How far should a healthcare practitioner go to ensure a patient is providing fully informed consent? Are they required to list all potential alternative treatments or only those that they think are clinically appropriate? These questions were at the heart of the recent Supreme Court case of McCulloch v Forth Valley Health Board.
The law on informed consent has never been far from the headlines ever since the Supreme Court judgement in the case of Montgomery v Lanarkshire Health Board was handed down back in 2015. Patients have the right to be made aware of the material risks involved in a recommended treatment and to be informed about any reasonable alternatives. However, interpreting the scope of this legal duty, and how it applies in clinical practice, has been a matter of ongoing uncertainty and debate in the legal and medical sectors.
In the case of McCulloch, the Supreme Court (the UK’s highest legal authority) provided helpful clarification regarding the legal scope of a healthcare professional’s duty to obtain a patient’s informed consent to treatment. Although the case related to hospital inpatient care, this key ruling will apply across the health and care sectors in the UK and will affect every healthcare professional when obtaining informed consent from their patients or clients.
In this article, we delve into the case details and explore the consent test's two components: the duty to inform patients about material risks and the duty to disclose reasonable alternative treatments.
The law on consent - Montgomery v Lanarkshire Health Board (2015)
The Supreme Court’s decision in the case of Montgomery continues to have a profound impact on how consent is obtained and recorded. The judgement has resulted in a sharp increase in clinical negligence litigation involving allegations of a failure to obtain informed consent and claims of this nature have been a constant and recurring theme ever since.
One of the principal reasons for this is because the Supreme Court in Montgomery applied a different legal test to the issue of consent to that which is traditionally used to determine other aspects of clinical negligence relating to diagnosis and treatment. This legal test was expressed as follows:
When obtaining informed consent, a healthcare practitioner is “….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 test has two components: the first is to take reasonable care to ensure the patient is made aware of any material risks in the recommended treatment. The second is to inform the patient of any reasonable alternative treatments, in addition to that which the doctor recommends.
In relation to the first component, a practitioner cannot not avoid liability simply by establishing that his or her view on what constituted “material” risks was supported by a responsible body of professional opinion (known as the “professional practice test” or the Bolam test). This was because the question of “reasonableness” in this context largely depended on the individual circumstances and characteristics of the patient and was, therefore, ultimately a question of fact for the Court to determine, and not a matter for expert evidence.
The Court made it clear that there was a fundamental difference between the role of a healthcare practitioner when making a diagnosis and providing treatment, which rests entirely on his or her professional skill and judgment (and is therefore determined by the Bolam test and expert evidence), and a professional’s advisory role which must also take into account the patient’s right to decide on the risks to their health which they are willing to run.
A recurrent cause of consent claims against health and care providers arises from alleged breaches of the second duty – namely, the duty to advise of reasonable alternative treatments (including, importantly, the option of no treatment). On the one hand, practitioners have long argued that the decision on what constitutes a reasonable alternative treatment is a matter of clinical judgement based on the practitioner’s training and experience. They say it is up to the practitioner to decide which alternative treatments are clinically appropriate for the individual patient, and to present only these options to the patient. On the other hand, patients and their lawyers have sought to argue that, based on Montgomery, the law requires practitioners to list all alternative treatments – even if the practitioner does not think a particular treatment is clinically appropriate, or even if their clinic or hospital cannot offer it.
It was this dispute that lay at the heart of the case of McCulloch.
What was the case of McCulloch about?
Mr McCulloch died in April 2012 after suffering a cardiac arrest. He had reported chest pain and received treatment at Forth Valley Hospital and was admitted and discharged on a number of occasions in the days leading up to his death. His treating cardiologist concluded that his presentation did not fit with pericarditis and that it was unnecessary to prescribe non-steroidal inflammatory drugs (“NSAIDs”). Mr McCulloch was again discharged from hospital but sadly died from a cardiac arrest the following day.
His widow brought a claim against the hospital alleging the cardiologist had breached her duty of care by failing to inform Mr McCulloch that NSAIDs were a possible treatment option.
The consensus of the expert evidence was that while some doctors would have prescribed NSAIDs, a responsible body of medical opinion would have supported the decision not to do so.
Mrs McCulloch’s case failed in the Scottish courts, and she appealed to the Supreme Court.
What was the Supreme Court asked to resolve in McCulloch?
The Supreme Court was asked to confirm the appropriate test for assessing whether an alternative treatment option needs to be discussed with a patient.
Mrs McCulloch’s lawyers argued that, as with the duty to advise on material risks, this question should also be unshackled from Bolam, and be determined by reference to the circumstances, objectives and values of the individual patient.
The hospital’s lawyers (supported by interventions on behalf of the GMC and BMA) argued that the question as to whether a particular treatment is a “reasonable alternative” was a matter of professional skill and judgment and, therefore, to be assessed by applying the Bolam test.
The Court’s decision
The Supreme Court confirmed that the correct legal test for establishing what is “reasonable alternative treatment” is the professional practice test, i.e., the Bolam test. A treatment provider will, therefore, not be negligent if he or she fails to inform the patient of a treatment option, provided the practitioner’s opinion that the treatment option is not reasonable is supported by a responsible body of relevant professional opinion.
In essence, this confirms a two-stage test for advising on alternative treatments, as follows:
- First, the practitioner should identify what he or she considers to be reasonable, clinically appropriate alternatives.
- Secondly, the practitioner should present this narrower list of options to the patient.
At Paragraph 57 of its judgement, the Court provided a helpful hypothetical example to illustrate how it intended the law to work in practice.
In this example, there are ten possible treatment options in relation to a specific diagnosis. However, the treating doctor, exercising his or her clinical judgment, and supported by a responsible body of medical opinion, decides that only four of them are reasonable. The doctor is not negligent by failing to inform the patient about the other six possible alternative treatments. The narrowing down from possible alternative treatments to reasonable alternative treatments is an exercise of clinical judgment to which the Bolam test should be applied. The duty of reasonable care would then require the doctor to inform the patient not only of the treatment option that the doctor is recommending but also of the other three reasonable alternative treatment options (plus no treatment if that is a reasonable alternative option) indicating their respective advantages and disadvantages and the material risks involved in such treatment options.
Why this decision matters
It is debatable whether McCulloch was actually a consent case at all, in the true sense. Essentially, the case concerned the reasonableness of the treating doctor’s working diagnosis (namely, her clinical judgment that the patient’s presenting symptoms did not fit with pericarditis) and her ensuing recommended treatment option (namely that NSAIDs were not clinically necessary). To this extent, viewing the case as a further attempt to weave consent into what was always traditional Bolam territory would not be unreasonable.
However, that door has now been firmly closed and there is little doubt that this decision presents very real difficulties for patients bringing informed consent cases based on a failure to advise of alternative treatments. In order for such claims to succeed, patients will now have to prove that the alternative treatment they were not told about would be on any practitioner’s shortlist, and that no reasonable practitioner would fail to include it as a reasonable treatment option. That is a high threshold.
Some commentators have suggested that the decision harks back to the bad old days of “doctor knows best” medical paternalism that Montgomery sought to move away from. The reality is that the law remains more nuanced than this. Healthcare practitioners still need to ensure that their explanations of the risks of the treatment options are tailored to the needs of the individual patient. However, they now only have to offer alternative options that they are satisfied are clinically appropriate based on their training, experience and clinical expertise.
