Medical law update: disclosure of risks to patients
Melanie Fellowes comments on Montgomery v Lanarkshire Health Board (General Medical Council intervener) [2015] UKSC 11, on the duty to warn patients of the risks inherent in a proposed procedure.
About the author
Melanie Fellowes is a senior law lecturer at the University of Huddersffield .
Nadine Montgomery claimed that she had not been warned of the risks involved in a natural delivery which, as a diabetic, increased the risk of injury to the unborn child. The risk was 9 to 10% of shoulder dystocia (where the baby’s shoulders are unable to pass through the pelvis) if a vaginal birth was the means of delivery. The risk materialised, and her son was born with severe disabilities. Nadine Montgomery claimed that the failure to warn, preoperatively , of the risks was negligent, and argued that if she had been informed of the risks she would have chosen delivery by caesarean section in order to avoid those risks.
The lower courts relied on the House of Lords’ decision in Sidaway v Board of Governors of Bethlem Royal Hospital and Maudsley Hospital [1985] AC 87, which held that the test in Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 would apply to the disclosure of risks as well as treatment of the patient ([ 2013] CSIH 3 and [2010] CSOH 104). The test for breach of duty was, therefore, whether a responsible body of medical opinion would have supported the doctor’s conduct. Nadine Montgomery’s claim was rejected, as evidence was provided that a responsible body of medical opinion would have acted as the doctor had done and would not have warned of the risk. It was also held that even if Nadine Montgomery had been informed of the risks to the baby, she would not have chosen a caesarean delivery, and so it would not have made any difference to the outcome.
However, the Supreme Court reversed the decision. The court held that as the 9 to 10% risk was substantial, the patient should have been informed of the risk. The law was thus held to be that a doctor is under a duty to take reasonable care to make sure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative treatments. The test of materiality was elaborated on further: the question to ask is whether, 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 [T]he judgment reinforces guidance … that doctors should participate in a meaningful dialogue with each patient
Since Montgomery was decided, there has been substantial discussion about what the case signifies for the law on consent to treatment and the duty to disclose risks inherent in a procedure. There is uncertainty concerning whether the ruling has really clarified the position for both the medical profession and potential claimants.
The case seems to be the death knell for the application of Bolam (above) to the duty to disclose risks, which was made clear in the judgments of Lords Kerr and Reed. ‘The test in Bolam [above], by which the extent of the duty to advise (and the question therefore of whether that duty has been breached) falls to be decided by reference to accepted medical practice in the form of an identified body of responsible medical opinion which would give or withhold advice in a particular case, has no place in advice and warning cases’ (para 1434 of Bolam). Rather, the justices preferred to rely on guidance from the General Medical Council, which requires ‘full, truthful and voluntary disclosure of risks and benefits of treatment, and of any available alternatives’ (para 1434 of Bolam).
Therefore, although Montgomery may indicate that what is being asked of the medical profession is more onerous, it is nevertheless in line with professional good practice. The doctor should ask whether the patient knows about the material risks involved in the proposed treatment or about any reasonable alternatives, and the doctor should ask themself whether reasonable care has been taken to ensure that the patient knows of the risks and alternatives. The focus is thus on what amounts to a material risk, and this is determined by whether a reasonable person in the patient’s position would be likely to attach significance to the risk or whether the doctor is aware, or should reasonably be aware, that the particular patient would be likely to attach significance to such risk. This will clearly require a meaningful dialogue between doctor and patient.
This casts doubt on the status of Sidaway and the different approaches of the justices in Montgomery, which have necessarily received extensive analysis and comment. However, there are still reservations about whether Montgomery has provided a definitive new position or whether it merely confirms how the case-law has progressed incrementally since Sidaway. There is certainly a move towards the ‘reasonable patient’ being at the heart of the standard to apply rather than the standard being that of the reasonable doctor.
Yet, this approach has been in evidence for some time. In Bolitho v City & Hackney Health Authority [1997] 4 All ER 771, another landmark case, it was held that a doctor’s actions had to be capable of withstanding logical analysis; however, this was not thought to apply to non-disclosure of risks, just to diagnosis and treatment.
[T]he judgment reinforces guidance … that doctors should participate in a meaningful dialogue with each patient
In Pearce and Pearce v United Bristol Healthcare NHS Trust [1999] ECC 167, Lord Woolf MR referred to significant risks which could affect the judgment of a reasonable patient, although the increased risk of stillbirth in that case was held to be 0.1 to 0.2% and was not regarded as significant. That said, Lord Woolf referred to what the doctors regarded as significant - not to what a reasonable pregnant woman in the patient’s situation would regard as significant - so it has been questioned whether there was, in fact, an adoption of the reasonable patient standard.
In Wyatt v Curtis and Central Nottinghamshire Health Authority [2003] EWCA Civ 1779, Sedley LJ, who gave the lead judgment, suggested that the approach in Pearce refined the judgment in Sidaway. He stated that whether a risk was substantial should be assessed from the patient’s point of view.
In Chester v Afshar [2004] UKHL 41, it was held that a patient had the right to be told of a small, but well-established , risk of serious injury.
In Birch v University College London Hospital NHS Foundation Trust [2008] EWHC 2237 (QB), there was even reference to whether a failure to discuss certain risks could be described as reasonable, responsible or logical, which implies the application of Bolitho above.
In Montgomery, Lords Kerr and Reed stated that whether a risk was material cannot be reduced to percentages as the significance of a risk was determined by other variables as well as the magnitude of the risk. The question is, however, whether reference to percentages is inevitable given that they are such an important part of risk assessment in medical treatment.
What is welcomed is that this part of the judgment recognises that other factors, such as the importance of the benefits to be achieved and the effect the materialisation of the risk would have on the life of the patient, would also feature in the assessment of materiality. What is apparent is that the judgment reinforces guidance from the medical profession that doctors should participate in a meaningful dialogue with each patient, and that their duty goes beyond mere provision of information.