Risk disclosure and informed consent: Practice caveats in the post Montgomery era

Abstract

The UK Supreme Court decision in Montgomery v Lanarkshire Health Board has overturned the use of the “accepted practice test” (Bolam) in deciding breach of duty cases related to risk disclosure and informed consent. Following Montgomery, a doctor is under a legal duty to take reasonable care to ensure his patient is aware of any material risks involved in the recommended treatment, and of any reasonable alternative or variant treatments. Based on Montgomery and a number of relevant published cases, this article highlights some practice caveats for surgeons to take note of when they participate in the consent process with the following headings: the objective and subjective elements of the legal test of materiality of risks; postoperative risks, follow‐up and management; timing and adequacy of risk disclosure; withholding information and therapeutic exception; and the incorporation of Montgomery into local professional code and case law. In order to minimize legal risks, surgeons are also encouraged to keep abreast of the medico‐legal development in this area, to reflect on their own practices, and to take proactive steps to enhance their interactions with patients.

Montgomery's legal and practical impact: A systematic review at 6 years

“…A dominant claim in the literature on Montgomery is that it transformed the law of informed consent 3‐26 . For example, one paper suggests that ‘the Montgomery decision redefined the standard for informed consent and disclosure’ 7 .…”

“…For example, Montgomery 's application in cases involving children is explored in both legal and medical papers, 39,56 and its application to health research and innovative treatment is explored in a small number of papers 25,57 . Citing two judicial decisions post‐ Montgomery , 105,106 one paper comments that the courts are applying Montgomery to the disclosure of information about ‘post‐treatment risks’ and ‘follow‐up managements’ 22 …”

“…Many articles focus on the Court's elevation of patient autonomy and its disapproval of medical paternalism 3,5‐10,12‐17,19,22,25‐28,30‐68,70‐86,90 . The case is described as ‘the final step in a legal power shift from paternalism to patient autonomy’ 40 and ‘a landmark case…which shifted focus from a traditional paternalistic model of consent towards a more patient‐centred approach’ 33 .…”

“…The application of the therapeutic exception under Montgomery 5,6,22,25,31,33,34,37,[58][59][60]78,82,92 5:…”

Artificial intelligence in medicine and the disclosure of risks

“…3 However, following the influential legal case of Montgomery v Lanarkshire Health Board (2015) , legal scholars and philosophers alike have claimed that even very low risks can require disclosure if a reasonable person would consider the risk material to his decision, e.g. a risk of paralysis should be disclosed even if it is considerably below 1% (Lee and Lai 2020 ). Moreover, just as in the assessment of the nature of a risk, the assessment of the likelihood also requires taking into account individual perspectives.…”