BMJ

Confidential: For Review Only

Safety of candour: How safe is an apology in open disclosure?

Journal: BMJ

Manuscript ID BMJ.2018.044752

Article Type: Analysis

BMJ Journal: BMJ

Date Submitted by the Author: 23-Apr-2018

Complete List of Authors: leung, gilberto; The University of Hong Kong, Department of surgery Porter, Gerard; The University of Edinburgh, School of Law

Keywords: duty of candour, apology law, open disclosure, liability, medico-legal

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1 2 3 Title 4 5 Safety of candour: How safe is an apology in open disclosure? 6 7 8 9 Authors 10 11 Confidential: For Review Only Gilberto K K Leung, Gerard Porter 12 13 14 15 16 Address and position for each author 17 18 Gilberto K K Leung, Department of Surgery, Li Ka Shing Faculty of Medicine, 19 20 The University of Hong Kong, Queen Mary Hospital, 102 Pokfulam Road, 21 22 Hong Kong. 23 24 Clinical Professor 25 26 27 28 29 Gerard Porter, School of Law, The University of Edinburgh, Old College, 30 31 South Bridge, Edinburgh, EH8 9YL, United Kingdom. 32 33 Lecturer 34 35 36 37 Correspondence: 38 39 40 Professor Gilberto K.K. Leung. Address as above. Email: [email protected]; 41 42 Tel: +852 22553368; Fax: +852 28184350. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 2 of 15

1 2 3 Safety of candour: How safe is an apology in open disclosure? 4 5 6 7 8 9 Introduction 10 11 Confidential: For Review Only

12 13 1 2 14 Under the statutory duty of candour in , and , 15 16 health service organisations and practitioners must give a factual account of 17 18 all known facts and apologise to the affected parties following a notifiable 19 20 medical incident. It is widely held, and probably believed, that existing apology 21 22 laws would confer sufficient protection as to remove fears about the legal 23 24 consequences of tendering such an apology.3-4 A closer look at the complex 25 26 27 matter of apology protection suggests that the situation is likely to be far from 28 29 straightforward. 30 31 32 33 34 35 Apology protection 36 37

38 39 40 There are over 50 apology laws around the world all of which aim to 41 42 encourage apology making by preventing an apology from amounting to an 43 44 admission of fault and liability. The scope of protection varies, depending on 45 46 the definition of apology, the applicable subject matter and proceeding, and 47 48 the evidential admissibility of apology statement according to individual 49 50 statues.5 In the context of medical open disclosure, a narrowly defined or 51 52 53 narrowly construed apology provision can mean that while an expression of 54 55 sorrow (e.g., ‘I am sorry that the complication happened’) is legally protected, 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 3 of 15 BMJ

1 2 3 an admission of fault (e.g., ‘I made a mistake during surgery’) or a statement 4 5 of fact (e.g., ‘A different surgical technique should have been used’) could be 6 7 admitted as evidence to determine fault and liability. 8 9 10 11 Confidential: For Review Only In the United States (US), for example, the majority of state apology laws only 12 13 14 protect ‘partial apologies’ containing an expression of sympathy, regret or 15 16 condolence; ‘full apologies’ containing both an expression of sympathy, regret 17 18 or condolence and an admission of fault are protected in a limited number of 19 20 states.5 Degree of protection and applicable proceeding similarly varies 21 22 among state apology laws in Australia.5 Canadian apology statutes expressly 23 24 disallow the evidential admission of apology statements to determine fault but 25 26 27 disputes still arise as demonstrated by the landmark case of Robinson v 28 29 Cragg, in which a factual statement was severed from the rest of an otherwise 30 31 protected apology letter and used as evidence against the defendant.6 32 33 Currently, the Hong Kong Apology Ordinance is the only apology statue that 34 35 expressly protects factual statements.5 36 37

38 39 40 The sheer existence of an apology statue does not therefore guarantee that 41 42 all apology statements will be protected to the same extent. It is against this 43 44 backdrop that the apology laws in Great Britain will be examined further with 45 46 respect to the protection of apologies made under the statutory duty of 47 48 candour. 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 4 of 15

1 2 3 England and Wales 4 5 6 7 The Compensation Act 2006 Act applies in England and Wales. Section 2 8 9 provides that: 10 11 Confidential: For Review Only

12 13 14 An apology, an offer of treatment or other redress, shall not of itself 15 16 amount to an admission of or breach of statutory duty. 17 18 19 20 Unlike many other apology laws, apology is not defined here, and this single 21 22 provision is silent on evidential admissibility and the relevance of apology 23 24 statements to the determination of fault and liability.7 The only relevant remark 25 26 27 in the explanatory note to the Act states that “the provision is intended to 28 29 reflect the existing law”, which is not overly helpful since judicial treatment of 30 31 apologies at is a complex matter itself. English courts have 32 33 previously denied8 or accepted9 an admission of fault in apologies as 34 35 establishing liability.7 36 37

38 39 40 In all likelihood, protection for apologies made during medical open disclosure 41 42 will be limited. Under Regulation 20, which governs the duty of candour in 43 44 England and Wales, apology is defined as ‘an expression of sorrow or regret 45 46 in respect of a notifiable safety incident’ (s. 20(7)).1 The factual account of and 47 48 the apology for an incident are treated as distinct elements for inclusion within 49 50 a notification to the affected parties (s. 20(3)).1 When read in conjunction with 51 52 53 the “of itself” part of the clause in the 2006 Act, there is no good reason to 54 55 think that any apology statement other than one that expresses sorrow or 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 5 of 15 BMJ

1 2 7 3 regret would fall under the ambit of the 2006 Act. As such, even if an 4 5 admission of fault or a factual statement contained within an out-of-court 6 7 apology would not automatically amount to an admission of fault and liability 8 9 in subsequent litigation, its evidential admission will likely be allowed or 10 11 Confidential: For Review Only subject to arguably unpredictable judicial discretion. 12 13 14 15 16 So far, the 2006 Act has not been tested in this regard but the inherent legal 17 18 uncertainties should not be ignored.10 It is notable that in its advice to 19 20 members, the Medical Protection Society recommends that an appropriate 21 22 apology should take the form of “I am sorry this happened to you” as opposed 23 24 to “I am sorry I caused this to happen to you and it is my fault”.11 The 2006 25 26 27 Act does not apply at all to disciplinary hearings such as those held by the 28 7 29 General Medical Council, and makes no provision on insurance benefits. 30 31 Criminal proceedings are not covered which is of concern given the rising 32 33 number of prosecutions brought against doctors. Contrary to the widespread 34 35 belief, an apology-maker cannot actually have full confidence as to the level of 36 37 apology protection available or any assurance concerning the other 38 39 12 40 implications of an apology. 41 42 43 44 45 46 Scotland 47 48 49 50 The situation is slightly different in Scotland in that the relevant apology 51 52 53 protection is contained within the duty of candour statue itself. Section 22 of 54 55 the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 sets out the 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 6 of 15

1 2 3 Duty of Candour Procedure. Apology is defined as a “statement of sorrow or 4 5 regret in respect of the unintended or unexpected incident” (s. 23(1)), while 6 7 section 23(2) provides that: 8 9 10 11 Confidential: For Review Only An apology or other step taken in accordance with the duty of candour 12 13 14 procedure under section 22 does not of itself amount to an admission 15 16 of negligence or a breach of a statutory duty. 17 18 19 20 Again, there is no provision on admissibility. Evidential admissibility of 21 22 apologies in general is set out by the Apologies (Scotland) Act 2016, which 23 24 provides that an apology: 25 26 27 28 29 1 (a) is not admissible as evidence of anything relevant to the 30 31 determination of liability in connection with that matter, and 32 33 (b) cannot be used in any other way to the prejudice of the person by 34 35 or on behalf of whom the apology was made. (s. 1) 36 37

38 39 40 However, this Act does not apply to apologies made in accordance with the 41 42 Duty of Candour Procedure, and the reason for this exception is “to avoid any 43 44 overlap” between the two statues (s. 2(2)). In our opinion, this is an 45 46 unsatisfactory design since it remains unclear whether an apology made in 47 48 accordance with the Duty of Candour Procedure would be inadmissible as 49 50 evidence because the two statutes are supposed to direct the same treatment 51 52 53 of apologies, or is admissible because it is not covered by the Apologies 54 13 55 (Scotland) Act 2016 as suggested by some authors. As in England and 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 7 of 15 BMJ

1 2 3 Wales, apology protection in Scotland does not extend to disciplinary hearing 4 5 or criminal proceeding; the effect of an apology on insurance benefits is 6 7 equally unclear. 8 9 10 11 Confidential: For Review Only

12 13 14 Protecting mandated apologies 15 16 17 18 The main goal of apology protection in the medical context is to promote open 19 20 disclosure, enhance patient safety, improve patient satisfaction and reduce 21 22 recourse to litigation through the wider use of alternative dispute resolution. 23 24 The extent to which an apology law can achieve these depends heavily on 25 26 27 how it is perceived to operate as much as how it actually operates in practice. 28 29 The lack of sufficient or sufficiently clear protection can deter the tendering of 30 31 ‘full apologies’ or indeed any apology. Worse still, the tendency to offer 32 33 cursory ‘partial apologies’ might actually provoke or exacerbate dispute. 34 35 36 37 The problem becomes more acute where apologies are mandated. An 38 39 40 analysis of disclosure laws in the US found that apology laws with structural 41 14 42 weaknesses can reduce compliance with disclosure. Non-compliance with 43 44 the statutory duty of candour is a punishable offence in England and Wales1 45 46 and reportable in Scotland.2 The current state of affairs in Great Britain thus 47 48 puts the responsible person in the know in a difficult position. 49 50 51 52 53 What is more worrisome though is the general lack of awareness about the 54 55 limitations of existing apology protection. Under Regulation 20, a notification 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 8 of 15

1 2 3 to the affected parties must be in writing whereby various apology statements 4 5 will be coupled to an expression of sorrow or regret in a single document. A - 6 7 mistaken - assumption could be made that the entire notification will be legally 8 9 protected. But as aforementioned, a court may be prepared to redact and 10 11 Confidential: For Review Only place under legal protection certain apology statements while leaving others, 12 13 6 14 such as those pointing to the standard of care, admissible in evidence. A 15 16 compliant and well-intentioned apologiser may conceivably give a ‘full 17 18 apology’, both orally and in writing, without realising the potential legal risks 19 20 that it might incur. Some form of remedial or supportive measure is needed. 21 22 23 24 Education and training should be strengthened and give clearer guidance 25 26 27 about the nuances of apology protection and apology making. Presently, 28 29 official guidance simply re-states the existing apology provision without 30 31 additional explanation.15-16 Many stakeholders are probably unaware that their 32 33 apology statements are potentially admissible evidence in court; that an 34 35 apology could possibly void an insurance contract; and the fact that existing 36 37 apology laws do not apply to disciplinary hearing or criminal proceeding. 38 39 40 Better communication regarding these important aspects of open disclosure is 41 42 essential. A key challenge is that some of the legal issues are still clouded 43 44 with uncertainties; any ill-guided attempt at ‘clarification’ could be 45 46 counterproductive and discourage apologies altogether. 47 48 49 50 A more fundamental and effective approach would be to improve or clarify the 51 52 53 law. The least that legislators in England and Wales can do is to provide a 54 55 working definition of apology within the Compensation Act. There should be 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 9 of 15 BMJ

1 2 3 clearer guidance on admissibility in both jurisdictions, or specific provisions 4 5 added to the duty of candour statues whereby express protection of an 6 7 admission of fault, for example, can be availed but limited to apologies made 8 9 under the statutory duties. Considerations must also be given to the effect of 10 11 Confidential: For Review Only an apology on insurance contract. 12 13 14 15 16 Whether the scope of apology protection should indeed be expanded is 17 18 debatable. On one hand, it has been recommended that apology laws should 19 20 be drafted in more expansive terms than other statues where disclosure and 21 22 apology are integrated, and that legal protection should apply to statements of 23 24 explanation and fault as well as sympathy.17 The Victorian Government in 25 26 27 Australia has already made a similar recommendation seeking amendments 28 29 to the Wrongs Act 1958 so that apologies are not admissible as evidence of 30 31 fault or liability.18 On the other hand, it can be argued that a healthy degree of 32 33 judicial discretion is necessary in deciding whether apology statements of high 34 35 probative value should be admitted lest apology protection interferes with a 36 37 claimant’s rights to justice unduly. 38 39 40 41 42 In any event, a significant change in apology protection is unlikely within Great 43 44 Britain in the near future. The two duty of candour statues are still in their 45 46 early days. In its post-legislative assessment of the Compensation Act, the 47 48 Ministry of Justice found no reason for changing the apology provision.19 49 50 During the implementation of the Apologies (Scotland) Act, the proposal to 51 52 53 protect statements of fact had to be withdrawn due to strong political 54 55 opposition. Education and training appears to be best way forward. 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 10 of 15

1 2 3 4 5 6 7 Conclusion 8 9 10 11 Confidential: For Review Only The prevailing notion that apology laws in England and Wales, and Scotland, 12 13 14 will provide sufficient protection to complement the statutory requirement for 15 16 apologies is not well supported. The foregoing analysis affirms an earlier 17 18 concern that the inclusion of a requirement for apologies under the statutory 19 20 duty of candour can be problematic.20 The current lack of sufficient and 21 22 sufficiently clear apology protection can hamper the implementation of the 23 24 statutory duties and put compliant apologisers unknowingly at risks. 25 26 27 Greater clarity in the way apology provisions will be interpreted and applied is 28 29 needed. Legislative steps to broaden the scope of apology protection, though 30 31 challenging and contestable, will facilitate the exercise of candour and the 32 33 safer use of mandated apologies to the ultimate benefit of patients and their 34 35 carers. Meanwhile, health service organisations and professionals should be 36 37 made aware of the scope and limitations of current apology protection without 38 39 40 being discouraged from giving proper and effective apologies. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 11 of 15 BMJ

1 2 3 Key messages: 4 5 6 • Health service organisations and practitioners in Great Britain must 7 8 apologise to the affected parties following a notifiable medical incident 9 10 but the level of apology protection is unclear. 11 Confidential: For Review Only 12 13 • Some apology statements could be admissible as evidence in litigation 14 15 and potentially affect insurance benefits. 16 17 • Professional disciplinary hearings and criminal proceedings are not 18 19 covered. 20 21 • Legal clarity and appropriate guidance for health service providers and 22 23 24 professionals is paramount. 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 12 of 15

1 2 3 References: 4 5 6 7 1.Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, 8 9 and (Amended) Regulations 2015, s. 20. 10 11 Confidential: For Review Only 2. Health (Tobacco, Nicotine etc. and Care) (Scotland) 2016. 12 13 14 3. Compensation Act 2006. 15 16 4. Apologies (Scotland) Act 2016. 17 18 5. Kleefeld JC. Promoting and protecting apologetic discourse through law: a 19 20 global survey and critique of apology legislation and case law. Oñati Socio- 21 22 Legal Series 2017;7(3):455-96. Available from: 23 24 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3028811 (accessed 29 25 26 27 January 2018). 28 29 6. Robinson v Cragg, 2010 ABQB 743. 30 31 7. Vines P. Apologies and civil liability in England, Wales and Scotland: the 32 33 view from elsewhere. Edin Law Rev 2008; 12(2): 200-30. 34 35 8. Muir v Glasgow Corporation [1943] AC 448. 36 37 9. Young v Charles Church (Southern) Ltd. (1998) 39 BMLR 146. 38 39 40 10. Godlee F. It’s time to apologise. BMJ 2015:351:h4695. 41 42 11. Medical protection Society. ‘Apologies’ – our advice to members (March 43 44 2016). Available from: http://www.medicalprotection.org/docs/default- 45 46 source/pdfs/factsheet-pdfs/england-factsheet-pdfs/apologies.pdf?sfvrsn=6 47 48 (accessed 16 February 2018). 49 50 12. Quick O. Regulating and legislating safety: the case of candour. BMJ Qual 51 52 53 Saf 2014;23(8):614-8. 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 13 of 15 BMJ

1 2 3 13. Stephenson DA. The Scottish statutory duty of candour. Edinburgh L Rev 4 5 2016;20:224-9. 6 7 14. Mastroianni A, Mello MM, Sommer S, Hardy M, Gallagher TH. The flaws 8 9 in state ‘apology’ and ‘disclosure’ laws dilute their intended impact on 10 11 Confidential: For Review Only malpractice suits. Health Affairs 2010;29(9):1611-9. 12 13 14 15. NHS Litigation Authority: Saying sorry. Available from: 15 16 https://resolution.nhs.uk/wp-content/uploads/2017/07/NHS-Resolution-Saying- 17 18 Sorry-Final.pdf (accessed 10 February 2018). 19 20 16. General Medical Council. Openness and honesty when things go wrong: 21 22 the professional duty of candour (June 2015). Available from: 23 24 https://www.nmc.org.uk/globalassets/sitedocuments/nmc- 25 26 27 publications/openness-and-honesty-professional-duty-of-candour.pdf 28 29 (accessed 14 February 2018). 30 31 17. National Quality Forum. Safe practices for better healthcare - 2009 32 33 update. Washington (DC): NQF;2009. Available from: 34 35 http://www.qualityforum.org/Publications/2009/03/Safe_Practices_for_Better_ 36 37 Healthcare–2009_Update.aspx (accessed 10 February 2018). 38 39 40 18. Victorian Government. Access to Justice Review (2016). Available from: 41 42 https://engage.vic.gov.au/accesstojustice (accessed 10 February 2018). 43 44 19. Ministry of Justice. Memorandum to the Justice Select Committee: Post- 45 46 Legislative Assessment of the Compensation Act 2006 January 2012. 47 48 20. Nisselle P. Duty of candour should not be tied to an apology. BMJ 49 50 2015;351:h5473. 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 14 of 15

1 2 3 Contributors and sources: 4 5 6 7 Professor Gilberto K.K. Leung is an academic neurosurgeon at the University 8 9 of Hong Kong, and holds a degree in LLM (Medical Law and Ethics) from the 10 11 Confidential: For Review Only University of Edinburgh. He serves as the guarantor of the article. Mr Gerard 12 13 14 Porter is a Lecturer in Medical Law and Ethics at the University of Edinburgh. 15 16 17 18 Both authors contributed to the central arguments and the writing of this 19 20 Analysis. The authors declare that this article represents their original work 21 22 based on primary literature research. The corresponding author attests that all 23 24 listed authors meet authorship criteria and that no others meeting the criteria 25 26 27 have been omitted. 28 29 30 31 32 33 Conflict of interest: 34 35 36 37 We have read and understood BMJ policy on declaration of interests and 38 39 40 declare that we have no competing interests. 41 42 43 44 45 46 Licence: 47 48 49 50 The Corresponding Author has the right to grant on behalf of all authors and 51 52 53 does grant on behalf of all authors, a worldwide licence to the Publishers and 54 55 its licensees in perpetuity, in all forms, formats and media (whether known 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj Page 15 of 15 BMJ

1 2 3 now or created in the future), to i) publish, reproduce, distribute, display and 4 5 store the Contribution, ii) translate the Contribution into other languages, 6 7 create adaptations, reprints, include within collections and create summaries, 8 9 extracts and/or, abstracts of the Contribution, iii) create any other derivative 10 11 Confidential: For Review Only work(s) based on the Contribution, iv) to exploit all subsidiary rights in the 12 13 14 Contribution, v) the inclusion of electronic links from the Contribution to third 15 16 party material where-ever it may be located; and, vi) licence any third party to 17 18 do any or all of the above. 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj