The duty to explain risks to patients: a new exposition on consent from the Supreme Court

The recent unanimous decision of the Supreme Court in Montgomery v Lanarkshire Health Board [2015] UKSC 11 makes it clear that the older case law based on medical paternalism and the assumption that patients are uninformed and incapable of understanding medical matters is now untenable. Access to information, the context in which medical practitioners operate and the way in which recipients of healthcare services view their relationship with practitioners has changed and this decision presents a change in the law on consent which is welcomed by Kingsley Napley’s Healthcare Standards initiative.

The old regime

Before the Supreme Court’s decision, English law did not recognise the doctrine of informed consent, namely, that a patient can only consent to treatment if they are aware of all of the relevant and necessary information to make an informed decision.

The legal position on advising patients of risk was initially determined by reference to the Bolam test, whereby practitioners would not be negligent in not informing the patient of risks if they were acting in accordance with a responsible body of medical opinion and that opinion was reasonable. In summary, medical practitioners owed a legal duty to warn patients in general terms of the risks involved in the procedure. That test was later modified to recognise that patients should be informed of small but well established risks of serious injury as a result of treatment. This principle operated with exceptions, including that in exceptional circumstances a practitioner may be excused from providing the information if the practitioner considers it in the patients best interests.

The old regime was criticised by some as failing to provide effective protection of a patient’s rights and their entitlement to understand information about risks and being placed in a position where they can use it.

What’s new?

The Supreme Court held that:

“An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under 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."

What is a material risk?

“The test of materiality 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.”

The question of is not confined to percentages or statistics. Risk should be determined by a number of different factors ranging from the characteristics of the patient, the alternative treatments and the risks of those options, the nature of the risks of the proposed treatment, the effect on the life of the patient, the benefits of the treatment and their importance to the patient.

What are the exceptions?

• In circumstances of necessity where, for example, the treatment is urgent and the patient is unconscious or otherwise unable to make a decision.
• The therapeutic exception: if a medical professional reasonably considers that disclosure of the risks would be seriously detrimental to the patient’s health. This should only be exercised with extreme care and should not be used to subvert the general principle that the patient should make the decision whether to undergo a proposed course of treatment. 
  
  This exception does not permit medical practitioners to prevent a patient making an informed choice, even if the practitioner considers that the patient may make a decision that is not in their best interests.

Impact for patients

Most patients build a strong and trusting relationship with their doctor and believe that their doctor will recommend appropriate treatment and give all of the necessary  information in clear language. The modification to the law will protect and nurture this relationship where it already exists and nurture it where it is not yet universally in place. 

Undergoing a medical procedure is a daunting prospect for most people. The decision of the Supreme Court recognises that it is far more sensible for patients to obtain proper information about the particular risks of that the procedure poses for from their doctor, rather than from “Doctor Google.”

Clinical negligence claims about consent are unusual. The consequences of not obtaining proper consent can have a devastating impact on patient’s lives, particularly in that their trust in the medical profession is destroyed. The Supreme Court’s decision clarifies that obtaining consent includes personalising details of the risks that an individual patient needs to consider and this must be welcomed.

Impact for regulators

Whilst the law did not recognise ‘informed consent’ previously, it is interesting to note that guidelines and professional standards published by regulatory bodies such as the General Medical Council and the Department of Health have for a long time placed more emphasis on providing information to the patient.  Further, the regulatory bodies have often brought fitness to practise proceedings based on those standards requiring practitioners to obtain informed consent. The decision of the Supreme Court could be said to bring the law into line with the professional standards expected by regulators and their professions.

However, the decision of the Supreme Court could be said to have gone further than the standards published by regulatory bodies. Most but not all of the healthcare regulators specifically mention explaining risks and benefits to patients in order to obtain valid consent. As a result of this decision, all healthcare regulators should review their standards to ensure that their guidance reflects this Supreme Court decision. In particular, all bodies should review their standards in detail and consider whether to reference ‘material risk’ and guidance as to what factors ought to be considered when undertaking this task for each patient. We hope the above summary is a useful starting point.

Impact for professionals

This decision reinforces what some medical practitioners are already doing to explain risks to their patients. However, this decision will have a significant impact on the way some medical practitioners approach obtaining consent. Practitioners will need to exercise caution to ensure that patients are involved in decisions on risk and they are not just deferring to their own professional judgement.

The decision highlights that practitioners perform two distinct roles when undertaking to obtain consent from a patient. The first relies on their professional skill, expertise and judgement in determining what investigatory and/or treatment options are available and recommended. The second is discussing the recommended treatment and alternatives, and the risks of injury which may be involved with the patient.

In summary medical practitioners should:

Provide enough information that respects the patient’s rights of autonomy

• Treat patients, so far as is possible, as adults who are capable of understanding that the success of medical treatment is uncertain and that it may involve risks
• Take reasonable care to ensure that a patient is aware of material risks of injury inherent in treatment
• Avoid exposing a person to a risk of injury which they would have otherwise avoided
• Respect if a patient decides they do not want to be informed of the risks of injury - that is their right.
• Ensure that discussions regarding consent are documented appropriately in the patient record

Greater training and education is usually provided when statutory changes are made to the law or when their regulatory body makes changes to standards. Professionals are often consulted on changes or they are advertised widely in professional journals.  Practitioners may therefore feel on the back foot when judicial changes to the law are made.

Impact for employers

Employers of medical professionals should ensure that practitioners employed by them are trained on the change to the law in obtaining consent and consideration ought to be given to amending information leaflets used in the consent process.

Kingsley Napley provides training to individuals, Trusts and other organisations on regulatory responsibilities and also assistance to patients who are concerned about treatment they have had. Please contact Sian Jones or Kirsty Allen to discuss your needs.