Here Paul Sankey, a leading Clinical Negligence lawyer at Enable Law, shares how the Montgomery judgement changed doctors’ duty in terms of obtaining informed consent to treatment.
Introduction
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. It is important that all doctors are aware of how the law has changed and ensure that they comply with what are now more onerous duties on them.
The Supreme Court decision in Montgomery v Lanarkshire Health Board [2015] UKSC 11 redefined the legal relationship between doctors and patients. It enshrined in law principles which were already present in GMC guidance. So far as that guidance is being implemented, it will not result in major changes to medical practice. The reality may well be however that busy doctors under significant time pressures may not find themselves giving sufficient priority to the consent process. With time allowed in NHS practice for consultations often being inadequate, the medical profession may struggle to change its practice sufficiently to comply with its legal duties.
The facts
Nadine Montgomery gave birth to her first child in October 1999 at a hospital in Lanarkshire. Because of complications of shoulder dystocia and then hypoxia at birth, her baby was born with severe disabilities. She claimed damages against the Lanarkshire Health Board, alleging negligence by the obstetrician who had managed the birth. The allegations were that the obstetrician 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. 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.
The obstetrician’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. Had she done so, most women in her situation would have elected for a caesarean section, which would not be in their interests. Implicit was the judgment that the doctor’s assessment of a patient’s interests outweighed her patient’s wishes.
The claim failed in at first instance, the court finding that neither the advice nor the management of labour were negligent. When the case reached the Supreme Court, the principal issue was whether the failure to warn of the risk was negligent.
The argument
The definition of negligence in medical practice is known as the Bolam test following the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582. The test is whether a doctor acted in accordance with a practice accepted as proper by a responsible body of medical practitioners skilled in that particular art. The test was applied in Bolam not just to diagnosis and treatment but also to advice. The question in Montgomery was whether it provided the correct test applied to the doctor’s duty to advise.
In a previous case (Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] AC 871) the Supreme Court (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. This might be described as the obstetrician’s position in Montgomery. Her advice was based on what she thought was responsible medical practice.
The minority view of Lord Scarman in Sidaway 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: a doctor’s duty was to explain the risks in a way which accorded with a responsible body of clinicians. The test was not a reasonable patient would expect to be told.
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.
First was 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’.
Secondly, 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. It is assumed that patients can understand their condition and weigh up treatment options.
Thirdly, there have been 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 1988. 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 Article 8 of the European Convention on Human Rights, which protects the right of respect for private life, and other international instruments.
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 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 of shoulder dystocia was 9-10% and of serious injury to her 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. Interestingly a later decision in Tasmin v Barts Health NHS Trust [2015] EWHC 1038 considered a risk of 0.1% as ‘too low to be material’.
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 her. What is material may be medical but it may well not be.
There are 3 exceptions to the general rule:
1 - Where a patient tells a doctor that she does not want to know the risks.
2 - The ‘therapeutic exception’: ie if disclosure of the risk would be seriously detrimental to a patient’s health; and
3 - 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 £5.25 million.
Implications
The Supreme Court has 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 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.
Patient autonomy has therefore largely displaced paternalism. This is a significant shift in the law to reflect changes in contemporary culture.
There are 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 her. 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, perhaps at pre-operative review. It is difficult to see how a patient-focused 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 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 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. Ms Montgomery’s obstetrician was concerned 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 involve a significant increase.
In fact several of the reported cases on consent decided since Montgomery involve exactly that issue. For example in SXX v Liverpool Women’s NHS Foundation Trust [2015] EWNC 4072, Tasmin v Barts Health NHS Trust and FM v Ipswich Hospital NHS Trust [2015] EWHC 775 the claims were all brought by mothers alleging that they were inadequately advised and that with adequate treatment they would have elected for caesarean sections. MC, JC v Birmingham Women’s NHS Foundation Trust on the other hand involved a claim that with adequate advice a mother would not have undergone induction of labour. 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 v Barts Health NHS Trust the claimant alleged that when a CTG was abnormal, she should have been offered a caesarean section as an alternative to foetal blood sampling. In fact the court rejected that allegation because until the foetal blood sample was available, there was insufficient information properly to advise her. However Defendant’s obstetrics expert, 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.’
So patient autonomy has taken its place at the centre of the doctor-patient relationship. The less attractive side of autonomy is consumerism. Autonomy respects a patient’s rights to be properly informed and make 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. Unchecked, consumerism risks giving the individual a degree of preference which could prejudice the wider interests of society. The challenge is to find a principled autonomy which can balance the rights of individuals 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.
If consumerism is the downside of autonomy, social welfare is the upside of paternalism. The NHS was founded on the basis of principles of social welfare but has been evolving into a more consumer-based form of healthcare. There ultimately needs to be a balance 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 apply to certain forms of treatment 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. There are some investigations and treatments a patient will want but cannot have.
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.