Patient safety and the problem and potential of law

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1 Patient safety and the problem and potential of law Oliver Quick Introduction This article considers whether law helps or hinders patient safety. 1 This is a difficult question to address, not least because it depends on how we define patient safety and law in the first place. Little, if anything, which takes place in healthcare is irrelevant to the safety of patients. Indeed, a comprehensive examination of patient safety would encompass the performance (and interaction) of all health professionals, and extend to the work of cleaners and porters, the design of buildings, the manufacture of drugs and devices, the effect of policy and management, and the design and funding of health systems. We might think that law is fairly well defined, but again, at its broadest it includes all the laws, regulations and guidelines which have some connection to improving safety in healthcare. However, this article focuses on established hard law mechanisms for responding to patient safety episodes, which largely revolve around the tort of negligence, and to a lesser extent, criminal law. These legal mechanisms are not designed primarily with patient safety in mind; at best, safety is an indirect side effect to the dominant issues of accountability, compensation and punishment. Furthermore, they do not operate in isolation and are best understood alongside related formal and informal rules of professional regulation and complaint systems. 2 Whilst it is difficult and somewhat artificial to try and isolate the effect of law from these other mechanisms, this article will try to understand whether there is (or could be) a connection between liability systems, legal rules and the safety of patients. It is frequently asserted that tort law, and the threat of tort law, is unhelpful in terms of patient safety as the fear of litigation discourages the open admission of error. 3 For the same reasons, the severe option of criminalising medical mistakes is also viewed negatively from a safety culture perspective. 4 However, this article will try and move beyond pessimistic accounts of law and the legal system to consider their potential for improving patient safety. In addition to the tort system, this requires attention to no-fault systems for dealing with medical error, especially those operating in New Zealand and the Nordic countries. There is also the underused option of pursuing healthcare providers 1 The focus is on England & Wales, although reference will be made to material and developments in other countries, notably America and Australia. 2 This article focuses on civil and criminal law mechanisms for attempting to secure patient safety. For discussion of the contribution of the NHS complaints system and professional regulation see: L Mulcahy, Disputing Doctors: The Socio-Legal Dynamics of Complaints about Medical Care (Buckingham: Open University Press, 2003) and M Davies, The demise of professional self-regulation? Evidence from the ideal type professions of medicine and law (2010) Journal of Professional Negligence 26 (1) Ian Kennedy (Chair), Learning from Bristol: The Report of the Public Inquiry into Children s Heart Surgery at the Bristol Royal Infirmary (Cm 5207, 2001) at recommendations 33 and O Quick, Medicine, Mistakes and Manslaughter: A Criminal Combination? (2010) 69 Cambridge Law Journal Prof Negligence-28.2.indd 78 02/07/ :30

2 Patient safety and the problem and potential of law directly for failing to provide a safe healthcare environment, or more onerously for breach of a non-delegable duty of care. The radical option of creating specially designed Health Courts, as suggested by scholars in the USA, will also be considered. However, the biggest omission is the absence of a legal duty of candour. It will be argued that law should support the ethical case for honesty by imposing a legal duty on healthcare professionals and providers of care to openly disclose adverse events to their patients. The Department of Health s recent consultation which proposes to incorporate a commitment to openness as a term in NHS Standard Contracts is a poor substitute for a statutory duty. Finally, whilst criminal law is seemingly unhelpful from a safety perspective, the overlooked option of existing health and safety law offers some promise. But this article will begin by setting out the nature and the problem of patient safety. 1. Patient safety The term safety is increasingly used in a variety of contexts in modern society, yet what does it actually mean? Safety is generally defined as freedom from hazard which increases as risk is reduced. 5 It involves planning the design of systems, products, processes and influencing the behaviour of individuals and institutions in order to prevent harm, and is demonstrated by reference to evidence, for example surgical complication rates. Yet safety is also deeply psychological in that we commonly feel safe when confronted by familiar and re-assuring images. Vincent has defined patient safety as [t]he avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare, and reminded us that whilst it ought to be the priority, in reality it competes with other important objectives such as efficiency and the effective use of resources. 6 However, patient safety is now recognised as an important global public health issue, albeit after a somewhat belated recognition of the size of the problem. Systematic attempts to investigate medical error only emerged in the second half of the twentieth century. From the 1960s onwards data started to accrue, suggesting that a high proportion of hospital patients experienced preventable iatrogenic harm. This attracted little attention until the 1990s, when the data were converted into estimates of the number of people in the US who died each year from iatrogenic injury (180,000), and (strikingly) of what this equated to in terms of jumbo jet crashes (three every two days). 7 Media coverage of these estimates greatly raised public awareness of the scale of the problem. 8 Yet, the 1990s also saw the emergence in the mainstream medical literature of a coherent challenge to the so-called bad apple theory of medical harm. This was based on the erroneous belief that flawed individuals (as opposed to failing systems) were the main cause of medical errors. Most notably, two Boston based physicians, Don Berwick and Lucian Leape, inspired by work in human factors and cognitive psychology 9 argued that insights from research into human error and systems failures could be applied to good effect in hospital 5 B Runciman et al, Safety and Ethics in Healthcare: A guide to getting it right (Aldershot, Ashgate, 2007) at p 2. 6 C Vincent, Patient Safety (2010) (Chichester, Wiley-Blackwell, 2010) at p L Leape, Error in Medicine (1994) 272 (23) Journal of the American Medical Association H T O Davies and A V Shields, Public trust and accountability for clinical performance: lessons from the national press reporting of the Bristol hearing (1999) 5 Journal of Evaluation in Clinical Practice 335 and M L Millenson, Pushing the profession: how the news media turned patient safety into a priority (2002) 11(1) Quality and Safety in Healthcare J Reason, Human Error (Cambridge, Cambridge University Press, 1990) Prof Negligence-28.2.indd 79 02/07/ :30

3 Professional Negligence, Vol. 28 No. 2, 2012 medicine. 10 These enlightened practitioners recognised that many safety problems arose as a result of the complexity of healthcare delivery systems. They recommended that efforts to identify and investigate errors be made routine, and that healthcare delivery systems be redesigned to reduce the likelihood of errors (eg by reducing reliance on human memory and standardising processes) and to increase the chances of intercepting errors before they cause harm (eg by building in multiple checking procedures). 11 These ideas moved into mainstream thinking about healthcare quality with the publication of the landmark report, To Err is Human. 12 This report emphasised the scale of the problem of errors and harms in healthcare and the fact that these problems were mainly attributable to features of healthcare delivery systems rather than individual health professionals. In the UK, the publication by the Chief Medical Officer of An Organisation with a Memory repeated this call for a paradigm shift and had a similarly energising effect. 13 These two major reports have inspired what is now a busy research area. There is no longer, as Charles Vincent opined in 1989, a negligent lack of research into errors and safety. 14 Reflecting the multi-disciplinary nature of healthcare safety, a substantial body of work is emerging from psychology, 15 medical sociology, 16 policy studies, 17 health services research 18 and medico-legal studies. 19 Encouragingly, the foundational work of Don Berwick, Lucian Leape, and Charles Vincent has been continued by an enthusiastic new generation of patient safety heroes, physician and policy activists such as Atul Gawande and Peter Pronovost. 20 In the UK, research is supported through a Patient Safety Research Portfolio 21 and the establishment of two Patient Safety and Service Quality research units at Imperial and Kings Colleges. Nevertheless, despite its higher profile, it remains a poor relation within academic medicine, although efforts to stimulate the science of healthcare improvement are underway D M Berwick, Continuous Improvement as an Ideal in Health Care (1989) 320 (1) The New England Journal of Medicine, pp 53 56, L Leape (1994) above note L L Leape, A systems analysis approach to medical error (1997) 3 (3) Journal of Evaluation in Clinical Practice Institute of Medicine, To Err is Human: Building a Safer Healthcare System (National Academy Press, Washington 1999). 13 Department of Health, An organisation with a memory: Report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer (London, The Stationery Office, 2000). 14 C Vincent, Risk, safety and the dark side of quality (1997) 314 British Medical Journal C Vincent et al, Medical Accidents (Oxford, Oxford University Press, 1993) and Patient Safety (Chichester, Wiley- Blackwell, 2010). 16 M S Bogner, Human Error in Medicine (Hillsdale, New Jersey, Lawrence Erlbaum Associates, 1994) M Dixon- Woods, Why is Patient Safety so hard? A Selective Review of Ethnographic Studies (2010) 15(1) Journal of Health Services Research & Policy M M Rosenthal, L Mulcahy & S Lloyd-Bostock (eds) Medical Mishaps: Pieces of the Puzzle (Buckingham, Open University Press, 1999). 18 J Waring, Constructing and re-constructing narratives of patient safety (2009) 69 Social Science & Medicine V A Sharpe and A I Faden, Medical Harm: Historical, Conceptual and Ethical Dimensions of Iatrogenic Illness (Cambridge, Cambridge University Press, 1998) A Merry and A McCall Smith, Errors, Medicine and the Law (Cambridge, Cambridge University Press, 2001), Linda Mulcahy, above note See A Gawande, Better: A Surgeon s Notes on Performance (London, Profile, 2007) and The Checklist Manifesto: How to Get things Right (London, Profile, 2009), P Pronovost, Safe Patients, Smart Hospitals (New York, Penguin, 2010). 21 J Waring et al, Narrative review of the UK patient safety portfolio (2010) 15(1) Journal of Health Services Research & Policy The work of Peter Pronovost in the USA is perhaps the best example, see above note 20. In the UK, see for example, the appointment by University College London of a Professor of Healthcare Improvement, Professor Martin Marshall Prof Negligence-28.2.indd 80 02/07/ :30

4 Patient safety and the problem and potential of law 2. The tort system and patient safety In the UK, most actions in the tort of negligence proceed against NHS trusts as vicariously liable for the conduct of their staff. Actions can also be brought against general practitioners or hospital doctors working privately. In practical terms, the NHS has provided indemnity for hospital doctors since and GPs and dentists are compelled to have private medical insurance, usually with the Medical Defence Union or the Medical Protection Society, as are hospital doctors working privately. In England, claims are managed by the NHS Litigation Authority which administers the Clinical Negligence Scheme for Trusts, which incentivises safety by offering subscription discounts for compliance with its risk management standards. 24 In Wales, similar functions are performed by the Welsh Risk Pool, a mutual self-assurance scheme, and Legal and Risk Services, which acts for all trusts and health boards. 25 Medical negligence causes physical, emotional and financial costs, although it is the latter which has dominated public and academic concern, with significant increases in both the number of claims and size of payouts. Historically, whilst the number of claims increased with the introduction of the National Health Service, compared with other areas of litigation, they remained low. In 1978, the Royal Commission on Personal Injury Compensation estimated that there were about 500 claims against medical services (doctors, dentists and pharmacists) per year (1978: 2). The 1980s witnessed a growth in the number of claims (up by approximately 500%) and an increase in the costs of settling claims (up by about 250%). 26 Research by Fenn et al suggested that the volume of litigation in 1998 was more than twice the level at the beginning of the 1990s. 27 In the period between 1978 and 2006, the level of claims increased dramatically by 1,200 per cent. 28 In 2010/11, 8,655 claims of clinical negligence and 4,346 claims of non-clinical negligence against NHS bodies were received by England s NHS Litigation Authority. In terms of financial cost, 863 million was paid in connection with clinical negligence claims during 2010/ This has fuelled fears of a compensation culture or a claims crisis, which is perceived negatively given the suggestion of bogus claims and a decline of individual responsibility. 30 However, research evidence from both the UK and USA suggests that such claims are exaggerated, if not wholly misleading. In 1991, the Harvard medical practice study found that there were 8 times as many adverse events as claims. 31 This has subsequently led to claims from the US that there is an epidemic of malpractice, not of malpractice litigation. 32 In the 23 Health Circular (89) 34, now covered by HSG (96) See (Accessed 13 April 2012). 25 See (Accessed 13 April 2012). 26 K Walshe, Medical accidents in the UK: a wasted opportunity for improvement? pp at 69 in M M Rosenthal, L Mulcahy & S Lloyd-Bostock (eds) Medical Mishaps: Pieces of the Puzzle (Buckingham, Open University Press, 1999). 27 See, for example: P Fenn et al, Current cost of medical negligence in NHS hospitals: analysis of claims database (2000) 320 British Medical Journal V Harpwood, Medicine, Malpractice and Misapprehensions (Abingdon, Routledge-Cavendish, 2007) 2. Harpwood notes that the various data measurement mechanisms all have limitations, so that obtaining a complete picture is likely to be impossible. 29 See: (accessed 13 April 2012). 30 F Furedi, Courting Mistrust (Centre for Policy Studies, 1999). 31 T A Brennan et al, Incidence of adverse events and negligence in hospitalised patients: Results of the Harvard Medical Practice Study I (1991) 324 New England Journal of Medicine T Baker, The Medical Malpractice Myth (Chicago, University of Chicago Press, 2005) Prof Negligence-28.2.indd 81 02/07/ :30

5 Professional Negligence, Vol. 28 No. 2, 2012 UK, numerous scholarly reviews have exposed the claim of a compensation culture for a lack of evidence, 33 leading Williams to conclude that the British are a nation of lumpers rather than litigators. 34 Unfortunately, the UK government has peddled the myth of a compensation culture in its terms of reference to Lord Young s review of health and safety laws. 35 And despite acknowledging that the idea of a compensation culture is driven by perceptions rather than reality, the report nevertheless buys into this premise with scant regard to the available evidence. 36 The fear of a flood of bogus claims is not supported by research evidence from the USA, which suggests that the tort system is adept at separating meritorious from unmeritorious cases. 37 In short, there is little evidence of a compensation culture, and in fact, substantial evidence that only a minority of potential claimants turn to law. This is not to deny the problem of the rising costs of claims, but the bigger problem is the lack of safety culture which warrants much greater attention. It is thus regrettable that the Young report is based on the assumption of an over the top safety culture when, certainly in healthcare, the prevailing culture of safety is relatively weak. Most commentators doubt a strong correlation between the tort system and patient safety. For some, they are culturally incompatible: the name and shame aspect of liability encourages secrecy rather than the candour essential for patient safety. 38 Of course, improving patient safety through deterring bad practice is somewhat secondary to tort s principal aim of compensation. Whilst the corrective justice rationale might work for the minority who are compensated, in that the wrongdoer has had to make financial amends for the victim s harm, it does nothing for the broader (and much bigger) problem of tackling unsafe cultures. And if survey research is to be believed, even the desire for compensation is questionable, given the conclusion that complainants are motivated more by explanations and apologies rather than money. 39 In short, tort law is not designed for patient safety, and as Miola reminds us, is only a retrospective remedy to compensate those who bring legal actions. 40 Jackson has similarly argued that tort law offers limited protection for patient autonomy despite seeming to punish the negligent failure to disclose required information R Dingwall, Litigation and the threat to medicine pp in J Gabe et al (eds.) Challenging Medicine (London, Routledge, 1994), R Lewis, A Morris and K Oliphant Tort Personal Injury Claims Statistics: Is There a Compensation Culture in the United Kingdom? (2006) 14(2) Torts Law Journal , and A Morris, Spiralling or Stabilising? The Compensation Culture and our Propensity to Claim Damages for Personal Injury (2007) 70 (3) Modern Law Review and A Morris, Common sense common safety : the compensation culture perspective. (2011) 27 (2) Journal of Professional Negligence K Williams, State of fear: Britain s compensation culture reviewed (2005) 25 (3) Legal studies Lord Young of Graffham (2010) Common Sense Common Safety: A report by Lord Young of Graffham to the Prime Minister following a Whitehall wide review of the operation of health and safety laws and the growth of the compensation culture (London, Cabinet Office). 36 See A Morris, Common sense common safety : the compensation culture perspective (2011) 27 (2) Journal of Professional Negligence D Studdert et al, Claims, Errors and Compensation Payments in Medical Malpractice Litigation (2006) 354 New England J of Med Ian Kennedy (Chair), Learning from Bristol: The Report of the Public Inquiry into Children s Heart Surgery at the Bristol Royal Infirmary (Cm 5207, 2001) at recommendations 33 and S Lloyd Bostock and L Mulcahy, The Social Psychology of Making and Responding to Hospital Complaints: An Account Model of Complaint Processes (1994) 16 (2) Law & Policy 123, and more generally, R M Kowalski, Whining, griping and complaining: Positivity in the negativity (2002) 58 (9) Journal of Clinical Psychology J Miola, The tort of negligence and patient safety pp in J Tingle and P Bark, Patient Safety, Law Policy and Practice (Abingdon, Routledge, 2011). 41 Jackson, Informed Consent to Medical Treatment and the Impotence of Tort pp in S McLean (ed) First Do No Harm: Law, Ethics and Healthcare (Aldershot, Ashgate, 2006) Prof Negligence-28.2.indd 82 02/07/ :30

6 Patient safety and the problem and potential of law Important common law decisions reveal no consistent approach in favour of respecting patient safety. The well known direction of McNair J in Bolam v Friern Hospital Management Committee 42 that A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, set the scene for the medicalisation of the standard of care. Tort law scholars have long noted that Judge McNair s direction was misinterpreted so that evidence about common professional practice appeared to be determinative rather than suggestive of the issue of negligence. 43 Yet judges opted for the latter approach, probably reflecting a deliberate policy of judicial paternalism towards the medical profession and fuelled by the fear of a litigation crisis, leading to claims about the professionalisation and Bolamisation of medical law. 44 However, the 1990s signalled the beginning of increased judicial interventionism in relation to the standard of care. Prior to this, there were only sporadic instances of judicial unease with Bolam. The House of Lords decision in Bolitho And Others v City and Hackney Health Authority 45 restored the conventional position in tort law, and thus potentially heralded the re-birth of external evaluation of the standard of care: in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning the defendant s conduct, the defendant can properly be held liable for negligence In my judgment that is because, in some cases, it cannot be demonstrated to the judge s satisfaction that the body of opinion relied upon is reasonable or responsible. Any suggestion that such sentiments signal a departure from judicial deference requires evidence: specifically, are judges more inclined to consider expert opinion as unreasonable or irresponsible and thus find in favour of claimants? The post Bolitho case law reveals some preliminary evidence of this: of the 29 reported cases of medical negligence decided since Bolitho, 16 were decided in the claimant s favour. 46 This is modest evidence suggesting a break with the previously defendant friendly system. And it appears that judges are not confining their renewed confidence to cases of informed consent, as initially predicted, 47 but also to cases based on technical competence or clinical judgment. There is thus some, albeit limited, evidence that judges are re-asserting their control over what constitutes reasonable care. However, other related decisions reflect the fact that tort law is not primarily concerned with the issue of patient safety. Thus whilst a majority of the House of Lords appeared to bend the rules on causation in Chester v Afshar 48 in the name of patient autonomy, and by association patient safety, a majority in Gregg v Scott 49 refused to recognise the claim for loss of chance of recovery following delayed diagnosis. The very 42 [1957] 2 All ER 118, at A Grubb, Causation and the Bolam test; Bolitho v City & Hackney Health Authority [1993] 1 (2) Medical Law Review 241, at J Montgomery, Medicine, Accountability, and Professionalism (1989) 16(2) Journal of Law and Society , at p 327, M Brazier & J Miola Bye bye Bolam: A medical litigation revolution? (2000) 8 Med L Rev at p [1997] 3 WLR 1151 at Cases analysed on Westlaw up until 24th January M Jones, Informed Consent and Other Fairy Stories [1999] 7 (2) Med Law Review [2004] UKHL 41. Whether in fact this did amount to bending the rules is, of course, a moot point, see: J Stapleton, Occam s Razor Reveals an Orthodox Basis for Chester v Afshar (2006)122 Law Quarterly Review [2005] UKHL 2; [2005] 2 AC Prof Negligence-28.2.indd 83 02/07/ :30

7 Professional Negligence, Vol. 28 No. 2, 2012 few cases of alleged medical negligence such as this which go to trial are not driven by the pursuit of patient safety. The main aim is to interpret the evidence appropriately in order to determine whether the elements of the tort of negligence have been established on the balance of probabilities. The question of what is in the best interests of the safety of patients is, at best, a background consideration. The most promising rationale for a connection between tort law and patient safety is that the threat of litigation deters dangerous practice the so-called defensive medicine thesis. It is important to note that this is not necessarily consistent with safety in that caution and conservatism may be unsafe in certain situations (ie not doing something for fear of being sued). A safer medicine thesis is arguably a more appropriate term. Clearly, deterrence theory has intuitive appeal in the hope that rational actors and systems will want to minimise harms and thus implement error learning and prevention strategies. It is also inspired by an optimistic belief in the ability to train individuals and design systems in a way which discourages unsafe practices. Nevertheless, there is no clear evidence connecting the threat of civil action with safer healthcare. Whilst respected commentators have long noted that litigation is a threat to clinical autonomy 50 there is scant research interrogating its linkages to safety directly, and any indirect evidence remains inconclusive. This is not to say that complaints and litigation have no effect on medical practice. For example, Mulcahy found that better note keeping and more detailed consultations were common reactions to the fear of litigation and complaints. 51 More generally, attention to the litigation system also sheds light on the issue of medical harm which has been a springboard for the study of patient safety. And the fear of litigation is likely to play some role in encouraging institutions to take patient safety seriously. This is partly based on the realist belief that financial penalties and shame are the only strategies that work. For example, George Annas cites the safety progress made by anaesthetists as an exemplar of what litigation can do in arguing for a legal right to safety. 52 However, literature reviews in both the US and the UK have found no firm evidence supporting deterrence theory. 53 Without sufficient empirical evidence, it is difficult to draw any firm conclusions on the linkages between litigation and patient safety. However, tort law is always likely to be limited in terms of safety. Safety goes beyond concern with errors and harmful outcomes, and extends to the cultural and communication problems which conspire to deliver unsafe healthcare and near misses. The cases which navigate the tort system are only the tip of the iceberg, which raises legitimate doubts about the merits of spending a disproportionate amount of time (and money) on a relatively small number of events. The narrow legalistic focus of tort law, beset by the professionally threatening term negligence, is likely to impede rather than improve safety. Furthermore, the law and system of negligence have not delivered the compensatory and deterrent effects desired, thus giving just cause to 50 R Dingwall, Litigation and the threat to medicine pp46 64 in J Gabe et al (eds) Challenging Medicine (London, Routledge, 1994). 51 L Mulcahy, 2000 From fear to fraternity: a socio-legal analysis of doctors responses to being called to account. (Unpublished PhD thesis, University of North London). 52 G Annas, The Patient s Right to Safety Improving the Quality of Care through Litigation against Hospitals (2006) 354 New England J of Medicine M M Mello and T A Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform (2002) 80 Texas Law Review 1595, P Fenn et al, Deterrence and Liability for Medical Negligence: Theory and Evidence Paper presented at the 19th Annual Conference of the European Association of Law and Economics, Athens, September Prof Negligence-28.2.indd 84 02/07/ :30

8 Patient safety and the problem and potential of law consider alternative options. But to what extent are these alternatives any better from a safety standpoint? 3. Safer alternatives? (a) No-fault systems Despite frustration with its inefficiency and unfairness, and high profile calls for its abolition 54 the use of tort law to deal with malpractice remains stable in the Anglo- American world. What about the experience of countries such as Denmark, France, Sweden and New Zealand which have established no-fault compensation schemes? Regrettably, in the absence of clear evidence, we are unable to reliably measure the potential safety gains of no-fault systems. Trends in the number of compensation claims is unlikely to be an accurate indicator of safety levels given that removing the burden of proving fault is likely to lead to a culture of entitlement regarding compensation. It is thus more realistic to consider whether such systems are more conducive to creating the open and honest climate necessary for a safety culture. The most well known scheme is that introduced by the Accident Compensation Act 1972 and administered by its Accident Compensation Corporation (ACC) in New Zealand. 55 It only became truly no-fault in 2005 with the replacement of the term medical misadventure with the broader concept of treatment injury. In New Zealand, injuries are potentially compensable unless a necessary part of the treatment or part of the ordinary consequences of treatment. This has benefitted claimants with an increase in accepted claims and a reduction in delay. 56 In theory, this is also good news for patient safety: the replacement of the fault based term medical misadventure was accompanied by a renewed attempt by the ACC to focus on safety culture. However, the decision to focus on treatment injury, rather than preventability, and thus on outcomes rather than processes of care, is a limitation from a safety perspective. Unlike the models in Sweden and Denmark, there is no Chinese wall between compensation cases and disciplinary action, as cases may be referred to the disciplinary bodies where there is a risk of harm to the public, which broadly interpreted, could include almost all cases, but in practice is interpreted to mean exceptional cases. 57 In terms of a connection between no-fault and patient safety, Ken Oliphant s review of the New Zealand system concluded that this remains an open question. 58 Similarly, in a careful review of the evidence, Stephen Todd is cautious about the claim that no-fault means safer care, and is only able to conclude that there is little evidence that barring tort claims has compromised safety standards. 59 And studies suggest that the incidence of adverse events in New Zealand hospitals at 54 Lord Pearson, Royal Commission on Civil Liability and Compensation for Personal Injury Cmnd 7054 (1978), Ian Kennedy (chair), Learning from Bristol: The Report of the Public Inquiry into Children s Heart Surgery at the Bristol Royal Infirmary (Cm 5207, 2001) p Accident Compensation Act See K Oliphant, Beyond Misadventure: Compensation for Medical Injuries in New Zealand (2007) 15 Medical Law Review , and S Todd, Treatment Injury in New Zealand (2011) 86 Chicago-Kent Law Review Between July 2005 to June ,661 such cases which were referred by the ACC, see Todd ibid at p K Oliphant, Compensation, Ideology and Patient Safety in New Zealand s No-Fault System (2009) 3 Opinio Juris in Comparatione. 59 S Todd, above note 56 at Prof Negligence-28.2.indd 85 02/07/ :30

9 Professional Negligence, Vol. 28 No. 2, % is very similar to that in the UK. 60 Yet, there is some evidence that information about adverse events appears to be annotated in detail in patient medical records in New Zealand, and that this might be connected to the system of no-fault liability. 61 However, apart from this, there is no clear evidence or even a confident belief from within New Zealand that no-fault has helped improve safety standards. New Zealand is not alone in rejecting tort law in this context, with similar systems operating in Scandinavia, Belgium and France. In theory, the Scandinavian approach appears to take safety more seriously. For example, all the Nordic systems adopt the experienced specialist standard, which is clearly a much higher standard than the reasonable doctor test for the tort of negligence in England and Wales. If liability or compensation systems do actually have a safer medicine effect, then we might legitimately expect that raising expectations to an excellence standard encourages safety and quality. In addition, the Danish and Swedish systems place healthcare professionals and providers under an obligation to report adverse events to the public authorities, and thus submit compensation applications on behalf of patients. However, as with New Zealand there is a lack of available evidence here. A recent review of the different systems in Scandinavia, whilst noting successes in terms of compensating patients, cannot make the same claim in relation to safety. 62 In France, a medical accident scheme compensates victims irrespective of fault, although professional liability insurers pick up the bill for cases where individuals are at fault. Thus whilst legislation seeks to encourage open dialogue about medical errors between doctors, patients and public health bodies, this is tempered somewhat by the retention of liability for fault, and the additional possibility of criminal conviction for negligently causing harm. Although there is a lack of reliable statistical data in terms of whether liability rates have increased or decreased, and a lack of research interest into the linkage between the system and safety, a recent review concludes that the scheme is unlikely to have had a great impact on accident reporting. 63 Another (indirect) measurement would be to compare safety culture surveys from countries with fault and no-fault based systems. In other words, does the absence of litigation fear lead to greater openness and shared learning around safety episodes? In the absence of directly relevant research findings, we are left with clearly unreliable anecdotal evidence which regrettably doubts a connection between no-fault and safer care. Unfortunately, the data does not exist in order to make reliable safety comparisons between fault and no-fault systems. At best, we can only hope that no-fault systems create the environment conducive to openness and safety culture. 64 In the UK, a no-fault system was rejected by a somewhat thin review of the evidence conducted by the Chief Medical Officer in This was largely based on fears 60 P Davis et al, Adverse events in New Zealand public hospitals I: occurrence and impact (2002) 115 (1167) New Zealand Medical Journal U P Davis et al, Acknowledgement of no fault medical injury: review of patients hospital records in New Zealand (2003) 11 (326) British Medical Journal V Ulfbeck, M Hartlev and M Schultz, Malpractice in Scandinavia (2012) Chicago-Kent Law Review (forthcoming). 63 S Taylor, Providing Redress for Medical Accidents in France: Conflicting Aims, Effective Solutions? (2011) 2 Journal of European Tort Law M Mello, A Kachalia and D Studdert, Administrative Compensation for Medical Injuries: Lessons from Three Foreign Systems (New York, Commonwealth Fund, 2011) Prof Negligence-28.2.indd 86 02/07/ :30

10 Patient safety and the problem and potential of law about the increased cost of such systems. 65 Instead, the report recommended a package of redress measures which included systems for investigating adverse events, offering explanations and apologies, providing remedial treatment and an administrative scheme for awarding financial compensation for low value claims, with a suggested upper limit of 30,000. Whilst not the radical reform proposals which some were hoping for, these recommendations nevertheless met some of the shortcomings of the tort system. However, they were diluted even further in the preferred government scheme introduced in the NHS Redress Act Eligibility is limited by the need to establish a qualifying liability in tort, as opposed to a less onerous threshold of avoidability, and any independence is compromised by the management of the scheme by the NHS Litigation Authority and the lack of an appeals process. It does not apply to primary care practitioners and the Act is vague in terms of the important requirement for providing explanations and apologies. In short, issues of containing costs trumped those of satisfying complainants. 66 However, such criticisms seem redundant given that the scheme has not yet been implemented in England. Nevertheless, similar proposals are envisaged by Lord Young s recommendation for extending the Road Traffic Act PI Scheme to clinical negligence cases with a proposed limit of 25, A pilot study has been established by the NHSLA and is expected to start in April Meanwhile, the Welsh government has taken forward the reforms in the NHS Redress Act 2006 by passing regulations as part of its Putting Things Right project. 69 Whilst it is too early to evaluate this scheme it should be noted that it suffers from the same weaknesses discussed above in relation to the 2006 Act. Given the unlikely abolition of the medical negligence action in the Anglo-American world, progress is more likely in terms of re-designing the system by considering other ways which law may make a contribution to encouraging a culture of safety. (b) Direct liability and non-delegable duties The supposed deterrent effect of negligence actions is arguably more promising when applied to systems rather than individuals. Whilst individuals will always make mistakes, systems can be designed to minimise the risks and financial costs of safety lapses. An obvious and modest option involves looking within, rather than beyond, tort law in terms of re-focusing negligence actions around systems rather than individuals. Whilst the majority of claims proceed against NHS institutions as vicariously liable for the conduct of their employees, most cases revolve around the acts or omissions of individuals. System factors remain a sideshow to the main event of individual error. Despite judicial endorsement of direct liability for system flaws such as failing to appoint sufficiently skilled 65 Chief Medical Officer, Making Amends: A consultation paper setting out proposals for reforming the approach to clinical negligence in the NHS (Department of Health, 2003). 66 See A M Farrell and S Devaney, Making Amends or Making Things Worse? (2007) 27(4) Legal Studies Lord Young, above note 35 at For further discussion of this scheme in the context of other options for redress, see E Cave, Redress in the NHS (2011) 27 (3) Journal of Professional Negligence Ministry of Justice, Solving Disputes in the County Courts: Creating a Quicker, Simpler and More Proportionate System Consultation Paper CP6/2011 para The NHS (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011, parts of which came into force on 1 April See A L Ferguson and E Braithwaite, Putting Things Right in Wales (2012) 18 Clinical Risk Prof Negligence-28.2.indd 87 02/07/ :30

11 Professional Negligence, Vol. 28 No. 2, 2012 or experienced staff, 70 or for communication failures, 71 such cases are rare. Yet empirical evidence supports the case for realigning tort doctrine in the name of patient safety. Mello and Studdert s study of closed malpractice claims found that two-thirds of cases involved both individual and systems factors, and that systems errors are more serious, in the sense of having a stronger connection with death, and more amenable to re-design. 72 Based on these findings, a more pragmatic option would re-align tort doctrine to focus its deterrent effect on systems. It may be that such classification is purely academic and that claims against hospitals proceed on the basis of a combination of individual and system factors. But it would sharpen the focus on systems and processes of care and help us move beyond individual blame to frame claims in such a way. Another option would be to place healthcare providers under a non-delegable duty, a more onerous obligation to ensure a safe healthcare environment. The classic example is the duty of employers to employees, and its relevance to healthcare was long ago envisaged by Lord Denning in Cassidy v Minister of Health. 73 Recent support for this can be found in the case of Farraj v King s Healthcare NHS Trust 74 which involved negligent failure of communication and system flaws for investigating the reliability of genetic testing for a condition called beta thalassaemia major. The Court of Appeal assumed (without deciding) that hospitals generally owe a non-delegable duty to patients to ensure that they are treated with skill and care regardless of the employment status of the person who is treating them. As Heywood explains, on one level, the imposition of such a duty is good news from a patient safety perspective, raising the relevant expectations and standards against which hospitals are judged, in the sense of ensuring that reasonable care is taken. However, the boundaries of such a duty are far from clear, which given the potentially far reaching implications may be a cause for concern for the health system. 75 And in practice this may have little effect given that under vicarious liability hospital trusts will be liable in this way for acts of its employees and for having unsafe systems. 76 (c) Health Courts A more radical option would be the creation of specially designed Health Courts as an alternative to the traditional tort system. Drawing inspiration from the Nordic no-fault model, Mello et al claim that this would improve fairness (by compensating more patients) and enhance safety (by maximising the learning opportunities from errors). 77 Under this proposed system, patients would be compensated where harm was avoidable (as opposed to negligent) which is defined as falling short of best (rather than reasonable) practice. Raising the bar to optimum (as opposed to reasonable) care is consistent with the aim of encouraging excellent healthcare. In terms of the mechanics, there would be a three tiered structure: 70 Wilsher v Essex Area Health Authority [1987] QB 730, per Glidewell LJ at 775 and Browne-Wilkinson VC at Bull v Devon AHA [1993] 4 Med LR 117, Robertson v Nottingham Health Authority [1997] 8 Med LR 1 and Richards v Swansea NHS Trust [2007] EWHC M M Mello & D M Studdert, Deconstructing negligence: the role of individual and system factors in causing medical injury. (2008) 96 (2) Georgetown Law Journal [1951] 2 KB [2010] PIQR P7. 75 R Heywood, Non-delegable duties and hospitals (2010) 26 (1) Journal of Professional Negligence I Kennedy and A Grubb, Medical Law (3rd edition, London, Butterworths 2000) at p M Mello et al, Health Courts and Accountability for Patient Safety (2006) 84 (3) The Milbank Quarterly Prof Negligence-28.2.indd 88 02/07/ :30

12 Patient safety and the problem and potential of law initially cases would be considered by an internal hospital/insurance panel, with both the decision and amount of compensation amount reviewable by the Health Court and also recourse to an independent Appeal Court. A centralised claims database would help with learning and prevention functions. It is claimed that this will clarify the deterrent signal to providers given the greater certainty about standards and standardisation of decisions and compensation. Compliance would be incentivised by insurance surcharges where a claim has begun without prior disclosure of the adverse event by the clinician to the insurer. Whilst litigation is not the only reason for secrecy about medical errors, Mello et al claim that removing the fear of getting sued should at least improve the environment for transparency. Despite their promise, Health Courts are unlikely to solve all the problems in this area. Whilst the replacement of the pejorative term negligence is welcomed, for the same reasons the term court might have been replaced with the less threatening tribunal or inquiry. This system would also require specially trained judges and the re-training of experts used to applying negligence standards. It also faces an entrenched legal culture in the USA which defends adversarialism and the right to jury trial. Perhaps most controversially, the proposed system envisages a limited form of openness by protecting any information from the reach of regulators and departments of public health. Such guarantees of immunity are seen as a necessary compromise in the name of patient safety and will be discussed below. Chinese walls undoubtedly weaken the individual s position in terms of seeking redress, yet are arguably necessary in terms of encouraging a culture of safety. However, whilst there may be sound reasons for protecting practitioners from disciplinary investigation, there is surely no justification for withholding information from patients about their treatment, especially when adverse events have caused them harm. The next section will consider the case for a duty of candour. (d) A legal duty of open disclosure The ethical case for disclosure of errors is clear: it is about truth telling and respect for persons. 78 However, despite the plea by Sir John Donaldson MR in 1985 that thought should be given to what is the duty of disclosure owed by a doctor and a hospital to a patient after treatment 79 we remain stuck in what Leape and Berwick call an ethically embarrassing debate about whether or not to disclose harmful events. 80 Whilst all patients (and hopefully all professionals) agree with the principle of disclosure, the evidence reveals a large gap between principle and practice. A National Audit Office report in 2005 revealed that only 24% of English hospital trusts routinely informed patients who had been victims of adverse incidents. 81 Research from the USA has suggested a disclosure rate of between 30% 82 and 40%. 83 And this available evidence suggests that doctors are 78 N Berlinger, After Harm: Medical Error and the Ethics of Forgiveness (Baltimore, Johns Hopkins University Press, 2005), M L Smith, & H P Forster, Morally Managing Medical Mistakes (2000) 9 Cambridge Quarterly of Healthcare Ethics Lee v South West Thames Regional Health Authority [1985] 1 WLR 845 at L Leape, and D M Berwick, Five years after To Err Is Human : What have we learned? (2005) 293 Journal of the American Medical Association at National Audit Office, A Safer Place for Patients: Learning to improve patient safety (Stationery Office, 2005) at R J Blendon et al, Views of practicing physicians and the public on medical errors. (2002) 347 (24) New England J Med L Lopez et al, Disclosure of Hospital Adverse Events and Its Association With Patients Ratings of the Quality of Care (2009) 169 (20) Arch Intern Med Prof Negligence-28.2.indd 89 02/07/ :30

13 Professional Negligence, Vol. 28 No. 2, 2012 less likely to disclose when errors are less obvious to patients, or when there are serious adverse events. Although informing patients about adverse events is clearly the right thing to do a complex range of factors conspire to explain this disclosure gap. Doctors harbour doubts about the safety of disclosing in terms of complaints and litigation, which is consistent with a more general aversion of external accountability. 84 Thus proponents of disclosure cannot ignore the medico-legal context which discourages disclosure, what Heimer calls the new legalism of medicine. 85 Survey research in the United States and Australia confirms the suspicion that the fear of medico-legal consequences is the main barrier to the practice of open disclosure. 86 In Australia, this is despite the presence of apology laws and qualified privilege laws, although these do not protect professionals from litigation in terms of all aspects of what they might disclose. 87 In the UK, whilst we lack the same sort of survey research evidence, the statutory assurance that an apology or offer of redress is not an admission of liability or breach of statutory duty 88 is unlikely to reassure professionals into disclosing. Doctors also lack the necessary communication skills to be comfortable and effective at disclosing, which is unsurprising given that it has not featured prominently in medical education. 89 Sadly, given the credibility problem facing the science of patient safety, the soft skills required for effective disclosure have not been considered to be essential medical work, which is an indictment for a caring profession. Other likely explanations include the paternalist based fear of harming patients with the truth, and the negative resource implications of doctors spending time explaining, accounting and apologising at the bed side. Disclosure is also interesting in terms of its potential for altering the dynamics of power and trust within patient-professional relationships. Whilst disclosure is crucial to a patient centred health system, the face to face accountability it requires challenges the professional dominance norm. 90 The reality that many doctors and hospitals dodge the issue of disclosure is unfortunate for a number of reasons. There is evidence that disclosure assists the learning central to improving safety culture. And there is some research suggesting that not only do patients want disclosure, but that it may also, counter intuitively, increase their perception of the quality of care. Thus Lopez et al found that disclosure of adverse events doubled the odds of patients giving high ratings to the quality of care even amongst patients suffering harm as a result. 91 Many have (hopefully) suggested that disclosure also decreases the risk of litigation yet the empirical evidence for this is currently somewhat thin. Studdert 84 L Mulcahy, above note C A Heimer, Thinking about how to avoid thought: Deep norms, shallow rules, and the structure of attention (2008) 2 Regulation & Governance at T H Gallagher et al, Patients and physicians attitudes regarding the disclosure of medical errors (2003) 289 J of the American Medical Association , and D Studdert et al, Legal aspects of open disclosure II: attitudes of health professionals findings from a national survey (2010) Vol 193 (6) Medical Journal of Australia D Studdert and M Richardson, Legal aspects of open disclosure: a review of Australian law (2010) 193 (5) Medical Journal of Australia Compensation Act 2006, s L Leape et al, Unmet Needs: Teaching Physicians to Provide Safe Patient Care (Report of the Lucian Leape Institute Roundtable on Reforming Medical Education, 2010). 90 The notion of professional dominance and whether it continues to appropriately describe the modern medical profession is discussed further in O L Quick, Regulating Safety and Trust in Medicine: Protecting Patients and Professions (Cambridge, Cambridge University Press, forthcoming). 91 L Lopez et al, Disclosure of Hospital Adverse Events and Its Association With Patients Ratings of the Quality of Care (2009) 169 (20) Quality of Care Arch Intern Med Prof Negligence-28.2.indd 90 02/07/ :30

14 Patient safety and the problem and potential of law et al, in a study drawing on the opinions of 78 experts, suggest that disclosure is an implausible risk management strategy, concluding that more disclosure is likely to mean more litigation and cost. 92 This is supported by a study by Wu et al suggesting that whilst disclosure increases patient trust in and ratings of physicians, it does not decrease the propensity to sue. 93 Overall, there is limited evidence, and what exists is only based on hypothetical as opposed to real experience of adverse events. 94 A notable exception is the University of Michigan Health System, which has, since 2001, operated a disclosure and offer system for medical error. Its early settlement model has no compensation cap, but an accepted offer waives the legal right to sue. 95 In a retrospective before-after analysis from , Kachalia et al present empirical evidence that the number of claims, rate of lawsuits, time for resolution and the costs have all decreased significantly. 96 Whilst the authors do not to claim a clear causal link here, given that claims declined in general in Michigan in the latter half of the study period, nevertheless, they are able to conclude that such a system does not increase costs, and quite possibly reduces cost. Hopefully this will instil some confidence in other providers to introduce similar systems. A similar reimbursement model is reflected in the 3Rs (Recognise, Respond and Resolve) system used by the COPIC insurance company in Colorado. Compensation is limited to $25,000 for expenses and $5000 for loss of time, acceptance of which does not waive legal rights, though patients pursuing litigation are not eligible for further program benefits. 97 In the UK, the National Patient Safety Agency has implemented a policy of being open 98 and the principle of openness has also been enshrined in the NHS Constitution. 99 Whilst laudable aspirations, these are unenforceable obligations at risk of getting lost amidst the masses of guidelines and policy documents directed at the health service. The ethical obligation to be open with patients who have suffered harm is also enshrined in professional guidance, 100 but to what extent is the duty of openness acknowledged in law? Whilst tort law has long considered the possibility that professionals ought to be under a legal duty of candour in relation to their work, 101 it has stopped short of recognising this. Such a duty should hardly be considered radical after all, existing tort law duties have begun to endorse the prudent patient test for determining the standard of care in relation to information disclosure before medical intervention, 102 so why not extend this to include communication after treatment? 92 D Studdert et al, Disclosure of Medical Injury To Patients: An Improbable Risk Management Strategy (2007) 26(1) Health Affairs (Milwood) A W Wu et al, Disclosing medical errors to patients: it s not what you say, it s what they hear (2009) 24(9) Journal of General Internal Medicine E O Connor et al, Disclosure of patient safety incidents: a comprehensive review (2010) 22(5) International Journal for Quality in Health Care M M Mello and T H Gallagher, Malpractice Reform opportunities for leadership by healthcare institutions and liability insurers (2010) 362 New England Journal of Medicine A Kachalia et al, Liability Claims and Costs Before and After Implementation of a Medical Error Disclosure Program (2010) 153 Ann Intern Med See M M Mello and T H Gallagher, above note National Patient Safety Agency, Patient Safety Alert: Being Open 19 November The NHS Constitution for England (2010). See part 3b which notes the duty of staff to be honest and truthful and also endorses the aim of being open when things go wrong. 100 For example, General Medical Council, Good Medical Practice 2006, paragraphs See obiter comments of Sir John Donaldson MR in Lee v South West Thames Regional Health Authority [1985] 1 WLR 845 and Naylor v Preston [1987] 1 WLR 958, at Eg Chester v Afshar [2004] UKHL 41, Birch v UCL [2008] EWHC Prof Negligence-28.2.indd 91 02/07/ :30

15 Professional Negligence, Vol. 28 No. 2, 2012 The most egregious example of the failure of tort law to endorse a duty of candour arose in the sad story of Robbie Powell, who died in 1990 after doctors failed to diagnose his Addison s disease. Whilst the Health Authority admitted liability and made a payment of 80,000 in respect of the death, in Powell v Boladz, 103 an action for psychiatric harm suffered by his parents, the Court of Appeal held that no duty of care existed between the doctor and the parents. In denying that doctors were legally obliged to explain the circumstances surrounding the death of Robbie to his parents, this was a regrettable abdication of responsibility from the Court of Appeal, and a further illustration of tort law s ambivalent relationship with patient safety. This was duly recognised in the revised GMC guidelines to practitioners in the aftermath of this case 104 yet the Powell family was refused leave to appeal to the House of Lords and was unsuccessful at the European Court of Human Rights, which endorsed the shameful situation that doctors have no duty to give parents of a child who died as a result of their negligence a truthful account of the circumstances of the death, nor even to refrain from deliberately falsifying records. 105 In fact, there followed a review by the Crown Prosecution Service about whether any offences of forgery or perverting the course of justice were committed in terms of the contents of Robbie s medical records, in addition to the offence of manslaughter by gross negligence. Although no prosecutions were brought, the fact that this was considered indicates the seriousness of this case. 106 Whilst the decision of the Court of Appeal in Powell has since been overruled by the House of Lords in a different context, 107 the common law has yet to establish a duty of candour and the Powell family continue to search for the truth. 108 Despite numerous calls for a duty of candour the plea for openness has fallen on deaf ears. 109 Reflecting a weak commitment to patient safety and patient autonomy, there remains considerable medical hostility to it. The Medical Defence Union response to the House of Commons Health Committee recommendation for introducing a statutory duty of candour in 2009 is revealing and worth quoting in full: 110 We do not support the Committee s recommendation that the CMO s proposal for a statutory duty of candour be considered. The inference of the recommendation is that no effective duty of candour currently exists, but this is not the case for doctors who already have an ethical duty and our experience is that doctors do raise concerns. We do not know what the sanction would be if such a legal duty were introduced, but doctors can already be erased 103 (1998) 39 BMLR Guidance was issued in 1998, and the updated version can now be found in General Medical Council, Good Medical Practice (2006) paragraphs Powell v UK Application No 45305/99 admissibility decision of 4 May updated_july_2008.pdf (Accessed 13 April 2012). 107 Customs and Excise Commissioners v Total Network SL [2008] UKHL The Welsh government has set up an inquiry into the events surrounding the death of Robbie Powell which was due to report in April I Kennedy (chair), The report of the public inquiry into children s heart surgery at the Bristol Royal Infirmary : Learning from Bristol Cmnd 5207 (2001) recommendation 33; Chief Medical Officer, Making Amends A consultation paper setting out proposals for reforming the approach to clinical negligence in the NHS (Department of Health, 2003) para 125, and House of Commons Select Committee Report on Patient Safety 2009: 35, para 91). 110 Medical Defence Union, Press release 3 July Available at: Article.asp?articleID=2011&contentType=Media+release&articleTitle=MDU+supports+apologies+to+patients +but+says+no+need+for+duty+of+candour&usertype= (Accessed April ) Prof Negligence-28.2.indd 92 02/07/ :30

16 Patient safety and the problem and potential of law from the medical register if their fitness to practise is impaired because they have not complied with GMC guidance. Surely that is sanction enough? Our experience is that many adverse clinical incidents arise because of system and equipment failures, which are not the responsibility of the individual. Doctors and other healthcare staff need to feel supported and to know they will not be unfairly blamed if they report such incidents so that lessons can be learned and necessary improvements to services can be made in the interests of patient safety. The claim that an ethical duty of candour is effective is implausible and ignores the research evidence which reveals that disclosure is by no means the norm, and is often half-hearted and based on half-truths. 111 This also places undue faith in professional guidance given its limited impact in affecting behavioural change around disclosure. Behavioural change is much more likely when various sources of influence such as law, regulation, peer group norms and pressure repeat the same message, in this case in favour of openness around safety. 112 The legitimacy of a parliamentary created legal duty should not be underestimated in terms of its ability to send a strong signal to organisations and individuals about acceptable behaviour. The MDU are correct that doctors need support to deal with the trauma of medical injury (as well as training in the skills of disclosure), but this is not a valid objection to a law signalling the value of honesty. The reference to sanctions is also questionable given that it is unlikely that doctors have been (or would be) erased from the register purely for failing to disclose an adverse event to a patient. 113 However, whilst the option of disciplinary action against individuals for gross dishonesty should remain, sanctions would be more appropriately targeted at organisations for failing to comply with a statutory duty of candour. Unfortunately, despite the campaigning efforts of Action Against Medical Accidents (AvMA) meaningful reforms appear unlikely in the foreseeable future. Whilst the Care Quality Commission now imposes a duty on health service bodies to disclose incidents causing injury to the National Patient Safety Agency, 114 regrettably this does not extend to informing patients and or their families. 115 We can also question the effectiveness of the existing duty given the abolition of the NPSA in the Health and Social Care Act Despite attempts by members of both Houses of Parliament to introduce a more meaningful and higher profile statutory duty of candour 116 the government has ruled out legislation and instead consulted on incorporating openness through a contractual 111 E O Connor et al, Disclosure of patient safety Incidents: a comprehensive review (2010) 22 (5) International Journal for Quality in Health Care See O Quick, A scoping study on the effects of health professional regulation on those regulated: a report submitted to the Council for Healthcare Regulatory Excellence (2011). Available on request from the author and available from the CHRE s website: 113 In fact, a parliamentary debate about the duty of candour reveals that the GMC has not brought a single case in relation to breach of the ethical duty of candour. See 1 December 2010 Column 276WH in the House of Commons. 114 Care Quality Commission (Registration) Regulations 2009, SI 2009/3112, Regulation 18, para Although it could be argued that disclosure to patients ought to form part of Regulation 17 (1) (b) which purports to provide service users with appropriate information and support in relation to their care or treatment. 116 See: 1 Dec 2010 : Column 269WH in the House of Commons and 27 Feb 2012 : Column 1047 in the House of Lords Prof Negligence-28.2.indd 93 02/07/ :30

17 Professional Negligence, Vol. 28 No. 2, 2012 obligation on providers. 117 This proposal would require providers to publish a declaration of a commitment to openness on their website, failure of which could lead to financial deductions. This fits with the coalition government s general dislike of regulation and the dogmatic commitment to commissioning and contracts evident in its Health and Social Care Act This is a weak form of accountability and is hardly an independent or external check on whether organisations are honouring their commitments of openness. As AvMA has rightly pointed out, a contractual duty is woefully insufficient and is insulting to patients. 118 The ethics and emotion of the professional patient relationship appear to have been forgotten here. In truth, this is not a proper consultation exercise given that the Department of Health states that it will not enter into a debate about the most appropriate mechanism for requiring openness and the decision to impose a contractual requirement is set. 119 One would have hoped that debating the most appropriate mechanism would be precisely what this consultation ought to be about! The Department of Health also acknowledges that the provisions may not apply to primary care contractors thus potentially excluding GPs, dentists, and opticians from the requirements. A clear advantage of a meaningful statutory duty of candour would be its universal application to all providers of healthcare, whether in the NHS or in the private sector. In an ideal world of law reform, a statutory duty of candour would be introduced as part of a package of measures designed to improve the system of redress for victims of medical harm. That is, it would be better introduced alongside a no-fault compensation scheme, akin to those operating in New Zealand and the Nordic countries or via a system such as Health Courts suggested by Mello et al. However, the unlikely abolition of tort law should not prevent reform which signals a clear requirement for honesty. A legal duty of candour should exist irrespective of the type of compensation system that is in place. Indeed, it is arguable that the need for such a duty is greater given the prospect of further cuts to the funding of legal actions envisaged by implementing the Jackson report recommendations. 120 If one of the reasons that claimants go to law is in order to seek a fuller explanation to the events in question, then reducing the funding available (and therefore likelihood) of such actions means that the need for a free standing duty of candour is even greater. The reforms sure to be enacted following the Jackson report are open to the obvious criticism of denying access to justice. Similarly, the lack of a statutory duty of candour is hardly conducive to attempts to access the truth. Ultimately, the arguments made against a duty of candour in no way come close to trumping the need to be honest with patients about their medical treatment. This should be a meaningful duty to be open with patients about their treatment, as opposed to a narrower duty not to withhold information when asked. It should apply to all providers of healthcare, whether public or private, and also include all primary healthcare practitioners. The question of appropriate sanctions for failing to comply with the duty is a difficult one, but these should arguably be confined to the existing powers which the CQC has in relation to providers which do not comply. 117 Department of Health, Implementing a Duty of Candour ; a new Contractual requirement on Providers Proposals for consultation AvMA s initial response is available at: DoH_Duty_of_Candour.pdf, (Accessed 27 March 2012). 119 Above note 117 at para Ministry of Justice, Legal Aid Reform in England and Wales: the Government Response, Cmnd 8072, June Prof Negligence-28.2.indd 94 02/07/ :30

18 Patient safety and the problem and potential of law However, creating and implementing a legal duty of candour is not unproblematic. It would undoubtedly be difficult to enforce, especially in cases where patients may be unaware that they have suffered an adverse event. And whilst disclosure sounds straightforward, there are difficult questions about who should disclose, and about what, how and when to disclose. However, the challenge of enforcement should not prevent a clear statement in favour of honesty. Many of the duties which apply in healthcare are evidently difficult to enforce, but this is not an argument against having these duties. The biggest concern is whether a legal duty may be counterproductive in terms of making professionals fearful of making and admitting their mistakes. Yet, it might justifiably be argued that any prevailing culture of openness or safety is currently so weak as to not be worth preserving. Or put another way, given that existing efforts in terms of ethical and policy guidance have clearly not helped foster a culture of openness, there is little that a legal duty could actually damage. And it should be noted that candour is not the same as an apology it does not have to be about blame and accountability, but rather a truthful explanation. Debates about the duty of candour have given undue weight to the unproven supposition that creating a legal duty would be damaging to the pursuit of a safety culture. This ignores the possibility that by sending out a strong signal in favour of honesty, coupled with appropriate safeguards for individual professionals, it may make a positive contribution to shaping more open and safety friendly behaviour. It could be argued that the lack of empirical evidence supporting the idea of a deterrent effect of the tort of negligence on unsafe practice might lead us to question the potential success of a duty of candour. But this is to confuse the different concepts of competency and honesty. Putting it simply, being honest is easier than being error free. Arguably, one of the reasons for legitimately doubting the safer medicine thesis in relation to negligence actions is that errors are an inevitable feature of medical work. This is likely to be the main reason why the incidence of adverse events has no clear connection to systems of fault or no-fault liability. The apparent failure of the tort of negligence to discourage unsafe practices does not mean that a duty of candour will be similarly unsuccessful. But the case for creating a duty of candour is more likely to be welcomed, and therefore successful, in the context of the abolition of the tort of negligence. It is more realistic to expect that professionals and providers of care will comply with such a duty safe in the knowledge that they will not be unduly penalised for their honesty. It is thus only realistic to expect professionals to disclose harmful events with assurances that they will not face repercussions in terms of sanctions by their employers or regulatory body, unless the conduct in question suggests criminal behaviour or a continued risk to the safety of others Criminalising breaches of patient safety? Fatal medical mistakes may also interest the criminal justice system in the form of manslaughter prosecutions against individuals and or corporate entities such as hospital trusts. In terms of individuals, such cases are prosecuted with reference to the controversial and catch all concept of gross negligence. 122 This is an unduly vague concept which is 121 This is in line with the recommendations by the CMO, above note The leading cases and attempts to define gross negligence are R v Adomako [1995] 1 AC 171 and R v Misra and Srivastava [2004] EWCA Crim Prof Negligence-28.2.indd 95 02/07/ :30

19 Professional Negligence, Vol. 28 No. 2, 2012 incapable of objective measurement and potentially unfair to those prosecuted given the difficulty of ensuring a consistent interpretation. 123 The challenge of establishing causation is also difficult here, as indeed it appears to be for the statutory offence of corporate manslaughter. 124 But leaving aside the criticisms of these homicide offences, the key question is about the relationship between criminal law and patient safety. Does it deter unsafe and bad practices? Although manslaughter prosecutions have increased since the mid 1980s they remain sufficiently rare to render any possible evidence of deterrence hard to find. 125 Whilst criminal cases essentially focus on individual fault, they can nevertheless allow high profile attention to be given to the context of fatal errors. In this sense, the publicity draws attention to problems with, for example, the design of devices or English language competency. The extent to which such lessons are learnt, both by the individual concerned and the wider medical community is not well understood. Perhaps the individual in question is less likely to repeat the same mistake again, but to what extent does such learning filter out to others? We might speculate that criminal law is likely to be unhelpful in terms of further fuelling a culture of secrecy and shame about errors. Whilst we lack direct evidence, manslaughter prosecutions are likely to be harmful rather than helpful to safe healthcare. 126 Yet, it would be premature to discount the possible role of criminal law in terms of encouraging safety, and this article concludes by considering the hidden potential of health and safety law, particularly in terms of its tradition of inspection for compliance with safety standards. 127 Recent attention to the subject of safety in healthcare can make it appear as a new problem for law. However, relevant legislation has existed for nearly forty years in the form of the Health and Safety at Work etc Act The Act was originally designed to protect the health and safety of workers and not as a response to patient safety incidents; thus prosecutions for breaches of duties owed to non employees under the legislation are uncommon. Events arising from clinical judgment or the quality of care are not a priority enforcement area for the Health and Safety Executive, 128 which would note the existence of healthcare regulators such as the Care Quality Commission here and to the reality of its limited capacity and resources. But in focusing squarely on safety, and particularly the contribution of flawed systems, such prosecutions offer a more appropriate (and possibly more effective) response to fatal adverse events in healthcare as opposed to cases against individual practitioners, which are by definition limited to fatal cases. Section 3(1) of 1974 Act appears to be the most relevant in the healthcare context. 129 It states that: 123 O Quick, Prosecuting Gross Medical Negligence: Manslaughter, Discretion and the Crown Prosecution Service (2006) 33(3) Journal of Law and Society Corporate Manslaughter and Corporate Homicide Act For discussion of its possible application to healthcare see P Gooderham, No-one fully responsible : a collusion of anonymity protecting health-care bodies from manslaughter charges? (2011) 6 Clinical Ethics R Ferner and S McDowell, Doctors charged with manslaughter in the course of medical practice, : a literature review (2006) 99 Journal of the Royal Society of Medicine This claim of increased prosecution has been questioned by D Griffiths and A Sanders, The Road to the Dock: Prosecution Decision- Making in Medical Manslaughter Cases in Medicine, Crime and Society (Cambridge, Cambridge University Press, forthcoming). 126 M Brazier and A Alghrani, (2009) Fatal Medical Malpractice and Criminal Liability (2009) 25 Journal of Professional Negligence Some argue that endangerment offences would offer greater potential for a positive deterrent effect: see A Alghrani et al, Healthcare scandals in the NHS: crime and punishment (2011) Journal of Medical Ethics , and A Sanders and D Griffiths, above note See (Accessed 13 April 2012). 129 Sections 7, 36 and 37 of the Act are also potentially applicable Prof Negligence-28.2.indd 96 02/07/ :30

20 Patient safety and the problem and potential of law It shall be the duty of every employer to conduct his undertaking in such a way as to ensure, so far as is reasonably practicable, that persons not in his employment who may be affected thereby are not thereby exposed to risks to their health or safety. Whilst prosecutions of healthcare trusts under Section 3 are relatively rare, there have been notable cases to remind us of the potential application of Health and Safety law in this context. In R v Southampton University Hospitals NHS Trust 130 it arose out of the events which led to the conviction of two junior doctors for gross negligent manslaughter. 131 They mismanaged the care of a 31 year old man who developed toxic shock syndrome after a routine knee operation. Specifically, they responded inadequately to obvious signs of infection, such as raised temperature and pulse rate, and failed to chase up blood test results that would have prompted the antibiotic care which would probably have averted disaster. The trust was convicted and fined 100,000. The initial indictment in the Southampton case included allegations that the trust employed one of the doctors without taking up references or conducting a face-to face interview, failed to organise ward rounds properly and to encourage nurses to report concerns about colleagues. Although these were dropped from the indictment, it indicates the potential to probe wider aspects of the system and its responsibility for safety lapses. It is possible to envisage a wide variety of problems stemming from failing systems as opposed to flawed individuals, and the potential greater use of health and safety law here. For example, the case transcript in Misra refers to misunderstandings about the correct procedures for obtaining blood results one of the doctors relied on the laboratory to flag up abnormalities, whilst the prosecution maintained that the onus was on the doctors to chase up the results. It is not hard to imagine the investigatory lens being broadened to encompass a variety of important organisational issues involving the recruitment and training of staff, as well as planning and communication problems which are currently relegated to the background context of prosecutions against individual practitioners. Similarly, Great Western Hospitals NHS Trust was convicted following the death of Mayra Cabrera, killed after being mistakenly given an epidural drug instead of saline solution. 132 This case is an example of a system factor causing an error, given that the two drugs had almost identical packaging and were stored in the same racking system. The trust was fined 75,000 for breach of section 3. These convictions are symbolically important as an official recognition of organisational fault, and remind us of the wide scope of health and safety offences as applied to the context of medical manslaughter cases. In terms of likely deterrent effect, the fact that trusts are unable to insure against the payment of criminal fines may be an important factor in terms of helping to incentivise compliance with safety standards. In other words, unlike compensation payments in relation to civil actions, such fines cannot be absorbed within insurance policies. Surely the performance of healthcare providers could be rigorously assessed against a series of health and safety standards, with prosecution the last resort for repeated failure to comply? 133 Arguably, if any branch of the 130 [2006] EWCA Crim R v Misra, Srivastava above note The Guardian, Hospital fined 100,000 after wrong drug killed new mother 17 May K Hawkins, Law as Last Resort: Prosecution Decision Making in a Regulatory Agency (Oxford, Oxford University Press, 2002) Prof Negligence-28.2.indd 97 02/07/ :30

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