Informed consent,Montgomery and the duty to discuss alternative treatments in England and Australia

Abstract

The UK Supreme Court in Montgomery v Lanarkshire Health Board imposes a duty on healthcare professionals in relation to information disclosure. The obligation is to take reasonable care to ensure that patients are aware, not just of material risks inherent in any recommended treatment, but of any reasonable alternative treatments. While liability for information non-provision was previously decided according to whether the profession would deem disclosure appropriate, the law now judges the sufficiency of information from a patient’s perspective. In doing so, it adopts the approach advocated for Australia in Rogers v Whitaker. However, commentators, in this journal and elsewhere, have expressed concern that the disclosure obligation is unclear. Although Montgomery defines what is ‘material’ for the purpose of identifying notifiable treatment risks, it offers less guidance as to when alternative treatments will be sufficiently ‘reasonable’ to warrant disclosure. Through an analysis of Australian and UK case law and examples, this article considers the ambit of a practitioner’s duty to discuss alternatives. It concludes that although likely subject to further litigation, the identification of reasonable treatment options requiring disclosure will be influenced by the patient’s clinical condition, their prognosis and viable options from a medical perspective, and various non-clinical matters influenced by the test of materiality.

Keywords

Informed consent information disclosure alternative treatments material risks medical negligence law

Introduction

To promote informed consent to medical interventions and avoidance of liability under negligence law, the UK Supreme Court in Montgomery v Lanarkshire Health Board¹ imposed a duty on healthcare professionals ‘to take reasonable care to ensure that [a] patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments’ (para 87, emphasis added). A risk is material where

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. (para 87)

Under this test, whether a risk is sufficiently material to warrant disclosure will not solely depend upon its probability of occurrence. Rather, the assessment will be influenced by the patient’s characteristics and surrounding circumstances. These include: the risk’s nature; its effect on the patient’s life; the importance to the patient of the treatment’s therapeutic or other benefits; and the risks present in alternatives.²

Montgomery concerned an obstetrician’s failure to advise their patient of a 9–10% risk of shoulder dystocia inherent in childbirth, and to discuss alternative delivery by caesarean section. Shoulder dystocia occurs where a baby’s shoulders cannot pass through the mother’s pelvis. Had the risk been known, Ms Montgomery would have elected to avoid vaginal delivery – dystocia would not have occurred, averting the harm to her child. Where dystocia transpires, the neonatal risk of brachial plexus injury was 1/500, while the risk of babies also sustaining more serious injury, such as the cerebral palsy sustained in Montgomery, was <1/25,000.³ Indeed, the obstetrician did not disclose this information because the chance of grave harm to the child was so small, and medical opinion supported this approach (paras 25–26). The obstetrician also believed that caesarean sections were ‘not in the maternal interests of women’ (para 13).

In finding the practitioner liable for non-disclosure (para 94), the Supreme Court concluded that the dystocia risk was material. Its probability and gravity were such that a reasonable person would attach significance to it. Having expressed concern about her ability to deliver vaginally, the significance of the risk to Ms Montgomery was also apparent. Comparatively, caesarean section posed less risk.⁴

The importance of Montgomery, regarding a practitioner’s duty to provide information to patients prior to obtaining their informed consent, lies in its departure from the Bolam⁵ test to regulate medical liability outside the areas of diagnosis and treatment. Previously, liability for information non-provision was decided by whether peer professional opinion would deem disclosure appropriate⁶ and Ms Montgomery’s obstetrician adopted this view. But the law now judges the sufficiency of information from a more patient-oriented perspective. It recognises the importance of tailoring advice to a patient’s ‘needs, concerns and circumstances’⁷ through dialogue with medical professionals⁸ and, in doing so, adopts the approach advocated for Australia in Rogers v Whitaker.⁹ Patents are no longer viewed as ‘passive recipients’ of medical care, but as ‘consumers exercising choices’ in relation to their health.¹⁰

Commentators^11,12 note that prioritisation of patients’ ‘informed choice’ may ‘give greater prominence’ to informing about alternatives.¹¹ However legal¹³ and academic discussion, in focusing upon the disclosure of the material risks inherent in the single treatment recommended, has traditionally placed ‘little emphasis’ on the provision of information about treatment options.¹¹ Montgomery itself defines ‘material’ for the purpose of identifying notifiable treatment risks, but offers less guidance as to when variant treatments will be sufficiently ‘reasonable’ to warrant disclosure. Accordingly, the extent of the Supreme Court’s requirement to advise of alternative options is argued to be unclear.^13–16

In light of post-Montgomery case law, this article considers the ambit of the health professional’s duty to discuss alternatives with patients. It further examines the position under Australian law since Rogers in order to provide a point of comparison in terms of outlining the likely extent of the similar UK obligation.

The Australian position: Rogers v Whitaker

In 1992, the Australian High Court in Rogers⁹ determined that under the law of negligence, and where needed for patients’ informed healthcare decisions,¹⁷ a medical practitioner’s duty of care extended to the provision of advice and information (pp. 483, 489). The case involved a surgeon’s failure to warn of the postoperative danger of sympathetic ophthalmia, where the patient’s claim was confined to the disclosure of risks inherent in the treatment recommended (p. 483). Rejecting professional opinion’s decisiveness to determining disclosure adequacy, the Court instead formulated a requirement to warn of all risks of undergoing or foregoing treatment when those risks were ‘material’ (pp. 490, 493). Noted previously, this more patient-centred test is now used in the UK and includes the same objective and subjective disclosure requirements. The first requires disclosure of risks significant to the decision-making of a reasonable patient in the circumstances, while the second mandates disclosure if the practitioner knows or ought reasonably to know of a risk’s significance to the particular patient.

Due to its limited factual context, Rogers (unlike Montgomery) did not explicitly impose an obligation to explain alternative or variant treatments. Indeed, in Richards v Rahilly,¹⁸ the New South Wales Supreme Court considered that

[a]n obligation to warn of a ‘material’ risk inherent in a proposed treatment is a significantly different obligation to one requiring the provision of full information concerning a number of treatment options preparatory to the patient choosing his or her treatment. (para 236)

The possibility of a requirement to disclose ‘alternative treatment promising greater benefit’ was however acknowledged by Gaudron J in Rogers.¹⁹ Subsequently, available alternatives and their comparative dangers have been held relevant to an objective identification of the material risks inherent in treatment proposed.^20,21 In the UK, Birch v University College London Hospital NHS Foundation Trust²² and now Montgomery (para 89) have similarly observed that patients are more likely to find a risk significant where other procedures carry no or fewer perils. Nevertheless, quite aside from warning patients of material risks, an independent obligation to apprise patients of different treatment options, and their strengths and weaknesses, has been considered. It is this requirement’s extent that this article now examines.

Unpacking the duty to discuss alternatives

The difficulty of identifying when a duty to discuss alternative treatments will arise has been acknowledged.²² Nonetheless, because the obligation falls within the law of negligence, the standard of conduct expected is ‘reasonable’ care, or information disclosure, only.^13,16 Regarding reasonableness, English and Australian case law raise the following issues for consideration:

Scope of disclosure

Montgomery refers to ‘reasonable’, ‘possible’ or ‘available forms of treatment to undergo’ (paras 82, 87, 90). Accordingly, although disclosure may require more than the discussion of the particular treatment or investigative option recommended,²³ it is unlikely to require mention of every conceivable alternative or those so inappropriate that their performance would, in itself, be negligent.²⁴ In Bayley v George Eliot Hospital NHS Trust,²⁵ in considering whether ‘all treatment options’ no matter how ‘fanciful’ had to be outlined (paras 54, 62), a distinction was drawn between ‘knowing that technically [a] procedure could be done, and the issue of whether it should be done’ (para 76). The case involved a claim that a patient had not been advised

of all treatment options that were available to her (both in the NHS and privately, whether in the UK or Europe), including the benefits and risks associated with those treatment options, so that [she] could make an informed choice as to the treatment she should consider…. (para 49)

The specific alternative in question concerned the treatment of deep vein thrombosis by ilio-femoral venous stenting, rather than conservatively via medication and anti-embolism stockings. The court concluded that in failing to advise of the procedure the patient’s vascular surgeons were not ‘Montgomery negligent’ because, at the time of consultation, it would have been too late to attempt stenting (paras 98–99). Similarly, there is no duty to warn of alternative diagnoses and their treatments where such diagnoses are ‘reasonably not suspected’ from a patient’s ‘clinical presentation or history’.²⁶ Furthermore, in Australia, the discussion of caesarean section was not required as an alternative to the option of induction, in Eagle v Prosser,²⁷ where such an option was not ‘medically necessary’.

Not every alternative therefore requires disclosure; but only those which are medically warranted, ‘available’²⁸ or ‘clinically suitable’.²⁴ Relevant to this assessment are a patient’s circumstances and prognosis. For example, in Jordan v Lee,²⁹ a neurosurgeon’s failure to advise of surgical resection, as the treatment of first choice for a brain tumour and as opposed to keeping the tumour under review, did not attract liability. At the time, the patient was ‘otherwise pursuing the normal activities of a boy his age’ (para 821) and the treatment carried a significant risk of hemiparesis, such that the District Court of Western Australia was

not persuaded that an attempt at resection would have been a reasonable choice … It carried associated high risk of neurological deficit to Daniel and this is especially so given his relatively good neurological circumstances … He was not dying or in extremis or under a death sentence in 1996. (para 819)

In KL v Farnsworth, the patient’s urinary tract infection was so severe that ‘to do nothing’ was ‘not really an option at all’,³⁰ while in Phelan v Melbourne Health, although calcaneal fracture surgery was not the recommended treatment, being contraindicated by the patient’s smoking and right ankle swelling, it remained sufficiently ‘open’ as to warrant discussion in addition to non-operative options.³¹ As such, where clinically viable in the manner described above, in Australia, disclosable alternatives have included both: the option of having no treatment; and the availability of conservative treatment not already known to the patient.³² In the UK, a patient was awarded £4.4 million on this basis in Hassell v Hillingdon Hospitals NHS Foundation Trust.³³ Having not been advised of non-surgical treatments, such as physiotherapy and analgesia, prior to spinal surgery, informed consent to the operation had not been given.

A professional’s duty extends beyond discussion of reasonable alternative treatments, to their relative risks and benefits.^30,34 In addition to informing a hernia patient of primary suture repair as ‘an option and, a possible alternative to, a mesh repair’ in Diamond v Royal Devon and Exeter NHS Foundation Trust,³⁵ a surgeon was obliged to explain the former method’s high chance of failure and the risks of the latter should pregnancy occur. Furthermore, as relevant clinical options can change over time, the requirement to advise of alternatives, to secure informed consent, may persist subsequent to medical care’s commencement. Consequently, Webster v Burton Hospitals NHS Foundation Trust³⁶ held that following an ultrasound identifying a foetus small for gestational age and polyhydramnios, the obstetrician should have revisited the labour management plan and advised of the risks of delaying labour leading to the option of induction. In Kennedy v Frankel,³⁷ once symptoms of impulse control disorder from Parkinson’s disease medication emerged, a duty to advise of alternative medication likely to end those symptoms arose.

Importance of medical evidence

Whilst the health profession no longer dictates the extent of information disclosure in the UK and Australia, there does remain scope for the exercise of professional judgement.^14,31,38 Indeed, Montgomery suggests that the identification of ‘available’ forms of treatment and their risks (independently of whether those forms ‘ought to be discussed with the patient’), falls ‘within the expertise of members of the medical profession’ (para 83). In Australia, Richards¹⁸ considered a hospital’s alleged omission to present Vigabatrin to parents as an alternative drug for treating their child’s seizures. The ailment was ‘not well understood’. According to medical evidence, there were ‘at least three, and perhaps five, well-recognized’ drugs that ‘were not necessarily alternatives but could be used in combination’. Consequently, there ‘were no clear-cut alternative treatments to choose between’ (para 233) and the court held that the hospital’s disclosure obligation extended only to the risks involved in the medication regime recommended.

Medical evidence also assists courts in identifying the available options, of which a professional knew or ought to have known, at the time of disclosure.^29,39 In addition to expert testimony on the state of medical knowledge, evidence may derive from published papers^29,36 and professional guidelines.⁴⁰ For example, in Bayley,²⁵ Worster J stated that in considering what is a reasonable alternative:

That a treatment is the subject of research published in a well-respected medical journal may well be an important factor … particularly if the published results are of a long-term comprehensive trial with positive results from a respected expert in the field. (para 63)

In that case, because ilio-femoral venous stenting was ‘nowhere near being accepted practice’, the court supported its conclusion of no negligence on the basis that no ‘reasonably competent vascular surgeon would or ought to have known’ of the treatment’s ‘availability or potential use’ in 2008 (para 99). Furthermore, information disclosure is not required in circumstances of necessity or where detrimental to patient health.⁴¹ Known as ‘therapeutic privilege’, professional practice may therefore remain relevant to determining whether a patient’s situation justifies such withholding.⁴²

Relevance of non-clinical matters

Unlike diagnosis and treatment, a practitioner’s duty to provide information does not depend solely upon medical considerations.⁴³ Rather, in addition to prognosis and viable therapeutic options, Montgomery makes clear that the particular patient’s views, concerns and characteristics must be ‘taken into account’ (para 115):

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 … circumstances of an individual patient may affect their attitude towards a proposed from of treatment and the reasonable alternatives. (para 46).

The relevance of an alternative’s significance from ‘the patient perspective’ was confirmed for Australia, in Sheppard v Swan⁴⁴ where the ‘principles developed in relation to the duty to warn’ of material risks were applied by analogy to determine the existence of a duty to advise of alternative treatments (para 42). Although finding that ‘at the material time a caesarean section was not medically necessary, indicated or desirable’, McLure J also held that ‘there were no objective or subjective grounds’ for the general practitioner to proffer, during labour, caesarean section as an option to vaginal delivery. While suffering pain and exhaustion, given that the patient’s situation was ‘not exceptional by objective standards’ caesarean section was ‘not an objectively material option’ requiring communication. Subjectively, the patient had determined to deliver the baby naturally (to the extent medically appropriate) and had given ‘no indication that she wanted to change course or discuss the option of doing so’ (paras 44–45).

The materiality test was again applied to alternatives in the UK in Britten v Tayside Health Board.⁴⁵ Where a patient had bipolar disorder, the treatment of their eye condition by steroid injection (having less risk of triggering a psychiatric event) was a reasonable and notifiable option to oral steroids. Pursuant to the test’s objective disclosure requirement, if the information would be significant to a reasonable person in the patient’s position, the Dundee Sheriff Court concluded:

[A] reasonable person … might reasonably have opted for treatment by steroid injection, had they been made aware of the relative risks and benefits of this treatment … This is so standing in particular the previous history of mental health problems from which the pursuer had suffered. (para 83)

While case-dependent, in addition to the patient’s physical characteristics,¹⁵ factors relevant to the objective limb may include the nature of their medical condition and need for treatment. Arguably, ‘[t]he less urgent and critical the need for the procedure, the greater the need for advice as to the possible risks involved and as to possible different means of treating the problem’.⁴⁶ Conversely, medical emergency may excuse non-disclosure.⁴⁷ The significance of information to a reasonable patient may also be strengthened in circumstances of heightened risk due to the treatment recommended. In Montgomery, where the patient’s diabetes increased the dystocia risk, Lady Hale stated that: ‘clearly’ practitioners should ‘volunteer the pros and cons of each option … where either the mother or the child is at heightened risk from a vaginal delivery’ (para 111). Previously in Birch,²² MRI carried no risk when compared to the preferred imaging method (cerebral angiography – with its risk of stroke exacerbated by the patient’s diabetes) and necessitated an explanation of both procedures.

Non-clinical matters such as a patient’s values, occupation, lifestyle and hobbies, while perhaps relevant under the objective limb to contextualising the ‘patient’s position’,¹³ assume particular importance, together with patient idiosyncrasies, in determining whether disclosure is required because the particular patient would consider an alternative significant. Extending only to subjective considerations of which a practitioner knows or ought to know,⁴⁸ conceivably from the patient’s notoriety or medical file, the relevance of such factors also highlights the importance of practitioner–patient dialogue.

For instance, a patient suffering hip stiffness and pain is recommended hip-replacement surgery. The patient, a keen sportsperson, has some knowledge of hip surgery; her father’s surgery lasted 30 years, whilst her mother-in-law suffered eight postsurgical dislocations. The patient therefore informs her orthopaedic surgeon of her lifestyle and desire for the option with the quickest recovery time, which is as good an option as possible and lasts as long as possible. She believes that her implant will be the same type given to her father. Despite this, a new device is used which, although allowing quick recovery, has unknown long-term success. The patient requires repeated operations. Here, given the patient’s expressed priorities, the surgeon is arguably obliged⁴⁹ to advise her of the risks and benefits of both the implant proposed and the alternative available when seeking her informed consent. Despite this, in Grimstone v Epsom and St Helier University Hospitals NHS Trust,⁵⁰ rather than the implant type, McGowan J focused solely upon the ‘nature of the surgery’ as the relevant information requiring disclosure (para 13). As such, because the patient had been advised of the risks and form of hip surgery proposed, it was held that adequate disclosure had been made. Even so, had the fuller disclosure argued for in this article occurred, as it was unproven that the patient would have elected the older implant type ‘over the option which would achieve a quicker recovery’ (para 12), the surgeon would nevertheless have remained not liable. Revelation during consultation of a patient’s occupation as an auctioneer would similarly warrant mention of alternatives where the recommended intervention harbours risk of vocal cord damage.

As Sheppard notes,⁴⁴ communicable options under the subjective disclosure requirement can also be influenced and enlarged by patient questioning.^17,20 While not required, a request about alternatives or a particular treatment option will ordinarily impose upon a practitioner a duty to truthfully answer.⁵¹ Arising even when disclosure is not otherwise medically warranted or reasonable, this obligation was considered by Tasmin v Barts Health NHS Trust.⁴⁰ There, caesarean section, as an alternative to foetal blood sampling during labour, was not a reasonable option requiring disclosure, being inconsistent with national guidance and standard practice. Even so, it was accepted (paras 102–103) that ‘in answer to a direct request for CS, a reasonable obstetrician would be mandated to discuss the risks’.⁵²

Conclusion

An analysis of Australian and UK case law highlights that, following Montgomery, identification of ‘reasonable’ treatment options requiring disclosure by healthcare professionals will be influenced by the patient’s clinical condition, their prognosis and viable options from a medical perspective, and non-clinical matters. The latter includes the individual patient’s characteristics, concerns and information requests and is influenced by the test of materiality. Specifically, if a particular patient, or the reasonable patient in their position, would regard an alternative significant or relevant, they ‘must be advised of it, and so be given the opportunity to consider whether [they] might want to receive it’.⁴³ An option’s significance, however, does not entitle a patient to demand it. Just as practitioners may still recommend, from those available, that option they consider best for the patient, it remains that they can withhold treatment considered futile or inappropriate.⁵³ Therefore, while further litigation and case law is likely in this area, by emphasising the importance of each patient’s personal context and values when deciding which treatment options ought to be discussed, the law’s benefits for shared decision-making are significant.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethics approval

No ethical approval was required for the research undertaken in writing this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Guarantor

Tracey Carver.

ORCID iD

Tracey Carver

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26.

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Bloodworth v The South Coast Regional Health Authority t/a Gold Coast Hospital [2004] NSWSC 234, [143]–[145] (failure to warn of the relative material risks of open versus laparoscopic surgery).

35.

[2017] EWHC 1495 (QB), [24]–[28]. Ultimately the surgeon was not liable. Had all relevant information been disclosed, the patient would still have proceeded via mesh repair: [2019] EWCA Civ 585. See also Mills v Oxford University Hospitals NHS Trust [2019] EWHC 936 (QB) (duty to advise of alternative surgical techniques).

36.

[2017] EWCA Civ 62, [34]–[41].

37.

[2019] EWHC 106 (QB), [111].

38.

See, e.g., Zaltron v Raptis [2001] SASC 209, [56].

39.

Keane v Tollafield [2018] 8 WLUK 306, [35]–[45]. At the time of consent, bunion surgery was the only realistic option. Experts had disavowed the usefulness of orthotics. Paracetamol use and changed footwear had proved unsuccessful.

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41.

Montgomery v Lanarkshire Health Board [2015] AC 1430, [85], [88], [91].

42.

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[2016] SC DUN 75.

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Tai v Saxon (Supreme Court of Western Australia, Pidgeon, Franklyn and Ipp JJ, 8 February 1996) 9.

47.

For example, ‘where the patient requires treatment urgently but is unconscious or otherwise unable to make a decision’: Montgomery v Lanarkshire Health Board [2015] AC 1430, [88]. See also Sheppard v Swan [2004] WASCA 215, [112]–[113].

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Grimstone v Epsom and St Helier University Hospitals NHS Trust : (it’s not) hip to be square. Medical Law Review 2018; 26: 665–674 at 669-670. DOI: 10.1093/medlaw/fwx053.

50.

[2015] EWHC 3756 (QB), [1], [8], [12].

51.

Subject to therapeutic privilege: Rogers v Whitaker (1992) 175 CLR 479, 487. See also Zaltron v Raptis [2001] SASC 209, [100]; Montgomery v Lanarkshire Health Board [2015] AC 1430, [58]; Phelan v Melbourne Health [2019] VCC 241, [34].

52.

52In Tasmin, had a request for caesarean section been maintained, the practitioner ‘would have respected that and undertaken the procedure, having first obtained informed consent’: [2015] EWHC 3135 (QB), [51]. However, where not medically indicated, there is evidence to suggest that a competent patient’s request for an elective caesarean, and their understanding and acceptance of its comparative risks and benefits, does not oblige an obstetrician to proceed with it. Referral to another practitioner is then recommended: National Institute for Health and Care Excellence (NICE). Caesarean section. Clinical guideline [CG132], 2011: 1–47, [1.2.9], www.nice.org.uk/guidance/cg132 (accessed 15 May 2020); Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). Caesarean Delivery on Maternal Request, 2017: 1–11, [2], https://ranzcog.edu.au/statements-guidelines (accessed 15 May 2020). See also n 53 and accompanying text. Furthermore, for a practitioner to be liable in negligence for failing to disclose an option of caesarean section, the patient would need to prove, that if so advised, that alternative would have been both accessible and pursued such that their claimed harm would then not have occurred.

53.

Montgomery v Lanarkshire Health Board [2015] AC 1430, [95], [115]; R (On the application of Burke) v The General Medical Council [2005] EWCA Civ 1003; General Medical Council. Decision making and consent: supporting patient choices about health and care. Draft guidance for consultation, 2018: 1–21, [15], [41]–[42], www.gmc-uk.org/about/get-involved/consultations/review-of-our-consent-guidance (accessed 15 May 2020); General Medical Council. Consent: patients and doctors making decisions together, 2008: 1–62, [5], www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consent (accessed 15 May 2020).