A doctor s duty of disclosure and the decline of The Bolam Test : A dramatic change in the law on patient consent

Transcription

1 Papers Presented to the Society A doctor s duty of disclosure and the decline of The Bolam Test : A dramatic change in the law on patient consent Medico-Legal Journal 2016, Vol. 84(1) 5 17! The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalspermissions.nav DOI: / mlj.sagepub.com James Badenoch QC The President: Hello everybody, welcome, members and guests. This, of course, is the Minty Lecture. Mr Minty was a former member of the Society who left a great deal of money to the Society to enable us to continue to provide good quality lectures, and I am sure he would be delighted to know that the lecture in his honour tonight is to be given by, of course, James Badenoch, who has had such a distinguished career. He is probably the most famous clinical negligence QC. He was called to the Bar in He was a pupil to Lord Woolf and took silk in He has had every famous case almost, from Wilsher, in the House of Lords, to the case he is going to talk about tonight, the earthshattering case in respect of informed consent in clinical negligence cases, Montgomery. He has had so many distinguished posts. He has been a deputy High Court judge; he is a former President of the Mental Health Tribunal; he is a Bencher of Lincoln s Inn and a Fellow of the Royal Society of Medicine. But you didn t come here to hear me sing his praises, you came here to listen to the great man speak, so over to you, James. (Applause.) Mr Badenoch: Thank you so much for that undeserved introduction and thank you also for the invitation to give this distinguished lecture. I am honoured to be here. The decision in the UK Supreme Court in the case of Montgomery v Lanarkshire Health Board, [2015] UK SC 11, is a momentous one. It has major implications for the practice of doctors and surgeons in the matter of disclosure of information to patients for the purpose of consent to treatment. It overturned the longstanding, and much cited, decision on consent of the Judicial Committee of the House of Lords (of which the A meeting of the Society was held at the Medical Society of London, 11 Chandos Street, Cavendish Square, London, W1G 9EB, on Thursday, 8 October The President, Ms Linda Lee, was in the Chair. This paper is based on lectures first given by the author in April 2015 to the Centre for Medical Ethics and Law at Hong Kong University and to the Hong Kong Academy of Medicine, and in September 2015 to the Chinese University of Hong Kong. Supreme Court is the successor) in Sidaway v The Board of Governors of Bethlem and Maudsley Hospitals [1985] 1 AC 900 HL. The decision in Sidaway has been the subject of whole chapters in textbooks, much criticised over the years by academics and lawyers around the world, and rejected in the courts of Australia, Canada and the USA. Its UK reversal is momentous for the inroad it has made on the dominance of the Bolam principle, named for the test of negligence in all aspects of clinical practice (including disclosure of information), which was established by the case of Bolam v Friern Barnet Hospital Management Committee in 1957, which had prevailed until this day. Applying Bolam, the issue of the adequacy or otherwise of disclosure for valid patient consent falls to be determined solely by the answer to the question whether the disclosure made was sanctioned as acceptable by a responsible body of the medical profession (even a minority one). The background to, and the judicial expression of, the Bolam test is instructive. The Bolam test or principle, and how it works Hector Bolam, the Plaintiff, was very depressed (and was no doubt more depressed when he lost his case and gave his name to the legal principle which caused him to lose it!). His doctors decided to treat him with ECT, by which powerful electric shocks are administered through paddles to the patient s head. These shocks (predictably) produce powerful muscular convulsions, which in his case threw him bodily from the couch onto the hard floor, causing bilateral leg fractures which left him permanently crippled. He sued the doctors, calling expert psychiatrists who attested that due care for his protection had required sedating him or strapping him to the couch before the shocks were applied. Strange as it may seem, the Defendants found and called other ostensibly responsible psychiatrists whose expert opinion was against the

2 6 Medico-Legal Journal 84(1) use of sedation or straps, on the grounds (which would appear profoundly questionable) that those measures themselves carried risk to the patient. They thus established that there was, purportedly, a school of medical thought which would at the time support and endorse as acceptable the administration of shocks without any such protection. In respect of that evidence, the direction to the jury of the trial judge, McNair J contained these much quoted words: A doctor is not guilty of negligence if he has acted in accordance with the practice accepted as proper by a responsible body of medical men skilled in that particular art... Putting it another way round, a doctor is not negligent if he is acting in accordance with such a practice, merely because there is a body of opinion which takes a contrary view. That direction, fatal as it proved to be to Mr Bolam s claims for damages, echoed the 1955 judgment of Lord President Clyde in the Scottish case of Hunter v Hanley, and it was thenceforward (long after jury trial for such claims had been abolished) repeatedly endorsed and applied by successive judgments in the UK appellate courts. It was perhaps most clearly restated by Lord Scarman, in Maynard v West Midlands Regional Health Authority [1984] 1 LWR 634, in this famous passage: A case which is based on an allegation that a fully considered decision of two consultants in the field of their special skill was negligent clearly presents certain difficulties of proof. It is not enough to show that there is a body of competent professional opinion which considers that theirs was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances... Differences of opinion and practice exist and will always exist in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A Court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence. These passages establish an approach to the standard of care expected of, and to be imposed upon, medical practitioners, which is exceptional in English law. In all other cases where negligence is disputed in some field of specialised human endeavour, such as navigating a tanker, designing a bridge or giving financial advice, it is the judge s function to determine whether negligence is proved or not. Having heard the opposing experts, who, respectively, condemn or approve the defendant s performance, the judge decides which he finds the more convincing and accordingly prefers, and which he rejects, and on that basis decides the case. The well-known Hong Kong case of Edward Wong Finance v Johnson, Stokes & Master [1984] A.C. 296 is instructive. The completion of property sales in what was termed Hong Kong style had caused loss to the Plaintiff. It was the style almost universally adopted by Hong Kong solicitors, and so accorded with, and was sanctioned as acceptable by, a (vast) body of professional opinion there. The Privy Council nevertheless held, discharging their proper judicial role, that the Defendant solicitors were liable for negligence in following the procedure because there was an obvious risk to which it gave rise from which it did not suitably protect the client. By contrast, the Bolam principle, as strictly applied, quite simply disqualifies the judge from performing that ordinary judicial function in respect of alleged medical negligence and effectively appoints the medical profession judge in its own cause, to arbitrate the issue. In consequence, a Bolam defence will succeed even if those who purportedly sanction the defendant s performance as acceptable are a very small minority indeed provided only that they are not dismissed as irresponsible, not respectable or incompetent. Yet, those are labels which a judge will seldom feel able to attach to a body of doctors and are labels which a judge does not have to attach before he rejects an expert opinion in any other species of negligence. If therefore such a body could be found, which approved or purportedly approved what the doctor had chosen to tell the patient, it was, by the authority of Sidaway applying Bolam, a complete defence to an allegation of breach of duty in failing to provide enough information for valid consent. It need hardly be said that, among doctors, it has always been possible to find a wide range of idiosyncratic views about how little or how much to tell their patients, some of which owed more to paternalism than to ethical principles, and the variety of those views made inevitably for great uncertainty about the supposed legal rights of patients, and so made justice very uncertain. Yet, the Sidaway ruling prevailed for 30 years in English law, with much consequent injustice to patients whose access to information on which to base their consent was often controlled and confined by the paternalistic attitudes of many doctors, which were endorsed, approved and legitimised in that case by Lord Diplock, and in different ways by the majority of the other Law Lords. That was what our arguments in Montgomery were directed against, and that is now what, in the end, has been entirely rejected by the unanimous decision of seven judges of the Supreme Court. That they did so was the culmination of a long slow

3 Badenoch 7 process in the development of judicial thinking, stimulated in part by the very different approach to the issue by the courts of other countries. Now, by the decision in Montgomery, directly following the lead in the development of the relevant law in those other countries (to which I will return), the Bolam test will no longer apply to disclosure for consent and is replaced with quite another, namely the so-called patient-centred test: did the doctor take reasonable care to ensure that the patient was made aware, before consenting, of any material risks, and of any reasonable alternative or variant treatments. And the test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it (Montgomery para. 87). To this duty, there will be a few closely confined exceptions, namely: 1. The so-called therapeutic privilege, by which the doctor may withhold or limit information if he believes on reasonable grounds that disclosure will harm the patient s health (physical or mental). 2. Cases of necessity, e.g. when treatment is essential but the patient is unconscious or otherwise incapable of understanding. 3. Possibly also where the patient has expressed the considered wish not to be told about risks or uncertainty of outcome. Patients and most lawyers who work in this field of law welcome this ruling, as do most doctors, but there are those who continue to oppose it. Detractors cling doggedly to arguments addressed and properly disposed of by the Supreme Court (who were fully aware of them). They maintain that unreasonable difficulties are presented for doctors in deciding what information is material according to the new test (and in finding time to deliver it). Their view, which the Supreme Court Justices have held is in modern times unacceptable, is that the generality of patients cannot be expected to understand scientific concepts; may achieve only an imperfect grasp of the significance of potential risks or perceived benefits; and may make foolish and wrong decisions based on irrelevances and against their own best interests. They insist that judicious rationing of information is the best way for doctors to secure necessary consent to necessary treatments. In Montgomery, the Supreme Court has dismissed those arguments, and the question will be asked: were they right to do so? The answer must in my opinion be yes, and a brief study of the shift over the last 50 or so years in society s attitudes to doctor/patient relations and to human rights serves to confirm it; but first it is worth examining the fallacious reasoning which underpinned Sidaway s application of Bolam to consent. Sidaway s application of Bolam to consent issues In this decision, which had prevailed for 30 years, the majority of the Law Lords had held (ambiguously and without consistency of reasoning) that the Bolam test applied as much to a doctor s advice and disclosure for the purpose of patient consent as it did to a doctor s decisions about diagnosis and treatment. Its most dogmatic and inflexible application to the question of consent was that of Lord Diplock (a judge of the old school, to whose opinions I do not willingly turn for enlightenment on any vexed area of the law). He expressed himself as follows: The message of the Bolam test is that the criterion of the duty of care owed by a doctor to his patient is whether he has acted in accordance with a practice accepted as proper by a body of responsible and skilled medical opinion... To decide what risks the existence of which a patient should be voluntarily warned, and the terms in which such warning, if any, should be given, having regard to the effect that the warning may have, is as much an exercise of professional skill and judgment as any other part of the doctor s comprehensive duty of care to the individual patient, and expert medical evidence on this matter should be treated in just the same way. The Bolam test should be applied. Lord Diplock s view of disclosure of information to patients was a prime example of the outmoded attitudes which Montgomery has replaced. What he said about it was this: The only effect that mention of risks can have on the patient s mind, if it has any at all, can be in the direction of deterring the patient from undergoing the treatment which in the expert opinion of the doctor it is in the patient s interest to undergo. I ask what could more revealingly express the condescending and paternalistic approach to the patient than this from a distinguished Law Lord? He assumes in the patient a lack of capacity for rational and independent thought, unquestioning subservience to the doctor s superior status and an abject surrender of personal autonomy. Lord Diplock, revealingly, in a passage particularly unattractive to modern thinking, then made an express

4 8 Medico-Legal Journal 84(1) exception by which this would not apply to highly educated people such as himself. What he said was: But when it comes to warning about risks, the kind of training and experience that a judge will have undergone at the Bar makes it natural for him to say (correctly) it is my right to decide whether any particular thing is done to my body, and I want to be fully informed of any risks there may be involved of which I am not already aware from my general knowledge as a highly educated man of experience, so that I may form my own judgment as to whether to refuse the advised treatment or not; Though he then added with apparent distaste: No doubt if the patient in fact manifested this attitude by means of questioning, the doctor would tell him whatever it was the patient wanted to know... (p. 895). So while Lord Diplock retained for himself and his intellectual equals the independent right to the full facts, and to apply to them their own reasoning when deciding whether to submit to proposed treatment, ordinary patients (the lesser mortals) had no such right unless they had the temerity to ask direct questions of the doctor. In this latter regard, it is plain that among earlier generations, brought up in the now vanished age of deference, it was a very rare patient who dared, or thought it proper, to question his doctor at all about anything, an attitude which attributed almost godlike status to doctors, but which (to the regret of some) has now largely disappeared from society, though it may still be found among the oldest in the population. In any event, as the Supreme Court recognised, there is something unreal about placing the onus of asking upon a patient who may not know there is anything to ask about... Ironically the ignorance which such patients seek to have dispelled disqualifies them from obtaining the information they desire. The fallacy and illogicality of Sidaway While the reasoning of Lord Diplock in Sidaway was direct and uncompromising (and I would add plainly wrong), there were in the varied reasoning of the other Law Lords ambiguities and inconsistencies, which exposed, we contended, the intellectual gymnastics required to fit Bolam to disclosure. Notable among these was Lord Bridge s asserted exception to the Bolam rule, by which a doctor would owe a duty to disclose a risk of the magnitude of 10%. This arbitrary figure was obviously unrelated to the concerns of the reasonable patient, which will be less about major risks of minor harm than with risks, however minor, of major harm. However, the key fallacy in Sidaway, as the Supreme Court in Montgomery agreed, lay in equating (a) the doctor s decisions about diagnosis, and about appropriate treatments and their risks, benefits and alternatives (which are decisions made on the basis of medical expertise, learning and experience) with (b) the patient s decision, which is his and his alone to make, whether to submit to that treatment, or to any alternative, or to refuse treatment altogether. The fallacious elision of these two quite different decision-making processes had been acknowledged in earlier decisions in other jurisdictions, to which I will return. Before I address that development in detail I will summarise the facts of the Montgomery case. They disturb and astonish, not merely because they are extreme, but also and principally because, as the Supreme Court by their decision agreed, their extremity invites the question of how the case came to be defended at all. Remarkably, the defence which was run, and the extraordinary acceptance of it by successive Scottish courts, was met in the Supreme Court by rejection and reversal of the trial judge s findings of fact, a step which by long precedent an appellate court will only take in the most exceptional circumstances. A summary of the facts in Montgomery Mrs Montgomery, an intelligent graduate in molecular biology, was pregnant with the Pursuer [Plaintiff], her first child. Two particular features of her case meant (as was agreed on both sides) that her pregnancy was properly designated high risk : 1. She was very small in stature, marginally over 5 feet tall. 2. She was a longstanding insulin-dependent diabetic, a chronic condition which is known to lead in sufferers pregnancies to excessive fetal growth in the womb ( macrosomia ). 3. Macrosomia in these cases is oddly associated with particular deposits of fat around the fetal shoulders, which may consequently become abnormally large. Those features together gave rise to a well-known danger of labour in such mothers, namely that when the fetal head is delivered the after-coming shoulders can get stuck behind the mother s pubic symphysis. This is a major obstetric emergency called shoulder dystocia, which occurs in the labour of about 10% of diabetic mothers and requires sometimes extreme

5 Badenoch 9 measures to overcome it, which can themselves cause injury to mother and/or baby. Worst of all there is the likelihood, while it remains unrelieved, of fetal asphyxia from the trapped and occluded umbilical cord, so that delay can mean brain damage or death for the baby, which occurs in about 1% of shoulder dystocia cases, though which cases among the 10% will end in delay and disaster cannot before the event be predicted. For this reason, the obstetrician Dr McLellan arranged, quite exceptionally, for fortnightly ultrasound measurements of this mother s fetus, which indeed grew very large especially for so small a mother. In consequence, as the doctor admitted, Mrs Montgomery exhibited mounting anxiety about her ability safely to deliver so big a baby vaginally and asked (in necessarily unknowledgeable terms) about risks of injury to herself or her baby from the process. Dr McLellan further admitted that she deliberately withheld from the mother any information about the risk of shoulder dystocia and the harm it could cause to her unborn child and even cancelled the last ultrasound measurements before the due date, because (as she put it) evidence of yet further fetal growth would only increase maternal anxiety! Instead, Dr McLellan chose to allow her to labour and to reassure her (the doctor s words) that if a problem arose during labour they could go to caesarean section. That reassurance was at best misleading and at worst false, because if shoulder dystocia occurs, it is too late for caesarean section, since the head is out and the baby s body too far down the birth canal. It is the fact that most if not all thinking obstetricians in the developed world would, in a case such as this, not only offer elective caesarean section, but would probably advise it, and Dr McLellan acknowledged in evidence that if offered it, Mrs Montgomery would have accepted it, as she put it, as most diabetic mothers do. That she nevertheless chose to withhold all information about risk and deliberately denied the mother the option of elective caesarean section, was frankly mystifying, and appears to have owed more, as Supreme Court Justice Lady Hale said, to a moral objection to the proliferation of caesarean section, than to any scientific justification. With hindsight, it appears that Dr McLellan s readiness to ignore the dangers from dystocia stemmed from the fact that she had never personally encountered it in her obstetric career. Her gross underestimation of the risks and the potentially disastrous outcome was apparent from her evidence that shoulder dystocia is often overcome with the mother unaware that it has happened, an assertion which to any obstetrician who has managed this dire emergency would be truly extraordinary. So, it was that the only delivery option offered was the pursuit of vaginal delivery, which was in reality imposed, and the die was cast for the terrible outcome. Labour was induced by prostaglandin and became predictably obstructed, but Dr McLellan did not go to caesarean section. Instead, she augmented the mother s contractions by increasingly large doses of the hormonal drug Syntocinon to force the baby down the birth canal, and eventually the head delivered and the shoulder stuck. The ensuing scenes were horrific. The McRoberts manoeuvre, an extreme positioning of the mother which is the first recourse, failed to deliver the shoulders. Dr McLellan then attempted to sever the mother s pubic symphysis (in the Third World, a substitute for caesarean section), but for lack of the appropriate instrument failed to sever it completely, abandoned it half done, and after a long delay managed, with great force, to pull the baby out with forceps. In that process, she avulsed the baby s brachial plexus (a known risk in overcoming dystocia), which left him with a useless flail arm, but most tragically he had by that time suffered catastrophic and irreversible asphyxial brain damage. This appalling outcome would, and should, have been avoided altogether by elective caesarean section and indeed by section carried out earlier in the labour. The child s resulting disability is extreme, and the expensive provision of care, etc, which he will always need, prompted his parents to seek damages through litigation. The history of the Montgomery litigation In the ensuing litigation, in the Scottish courts, negligent mismanagement of the mode of delivery and the labour was (rightly) alleged, though the trial judge (wrongly as most would see it) dismissed that case. Also of course alleged was lack of valid consent to the induction of labour and the pursuit of vaginal delivery because of the total lack of information to this anxious mother about the special risks in her case, and about the alternative to running those risks before she agreed to submit to the imposition (for such it certainly was) of that course. Very surprisingly, the Defendant s lawyers defended on every front: 1. First, they argued, and found and called expert obstetric evidence to support it that the withholding of all information about risk was acceptable to a responsible body of obstetric opinion and so passed the Bolam test as a complete defence. 2. Second, they maintained that the acknowledged 10% risk of shoulder dystocia did not engage the express exception in Sidaway that risks of that

6 10 Medico-Legal Journal 84(1) magnitude do require disclosure because of those 10% only about 1 or 2% will end in disaster (though which ones was of course impossible prospectively to know). 3. Third, and particularly bizarrely, they argued that although existing law in Sidaway obliged the doctor to answer truthfully a patient s direct questions about risks that further exception was not engaged here because Mrs Montgomery s questions about her capability safely to deliver such a big baby vaginally had amounted to nothing more than the expression of generalised anxiety. 4. Finally, and most startlingly, they asserted, in direct contradiction to the mother s evidence, and Dr McLellan s own evidence, and the evidence of all the expert witnesses on both sides, which had all been to precisely the opposite effect, that if advised of the risks and offered elective caesarean section Mrs Montgomery would have refused it! Inexplicable as it seems, the Scottish trial judge Lord Bannatyne accepted all those remarkable defence arguments in their entirety, as did the three Scottish Appeal Court judges, Lords Eassie, Hardie and Emslie. The claim was lost, and the stage was set for the final appeal to the Supreme Court. The irony is that had liability been admitted, as at the least under the existing law relating to 10% risks and to direct patient questions it certainly should have been, and had the Defence admitted the obvious truth that elective caesarean should have been offered and would have been accepted, the trial (if not settled) would have been of quantum only, appropriate damages would rightly have been awarded and no further appeal would have been necessary. It can therefore be said with certainty that the Defendant s legal advisers were, by their approach to this case, personally responsible for the ultimate reversal of the legal principle on which they placed such misguided reliance, and on which in so many cases defendant Health Boards such as their client had been able, to their advantage, to rely in the past. If the matter had not come before the Supreme Court, defendants would have been able to continue to rely on Sidaway s application of Bolam to consent. Only they can explain how lawyers experienced in medical law and medical cases came to espouse and assiduously to pursue arguments on the facts and the law which were so devoid of merit. Patient consent and the development of public and legal attitudes to it To put the overruling of Sidaway into context, it is important to remember that in UK law, as in other common law jurisdictions, it has long been established that a doctor s treatment of a patient whether by physical intervention or by the prescription and administration of drugs is unlawful if the patient has not given a valid consent to it. Indeed, it used to be argued (until the courts expressly disapproved it) that it would amount to assault and battery. The central precept derives from ethical and legal principles concerning the inviolability of our bodies, and the concept of an adult human s individual autonomy, which admits of very few, and very strictly confined, exceptions. As the American Justice Cardozo expressed it famously in Shloendorff v New York Hospital in 1914: Every human being of adult years and sound mind has a right to determine what shall be done with his own body. Abuse of this principle may take many forms. At one extreme is the evil experimental use by the Nazi Dr Mengele of the bodies of live and unwilling concentration camp inmates. At the other is the well-intentioned but paternalistic attitude of the doctor who deliberately overrides the free will of patients by deciding upon and imposing treatments which the doctor himself considers appropriate ( doctor knows best ), without involving them in the decision adequately or at all. Take these pills, or We are going to cut off your leg. It is that approach which Montgomery has said is no longer acceptable in law. As recently as the mid-20th century, the precept that doctor knows best was widely accepted in the UK and elsewhere by the medical and legal professions and ingrained in populations at large. Its acceptance was no doubt partly due to the historically prevailing culture of subservience to those in authority or possessed of greater learning, and in part to generalised ignorance and even awe of the wondrous science of medicine and consequent deference to its supposedly heroic practitioners. That awe was itself founded, it seems to me, on a fatalistic acceptance of the cruelty of disease and its often inexorable course, and on the associated belief borne of scientific ignorance that doctors practise quasi-magical arts which are not for mere mortals to understand or to question. Such beliefs persist today but to a limited extent only, and largely among the elderly and the less educated. Yet, UK law as it has historically been applied to the profession and practice of medicine is in my view largely the product of those outdated attitudes, which are embodied in the Bolam test, but which are no longer societal norms. They have been displaced by greater education, and by the vast and accessible internet and media publicity for, and dissemination of knowledge about, modern medicine and its remarkable advances. Most of us now expect to understand the rationale for our treatment and to make a reasoned decision about it for ourselves. For consent, it was time to consign Bolam to history as other jurisdictions have done, and I turn to a brief review of the

7 Badenoch 11 development of case law in the UK and elsewhere on which the Montgomery decision was founded. The influential historic case law A major focus of the arguments in Montgomery was the powerful and ultimately influential dissenting opinion in Sidaway from the radical judge Lord Scarman, in which he approved, and in his reasoning followed, two statements of principle from transatlantic judges about the patient s decision to consent, both of which had been unimpressively and (as we argued and the Supreme Court agreed) spuriously disparaged by the majority in Sidaway, and both of which, it was contended, should in light of modern thought be considered incontrovertible. The two cases and their central tenets were: 1. From the American case of Canterbury v Spence in 1964: Respect for the patient s right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves. 2. From the Canadian judgment in Reibl v Hughes in 1980: Expert medical evidence is, of course, relevant to findings as to the risks that reside in or are a result of recommended surgery or other treatment. It will also have a bearing on their materiality, but this is not a question that is to be concluded on the basis of the expert medical evidence alone. The issue under consideration is a different issue from that involved where the question is whether the doctor carried out his professional activities by applicable professional standards. What is under consideration here is the patient s right to know what risks are involved in undergoing or foregoing certain surgery or other treatment. Those statements were echoed in the 1993 decision of the High Court of Australia in Rogers v Whittaker, in which they robustly dismissed the Bolam test for the adequacy of advice and consent, in terms cited and relied upon in Montgomery. The Plaintiff was blind in one eye. She was offered an operation on her blind eye, which would improve its cosmetic appearance and might also restore some limited sight in it. There was a tiny risk from the operation, about 1 in 14,000, of sympathetic ophthalmia, which would destroy the sight of her one good eye. She asked anxiously about risks, but was kept in ignorance by her surgeon. She consented to the operation. The risk materialised and she was rendered totally blind. There was unchallenged expert evidence before the trial judge that a very substantial body of responsible eye surgeons world-wide would not, as a matter of Bolam acceptable practice, have disclosed such a tiny risk to this Plaintiff a cast iron Bolam defence which was doggedly pursued. The judges nevertheless dismissed the application of Bolam to the patient s choice to consent or not, with the observation that: the choice is, in reality, meaningless unless it is made on the basis of relevant information and advice. Because the choice to be made calls for a decision by the patient on information known to the medical practitioner but not to the patient, it would be illogical to hold that the amount of information to be provided by the medical practitioner can be determined from the perspective of the practitioner alone or, for that matter, of the medical profession. Belated conformity with GMC guidance The irony of the belated recognition of these propositions by the highest court in the land, and of the determined attempt by the Defendant in this case, and by other Defendants, to adhere to what are outdated and to the modern mind unacceptable attitudes, is that the General Medical Council (GMC) of the UK has for very many years espoused and enjoined the principle of full and frank disclosure in all cases. Quotations from the Good Practice Guidance from the GMC, which were cited in the Supreme Court s decision in Montgomery, include the following: Working partnership with patients. Listen to, and respond to their concerns and preferences. Give patients the information they want or need in a way they can understand. Respect patients right to reach decisions with you about their treatment and care. (GMC publication Good Medical Practice of 2013, under the heading of The Duties of a Doctor Registered with the General Medical Council) That current injunction from the GMC echoes what has been their mantra from as early as In the GMC document of 2008 Consent: patients and doctors making decisions together appears the following: The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option

8 12 Medico-Legal Journal 84(1) which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. The patient weighs up the potential benefits, risks and burdens of the various options, as well as any non-clinical issues which are relevant to them. The patient decides whether to accept any of the options and, if so, which one. In the 2008 document is also found this: A doctor must tell patients if treatment might result in a serious adverse outcome, even if the risk is very small, and should also tell patients about less serious complications if they occur frequently. (para. 32) It is of note that the preamble to these GMC publications stresses that the injunctions about disclosure are mandatory, rather than guidelines only or mere suggestions for best practice. It is therefore unsurprising that in Montgomery in the Supreme Court, the GMC intervened to argue that Sidaway should no longer hold sway and made an important additional point about the merits of full disclosure, which the Supreme Court cited with evident approval, as follows: The submissions on behalf of the General Medical Council [who intervened at the hearing] in relation to these documents is that an approach based upon the informed involvement of patients in their treatment, rather than their being passive and potentially reluctant recipients, can have therapeutic benefits, and is regarded as an integral aspect of professionalism in treatment. The above citations show that the decision in Montgomery belatedly brings UK law into line with the long held and published standards of the medical professions own regulatory body. What is more, until it was decided it was, so I believe, only the UK and Northern Ireland of all common law jurisdictions which had failed to introduce the patient-centred test which Lord Scarman had so powerfully advocated in his dissenting judgment in Sidaway in It might well be said:...and about time too. Conclusion If the patient s right in law to decide for himself whether to consent or not is real, it obviously requires that the Bolam professional acceptance test of doctorlimited information disclosure be replaced with the patient-centred or reasonable patient test, both objectively and subjectively applied. That is what the Supreme Court judges in Montgomery unanimously recognised and decided when overturning Sidaway. They accepted and endorsed the Appellant s argument that to allow the doctor in today s society to decide what, if anything, the patient should know about his treatment before he consents to it is patronising, condescending, inconsistent with the patient s rights and repugnant to modern thinking. As for the future of the Bolam test in other fields of clinical practice, I suggest that the writing is on the wall. Bolitho rightly marked and reflected modern distaste for the strict application of Bolam, by restoring at least partially the normal judicial function of deciding which of the opposing expert medical opinions is to be preferred and which rejected. My contention is that the law should now go further and remove Bolam from its pedestal altogether. In advocating the slaughter of the Bolam sacred cow, I acknowledge that there is some justification, as recognised in some of the cases, for applying the Bolam test of professional sanction to decisions made by doctors about diagnosis and treatment. For those are clinical decisions about disease, and about the need for, and the risks and benefits of, a given treatment and its alternatives if any. They accordingly require the exercise of the special skill and learning of a qualified doctor, which may be difficult and may legitimately admit prospectively of different answers, each prospectively valid and defensible as consistent with due care, though one or the other is shown retrospectively to have been wrong. Clearly, therefore, prevailing professional standards will be relevant to the adequacy of a doctor s performance of that skilled function, from which it follows that acceptability of that performance to at least a body of responsible medical opinion will be relevant to a judge s conclusions, may well be persuasive and indeed may (perhaps often) be decisive. What I maintain is that it should not in any case be definitive of the duty and standard of care required by law of a doctor as Bolam says that it is. For the question is: who ultimately sets the standard of care for doctors? Is it the medical profession itself, with the judges as interested and occasionally intervening bystanders, or is it the judges defining and imposing in accordance with legal principles (as they do in all other areas of human activity) standards which are set and imposed by the law? Montgomery has established that in one area of medical practice, Bolam shall no longer hold sway, and it is necessary to ask whether Bolam can survive much longer before it is banished from the issue of clinical negligence altogether. I believe that Montgomery will prove to be a turning point and that it spells the beginning of the end for the Bolam test in all its applications. In this regard, I note some important observations of Lord Justice Jackson in the Peter Taylor Memorial Lecture he gave in London on 21 April 2015, which was entitled The

9 Badenoch 13 Professions: Power, Privilege and Legal Liability. I refer in particular to this passage about Bolam and Montgomery: The attack on Bolam. In the latter part of the twentieth century many claimants had their guns trained on Bolam. My impression during 25 years practice at the Bar (l973 to 1998) was that, although everyone paid lip service to Bolam, it became steadily more difficult to persuade judges that errors made by professional people were non-negligent mistakes. The one exception was the medical profession, where the full majesty of the Bolam test continued to hold sway. But even that stronghold of Bolam was coming under attack. In Sidaway v Board of Governors of Bethlem Royal Hospital [1985] AC 871 (a case concerning the doctor s duty to advise) the Bolam test only survived by a 3:2 majority. Finally, just a month ago, the invaders captured the citadel. In Montgomery v Lanarkshire Health Board [2015] UKSC 11; [2015] 2 WLR 768 the Supreme Court held that the majority in Sidaway was wrong. The Bolam test did not determine the extent of a doctor s duty to advise. To this Lord Justice Jackson added, under the heading Future battles: Now that the invaders have broken through the castle walls, they will not stop there. I predict that over the coming years there will be continuous onslaught on Bolam. The argument will be that the ordinary principles of tortious liability should apply to the professions in the same way that they apply to everybody else. There is no reason for the courts to accord special protection to the professions. Whether any of those attacks will succeed I do not know and it would be wrong for me, as a judge, to predict. I merely state where I foresee the next battles being fought. I have long contended that Bolam acceptability ought not uniquely in medical cases to replace the normal judicial function of discriminating between opposing arguments about the standard of care expected of doctors (as exercised e.g. in respect of lawyers practices in Edward Wong Finance). What is surely required in all areas of clinical practice is a standard set by law for physicians rather than one which physicians may or may not impose upon themselves, as the court in the American case of Canterbury v Spence expressed it. To confine that principle, which is so obviously right and is otherwise of universal application in UK law, to one, limited area of medical practice only (disclosure for consent) makes no sense. Adherence to the Bolam principle that professional approval is a complete defence in any aspect of the profession of medicine should be overthrown in the UK as it has been in the jurisprudence of other common law jurisdictions though that is for another time and another case. Mr Badenoch: I thought it might be interesting to you if I just run through what the practical effect of Montgomery is on the practice of medicine and surgery. These are my suggestions; I hope they are right. They may not be, but I think they are. The practical effect of Montgomery on the practice of doctors 1. The proforma approach to patient consent must be abandoned. 2. The signature on a consent form proves nothing, except that the patient can write and can sign his/ her own name. 3. There must be genuine dialogue between doctor and patient. Merely rehearsing or reading out predrafted or standard wording will not do. 4. When discussing the risks and benefits, and alternatives if any, the doctor must: (i) Be sure to use words that the patient can readily understand and check that there is real understanding; (ii) Avoid overloading the patient with excessively detailed information keep it simple; (iii) So far as possible avoid technical jargon, using it only where there is no other way of describing what is proposed; (iv) Tailor the discussion to the patient, which means: (a) First, consider what are the risks of the proposed treatment about which is a reasonable patient in this patient s position would need and want to know (the objective test). (b) Next, consider the particular patient and his/her individual characteristics and situation in life, e.g. age, intellectual ability, nature and demands of employment, family and other responsibilities, social and other problems, prospects if untreated, etc (the subjective test), and having done that: (c) Personalise the issue so as to identify what this particular patient in the given situation would be expected to need and want to know, and add to or modify the disclosure accordingly. 5. If a doctor is expressly told by the patient, and/or has clear and compelling reasons to believe, that the patient is unwilling or unable to face disclosure of chances, risks, and uncertainties, the doctor: (i) Should first decide whether there is nevertheless a compelling need to disclose a risk (e.g. a

10 14 Medico-Legal Journal 84(1) known complication which would result in very serious harm), the withholding of which could vitiate consent. (ii) May, absent such a compelling need, accept the patient s wish not to be told, and limit disclosure accordingly. (iii) Should in either case make a careful note of the matter. 6. Sensitivity to the characteristics of the patients is expressly required by Montgomery, so that, by way of example, discussion of the risks of labour with a nervous first-time mother might be very different from that discussion with a woman who has previously given birth. 7. Statistics relating to risk are not a decisive measure of whether it requires to be disclosed. A small risk of serious consequences, if well recognised, may be expected to be of significance to most patients, and particularly significant to a patient undergoing a non-urgent, strictly unnecessary or purely cosmetic treatment. A large risk of very minor or transient side-effects (such as are found in drug data sheets) will usually not require disclosure. 8. A specific risk, however small, may be of particular significance to patients whose lives or livelihood would be especially affected if the risk materialised, e.g. damage to the voice for a singer, or a failure rate of sterilisation for a mother with too many children to cope with. 9. A doctor who is not good at communicating with patients, whether because inexpert or unwilling, must recognise the fact and take steps to acquire the necessary skills. 10. Lack of time for adequate dialogue with the patient may seem an ever present and even insuperable problem. It must be overcome, because what is at issue is the patient s most basic and fundamental right to decide, on adequate information, whether to submit or not to proposed treatment, or which of alternatives to choose or accept. 11. Whenever practicable the person advising and/or carrying out the treatment should obtain the consent, though it may be reasonable where necessary to delegate this task, provided that the delegate is possessed of all relevant information and adequately trained in the task. 12. The standard required in respect of disclosure is a reasonable one (not perfection). This means that in all ordinary circumstances. (i) A huge catalogue of every extremely remote and even theoretical risk, of the kind found in the information sheets supplied with drugs, can, and almost always should, be avoided. The test of reasonableness will recognise good sense in this regard. See the decision of Dingemans J in Mrs A v East Kent Hospital University NHS Foundation Trust [2015] EWHC 1038 (QB). (ii) In giving information and seeking consent the doctor may, and if asked no doubt will, express his own view of the patient s best course, always without seeking or appearing to impose it, by telling the patient: It is entirely your choice, but this is what I would do myself, or what I would wish my partner or child to do. 13. Sensitive and frank disclosure in advance of risks and benefits, including acknowledgement of any real uncertainty of a successful outcome, may be expected to engender less anger, bewilderment and recrimination in the patient when things do not turn out well. 14. Information which displaces ignorance will (as the GMC have asserted and the Supreme Court agree) make it less likely that the patient will have recourse to lawyers in the belief that a bad outcome must be the result of bad performance, and this should ultimately reduce litigation. Mr Badenoch: Now, I have gone on a bit and I have been rather serious, which is not always my way, but I think you probably have the impression, which I hope I have given, that this change made to the English law in Montgomery was long overdue, and I also take the view that the objectors to this change ought to think very carefully before they take their objection very far, because, whatever else is true, it is indeed unlawful for you as a doctor to administer a drug or to take a scalpel, or any other instrument, to my body or any other patient s body without that patient s consent, and you may, I hope, agree with the Supreme Court who said, echoing the judgments of courts in other jurisdictions long since, that consent is unreal if the person allegedly consenting is not possessed of relevant information on which to make a reasoned personal judgment consistent with his own autonomy. Well, there it is. I know it sounded a bit sermonising, but I do hope that in the main you agree with my propositions. Thank you very much. (Applause) Discussion A male member of the audience: Hi. I am... (inaudible), a general surgeon, and I do some medico-legal work as well. My question is: how do you think Bolam for diagnosis or treatment is going to get overthrown, when the process you describe for dealing with consent started with a defence which should probably never have been made? Usually, people don t want to run with these cases because they are too high risk. I am just interested in how you think it is going to change?