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From Bolam to Bolitho : unravelling medical protectionism
Christopher Stone January 2011 Introduction In 1990/91 the cost of clinical negligence claims to the NHS was estimated at around £52 million^1. Twenty years later, by 2009/10, the NHS Litigation Authority (NHSLA) received a record 6,652 negligence claims, a 10% increase on the previous year, and paid almost £800 million in damages 2 . This seemingly inexorable rise in the cost of clinical negligence litigation poses a limitless drain upon the finite health service purse. Contrary to the principles of beneficence, in which resources are equitably distributed for the maximum benefit of the maximum number of patients, large sums of money are diverted away from the wider patient population through the restriction of clinical services and approved treatments to a small number of successful claimants. Notwithstanding the spiralling cost of clinical negligence claims, fuelled partly by contingency fee arrangements and after the event insurance, the potential number of claimants extends far beyond that which is currently forthcoming. Holding back the tide of litigation remains the hurdle faced in proving liability, a hurdle embodied by the Bolam defence. However, with the courts moving steadily towards a lower, more measurable, standard of proof of liability, stripping away the layer of protection afforded to doctors by Bolam , the need for an alternative mechanism for controlling the cost of litigation is easy to understand. The new NHS Redress Act, which returns an element of beneficence to the compensation equation, appears to be a natural and logical response, but it is a gamble as yet untested. This discussion concerns breach of duty and the Bolam defence. It will assess the validity of the assertion that the Bolam test unfairly favours doctors at the expense patients who bring claims in clinical negligence against them, and will investigate the effect of the ruling in the Bolitho case upon that perceived imbalance. Firstly, the facts of the Bolam case will be outlined, and the importance of the precedent it established will be examined through an analysis of subsequent clinical negligence case law. The problems inherent within the Bolam liability test will then be considered to contextualise the judgement in the Bolitho case. Finally, the post- Bolitho case law will be analysed to determine not only the extent to which the law has distanced itself from Bolam but also to predict where deficiencies (^1) Fenn P, Diacon S, Gray A, Hodges R, Rickman N. Current cost of medical negligence in NHS hospitals: analysis of claims database. BMJ 2000;320:1567– 71. (^2) The NHSLA Report and Accounts 2010 available at www.nhsla.com.
remain and the likely trajectory of a more patient-centred judicial approach to medical negligence claims. The Bolam Case 3
- the product of a bygone era? The 1950s were a ‘golden’ era for the fledgling NHS. The medical profession was both paternalistic and largely unregulated. Medical professionals enjoyed unquestioning compliance from patients and were treated with great deference by society in general, including the judiciary. Hospital consultants were not accountable to hospital managers as they are today and clinical negligence litigation was in its infancy. It is important to understand this backdrop, for herein lies the reasoning behind the High Court judgement in Bolam v Friern Hospital Management Committee , and a legal precedent that, with the passage of time, is feeling its age. In 1954, John Hector Bolam, a patient suffering from depression, was voluntarily admitted to the Friern Hospital to undergo Electroconvulsive Therapy (ECT), a recognised treatment for intractable depression. The ECT was delivered ‘unmodified’, that is to say no muscle relaxing drugs were administered. He was unrestrained during treatment apart from the presence of nursing staff at the side of the bed to prevent him from falling. During the course of his treatment Mr Bolam sustained such violent muscles spasms as to cause fractures of both hips. He pursued a claim in negligence, firstly on the grounds that had he been warned of this risk he would not have undergone treatment, and secondly that had he received a muscle relaxant drug his injuries would not have occurred. Expert evidence revealed a range of professional opinion as to whether or not ECT should be undertaken unmodified, and if no muscle relaxant was used whether or not there was a need for manual restraint to reduce the potential for bone fractures. On the disclosure of risk, the defence maintained that there was no requirement to explain the risks of treatment unless asked specifically to do so by the patient. McNair J reflected upon the competing testimony of experts, whose opinions he respected equally, in his direction to the jury, and referred to the test of negligence applied by Lord President Clyde in the earlier Scottish case of Hunter v Hanley^4 : ‘ In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men, nor because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. ’ To this McNair J added his own interpretation, contending that a doctor is: (^3) Bolam v Friern Hospital Management Committee [1957] 1 W.L.R. 582 (^4) Hunter v Hanley 1955 S.C. 200
preferred. If this was the real reason for the judge's finding, he erred in law even though elsewhere in his judgment he stated the law correctly. For in the realm of diagnosis and treatment negligence is not established by preferring one respectable body of professional opinion to another. Failure to exercise the ordinary skill of a doctor (in the appropriate speciality, if he be a specialist) is necessary. ’ What is not clear is what McNair J meant in his Bolam dicta by ‘responsible’ for the word itself, contrary to how it has been interpreted in law, does not quite conjure up the notion of ‘majority’, or indeed ‘significant minority’. It would appear that no matter how small a minority adopt a particular opinion, if that opinion is ‘responsibly’ held it confers a valid defence to liability. This was explored further in De Freitas v O'Brien 8
. The claimant in this case underwent orthopaedic surgery to fuse two lumbar vertebrae, and a second operation to correct the resultant complication of nerve root compression. It was the performance of the second operation that was at issue, an operation which led to leakage of cerebrospinal fluid, infection and chronic disabling pain. The defendant surgeon called upon expert opinion that existed within a small body of only eleven so- called ‘spinal’ surgeons practising in the UK at that time; opinion within this group of specialists was always likely to differ from the larger body of over a thousand orthopaedic or neurosurgical non-specialists. Although a responsible body of opinion does not have to be substantial one, Otton LJ recognised the potential inequity in attaching disproportionate weight to the opinion of a very small minority and a defence in Bolam to which it thereby gives effect: ‘ It was submitted that the Bolam test was not designed to enable small numbers of medical practitioners, intent on carrying out otherwise unjustified exploratory surgery, to assert that their practices are reasonable because they are accepted by more than one doctor. If it appears from the evidence that the body of medical opinion relied upon by the defendant is both very small and diametrically opposed in its views to the conventional views of the vast majority of medical practitioners, the court should be vigilant in carrying out its duty to test whether the body of medical opinion relied upon by the defendant is a “responsible” body. ’ Notwithstanding the apparent anomaly that in civil cases the standard of proof is the balance of probabilities while the Bolam test permits a minority view to be determinative, Otton LJ was reluctant to dismantle Bolam further for fear that it would degenerate into a ‘head count’ of opinion: ‘ The issue whether or not to operate could not be determined by counting heads. It was open to him to find as a fact that a small number of specialists constituted a responsible body and that the body would have considered the first defendant's decision justified ’ (^8) De Freitas v O'Brien [1995] P.I.Q.R. P
Nevertheless, the effect of De Freitas was to restore some measure of judicial discretion in the interpretation of witness testimony in cases where it is the minority view that holds sway. The problem with Bolam There are a number of difficulties with the Bolam test which still apply asymmetrically in negligence cases, mainly to the advantage of the defendant doctor or health authority; it is often simply too easy to invoke Bolam on the basis of a single expert’s opinion and conversely, too difficult for the claimant to show that no other doctor would have acted similarly. As a measure of liability, Bolam gives weight to what medical practice is (or what contemporary practice was ) rather than what practice should be. So instead of upholding a standard of care that is good, Bolam defaults to a standard of care that can be supported, even if it falls below what is objectively acceptable. Consequently, the court has little discretion to decide what the standard of care should have been considering all the circumstances of a particular case; there is no option to prefer one expert’s opinion over another, the choice is all or nothing - can the action be supported or can it not? Bolam therefore, is a clumsy tool, born out of medical nepotism and implemented through a system of peer review, where doctors set the standards required of them and give testimony in each other’s defence. Under Bolam , doctors and defence organisations enjoy a degree of protection that validates and perpetuates outdated medical practice simply because that practice remains entrenched in some doctors. The fault lines in Bolam as applied to consent to treatment and the disclosure of risk, have been exposed through a series of cases that have moved the law step-wise to a position more in alignment with that of North American jurisdictions 9 , 10 , 11
. Where liability for diagnosis and treatment is concerned, however, Bolitho pointed to a palpable indication of judicial dissatisfaction with Bolam , and a shift towards redressing of the balance in favour of claimants. A logical defence: Bolitho v City and Hackney Health Authority 12 At the age of two years Patrick Bolitho was diagnosed with a patent ductus arteriosus, a condition that prolongs the foetal circulation after birth to the detriment of the normal oxygenation of the blood. An operation to correct the anomaly had been undertaken in 1983 from which he made a good recovery. A year later he was admitted to St Bartholomew’s Hospital with croup. During the course of his admission he experienced a precipitous deterioration in his breathing on several occasions, a sequence of events which culminated in a respiratory collapse and cardiac arrest from which Patrick emerged with severe brain damage and subsequently died. (^9) Pearce v United Bristol Healthcare NHS Trust [1999] E.C.C. 167 (^10) Sarah Wyatt v Dr Anne Curtis, Central Nottinghamshire Health Authority [2003] EWCA Civ 1779 (^11) Birch v UCL Hospital NHS Foundation Trust [2008] EWHC 2237 (QB) (^12) Bolitho (Deceased) v City and Hackney HA [1993] P.I.Q.R. P
logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible. Redressing the balance? Bolitho applied Bolitho therefore, built upon De Freitas to require that a defence in Bolam must be reasonable both in terms of its logic and in demonstrating that the risks and benefits of a particular course of action have been properly considered. There was some initial reticence on the part of the judiciary to implement Bolitho as illustrated by Wisniewski v Central Manchester Health Authority 14
. Wisniewski closely resembled Bolitho in that it also dealt with an act of omission, in this case the failure of a doctor to act upon an abnormal cardiotocograph (CTG) which led to birth asphyxia and cerebral palsy. It was suggested that either the doctor negligently failed to attend when summoned by the midwife, or that the midwife negligently failed to inform him of the abnormality. The trial judge, without the benefit of Bolitho , considered what the defendant doctor would have done had he attended and, in finding for the claimant and contrary to some expert opinion, concluded that the abnormal CTG would have alerted him to the need to rupture the foetal membranes and proceed to a caesarean section. The Court of Appeal however, post- Bolitho , concluded that the trial judge was not entitled to substitute his own opinion for that of the defendant’s experts and overturned the decision with the comment ‘ it is quite impossible for a court to hold that the views sincerely held by Mr Macdonald (“an eminent consultant and an impressive witness”) and Professor Thomas cannot logically be supported at all .’ Were this degree of deference to medical opinion to have prevailed, then Bolitho may never have succeeded in law at all 15 . However, a typical example of Bolitho ‘in action’ arose in 2002 with Reynolds v North Tyneside Health Authority 16 . Here the court held that the defendant midwife negligently failed to perform a vaginal examination at an appropriate time and, in so doing, missed a foot breach presentation that resulted in cord prolapse, birth asphyxia and cerebral palsy. Gross J dismissed argument on behalf of the defence in classic Bolitho style: ‘ Where the sole reason relied upon in support of a practice is untenable, it follows (at least absent very special circumstances) that the practice itself is not defensible and lacks a logical basis. That is the case here. The suggested contrary practice (or body of opinion) is neither defensible nor logical. Having carefully examined the evidence, this is one of those rare cases where it is appropriate to conclude that there is a lacuna in the practice for which there is no proper basis. ’ (^14) Wisniewski v Central Manchester Health Authority [1998] P.I.Q.R. P (^15) Rachael Mulheron. Trumping Bolam: a critical legal analysis of Bolitho's "gloss" (2010) 69 Cambridge Law Journal 609 (^16) Reynolds v North Tyneside Health Authority [2002] Lloyd's Rep. Med. 459
The issue of benefit versus risk resurfaced as the focus of Marriott v West Midlands Regional Health Authority^17 concerning a GP who, having attended a patient who had fallen, failed to request tests to exclude an extra-dural haemorrhage. The court heard that the risk of intracranial bleeding after a fall was extremely low, but determined that while a responsible body of opinion would have acted similarly, the seriousness of the complication was sufficient to make a defence in Bolam unreasonable. In Marriott , therefore, the approach by the court was to question whether the action taken was Bolitho justifiable rather than Bolam defensible, a significant step towards redressing the balance in negligence cases in favour of the claimant. However, in considering what might or might not be Bolitho justifiable, the court must be careful to avoid undue haste in reaching a conclusion without assimilating the entirety of expert opinion. It was on these grounds that the Court of Appeal, in favour of the defendant doctor, ordered a retrial following the trial judge’s ruling in Burne v A^18 for failing to allow medical experts to fully explain common practice in the defence of a General Practitioner accused of negligence. Furthermore, where a judge, in weighing the medical evidence, rejects the opinion of the defendant expert, a full explanation of the reasoning behind that decision must be given. In Glicksman v Redbridge Healthcare NHS Trust 19 the Court of Appeal reversed the trial judge’s findings in favour of the claimant, since she had failed to provide a reasoned explanation for her rebuttal of the defendant expert evidence. Henry LJ observed that: ‘ ... no reasoned rebuttal of any expert's view was attempted by the judge: her conclusions alone were stated in circumstances which called out for definition of the issues, for marshalling of the evidence, and for reasons to be given. ’ Similar circumstances arose in Smith v Southampton University Hospitals NHS Trust 20 where complex issues were debated in relation to complications following pelvic cancer surgery. In this case the Court of Appeal found for the claimant, and reversed in part the trial judge’s decision since no adequate explanation had been given for preferring a defence in Bolam over other medical opinion. Wall LJ re- iterated the view that: ‘ Where there is a clear conflict of medical opinion, the court's duty is not merely to say which view it prefers, but to explain why it prefers one to the other. ’ Consequently, where a case is determined on the basis of either Bolam or Bolitho , the judge’s decision must be supported by a reasoned explanation having properly considered the full the range of professional opinion. In redressing the balance, therefore, the claimant’s case is strengthened by the fact that if a judge is to accept a defence in Bolam it becomes incumbent upon them, as well as the defendant, to demonstrate the logic underpinning that defence making it Bolitho justifiable. (^17) Marriott v West Midlands Regional Health Authority [1999] Lloyd's Rep. Med. 23 (^18) Burne v A [2006] EWCA Civ 24 (^19) Glicksman v Redbridge Healthcare NHS Trust [2001] EWCA Civ 1097 (^20) Smith v Southampton University Hospitals NHS Trust [2007] EWCA Civ 387
Guidelines and the NHS Redress Act: objectivity and pragmatism? Since Bolam , the law has gradually moved from a position where the support of one’s peers alone provides an effective defence in negligence, to one where that defence must be reasonable in terms of its logic and regard to risk, where the judge must provide reasons for rejecting medical opinion and where expert evidence is under greater scrutiny for bias. Bolam , however, still remains the cornerstone of breach of duty, but with the passage of time medical practice is becoming more protocol-driven with guidelines emerging as the new standard of care. Hence a position adopted in Bolam must be increasingly qualified by adherence to those objective professional standards, and any departure from clinical guidelines, endorsed by the Royal Colleges, NICE or other bodies, can be easily exposed. Where a doctor deviates from clinical guidelines the balance of favour shifts further in the direction of the claimant; in such cases the burden of proof falls upon the doctor (rather than the claimant) to demonstrate that they were not negligent. In Clark v MacLennan 27 guidelines existed to prevent haemorrhage following surgery for post- partum stress incontinence. In breach of those guidelines, surgery was undertaken within one month of giving birth; the risk of bleeding eventuated and resulted in permanent and disabling incontinence. Other examples in case law have illustrated the persuasiveness of clinical guidelines in benchmarking the standard of medical care 28 , 29 . For the doctor, therefore, guidelines are a double-edged sword; on the one hand obedient adherence to guidelines (relevant at least to the time of their writing) confers an objective, evidenced-based confirmation of best practice, while on the other hand doctors remain vulnerable to close scrutiny of their management of any given patient and the potential to unmask inconsistencies with one guideline or another. Guidelines are fluid and subject to updates and reviews, shifting the medico-legal goal posts at regular intervals. Moreover, reliance upon clinical guidelines as the lowest common denominator of best practice removes independent clinical decision making, arguably contrary to the best interests of patients. Laudably, therefore, the Supreme Court of Western Australia has ruled that lawful practice can indeed exist outside of established clinical guidance 30 while in the United States guidelines informed by unproven scientific methodology, in failing to meet the Daubert standard 31 , are of little or no evidential value. (^27) Clark v MacLennan [1983] 1 All E.R. 416 (^28) Early v Newham Health Authority [1994] 5 Med. L.R. 214 (^29) Fotedar v St George's Healthcare NHS Trust [2005] EWHC 1327 (QB) (^30) Albrighton v Royal Prince Alfred Hospital [1980] 2 NSWLR 542(CA), 562 (^31) Daubert v Merrill Dow Pharmaceuticals Inc. 509 US 579 (1993)
Nevertheless, studies indicate that lawyers at home 32 and abroad 33 are likely to continue to make use of clinical guidelines, but for now, according to Brian Hurwitz^34 , guidelines are simply a starting point representing: ‘ …justified, advocated medical standards—from which to make an assessment of questionable conduct, and this represents quite a departure for the process of adjudication hitherto adopted by the courts, which has relied almost exclusively on expert witnesses setting normative boundaries. ’ In the aftermath of Bolitho clinical negligence claims have become more difficult to defend. The pragmatic response by policy-makers has been the NHS Redress Act 35 , designed to facilitate the expedient compensation of increasing numbers of claimants, while limiting legal costs and as damages in return. No doubt it is hoped that unworthy cases will cease to be litigated and that the net result will be to limit the overall financial burden of medical litigation to the NHS. This aspiration accords with the principles of beneficence and distributive justice, even though it is one that is denied as the motivating force behind the Act^36. Conclusion The Bolam test may well be an anachronistic throwback to 1950s medical paternalism but it remains an enduring comparator in medical negligence litigation. Modern day values, however, pay less heed to the pedestal upon which doctors have hitherto been placed, while the internet revolution has created a new generation of well informed patients, fully acquainted with the intricacies of medical treatments as well as the objective care standards established in clinical guidelines. Undeniably, Bolitho marked the beginning of the protracted erosion of medical protectionism enshrined in Bolam and a process that gives greater effect to judicial discretion when determining liability in negligence. Lord Woolf summarises the still current position in law, such that ‘ when interference is justified (the courts) must not be deterred from doing so by any principle such as the fact that what has been done is in accord with a practice approved of by a respectable body of medical opinion .’^37 While the direction of travel does not appear as yet to have over-compensated for previous inequalities, it certainly seems to have created more favourable conditions for bringing claims. The NHS Redress Act may yet prove effective in creating an alternative and fairer system for compensating the victims of medical accidents but it could equally be forgiven for appearing to represent an exercise in damage limitation. (^32) Ash Samanta, Michelle M. Mello, Charles Foster, John Tingle, Jo Samanta. The Role Of Clinical Guidelines In Medical Negligence Litigation: A Shift From The Bolam Standard? (2006) 14 Med Law Rev 321 (^33) Hyams AL, Brandenburg JA, Lipsitz SR, Shapiro DW, Brennan TA. Practice guidelines and malpractice litigation: a two way street. Ann Intern Med1995; 122: 450-5. (^34) How Does Evidence Based Guidance Influence Determinations of Medical Negligence? Hurwitz, B. BMJ 2004; 329: 1024-8. (^35) NHS Redress Act 2006 c. 44 (^36) Lord Warner, Minister of State, Department of Health. Hansard, HL Vol.675, col.207. November 2,
(^37) Lord Woolf. Are The Courts Excessively Deferential To The Medical Profession? (2001) 9 Med Law Rev 1
