Doctors duties in obtaining consent

Transcription

1 Doctors duties in obtaining consent Paul Sankey highlights the ongoing implications of Montgomery v Lanarkshire Health Board Paul Sankey is a partner at Foot Anstey Patient autonomy has largely displaced paternalism. This is a significant shift in the law to reflect changes in contemporary culture. A very significant change in the law took place in March 2015 which has serious implications for doctors discussing options for treatment with patients and obtaining consent for them. The case of Montgomery v Lanarkshire Health Board [2015] is now familiar law for practitioners in the field. It redefined the legal relationship between doctors and patients. It is surprising, however, how little the implications have been tested in subsequent case law. However more than a year on it is appropriate to consider the impact of the decision both in terms of the law and medical practice. The facts Nadine Montgomery gave birth to her first child in October 1999 at a hospital in Lanarkshire. Because of complications of shoulder dystocia at birth, her baby was born with severe disabilities. She claimed damages against the Lanarkshire Health Board, alleging negligence by Dr McLellan, the obstetrician who had managed the birth. The allegations were that Dr McLellan negligently failed to advise her of the risks of a vaginal delivery as opposed to elective caesarean section and then failed to carry out a caesarean section in response to abnormalities in the CTG trace. The risks for Ms Montgomery s baby of shoulder dystocia were around 9-10%, higher than average because of her small size (just over 5 foot) and diabetes. Diabetes increased the likelihood of having a large baby with wide shoulders. The risk of prolonged hypoxia from shoulder dystocia was less than 0.1%, which of course is extremely low. Unfortunately the risk materialised. Ms Montgomery was described as a highly intelligent woman. She had a degree in molecular biology. She was therefore undoubtedly capable of weighing up medical advice as to the mode of delivery of her baby. Dr McLellan s evidence was that she did not advise Ms Montgomery of the increased possibility of shoulder dystocia because the risk of a grave problem for the baby was so small. If the condition had been mentioned, in her words: Most women will actually say, I d rather have a caesarean section if you were to mention shoulder dystocia to every [diabetic] patient, if you were to mention to any mother who faces labour that there is a very small risk of the baby dying in labour, then everyone would ask for a caesarean section, and it s not in the maternal interests for women to have caesarean sections. Implicit within these words was the judgment that a doctor s assessment of a patient s interests outweighed the patient s wishes in these circumstances. The claim failed in at first instance, the court finding that Dr McLellan had not been negligent either in her advice or her management of the labour. When the case reached the Supreme Court, the principal issue was whether Dr McLellan s failure to warn Ms Montgomery of the risk was negligent. The argument Bolam v Friern Hospital Management Committee [1957] established that a doctor was not guilty of negligence if they have acted in accordance with a practice accepted as proper by a responsible 20 Personal Injury Law Journal

2 body of medical practitioners skilled in that particular art. The Bolam test of negligence was applied in that case not just to diagnosis and treatment but also to advise. The question in Montgomery was whether it provided the correct test to be applied to the doctor s duty to advise. In Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] the House of Lords (the predecessor of the Supreme Court) held that it did. The prevailing view of the Law Lords was that it was enough for a doctor to explain the risks in a manner which accorded with the practice of a responsible body of clinicians. In other words it was the medical profession who decided what a patient needed to know. Further there was no duty to provide unsolicited information about risks although if a patient asked questions there was a duty to respond appropriately. This might be described as Dr McLellan s position. Her advice to Ms Montgomery was based on what she thought amounted to responsible medical practice. The minority view of Lord Scarman, however, put a greater onus on the patient s concerns. He thought a doctor should take reasonable care to respect a patient s right to decide whether to incur a risk. That decision may not just involve medical considerations: other factors may well be important to the patient. The relative importance attached by patients to quality as against length of life, or to physical appearance or bodily integrity as against the relief of pain, will vary from one patient to another. Countless other examples could be given of the ways in which the views or circumstances of an individual patient may affect their attitude towards a proposed form of treatment and the reasonable alternatives. The doctor cannot form an objective, medical view of these matters, and is therefore not in a position to take the right decision as a matter of clinical judgment. However until Montgomery it was the majority position that prevailed: the Bolam test applied and a doctor s duty was to explain the risks in a way which accorded with a responsible body of clinicians. A changed landscape The Supreme Court in Montgomery noted that English courts had nevertheless recently been moving in a different direction and, when it came to advice, the Bolam test had been undermined by some recent decisions. It noted that behind the scenes there had been a change in the social, medical and legal landscape since Sidaway. The first change was in a different cultural approach to the doctor-patient relationship. People are now regarded as autonomous bearers of rights, governing their own lives. In making choices for themselves, patients are regarded as: persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices: a viewpoint which has underpinned recent developments in healthcare provision. A second change is that patients are more able than before to obtain medical information. They are often well-informed about symptoms, investigations, treatment options, risks and side-effects. They have ready access to the internet, patient support groups and information leaflets. There are also increasing legal requirements on suppliers of medicines to label their products and provide information leaflets. Underlying this is an assumption that patients are capable of understanding the nature of their condition and weighing up treatment options. This assumption contrasts to the more paternalistic position taken in Sidaway, which was now manifestly untenable. A third change is developments in medical practice. Guidance such as Good Medical Practice (2013) states that the duties of a doctor are to: Work in 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. Fourthly, Human Rights law has developed under the stimulus of the Human Rights Act The courts have become increasingly conscious of the value of self-determination for instance in cases involving issues of withdrawal of treatment. The same value is reflected in Art 8 of the European Convention on Human Rights, which protects the right of respect for private life, and other international instruments. Until Montgomery it was the majority position that prevailed: the Bolam test applied and a doctor s duty was to explain the risks in a way which accorded with a responsible body of clinicians. The landscape has therefore changed and with it the nature of the doctor-patient relationship. Medical paternalism, under which patients are entirely dependent upon guidance from their doctor, has given way to a relationship where patients are autonomous decision-makers who may wish to factor a variety of medical and non-medical considerations into their decisions. Montgomery: the decision In Montgomery the Supreme Court therefore rejected the Bolam test s application to a doctor s duty to advise. The test was not whether a doctor acted in accordance with a practice accepted as proper by a responsible body of medical practitioners but was based instead on what a particular patient would expect to know. It set out the test as follows: An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material Personal Injury Law Journal 21

3 risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. 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. The most important part of this test concerns what is material. This is assessed by reference to the particular patient, or more accurately, a reasonable person in the patient s position. The risk to Ms Montgomery s baby was 0.1% but whether the risk is material is not a matter of percentages. It will depend on the nature of the risk, its effect on the patient s life, the importance to the patient of the benefits of treatment, alternatives and the risks of those alternatives. It is fact-sensitive, depending on the particular patient s characteristics. Therefore the doctor s advisory role cannot be regarded as solely an exercise of medical skill. The doctor will only know what is material to the patient by talking and listening to them. What is material may be medical but it may well not be. There are three exceptions to the general rule: where a patient tells a doctor that they do not want to know the risks; the therapeutic exception : ie if disclosure of the risk would be seriously detrimental to a patient s health; and necessity: for instance an unconscious patient requiring urgent treatment. However those exceptions should be regarded narrowly and not abused. Turning to the detail of Ms Montgomery s case, she was found to have the right to be advised of the risk of shoulder dystocia, to make her own decision on the risks she was prepared to run. The court accepted that she would have opted for a caesarean section had she been properly advised. Damages were valued on the evidence at 5.25m. Subsequent cases There are two cases with contrasting results concerning birth injuries. In SXX v Liverpool NHS Foundation Trust [2005] the claimant, a child injured at birth, established that his mother should have been advised to consider a caesarean section, which would have avoided his injury. In MC, JC v Birmingham Women s NHS Foundation Trust [2016] the claimants, mother and child both injured at birth, failed to establish The risk to Ms Montgomery s baby was 0.1% but whether the risk is material is not a matter of percentages. that the mother had not consented to induction of labour. There are then two cases concerning cardiac procedures. In Julie Connolly v Croydon Health Services NHS Trust [2015] the claimant failed to establish that she had not been properly warned of the risks of an angiogram or that she had withdrawn her consent when complications arose. In Shaw v Kovac [2015], a claim succeeded on behalf of the estate of a man who died following transcatheter aortic valve implantation. It was found that he had not been offered the alternatives of open heart surgery or conservative symptomatic treatment and would have elected for one or the other. The court rejected a claim that Montgomery created a freestanding head of damages described as loss of expectation of life, a claim which is in any event precluded by s1 of the Administration of Justice Act In David Spencer v Hillingdon Hospital NHS Trust [2015] the court used the Montgomery approach to consent to define the advice a patient should have been given of post-operative complications. In that case the claimant had suffered a deep vein thrombosis (DVT) after a hernia repair. Not having been advised of the risk, he did not return to hospital when he developed symptoms of a DVT. The case is not therefore about consent but it shows the impact of Montgomery in establishing the standard of care required in relation to advice. The most significant case may be Tasmin v Barts Health NHS Trust [2015] which was a claim on behalf of a child who suffered a profound hypoxic injury at birth. The claimant alleged that in response to a pathological CTG, her mother should have been offered a caesarean section as an alternative to foetal blood sampling. The court preferred the defendant s expert evidence that a CTG is not of itself diagnostic and good medical practice (reflected in RCOG and NICE guidelines) would have required foetal blood sampling before considering whether a caesarean section might be appropriate. Further, the blood results would have been reassuring and the advice would have been to proceed to a vaginal delivery. Had her mother been advised of the options at that stage the risk of serious injury would have been only 1 in 1,000. The court reconciled good medical practice with the legal duty to advise by saying: The reason the guidance has been formulated in the terms it has been is that the risks are sufficiently low that it is not regarded as mandatory or even good practice to spell them out to labouring mother and/or confuse them by routinely offering a CS. In this way it is not difficult, in my judgment, to harmonise standard practice with the highest judicial authority. Although the Supreme Court in Montgomery had said that whether a risk is material is not a matter of percentages, Jay J said it was doing so in the context of defining the borderline between material and immaterial. He found that 1:1,000 was too low to be material. The decision in Tasmin therefore could be regarded as something of a brake on the momentum of Montgomery. Implications The Supreme Court in Montgomery rejected a clinician-centred and paternalistic approach to consent. The test is no longer what a responsible body of clinicians would advise, a test whose yardstick is the current practice of the medical profession. That test 22 Personal Injury Law Journal

4 has been replaced with one that treats patients as adults capable of making their own decisions based on medical information but also on non-medical considerations. The recognition that non-medical factors may be important to a patient is important because these are factors a doctor will not necessarily know without discussion with the patient. Lady Hale was particularly scathing about the paternalistic approach taken by Dr McLellan: Whatever Dr McLellan may have had in mind, this does not look like a purely medical judgment. It looks like a judgment that vaginal delivery is in some way morally preferable to a caesarean section: so much so that it justifies depriving the pregnant woman of the information needed for her to make a free choice in the matter. Patient autonomy has therefore largely displaced paternalism. This is a significant shift in the law to reflect changes in contemporary culture. Tasmin, however, suggests a degree of restraint. There the court found that it was not appropriate to offer a caesarean in circumstances which would breach good medical practice, a decision which will no doubt give comfort to the medical profession. The current law leaves a number of significant implications for medical practitioners and for NHS services more widely. The first is that obtaining consent will need to be regarded as a process in which the patient plays a greater role. It will have to be done more carefully. Doctors will need to take time to find out what is material to the particular patient. They will need to ensure the patient understands the seriousness of the condition, the anticipated benefits and risks of the proposed treatment and any alternatives. But they will also need to ensure that they understand other matters of importance to the patient matters including quality of life, the impact of treatment on appearance and the patient s values. They will only be able to understand what factors are important to a patient and how the patient assesses the impact of treatment on those factors by talking to them. There will need to be proper dialogue. Taking consent will therefore need to be more than a matter of running quickly through a standard form shortly before theatre. It needs to be done at the right time. This will normally mean earlier than the day of admission in the case of elective procedures. It is difficult to see how a patient-focussed decision can be made when a patient has already made the emotional and practical commitment to a procedure, arranging time off work, transport to and from hospital and post-operative care. By then the decision will largely have been made. It should probably be the responsibility of the doctor carrying out the procedure rather than a task delegated to a junior. Consent will need to be recorded fully and if standard forms to be used they will need to look different with space to record a more detailed and wider-ranging discussion. This will need to be much more than a tick-box exercise recording standard risks and benefits. Written records will need to reflect a patient s priorities. A second implication is that consultations where treatment is discussed will often need to be longer. The sort of dialogue required by the Supreme Court in Montgomery The sort of dialogue required by the Supreme Court in Montgomery will in many cases take time. This of course has implications for stretched NHS resources. FAMILY LAW JOURNAL will in many cases take time. This of course has implications for stretched NHS resources. The Supreme Court considered some of the possible objections from the medical profession. One was that there would not be time for the degree of dialogue it envisaged during a healthcare consultation. It answered uncompromisingly: respect for the dignity of patients requires no less. A third is that hospitals may well find themselves with patients who elect We read Family Law Journal from cover to cover every month. It is always full of articles by the best firms and chambers; articles which are useful on a day-to-day basis. Huw Miles, Head of Family, Paris, Smith & Randall Solicitors Each issue provides: Practical guidance on real issues Analysis of key cases and legislation Advice on implementing the latest developments Expert comment and opinion Concise, useful information that saves you time For a FREE sample copy, call us on or subscriptions@legalease.co.uk Personal Injury Law Journal 23

5 for costlier forms of treatment. They may express preferences for further investigations or for treatments which clinicians would have preferred to avoid given cost constraints. An obvious example is caesarean sections, which may present the most significant area of medicine to be affected. Dr McLellan s concern was that if she advised diabetic patients of the risks of shoulder dystocia and the very small risk of serious brain injury to the baby they would all elect for caesarean sections. That may be an exaggeration but she was probably right that it would decisions. Consumerism emphasises patient choice. Consumers are free to spend their money to buy goods and services as they wish. However, in the context of NHS healthcare it is not their money they are spending. Their choices are funded by limited resources meeting the needs of an entire population. There is a danger that consumerism risks giving preference to the individual s wishes in a way which undermines the wider interests of society. The challenge is to find a principled autonomy which can balance the rights of individuals provide depends not only on clinical judgment but also upon bureaucratic decisions as to such matters as resource allocation, cost-containment and hospital administration: decisions which are taken by non-medical professionals. It added: Such decisions are generally understood within a framework of institutional rather than personal responsibilities, and are in principle susceptible to challenge under public law rather than, or in addition to, the law of delict or tort. One of the areas in which the decision in Montgomery will probably be tested by the courts in years to come is the point at which patient autonomy must give way to social welfare. involve a significant increase. It is of course significant that three reported cases on consent since Montgomery concern birth injuries and two concern caesarean sections. The decision may well therefore generate increased costs for a stretched NHS service. A fourth is that doctors will at times need to be alert to the need to consult their patients when risks change during a procedure. In reality there is no change in the law here. However doctors will need to remember that the duty to obtain consent is a continuing one and in the context of a changing situation this may not be easy. In Tasmin, Mr Tuffnell, obstetrician for the defendant, commented, the obligations of the new law are extremely challenging. Labour is a dynamic process. You can t have a lengthy discussion as the risks are changing. In the particular circumstances of that case the court accepted that a pathological CTG was not a point at which the obstetrician needed to review the advice given to the mother but in other circumstances the decision may have been different. So patient autonomy has taken pride of place at the centre of the doctor-patient relationship. The less attractive side of autonomy is consumerism. Autonomy rightly respects a patient s rights to be properly informed and make with a responsibility to recognise the needs of others. It needs to recognise the finite nature of NHS resources and the fact that other patients may have a more justifiable claim to limited resources. The NHS was founded on the basis of principles of social welfare rather than consumerism but has been evolving into a more consumer-based form of healthcare. There may well be something of a tension between autonomy and social welfare. There are some services that a public healthcare system with finite resources cannot provide. One of the tasks of NICE for instance is to assess the benefits of drugs in relation to cost. The same principle of balancing costs and benefits will limit the forms of treatment public healthcare can provide whatever a patient s wishes. One of the areas in which the decision in Montgomery will probably be tested by the courts in years to come is the point at which patient autonomy must give way to social welfare. The very blunt statement of Lady Hale, the medical profession must respect her choice, unless she lacks the legal capacity to decide is no doubt entirely correct in relation to Ms Montgomery s delivery but needs qualification in relation to healthcare provision more widely. The court alluded rather obliquely to this issue in commenting that the treatment healthcare professionals can In other words, some decisions as to what options are available for patients are and will be made as a matter of hospital or even governmental policy. Those decisions form a framework within which individual doctors work. If certain decisions are wrong they may be challenged in court using public law rather than by actions for damages for breach of duty by individual doctors. In the meantime Montgomery represents a major landmark in the law reinforcing patient s rights over their medical treatment and a significant challenge to the medical profession and to NHS services. It is bound to require changes in practice. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 David Spencer v Hillingdon Hospital NHS Trust [2015] EWHC 1058 (QB) Julie Connolly v Croydon Health Services NHS Trust [2015] EWHC 1339 (QB) MC, JC v Birmingham Women s NHS Foundation Trust [2016] 1334 (QB) Montgomery v Lanarkshire Health Board [2015] UKSC 11 SXX v Liverpool NHS Foundation Trust [2005] EWHC 4072 (QB) Shaw v Kovac [2015] EWHC 3335 (QB) Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1 Tasmin v Barts Health NHS Trust [2015] EWHC 3135 (QB) 24 Personal Injury Law Journal