In Montgomery v Lanarkshire Health Board,[1]the Supreme Court (UKSC) held that Bolam v Friern Hospital[2] is no longer applicable in assessing breach of duty in clinical negligence cases involving informed consent, overturning Sidaway v Board of Governors.[3] The Bolam test had established that the conduct of a medical professional was negligent if it did not accord with the views of a responsible body of medical opinion.[4]The Court in Montgomery instead favoured an approach which respected patient“autonomy”[5] and moved away from “medical paternalism.”[6] The Supreme Court devised a new test to govern the law of informed consent in the medical context, drawing inspiration from the Australian Rogers v Whitaker[7] decision.Claimants must now show that the defendant failed to warn them of a material risk involved in the recommended treatment, or of any reasonable alternative or variant treatments in order to establish breach.[8]Although the question whether a doctor ought reasonably to know of the risk remains within the ambit of the Bolam test, as confirmed in Duce v WorcestershireAcute Hospitals,[9]the courts have effectively demarcated the materiality element of informed consent as firmly within their territory rather than with the medical profession.
Much ink has been spilled over whether Montgomery provides a normatively satisfactory approach to informed consent and what wider implications the decision may have for the Bolam test.[10]However, less clear is what the test of materiality involves, including the indicia which should be considered within the assessment and its operation as an objective-subjective test. In this article, I analyse the decision in Montgomery itself and the plethora of case law following it and attempt to present a cohesive overview of materiality after Montgomery. Ultimately, I suggest that Nicola Davies LJ in Diamond v Royal Devon provided an accurate overview of the test when she noted, obiter, that the materiality assessment involves “[taking] into account … the reasonable person in the patient’s position but also [giving] weight to the characteristics of the appellant themselves.”[11]
Lords Kerr and Reed established that a claimant could prove that a risk involved in surgery is material by satisfying objective indicia: “a risk is material if a reasonable person in the patient’s position would be likely to attach significance to the risk.”[12]Dunn opines that the reasonable person in Montgomery is not devoid of moral considerations,[13]in the way that the “reasonable man on the Clapham omnibus” in Hall v Brooklands,[14]is. As Dunn puts it, in the context of Montgomery, “the reasonable mother is the mother who is able to give appropriate moral weight to, and therefore is able to differentiate between, the significance of the risk that arise in the relevant situations.”[15]This is surely correct, especially considering the UKSC’s desire to highlight patient autonomy and other similar moral normative considerations[16]in moving away from the Bolam test. Where the ultimatedestination is respect for bodily autonomy, a vacuous reasonable person is aninsufficient vessel with which to assess what is objectively material.With this established, two factors appear particularly pertinent in theobjective assessment: (1) magnitude of risk and (2) seriousness of risk.
The first relevant factor is the magnitude of the risk. The UKSC in Montgomery emphatically rejected any assessment which focussed solely on pure percentages to evaluate the magnitude of the risk. Indeed, as Lords Kerr and Reed noted, the test of materiality“cannot be reduced to percentages.”[17]Nevertheless, the magnitude of risk remains a relevant indicium in assessing materiality. Clarification was provided in A v East Kent that a doctor need not warn of “theoretical” or “negligible” risks.[18] Here, a 1 in 1,000 risk of foetal abnormality was found not to be material. Similarly, in Tasmin v Barts, a 1 in 1,000 risk of cerebral palsy as also deemed to be “immaterial” for the purposes of materiality.[19]In this respect, the case of Spencer v Hillingdon, where the 1 in 50,000risk of pulmonary embolism was deemed a material risk, appears superficially contradictory.[20] How can a 1 in 1,000 risk be “theoretical,” but a 1 in 50,000 risk be “material?” Admittedly, these cases seem to be at opposite ends of the spectrum;[21]nevertheless, A and Spencer can be reconciled by considering the second relevant criterion: the “nature of the risk”,[22]or its “seriousness”.
Lords Kerr and Reed point to four different considerations in Montgomery in assessing the seriousness of risk. First, the court must ask itself what effect the risk would have on the life of the patient.[23]Inevitably, a risk such as tetraplegia would have a considerable “effect” on the life of any patient. However, the risk of a permanent ankle injury, which could still allow the patient to walk easily, but not run, would have a considerable effect on the life of an athlete. It is less clear, however, whether such a risk would have a substantial effect on the life of an office worker who never exercised. Therefore, it appears that even within the objective limb, subjective considerations must be considered within the indicia of materiality.Secondly, the UKSC noted the importance to the patient of the benefits sought to be achieved by the treatment.[24]Again, objectively, the reasonable patient would see considerable benefit in a life-saving quadruple bypass surgery or appendicectomy. However, the subjective patient may see considerable benefit in the surgery itself, where others would not; at this point, therefore, subjective considerations are dictating materiality, even under the seemingly objective indicium of the nature of the risk. The same logic can be applied to the third and fourth considerations outlined in Montgomery—the alternatives available and the risk involved in those alternatives.[25]It is these considerations which allow A and Spencer to be reconciled via the seriousness indicium: fundamentally, the pulmonary embolism under consideration in Spencer (with its significant mortality rate[26])presents a particularly serious risk, justifying it being deemed material, despite its lower magnitude.
Montgomery also provides for subjective indicia to be considered within the materiality assessment; whether the “doctor is or should reasonably be aware that the particular patient would be likely to attach significance to [the risk].”[27]Lords Kerr and Reed noted that the test was sensitive to the “characteristics”of the patient.[28]
Post-Montgomery case-law clarifies these characteristics. In Thefaut v Johnston,[29]the High Court held that the fact that the claimant was a particularly cautious character meant that the risk of her back pain being exacerbated by the surgery was material. The court noted that it was important to take into account if a patient was “fragile”[30]and what their “tolerance or stoicism for pain”[31]was like in assessing materiality.
Further, in Diamond vRoyal Devon,[32]the Court of Appeal held that a “scrupulous” assessment involved taking account of the patient’s “personal and social considerations,” as well as the “clinical facts in the context of the [patient’s] character and circumstances.” The Court also repeated that a “single test of rationality” is inappropriate by virtue of its failure to inquire into the relevant subjective considerations within the assessment of materiality. As such, it is clear that the effect of Diamond is that a wide range of patient-specific factors must be considered.
Britten opines that the natural normative extension of relevant characteristics outlined in Montgomery, Thefaut, and Diamond is to include matters such as their specific eccentricities and religious views.[33]Since the trend in recent years clearly has been to incorporate a wide range of characteristics baring on a patient’s decision-making capacity when assessing whether a risk is material, the factors identified by Britten ought reasonably to be included within the subjective assessment. This is normatively justifiable, considering that the ultimate goal of the move away from Bolam in Montgomery was to ensure greater respect for patient autonomy.[34]As the standard required in identifying these patient characteristics falls under the Bolam test,[35]any concerns, such as those raised in Montgomery, relating to defensive medicine or intrusive questioning by healthcare professionals,[36]are alleviated.
It is therefore clear that the assessment of materiality is an objective-subjective test. However, as the foundational basis for the decision in Montgomery would suggest, applying a patient-sensitive[37]approach is essential even when considering objective factors. The approach taken by Green J in Thefaut provides a useful starting point inassessing materiality. First, one ought to consider the objective factors, magnitude and seriousness of risk, to reach a prima facie conclusion regarding materiality. This prima facie position can then be tested against the subjective indicia in the particular case.[38]
Within the objective inquiry, the magnitude of the risk is a necessary starting point. As A and Tasmin make clear, background risks are not material. Nevertheless, Spencer indicates that the seriousness of the inherent risk itself is important indetermining materiality, especially where the particular risk carries a risk of mortality.
Next, the subjective factors in the specific case ought to be considered. There is precedent for the inclusion of fragility, stoicism, pain tolerance, other personal and social circumstances, and the clinical facts in the context of the patient’s character and circumstance. It would also be reasonable to assert that factors such as religious beliefs and particular eccentricities should be considered as part of the subjective inquiries.
Inevitably, a strict formula will not provide the answer in every case. Rigidly following the Thefaut approach will not always be satisfactory; in some cases, within the objective inquiry used to reach the prima facie position, subjective factors will play an important role, as indicated by the above analysis of the “seriousness” indicium. Instead, the “fact-sensitive”[39]nature of the materiality inquiry demands that in some cases, a holistic assessment be taken, with due attention given to the specific characteristics of the particular patient.
[1] Montgomeryv Lanarkshire Health Board [2015] UKSC 10.
[2] Bolamv Friern Hospital Management Committee [1957] 1 WLR 583.
[3] Sidawayv Board of Governors of the Bethlem Royal Hospital [1985] AC 871.
[4] Bolam,[587].
[5] Montgomery,[108].
[6] Ibid,[81].
[7] Rogersv Whitaker (1992) 67 ALRJ 47 (High Court of Australia).
[8] Montgomery.
[9] Ducev Worcestershire Acute Hospital Board [2018] EWCA Civ 1307.
[10]See, for example, Swoboda, ‘Bolam: Going, Going… Gone’ Journal of PersonalInjury Law 9(1) (2018).
[11] Diamondv Royal Devon and Exeter NHS Foundation Trust [2019] EWCA Civ 585.
[12] Montgomery[87].
[13]Dunn, ‘Between the Reasonable and the Particular: Deflating Autonomy in theLegal Regulation of Informed Consent to Medical Treatment, Health Care Analysis(2019) 27:110-127.
[14] Hallv Brooklands Auto Racing Club [1933] 1 KB 205.
[15]Dunn.
[16] Montgomery,[108].
[17] Montgomery,[89].
[18] Av East Kent Hospitals and NHS Foundation Trust [2015] EWHC 1662 (QB).
[19] Tasminv Barts Health NHS Trust [2015] EWHC 3135 (QB).
[20] Spencerv Hillingdon Hospital NHS Trust [2015] EWHC 1058 (QB).
[21]See, for example, the 1 in 20 risk of chronic pain found to be material in Ollossonv Lee [2019] EWHC 784 (QB).
[22] Montgomery,[89].
[23] Ibid.
[24] Ibid.
[25] Ibid.
[26] StefanoBarco et al., ‘Age-sex specific pulmonary embolism-related mortality in the USAand Canada, 2000-18: an analysis of the WHO Mortality Database and of the CDCMultiple Cause of Death database’, Lancet Respir Med 2021 Jan; 9(1): 33-42.
[27] Montgomery,[87].
[28]Montgomery, [89].
[29] Thefautv Johnston [2017] EWHC 497 (QB).
[30] Thefaut,[55].
[31] Ibid.
[32] Diamond.
[33] Britten,Evolution of the objective-subjective test for material risk in consent, (2018)6:4, p.44.
[34] Montgomery,[68], [108].
[35] Duce,[33].
[36] Montgomery,[92].
[37] Montgomery,[89].
[38] Thefaut,[79].
[39] Montgomery,[89].
