Back to the drawing board for patient autonomy? Informed consent following McCulloch

24/10/2023

In the most significant decision on informed consent since Montgomery,[1] the Supreme Court have held that the question of what “reasonable alternative treatments” a doctor has a duty to inform their patient about is governed by the “professional practice test” (as in Bolam).[2] As to the disclosure of “material risks” inherent in treatment, the test in Montgomery endures.

Facts

Mr McCulloch died after suffering cardiac arrest, having been discharged from hospital the previous day. His death followed several recent hospital admissions for nausea, vomiting and chest pain. The cause of death was recorded as idiopathic pericarditis and pericardial effusion (inflammation and excess of fluid in the sac around the heart from an unknown cause).

Prior to his discharge, the consultant cardiologist considered that Mr McCulloch’s echocardiograms did not reveal any cause for concern. There was no clear diagnosis of pericarditis. A few days prior to his death, Mr McCulloch denied currently suffering from any chest pain. As a result, the consultant cardiologist did not consider it necessary or appropriate to prescribe non-steroidal anti-inflammatory drugs (“NSAIDs”), such as ibuprofen.

A claim in negligence was brought by his widow. The Claimant’s case was that the consultant cardiologist should have advised Mr McCulloch of the option of NSAIDs. The Claimant alleged that Mr McCulloch would thereafter have taken an NSAID and would not have died.

Both lower Courts held there was a responsible body of medical opinion to support the consultant’s decision not to offer NSAIDs. The Claimant’s case was dismissed.

The Claimant appealed, alleging that Montgomery applies to the test of what is a “reasonable alternative treatment.” I.e., that a doctor is under a duty to take reasonable care to ensure that a patient was aware of any “material risks” involved in any recommended treatment, and of any reasonable alternative treatments. There are two limbs to the test of materiality:

1. an objective limb: what would the reasonable person in the patient’s position consider significant?; and

• a subjective limb: what would this particular patient consider significant?

Conversely, the Health Board argued that the “professional practice test” should apply. The “professional practice test” is whether a doctor has acted in accordance with a practice accepted as proper by a responsible body of medical opinion (Bolam),[3] provided that body of medical opinion is capable of withstanding logical analysis (Bolitho).[4]

Decision

The Supreme Court unanimously dismissed the appeal, holding that Bolam is the test applicable to reasonable alternative treatments.

The Court held that distinguishing between reasonable and unreasonable alternative treatments is necessarily an exercise of professional skill and judgment. This position is reinforced by alternatives often being referred to as “clinical alternatives.” The Court also considered this approach consistent with the 2018 Court of Appeal decision in Duce.[5] In that case, the Claimant developed chronic post-surgical pain, which she alleged she should have been warned of prior to surgery. The Court held that identifying the risk associated with medical treatment is a matter of professional skill and judgment (to which Bolam applies). Thereafter, whether a patient should be informed of a risk is a question of materiality (to which Montgomery applies).

Discussion

Clarity for doctors?

Montgomery represented a potent levelling of the playing field between doctors and patients. It followed the gradual erosion of medical paternalism, allowing case law to parallel General Medical Council (“GMC”) guidance, which had long championed a patient’s right to autonomy.

Given the patient-centric nature of Montgomery, some have worried that it would lead to doctors practising defensive medicine, focusing on minimising the opportunity for litigation, rather than developing a holistic understanding of what treatment each individual patient might benefit from. In so doing, doctors may therefore overwhelm patients with options, leading to the ordering of unnecessary diagnostic tests, procedures and overuse or mistreatment of medicines. As the Supreme Court in McCulloch emphasised, it is not beneficial for patients to be “bombarded” with information about every possible treatment for every potential diagnosis, when, in reality, many will prove fruitless. Further downsides of defensive medicine are that it is virtually impossible to measure, and self-evidently expensive.

The GMC and British Medical Association (“BMA”) were joined as interveners in the appeal. Both stressed that identifying alternative treatments is a clinical question, which necessarily relies on a doctor’s knowledge and experience. This position is correspondent with existing GMC and BMA guidance and avoids the potential tension of a doctor having to offer an option they do not consider clinically reasonable. If the Appellant had succeeded, the test would allow the Court to judge with the benefit of hindsight in a way a doctor might not foresee (or as Counsel for the GMC put it, through a “retrospectoscope”).

The outcome may therefore be welcome clarification for many clinicians in the UK.

The judgment is also in harmony with the Court of Appeal’s decision in Bilal, handed down a month before McCulloch.[6] Curiously, Bilal is not referred to in McCulloch.

A setback for patients?

At first glance, McCulloch might appear to be a blow to Montgomery. In reality, it is not a dilution, but clarification of the law on consent.

The application of different tests to “alternatives” and “risks” was seemingly already envisioned by the Court in Montgomery. Paragraph 87 of the judgment draws a distinction between the two aspects of a clinician’s role (as pointed out in Bilal and the first instance Court in McCulloch): “[T]he doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.” The two are discrete elements of one dialogue: the clinical assessment of “reasonable” is a logical pre-requisite to enable the doctor to perform their advisory role as to risks. If reasonableness was shorn of professional judgment, doctors would arguably become dispensable. Whereas decisions about whether or not to accept a risk associated with treatment are often tangentially medical at best, whether a treatment is reasonable in the first place unavoidably relies on clinical knowledge.

Furthermore, the Court in McCulloch emphasised that the decision does not enable doctors to only offer reasonable alternatives they personally prefer. If the Court had concluded that NSAIDs were a reasonable option, and the consultant cardiologist’s decision not to prescribe them could not withstand logical analysis, failing to offer NSAIDs would have been negligent. The duty “is to inform the patient of all reasonable treatment options applying the professional practice test.” As stressed by the Court in McCulloch, this test “in no sense diminishes the force of the doctor’s duty of care to inform.”[7]

The application of McCulloch remains to be seen, but any suggestion that it signals a return to paternalism is doubtful. The decision is arguably a triumph for doctors and patients in equal measure.

^[1] Montgomery v Lanarkshire Health Board [2015] UKSC 11

[2] McCulloch v Forth Valley Health Board [2023] UKSC 26

^[3] Bolam v Friern Hospital Management Committee [1957] 1 W.L.R. 582

[4] Bolitho v City and Hackney Health Authority [1998] A.C. 232

[5] Duce v Worcestershire Acute Hospitals NHS Trust [2018] EWCA Civ 1307

^[6] Sidra Bilal & Hassaan Aziz Malik (Administrators on behalf of the estate of Mukhtar Malik, deceased) v St George’s University Hospitals NHS Foundation Trust [2023] EWCA Civ 605;

[7] McCulloch v Forth Valley Health Board [2023] UKSC 26, paragraph 61