Montgomery v Lanarkshire Health Board  UKSC 11 is a judgment that is required reading for all medical professionals, because the Supreme Court has made clear that the doctrine of informed consent is now part of English (and Scottish) law.
The issue arose in the context of whether a doctor was negligent in not informing a pregnant diabetic woman that there was a 9-10% risk of shoulder dystocia during vaginal delivery (the baby’s shoulders being too wide to pass through the mother’s pelvis). The doctor’s policy was not routinely to advise diabetic women about shoulder dystocia as, in her view, the risk of a grave problem for the baby was very small, but if advised of the risks of shoulder dystocia women would opt for a caesarean section, which was not in the maternal interest.
In the Court of Session (this being a Scottish case), the woman’s claim for damages on behalf of her son for the injuries he suffered as a result of shoulder dystocia during his birth was rejected, on the grounds that the doctor was not negligent, and on the basis that any negligence did not cause the injuries as the woman would have not elected to have a caesarean section even had she been told of the risks. In relation to the question of whether the doctor had been negligent, the Court of Session had applied the decision of the House of Lords in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital  AC 871, holding that whether a doctor’s omission to warn a patient of risks of treatment was a breach of her duty of care was normally to be determined by the application of the “Bolam test” (Bolam v Frierm Hospital Management Committee  1 WLR 582 i.e., whether the omission was accepted as proper by a responsible body of medical opinion, which could not be rejected as irrational. Expert evidence was before the Court of Session advanced on behalf of the Health Board was to the effect that the doctor’s policy was proper.
The decision of the Court of Session was upheld by the Inner House. Mrs Montgomery appealed to the Supreme Court.
Lords Kerr and Reed gave the lead judgment (Lords Neuberger, Clarke, Wilson and Hodge agreeing with them), and undertook a comprehensive review of the jurisprudence both in England and elsewhere. Their conclusions were that Sidaway reflected a paradigm of the doctor-patient relationship that had ceased to reflect the reality and complexity of the way in which healthcare services are provided, or the way in which the providers and recipients of such services view their relationship:
“75. […] One development which is particularly significant in the present context is that patients are now widely 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 some of the developments in the provision of healthcare services. In addition, a wider range of healthcare professionals now provide treatment and advice of one kind or another to members of the public, either as individuals, or as members of a team drawn from different professional backgrounds (with the consequence that, although this judgment is concerned particularly with doctors, it is also relevant, mutatis mutandis, to other healthcare providers). The treatment which they can offer is now understood to depend not only upon their clinical judgment, but upon bureaucratic decisions as to such matters as resource allocation, cost-containment and hospital administration: decisions which are taken by non-medical professionals. 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.
76. Other changes in society, and in the provision of healthcare services, should also be borne in mind. One which is particularly relevant in the present context is that it has become far easier, and far more common, for members of the public to obtain information about symptoms, investigations, treatment options, risks and side-effects via such media as the internet (where, although the information available is of variable quality, reliable sources of information can readily be found), patient support groups, and leaflets issued by healthcare institutions. The labelling of pharmaceutical products and the provision of information sheets is a further example, which is of particular significance because it is required by laws premised on the ability of the citizen to comprehend the information provided. It would therefore be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent upon a flow of information from doctors. The idea that patients were medically uninformed and incapable of understanding medical matters was always a questionable generalisation, as Lord Diplock implicitly acknowledged by making an exception for highly educated men of experience. To make it the default assumption on which the law is to be based is now manifestly untenable.”
The judicial tour d’horizon continued with a review of the developments brought about under the stimulus of the HRA 1998 and the Oviedo Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. As they noted:
“82. In the law of negligence, this approach entails a duty on the part of doctors to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment. This can be understood, within the traditional framework of negligence, as a duty of care to avoid exposing a person to a risk of injury which she would otherwise have avoided, but it is also the counterpart of the patient’s entitlement to decide whether or not to incur that risk. The existence of that entitlement, and the fact that its exercise does not depend exclusively on medical considerations, are important. They point to a fundamental distinction between, on the one hand, the doctor’s role when considering possible investigatory or treatment options and, on the other, her role in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury which may be involved.
83. The former role is an exercise of professional skill and judgment: what risks of injury are involved in an operation, for example, is a matter falling within the expertise of members of the medical profession. But it is a non sequitur to conclude that the question whether a risk of injury, or the availability of an alternative form of treatment, ought to be discussed with the patient is also a matter of purely professional judgment. The doctor’s advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient’s entitlement to decide on the risks to her health which she is willing to run (a decision which may be influenced by non-medical considerations). Responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical professions.
84. Furthermore, because the extent to which a doctor may be inclined to discuss risks with a patient is not determined by medical learning or experience, the application of the Bolam test to this question is liable to result in the sanctioning of differences in practice which are attributable not to divergent schools of thought in medical science, but merely to divergent attitudes among doctors as to the degree of respect owed to their patients.”
Lords Reed and Kerr therefore held that the decision in Sidaway was unsatisfactory (and acknowledged that the courts in England and Wales had in reality departed from it). They held that the correct position in relation to the risks of injury involved in treatment is that:
“87. […] 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.
88. The doctor is however entitled to withhold from the patient information as to a risk if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health. The doctor is also excused from conferring with the patient in circumstances of necessity, as for example where the patient requires treatment urgently but is unconscious or otherwise unable to make a decision. It is unnecessary for the purposes of this case to consider in detail the scope of those exceptions.”
At paragraphs 89-91, their Lordships noted that three further points arose in consequence:
- The assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.
- The doctor’s advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.
- It is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests.
Lords Kerr and Reed noted that there would be arguments against the approach that they set out: (1) that some patients would rather trust their doctors than be informed of all the ways in which their treatment might go wrong; (2) that it is impossible to discuss the risks associated with a medical procedure within the time typically available for a healthcare consultation; (3) that the requirements imposed are liable to result in defensive practices and an increase in litigation; and (4) that the outcome of such litigation may be less predictable. However, they rejected these arguments:
“85. The first of these points has been addressed in para 85 above. In relation to the second, the guidance issued by the General Medical Council has long required a broadly similar approach. It is nevertheless necessary to impose legal obligations, so that even those doctors who have less skill or inclination for communication, or who are more hurried, are obliged to pause and engage in the discussion which the law requires. This may not be welcomed by some healthcare providers; but the reasoning of the House of Lords in Donoghue v Stevenson  AC 562 was no doubt received in a similar way by the manufacturers of bottled drinks. The approach which we have described has long been operated in other jurisdictions, where healthcare practice presumably adjusted to its requirements. In relation to the third point, in so far as the law contributes to the incidence of litigation, an approach which results in patients being aware that the outcome of treatment is uncertain and potentially dangerous, and in their taking responsibility for the ultimate choice to undergo that treatment, may be less likely to encourage recriminations and litigation, in the event of an adverse outcome, than an approach which requires patients to rely on their doctors to determine whether a risk inherent in a particular form of treatment should be incurred. In relation to the fourth point, we would accept that a departure from the Bolam test will reduce the predictability of the outcome of litigation, given the difficulty of overcoming that test in contested proceedings. It appears to us however that a degree of unpredictability can be tolerated as the consequence of protecting patients from exposure to risks of injury which they would otherwise have chosen to avoid. The more fundamental response to such points, however, is that respect for the dignity of patients requires no less.”
Applying this approach, Lords Kerr and Reed held that Mrs Montgomery should have been told of the risks of shoulder dystocia, and, further, that had she been told that she would probably have elected to have had a caesarean section. Her appeal therefore succeeded.
Lady Hale, expressing her complete agreement with Lords Kerr and Reed, added what she described as a footnote in relation to the particular issue of pregnancy and childbirth. She noted that it appeared that the doctor’s approach to disclosure was based, at least in part, upon a value judgment as to whether a caesarean section is the maternal interest and that:
“115. […] once the argument departs from purely medical considerations and involves value judgments of this sort, it becomes clear, as Lord Kerr and Lord Reed conclude at para 85, that the Bolam test, of conduct supported by a responsible body of medical opinion, becomes quite inapposite. A patient is entitled to take into account her own values, her own assessment of the comparative merits of giving birth in the “natural” and traditional way and of giving birth by caesarean section, whatever medical opinion may say, alongside the medical evaluation of the risks to herself and her baby. She may place great value on giving birth in the natural way and be prepared to take the risks to herself and her baby which this entails. The medical profession must respect her choice, unless she lacks the legal capacity to decide (St George’s Healthcare NHS Trust v S  Fam 26). There is no good reason why the same should not apply in reverse, if she is prepared to forgo the joys of natural childbirth in order to avoid some not insignificant risks to herself or her baby. She cannot force her doctor to offer treatment which he or she considers futile or inappropriate. But she is at least entitled to the information which will enable her to take a proper part in that decision.”
In some ways, this case does no more than recognise social and, indeed, professional realities and to remove what had become an increasingly obvious tension between those realities and the venerable decision in Sidaway. However, the ringing terms in which Lords Kerr and Reed identified the basis upon which doctors are required to engage with their patients (and the counter-arguments that they set down to the propositions that ‘doctor knows best’ as regards disclosure) make clear that we are indeed a world where both doctor and patient are active agents.
As regards the question of how clinicians are to engage in discussions with those of impaired capacity, I suggest that
- What is required of the patient remains as set out clearly by Peter Jackson J in Re JB  EWHC 342 (COP), namely that they should understand the nature, purpose and effects of the proposed treatment, the last of these entailing an understanding of the benefits and risks of deciding to have or not to have the proposed treatment, or of not making a decision. Further, and crucially, as Peter Jackson J made clear, what is required is a broad, general understanding of the kind that is expected from the population at large;
- What is required of the doctor is as set out in Montgomery, with a particular emphasis upon the injunction of Lords Kerr and Reed in Montgomery against bombarding the patient with technical information which she cannot reasonably be expected to understand. How the information is to be made comprehensible is self-evidently a task that must be calibrated to the patient in question. If not, the doctor will not be able to say that they have complied with the injunction in s.1(2) MCA 2005 to take all practicable steps to enable the person to take the decision.