By Jennifer O’Neill.
This week, the United Kingdom Supreme Court (UKSC) revisited its ruling in the landmark case of Montgomery v Lanarkshire [2015]. In McCulloch v Forth Valley Health Board [2023], the Supreme Court Justices established that doctors do not need to inform patients of all possible treatment alternatives as a requirement of informed consent. In applying Bolam’s test of professional judgement to disclosure of treatment alternatives, the Supreme Court Justices stressed that “…it is not being suggested that the doctor can simply inform the patient about the treatment option or options that the doctor himself or herself prefers…”
However, the ruling does mean that doctors do not need to apply Montgomery’s test of materiality to disclosable treatment options. Accordingly, there is no duty upon doctors to consider what information – about treatments options – a reasonable person, or the particular patient, are likely to consider significant. The ruling, therefore, undermines recent moves to promote patient-centric healthcare and is likely to pose a barrier to meaningful patient decision-making. In a poster presented to the UK Clinical Ethics Network earlier this month, my colleague and I argued that, in the case of the Multi-Disciplinary Team, doctors already plan “…the treatment they feel is best…” for the patient, without considering the patient’s non-clinical values or circumstances. The McCulloch ruling is likely to further disempower patients by undermining their ability to make informed medical decisions that are rooted in the context of available options and give consideration to their own, unique circumstances.
The legal test for medical negligence, established in the case of Bolam v Friern Hospital Management Committee [1956], considers whether a doctor has acted in accordance with a practice accepted as proper by a body of medical opinion – otherwise known as a test of professional judgement. Bolam has been criticised for its failure to meaningfully involve patients in their care and for facilitating medical paternalism. Despite legal challenges – which examined whether the test was a suitable means of determining what information should be disclosed to patients – the test prevailed for decades. In Sidaway v Board of Governors of the Bethlem Royal Hospital [1985], Lord Scarman famously argued in favour of a new ‘prudent patient’ test. The test recognised that patients have a broad range of non-clinical considerations the doctor may be unaware of, such as “circumstances, objectives and values” that can influence decision-making. He was, however, in the minority and it was held that the Bolam Test remained. In Pearce v United Bristol Healthcare [1998], the Court of Appeal also considered whether the ‘reasonable patient’ had a right to be informed of ‘significant’ risk.
However, it was in the 2015 case of Montgomery that the Supreme Court Justices marked a meaningful move towards greater patient-centricity in healthcare. Patients were no longer to be treated as placing themselves into the hands of doctors, but rather as autonomous adults capable of understanding, and giving consideration to, medical information. The doctor’s role in disclosing information was described as an advisory one. Accordingly, doctors were duty-bound 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 treatment.” In a departure from Bolam’s professional judgement test a new, two-stage standard was applied in determining material risk. Doctors were required to consider:
- An objective test of what a reasonable person in the patient’s situation would consider significant and,
- A subjective test of what the particular patient would consider significant given their unique values and characteristics.
The Supreme Court Justices clarified that the ruling would not replace Bolam but would apply to the doctor’s capacity as an advisor. However, this created ambiguity as to surround the scope of the test and whether it applied to determining reasonable, and therefore disclosable, treatment alternatives.
This week’s ruling ended such ambiguity. McCulloch v Forth Valley Health Board [2023], examined whether Bolam’s professional judgement test or Montgomery’s materiality test should be applied to treatment alternatives. The case, brought by the widow of 39-year-old Mr McCulloch, concerned negligent non-disclosure of treatment alternatives resulting in his death. Mr McCulloch’s widow argued that her husband’s cardiologist had failed to advise him of the option of taking a non-steroidal anti-inflammatory (NSAID) for pericarditis which, she argued, he would have taken and, that such treatment would have avoided his death. Pericarditis – an inflammation of the sac that surrounds the heart – can be associated with a build up of fluid around the heart. Expert evidence suggested an association between NSAIDs use and rapid improvement in confirmed cases of pericarditis, including a reduction in the fluid surrounding the heart. However, Mr McCulloch’s cardiologist argued that NSAIDs were not prescribed in Mr McCulloch’s case as there was no clear diagnosis of pericarditis made, despite there being an increase in fluid surrounding his heart. Accordingly, NSAIDs were not prescribed on the grounds of professional judgement – an action supported by a responsible body of medical opinion.
In addressing the correct legal test for assessing whether a treatment is reasonable, and disclosable, the UKSC established that Bolam’s test of professional judgement should be applied. Arguably, however, the ruling fails to account for differences in clinical opinion or skill which may influence whether a treatment option is preferred by the doctor, and therefore disclosed to the patient. This could effectively deprive the patient of the opportunity to give consideration to other, valid treatment options. The decision also fails to require doctors to consider the non-clinical factors which may influence whether a patient finds a treatment option to be in their own best interests. A particular patient may, for example, prefer a more conservative, rather than radical, alternative.
Other common law jurisdictions, such as Canada, have adopted patient-centric approaches to considering disclosure of alternative treatments. In the Canadian case Dickson v Pinder, 2010 Mr Justice Yamauchi gave careful consideration of whether “alternative treatments to the proposed therapy” should be disclosed and explicitly concluded that “Canadian jurisprudence has established that there is no question on that point. A patient cannot meaningfully choose a therapy unless the medical practitioner places that therapy in context, with alternatives and the consequence of inaction.” In clearly explaining the need to contextualise risk, Yamauchi J., referred to Zimmer v Ringrose [1981] which held that practitioners should “….discuss the benefits to be gained … the advantages and disadvantages associated with alternative procedures and the consequences of foregoing treatment. Such a discussion is essential since a patient cannot measure risks in the abstract. To discharge his duty of care, the doctor must give the patient some yardstick against which he can assess the options.” Whether treatment alternatives are considered ‘reasonable’, he explained, “will depend on the facts and the patient’s circumstances.”. Accordingly, a dual objective and subjective test of treatment alternatives – mirroring Montgomery’s materiality – is applied.
It is, therefore, regrettable that UKSC have missed a golden opportunity to fully embrace patient-centricity and inclusion in healthcare decision-making. As the Canadian courts have recognised, meaningful treatment decision-making cannot exist in a vacuum. It must be set within the context of the alternatives that exist, with due consideration given to that which is likely to be considered significant by a reasonable person and the particular patient, given their unique circumstances.
Author: Jennifer O’Neill
Affiliations:
Lecturer, University of Glasgow School of Medicine, Dentistry and Nursing.
Acknowledgements:
I would like to thank my colleague, Dr Kirsty McIntyre, for our continued discussions and collaborations on the important issue of patient and public involvement in healthcare.
Competing interests: None declared