The test of availability of medical treatment

Abstract

In Montgomery v Lanarkshire Health Board, the Supreme Court declared that patients are entitled to choose among all available treatments. But, who decides what is ‘available’? Doctors rely upon evidence-based medicine (EBM) – a complex epistemology that generates normative recommendations – for determining treatment availability. EBM is required to be applied through exercise of the treating doctor’s clinical judgement, which inescapably involves some value judgements. EBM attempts to accommodate patient values through shared decision-making (SDM). However, SDM remains contingent upon EBM for its starting points, and this contingency provokes a charge of epistemic injustice because it privileges the treating doctor’s judgement over conflicting views. Such a charge was implicit in Montgomery. The Court responded by adopting a strategy that retains reliance on clinical judgement, yet attempts to restrict the treating doctor’s privilege by admitting other professional views. This strategy permits the induction of a three-step test for availability of treatment, which is theoretically appealing but challenges the practical organisation of the medical profession.

Introduction

Historically, allegations of malpractice by doctors in obtaining patients’ consent for treatment have focussed on whether, or not, the doctor had provided the patient with sufficient information about the ‘risks’ (potential harms) of the proposed treatment, so that the patient had adequate opportunity to decline this treatment, that is, to withhold her consent. ¹ For instance, in the case of Bolam v Friern Hospital Management Committee ² – the locus classicus of medical negligence law – doctors had conducted electroconvulsive therapy (ECT) for a patient with depression without informing him of the risk of fractures, which then eventuated. The dispute, in this case, was about whether Mr Bolam should have been supplied with this risk information. ³ Notably, there was no argument that Mr Bolam should have been informed about other treatments for depression, so that he could choose between ECT and its alternatives. ⁴ The implicit contention was that, if informed, he would have declined ECT and he would have continued in his current state. ⁵

The approach to consent has changed considerably since Bolam. In Montgomery v Lanarkshire Health Board, Lord Kerr and Lord Reed JJSC declared that ‘An adult patient of sound mind entitled to decide which, if any, of the available forms of treatment to undergo’, ⁶ and that ‘The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in recommended treatment, and of any reasonable alternative or variant treatment’. ⁷ Here, the form of childbirth (the ‘treatment’) that was recommended to a pregnant woman, by her obstetrician, was vaginal delivery. Mrs Montgomery was not informed that, given her particular health circumstances, vaginal delivery was associated with an increased risk of shoulder dystocia. ⁸ The Supreme Court ruled that this risk was material, and that Mrs Montgomery should have been made aware of it, which would have led her to decline vaginal delivery. Moreover, it was clear that, having declined vaginal delivery, she could not (unlike Mr Bolam) simply continue in her current state. As stated by Lady Hale, ‘Once a woman is pregnant, the foetus has somehow to be delivered’. ⁹ It was, thus, unavoidable that the rejection of vaginal delivery had to be linked to an alternative form of childbirth, and the Supreme Court ruled that caesarean section was a reasonable alternative that should have been made available to Mrs Montgomery.

The Supreme Court does not explicate its meanings of ‘reasonable’ and ‘available’. Are these terms meant to refer to any treatment that is technologically and technically feasible in the context of a certain health condition? Ian Kennedy’s proposal to separate medical decisions into ‘technical’ and ‘not technical’ categories might suggest that all technically feasible treatments should be made available to the patient, so that the patient can make the ‘not technical’ decision about which treatment to undergo (or to forgo all treatment). ¹⁰ However, such an interpretation of the Supreme Court’s terminology can be problematic in medical practice. For example, consider the case of gastric (stomach) cancer. The only curative treatment is gastrectomy. ¹¹ However, if a patient’s general health is poor, then surgeons might conclude that the patient is not ‘fit’ for this operation. ¹² Instead, the patient may be offered chemotherapy, with supportive care only as an alternative. But, the patient may insist on a gastrectomy, with full awareness of the material risks, regardless of the surgeon’s views. Should gastrectomy now be considered as a ‘reasonable alternative or variant treatment’ to chemotherapy, and should it be made ‘available’ to the patient? ¹³

To be clear, the present question is not about a departure ‘from the existing range of accepted medical treatments for a condition’, that is, the availability of ‘innovative treatment’, as was envisaged in the failed Medical Innovation Bill. ¹⁴ This bill envisaged a situation in which a doctor was of the view that a certain treatment, which was not in ‘the existing range of accepted treatments’ for a health condition, would be of benefit to a particular patient, and the common law of negligence deterred the doctor from offering this innovative treatment to the patient. ¹⁵ In contrast, the present question is about whether a treatment that is within the existing range of accepted treatments for a certain health condition, in general, should be made available to the particular patient. Also, the present question is not about the availability of treatments that are subject to funding restrictions as a matter of public policy; ¹⁶ rather, it is about the process of selecting treatments, which are unrestricted in the National Health Service (NHS) that should be made available to an individual patient by her doctor.

The present article aims to specify the standard of doctor’s obligation to select and to make available treatments to individual patients, from among the existing range of accepted and funded treatments. The argument in this article is organised as follows: The ‘Knowledge as the basis of professionalism’ section observes that medicine, like any profession, pivots on a certain account of knowledge – an epistemology – and that the practice of medicine, by doctors, necessarily abides by this account. The ‘Evidence-based medicine’ section identifies evidence-based medicine (EBM) as the epistemology of modern, Western medicine, and it explores the structure of EBM. The ‘Clinical judgement’ section argues that EBM reduces to the clinical judgements that are made by doctors, and it claims that differences in clinical judgements among doctors are widespread. The ‘Value judgements’ section explains that value judgements are inherent to EBM (and to clinical judgements), because it seeks to provide not only facts but also normative solutions to practical problems. The ‘Shared decision-making’ section discusses how all models of shared decision-making (SDM) between patients and doctors accept EBM as their basis or starting point. As such, EBM instigates a charge of epistemic injustice, because its own account of knowledge is privileged over other accounts in identifying available treatments. ‘The test of available treatments’ section suggests that the Montgomery claim was essentially a charge of epistemic injustice, and it deals with the Supreme Court’s response to this implicit charge. Through doctrinal analysis, a three-step test for the identification of available treatments – the test of availability – is induced. The ‘Conclusion’ section outlines some of the practical difficulties that assail the test of availability.

Knowledge as the basis of professionalism

In an influential sociological account, Eliot Freidson identifies medicine as the prototype profession. ¹⁷ He distinguishes a profession from other forms of work on the basis that only professionals ‘have the specialised knowledge that allows them to provide especially important services (and) have the power to organise and control their own work’. ¹⁸ He explains that this essential characteristic – the professionals’ control of their own work – derives from a fundamental sociological acceptance that all occupations involve certain knowledge, and that work is the practice of this knowledge. In the case of a profession, the unique claim is that the knowledge is ‘too esoteric and complex to be understood spontaneously or to be learned quickly by the average person’. ¹⁹ Consequently, society grants ‘the privileged status of monopoly, or control over their own work’ to professionals, and it is this monopolistic control, which Freidson describes as ‘autonomy’, that differentiates professions from other occupations. ²⁰

Freidson reflects that, in order to claim the privileges of a profession, an occupation has to not only establish a certain ‘knowledge mandate’ or ‘epistemological foundation’ ²¹ as its distinguishing hallmark, but also that this epistemological foundation has to ‘embody values held by the public at large’. ²² Because society, through the political arrangements of a state, will grant professional privileges to valued knowledge mandates only; and not simply to any or all claims by occupational groups that they possess unique knowledge. For instance, consider the historical distinction between medical practitioners who were Members of a Royal College and ‘quacks’, and compare the respect afforded to Members with the disdain towards quacks. ²³ The distinction pivots on the value that was placed by society on the type of knowledge that was possessed by Members, versus quacks. This societal value of Membership can, in turn, be linked to the insistence of the Royal Colleges on what Freidson terms ‘formal knowledge’ – ‘bodies of information and ideas organised by theories and abstract concepts’ ²⁴ – through an approved system of education and training, as opposed to the unstructured knowledge of quacks. Such socially valued, knowledge-based entry to the medical profession is reflected presently in registration and licensure to practice medicine by the General Medical Council (GMC) being subject to the completion of only certain courses of education and examinations. ²⁵

In summary, it is a ‘particular kind of knowledge which is granted the social and economic privileges required for the institutions of professionalism’. ²⁶ Hence, the status of medicine as a profession is based on the espousal by medical professionals (doctors) of a particular knowledge mandate or epistemological foundation, and not simply any theory of ‘medical’ knowledge. Notably, this centrality of a knowledge mandate is not challenged in revisions of Freidson’s thesis ²⁷ or in other sociological accounts of professionalism. ²⁸

Evidence-based medicine

What is the epistemological foundation of modern medicine? The GMC emphasises ‘professional knowledge’, ²⁹ but it does not specify any theory or account of professional knowledge. Nonetheless, the GMC instructs doctors to provide ‘effective treatments based on the best available evidence’; ³⁰ and this reliance on ‘evidence’, as the proper basis for medical practice, is reiterated in the NHS Constitution ³¹ and by NHS England. ³² The emphasis on evidence by the regulator and by policymakers implies that doctors should practice EBM, and this tacit reliance on EBM is widely echoed. Therefore, the knowledge mandate or epistemology of modern, Western medicine should be EBM. The epistemology will be different for other systems of medicine, for example, Ayurveda or Homoeopathy or Chinese medicine. As pointed out by Aliki Thomas and colleagues, ‘Health professions are all situated within traditions, each carrying its set of prejudices, embodied, for example, by the ways of knowing and knowledges privileged within a given professional community’. ³³ The present article focuses on Western medicine.

The term EBM was coined by Gordon Guyatt and colleagues in the early 1990s. ³⁴ It can be viewed as the product of an epistemological revolution, which started in the 1950s, against traditional medical practice that was based largely on deference to authority, pathophysiological reasoning, intuition and personal experience. ³⁵ In contrast, EBM pivots upon ‘evidence’. As explained by Benjamin Djulbegovic and Guyatt, ‘Central to the epistemology of EBM is that what is justifiable or reasonable to believe depends on the trustworthiness of the evidence, and the extent to which we believe that evidence is determined by credible processes’. ³⁶ These authors explain that the reliance on ‘credible processes’ to identify trustworthy evidence involves a foundational proposition that ‘not all evidence is created equal’, and a parallel conviction ‘that the practice of medicine should be based on the best available evidence’. ³⁷ As such, EBM relies on certain types of evidence only, with the rejection of other types of evidence, and, critically, this distinction is made by certain credible processes only. It is these credible processes, then, that set EBM apart from traditional, Western medical practice and from other systems of medicine.

Djulbegovic and Guyatt explain that a core premise of EBM is ‘that controlled clinical observations provide more trustworthy evidence than do uncontrolled observations, biological experiments, or individual clinician’s experiences’. ³⁸ The processes of EBM seek to sift out trustworthy observations from all other forms of evidence, and to construct a hierarchy of reliability, such that ‘the higher the quality of evidence, the closer to the truth are estimates of diagnostic test properties, prognosis and the effects of health intervention’. ³⁹ An early model of evidence-hierarchy was a simple pyramidal design, in which randomised controlled trials occupied the apex and were considered to provide the highest quality of evidence, and other types of studies followed in a pre-determined order. ⁴⁰ However, limitations of such a simple hierarchy soon emerged. ⁴¹ It also became apparent that most doctors individually did not have the time or analytical skills to collate and appraise published papers in order to identify ‘evidence’. ⁴² Consequently, EBM re-adjusted its focus to creating clinical practice guidelines for use by doctors, and such guidelines increasingly form the epistemology of modern medicine. ⁴³

A fundamental premise of guideline construction is that merely the selection and stratification of trustworthy evidence are not sufficient. Rather, the goal is to supply doctors with recommendations for what they should do or how they ought to advise their patients. ⁴⁴ For example, the National Institute for Health and Care Excellence’s (NICE) guideline on oesophago-gastric cancer sets out the various options that doctors should ‘offer’ or ‘consider’ for radical treatment (intent to cure cancer) or palliative treatment (intent to control symptoms and prolong survival). ⁴⁵ It thus becomes clear that EBM has important normative aspects, over and above its purely scientific aspects. From a sociological perspective, EBM can be seen as an attempt by medical professionals to integrate connections and co-dependencies between the substance of their work and the demands of the institutions within which they work, without ceding control of their professional knowledge mandate. ⁴⁶ In any case, since EBM is widely accepted as the basis of Western medicine, professionalism obliges doctors to adhere to the scheme of EBM.

Clinical judgement

Importantly, the practice of EBM is not determined entirely by guidelines or, where guidelines do not exist, by other sources of evidence. Rather, as explained by David Sackett and colleagues:

The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. ⁴⁷

Sackett and colleagues further highlight that:

External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision. ⁴⁸

This emphasis on the doctor’s professional expertise, often referred to as the doctor’s clinical judgement, is widely reiterated in the EBM literature. ⁴⁹

EBM can now be seen as a complex construct that requires the application of a doctor’s clinical judgement to ‘external evidence’ (e.g. a clinical guideline) in the context of an individual patient’s circumstances. ⁵⁰ Such overlay of clinical judgement is implicit in clinical guidelines. For instance, NICE’s guideline on oesophago-gastric cancer directs doctors to ‘Provide information about possible treatment options, such as surgery, radiotherapy or chemotherapy, in all discussion with people with oesophago-gastric cancer who are going to have radical treatment’. ⁵¹ And ‘For people with oesophago-gastric cancer who can only have palliative treatment, offer personalised information and support . . .’. ⁵² The guideline then proceeds to make various recommendations about radical and palliative treatment options. But, the guideline does not provide any direction on how to decide about ‘who are going to have radical treatment’ or ‘who can only have palliative treatment’. This decision about treatment intent – radical versus palliative – is implicitly assigned to the clinical judgement of the doctors who are treating the patient.

In current practice, such decisions about treatment intent are usually made by a multi-disciplinary team (MDT) of healthcare professionals. These decisions involve various considerations, such as cancer stage, past medical history and functional performance status, and on the basis of such considerations, the MDT strives to arrive at a consensus, so that the patient can be presented with a unanimous view. ⁵³ This view represents the collective clinical judgement of the MDT. The recommendations that are set out in the guideline now apply to the individual patient according to the treatment intent that has been decided by the MDT. For example, if the MDT has made the clinical judgement that a certain patient ‘can only have palliative treatment’, then the practice of EBM does not allow for any radical treatment to be provided to this patient. Similarly, in situations where MDTs do not exist, a clinical judgement has to be made by the patient’s treating doctor about applying ‘external evidence’ to that particular patient’s individual health circumstances. Thus, clinical judgements by doctors are ubiquitous to the practice of EBM.

The conception of a clinical judgement – what, exactly, is a ‘clinical judgement’? – is elusive. In an insightful review, Benjamin Chin-Yee and Ross Upshur discuss that there are two approaches to conceiving a clinical judgement: a statistical or evidence-based approach and a narrative or virtue-based approach. ⁵⁴ The former draws on formal tools of EBM, such as clinical trials and other controlled observations, whereas the latter calls upon the exercise of practical wisdom, which is tacit and experiential. Practical wisdom is, essentially, a form of practical reason, which asks: ‘what among the many things than can be done ought to be done for this patient’? ⁵⁵ Chin-Yee and Upshur argue that these two approaches – evidence-based and practical reason – are inextricably linked and that ‘neither has straightforward domain over the other from an epistemic point of view’. ⁵⁶ In other words, a clinical judgement does not prioritise either evidence or practical reason: the two approaches are complementary and to be applied contextually.

It is commonly recognised that doctors may differ in their clinical judgements about treatment for the same patient. This commonplace observation is captured empirically in reports of significant differences in the treatment of patients with similar health characteristics by different doctors: for example, variations in the use of laparoscopy and open surgery for patients with bowel cancer at the same stage. ⁵⁷ Notably, such treatment differences do not represent the practices of maverick or rogue doctors. Rather, the differences reflect distinct patterns of medical practice, and underlying differences in clinical judgements. ⁵⁸ Such differences in clinical judgement seem to be mainly the result of uncertainties in evidence, because the differences are most prominent in situations of greatest uncertainty and least when evidence is conclusive. ⁵⁹ When evidence is uncertain, there is a greater call on the exercise of practical reason, which, in turn, involves value judgements, that is, values have to be placed on the outcomes of different possible courses of action in order to settle upon one course. ⁶⁰ As such, it would seem that differences in clinical judgements among doctors stem from underlying differences in value judgements by different doctors, and empirical observations of differences in clinical judgements highlight the centrality of value judgements to EBM. Moreover, as discussed in the next section, value judgements are central not only to clinical judgements but also to the ‘external evidence’ of EBM.

Value judgements

EBM is ostensibly value-neutral; but, actually, it is ingrained with value judgements. ⁶¹ Mona Gupta separates the value judgements in EBM into two types: external and internal. ⁶² External value judgements are imbued in the decisions made by researchers and funding organisations about whether, or not, to pursue a particular question. Internal value judgements, on the other hand, pertain to decisions about what counts as evidence, how to set levels or thresholds when assessing effectiveness and harms of treatments, and which treatment to recommend.

As discussed earlier, EBM admits only certain types of evidence, and it does not treat all evidence equally. But, the hierarchical treatment of evidence – for example, the greater weightage that is assigned to randomised trials than to case studies – is not based on any empirical finding; rather, it is an epistemic assertion that is underpinned by certain value judgements. ⁶³ Furthermore, regardless of the type of ‘evidence’, value judgements have to be exercised in acting on this evidence. For example, a trial may report that a novel chemotherapy results in 6% longer survival, with 3% more complications, at 10% greater cost than currently used chemotherapy. A value judgement now has to be exercised about whether, or not, the novel chemotherapy should be included in the ‘range of accepted medical treatments’. ⁶⁴ Hence, as noted by Michael Kelly and colleagues, ‘EBM, like all science, is necessarily value laden’. ⁶⁵

Guyatt and colleagues admit that ‘judgments will always be required for each step’ of creating guidelines. ⁶⁶ NICE, too, admits that certain ‘principles’ (previously called ‘social value judgements’) are central to the development of its clinical guidelines. ⁶⁷ Djulbegovic and Guyatt address the centrality of value judgements to EBM by asserting that an ‘epistemological principle of EBM is that clinical decision making requires consideration of patients’ values and preferences’. ⁶⁸ Yet, as pointed out by Gupta, ‘the “patient values” referred to within EBM are really the values that inform decision making at terminal points – namely, when there are choices between competing treatment options’. ⁶⁹ The values that guide the identification of these terminal points, that is, the selection of treatment options that are, in the first place, available (and, therefore, ‘competing’), are ingrained in the structure of EBM, and these ingrained values are immutable at the point of the patient–doctor interaction. For example, for a patient with gastric cancer and extensive distant metastasis, NICE’s guideline would emphasise attention to the patient’s preferences for different types of palliative treatment. ⁷⁰ However, radical treatment (a gastrectomy operation) would not be offered to this patient, regardless of her individual values and preferences. ⁷¹

Gupta compares the availability of treatment options to a restaurant menu, and she remonstrates that ‘EBM seems to allow a role for patients’ values in choosing from amongst menu options but developing the menu seems to exclude patients’ values’. ⁷² Proponents of EBM, such as Djulbegovic and Guyatt, do not respond to this charge directly. Instead, they equivocate that ‘EBM is in keeping with a culture change in medicine over the past 20 years: the growing emphasis on patient autonomy, and the associated priority given to shared decision making’. ⁷³ In other words, the implicit claim is that EBM provides adequate or fair attention to patients’ values through SDM. The GMC would seem to support such a view in asserting that ‘Shared decision making and consent are fundamental to good medical practice’. ⁷⁴ But, how far does SDM counter Gupta’s observation? The next section addresses this question.

Shared decision-making

In a recently published guideline, NICE defines SDM as:

[A] collaborative process that involves a person and their healthcare professional working together to reach a joint decision about care . . . It involves choosing treatments based both on evidence and on the person’s individual preferences, beliefs and values. ⁷⁵

At the same time, NICE makes it clear that ‘healthcare professionals are not obliged to provide any treatment that in their clinical opinion is medically futile . . . Healthcare professionals cannot provide access to treatments that are not available’. ⁷⁶ Likewise, the GMC directs that ‘Doctors must try to find out what matters to patients so they can share relevant information of proposed options and reasonable alternatives, including the option to take no action’, and it emphasises ‘dialogue’ about ‘available options’. ⁷⁷ Yet, ‘If a patient asks for treatment or care that you don’t think would be in their clinical interests . . . then you (the doctor) should not provide it’. ⁷⁸ As such, both NICE and the GMC would seem to accept that there is a starting point for SDM – a menu of treatments that are variously described as available, reasonable or in the patient’s clinical interests – and patient choice is restricted to this starting point. Hence, SDM is not a free-standing process: it is contingent upon some other mechanism to identify available treatment. Neither NICE nor the GMC makes explicit the contingency of SDM or specifies the process for the identification of available treatments.

The contingency of SDM is recognised in nuanced theoretical discourse. In an influential characterisation of SDM, Cathy Charles and colleagues explain that their arguments apply to the ‘micro’ level only, such that where ‘there are several treatment options available the choice of best treatment for a particular patient requires value judgments on the part of the patient and the physician’. ⁷⁹ The authors acknowledge that this micro-level SDM depends upon, and follows, the ‘macro’ level, at which decisions are made about what is ‘available’ and what is not. Not dissimilarly, Glyn Elwyn and colleagues propose a ‘three-talk model’ of SDM, which involves making patients aware that choices exist (‘choice talk’), followed by detailed information about available options (‘option talk’) and then decision-making that focuses on the patient’s preferences (‘decision talk’). This model, too, admits that the doctor has to ‘present a list of options’ that, then, forms the basis for the ‘decision talk’. ⁸⁰

Elwyn and colleagues point out that SDM assumes ‘that healthcare contexts exist where it is reasonable to offer choice’, ⁸¹ and they argue that the reasonableness relies upon the existence of ‘professionally situated equipoise’. ⁸² They explain equipoise as ‘the existence of options that are in balance in terms of their attractiveness, or that the outcomes are to, a degree at least, equally desirable (or possibly, undesirable)’. ⁸³ It is essential that the doctor is in this state of equipoise, because, otherwise, he or she simply will not be able to point out choices and discuss options. If the doctor is in equipoise about competing treatment options, then the decision is regarded as ‘patient-preference sensitive’, that is, the choice of treatment should be the outcome of a patient–doctor dialogue about these options. ⁸⁴ On the other hand, ‘For some decisions, there is one clearly superior path, and patient preferences play little or no role – a fractured hip needs repair, acute appendicitis necessitates surgery, and bacterial meningitis requires antibiotics’. ⁸⁵ Now, SDM allows patients ‘the options of choosing to have no treatment or not changing what they are currently doing’; ⁸⁶ but patients cannot demand anything other than treatments that are in their ‘clinical interests’. ⁸⁷

The paradigm of SDM that is set out above is challenged by some authors. For instance, Veronika Wirtz and colleagues argue that ‘If patient involvement has a value, there is no absolute reason why it should have a role only after the construction of the option set’. ⁸⁸ Lars Sandman and Christian Munthe endorse Wirtz’s objection, and they advocate a decision-making model ‘where both parties agree on a decision found to be optimal given the situation’. ⁸⁹ Emma Cave proposes that a model of SDM that is set out by Sandman and Munthe should be used to select the treatment options that are available to the patient. ⁹⁰ Yet, Cave acknowledges that, in making treatments available, doctors will ‘have a line that cannot be crossed’. ⁹¹ Wirtz and colleagues, too, have conceded the centrality of the doctor’s ‘professional judgment’, and that there is no clear answer to the ‘question of which decisions are “left to” patient’. ⁹² Not dissimilarly, Sandman and Munthe admit that ‘the professional cannot transcend the limits of what is considered important considerations set by the internal goals of the institution of health care, its ethical constraints, formal placing in the larger societal apparatus, etc.’. ⁹³ Cave proposes that these limits – ‘the line that cannot be crossed’ – should be set by prevailing standards of the medical profession. But, she does not explain how these standards, themselves, are to be determined.

As discussed earlier, sociological theory holds that doctors are bound by the epistemological mandate of the medical profession, and this mandate is EBM. As such, it would seem that SDM, however conceived, must be contingent upon EBM, which, as discussed earlier, reduces ultimately to the clinical judgement of the doctor who is treating the patient. Now, it could be claimed that the contingency of SDM upon EBM is unfair, since it privileges the doctor’s clinical judgement over conflicting claims of knowledge by patients and others. As explained by Thomas and colleagues:

The crux of many disputes about EBM rests on the legitimacy of various ways of knowing. Although the EBM movement appears to advocate for a shared perspective between the patient and the healthcare practitioner (emphasising the patient’s contribution in decision-making), its positivist legacy carries an underlying assumption that there is a truth to be known in every clinical situation and that ‘patient preferences’ can be unproblematically weighed alongside research evidence and clinical expertise in the decision-making process. But such a view risks mischaracterising patient-provider interactions, which are fraught with power dynamics and require an awareness of the risk of epistemic injustice and the negotiation of different ways of knowing (experiential and technical knowledge). ⁹⁴

In short, the claim is that EBM engenders a form of epistemic injustice, because some patients may be wronged insofar that their accounts of knowledge are not given credit that is equal to their doctor’s clinical judgement. ⁹⁵ The next section explores the law’s response to the charge of epistemic injustice in EBM.

The test of available treatments

As discussed earlier, Montgomery ⁹⁶ deals with a dispute about the availability of treatment. This dispute can be viewed as a charge of epistemic injustice insofar that the obstetrician had made a clinical judgement that caesarean section was not in the ‘maternal interests’, ⁹⁷ and, therefore, she did not make this treatment available to her patient, whereas the patient considered that caesarean section ought to have been available. The Supreme Court agreed with the patient. It would follow that a model of EBM that is reducible to the clinical judgement of the treating doctor for selecting available treatments was deemed to be unjust. Instead, as observed by Judy Laing, ‘Montgomery recognises that we have arrived at a new model of professionalism’. ⁹⁸

This section explores the new model of professionalism that is envisaged by the Supreme Court. ‘The Bolam principle’ sub-section discusses how the Bolam principle conforms to the traditional practice of medical professionalism. ‘The rejection of Bolam: where does it lead?’ sub-section discusses that Montgomery rejects the Bolam test for identifying available treatments, but it does not explicitly set out a replacement. ‘The test of availability’ sub-section induces the test of availability of treatment – the ‘new model’ ⁹⁹ of medical professionalism – that emerges from Montgomery.

The Bolam principle

Jonathan Montgomery has pointed out that the traditional characteristics of medical professionalism are captured in the test that was set out in Bolam. ¹⁰⁰ Here, McNair J. had directed the jury to consider that ‘he (the doctor) is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’. ¹⁰¹ Furthermore, the doctor had not failed to be reasonable ‘merely because there is a body of opinion who would take a contrary view’. ¹⁰²

Later, in approving McNair J.’s dicta, Lord Scarman has explained that

The Bolam principle may be formulated as a rule that a doctor is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion even though other doctors adopt a different practice. ¹⁰³

Fundamentally, there are two sociological propositions within the Bolam principle. The first proposition – that a doctor has acted reasonably if his actions are endorsed by his peers – conforms to the essential characteristic of professionalism in Freidson’s account: only the professionals, and none other, can decide on what is right or wrong in their area of work. The second proposition – that a doctor had not acted unreasonably merely because some of his peers would have done differently – imparts a normative basis to the empirical observation that doctors may make different clinical judgements, resulting in different solutions to the same problem. As declared by Lord Scarman, ‘Difference of opinion 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’. ¹⁰⁴

An important qualification to the Bolam principle was added in Bolitho v City and Hackney Health Authority. ¹⁰⁵ Here, Lord Browne-Wilkinson emphasised that it was not sufficient simply to establish that a body of professional opinion supported a particular treatment; rather, the ‘the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such an opinion has a logical basis’. ¹⁰⁶ Thus, Lord Browne-Wilkinson added an important normative aspect to the Bolam test. By insisting that accepted practice must have a logical basis, his Lordship requires judges to make an assessment of what is acceptable over and above the actually accepted practice. ¹⁰⁷ Accordingly, Bolitho expands the Bolam principle by adding a third proposition: the acceptability of a doctor’s practice, independent of the actual opinions of the doctor’s professional peers. From the sociological perspective, Bolitho can be viewed as addressing objections to the seeming lack of professional accountability in Freidson’s model. ¹⁰⁸

Prior to Montgomery, the Bolam test applied to all aspects of medical practice, including consent. ¹⁰⁹ Accordingly, claims about the availability of treatment would generate the following questions for a court: first, was the treatment (or choice of treatments) that was actually made available by the doctor ‘accepted as proper’ ¹¹⁰ by his or her peers (in the form of an expert witness)? and second, was that treatment acceptable, insofar that it had a ‘logical basis’, over and above the fact that it was actually accepted by an expert witness? ¹¹¹ If the court was able to answer both these questions in the affirmative, then it would be deemed that the doctor had made appropriate treatment available to the patient. The court would not engage in the assessment of any claimed alternative treatment, even if such alternative treatment was supported by expert witnesses and claimed to be logical; ¹¹² because, as discussed earlier, the Bolam paradigm of professionalism accepts that genuine differences in opinion may exist among responsible doctors. For instance, in Montgomery, the obstetrician’s decision to make available vaginal delivery only, and to withhold caesarean section, was accepted as proper by three expert witnesses in obstetrics, and there was no argument to the effect that vaginal delivery did not have a logical basis. As such, notwithstanding that the other two experts would have offered a choice between vaginal delivery and caesarean section, the Courts of Session did not consider that the obstetrician had been negligent. ¹¹³

The Bolam paradigm intrinsically gives priority to the clinical judgement of the doctor against whom the malpractice claim was levelled, that is, the patient’s treating doctor; because, provided that the treating doctor’s clinical judgement is supported by a responsible body of his or her peers, the opinions of others are irrelevant. As explained by Lord Donaldson MR, the doctor is entitled:

[T]o treat the patient in accordance with his own best clinical judgment, notwithstanding that other practitioners who are not called upon to treat the patient may have formed quite different judgment or that the court, acting on expert evidence, may disagree with him. ¹¹⁴

In other words, the treating doctor’s judgement – her account or understanding of medical knowledge as applied to an individual patient – trumps that of all others in deciding the availability of treatment to that patient. As discussed earlier, it is such differences in accounts of knowledge that expose EBM to charges of epistemic injustice. The privileging of the treating doctor’s account of knowledge can be seen as the centrepiece of this charge; because, the patient’s interaction with the medical profession is, after all, through her treating doctor.

The rejection of Bolam: where does it lead?

In contrast to the Court of Session, the Supreme Court rejected the Bolam test. ¹¹⁵ At the same time, Lord Kerr and Lord Reed JJSC pointed out a ‘fundamental distinction’ in the doctor’s role ‘when considering possible investigatory or treatment options’ versus when discussing ‘the risks of injury which may be involved’. ¹¹⁶ Their Lordships explain that the ‘former role (the identification of treatment options) is an exercise of professional skill and judgment’; ¹¹⁷ whereas for assessing the latter role, they advance a test of materiality of risk. ¹¹⁸ The purpose of the test of materiality is to identify the risks of the available treatments – the treatment options – that would be significant to the patient, and of which the patient should be made aware by the doctor, so that the patient can now make an informed choice between these options. ¹¹⁹ But, as highlighted by Judge Worster in Bayley v George Eliot Hospital, the test of materiality is not applicable to:

[P]rovision of information as to alternative treatments. The concept of materiality has an obvious application to risks, but the question of what is a reasonable treatment is a different one, and the concept of materiality is not such an easy fit. ¹²⁰

As such, the test of materiality would come into play only after the available treatments have, in the first place, been identified. ¹²¹

What, then, is the test for identifying the treatments that should have been made available to a patient? The Supreme Court does not set out this test explicitly. However, Lord Kerr and Lord Reed JJSC do explain that:

The treatment which they (doctors) can offer is now understood to depend not only on 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. ¹²²

From this dictum, the identification of available treatments involves two principles: clinical judgement and bureaucratic decisions. Their lordships clarify that the bureaucratic decisions are ‘susceptible to challenge under public law’. ¹²³ In brief, public law acknowledges that the resources of the NHS are inescapably finite, and, therefore, limits have to be set on the treatments that can be made available to patients. ¹²⁴ As explained by Lord Bingham MR:

[I]n a perfect world any treatment which a patient, or a patient’s family, sought would be provided if doctors were willing to give it, no matter how much it cost, particularly when a life was potentially at stake. It would however, in my view, be shutting one’s eyes to the real world if the court were to proceed on the basis that we do live in such a world . . . Difficult and agonising judgments have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum number of patients. ¹²⁵

On the basis of such reasoning, the Court of Appeal has repeatedly disallowed challenges of bureaucratic decisions to withhold certain treatments. ¹²⁶ Now, doctors were simply unable to offer (to ‘make available’) the contested treatments, regardless of their clinical judgements, because a bureaucratic decision had determined otherwise. Hence, bureaucratic decisions can be seen as the starting point for treatment availability in the NHS. If patients, or doctors, disagree with a bureaucratic decision to withhold a treatment, then, as pointed out by the Supreme Court, this decision can be challenged under public law; but doctors cannot make available treatments that are not, in the first place, at this starting point.

It is not the aim of the present article to explore public law. The aim is to analyse the Supreme Court’s approach to the availability of treatment in situations where bureaucratic decisions do not impose any restrictions. For instance, in cases of childbirth or gastric cancer, non-medical professionals do not impose any explicit restrictions on the availability of caesarean section or gastrectomy. If surgeons recommend these operations, and if patients accept the surgeons’ advice, then the NHS will provide these treatments. As such, the availability of these treatments rests entirely on the treating doctor’s clinical judgement. However, as discussed earlier, the Supreme Court rejects the Bolam test for the assessment of this clinical judgement, and it does not set out a replacement.

Does the rejection of the Bolam test imply that any treatment that is desired by a patient becomes available simply because it is technologically as well as technically feasible and funded? ¹²⁷ Prima facie, the Supreme Court’s approving references to patients’ rights to personal ‘autonomy’ ¹²⁸ and ‘self-determination’ ¹²⁹ might be used to argue for an affirmative answer. However, in Burke v GMC, Lord Phillips MR has made it clear that:

Autonomy and the right of self-determination do not entitle the patient to insist on receiving a particular medical treatment regardless of the nature of the treatment. In so far as the doctor has a legal obligation to provide treatment this cannot be founded simply upon the fact that the patient demands it. The source of the duty lies elsewhere. ¹³⁰

Lord Donaldson MR had previously ruled similarly in the context of deciding treatment for a child without capacity:

The doctors can recommend treatment A in preference to treatment B. They can also refuse to adopt treatment C on the grounds that it is medically contra-indicated for some other reason is a treatment which they could not conscientiously administer. The court or parents for their part can refuse to consent to treatment A or B or both, but cannot insist upon treatment C. ¹³¹

Furthermore, Lord Donaldson MR has clarified that ‘consent by itself creates no obligation to treat. It is merely a key which unlocks a door’. ¹³²

In Aintree University Hospitals NHS Trust v James, Lady Hale approves the judgments of Lord Donaldson MR and Lord Phillips MR. ¹³³ In Montgomery, the Supreme Court does not make reference to Aintree or to the judgments that were cited in this case, and there is no indication that the Supreme Court intended to disturb the doctrine that this Court, itself, had previously approved. ¹³⁴ It is, thus, clear that simply any treatment that is chosen, or consented to, by a patient does not become available to her. As such, it can be inferred that the Supreme Court had in mind a strategy other than either patient choice or the treating doctor’s clinical judgement for identifying available treatments.

The test of availability

In Montgomery, Lord Kerr and Lord Reed JJSC concluded that:

[I]t was incumbent on Dr McLellan (the obstetrician) to advise Mrs Montgomery of the risk of shoulder dystocia if she were to have her baby by vaginal delivery, and to discuss with her the alternative of delivery by caesarean section. ¹³⁵

Implicitly, their Lordships deemed that both vaginal delivery and caesarean section were ‘available forms of treatment’, and that Dr McLellan should have offered both to Mrs Montgomery, accompanied by advice about the material risks of each form of treatment. In arriving at this conclusion, the Supreme Court would seem to have employed a test of availability of treatment, which asks three sequential questions:

What treatments are actually accepted by medical professionals?

It is salient that the Supreme Court does not allow Mrs Montgomery’s appeal that a caesarean section should have been made available to her simply on the basis that this route of delivery was technically feasible and that she desired to have it. Rather, the Court will have noted that her claim for a caesarean section was supported by experts in obstetrics. ¹³⁶ Implicitly, the Court will have appreciated that a caesarean section was accepted within the epistemology of the profession of obstetrics, and it will have been guided by this epistemic assertion.

In being so guided, the Supreme Court would seem to have followed, and preserved, the judicial approach that, for any treatment to be considered to be available, the question that had to be first confronted was whether, or not, there was a doctor who was not only ‘ready and willing but also able to provide the treatment’. ¹³⁷ If no doctor was willing to provide a certain treatment, then it simply could not be considered to be available, regardless of any argument to the contrary. ¹³⁸ This approach is set out clearly in judgements on best interests decision-making. For instance, in disallowing the appeal for an experimental treatment to be made available to patient without capacity, Ward L.J. reasoned that without evidence that some doctor would have been prepared to administer the disputed treatment, ‘we are dealing with a purely hypothetical matter’, ¹³⁹ and ‘It is well established that the court does not decide hypothetical questions’. ¹⁴⁰ For another instance, consider NHS Trust v L. ¹⁴¹ Here, all treating doctors and expert witnesses were unanimous that invasive ventilation or cardiopulmonary resuscitation should not be given to a patient who lacked capacity, but the patient’s family insisted that ‘all possible treatment should be provided’. ¹⁴² It was submitted to the court that ‘because there is no evidence there is no clinician who would be willing to provide such treatment, this is not a case in which there are not available options for the court to choose between’. ¹⁴³ Moylan J. rejected this argument on the ground that:

It is not a theoretical issue about the treatment in general. It is an evidential issue about the treatment options in the specific case. Does the evidence establish that there are treatment options? If it does not, I question whether the Court is entitled to assume that there are. ¹⁴⁴

Following Montgomery, the reliance of courts on treatments that are actually accepted by doctors (as represented by expert witnesses) to determine availability is clearly illustrated by the following two cases in the Court of Session. AH v Greater Glasgow Health Board was one of four cases in the Outer House, pertaining to the use of mesh products in the vagina and pelvis of women with stress urinary incontinence or genital prolapse. ¹⁴⁵ AH and others, who had experienced various mesh-related complications, pleaded that a variety of alternative treatments should have been made available to them. However, the litigation was conducted without any expert witness. As such, there was no evidence that the claimed alternatives would actually have been offered by any gynaecologist. AH and others argued that ‘what is a reasonable alternative is to be defined by the patient’ ¹⁴⁶ and not by a doctor. Lord Boyd rejected this argument, and he explained that ‘This is not consistent with the approach in Montgomery . . . the ratio of Montgomery is a limited, albeit important, innovation on the rule in Bolam/Hunter v Hanley’. ¹⁴⁷ Accordingly, it may be inferred that Lord Boyd retains the first proposition of the Bolam principle: that for a treatment to be considered as ‘available’, there must be medical professional evidence to this effect. The Montgomery ‘innovation’ to the Bolam test would, therefore, seem to be located elsewhere, but Lord Boyd does not clarify it.

Further, in LT v Lothian NHS Health Board, it was appealed to the Inner House that the option of expediting vaginal delivery should have been offered to a pregnant woman because a suspicious cardiotocograph tracing was indicative of a material increase in the risk of foetal hypoxia. ¹⁴⁸ But, this argument had not been advanced by any expert witness. In disallowing the appeal, Lord Brodie emphasised that

For a decision or choice to have to be made there must of course be more than one choice which is available and as to which a decision must be made. The availability of choice in any particular case is again a matter for medical evidence. ¹⁴⁹

Lord Brodie, too, can be thus seen to retain the first proposition of the Bolam principle.

Moreover, it is noteworthy that the Supreme Court relied on the clinical judgement of doctors (in the form of the expert witness opinions), and not on any other form of evidence, such as a clinical guideline, for deciding treatment availability. In fact, a clinical guideline from the Royal College of Obstetricians and Gynaecologists (RCOG) did not require that a caesarean section ‘should be considered’ ¹⁵⁰ in the particular circumstances of the Montgomery case. Nonetheless, the clinical judgement of two expert witnesses was that a caesarean section was available to Mrs Montgomery, ¹⁵¹ and the Court relied on this clinical judgement and not on the RCOG guideline. As discussed earlier, EBM reduces to clinical judgements, and the Supreme Court would seem to have recognised, and endorsed, this epistemological premise. Later, following the Supreme Court’s approach, Lord Brodie explicitly cautions that guidelines:

[A]re of the nature of a specialised medical text aimed at a specialised medical audience . . . it is not the role of counsel to embark on the exposition of a technical text which has not been the subject of the evidence of an appropriately qualified witness. ¹⁵²

Finally, the Supreme Court recognised that there was a differing clinical judgement – that of the treating obstetrician, Dr McLellan – which was supported by three experts in obstetrics. Accordingly, the Court did not criticise Dr McLellan for having offered vaginal delivery: the criticism was that she did not offer caesarean section as an alternative to vaginal delivery. ¹⁵³

In summary, any claim for treatment availability has to, first, face the question of what treatments were actually accepted, that is, treatments that would actually have been offered by any doctor (in the relevant speciality) in the context of an individual patient. If a contested treatment is not supported by any doctor, then the claim would fail at this stage.

Are the accepted treatments acceptable?

Treatments that are accepted by medical professionals pass to the second step of the test of availability. A treatment will not be accepted by judges simply because it has been endorsed by doctors. Rather, as pointed out by Judge Freedman in the case of Holdsworth v Luton and Dunstable NHS Trust, judges will assess the accepted treatments to ascertain whether ‘In accordance with Bolitho . . . the decision withstands logical scrutiny’. ¹⁵⁴ Such an approach was implicit in Montgomery. It can be inferred that the Supreme Court did not conclude that caesarean section was an available treatment simply because it was accepted by experts in obstetrics; rather, over and above the actual acceptance by experts, the Court found that caesarean section was acceptable, that is, it had a logical basis. ¹⁵⁵

The logical scrutiny applies to both the treatment that was actually proposed by the treating doctor and the alternative treatment that was claimed to be available. In Holdworth, it was the former situation: it was alleged that uni-compartmental knee replacement was not a reasonable alternative to total knee replacement and it should not have been offered to the patient. ¹⁵⁶ Judge Freedman did not rely simply on an expert witness’ assertion that uni-compartmental replacement was a proper operation; rather, he scrutinised the logic of the expert’s argument, which he then found to be acceptable. Indeed, in Montgomery, itself, the Supreme Court did not reject the obstetrician’s proposal of vaginal delivery as illogical or unacceptable ¹⁵⁷ (rather, as pointed out earlier, the Court concluded that both vaginal delivery and caesarean section should have been made available to Mrs Montgomery).

On the other hand, in Bayley, an expert had contended that venous stenting should have been made available, as an alternative to compression stockings, for the treatment of deep vein thrombosis. Judge Worster dismissed this claim on the grounds that ‘not enough was known about this procedure by the reasonably competent vascular surgeon in 2008 for it to be Montgomery negligent to fail to inform the Claimant about it’. ¹⁵⁸ Implicitly, the judge did not regard stenting to be acceptable because he did not find sufficient supporting evidence. Again, in Malik v St George’s University Hospital, ¹⁵⁹ an expert contended that nerve root injection and specialist pain therapy should have been offered as alternatives to revision of spinal surgery. Judge Blair rejected this claim. It can be inferred that he did not consider it logical that the surgeon should offer treatments that were not ‘available in the context of the parameters’ ¹⁶⁰ of that individual patient (who had intractable and severe pain following previous spine surgery), regardless of the fact that these treatments could be undertaken for spinal pain in general.

The assessment of acceptability of medical treatment by a judge is challenging. ¹⁶¹ Essentially, a judge now has to decide what constitutes evidence and how a doctor should exercise clinical judgement in applying this evidence to the individual patient’s circumstances. ¹⁶² Debate on whether judges are suitably equipped for this task is outside the scope of the present article. For the present purpose: if an accepted treatment is found to be unacceptable, then it would not receive further consideration, and the claim would fail at this step of the test of availability. Otherwise, as in Montgomery, where both contested treatments were accepted and acceptable, the claim would proceed to the third step.

Were all accepted and acceptable treatments offered to the patient?

It is the third step of the test of availability that represents the important innovation of the Bolam principle that was perceived by Lord Boyd in AH v Glasgow. As discussed earlier, the second proposition of the Bolam principle accepts the existence of genuine differences in clinical judgements among doctors, and the Bolam test resolves such differences by privileging the clinical judgement of the treating doctor (provided that it is endorsed by the doctor’s peers and it is logical). Montgomery innovates by removing the treating doctor’s privilege to decide the treatment that was available to the patient. Instead, Montgomery can be seen to require that all treatments that are actually accepted by doctors, and are acceptable, should be made available to the patient, regardless of the view of the treating doctor.

It can be inferred that the Supreme Court adopted the reasoning that had been articulated previously, in the context of best interests decision-making, by Butler-Sloss P in Re S (Adult Patient: Sterilisation) that ‘the duty to act in accordance with responsible and competent professional opinion may give the doctor more than one option since there may well be more than one acceptable medical opinion’. ¹⁶³ In Montgomery, there were two options – vaginal delivery and caesarean section – and each was accepted (by at least some, but not all, doctors) and acceptable. The treating obstetrician, Dr McLellan, did not accept caesarean section. Nonetheless, the Supreme Court concluded that she should have offered both vaginal delivery and caesarean section to her patient. Fundamentally, the Court’s ratio decidendi was all treatments that are accepted by doctors (in the relevant specialty), and are acceptable, should be made available to the patient; even if the treating doctor, himself or herself, does not accept one or more of these treatments. From a sociological perspective, the Supreme Court would seem to endorse a revised form of Freidson’s thesis, in which professional autonomy rests collectively with the medical profession, and not with individual doctors. ¹⁶⁴

Lower courts can be seen to have adopted such a revised thesis, even prior to Montgomery, in Birch v University College London Hospital ¹⁶⁵ and in Jones v Northwest Strategic Health Authority. ¹⁶⁶ Following Montgomery, the Court of Appeal applies such reasoning in Webster v Burton NHS Trust. ¹⁶⁷ Here, it was claimed that induction of labour should have been offered as an alternative to awaiting spontaneous delivery, as was decided by the treating obstetrician. Opposing expert witnesses supported both approaches, and there was no argument that either approach was illogical. At first instance, the judge had ruled in favour of the obstetrician. As pointed out later by Simon L.J., ‘the Judge followed the Bolam approach of basing his judgment on whether Mr Hollingworth (the obstetrician) acted in accordance with a responsible body of expert medical opinion. It is now clear from Montgomery that this is no longer the correct approach’. ¹⁶⁸ Accordingly, Simon L.J. ruled that the treating obstetrician should have offered to induce labour as an alternative to awaiting natural childbirth. A similar application of the Montgomery ratio can be detected in Diamond v Royal Devon and Exeter NHS Trust too. ¹⁶⁹

In closing, Montgomery resolves the charge of epistemic injustice by making all treatments that are accepted by any doctor (in the relevant specialty), and acceptable, available to the patient. As discussed in the ‘Clinical judgement’ section, doctors identify (‘accept’) treatment through the exercise of their individual clinical judgements; and clinical judgements can differ because of underlying differences in value judgements among doctors. Implicitly, the Supreme Court decided that it was unfair that such differences in value judgements should restrict treatment-availability for a patient, and the Court responded by extending the patient’s access to the value judgements of all doctors. It may be inferred that the Supreme Court’s view of justice was that all patients with similar health circumstances should have equal availability of medical treatment.

It would be a fallacy, however, to infer that the Supreme Court rejects any role, whatsoever, for value judgements by doctors. Such a misconception might arise from Lady Hale's reproval of Dr McLellan’s reason for withholding caesarean section (‘not in the maternal interests’ ¹⁷⁰ ) as an ‘argument (that) departs from purely medical considerations and involves value judgments’. ¹⁷¹ Prima facie, her Ladyship rebuke would imply that value judgements do not have any place in the practice of EBM. However, contextually, Lady Hale had regarded the risks of caesarean section as ‘so low’ ¹⁷² that there could be no benefit to vaginal delivery other than it being a ‘unique and wonderful experience’. ¹⁷³ Accordingly, she would seem to have considered that Dr McLellan had exercised a personal or private value judgement, akin to a conscience-based objection, ¹⁷⁴ and not a professional value judgement; and Lady Hale's criticism was directed at the former and not at the latter. As discussed in the ‘Value judgements’ section, professional value judgements are integral to EBM; and the Supreme Court implicitly upholds the place of such value judgements by continuing to rely on the clinical judgements of doctors to identify accepted treatments (step 1 of the test of availability).

Conclusion

In Re J, Lord Donaldson MR mused: ‘what is meant by the concept of being reasonably available’? ¹⁷⁵ The present article responds to this question by attempting to specify the doctor’s obligation to make treatments available to the patient. The medical profession is grounded in a certain epistemology called EBM, and EBM allows, through the exercise of clinical judgement by doctors, for the identification of more than one treatment in some circumstances. Traditionally, only the treatment that was identified by the treating doctor was made available to the patient. In contradistinction, the law from Montgomery would seem to be that all treatments that are allowed by EBM (as practised through the clinical judgement of doctors) should be made available to the patient, irrespective of the views of the patient’s treating doctor. At the same time, the Supreme Court maintains that available treatments emerge from the practice of EBM only, and not from any other source.

As pointed out earlier, the Supreme Court’s approach is consistent with a revised sociological model of medical professionalism, and it has been widely acclaimed. ¹⁷⁶ In dissent, Jonathan Montgomery has criticised it for ‘a new judicial activism but that it is inherently unstable because its concepts of the professional role and patient are deeply flawed’. ¹⁷⁷ The criticism is thought-provoking. While the test of availability supplies an appealing tool for malpractice litigation, it imposes some invidious demands on doctors. Essentially, the treating doctor is now required to ‘second guess’ treatments that would be provided by other doctors. ¹⁷⁸ But, how can any doctor ascertain the treatments that would be offered by colleagues elsewhere in the particular context of an individual patient? It would be practically infeasible, even in cases where the identification of available treatments is clearly difficult, for a doctor to canvass the opinions of all other doctors in that specialty.

Also, there is a technical skill-related difficulty. What if a surgeon knows that there is an alternative operation that would be offered by a more specialised colleague, but he or she does not have the expertise to perform that alternative operation? It is disingenuous to respond that patients should be informed of this alternative operation, and those who prefer it should be referred to the more expert surgeon, because a sufficient workforce of super-specialist surgeons may often simply not exist. Montgomery’s mandate challenges the current organisation of the medical profession and it poses significant practical difficulties that require to be acknowledged and addressed.