Commission & Anor (1993) 177 CLR 472, at 479 and n.20 Abalos v. Australian Postal Commission (1990) 171 CLR 167 FC. 138 In Knight v. Stocken [2002] NSW SC 1161 (6 December 2002) the expert witness was described as "…aggressive (and) combative…". The expert witness for the claimant was described, in her judgement, by Carolyn Simpson J as "I am bound to disclose that [this Witness] was as aggressive a Witness as I have ever observed…She was combative…she sought to score points…her answers were frequently unresponsive…". Simpson J further described the Witness "…aggressive manner bespoke an absence of the requisite objectivity which the Court relies upon expert witnesses to display. Without that objectivity and expert witness' creditability is diminished." The claimant lost the case. G Samuels J, in contrast, reports that "judicial comment (per Manning J) has also included pleasing accolades such as those bestowed in a case in NSW on medical witnesses who were demonstrating with singular tenacity the philosophical dichotomy between physician and surgeon. The physicians who gave evidence preferred proof by scientific means and the surgeons by experience and observation". See also Burgess v. Brownlow (1964) NSW R 1275 at 1277 per Manning J.
8.27 Judges are about to modify their methods of dealing with expert
evidence."139
8.39 That evidence can also be misused because of its unreliability is another
problem.140 It is particularly for this reason that the cases involving Sally
Clark141 in the United Kingdom have shaken public confidence142 in the role of the expert witness in a way that has potential for there to be far reaching consequences in Australia. Mrs Clark, a Solicitor, was convicted for the murder of her two baby sons [partly] on the basis of expert evidence provided by Professor Sir Roy Meadow. Errors were
identified in the evidence of Sir Roy Meadow143 and those errors formed the grounds for successive Appeals, that were eventually successful, but only after Mrs Clark had been in prison for three years. In the case involving Sally Clark, one expert witness presented erroneous statistical
evidence144 that damaged the defence while another withheld pathological
evidence145 that might have assisted.146 The erroneous statistical evidence in this case has become known as Meadow's Law. Meadow's Law states
that: 147
139 See vide supra n.5 and n.122. 140 This is a view held by J Bourke, “Misapplied Science - Unreliability in Scientific Test Evidence” (1993) 10 (124) Aust Bar Rev, 124. 141 See vide supra n.128. 142 See SJ Watkins, “Conviction by Mathematical Error?” (2000) 320 BMJ, 2-3. See also CJ Bacon, “The Case of Sally Clark” (2003) 86 (3) J R Soc Med, 102. The Sally Clark case was dissected in detail by Professor R Byard (Forensic Science Centre, Adelaide) and Mr P Johnson (Barrister) in their addresses to the Plenary Session of the Australian Academy of Forensic Sciences, in Sydney, on 13 August 2003. Professor Byard's presentation was entitled Sally Clark and Beyond and Mr Johnson's presentation was entitled Paediatric and Forensic Pathology. 143 N Marks, “An Expert Witness Falls From Grace - Sir Roy Meadow in the Media Firing Line” (2003) 327 (7406) BMJ, 110. Sir Roy Meadow (former President of the Royal College of Paediatrics and Child Health in the United Kingdom) was Professor of Paediatrics and known to have a lifetime's experience of investigating cases of suspected child abuse. Following the Sally Clark case, Sir Roy Meadow was also an expert witness in the cases of Trupti Patel and Angela Cannings. In each case the convictions have been overturned on Appeal. For further information see also R Meadow, “Personal Paper: A Case of Murder” (2002) 324 BMJ, 41-42. Also see E Hey, “Suspected Child Abuse: Potential for Justice to Miscarry” (2003) 327 (7410) BMJ, 299-300. 144 See vide supra n.142. 145 Dr AR Williams, Home Office Pathologist, did not disclose results of microbiology reports. Dr Williams was subsequently found by the United Kingdom General Medical Council (GMC) to be guilty of serious professional misconduct. See also C Dyer, “Pathologist in Sally Clark Case Suspended from Court Work” (2005) 330 (7504) BMJ, 1347. 146 The consequence of failure to disclose an expert's report is that the expert's report may not be used and the expert may not be called to give evidence orally unless the Court provides permission. 147 Though now retired, Professor Meadow recently lectured to the Manchester Medical Society on The Problem of Giving Evidence in Cases of Alleged Child Abuse. Professor Meadow has faced charges of serious professional misconduct before the General Medical Council (GMC) in the United Kingdom. A report in the London newspaper, the Daily Mail, GMC Snub for Mother Cleared of Killing Sons by Jo Knowsley (Social Affairs Editor), p.1, 21 November 2004 reports that the General Medical Council (GMC) in the United Kingdom has acknowledged that Professor Meadow might have been seen as having "promoted his own opinion" which could be viewed to "over-ride the interest of the Court". Complaints to the GMC had been made by Angela Cannings, the mother, cleared on Appeal in December 2003, of killing her two baby sons, and by Frank Lockyer, the father of Sally Clark. On 15 July 2005 the GMC found Sir Roy Meadow to be guilty of serious professional misconduct. For this, Sir Roy Meadow was struck off from the United Kingdom Medical Register. See report, GMC Strikes Off Meadow for “Abusing Position” in Cot Death Trial, The Daily Telegraph (United Kingdom), 16th July 2005, 11. A significant and potentially disastrous consequence of the Sally Clark cases is that doctors in the United Kingdom are becoming reluctant to report cases of suspected child
8.28 "One infant death is a tragedy, two is suspicious and three is murder, unless proven otherwise".
8.40 The quashing of Sally Clark's conviction (and other similar cases) have caused the Attorney General in the United Kingdom, Lord Goldsmith, to establish a review of these and other related cases and to scrutinise the
actions of individuals148, including expert witnesses.149
8.41 That the opinion of the expert witness can enable the course of justice to be so influenced so as to cause the wrong result, (a miscarriage of justice), should not be in doubt. In all of this one other conclusion is permissible. It is that medical practitioners must remain aware that they are accountable for their professional conduct and that when undertaking the role of the expert witness they are acting in a professional capacity. In the event it is very difficult to charge an expert witness with perjury for the simple reason that his or her evidence is frequently evidence as to
a matter of opinion only and not always evidence as to fact.150 To date, in Australia, no medical practitioner has been de-registered for misconduct
as an expert witness though this could be the outcome.151 It is interesting to observe that in the United Kingdom a number of medical practitioners have been exposed to the scrutiny of the General Medical Council for abuse – personal communication from Dr A Edelston, Senior Paediatrician, Sir James Paget Hospital, Great Yarmouth, 8th July 2005. 148 Dr Colin Paterson, a Scottish Chemical Pathologist, is now facing charges before the General Medical Council, in the United Kingdom, for misrepresenting medical evidence as an expert defence witness in child abuse cases. Dr Paterson frequently testified that seemingly non-accidental injuries in children were caused by a temporary brittle bone disease. This is a condition that was described by Dr Paterson but is disputed by many other experts, including Dr B Spivack, an American expert in the biomechanics of abusive child injury. Dr Spivack, in evidence to the GMC, described Dr Paterson as "…not having the experience and training in this field…" On three occasions, Judges in the United Kingdom have criticised Dr Paterson's evidence. On the last of these occasions, in the High Court, in March 2001, a young girl referred to only as X, Mr Justice Singer accused him of "tunnel vision," saying his evidence was “woeful”. For further information see Editorials (2003) 327 BMJ, 1124, and (2004) 328 BMJ, 187. 149 See Medical Editorial (Celia Hall), The Weekly Telegaph (United Kingdom), 24-30 December 2003, 11. Lord Justice Judge, sitting with Mrs Justice Rafferty and Mr Justice Pitchers, have ruled that in future no parent who had lost two or more babies should be prosecuted if the case relied solely on expert evidence that was disputed by other professionals who believed that the death could have been caused by natural, if unexplained, causes. It is now the case that 258 convictions of parents over ten years for infanticide, murder and manslaughter are to be reviewed as a matter of urgency. Lord Justice Judge's ruling follows the quashing of 39 year old Sally Clark's conviction in January 2003 for killing her two babies and in June the acquittal of Trupti Patel, aged 35, for killing her three babies. The wholesale review announced by Lord Goldsmith, the Attorney General, followed the judgement of the Court of Appeal in the case of Angela Cannings, aged 40. Mrs Cannings spent seventeen months in prison. For further information see Sandra Laville, “258 Baby Deaths are to be Reviewed”, Weekly Telegraph (United Kingdom), Issue 653, January 2004, 10. With regard to those cases that have concerned Professor Roy Meadow it is the case that 5,000 Civil cases of families affected over the past 15 years will be reviewed. For further information see (Melissa Kite), “Parents Will Not Get Their Children Back”, Weekly Telegraph (United Kingdom), Issue 652, January 2004, 2. 150 An opinion can be fact in that when stating an opinion the matter of the statement is qualified as "I believe this to be the case". If the statement is qualified as "I believe the opinion to be the case" then this is a false statement of fact.
8.29 misrepresenting medical evidence as expert defence witnesses in child
abuse cases.152
IMMUNITY OF THE EXPERT WITNESS
8.42 The fundamental issue that follows on from the previous discussion is that which concerns the debate as to whether or not expert witnesses should benefit from and continue to enjoy the shelter of immunity from prosecution in the event that their evidence is found seriously wanting, whether the evidence be of fact or opinion or of both. Jonathan Selby holds that there is no valid reason to treat the expert witness any differently from that witness who presents as an advocate for one side or
the other. 153 There should be no great argument to the contrary when the expert witness (wrongly) assumes the role of the advocate for one side or the other rather than for the Court. Selby's view can find some foundation for support in those cases, associated with a miscarriage of justice, that have been referred to in previous paragraphs.
8.43 Following the House of Lords' decision in Hall v. Simons154, the only professional participants in the judicial process who enjoy immunity
from suit in negligence are Judges155 and those who provide expert
witness testimony. 156 The argument is stronger in favour of the immunity
151 This is the view of Dr Joanna Flynn, President of the Medical Practitioners' Board of Victoria. See also vide supra n.147. 152 See Owen Dyer, “Doctor Accused of Misrepresenting Evidence in Child Abuse Cases”, (2004) 328 (7433) BMJ, 187. 153 J Selby, “Abolish Expert Witness Immunity” (2003) 8 (1) Expert and Dispute Resolver, The Journal of the Academy of Experts, 7-9. Advocates previously enjoyed immunity from legal action in the United Kingdom. The decision of the House of Lords in Arthur JS Hall & Co v. Simmons [2000] 3 WLR 543 (unanimously) reversed this with respect to civil cases. This case was not concerned specifically with the immunity for experts though the immunity of experts remains tenuous. 154 See Hall v. Simons [2000] 3 WLR 543. In Australia attempts to hold judges liable have failed. See Sirros v. Moore [1975] QB 118 (CA) – this case concerned a Circuit Judge who had ordered the detention of a plaintiff without adhering or following the proper procedures. See also Gallow v. Dawson (1988) 82 ALR 401, this case concerned the alleged bias of a High Court Judge. See also Giannarelli v. Wraith(1988) 165 CLR 543; 81 ALR 417 HCA, where the immunity from suit of advocates and other participants was reaffirmed. 155 There have been attempts to hold Judges liable. These attempts failed in Moll v. Butler (1985) 4 NSWLR 231 where a Family Court Judge erroneously committed a person for contempt of court. Also in Rajski v. Powell (1987) 11 NSWLR 522 (CA) and Gallo v. Dawson (1988) 82 ALR 401 there were allegations of bias by a Supreme Court Judge and a High Court Judge respectively. 156 See Palmer v. Durnford [1992] QB 483 where it was held that the immunity of expert witnesses from liability extends only so far as necessary to prevent them from being inhibited from giving truthful and fair evidence in court. The case that conflicts with the policy of protecting witnesses is Chapman v. Honij [1963] 2 QB 503 (CA). See also Reiffel v. ACN 075 839 226 Ltd (2003) ATPR 41-934. Here an experts report was found to be misleading and deceptive as a consequence of a negative assurance in a prospectus – “Nothing has come to our attention…”. This case emphasised that negative assurances should not be taken literally.
8.30 of Judges157 than is the case with regard to the immunity of experts and there is a view that the immunity under which experts have sheltered
should be abolished.158
8.44 There are contrary arguments which support a view that the immunity of experts should not be abolished as to do so might inhibit the expert from giving truthful and fair evidence in court. This view is argued both in
Palmer v. Durnford159 and in Stanton v. Callaghan.160 Those serious miscarriages of justice referred to earlier in this Chapter do not support this argument well. It is interesting though, that, in Stanton v. Callaghan it was held that the expert's immunity extends to evidence given by the expert in court and to work which is preliminary to giving that
evidence,161 but does not extend to that work that may have been undertaken in advising a client as to the merits of their case or to advice as to whether the expert is qualified to advise at all, as was the finding in Palmer v. Durnford.
8.45 Certainly the blanket immunity of experts has been frowned upon by the European Court of Human Rights where the view is taken that each case must be considered on its own merits and that experts who have demonstrated a role of advocacy to one side or the other, rather than
maintaining a duty to the Court, should no longer have immunity.162
8.46 I have little doubt that the immunity of experts will attract further debate. It remains a contentious issue that is aggravated by the conduct of experts themselves who have too frequently become the victim of those two imposters, advocacy and junk science. There is no disputing the fact
157 There is a possible margin in immunity where a Judge knowingly acts without jurisdiction. See RJ Sadler, “Judicial and Quasi- Judicial Immunities: a Remedy Denied” (1982) 13 MULR, 508 and AA Olowofoyeku, “The Crumbling Citadel: Absolute Judicial Immunity Derationalised” (1990) 10 Leg Studs 271-323. 158 See vide supra n.153. 159 [1992] QB 483, at pp.774-76. 160 [1999] 2 WLR 745, at p.488. 161 See also Saif Ali v. Sydney Mitchell & Co [1980] AC 198. 162 Marion Simmons QC, Role, Responsibility and Immunity of the Expert, in the Expert and Dispute Resolver, The Journal of the Academy of Experts, Vol 8, No 3, pp.15-17, Winter 2003.
8.31 that the immunity of experts hangs by a thin thread that can be easily cut by a simple Statute or by the decision of an appropriate case.
REFORM OF THE EXPERT WITNESS SYSTEM
8.47 It is generally accepted in Australia, and also in the United Kingdom, that reform to the expert witness system is long overdue. Ipp J considered the expert evidence procedures, and identified the need for
reform, and acknowledged163 that there is -
"…deep dissatisfaction with expert evidence due to conflicting expert testimony and the growth of the expert evidence industry."
8.48 Reform is clearly indicated for many reasons and is regarded to be
particularly necessary following those cases164 that have in recent years, both in Australia and in the United Kingdom, become associated with a miscarriage of justice whose foundation has been the admission of dubious scientific evidence. As we have already observed, Justice Gordon Samuels, in his 1997 Australian Medical Association (NSW)
Oration165 described these cases as being associated with a wrong result. Justice Samuels also, in the same Oration, described the expert witness as having "not always enjoyed a good reputation" and he observes that "it is unfortunately true that the Law does not require the best possible witness as it requires the best possible evidence…" Justice Samuels is not alone in his criticism of the expert witness. In Pearce v. Ove Arup
Partnerships (No 2)166 Jacob J observed that experts have been criticised
for failing to "stand back and take an objective view".167
163 Cited by Pamela Burton (Legal Counsel, Federal AMA), “Expert Opinions, It's Time We Progressed” (2003) 2 Australian Medicine, 12. 164 See ¶ 8.35-8.41. 165 See vide supra n.5 and n.122. 166 See Pearce v. Ove Arup Partnerships (No 2) [2001] All ER (d) 32, 2 November 2001. 167 Jacob J [at 60] in Pearce v. Ove Arup Partnerships (No 2) [2001] All ER (d) 32, 2 November 2001.
8.32 8.49 Regrettably, as we have already seen,168 it is also too often the case that
expert evidence has been contaminated by bias.169 Frequently, the expert
witness has attracted criticised170 and deservedly been described as the
Hired Gun171 or the Saxophone172 on which "any good lawyer can play any tune". Justice Margaret Wilson, in her address to the Australian Insurance Law Association recalls the article - The Expert Witness: Partisan with a Conscience - written by an Architect who was called as
an expert witness in an English copyright infringement case.173 He had described the expert as "the man who works the Three Card Trick", who
goes through three phases: 174
(i) that of candid friend, who tells the client all the faults in his or her case; (ii) that of the hired gun, who writes a report intended to be shown to the other side; and (iii) that of the witness in Court whose earlier pragmatic flexibility is brought under sharp curb, whether of conscience, or fear of perjury, or fear of losing professional credibility.
168 See ¶ 8.25-8.34. 169.See vide supra n.32. 170 See vide supra n.33. 171 See Cala Homes (South) Ltd & Ors v. Alfred McAlpine Homes East Ltd [1995] FSR 818. See also T Boland, “Science vs. The Law” (2001) Health Law Seminar Series and “Proof in Medical Litigation: Expert Evidence and Causation,” (23 July 2001) Faculty of Law CLE Seminar, The University of Sydney. Boland has asserted that there are healthcare practitioners of all persuasions who are willing to prostitute their professional principles and make their opinions suit and be available to those lawyers with the biggest cheque book. The contempt with which these people are held is obvious in the nicknames their group is given, such as; "Hired Gun", "Liar for Hire" and "Law Whore". Boland continues …The "Hired Gun" has no personal involvement in the outcome of the trial and is also happy to bias or misrepresent his expertise in order to help the lawyer who retained him achieve the legal outcome the lawyer wants…this does…raise an interesting ethical question however: How ethical is it for a lawyer to shop around until he can find an expert witness who is prepared to adopt a "Hired Gun" role? The legal profession can hardly complain about the existence of "Hired Guns" when by simply not engaging them they would cease to exist. The Sydney-based accounting damages expert Troy Peisley recently claimed that lawyers continued to "shoot themselves in the foot" by maintaining "Hired Guns" as experts. The sustained incidence, he added, of experts representing either side of a dispute and forming opinions based on different information must cease in the interest of speed and efficiency of the Court process. Lawyers, in many cases to their detriment tend to shop for experts based on fee or favourable opinion. "Hired Guns" tend to apply incorrect methodologies, they display bias by selectively excluding important information, or they stray outside their area of expertise. Peisley continues that "This provides fertile ground for Counsel to discredit them in cross-examination and their opinion ends up carrying less weight than the paper it is written on." During a Hearing, the Judge is presented with two experts and invariably two completely different opinions. At the end of the day, the Judge has to choose one expert's opinion over another. It is not like settlement negotiations; they do not take the average of the two figures. Peisley's observations follow Chief Justice Jim Spigelman's proposal that there should be greater use of a single - and possibly Court-appointed expert in future cases. This is a sentiment that mirrors that initiated by Chief Justice Paul de Jersey, in Queensland. For further reading see Expert Overhaul on the Horizon in Lawyers Weekly, Issue 165, pp.1 & 6, 17 October 2003. 172 "The Saxophone" - Mr Justice David Ipp introduced this term in his informative presentation to the Institution of Engineers in November 1999. "The Saxophone" is further discussed by Peter C Bruechle, “Learning from Failure and a Musical Instrument,” a paper presented to The Institution of Engineers, Perth Division, in May 2001. 173 See Cala Homes (South) Ltd & Ors v. Alfred McAlpine Homes (East) Ltd [1995] FSR 818. 174 See vide supra n.11.
8.33 8.50 Whilst the reform of the expert witness system has, and continues to be, largely driven by the legal profession it is also the case that medical
practitioners,175 the Australian Medical Association (AMA),176 the Colleges [surgical and medical] and [other] paternal bodies are also conscious of the need for reform and are not divorced from the process. Notwithstanding this, the role in reform, if any, of Medical Colleges and
other paternal bodies remains uncertain. 177 It is acknowledged though that any reform must include initiatives that are intended to modify the role of the expert in the adversarial arena where the gap between medicine and the law is at its widest. That there is a gap is not
unexpected as medicine is a science and law is not.178 However medicine and law are disciplines that have at least one thing in common - to seek
the truth.179 This is the real interface between medicine and law that is now very much the domain of the expert witness where advocacy must
be for the law, for the Court.180
8.51 The Australian Medical Association181 retains the view that the medical profession would like to see:
(a) More effective, less expensive and less time-consuming methods of obtaining relevant opinions than pitting
175 See vide supra n.53. 176 See vide supra n.163. 177 The Royal Australasian College of Surgeons provides Guidelines for Fellows of the College that concern the provision of expert opinion for medico-legal cases. For further information see the Professional Development page of the College Website online at www.ranzcog.edu.au. 178 See vide supra n.5. Justice Samuels describes developments in medicine as being made by experiment and observation where, in contrast, in law, developments are made by the decisions of legislatures and judges. The Medical Fact is one which can be empirically supported or clinically determined; the Legal Fact is one which is more probable than other facts or beyond (the) reasonable doubt standard of proof. The trial lawyer seeks to win by tipping the scales of proof in his or her favour by the preponderance of cogent expert (my edit) evidence. The expert is introduced to carry the proof to the conclusion for which the party presenting that evidence contends. 179 See vide supra n.53. Tjiong describes the approaches to establish the respective truths of medicine and the law as being fundamentally different. Common Law is based on an adversarial process in which opposing parties present evidence to a Judge or Jury who determine the outcome. Litigants construct their cases largely by selecting evidence that is advantageous to themselves rather than the absolute truth. In contrast, medicine is based on scientific evidence that seeks to establish its truth through rigorous scientific methods. These rigorous scientific methods are somewhat alien to the legal profession in its training and practice. 180 In NSW see Sch 1, Code of Conduct for Expert Witnesses (Pt 28 rule 9C and Pt 28 rule 2 - the expert witness "general duty to the Court is to 'assist the Court impartially on matters relevant to the expert's area of expertise' an expert witness' paramount duty is to the Court and not to the person retaining the report. An expert witness is not an advocate for a party"). 181 See Pamela Burton, vide supra n.163. See also Andrew Pesce, “United Front Needed on Expert Witnesses” (2004) 16 (15) Australian Medicine, 22. Dr Andrew Pesce is Chairperson of the AMA Medical Professional Indemnity Taskforce.
8.34 experts against each other and subjecting them to cross- examination in the Courtroom; (b) Uniform criteria for medico-legal report writing to ensure quality and consistency (conformity); and (c) The establishment of a uniform Code of Conduct for all expert witnesses [in all jurisdictions].
8.52 In addition to these recommendations, the Royal Australasian College of Surgeons, has proposed the establishment of a Register of Expert
Witnesses182 on the basis that this would be useful for the purpose of identifying potential expert witnesses and with the proviso that any Register should only be used on this basis. There is though some tension as to whether or not such experts should be "College-appointed" and/or "Court-appointed". Both the medical and the legal professions recognise the potential for the Colleges and for Court-appointed expert witnesses to assume a mantel of judicial authority and it is further recognised that this mantle should continue to be, the property of the presiding Judge whose function must continue to be to balance the evidence and the opinions of both parties and to adjudicate on the basis of that which is fact, in the
context of that which is law.183
8.53 The Ipp Panel184 recommended185 that in jurisdictions where there are
serious problems, a system of Court-appointed experts186 should be tried
182 See Royal Australasian College website online at www.ranzcog.edu.au. The Royal Australasian College of Surgeons has established a Register of Expert Witness working party that is seeking to establish a Register of Expert Witnesses for medical (surgical) negligence cases. The College working group is chaired by Russell Stilz and was set up in response to pressure from the legal profession, the community, and from within the College. It is not, at this time, intended that the Register will apply to other matters such as personal injury, workers’ compensation, motor vehicle accidents, etc. For further information see T Buzzard, “Medico-Legal Registrar of Expert Witness Working Party” (2005) 6 (3) RACS Surgical News, 13. Here can be found the Guidelines for medico-legal cases recorded on the Professional Development page of the College. Any College Register is intended to be used only for the purpose of identifying potential expert witnesses with the disclaimer that the information should only be used on that basis. This recommendation is in accord with that view taken by the United Medical Protection (UMP) organisation of NSW - see United Journal, (2001) 3, 19. 183 Cited by Pamela Burton. See vide supra n.163. 184 See Review of the Law of Negligence, Report 30 September 2002, - Chaired by D Ipp J. The full report can be accessed on the Federal Treasury Website at http://revofneg.treasury.gov.au. 185 Cited by Pamela Burton, see vide supra n.163. 186 Part 39 of the Supreme Court Rules provides for the use of an expert appointed by the Court in matters involving complex technical issues. The provisions can be utilized by the Court of its own motion, as well as by a party (Part 39 Rule 2(1) SCR). The expert's report is sent to the Court which then forwards a copy to each party (Part 39 Rule 3 SCR). The parties are jointly and severally liable for the expert's costs which are fixed by the Court (Part 39 Rule 5 SCR). The parties are entitled to cross-examine the Court Expert upon application by them (Part 39 Rule 4 SCR).
8.35 and evaluated.187 Considering the role of expert testimony, the Ipp Report further suggested that a system of Court-appointed witnesses might avoid that lack of objectivity and the conflicting testimony that is so often associated with expert evidence. In New South Wales, on 18 November 2004, Chief Justice Spigelman issued Practice Note 128 - Single Expert Witnesses - that become effective on 31 January 2005. From that time experts retained [in all] Personal Injury and Disability claims will be jointly retained or Court-appointed (pursuant to Pt 39) if the parties cannot agree. The intent in New South Wales is that the Court-appointed expert should function as an expert for both the claimant and the respondent and that opinions should be open to cross- examination by both parties to the dispute. In the event, the expert might better be able to function as an advocate for the Court and in doing so render the entitlement for each party to call their own expert witnesses as redundant. At this time not all State and Territory Governments are prepared to implement the Ipp recommendations and it remains also the case that there is no consensus of agreement within and between the medical and legal professions.
8.54 There probably is little argument that any reform of the law as it relates to the expert witness should provide for, and encourage, an environment that is less rigid and less adversarial. There is a view that adversarial competition might be diminished or even excluded from debate by allowing the evidence of a single appointed expert witness that might permit the "metamorphosis of conflicting arguments into an investigation" that can determine whether or not an adverse event reflects the suffering of an outcome that is worse than that which might have
been "reasonably expected".188
187 A regime of Court appointed experts was introduced in the NSW Land and Environment Court in March 2004. The Chief Justice of that Court is Justice P McClellan. See P McClellan, “The Recent Experience of the Land and Environment Court,” Paper delivered to the 22nd AIJA Annual Conference, Sydney 18 September 2004. 188 See N Gray, “Reforming the Relationship Between Medicine and the Law of Tort” (2004) 11 (3) J of Law and Medicine, 324-30. See also MA James, “The Bolam Test and the Responsible Expert” (1999) Tort L Rev, 226.
8.36 8.55 Reforms in the United Kingdom have progressed under the stewardship
of Lord Woolf.189 Lord Woolf's interim report was published in 1995.190 In that report it was recommended that the Courts should have complete
control over the admission of expert evidence.191 This recommendation
was reaffirmed in Lord Woolf's final report that was published in 1996.192
8.56 Lord Woolf's final report (the Woolf Report) has caused there to be a major overhaul of the manner in which expert evidence is obtained and used in civil trials in the United Kingdom. The Woolf Report has very much been concerned with addressing the rising inadequacies of the
existing expert witness system that is considered193 to be "dominated by
delays194, is bereft of impartiality, is overly adversarial, too costly, and is at times a process of justice that is too often corrupted by the use of
experts." In this regard, the principal aims of reforms195 have been to raise standards, and to maintain a system that requires that total Judicial control must be exercised over the use of expert evidence. The report did also question whether an expert should be appointed at all in every case, and considered the defining of an expert's evidence with regard to matters that should be covered and to the manner of its presentation.
189 Lord Woolf is Master of the Rolls, and was appointed in 1994 to review the Civil Justice System in England and Wales. 190 The Right Hon The Lord Woolf. “Access to Justice: Interim Report to the Lord Chancellor on the Civil Justice System in England and Wales” (1995) HMSO, London. 191 See vide supra n.190. 192 The Right Hon The Lord Woolf, “Access to Justice: Final Report to the Lord Chancellor on the Civil Justice System in England and Wales” (1996) HMSO, London, 139. 193 Following the Woolf report a core set of Rules was developed in the United Kingdom to replace those of the Supreme Court and the County Court. These came into effect in April 1995. Pt 35 of those Rules creates an over-riding duty, in the expert, to help the Court on matters within his or her expertise, which is not to be compromised by any obligation towards the engaging party. Under these Rules, the calling of experts is not completely within the control of the Court in that no party can call an expert without the Court's permission. The Court is also able (in advance) to limit the expert's fees and expenses that may be recovered from the other party. The Court also closely manages how an expert gives evidence and endeavours to try to restrict that evidence to written evidence, rather than all evidence. The Rules also encourage the use of single jointly instructed experts. To a significant extent many of these provisions have been taken up within Australian jurisdictions, by Rules of Court, Practices Notices, or Guidelines. The common objectives are to emphasise the over-riding duty of the expert to assist the Court on matters relevant to the expert's area of expertise, to ensure that there is proper disclosure of information of relevance of the basis on which an expert opinion is formulated, to remove any restriction that imposes upon the freedom to agree to matters discussed in any joint conference and finally to ensure that any change of opinion is disclosed. 194 There is a conclusion that the use of experts is a major contributor to delays in cases involving children where mental health experts are engaged. Dame Margaret Booth in the United Kingdom investigated this and that investigation demonstrated an increasing delay between 1996 and 2000. In 1996 the delay averaged 46 weeks but by the end of 2000 it was approximately 50 weeks, (cited by Butler-Sloss and Hall - see vide supra n.10). The use of experts as a cause for delay has somewhat been thwarted by the Study commissioned in the Year 2000 by the Lord Chancellor's Department in the UK. Experts were directed to facilitate transmission of their reports within a time frame that is required by the Court, and if unable to do so, the Court should be advised from the outset. Butler-Sloss & Hall report that one of the reasons for delay is a consequence of the fact that the pool of experts, that are "willing and able", is small. 195 The Civil Procedure Rules 1998, Statutory Instrument 1998 No 3132 L.17 (ISBN 0 11 080378 7) Supreme Court of England and County Court - laid before Parliament 17 December 1998 and passed into force on 26 April 1999, Pt 35 rule 3.51 (Experts and Assessors) and rule 35.3 (Expert's Over-riding Duty to the Court).
8.37 8.57 Probably the most significant recommendation of the Woolf Report was that where two or more experts become involved in a case they should be encouraged to meet in conference in order to clarify and to debate matters of agreement and disagreement. The intention being that a face to face conference has the potential to facilitate a "consensus that can
avoid the need for lengthy cross-examination".196
8.58 Proposals for the reformation of the expert witness system in Australia are close to, and in harmony with, those recommendations of Lord Woolf. Justice Michael Black, the Chief Justice of the Federal Court of Australia, has made proposals regarding the use of expert evidence and has encouraged submissions from the Australian Law Council and from
other professional bodies.197 Black CJ later amended his proposals and
stated that198 -
"…Expert evidence would usually be subject to the control of parties, with the Court taking some control in exceptional cases."
Other proposals have included:
(a) the development of a Code of Conduct for experts199;
196 See vide supra n.23 – E Butler-Sloss & A Hall, “Expert Witnesses, Courts and the Law” (2002) 95 J Roy Soc Med, 431-34, observe that the experience is that "When experts come face to face, they tend to agree on more than they expected. Disagreement sometimes arises out of differences in expression and meetings are useful in narrowing the issue in dispute." 197 M Black CJ, Letter to the Australian Law Council, dated 24 October 1996, available from the Registrar, Federal Court of Australia, Sydney NSW. The other Professional Bodies included economists, patent attorneys, engineers, accountants, and those concerned with Trade Marks and Copywright. 198 M Black CJ, Letter to the Australian Law Council, dated 20 August 1997. Available from the Registrar, Federal Court of Australia, Sydney NSW. 199 In October 1998 the Federal Court of Australia announced a Practice Direction that governed the use of expert witnesses within the Court. A full text of the Practice Direction can be accessed online at www.fedcourt.gov.au/pracproc/practice_direct.html. The Practice Direction was developed by the Federal Court with the assistance of the Law Council of Australia and the document has clarified the role and the use of expert witnesses, and emphasised that an expert's over-riding duty is to the Court and not to the party retaining them. Furthermore the Guidelines determine that an expert witness has an over-riding duty to assist the Court on matters relevant to the expert's area of expertise. A Abadee, J of the NSW Supreme Court (now retired) has stated that "adherence to the [Expert Witness] Code will contribute to the elimination of the Hired Gun-Expert." Expert witnesses must comply with that Code of Conduct that is specific to each jurisdiction. NSW has a Code of Conduct for expert witnesses. (District Court of NSW, Sch 1, Code of Conduct for Expert Witnesses - (Pt 28 rule 9C and Pt 28A rule 2). The Federal Court and Family Law Courts have similar Guidelines. These Codes and Guidelines also describe the duties, obligations and requirements concerning the form and content of expert opinions that are described in reports. The various Codes of Conduct in Australian jurisdictions is in accord with those Codes or Rules in other jurisdictions such as in the United Kingdom where, in 1998, The Civil Procedure Rules (CPR), Part 35, was introduced. The dominant theme of all of these Codes (or Rules) of Conduct is that over-riding duty to the Court wherein it is implicit that advocacy should be demonstrated only to the Court and not to any other party to the dispute. The Code of Guidance has also been produced by the Academy of Experts - Handbook of Expert Witnesses in Child Act Cases, written by Wall J, Family Division Judge. Recent publications, helpful in clarifying the responsibilities of the expert witness include The Law and You: Code
8.38 (b) that expert evidence be addressed to the Court; and
(c) the use of a panel of experts.200
8.59 The Australian Law Reform Commission (ALRC)201 and the Law Reform Commission (LRC) of New South Wales have both included the issue of reform to the expert evidence system in their respective reviews of the
adversarial system of litigation in Federal Courts and Tribunals.202
8.60 The ALRC has completed a Background Paper.203 The Background Paper remains a working document to which the ALRC welcomes comments. The ALRC summary of draft recommendations includes 15 recommendations. In that list of draft recommendations there are 9 recommendations that are probably the more important reforms under consideration. These recommendations are that:
(i) Courts and Tribunals exercising Federal jurisdiction should develop case management guidelines to control the use of expert evidence for particular case types; (ii) Federal Courts and Tribunals should, as a standard procedure, encourage communication between relevant experts and should order or facilitate conferences and other pre-trial contact between such experts wherever appropriate;
of Guidance for Expert Witnesses, 2002, Expert Witnesses Institute, London, EW1, 2002. This publication can be accessed online at www.ewi.org.uk/code_of_guidance.asp. 200 This last proposal recommends the use of a panel of experts in a manner similar to that used by the Australian Competition Tribunal (ACT). In this Tribunal, Expert Economists submit written statements before the oral proceedings, and after having had access to all of the evidence, the experts are entitled to modify their written views if necessary and as required. 201 The ALRC was established in 1975 as an Independent Federal Statutory Corporation operating under The Australian Law Reform Commission Act 1996 (Cth). 202 See Australian Law Reform Commission, Review of the Adversarial System of Litigation, Issues Paper 20, ADPS ¶7.76-7.79, Canberra, April 1997. In October 1998 the Federal Court of Australia announced a Practice Direction governing the use of expert witnesses within the Court. Guidelines, developed jointly by the Federal Court and the Law Council of Australia, are designed to clarify the role of witnesses and how they are to be used, both for witnesses themselves, and for lawyers and their clients. The full text of the Practice Direction is available online at www.fedcourt.gov.au/pracproc/practice_direct.html. See also Law Reform Commission of NSW Issues Paper 25 2004 Expert Witnesses. The Commissioner in Charge is The Hon Justice Michael Adams. The Terms of Reference were received by the Commission on 16 September 2004 from the NSW Attorney General , The Hon R. J. Debus MP. 203 The Australian Law reform Commission, and Experts Adversarial Background Paper 6 January 1999.
8.39 (iii) the Australian Council of Professions develop a code of practice for expert witnesses, in co- operation with the Law Council, drawing on the Federal Court's guidelines for expert witnesses. The Council should also encourage other professional bodies to supplement this code with discipline/specific provisions where appropriate; (iv) the Australian Council of Professions, the Council of Chief Justices and the Law Council co-operate in reviewing the training needs of expert witnesses and how such training might be further
developed;204 (v) parties, Courts and Tribunals should, as a matter of course, consider whether a single expert agreed between the parties or a Court appointed expert should be appointed in a case or to deal with a
particular issue;205 (vi) the Federal Court [should] in co-operation with the Family Court and the Administrative Appeals Tribunal (AAT), in co-operation with legal professional and user groups, review whether steps should be taken to encourage the increased use of assessors in particular categories of cases; (vii) the Federal Court [should] promulgate rules or practice directions setting down procedures for adducing expert evidence in a panel format; (viii) Federal Courts and Tribunals and parties to proceedings should consider more frequent use of video-conferencing for adducing expert evidence; and
204 In this recommendation (Rec 8) it is also stated that the Australian Institute of Judicial Administration may have a role to play in promoting discussion about the ethical and other training needs of expert witnesses. 205 Examples of categories of cases where the use of a single Court appointed experts are listed to include Federal Court Trade Practices cases.
8.40 (ix) that there is support for the use of panels of experts to provide independent medical review in the employee's compensation jurisdictions of the new ART.
8.61 In New South Wales the Law Reform Commission206 has been required by the Attorney General, The Hon R J Debus MP, to enquire into and to report on the operation and effectiveness of the rules and procedures
governing expert witnesses in New South Wales. 207 In undertaking this
enquiry, the Commission is required to have regard to: 208
(i) recent developments in New South Wales and in other Australian and International jurisdictions in relation to the use of expert witnesses, including developments in the areas of single or joint expert witnesses, Court- appointed expert witnesses, and expert panels or conferences; (ii) to current mechanisms for the accreditation and accountability of expert witnesses for the purpose of Court proceedings, including the practice of expert witnesses offering their services on a "no win, no fee" basis; and (iii) to the desirability of sanctions for inappropriate or unethical conduct by expert witnesses; and any other related matters.
The New South Wales Law Reform Commission Issues Paper 25 (2004) - Expert Witnesses is available from the Commission and the Paper details the background to the reference, the scope of the reference, and the Commission's proposed action plan. The Terms of Reference are described as having been stimulated by -
206 The Law Reform Commission of NSW commenced operations in 1966 and was, in 1967 formally created under statute. See Law Reform Commission Act 1967 (NSW). 207 The Commission is to report no later than 31 March 2005.
8.41 "…expressed concerns about the widespread use of expert witnesses, the costs involved, possible bias and other associated problems. These [are] concerns [that are] shared by some members of the judiciary as well as the Legal Services Commissioner who has received complaints about the use of expert witnesses."
The Commission's Terms of Reference209 were received in September 2004. In the Commission's Issue Paper those matters that are under consideration are presented and set down in chapters that include -
(a) Chapter 2: "Measures to enhance the objectivity and accountability of experts". This Chapter includes a consideration of measures to exclude bias, emphasises the desirability of a Code of Conduct, includes mechanisms for accreditation and accountability of expert witnesses and sanctions for inappropriate or unethical conduct, and has concern for the undesirability of services that are provided
on a "no win, no fee" basis. 210 (b) Chapter 3: "Measures to increase transparency". Here the Commission is concerned with the requirement for disclosure of expert reports prior to any Court hearing. (c) Chapter 4: "Measures for the efficient use of experts". This Chapter investigates the benefits (or otherwise) of experts meeting in conference for the purpose of resolving matters of agreement and
208 See Law Reform Commission of NSW Issues Paper 25 (2004) - Expert Witnesses. 209 The NSW Commission's Terms of Reference are not limited to any particular jurisdiction, or even to Courts as distinct from Tribunals. The Commission does not anticipate that the Report will be concerned with criminal law matters. The efforts of the Commission appear to be confined to civil law. 210 These are arrangements where a party to ligation who retains an expert witness on the basis that the expert will be paid only if the case succeeds. The obvious problem with such arrangements is that there can be an incentive for the witness to give evidence favouring the litigant who has engaged him or her. Such arrangements can deter the expert witness' over-riding duty to assist [only] the Court in an objective way. The American Bar Association also addresses this problem in Model Rules of Professional Conduct, 2003 at 80-81. See also vide supra n.109.
8.42 disagreement and to avoid duplication and time wasting. (d) Chapter 5: "Measures to the limit the number of experts". This Chapter considers a number of issues including that important issue that concerns the appointment of the Court Expert, or a Single Expert. (e) Chapter 6: "Alternatives to experts". This Chapter focuses on the provision of technical assistance to the Court, as distinct from the use of experts. This Chapter investigates the use of assessors and referees.
8.62 The medical profession, through its medical indemnity insurers211 in New South Wales has proposed and endorsed further reform to the Laws on Expert Medical Evidence that should include:
(i) the addition of a reliability threshold test such as
exists in Daubert;212 (ii) the requirement that evidence of accepted practice
or standard213 within a specialised area be given only by a person with qualifications and with currency of practice in that specialised area;
211 See vide supra n.53. 212 Daubert v. Merrell Dow Pharmaceuticals Inc 113 Sct 2786 (1993). 213 Bolam v. Friern Hospital Management Committee [1957] 1 WLR 593. The claimant suffered fractures whilst undergoing Electro-Convulsive Therapy (ECT). The treatment had been undertaken without the use of muscle relaxants in a manner endorsed at the time by a reasonable body of medical opinion. In Australia the Bolam Principle was rejected in Rogers v. Whittaker [1992] 4 Med LR 79 HCA. Here ophthalmic surgery was complicated by a sympathetic ophthalmia resulting in near blindness. The claimant had enquired about possible complications and had been reassured. It was found that it was for the Courts to adjudicate on what is an appropriate standard of care and that breach of duty is not be concluded on expert medical evidence alone. In the UK the Bolam Principle has been restated in Bolitho v. City & Hackney Health Authority [1998] Lloyd's Rep Med 26. This case concerned failure to attend to a child's respiratory crisis. It was found that the Court is not always to be bound by expert opinion. Though expert opinion will demonstrate that there has been reasonableness it may be the case that expert opinion is incapable of withstanding logical analysis. In the event the Judge is entitled to determine if there has not been reasonableness or responsibility. When expert opinion conflicts, the Judge is not permitted to refer one opinion to another but must decide between them by assessing their rationality. The House of Lords confirm the test to be applied to determine the consequences of a failure to act: What would the practitioner have done? And what should the practitioner have done? These cases are vital to any debate of what is reasonable generally when considering treatment that has, or has not, been provided and to the interpretation by an expert witness of those events. For further information the reader is recommended to M Branthwaite & N Beresford, Law For Doctors - Principles and Practicalities, (2nd ed 2003) The Royal Society of Medicine Press Ltd., Ch 2, 3 & 7.
8.43 (iii) the involvement of learned medical and surgical Colleges in establishing panels of accredited
experts, 214 expert witness lists215 and in formulating a Code of Conduct for Expert Witnesses; and (iv) the adoption of those better elements of the Roman
Inquisitorial Process216 in regard to expert evidence, such as the use of Court-appointed experts or expert assessors to sit with, and to advise the Judge.
8.63 One further area of reform that may be regarded as challenging the concept of the expert witness, as we know it, is embraced by the
perception that benefit might be derived from training217 medical practitioners to be as competent as experts in the Courtroom as they are as clinicians. Butler-Sloss and Hall are particularly concerned to ensure that more junior experts become invited to participate in Court
proceedings and to become trained in the delivery of evidence.218 The questions as to who should conduct witness training and as to the methodology of any training program remains unanswered but there are
a number of participants to the debate.219 Another [unresolved]
214 An unanswered question is “Who appoints the experts to appoint the experts?” 215 See vide supra n.182. 216 See vide supra n.8. 217 See The Right Hon The Lord Woolf in “Access to Justice (The Final Report by the Right Honourable Lord Woolf, Master of the Rolls)” (1996) HMSO III 13.54 – here Lord Woolf states “I certainly support the provision of training for experts, both through attendance of courses and through the dissemination of published material … professional people who take on responsibilities as expert witnesses need a basic understanding of the legal system and their role within it. They also need to be able to present their evidence effectively, both in written reports and orally under cross-examination. Training in presentation skills, however, should never lose sight of the fundamental point that the expert’s duty is to assist the court. Otherwise it is not in the interest of justice because it may result in the truth being concealed”. Monash University’s Internal Institute of Forensic Studies already teaches witnesses to understand their duties to the Court and to give more reliable evidence. The University of New South Wales Directory, Unisearch Expert Opinion Services, offers access to about 5,000 experts across Australia. The organisation provides expert witness training. In 2004 this service sold more than 3,500 expert reports to $6.35m. This was a drop from $8.97m in 2002 when a crop of last minute claims were filed before changes were made to negligence laws. The [privately owned] Expert Witness Directory lists about 700 experts in 400 areas of expertise. This Directory though probably reflects an ability to pay for listing rather than an ability to be an expert witness. To be listed in this Directory fees from $149 a year for a one-page listing in one area of expertise to $749 a year for the “premium package” of listings in up to 20 areas. The Expert Witness Directory site owner, Jeff Marr, is a former lawyer. See also Mouths for Hire, The Sydney Morning Herald, 6th September 2004, 11. 218 See vide supra n.23. 219 At the national level, in collaboration with the Australian College of Legal Medicine there is involvement of the Expert Witness Institute. The Royal Australian College of Surgeons, through its Medico-legal Section, already provides Expert Witness Workshops in conjunction with the Leo Cussen Institute. Medico-legal training is also undertaken by the Royal Australasian College of General Practitioners and the Royal Australian & New Zealand College of Obstetricians & Gynaecologists. In each case, the learned Colleges focus training programs on the role of the expert witness, the nature of Courtroom conduct, the Duty to and the Code of Conduct associated with providing expert evidence, and the nature of Courtroom cross-examination.
8.44 contentious issue is that which questions whether lawyers should assist
experts with the preparation of reports. 220
EXPERT WITNESS CONFERENCES
8.64 Conferences between experts were introduced in the United Kingdom in
1999 as part of the Woolf Reforms.221 In Australia, in New South Wales, it is the case with regard to conferences between experts, that the extension of the Civil Procedures Rules in New South Wales, concerns the duties of expert witnesses, including the power to direct such
witnesses to confer and to produce a joint report.222 There is general agreement that, in civil litigation, joint conferencing, or as the process is sometimes known, hot tubbing, has proven to be successful in that the
narrowing of issues has greatly facilitated a settlement.223 It is now common practice in all jurisdictions for expert witnesses to meet with a view to identifying areas both of agreement and of disagreement that will facilitate consensus. Conferences may be beneficial for a number of
reasons that include:224
(a) an opportunity for experts to exchange information that may not otherwise have been known or disclosed; (b) an opportunity (and an obligation) for experts to justify opinions with fellow experts particularly where there may be bias, and attitudes that are not independent and
220 See Harrington-Smith on behalf of the Wongatha People v. State of Western Australia (No 7) [2003] FCA 893 at [19] per Lindgren J. Lindgren J observed that "[L]awyers should be involved in the writing of reports by experts: not of course, in relation to the substance of the reports (in particular, in arriving at the opinions to be expressed); but in relation to their form, in order to ensure that the legal tests of admissibility are addressed". 221 See vide supra n.189, n.190, n.192 and n.217. 222 The process of the Expert Witness Conference is outlined in a joint report developed in NSW by Justice Sperling in concert with representatives of the Law Society in NSW, the NSW Bar Association, the Legal Aid Commission, the Public Defender's Office, the Director of Public Prosecutions, Department of Justice, the NSW Institute of Forensic Medicine and the Australian Academy of Forensic Sciences. 223 For further information see James Wood, “Forensic Sciences From the Judicial Perspective” (2003) 35 (1) Aust J of For Sci, 115- 32. This was a presentation by Justice James Wood of the Supreme Court of NSW in the form of a Plenary Lecture delivered at the 16th Australia and New Zealand Forensic Sciences Society International Symposium on the Forensic Sciences, 13-17 May 2002. 224 See vide supra n.223.
8.45 that may be associated with extreme views that may otherwise be difficult to conceal or to disguise; (c) an opportunity to more clearly identify any significant agreement or disagreement or the basis for any difference of opinion that may facilitate compromise; (d) an opportunity to confer again, on another occasion, for the purpose of resolving issues where there has been substantial disagreement and for the purpose of preparing a joint statement that clearly sets out that evidence where there is continuing disagreement and where there is agreement; and (e) by enabling the process of litigation, by facilitating the narrowing of issues for debate, the reduction of time and avoidance of delay, and the minimisation of the cost of the entire litigation process.
8.65 Butler-Sloss and Hall have summarised the benefits of conferencing as
providing an environment that225 -
"when experts come face to face, they tend to agree on more than they expected. Disagreements sometimes arise out of differences in expression, and meetings are useful in narrowing the issues in dispute. It is the case that conferencing can moderate extreme views, render bias or adherence to junk science unacceptable, facilitate the disclosure of information with discussion that is more appropriately scientific, permit concession to be made with less confrontation and cause there to be a more direct focus on the issues for debate in a manner that will permit peripheral issues to be agreed upon or to be disregarded if mostly irrelevant."
Furthermore Stephens J is of the view that226 -
"These meetings are now where cases are won or lost. No amount of legal repair work can patch up the damage that can be caused to your
225 See vide-supra n.23.
8.46 case if your expert has been steamrollered [into] a concession by his or her opposite number."
8.66 It is to be expected that at all times conferences will be conducted in an
appropriate manner and the English cases of Re C B and J B227 provide
useful guidance in this regard. The guidelines228 for conferences include
the requirement that there should be a proper agenda229, that specific questions should be identified and answered, and that the conferences
should be chaired and properly minuted.230 Branthwaite and Beresford are of the view that any legal agenda should preferably be prepared with medical input and it is preferred that any questions raised should have
only a yes or no answer. 231
8.67 Although the Courts have commonly directed that experts meet and confer, there are Solicitors who have taken the view that this direction
could be ignored and that telephone conferences would suffice.232 The experience though is that it is the case that telephone conferences have
been found to be associated with a number of problems. Pringle233 in an audit of medico-legal conferencing reviewed 50 conferences that concerned 47 claimants and found that conferences in person are generally more productive than are telephone conferences. Of the 50 conferences reviewed by Pringle, 34 (68%) conferences were conducted by telephone. The remainder of the conferences (32%) were undertaken in person. In the event that experts did meet, a joint statement was prepared and agreed to at the conclusion of the meeting. In the case of telephone conferences most statements were drafted by one expert after
226 J Stephens, “Legal View: UK Case Book 19” (2003) Medical Protection Society, London. 227 (Care Proceedings): Guidelines ([1998] 2 FLR 211). 228 While guidelines provide a general statement to facilitate compliance with directions, more specific detail is provided in the Practice Note titled Joint Conferences of Expert Witnesses introduced by the NSW Supreme Court in July 2001. 229 In a survey of expert witnesses, reported in the Expert Witness Institute Newsletter, (Autumn/Winter) (Suppl) 2001, it is found that 36% of respondents said the agenda had been prepared by solicitors and 32% said that the agenda had been set by experts. In contrast 28% claim to have conferred without any agenda. It remains uncertain as to where the responsibility lies for the formulation of any agenda and there is no agreement amongst the legal profession in this regard. 230 P Mendelow, “Expert Evidence: Legal Professional Privilege and Expert's Reports” (2001) 75 Australian Law Journal, 258. 231 See M Branthwaite & N Beresford (eds), “Legal Procedures” in Law for Doctors - Principles and Practicalities, (2nd ed, 2002) The Royal Society of Medicine Press Ltd, Ch 5, 27-36. See also The Right Hon The Lord Woolf, “The Woolf Reforms: Role of Expert Witnesses” (1996) HMSO London, 34-35. 232 See MF MacNicol, “The Impact of the Woolf Reforms” (2000) British Orthopaedic News, 24-5.
8.47 the discussions had concluded and later submitted to the other for comment. In review of the statements it was identified that significant disagreement occurred in 25 (50%). There was no significant disagreement in 17 (34%) conferences, a moderate disagreement in 2 (4%), and a major disagreement in 6 (12%). It is interesting to observe also that the 50 conferences reviewed by Pringle included 200 telephone calls (both made and received) and over 200 letters - representing an average of 8 episodes per conference.
8.68 It has been suggested that the presence of lawyers at conferences may be
helpful though seldom necessary.234 Notwithstanding the guidelines provided by the Expert Witness Institute of Australia there is a view that
meeting without the presence of lawyers may be undesirable.235 A view can be taken that the presence of lawyers might be crucial to ensuring that legal issues which determine the outcome of a case are dealt with fairly and properly. Issues of medical liability and causation are as much a matter of law as of medicine, and misconceptions as to the requirements of the law are common to the medical profession - even among experts. If these misconceptions can be satisfactorily addressed then the presence of lawyers [to assist doctors] may have some merit.
8.69 It is a matter for the Court that judgement on issues of fact should not be left only to medical experts but should remain the prerogative of the Court. In this context, it can be held that the expert should not provide
an opinion on issues that relate to the evidence of others.236 The debate as to whether or not a member of the legal profession should or should not be present at conferences has not been resolved and continues to be exposed to further debate. However, at the very least it would not be inappropriate for there to be an opportunity for the legal practitioner, and
233 RG Pringle, “An Audit of Medico-Legal Conferencing” (2003) 96 J Roy Soc Med, 454-57. One significant problem identified by Pringle was that 8 of 50 (16%) conferences the situation was identified (at the time of conference) where one or other expert had not seen all of the evidence. 234 The draft Code of Guidance for Experts produced by the Expert Witness Institute of Australia states that Lawyers for the parties will not usually be present at such discussions. 235 MJ Powers QC, The Role of the Expert Witness, (2002) The Medical Law Group for Paper Buildings, Temple, London, ECY 70Z.
8.48 for the medical practitioner, to audit the conduct and the conclusions of
the conference process.237
CONCLUSION
8.70 In this chapter the role of the expert witness has been reviewed in an endeavour to identify those [acknowledged] major strengths and
weaknesses of the Expert Witness System as it exists today. 238 Though there are weaknesses that do compel a need for reform there is no doubt that the value of expert testimony in itself is not in dispute. The survey conducted by Freckelton et al, undertaken in 2001, found that three-
quarters (75%) of magistrates who responded to the survey,239 found expert evidence useful. The authors concluded that -
"Without expert opinions, the Magistrate would be deprived of the benefit of insights and perspectives from other disciplines and may misconstrue evidence."
8.71 The Woolf reports240 have indicated that expert evidence is one of the two
principal causes for the excessive expense241 and complexity of the civil justice system. To these is a third cause that is the issue of discovery or
236 Others include the claimant, other witnesses, etc. 237 The NSW Supreme Court Rules - 1970 (NSW), s36.13 CA describe matters relating to conferencing with respect to the preparation of a report that specifies matters agreed, and matters not agreed, and the reasons for non-agreement. These Rules, Gazetted in January 2000, do take the effect of providing an opportunity for audit. Most Australian Judges, in principle, support this procedure. For further information see I Freckelton, T Reddy & H Selby, “Australian Judicial Perspectives on Expert Evidence: An Empirical Study” (1999) Australian Institute of Judicial Administration, Melbourne, 1-13. 238 I Freckelton, P Reddy & H Selby, “Australian Magistrates' Perspectives on Expert Evidence: A Comparative Study” (2001) Melbourne: Australian Institute of Judicial Administration. This survey of Australian Magistrates highlighted several concerns with respect to expert testimony. There concerns included a lack of objectivity, the quality of experts, the communication abilities of expert witnesses, and the difficulties that Magistrates face in evaluating conflicting expert views. Furthermore it was concluded that it was the unusual nature of expert testimony, compared with other forms of Courtroom evidence , that has created many of the problems. See also Pearce v.Ove ArupPartnerships Ltd (No 2) [2001] All ER (D) 32 unreported 2 November 2001. Jacob A at para 60 - "experts have been criticised for failing to stand back and take an objective view" and Stevens v. Gullis [1999] BLR 394 - where experts were criticised for breaching Court directions as well as CPR Pt.35 Practice Direction. 239 See vide supra n.238. 240 See vide supra n.190 and n.192. 241 Justice Margaret Wilson, in her address to the Australian Insurance Law Association on 28 October 2004 described the litigation process as having a "voracious appetite for the consumption of public and private resources". Justice GL Davies, in his Paper, Court Appointed Experts, presented at the Annual Supreme and Federal Court Judges' Conference, Auckland, New Zealand, 29 January 2004, in pursuing an argument for the need for new Court rules described the problems with old rules as being cause for a "waste of time and cost'.
8.49 more particularly, non-disclosure.242 The expert witness clearly has a duty only to express opinions that are genuinely held, to consider all material
facts that are available, and not to be mislead by any omission.243 It is an imperative to the achievement of justice that the non-disclosure of all relevant evidence be avoided.
8.72 In this chapter we have seen that the Courts have long recognised244 that expert evidence should be the independent product of the independent expert witness. Furthermore, it has long been recognised that the evidence of an expert should not be influenced as to form and content by
the exigencies of litigation.245
8.73 In order that all of these objectives can be achieved Federal, State and Territory Courts have developed Rules and Practice Directions. These Rules and Directions have the benefit of the support of the Australian Law Reform Commission and, in the United Kingdom, are consistent
with the recommendations of the Woolf Report.246 Furthermore, taking a view that is somewhat reflective of the Australian Law Reform Commission, and the Woolf Report it is the case that a number of professional associations, including the Australian Medical Association, the Royal Australasian College of Surgeons, and the Australian Orthopaedic Association, have developed their own Codes of Ethics that are directed towards emphasising the objectivity of their members and to raising the standards of expert evidence. Further the Royal Australasian College of Surgeons has endorsed the establishment of an Expert Witness List. The College view is that the establishment of an Expert
242 s.193 of the Evidence Act 1995 (Cth) accords power to a Court to order discovery in relation to documents. The consequences of non-disclosure of evidence by Experts can impact greatly on the outcome of the process of litigation and the now classic contemporary case is that of Sally Clark where the results of microbiology reports were not included in the report, and the evidence provided by Dr AR Williams, Home Office Pathologist. See also vide supra n.128, n.143 & n.145. See also John Batt, Stolen Innocence, (2004) Ebury Press, 333. 243 R E & J (1991) FCR 193 per Cazalet J at 226. 244 See the classic statement by Cresswell J in the Ikarian Reefer (1993) 20 FCR F63, confirmed on Appeal (1995) 1 Lloyd's Rep 455. Cresswell J here provided a classic analysis of the duties and responsibilities of the expert witness. 245 Whitehorse v. Jordan (1981) 1 WLR per Lord Wilberforce at 256-257. 246 See vide supra n.190 and n.192. See also “Keeping the Woolf away from your Expert” (2001) NLJ Expert Witness Supplement, 768.
8.50 Witness List, and indeed of an Expert Witness Institute247, would put into effect the objective of many professional organisations that includes that protocols should be developed for the training of, and even for the accreditation, or certification, of the expert witness.
8.74 It has rarely been the case that medical and engineering disciplines have become so specialised that there is difficulty with regard to sourcing an expert who might provide a report on the matters in question. However, medical and surgical product liability issues are now becoming so diverse and so highly specialised that it probably is the case that a basic surgical degree or a basic engineering degree should not be regarded as sufficient to qualify any surgeon or any engineer as an expert witness. An interest in the subject, and legally registrable qualifications as a surgeon or as an engineer should not automatically permit the individual to be regarded as an expert who can express an opinion in a court case on
any matter relating to the issues at debate.248 Issues of implantable surgical device product liability that may involve personal injury can become characterised by a debate that will inevitably move backwards and forwards across the boundaries of medicine and engineering in a forum that is legal. Within all of this there is a persuasive argument that can be constructed that might cause the Court to examine the credentials of experts more closely and to form a conclusion that, in this area of litigation, experts should be chosen by the Court for the purpose of assisting the judiciary with the task of judging scientific evidence that is bioengineering more than anything else. It was the lawyers who originally altered the expert's function from that of assessor to that of a
witness.249 It can be suggested that it is now time for the lawyers to again alter the expert's function from that of witness to that of auxiliari, if not also to that of opitulari.
247 Expert Witness Institutes were first established in the United Kingdom in 1996 and the Expert Witness Institute of Australia was formed in 2001. The Hon. Alan Abadee QC has been chairman of the Expert Witness Institute of Australia. 248 See The Commissioner for Government Transport v. Adam Cik (1961) 106 CLR 292. 249 See vide supra n.5.
8.51 CHAPTER 9
REGULATION and REPORTING INTRODUCTION
9.1 The reporting of adverse events concerns patient safety and there are very few discussions on the subject that get very far before someone
cites the groundbreaking work of Lucian L Leape.1 It is Leape who, in his many articles on patient safety, has emphasised the benefit to any health care environment that can be derived from openness with regard
to the disclosure (reporting) of complications and errors.2 An equally important aspect of Leape’s patient safety debate examines the place of regulation with respect to the reporting of adverse events, complications and errors. There is what may be described as a “policy
debate”3 that has examined whether or not reporting should be voluntary or mandatory, ie, based on some statutory regulation. In this
debate it is the view of Monaghan4 that the place of regulation provides a balance between the two as regulations can permit real value to be added to the quality and usefulness of any reporting process that has, as its main purposes, the maintenance of safety and the creation of benefits for the community at large and for the stakeholders concerned.
9.2 In this chapter a number of observations are made regarding the impact of regulations on the effectiveness or otherwise of any reporting process; and there are recommendations in respect to matters relating specifically to the reporting of surgical implant device related adverse events. It is here that the principal challenge is to be able, at the earliest opportunity, to identify devices that are ineffective and potentially
1 LL Leape, “Reporting of Adverse Events” (2002) 347 (20) New Engl J Med, 1633-38. See also V Barley, G Neale, C Burns- Cox et al, “Reducing Error, Improving Safety” (2000) 321 (7259) BMJ, 505. 2 Throughout this chapter the terms disclosure and reporting are frequently used. Unless otherwise specified the meaning of the terms should be regarded as interchangeable and as representing an act of communication between individuals, organisations, regulatory authorities, and other stakeholders who might benefit from the information that is communicated. The terms report[ing] and disclosure should not, unless otherwise stated, be interpreted as to their legal meaning. The term report[ing] should not be interpreted as referring to a published account or record of a legal proceeding and disclosure should not be interpreted as being implicit to a principle of procedural fairness that requires that information (evidence) be made available to all parties to a conflict or dispute. The term discovery is also frequently used and the term, unless otherwise stated, relates to the acquisition of knowledge as distinct from a pre-trial procedure where a party to proceedings makes available for inspection all relevant information. 3 P Monaghan, “Impacts of Reporting: Uncovering the “Voluntary vs Mandatory Myth”: Does Reporting Work? The Effect of Regulation” (2003) AQ21 Accountability Quarterly, 8. 4 See vide supra n.3.
9. 1 harmful and to be able to share the information that is gained by the experience of others that is not always published.
9.3 The reporting of adverse surgical events should be viewed as a form of disclosure that is an integral part of any risk management system that will be at its most effective when the goals of that system can be
achieved. Monaghan summarised these goals as including5 –
(a) The enhancement of consumer protection; (b) The detection of problems before they result in injury to patients; (c) Systems that allow more efficiency of response in the surgical market-place; and (d) Measures that enable consumers to make better choices.
9.4 Unfortunately there are a number of barriers to widespread reporting and this probably will be the case even in the face of the most regulated or voluntary system. The barriers to reporting generally fall
into 3 major categories6 –
(i) The potential legal discovery of adverse event reports; (ii) Fear of individual or organisational exposure to criticism
and even litigation that can be based on skepticism7 or mistrust; and (iii)That adverse events might be used as a measure of
competence.8
5 See vide supra n.3. 6 R Lawton & D Parker, “Barriers to Incident Reporting in a Healthcare System” (2002) 11 Qual Saf Health Care, 15-18. See also MR Cohen, Editorial, “Why Error Reporting Systems Should be Voluntary. They provide better information for reducing errors” (2000) 320 BMJ, 728-29. Michael R Cohen is President of the Institute for Safe Medication Practices, 1800 Byberry Road, Huntingdon Valley, PA 19006, USA. 7 SM Evans, JG Berry, BJ Smith & AJ Esterman, “Anonymity or Transparency in Reporting of Medical Error: a Community- Based Survey in South Australia” (2004) 180 (11) MJA, 577-80. 8 LT Kohn, JM Corrigan, MS Donaldson, To Err is Human: Building a Safer Health System (2000) 119-121, National Academy Press, New York. See also Safe Medical Devices Act 1990 (USA), - at 21 CFR 803, 32© it is established that the reporting of adverse events is not evidence of any admission to contribution to an event provided the report is made in accordance with the requires of the Act and providing the report does not contain any false information.
9. 2 Associated with, and inseparable from, these barriers there are also a number of other problems. One major concern for any reporting
system is the potential for the under-reporting of adverse events.9 The reporting of adverse drug reactions, though not directly related to adverse surgical device events, does reflect that culture of under- reporting that can exist in the health care environment. In the United Kingdom it has been estimated that it is rarely ever the case that more than 10% of serious adverse drug reactions, and 2-4% of non-serious
reactions are reported to the British Spontaneous Reporting Program.10 Another problem associated with any system of adverse event reporting is the uncertainty that frequently is associated with the identification of the cause for the event. Proof of causality can be
difficult and not unusual even in the best PMS environment.11 Adverse event reports though can create an index of suspicion that should be considered as a sufficient basis for the implementation of damage control measures and even for regulatory decisions and
intervention. 12
POST-MARKET SURVEILLANCE (PMS)
9.5 PMS is fundamental to the success of any adverse event reporting system. If there is no PMS then it is unlikely that there will be any great stimulus to report information for the simple reason that the information that should permit the implementation of appropriate risk management procedures will not be harvested.
9.6 PMS for implantable surgical devices must be an imperative if there is to be no failure to detect device problems until they are in widespread use. There should be little doubt that health care in general and implantable device surgery in particular commands a need to create
9 RT Chen, SC Rastogi, JR Mullen, SW Hayes, SL Cochi, JA Donlon, et al, “The Vaccine Adverse Event Reporting System (VAERS)” (1994) 12 Vaccine, 542-50; HD Scott, SE Rosenbaum, WJ Waters, AM Colt, LG Andrews, JP Juergens, et al, “Rhode Island Physician’s Recognition and Reporting of Adverse Drug Reactions” (1987) 70 Rhode Island Med J, 311-16. 10 MD Rawlins, “Pharmaco-vigilance: Paradise Lost, Regained or Postponed?”, The William Withering Lecture 1994 (1995) 29 J Roy Coll Phys, 41-49. 11 M Auriche, E Loupi, “Does Proof of Causality ever exist in Pharmaco-vigilance?” (1993) 9 J Drug Saf, 230-35. 12 See vide supra n.11.
9. 3 reliable systems to detect and to share information about adverse surgical events.
9.7 The European Directive13 defines PMS as –
“An undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post- production phase and to implement an appropriate means to apply any necessary corrective action ….”
PMS is mandatory under the European Directive14 and is regarded to be necessary for -
(a) the understanding of performance; (b) the assessment of risk; (c) the identification of any need for changes to a device that is in production; and (d) the understanding of changes to requirements for devices in design.
Article 10 of the European Directive15 states that there is an obligation on manufacturers to report …
“… any deterioration or malfunction in the characteristics and/or performance of a device as well as any inadequacies in the labelling or the instructions for use which might lead or might have led to the death of a patient or user or to a serious deterioration in his/her state of health.”
9.8 In the USA the Safe Medical Devices Act (SMDA)16 was enacted in 1990. One major function of the SMDA has been an attempt to ensure the safety of medical devices that have entered the market-place and one of the aims of the SMDA was to ensure that implanted surgical devices are demonstrated to perform safely and effectively. The
13 EEC Medical Devices Directive 93/42/EEC/Annexes II, IV, V, VI, VII. 14 See vide supra n.13. 15 EEC Directive 85/374/EEC. 16 Safe Medical Devices Act 1990 (USA) – Enacted by Congress on 28 November 1990.
9. 4 SMDA strongly encourages PMS activities that should permit the FDA in the United States to benefit from the identification of any
serious therapeutic drug or device problem at the earliest opportunity17 and to be able to quickly remove defective drugs or devices from the
market-place18. Before the introduction of the current regulatory
regime19 in Australia there could have been identified a need for a [similar] SMDA. It is permissible to conclude though that the regulations that are now in place, as they apply to implantable surgical devices, should ensure that only safe and effective devices will be used in the Australian market-place and that their clinical performance will be monitored by appropriate PMS. It should also be the case that in the event that a surgical device is found to be defective it will be quickly removed from the market-place. If there is any criticism to be made of the current regulatory regime it is particularly in regard to the medical device reporting program that is mandatory only for
manufacturers, and their sponsors.20 Only manufacturers and sponsors are required to report the identification of any adverse event that is exposed by in any PMS program. This is a criticism that is a recurring theme that can be identified throughout this thesis.
9.9 Under current therapeutic goods regulations the manufacturers of
surgically implantable devices are required by the TGA21 to undertake PMS of their products. This is a burden that should not be a task for manufacturers alone. Other stakeholders such as medical practitioners, hospitals, and even consumers should become part of any process of
17 In June 1993 the FDA introduced the MedWatch program. This program includes three basic components, (i) Medical device reporting by manufacturers, (ii) an effort to encourage reporting by doctors and other health care professionals; and (iii) a user facility reporting requirement as mandated by the SMDA. The MedWatch Regulations define an injury as any event requiring medical or surgical intervention to preclude impairment of a body structure or function. 18 The recent FDA recall of the arthritis drug Vioxx in September 2004 does reflect circumstances where the FDA probably failed in this regard. It is alleged that in the year 2000 the FDA was already aware of the serious problems associated with the use of Vioxx. See also P Jüni, L Nartey, S Reichenbach, R Sterchi, P Dieppe & M Egger, “Risk of Cardiovascular Events and Rofecoxid: Accumulative Meta-analysis” (2004) 364 (9449) Lancet, 4999. 19 In October 2002 major amendments were made to the TGAct instituting new legislative requirements in relation to medical devices: Therapeutic Goods Amendment (Medical Devices) Act 2002 (Cth) and the Therapeutic Goods (Charges) Amendment Act 2002 (Cth) and new Regulations relating to medical devices, the Therapeutic Goods (Medical Devices ) Regulations 2002 (Cth). 20 Implicit in the requirements of the Therapeutic Goods Amendment(Medical Devices) Act 2002 (Cth) is that manufacturers and sponsors report any incident of any adverse event (see TGAct s.41MP(2) & 41MQ). TGAct s.3 includes a definition of a person who is considered to be the sponsor of a medical device. 21 Flood M.: Conformity Assessment Procedures, Post Market Responsibilities and Mutual Recognition Agreement with the EU. Department of Medical Physics, Presentation to the Department of Medical Physics, Royal Perth Hospital, 24 May 2004.
9. 5 PMS in order that the regulatory authority, the TGA, and
manufacturers, can be provided22 with the information to assist them in their tasks and to enable the better identification of the less common, but potentially serious, problem that was not evident during product development nor perhaps when the product was first placed into the market-place. An effective PMS program that involves all stakeholders is one that should permit the identification of problems that were not seen as serious enough to warrant keeping the product from reaching the market-place. For PMS to be effective there has to be increased communication between all of the stakeholders and the regulatory authority. Also, even if reporting for some stakeholders is mandatory then there should also be increased visibility of voluntary
reporting for consumers.23 Consumers should have the opportunity to report the occurrence of complications and of events and circumstances that are cause for there to have been a failure of expectations.
9.10 Though PMS and adverse event reporting are important there can be exemptions to both. Rebecca Sheridan, Regulatory Manager, of the UK and Nordic Post-Marketing Surveillance and Vigilance operation has identified a number of exemptions to PMS, (where there is no perceived increased risk of harm to individuals or to the community),
and to reporting. These are24 –
(a) Circumstances where a deficiency of a new device is found by the user prior to its use and where no serious injury has occurred; (b) when the adverse event is caused by patient conditions, ie, the adverse event is due to the patient’s disease or disorder and
22 The TGA operates the Medical Device Incident Report Investigation Scheme (IRIS). The IRIS scheme is intended to maintain the standards of devices that are used in health care through the voluntary co-operation between users, government, and industry through the investigation of medical device adverse events reports. 23 Rebecca Sheridan, Regulatory Manager, UK & Nordic Post-Marketing Surveillance and Vigilance 10th Annual ABHI Conference – Medical Device Regulation (organised by Legal Division, IBC UK Conferences Ltd, London, 1st July 2002). 24 Vide supra n.23.
9. 6 these conditions are pre-existing or occurring (co-existing) with device use; (c) when the adverse event did not lead to serious injury or death (near incident), because a design feature protected against a fault becoming a hazard; (d) in the event where the incidence of death or serious injury has been quantified and found to be negligibly small (and also when there has been no incident) and the risk has been characterised and documented as acceptable within a full risk assessment; (e) in circumstances where there are expected and foreseeable side effects – that are clinically acceptable in view of the individual patient benefit and where there is a numerical predicability when the device was used as intended; and (f) where there is reporting exemption that is granted by the Regulatory Authority.
Rebecca Sheridan has identified two other reasons for there to be an exemption to PMS that include matters relating to the -
(a) Service life or shelf life of a device - when the only cause for the adverse event was that the device exceeded its service life and/or shelf life as specified by the manufacturer; and (b) at times when the adverse event occurs after the manufacturer has issued an advisory notice and the event is specified in the notice, has initiated corrective action and/or product recalls. Advisory notices include warnings and hazard notices.
In contrast to Sheridan, I am not convinced that these two circumstances represent a valid reason for exemption to PMS and to reporting as in both circumstances there might still be found a contraindication for the use of the device.25 Sheridan, does though,
25 The degradation of polymer (plastic) materials that are used for prosthetic joint replacement that can occur during periods of shelf storage is a cause for significant deterioration of performance that is associated with an increased propensity to the process
9. 7 emphasis that there should be no exemption from PMS or from reporting where an adverse event is seen to involve a particular issue of public health or where a definite change in a trend has been identified.
9.11 Any delays with respect to the reporting of adverse events that might be associated with any deficiency in a PMS program can undermine the safety checks that are intended to be part of any implantable surgical device regulatory program. Delays in the reporting of adverse events that are associated with the failure of an implantable surgical device can permit those devices that are defective, or at risk of being defective, to continue to be used and there is the very serious potential
for avoidable injury and even death.26 However, in the analysis of any adverse event it remains the case that reporting is only the first step in
the process that does not on its own improve safety.27 A PMS program that provides the impetus for reporting has the capacity to alert the community to a problem but it is the response to that report that will
improve safety.28
THE SAFE MEDICAL DEVICES ACT OF THE UNITED STATES OF AMERICA
9.12 The Safe Medical Devices Act 1990 (USA) (SMDA) was signed by
President Bush (Sr) in 1990.29 The SMDA was enacted by the United States Congress on 28/11/90 and was fashioned to provide the FDA in the United States, the regulatory authority, with more control over the pre-marketing and the PMS activities of manufactures. The SMDA followed on from a long history that dates back to 1848 when the US
of wear. Prolonged periods of shelf storage can cause polymer materials to become increasingly stiff (modulus) and there can also be polymer chain cission. 26 Under 21 CFR 803.3 (r) of the Safe Medical Devices Act 1990 (USA) an injury is that event that results in a permanent body function impairment or permanent damage to a body structure. 27 M Crane, “The Godfather of Patient Safety Sees Progress” (2003) 80 Medical Economics, 29. 28 See vide supra n.27. 29 The Safe Medical Devices Act 1990 (USA), (Public Law 102-629). The SMDA has been amended on a number of occasions. The SMDA was amended in 1976, 1992, 1995, and again in 1996. The Medical Device Amendment Act 1976 (USA) (Public Law 94-295) was directed towards improving the safety and efficacy of therapeutic devices. The Medical Devices Amendment Act 1992 (USA) further revised and expanded the 1976 Act. Amendments also have included matters relating to device related adverse event reporting, 60 Fed Reg 63579 [1995], reporting by health care facilities 60 Fed Reg 63599 [1995] and 21 USCA [sections] 360 [b] [1] [A], and reporting of adverse events [West supp 1996] to manufacturers 21 USC [sections] 360i [b] [1] [B] [West supp 1996 1].
9. 8 Congress required the United States Customs Service to prevent adulterated drugs from entering the United States. In 1880, the then chief chemist, Peter Collier, Division of Chemistry, US Department of Agriculture, recommended the enactment of a national food and drug law. As a consequence the Food and Drug Act 1906 (USA) was
passed by Congress and signed by Theodore Roosevelt.30
9.13 The main thrust of the SMDA is that hospitals are required to report adverse device related incidents to the FDA and/or to the manufacturer of the device within ten days of the institution learning of the
incident.31 Not only has the SMDA strengthened existing pre-market requirements but there has also been a more intense focus on PMS and
other vigilance programs.32 The requirement for hospitals to report adverse events is in contrast to the current regulatory environment in Australia where there is no obligation on hospitals, nor on any other
stakeholder, other than the manufacturer and the sponsor,33 to report the occurrence and nature of adverse incidents. Generally, adverse incidents that must be reported under the SMDA are those where it has been identified that there is a suspicion that a certain medical device
did cause or did contribute to the death34 or serious illness, or to the
serious injury35 of a patient, or to an event where immediate medical or
30 In the 1930s the need to revise the 1906 Act was recognised and it was, in 1938, that the Federal Food, Drug and Cosmetic Act 1938 (USA) was enacted. 31 SMDA, 21 USCA [sections] 360 [b] [1] [A], [West supp 1996] and 60 Fed Reg 63599 [1995]. 32 The Safe Medical Devices Act 1990 (USA) provided the FDA with the ability to mandate Good Manufacturing Practices (GMP) and to include pre-production quality controls into GMP. Manufacturers are required not only to repeatedly test a product in all phases of design, but also to validate the ultimate device design. The validation entails testing the device, either in an actual clinical situation or a simulation, documenting that the device performs to the individual user’s needs. In doing this manufacturers are required to apply Human Factors Engineering (HFE) methods throughout all phases of device design and development. HFE is also known as Useability Engineering or Ergonomics . This is a study of how humans interact with machines in complex systems. HFE is a powerful component in the design of useable safe medical devices can be incorporated as safety practices that occur at various points during device development and usage. HFE principals can also be incorporated into the ongoing evaluation of devices (PMS) that have already been purchased and are in use. 33 These reports are publicly available through application of the Freedom of Information Act (1982) (Cth). Access to documents is limited only by exemptions that are necessary for the protection of essential public interest and the private and business affairs of individuals. In all jurisdictions in Australia patients though may obtain access to their medical records by using Freedom of Information legislation. The principal that the activities of government bodies should be open to public scrutiny is permitted by the Freedom of Information Act (1982) (Cth), s.3. See also Freedom of Information Act (1989) (ACT); Freedom of Information Act 1989 (NSW); Information Act 2002 (NT); Freedom of Information Act 1992 (Qld); Freedom of Information Act 1991 (SA); Freedom of Information Act 1991(Tas); Freedom of Information Act 1982 (Vic); and Freedom of Information Act 1992 (WA). The State and Territory Freedom of Information legislation, like the Federal Act, does not apply to private facilities or to doctors in private practice. In Victoria and in NSW there are also Information Privacy Acts, Privacy and Personal Information Protection Act 1989 (NSW) and Information Privacy Act 2000 (Vic), that apply to public sector agencies and give a right of access to information held by such agencies. Other privacy legislation has been passed in NSW that includes the Privacy and Personal Information Protection Act 2002 (NSW). 34 Death reports must be directed to the FDA. In contrast injury or illness reports can be directed to the manufacturer, Sec ¶ 48- 104 US Stat, 4511. 35 Safe Medical Devices Act 1990 (USA), s21 CFR 803.3 (r) 803.3 (r).
9. 9 surgical intervention was necessary to preclude serious illness, injury or death to the patient.
9.14 The provisions of the SMDA are intended to bring into effect an early warning system that should ensure that the regulatory authority becomes aware of information with regard to drug and device problems. All employees of facilities that are involved with patient care, that review patient care, repair devices or provide device preventative maintenance, have a duty under the SMDA to report device-related incidents, (eg. device failure, device malfunction, inadequate design or labelling and user error). The SMDA extends this
duty to medical practitioners working in hospitals,36 and to nurses, allied health care professionals, students, volunteers, and all other
persons associated with the treating facility.37 I have a view that there are many lessons to be learned from the SMDA that are appropriate to any PMS endeavour in Australia.
9.15 The SMDA mandates the reporting of injuries that result from defective medical devices. Unfortunately, though there is a view that
the SMDA has not always been successful in gaining compliance38 with reporting requirements and that, furthermore, little action is taken
unless significant numbers of harmful errors have been reported.39
9.16 The SMDA mandatory reporting system has generated some concern with regard to the perception that reports could be interpreted as the admission of liability by the user. It is the case though, that in order to encourage reporting of adverse events, the FDA regulations do provide substantial protection against disclosure of the identities of both the
36 User facilities are defined in the SMDA at Reg 60 Fed Reg, 63598-63599 [1995]. Under SMDA s (Id) the private offices of medical practitioners are excluded from the user facility definition and medical practitioners working in the private sector are thus exempt from the mandatory reporting requirements relating to events that are recognised in their practice outside of the hospital environment. 37 Medical establishments that treat patients include ambulatory care clinics. 38 MD Rawlins, “Pharmaceutico-Vigilance: Paradise Lost, Regained or Postponed?” (the William Withering lecture 1994) (1995) 29 J Roy Coll Phys, 41. 39 P Monaghan, “Impacts of Reporting: Uncovering the “Voluntary vs Mandatory Myth”: Does Reporting Work? The Effect of Regulation” (2003) AQ21 Accountability Quarterly, 21.
9. 10 reporter and of the patients concerned.40 The SMDA does state that reports are not admissible into evidence unless the report contains false information and the facility, individual, or medical practitioner filing
the report knew that this information was false.41
REGULATION
9.17 With specific regard to the regulation of the medical profession,
Samanta and Samanta have observed that42 –
“The past decade [has] witnessed a series of high-profile inquiries that cast a noxious miasma over the medical profession and provoke demands for strict regulations. Somehow, a balance must be struck whereby the public can be confident that doctors practice competently, with due regard to ethical and technical standards, yet the regulations are not so overwhelming as to represent a sword of Damocles permanently hanging over doctors’ heads.”
The balance referred to by Samanta and Samanta is that delicate balance that exists between the regulated and the unregulated environment. Though Samanta and Samanta have referred to the medical profession in isolation, their statement is equally true for the manufacturers (and their sponsors) of surgically implantable devices and probably also even for the regulatory authority, the TGA.
9.18 Though the medical profession has been able to avoid lay intervention far more effectively than has been the case with regard to some other professions, it is evident that the balance between regulation and
freedom is gradually tipping in favour of regulation.43 Notwithstanding this, from a legislative and regulatory view point, self regulation should be less costly to any national economy than is the command and
40 Medical device user facilities are protected from litigation arising from their Medical Device Reports providing that reports are “submitted in accordance with SMDA Reg 21 CFR 803.32 (c)”. 41 SMDA Rule 10. 42 A Samanta & J Samanta, “Regulation of the Medical Profession; Fantasy, Reality and Legality” (2004) 97 J Roy Soc Med, 211-218. Ash Samanta is both a lawyer and a specialist physician employed at the Musculo-skeletal Directorate, University Hospitals of Leicester, NHS Trust, Leicester, Royal Infirmary, Leicester, LE1 5WW. Jo Samanta is from the Department of Law, De Montfort University, Leicester, LE1 9BH, UK. 43 CV Burton, “The Balance Between Regulation and Freedom” (1997) 1 (3) Neurosurgery, 322-3.
9. 11 control by government authorities. It does though, contrary to popular belief, remain the case that regulation can be more of a benefit than a
hindrance44 to medical practitioners (surgeons) and to the manufacturers of implantable surgical devices. Regulation can confer
on those who are regulated a status that may be denied to others45 and this can be cause for the creation of the monopoly that is, for example, enjoyed by registered medical practitioners. Though, in these circumstances there is an outward impression of accountability, there can exist an environment that allows for substantial self regulation and
freedom.46
9.19 The balance that exists between regulation and freedom has been
considered in detail by Charles V Burton M.D., in his review47 of the regulatory process of the US Federal Government with respect to the regulation of the medical industry. Following his review, Burton formed a number of conclusions that are relevant to the regulatory process and to the balance between regulation and freedom from regulation that exists in Australia. It is appropriate to quote from the
Burton Report48 –
“We exist in a society governed by law, and there is a natural tendency to focus attention on the laws themselves. The rather remarkable thing is that laws are often irrelevant. It is the interpretation and application of these laws that are the significant factors. Not only do these processes sometimes bear no relationship whatever to the laws themselves or to the intent of the Congress that created them, there are many cases in which interpretation and application may actually be at significant variance with the legislation, evident only to the few willing and able to read and understand the foreign language of ‘legalese’.
We now live in an era characterised by increasing Governmental intervention in the practice of medicine. It is well recognised that, within increased regulation, there is invariably decreased invasion and associated
44 M Moran & B Wood, States, Regulation and the Medical Profession (1993) Ch 6. 45 See vide supra n.40. 46 See vide supra n.40. 47 See CV Burton, “The Burton Report©”, delivered to the United States Congress of Neurological Surgeons, 1997. 48 See vide supra n.43 and n.47.
9. 12 decrease in the quality of health care. The significance of this cannot be fully appreciated until our health care system is compared to those of other countries.
Burton continues ( my edit)… the opportunity to innovate and the associated serendipity are the very bases upon which American medicine has made such giant strides in the past decade alone. The progression of drug and device legislation and associated regulation, combined with increased cost of drug and device manufacturers of legal assistance in coping with these, ever increasing product liability insurance costs, and the now proposed hospital costs contained within the legislation, it is not surprising that we seem to be on a course of self immolation.”
For the most part surgeons and implantable surgical device manufacturers have enjoyed self regulation. Nevertheless the recent
reforms to the TGAct49 have seen that self regulation enjoyed by the manufacturer, and the distributor (sponsor), pruned to a significant degree. In the environment of the current regulatory system it is not too far fetched to expect that the self regulation enjoyed by the medical profession may also soon be subject of some further review and
pruning.50 To be able to continue to self regulate demands a discipline and the ethical imperative that is good conduct based upon the ideals of virtue of character applied to the demands of professional practice, personal accountability to an educated conscience, and frequently submission to the authority of a regulatory body such as the TGA that
is answerable to the government of the day. 51
9.20 The TGA has, in the past, mostly relied upon a voluntary system among manufacturers for the reporting of adverse events. For this reason manufacturers may not always have fully complied with regulatory requirements and even in the event when compliance was the case it may also have been the case that the TGA may have found
49 See vide supra n.19. 50 R Smith, “All Changed, Changed Utterly” (1998) 316 BMJ, 1917. 51 See General Medical Council, Good Medical Practice (1994) London. See also KN Boyd, R Higgs & AJ Pinching (eds), The New Dictionary of Medical Ethics (1997), 233.
9. 13 difficulty in analysing the reports that were received.52 The recent past
is littered with events53 that are cause for the manufacturers of therapeutic goods, and of implantable surgical devices in particular, to attract an increased regulatory burden. I have a view that implant manufacturers may occasionally have been slow to respond to warnings provided by the surgical profession, with respect to problems that have been identified to be associated with implantable devices. I also have no doubt that in the past manufacturers may have been slow to issue product recalls or alternatively may have continued to have marketed implantable devices up to, or very close to, the
announcement of any recalls.54 There is little doubt that the mechanics of regulation have in the past been greatly at risk of being less than effective. The recent Pan Pharmaceutical audit by the TGA, (though revealing a range of critical manufacturing deficiencies, including test data being systematically and deliberately manipulated to give false results that a product was within specification to enable its release into the market), has somewhat belatedly exposed the TGA to a number of
serious allegations.55
9.21 Whatever the depth of regulation there probably can be some scope within the regulations for an environment of self regulation providing, as already noted, the key note is discipline and the ethical imperative is
good conduct56.
REPORTING
9.22 The objectives of any reporting program should be to ensure that there is a timely reporting of adverse events and that there is an effective
52 The Pan Pharmaceutical case is the classic contemporary example of a manufacturing conduct that demonstrates the problematic imperatives of the regulation of manufacturers of therapeutic products by the TGA. 53 See Carey-Hazell v Getz Bros & Co (Aust) Pty Ltd [2004] FCA 853. This case is discussed in detail in Ch 3, ¶ 3.93-3.94. 54 See the Sulzer Case, ¶ 2.23-2.29. 55 Following the Pan Pharmaceutical recall incident the TGA was described as being involved in “a particularly ugly cocktail of regulatory failure …” by Brian Toohey, Sunday Herald (Sydney), 4 May 2003, 24. In this article the TGA was further described as a “soft touch” regulator “who [are] far too slow to crack down on companies that cut corners while they are trying to keep their share price up … although it had good reason to keep a close eye on the company, the TGA took a remarkably relaxed approach until 19 people were hospitalised, in January (2003) after taking Travalcalm, one of Pan’s products”. See also News Update (2002) 14 (7) Australian Product Liability Reporter, 108. The TGA has also attracted criticism of its conduct following the case of Carey-Hazell v. Getz Bros & Co. (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014. For further information see Ch 3 ¶ 3.93.
9. 14 response to each and every report. It is also of importance that whatever is the method of reporting there should be safeguards to guarantee the privacy of the patient demographics included in the report. It is also desirable that immunity from litigation for the
reporter should be preserved.57 These are all legitimate concerns whether the system of reporting be voluntary, mandatory or a mix of both.
9.23 One of the major challenges associated with any reporting system for surgical device adverse events is the way in which the system interacts
with society’s prevailing culture of blame58 and secrecy59 as both can deter openness. This might be changed if the culture of reporting could be less intimidating and if there could be a move away from placing blame on individuals (eg. employees) and a move towards correcting the failings of institutions and organisations (eg. employers and manufacturers).60 Sanctions should not be focused on individuals. The individualising of errors is contrary to any current quality improvement philosophy that promotes a system based approach to
post market surveillance (PMS).61 It is argued that any reporting system will never be truly effective, and might indeed also be at risk of being counterproductive, in an environment where reports might be
interpreted as an admission of liability by the reporter62 and be
associated with a fear of malpractice litigation.63 It probably is the case that not enough research has been undertaken to explore and to identify the most the effective ways to promote the candid disclosure of adverse events and errors that might be associated with any surgical
56 See vide supra n.50. 57 The fear of litigation can be a barrier to the reporting of adverse events. Even though a treating surgeon may not have been negligent and there is clear evidence of device failure it can still be the case that the surgeon’s incorporated entity can have exposure to liability under TPA s.74(1) and s.74(2), Pt V Div 2. 58 See WB Runcman, AF Merry & F Tito, “Error, Blame and the Law in Healthcare – an Antipodean Perspective” (2003) 138 Ann Intern Med, 974-79. See also Department of Health (UK), An Organisation with a Memory – Report of an Expert Group on Learning from Adverse Events in the NHS, (2001) HMSO, London. 59 S Fazel & J McMillan, “Commentary: A Climate of Secrecy Undermines Public Trust” (2001) 322 BMJ, 1239-40. See also T Nordenberg, “Onlooker Culture of Secrecy” (2002) 265 (7125) The Pharmaceutical Journal, 804. 60 See KN Boyd, R Higgs & AJ Pinching (eds), Good Medical Practice, (1997) (BMJ Publishing Group). 61 See vide supra n.7. 62 See vide supra n.8. 63 See vide supra n.8. See also Co-ordination Taskforce.: Doing what counts for a patient’s safety: Federal actions to reduce medical errors and their impact. Washington, DR: Agency for Healthcare Research and Quality, 2000, accessed online at www.qic.gov/R/errors6.pdf.
9. 15 intervention.64 Whatever is the nature of the reporting system it should not be one that is viewed as demonstrating an emphasis on individuals
for the purpose of identifying bad practitioners65, or poor facilities. The focus of the system should be to identify substandard devices and/or manufacturing processes.
9.24 Whether the reporting of adverse events should be mandatory or voluntary is a long unresolved debate of the potential advantages and disadvantages of both. It is a debate that has remained clouded by
ideology66 and there are proponents and advocates for both voluntary67
and for mandatory68 reporting systems. On the one hand the proponents of voluntary reporting argue that mandatory reporting systems will ultimately fail due to under-reporting that is based on the consequence
of the fear of litigation.69 On the other hand the advocates of mandatory reporting argue that voluntary programs will not produce useful and complete information recognising also the problems associated with under-reporting. They suggest that only mandatory reporting will provide the most data, despite the limitations and
concerns surrounding its implementation.70
9.25 With regard to the reporting of adverse events that relate to implanted surgical devices it remains the case at this time that reporting to the
TGA is only mandatory for manufacturers and their sponsors.71 If the TGA is pro-active there is probably sufficient legal authority under existing legislation to ensure that the industry (at least) does submit the required data. However, as has so frequently been observed in many of the chapters of this thesis, there is no statutory requirement for any other stakeholder to report adverse events to the regulatory authority.
64 See Quality Inter-agency Co-ordination Task Force. Doing What Counts for Patients Safety: Federal Actions to Reduce Medical Errors and Their Impact. Washington, DC: Agency for Healthcare Research and Quality, 2000, accessed online at www.qic.gov/R/errors6.pdf and see vide supra n.8. 65 See vide supra n.8. 66 See vide supra n.3. 67 See MR Cohen, “Why Error Reporting Systems should be Voluntary. They provide better information for reducing errors” (2000) 320 BMJ, 728-29. 68 RJ Blendon, CM Des Roches, M Brodie, et al, “Views of Practising Physicians and the Public on Medical Error” (2002) 347 N Engl J Med, 1933-40. 69 See vide supra n.8. 70 See vide supra n.8.
9. 16 The reporting of adverse events by other stakeholders continues to be only voluntary and there is no evidence of any strategy or incentive to encourage them to report. In this climate the question is whether or not any new legislation or regulation needs to be created to address the problem. The other questions are in regard to whether compliance with
reporting can be improved, and if so, how will this be ensured.72
9.26 In the context of the current regulatory environment for surgical devices it is necessary to identify the potential advantages and disadvantages of mandatory and of voluntary reporting systems for all stakeholders that include –
(a) Consumers; (b) Surgeons; (c) Treating hospitals; (d) Manufacturers and distributors (sponsors); and (e) Other health care professionals
All of these groups should have a duty to see that all safety-related incidents are reported. If reporting is to be mandatory, it is clear that within present legislation, there is insufficient authority for the TGA to enforce any requirement that all stakeholders submit data, and inevitably new legislation or regulations will need to be created. In contrast if reporting is to be voluntary, there is a need for strategies and/or incentives to encourage reporting.
9.27 There is experience in other industrial environments that supports the view that whatever system of reporting is implemented it does remain important that all stakeholders become involved in the reporting
71 TGAct ss 41MP(1) & 41MP (2). 72 The mandatory versus voluntary reporting debate is not confined to medicine and the interested reader is referred to a debate of this issue that can be found in OECD, Pollutant Release and Transfer Registers (PRTRs): A Tool for Environmental Policy and Sustainable Development: Guidance Management for Governments, Paris, VP 19-20, 1996. See also the legal basis for PRTR reporting and for ensuring compliance in Toxics and the Community: Legislating the Right to Know, Australian Centre for Environment Law, Canberra, 1997.
9. 17 program. This is no more evident than is the case in the aviation
industry. Charles Billings, M.D., in his editorial observed that73 –
“ One reason that an incident reporting system worked in aviation … was that the entire aviation community … and essentially all of the stakeholders, including air passengers (consumers) were involved in the process from the beginning and then became advocates for the reporting system (as well as severe, but constructive critics), (my edits).
9.28 It may be that the optimal system for the reporting of adverse events associated with implantable surgical devices will be a blend of voluntary and mandatory (statutory) requirements. It is appropriate to briefly look at the benefits and deficiencies of all of these systems though whatever is the conclusion it is fundamental that any system of reporting must be well designed for the analysis of reports and dedicated to a culture that is characterised by the timely dissemination
of information74 and an appropriate response.75 The recognition that a lack of timely dissemination of information is currently a problem has
frequently raised the question, how it can be done better?76 It is accepted by most surgeons, and particularly by orthopaedic surgeons, that where implantable devices have failed, the salvage surgery burden is too high and that the burden is very definitely related, in part, to
products that do not perform as intended.77 The early dissemination of
this information is an imperative78 if surgeons are to be made aware of the potential catastrophic failure of a particular surgically implantable device. There are too many examples of this not being the case. The classic examples already referred to are associated with the use of
73 CE Billings, Editorial (1998) 121 Arch Pathol Lab Med, 214-15. 74 DF Craviotto, “Dissemination of Information Among Orthopaedic Surgeons Regarding Early Failure of Total Joint Implants” (2001) 83A (10) JBJS, 1580-81. See also WJ Maloney, “National Joint Replacement Registries: Has the Time Come?” (2001) 83A (10) JBJS, 1582-85. 75 These responses include warning, hazard notices, and the recall of defective devices. See also M Crane, “The Godfather of Patient Safety sees Progress” (2003) 80 Medical Economics, 29. 76 See vide supra n.74. 77 WJ Maloney, “National Joint Replacement Registries: Has The Time Come?” (2001) 83A (10) JBJS, 1582-85. 78 See C Whitewood & A Cop, “Damage of an Oxinium Femoral Head associated with Hip Arthroplasty Dislocation”, presentation at 33rd Scientific Meeting of the Australian Orthopaedic Association (Western Australia – Regional Branch), AGM, Perth, 11 September 2004.
9. 18 silicone-gel-filled breast implants79 and the Sulzer Orthopaedics Inter-
Op Acetabular Shell.80
VOLUNTARY REPORTING
9.29 The medical profession has traditionally promoted and fostered an environment where there is individual autonomy rather than teamwork and where there is personal accountability rather than the admission [to
others] of fault.81 For these reasons the prevailing culture within the medical profession is probably not in harmony with any concept of a mandatory reporting system. It might also be argued that this state of affairs is one that is very much associated with the environment of self regulation that is cherished by the medical profession and where only voluntary reporting of errors, complications and adverse events is viewed as the norm. It remains the case that the providers of health care have generally preferred voluntary reporting to mandatory reporting. In these circumstances, the TGA has been entirely dependent upon the voluntary reporting of problems by surgeons. In Australia an excellent example of a workable and voluntary reporting system is that undertaken by the Australian Incident Monitoring Study
(AIMS).82 The AIMS database attracts information relating to undesirable anaesthetic events that is provided by Australian Anaesthetists. The reporting system is anonymous, participation is voluntary, and the identity of individuals is protected. All of this has fostered a ready compliance and an open and comprehensive dialogue of communication that has included the reporting of worthwhile
information.83
79 See M Angell, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case (1996). See also Ch 2 ¶ 2.5-2.17. 80 See Ch 2 ¶ 2.23-2.29. See also GM Fleming & A Perrira, “The Proposed Sulzer Class Action Settlement: An Example of the Mass Tort Defense Du Jour” (2001 6 (19) Emerging Drugs & Devices, 25-31. 81 See Health Economics Program Issue Paper, December 2000. Medical Errors and Patient Safety: Key Issues. Minnesota Department of Health, Health Economics Program, accessed online at www.health.state.mn.us/divs/hpsc/atp/atpintro.htm 82 R Holland, “Symposium – Australian Incident Monitoring Study” (1993) 21 Anaesthesia and Intensive Care, 501. 83 See vide supra n.77.
9. 19 9.30 Voluntary health care reporting systems generally appear to be driven by the altruism of individual medical practitioners that is a concern for patients. In contrast mandatory reporting systems are more driven by
the threat of sanctions that can be the bedfellow of non-compliance.84 Nonetheless, in both cases, a major barrier to reporting is the potential loss of legal protection for the reporter. If legal protection is evident, then stakeholders will probably not need mandates to enforce the reporting of adverse events. It is desirable that any reporting system can preserve the confidentiality of the reporter. This is particularly
necessary for patients85 (consumers) who may be the subject of a report. The preservation of privacy should provide an advantage that will enable the reporter to have the confidence to provide reports that
are both timely and frank. In such an environment the threshold86 to reporting should be low and the general information gathered may be of a type that might otherwise have been ignored or only discovered after prolonged investigations. There is the potential to accumulate considerable information that might identify adverse trends before they
become adverse events.87 Earlier in this chapter88 and in chapter 5,89 we have seen that there is sound evidence that voluntary reporting programs, as are undertaken in the aviation industry, do encourage stakeholders to report even of situations and errors that did not cause any harm but may have had the potential to do so.
9.31 There are persuasive arguments90 that support a view that an effective reporting program should be voluntary and non punitive. It should be the case that non-punitive and confidential voluntary reporting programs will tend to provide more useful information about adverse
84 DR Tulp, CE Hoy, GL Kusch, SJ Cole, Non-response Under Mandatory vs Voluntary Reporting in the 1989 Survery of Pollution Abatement Costs and Expenditures (PACE); US Bureau of the Census, Washington, DC 20233. 85 The involvement of patients in any reporting system can be a powerful driver for improving services. For further information see DM Berwick, “The Total Customer Relationship in Health Care: Broadening the Bandwidths” (1997) 23 Joint Commission Journal on Quality Improvement, 245-50. 86 A probable advantage of a voluntary reporting program is that reports can generally occur without there being any numerical threshold for the report. 87 CR Billings, WD Reynard, “Human Factors in Aircraft Incidents: Results of a 7-Year Study” (1984) 55 Aviat Environ Med, 960-65. 88 See vide supra ¶ 9.27 and n.73. 89 Ch 5 ¶ 5.14. 90 See Institute for Safe Medication Practices, “Voluntary Error Reporting is Best Public Policy” (1999) 4 (1) ISMP Medication Safety Alert.
9. 20 surgical events than will any mandatory reporting system. This is certainly the experience that has been derived from the Australian Orthopaedic Association (AOA) National Joint Replacement Registry (AOANJRR). This registry was implemented in September 1999 and the data management TDM and Analysis Centre, at the University of Adelaide, is contracted by the AOA to provide data management and analytical services. The AOANJRR was declared a Federal Quality
Assurance Activity91 by the then Federal Minister for Health and Aged Care, Dr Wooldridge, in March 1999 and again in November 2001. This ensures freedom from subpoena and absolute confidentiality of
information held by the Registry.92 The protection provided by declaration as a Quality Assurance activity provides protection that assures surgeons, hospitals and government that information supplied to the Registry remains confidential and secure. The Health Insurance Act 1973 (Cth) also protects persons engaging, in good faith, in activities of reporting and volunteering information from civil liability
in respect of those activities.93 This protection from legal discovery for information that is harvested and is voluntarily shared, and for information that is published in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) is seen as vital. It is well known that individuals will simply not report adverse events if they fear that doing so will place them or someone else at risk. Such legislation does not inhibit the right of people to sue or the ability of lawyers to obtain information. What the Health Insurance Act 1973 (Cth) does ensure is that information that is voluntarily shared is not used against those who share it.
9.32 The success of the AOANJRR contrasts with the experience in the litigious environment of the United States where voluntary medical
91 The Quality Assurance Legislation is part of the Health Insurance Act 1973 (Cth). This Act was amended in 1992 to include Quality Assurance Confidentiality. The Act operates on the underlying assumption that quality assurance activities are in the public interest. A declaration as a Quality Assurance activity by the Commonwealth Minister of Health and Age Care prohibits the disclosure of information, which identifies individual patients or health care providers that is known solely as a result of the declare quality assurance activity. It is not possible to provide identifying information to any individual or organisation including the government. 92 The Health Insurance Act 1973 (Cth), Pt VC s.124 V(2)(a)(i), (ii) - Protection of Confidentiality of Inquiries. 93 The Health Insurance Act 1973 (Cth), s.124 Zb – Immunity from Suit.
9. 21 device reporting demonstrates an apparent inability to serve as an effective surveillance system. It is the case that only (approximately) 3% of hip replacement and 10% of knee replacement problems are
reported in the United States.94 The Australian experience also contrasts with the experience in the United Kingdom where voluntary reporting systems have proved to be unsuccessful in that only 10% of
serious adverse drug reactions were reported.95
MANDATORY REPORTING
9.33 As in any program of reporting, a mandatory reporting process can also continue to be associated with non-compliance that is a response to an individual’s or organisation’s fear of punitive measures, associated with sanctions, and with the attendant burden of the system. Any mandatory reporting program should probably include a no-fault
culture that has the potential to increase compliance.96 A no-fault system finds support in that experience associated with the mandatory
reporting programs in the USA.97 In contrast though it remains the case in the USA that the information generated by [some] mandatory reporting systems has only rarely been used to warn others of the
potential for similar adverse events.98 Tulp et al have identified the most problematic issues of any mandatory reporting program as including the punitive remedies for non-compliance with the program
and also the ineffective use of data. 99
9.34 Under-reporting or non-reporting will have the potential to reduce the effectiveness of any mandatory (or voluntary) reporting system. This
94 AS Greenwald, “What Can Be Done, What Should Be Done, and Who is Responsible?” (1998) presentation to Industry and Federal Interactions in Developing and Applying New Technology for Orthopaedics, Section V, Surveillance Issues, American Academy of Orthopaedic Surgeons. 95 PL Cervi, “Technology to Collect and Share Information about Harms already Exist” (2004) 329 (7463) BMJ, 445-47. 96 Department of Health (UK), “An Organisation with a Memory – Report of an Expert Group on Learning from Adverse Events in the NHS” (2001) HMSO London. See also Department of Health, “Building a Safer NHS for Patients” (2001) HMSO London. 97 The Safe Medical Devices Act 1990 (USA) states that reports are not admissible into evidence unless the report contains false information and the individual or physician filing the report knew that the information was false and to protect against a claimant’s attorney from using the contents of a report to build a case it is advised that reports include a disclaimer indicating that (in the USA) the report is submitted in accordance with the Safe Medical Devices Act 1990 (USA) – s.21 SFR 803.32(c). 98 LT Kohn, JM Corrigan, MS Donaldson, To Err is Human: Building a Safer Health System (2000), 119-121. 99 See vide supra n.84.
9. 22 chapter has identified a number of reasons for under-reporting though it may just be the burden of the system, or simply the culture of secrecy that exists within the medical profession that is the impediment to any reporting program. In the United States the American Medical
Association100 and the American Dental Association101 have resolved this impediment by imposing the obligation on physicians and dentists respectively to participate in adverse event reporting. It is also the case that the Journal of the American Medical Association (JAMA) instructs authors that adverse drug or device reactions should be reported to the appropriate government agency in addition to
submitting such information for publication.102 If a reporting system is to be mandatory then it probably will necessarily have to include sanctions for non-reporting and it probably is desirable that any sanction should be strong enough to encourage appropriate levels of reporting. Furthermore, I have a view that any punitive measure should be directed at the organisation rather than at the individual as this will provide some sense of immunity from litigation for the reporter.
9.35 If reporters are not protected from exposure to liability for adverse events then it can be the case that individuals and organisations might only report the statutory minimum that is required by any current or proposed legislation and by the regulatory authority. Where a minimum of information is communicated there might be a tendency for that minimum to become the standard for a particular institution’s own reporting system. For this reason important information about adverse events that should be reported may remain unknown to the regulatory authority and future adverse events may not be effectively anticipated by other stakeholders.
100 American Medical Association, “Reporting Adverse Drug and Medical Devices Events. Report of the AMA’s Council on Ethical and Judicial Affairs” (1994) 49 Food and Drug Law Journal, 359-66. 101 See Advisory Opinion No 12, Section 4-A, Devices and Therapeutic Methods, of the American Dental Association Principals of Ethics and Code of Profession Conduct, 1992. 102 Editorial, “The Journal of the American Medical Association Instructions for Authors” (1996) 275 JAMA, 5-12.
9. 23 9.36 One other major issue for any mandatory reporting system is that the regulatory authority should not be under resourced. Any mandatory reporting process may not contribute much to patient safety if the regulator is under-funded. In the event the reporting program can quickly become ineffective. Another important issue is that the maintenance of any mandatory reporting system should require an investment that is not generated from the stakeholders as is now the case with respect to the funding of the TGA in the undertaking of its general role as the regulator of the supply of therapeutic goods.
CONCLUSION
9.37 The reporting of adverse surgical events is the first step in any chain of response to the unexpected incident. Reporting permits there to be an awareness that there might be a problem but it is the response to that
report that has the potential to improve safety.103
9.38 Whatever is the nature of the reporting system that is introduced it is fundamental that there is an appropriate mechanism for any report to be received, to be analysed, and for there to be a timely response by the regulatory authority and by those stakeholders who are able to respond. It is fundamental for any reporting system to work that the system adopted will efficiently –
(a) receive reports; (b) respond to reports; (c) co-ordinate information with other agencies and organisations who have a need to know, (this includes all of the stakeholders including consumers); and (d) regulate disclosure.
It may be that for all of this to be possible the system that is crafted might be a blend of voluntary and mandatory (statutory) requirements.
9. 24 It is important also that standards must be in place so that in any response to a report there is a sharing of information that does retain the confidentiality and the legal protection of reporters and of
patients.104
9.39 The serious problem facing the implementation of any reporting system, whether it be voluntary, mandatory or a mixed system, and especially one that is operated federal wide, is the lack of any standardised definition of what is to be interpreted as an adverse event where the event concerns the implanted surgical device. In Chapter 5 there is an endeavour to clarify the definition. However it does remain the case that until the term is agreeably defined and understood by all stakeholders and by the regulatory authority there will be a barrier to the effectiveness and comparability of any reporting system that is based on there being no clear understanding of that which should be reported. There has to be a resolve to formulate an agreed definition of what represents an adverse implanted surgical device event that should deter the sometimes chronic failure to recognise and to report adverse events. Standardisation of the definition should also permit the distinction between those adverse events that are associated with the improper use of a device from those events that are demonstrably associated with a failure of the device.
9.40 It is important also that a culture of reporting be encouraged and that the culture is one that moves away from any culture of blame or secrecy and moves more towards an altruistic understanding of the underlying aetiology for the event. In all of this there might be seen to be a problem that is to encourage maximum levels of reporting, and
103 See vide supra n.27. 104 In the USA the SMDA has generated concern amongst Surgeons, Risk Managers and others that reports could be interpreted as an admission of liability by the user. The law does however state that medical device reports (MDRs) are not admissible into evidence unless the report contains false information and the facility, individual, or medical practitioner filing the report knew this information was false. Reports however can be obtained by a claimant’s legal representative and possibly used as background information to develop a case. To protect against this it is advised that reports should include a disclaimer indicating that (in the USA) it is submitted “in accordance with the Safe Medical Devices Act (21 CFR 803.32(c)) and does not constitute an admission that the surgical device, the reporting facility, or its employees caused or contributed to the adverse event that is the subject of the report”.
9. 25 having done so, to be able to craft a mechanism to compensate those who may have suffered harm in the event that it is legitimate to do so.
9.41 It is evident that there is a continuing and unresolved debate as to whether or not the reporting process should be voluntary, mandatory, or a blend of both. Whatever system of reporting is in place it probably is the fact that voluntary programs will never be the whole answer although they can be effective early warning systems that can identify emerging risks, and be able to provide information on risks that mandatory reporting systems may not. Whatever is the case it is permissible to conclude that any reporting system should remain under the control of the regulatory authority, the TGA. Whatever is the system for reporting the TGA should not be under resourced. Furthermore it has to be the case that the resources for the regulator should not be generated by the regulated.
9.42 In Chapters 3105 and 10106 it has been recommended that there should be
a National Register of Implanted Surgical Devices. In Chapters 4107
and 10108 it has also been recommended that there should be a National Register of Clinical Trials. The underlying theme to both recommendations rests on a conclusion that the recognition and the early reporting of adverse surgical events is vital to the well being of those consumers and volunteers who have undergone surgical procedures associated with the implantation of one surgical device or another. These are major surgical interventions whose outcomes are mostly satisfactory but can at times be unpredictable, cause for adverse events and harm, serious injury, death, and even more rarely with no identifiable benefits. It is the case that within this hypothesis there can
also be identified the opportunity to recommend that potential109 consumers of implantable surgical devices might benefit from having the opportunity to access the findings and the conclusions of any
105 Ch 3 ¶ 3.101. 106 Ch 10 ¶ 10.10. 107 Ch 4 ¶ 4.93-4.95. 108 Ch 10 ¶ 10.10.
9. 26 register that might relate specifically to the performance and to the failure associated with the use of a particular device. Such information has the potential to improve consumer choice that may be derived from the opportunity to benefit from demographic information that can then be discussed with treating medical practitioners.
9.43 My conclusion is that any reporting system should be a blend of both voluntary and mandatory requirements and that each stakeholder should have the opportunity to report any adverse event [incident] that is cause for some concern or other. There can be persuasive argument for manufacturers, sponsors, and surgeons to have an obligation to report to each register those events that are recognised as being adverse and where it is recognised that there can be a causal nexus between the adverse event and the implanted surgical device. I am concerned also that consumer privacy must not be compromised by any register and that consumer demographics should remain privileged information that cannot be disclosed for any other reason than is associated with the maintenance and generation of safety, with the efficacy of a particular surgical intervention and with improving health care outcomes. Furthermore, I have a view that consumers should only be required to voluntarily report information to any register. It may be the case that consumers will only report matters that relate to the individual’s failure to achieve expectations. However there can be occasions when consumers become aware of significant events that might otherwise, perhaps through the non-compliance of others, remain undetected or unreported. For all other stakeholders though there is a need for there to be a legal definition of what is to be reported and that anything that is reported is not seen to have any ethical conflict with the reporter’s obligations to consumers. Whatever is the basis of any reporting program it will be the case that the program will prove futile in the absence of a strong, well-designed system for reporting, for analysis, and for response.
109 In this context potential consumers are those patients who are awaiting elective implant surgery.
9. 27 9.44 Two final conclusions are that, whatever is the nature of the system of reporting, it should be the case that there must be protection from the legal discovery of adverse event reports that are voluntarily shared and reporting individuals and organisations should have no fear that the reporting of adverse events can place them at risk. It may also be suggested that there should be no sanctions if you report but sanctions if you do not. Any system of reporting should be seen only to improve the health and safety of those in the community who have undergone, or are in need of, the implantation of a surgical device to restore the function of one body system or another. Whatever is the human endeavour there will never be complete freedom from risk of harm and
it is appropriate to quote Arthur L Bloomfield110 –
“There are some patients that we cannot help; there are none whom we cannot harm.”
It is important that the reasons for both should not go unreported.
110 Quotation cited by LG Cuervo & JK Aronson, Editorial, “The Road to Health Care – Balancing Benefits and Harms of Interventions is Essential” (2004) 329 (7456) BMJ, 1-2. Cuervo and Aronson emphasis how much more challenging it is to assess the benefit to harm balance for surgical treatment interventions when there are occasions when these interventions are implemented without reliable evidence of their beneficial effects, let alone their harmful ones. For example, most evaluations of different total hip replacement prosthetic devices have been uncontrolled and a systematic review by Scott et al has found that the primary evidence following the surgical interventions was too weak to draw any value conclusions. See D Scott, C Smith, S Lohmander & J Chard, “Osteoarthritis” (2004) 11 Clin Evid, 1560-88.
9. 28 CHAPTER 10
CONCLUSIONS and RECOMMENDATIONS CONCLUSIONS
10.1 Throughout this thesis, and particularly in Chapter 2, The Magnitude of Therapeutic Goods Failure, it should have become evident to the reader that implantable surgical device adverse events that are causally associated with defective products or with products were there is found to be a superadded risk of a defect, are, by any standards, common events. The magnitude of many of these events, both in economic and in human terms, is clearly very much out of proportion to society’s expectation that health care will be distinguished by those two important characteristics that are safety and efficacy. Whilst no human endeavour can be entirely free from risk of harm, the events and statistics presented in Chapter 2 reflect an incidence of risk, particularly to surgical patients, that is far in excess of anything that can, in this day and age of technological advance, be considered acceptable or desirable. Implantable surgical device failure, and the subsequent need for the explantation of the device, are both serious adverse events. The former (failure) is product liability and the latter (explantation) can be considered to be a personal injury. It is in some sense regrettable that, for the most part, the energy of the law has, to the present time, mostly been expended with a pro-active concern for those surgical product liability issues that have resulted in class (or representative) actions, which allow for the claims of many individual claimants to be joined against a common defendant. In almost all jurisdictions around the world the case law is littered with episodes of class (or representative) action against the manufacturers of
implantable surgical devices.1 The suffering that can be associated with one individual’s product liability issue is no less important, and it is, in a sense somewhat, reassuring that in Australia there is evidence that the class action may not always be the most appropriate legal
1 Marcia Angell, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case (1st ed, 1996): see also JM Fleming & A Perrira, “The Proposed Sulzer Class Action Settlement: An Example of the Mass Tort Defense Du Jour” (2001) 6 (19) Emerging Drugs & Devices, 25-31.
10. 1 process. The cases of Courtney2 and of Carey-Hazell3 are noteworthy examples that strengthen this view.
10.2 Another finding that is permitted by the consideration of the magnitude of implantable surgical device failure is the conclusion that the reporting of adverse surgical device events has historically been associated with too many deficiencies. I have no hesitation in emphasising that there can be no other conclusion than this: there continues to be a woeful lack of any timely dissemination of information regarding adverse events and there is an urgent need to ask ourselves the question as to how the dissemination of this information can be improved?
10.3 The conclusion that the reporting of adverse events is less than adequate is something that is more clear than are the reasons for under- reporting. The reasons for under-reporting are as complex as are the attitudes that reflect the lack of agreement as to the nature and methodology of any system of reporting. In Chapter 9, Reporting and Regulation, there is a conceptual argument that forms the basis for the debate of whether any system of reporting should be mandatory, voluntary, or a mix of both. Whatever is the system of reporting that is adopted the fundamental aim should be that the reporting of adverse events must have the potential to improve health care and to ensure that there is safety in health care. It should be that a culture or reporting will benefit not only consumers but also all other stakeholders that include manufacturers, hospitals, clinics, and health care providers. Whatever is the system of reporting it is a logical conclusion that any barrier to reporting should be lowered and that the culture of reporting should be divorced from any culture of blame and/or punishment of the reporter. In contrast, it is probably more appropriate to any process of reporting that any punitive measure should be focused on those who are identified to have failed to report.
2 Courtney v. Medtel Pty Ltd [2003] FCA 36; BC 200300120. 3 Carey-Hazell v. Getz Bros & Co. (Aust) Pty Ltd [2004] FCA 853; (2004) ATPR 42-014.
10. 2 Whatever is the structure of any reporting system it is desirable that the process should be based upon a culture that includes the understanding and acceptance of a need to share information and an altruism that will engender a sense of ownership and accountability in an environment where there is legal protection for those who voluntarily share the information. My consideration of the structure for any system of reporting has caused me to come to the conclusion that the system for reporting should include a mix of voluntary and mandatory requirements. I have the view that all stakeholders, including consumers (patients), should be encouraged to report adverse surgical events and also to report even those circumstances that might only be associated with a failed realisation of expectations. I am confident in the conclusion that mandatory reporting should be the case for manufacturers (and/or their sponsors), for health care providers, and for health care institutions (eg hospitals) and that the requirement for consumers to report should be voluntary. Whatever is the process, reporting is only the first step in any risk management strategy and, more importantly, it is the response to that report that is so vital. Fundamental to the success of the reporting process is that the nature of that which is to be reported is known to, and generally agreed by, all stakeholders. It may be the case that under-reporting has simply been one consequence of the fact that there has been, and remains, no general agreement and understanding as to what should be reported. It is for this reason that, in Chapter 5, The Medical and Legal Definitions of Adverse Events and Injury, and of Defective Goods and Defects, in the Context of the Surgically Implanted Device, I have endeavoured to clarify the definitions of these terms in a manner that is intended to be more appropriate to the novel nature of surgically implantable devices as products and to the unique and hostile environment where their satisfactory function (or performance) is the desirable and expected outcome.
10.4 In Chapter 7, The Learned Intermediary – The Delicate Balance Between a Defence and the Duty to Warn and to Educate, and in
10. 3 Chapter 8, The Expert Witness, I have considered the roles of those two principal functionaries who are able to most contribute to the direction that any debate of issues of implantable surgical device product liability will take. Whilst it is arguably unfortunate that court procedure provides the only opportunity for these experts to be
challenged,4 it remains the case that legal history clearly demonstrates a capacity for the expert witness to influence the carriage or
miscarriage of justice.5 Furthermore, only marginally less is the capacity of the learned intermediary to provide a defence that can mitigate or extinguish any exposure to product liability on the one hand, or on the other hand, to be able to substantially impact on the use of implantable surgical devices. I have formed the conclusion though that the learned intermediary stands alone on the merits, or otherwise, of his or her qualification, knowledge and experience. This is in contrast to the expert witness whose sporadic intemperate advocacy can be an uncontrolled stumble from one side of the courtroom to the other that reflects the requirements of the party that has retained the expert. The facts are that there is considerable gravity to the expert witness system in Australia. However it is encouraging to observe that the reform of the expert witness system in the United Kingdom, set in
motion by Lord Woolf,6 is now proceeding in Australia at a rapid
pace.7
10.5 The Australian Commonwealth and State/Territory Governments have, since the early 1990s, and particularly over the past few years, demonstrated the motivation to significantly reform the law as it relates to consumer protection and to personal injury. The measure of reform to the Trade Practices Act 1974 (Cth), to the Therapeutic Goods Act 1989 (Cth), and to State/Territory law (that relates to personal injury
4 MC Bishop, “Personal View – The negligence of medical experts” (2004) 329 (7478) BMJ, 1353. 5 G Samuels, “ Is This The Best We Can Do?” (1993) 25 (3) Aust J For Sci, 3-9. See also Regina v. Veleski [1999] NSW CCA 96 and Veleski v. The Queen [2002] 76 ALJR 402; [2002] HCA 4. 6 The Right Hon The Lord Woolf.: Access to Justice: Interim Report to the Lord Chancellor on the Civil Justice System in England and Wales. London: HMSO, 1995 and The Right Hon The Lord Woolf. Access to Justice: Final Report to the Lord Chancellor on the Civil Justice System in England and Wales. London: HMSO, 1996. 7 See the Australian Law Reform Commission, Review of the Adversarial System of Litigation, Issues Paper 20, ADPS ¶ 7.76- 7.79, Canberra, Apr 1994: see also Law Reform Commission of NSW Issues Paper 25, 2004, Expert Witness: see also the Australian Law Reform Commission, Adversarial Background Paper, Expert, 6 Jan 1999.
10. 4 and negligence) following the recommendations of the Ipp Report8 of 2002 has been reviewed in some detail in Chapter 3, Product Liability in Australia. There should be no disagreement that the reforms in both Federal and State/Territory jurisdictions have been ambitious, are timely, and do reflect expeditious efforts to improve the law that applies to personal injury claims whether these be based on issues of product liability or otherwise. Notwithstanding these reforms it remains the case, as we have already seen in Chapter 3, that the regulatory control of surgically implantable devices in Australia is an amalgam of legislation that is administered by Commonwealth, State and Territory agencies, each with their own specific and frequently different product liability and consumer protection legislation. The legislation is essentially based on a foundation that is the Trades Practices Act 1974 (Cth) and the Therapeutic Goods Act 1989 (Cth) where matters relate to therapeutic goods. Any issue of product safety is fundamentally regulated by the Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ACCC). Notwithstanding the reformist milieu of recent times it is permissible to form the conclusion that the regulation of implantable surgical devices, though strengthened, does remain too porous and in some respects demonstrably ailing. The porosity and the ailment have at their aetiology a number of short comings that include, but are not restricted to, the following conclusions:
(a) The dubious circumstances where the regulator (the TGA) is funded by the regulated; (b) There is no great incentive to report adverse events and there is little that might engender a culture of reporting; (c) It remains mandatory only for manufacturers and/or their sponsors to report adverse events; (d) Australian resources are not generally recruited to investigate the cause for any implanted surgical device product related adverse event;
8 See Ch 3, ¶ 3.17.
10. 5 (e) There is no regulatory control over the relationships and the partnerships that can exist between health care researchers, the providers of health care, and the manufacturers of health related products; (f) There is no clear regulation of manufacturers and/or sponsors with respect to their conduct (behaviour) in the health care marketplace, and (g) There is no national mechanism whereby the knowledge of adverse events can be gathered, analysed, quickly disseminated to all stakeholders who may have a need to know, and that will initiate speedy remedial action.
10.6 I have a view that the law, as it has been concerned with issues of health care, and particularly the tort of negligence, has been characterised by a soft underbelly that has always been the medical practitioner. For reasons, that are not theoretically too different, the soft underbelly for issues of product liability has traditionally been the manufacturer. In Chapter 6, Implantable Surgical Device Manufacturers’ Defences to Liability the defences available to a manufacturer in product liability claims have been reviewed. Chapter 6 is just that, a review, and there is no effort to generate any new conclusions or recommendations. However, as the reforms to personal injury and negligence legislation continues it is permissible to form a
conclusion that medical practitioners9 are at risk of joining manufacturers at the soft underbelly of product liability litigation and as such the defences reviewed in Chapter 6 might be no less appropriate to clinicians than they are to manufacturers and/or their sponsors.
10.7 In Chapter 4, The Evolution of the Surgical Implant, the development of an implantable surgical device has been examined in some detail and a number of regulatory maladies have been identified in the
10. 6 process. It should be axiomatic that the evolutionary process that is the development of a surgically implantable device must, at each stage, be exposed to the scrutiny and to the regulation of the competent authority that is in Australia the TGA. At each stage of research and development it is important that there is a transparency to events that can be seen to preserve the freedom and the integrity of all stakeholders involved, particularly that of medical practitioners. That relationships between manufacturers and medical practitioners can deteriorate to a level where there is potential for bias, for conflicts of interest, and even for there to be an undesirable impact on the doctor/patient relationship is very evident and there are numerous
examples that have been cited throughout this thesis.10 The recent
recall of the arthritis drug Vioxx11 – for that unequal partnership between safety and efficacy - is testimony to this conclusion. It should be an imperative for any program of clinical research and development, and particularly one that includes the (experimental) use of any new interventional procedure and/or the use of new implantable surgical devices in humans, that there is exposure to the scrutiny of a government appointed regulatory authority. There is a need for an environment of regulation that will ensure that all clinical trials are undertaken ethically and that they are exposed to optimal examination and evaluation and that any collaboration between stakeholders is seen to be doing more than the minimum required by any regulator or regulation. Furthermore it is vital that there be an openness with regard to the reporting or the publication of the results of clinical trials. Yet again it will be seen that there is this constant theme that focuses on the importance of the reporting of information that is at the hub of any discussion of implantable surgical device product liability.
9 The group of medical practitioners that are particularly at risk to exposure to liability and issues of product liability are those medical practitioners that are incorporated. These clinicians are very much at risk particularly in relation to matters concerning the supply of services – see TPA s.74(1) and s.74(2). 10 See Ch 4, ¶ 4.46-4.48 and ¶ 4.59. 11 P Jüni, L Nartey, S Reichenbach, R Sterchi, P Dieppe, & M Egger, “Risk of Cardiovascular Events and Rofecoxib: Accumlative Meta-analysis” (2004) 364 (9449) Lancet, 4999.
10. 7 RECOMMENDATIONS
10.8 In the preceding paragraphs it should have become evident that any consideration of those issues of product liability that can be generated by the use of, and by the failure of, implantable surgical devices will permit a number of conclusions to be identified that do recognise the opportunity to formulate a number of recommendations. In the final paragraphs of this thesis it is appropriate to make a number of recommendations but, before doing so, I have to admit that after more than three years of disciplined legal research the words of Baron
Bramwell12 in Andrews v. Sturop13 are so very relevant –
“The matter does not appear to me now as it appears to have appeared to me then.”
10.9 My early research did direct me towards the conclusion that circumstances pertaining to issues of surgical implantable device product liability identified a need for a Safe Medical Devices Act. This is probably now not the case as it is clear that the law that relates to matters of consumer protection in general and to matters relating to implantable surgical devices in particular does provide opportunities for the regulatory authority (the TGA) to address many of the issues that have been exposed in this thesis. The view has already been expressed, and it is a view that I retain, that the legislation as it relates to consumer protection is, particularly with respect to issues of implantable surgical device product liability, chiefly lacking in regulatory authority that is concerned with –
(a) the reporting and investigation of adverse events; (b) the conduct of research and development and clinical trials;
12 Baron George William Wilshire Bramwell (1808-1892) was called to the bar at Lincoln’s Inn and at the Inner Temple in 1838. The exact date of Baron Bramwell’s observation is not reported but it is probable that the statement was made early in the 1850s when the Baron served on the Royal Commission to inquire into the assimilation of the Mercantile Laws of Scotland and England and the Law of Partnership which had as its result the Companies Act 1862. Interestingly Baron Bramwell’s younger brother, Sir Frederick Bramwell (1818-1903) was a well known consulting engineer and “expert witness”. 13 26 LTNS 704, 706.
10. 8 (c) the conduct and behaviour of manufacturers and medical practitioners both separately and in partnership; and (d) the use of and the role of the expert witness.
These are the main issues that deserve our attention.
10.10 I have found it appropriate to recommend that the community that are the stakeholders, gatekeepers and shareholders of matters relating to implantable surgical device product liability would benefit from amendments to the Therapeutic Goods Act 1989 (Cth) that can address these issues. Those amendments might take the form of a Therapeutic Goods (Safe Medical Devices) Amendment Act (Cth) that would include the regulatory authority to permit the implementation of the following initiatives –
(a) A National Register of Implantable Surgical Devices: It is proposed that a National Register of Implantable Surgical Devices should be brought into being to ensure that the use of implanted surgical devices, their efficacy and performance, and the occurrence of adverse events can be identified at the earliest opportunity that would permit prompt analysis of any concern, and the undertaking of a remedial response without any unnecessary delay. It is proposed that each and every implanted surgical device event be recorded on the register and that any adverse event should be reported to the register throughout the lifetime of the implanted device or until the death of the consumer. It is further proposed that all stakeholders be provided with the opportunity to report to the register and that the stakeholders should include consumers. It is further recommended that mandatory reporting of adverse events be required of manufacturers (and/or sponsors), medical practitioners and treating institutions (to included hospitals, ambulatory care clinics, and ancillary health care provider
10. 9 organisations). The obligation to report should be voluntary only for consumers. It can also be recommended that the register be a public document that preserves the privacy of consumers and is not associated with any concept of blame or with any punitive measure for the reporting individual or organisation. In contrast it should be that the failure to report the occurrence and the nature of adverse events might expose the liability of the individual or organisation concerned.
(b) A National Register of Clinical Trials: It is permissible to hold the view that a clinical trial is nothing more or less than the experimental use of an implantable surgical device, or of a new interventional surgical technique, that is undertaken [usually] with the [informed] consent of volunteers in an environment that [should be] identical to the environment of the contemplated marketplace. It is evident that the results of clinical trials may only ever be made known to other stakeholders when the results of the trial are published. It is evident, for a variety of reasons, that surgical trials can be exposed to undesirable influences, that can be cause for bias and for the generation of a conflict of interest, and it is not unknown for unfavourable
results and conclusions to escape publication.14 The undertaking of clinical trials should be associated with a transparency that can be derived from the opportunity for any individual member of the community, or organisation, to benefit from access to the public record that is the Register of Clinical Trials.
14 See Ch 4, ¶ 4.49-4.63.
10.10 (c) A Code of Conduct for Manufacturers, Researchers, Health Care Providers and Health Care Institutions: It is very evident that the activities of each, and the consequences of partnerships, can be cause for a plethora of acts, arrangements, dealings, deals, doings, interests, policies, practices, proceedings, relationships, transactions,
understandings and undertakings15 that are not always ethical, not always in the best interests of consumers (patients) and are of a nature that can be cause for an interference with, and an undue influence on, academic freedom and the doctor-patient relationship with even the potential to impact on the nature of treatment that is provided. The formation of a Code of Conduct is not inconsequential.
(d) A National Code of Conduct for Expert Witnesses: This is a matter that is already exposed to considerable debate and it is an issue where reform has already commenced and is gathering momentum.
It might be considered by some to be coincidental, or perhaps it is mere chance, that this thesis was completed at a time when patients are the casualties of the greatest therapeutic product recall in medical history – that is Vioxx. The controversy and the challenges that will be the legal and medical aftermath of the recall of the arthritis drug Vioxx are difficult to predict but they will be substantial and should have the potential to drive and to animate more ambitious reform of the regulation of therapeutic goods than might otherwise have been the case. This is timely.
15 For the alternative use of the descriptive Activities see William C Burton, Burton’s Legal Thesaurus, (3rd Ed 1980), McGraw- Hill, New York, London, Sydney.
10.11