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Implantable Surgical Devices Issues of Product Liability

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Implantable Surgical Devices Issues of Product Liability 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 A & Anor v. National Blood Authority, (2001) 3 All ER 289; [2001] EWHC QB 446 Abalos v. Australian Postal Commission, (1990) 171 CLR 167 FC ACCC v. Cadbury Schweppes Pty Ltd, [2004] FCA 516 ACCC v. Murray, (2002) ATPR 41-899 ACCC v. The Glendale Chemical Products Pty Ltd, [1998] ATPR 41 6-32; [1999] ATPR 41-672 Adams v. Eta Foods Ltd, (1987) 19 FCR 93; ATPR 40 (831) Adler v. Australian Securities and Investment Commission, [2003] NSW CA 131 Alcock v. Raith, 59 BLR 20, CA 1991 Alexander v. Heise, [2001] NSW SC 69 Andrews v. Hopkinson, [1957] 1 QB 229 Anns v. Merton London Borough Council, (1978) AC 728 Appleby v. Sleep, [1968] 2 Al ER 265 Arnotts Ltd v. Trade Practices Commission, (1990) 24 FCR 313 Arrendale v. Canada Bread Co., [1941] 2 DLR 41 Artiglio v. Corning Inc., 18 CAL 4th 604 1998 Arthur JS Hall & Co. v. Simmons, [2000] 3 WLR 543 Ashington Piggeries Ltd v. Christopher Hill Ltd, [1971] 1 All ER 847 Astley v. Aus Trust Ltd, (1999) 73 ALJR 403 Australian Beauty Trade Supplies Ltd v. Conference and Exhibition Organisers Pty Ltd, (1991) 29 FCR 68 Austrian Supreme Court, 8th April 1997 4 Ob 87/97s and 24th October 2001 9 Ob 238/01t Baldry v. Marshall, [1925] 1 KB 260; [1924] All ER Rep 155 Barnes v. Glendale Chemical Products Pty Ltd, [1998] 8TPR 41-632 Basildon District Council v. JE Lesser (Properties) Ltd, [1985] QB 839; [1985] 1 All ER 20 Beck v. State of NSW, [2001] NSWSC 278; BC 200101695 Bellotte v. Zayre Corp., 531 F 2d 1100 (1st Cir) 1976 Bichler v. Eli Lilly & Co., 55 NY2d 571, 450 NYS2d 776, 436 NE2d 182 1982 Bickford v. Imperial Chemicals Industries, [1998] 1 WLR 1189 (HL) Bolitho v. City & Hackney Health Authority, [1997] 4 All ER 771;[1998] AC 232 (HL); 39 BMLR 1; [1998] 1 Lloyd’s Rep Med 26 Bone Screw Products Liability Litigation, 193 F.
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