The Supreme Court’s landmark decision in the case of Montgomery v Lanarkshire Health Board (2015) reshaped the legal landscape of informed consent in the UK. This ruling aligned the law with the General Medical Council’s (GMC’s) guidance on Good Medical Practice, establishing that doctors must disclose all material risks relevant to the patient and discuss any reasonable alternative treatments.
Now, a decade on from this pivotal judgement, we reflect on how it changed the standard of care in law, consider its lasting implications for everyday clinical practice, and revisit the GMC’s key principles for obtaining valid informed consent.
What was the Montgomery ruling?
In March 2015, Nadine Montgomery appealed to the UK Supreme Court in her case vs Lanarkshire Health Board. She had sued for negligence, arguing that she had not been informed of a significant risk of complications in the birth of her son, which may have led her to opt for a caesarean section.
Montgomery had type 1 diabetes and was of small stature, meaning that her baby was likely to be large and at risk of experiencing complications due to shoulder dystocia if delivered vaginally. However, Montgomery’s obstetrician had chosen not to discuss this with her, despite Montgomery expressing concern. The obstetrician’s view was that a mother advised of the risk of shoulder dystocia would ask for a caesarean section, which would not be in the maternal interest, whereas the risk to the baby was very small. Unfortunately, Montgomery’s son experienced complications resulting from shoulder dystocia, leading to cerebral palsy.
After a 16-year legal fight, the Supreme Court ruled in favour of Montgomery and she was awarded over £5 million in damages. The judgement overturned a previous decision by the lower courts that rested on the ‘Bolam test’ (the ‘prudent doctor’ standard), i.e. whether the doctor’s practice was in line with a responsible body of medical opinion.
Instead, the Supreme Court’s decision established that doctors have a duty to ensure, within reason, that their patients are aware of any material risks of the recommended treatment, and of any reasonable alternative treatments.
How is a ‘material risk’ defined?
The Supreme Court concluded that an adult with capacity should be entitled to decide on their treatment, and give informed consent, having been advised of the material risks involved. A risk was deemed to be ‘material’ if ‘a reasonable person in the patient’s position would be likely to attach significance to it, or if the doctor is or should reasonably be aware that their patient would be likely to attach significance to it’. This established the ‘reasonable patient’ standard.
The Supreme Court also held that a doctor, in their advisory role, should ensure that the patient understands the seriousness of their condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, to inform their decision.
In commenting on the case, the GMC emphasised that conversations with patients about risk are not about bombarding them with information on every conceivable risk, and the information should not be reduced to statistics. Instead, a doctor needs to engage in dialogue with the patient, to do their best to understand their views and preferences, the activities that are important to their quality of life, and the adverse effects that they are most concerned about, so that they can tailor the conversation to support the patient in their decision making.
The GMC’s guidance on shared decision making and consent
The GMC intervened in the Montgomery case to explain their guidance on shared decision-making and consent in Good Medical Practice. The Supreme Court’s decision endorsed the GMC’s approach and the principle that a patient has a right to be involved in a shared decision-making process with their doctor.
In effect, the judgement brought the law up to date with good medical practice, and it remains relevant to GPs practicing today. All should be familiar with the GMC’s 2020 guidance on Decision making and consent, including The seven principles of decision-making and consent.
Principle four states that, ‘Medical professionals must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action.’
Conversations should be tailored to individual patients, sharing information in a way that they can understand, and supporting them to assess the likely impact of each treatment option according to what matters to them. A GP should ask the patient questions to find out what might influence their choice, including exploring how the risk of side effects or complications may affect their decision.
The guidance says that doctors must give patients the information they want or need to make a decision. This must be clear, accurate, up to date information, based on the best available evidence.
When discussing benefits and harms, doctors should tell the patient about:
- Recognised risks of harm that anyone in the patient’s position would want to know.
- The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring.
- Risks of harm and potential benefits that the patient would consider significant for any reason.
- Any risk of serious harm, however unlikely it is to occur.
- Expected harms, including common side effects and what to do if they occur.
Medical records should include how consent was given and any relevant details of the discussion.
When are GPs not obliged to disclose risk information?
In exceptional circumstances, GPs may be entitled to withhold information about risk from a patient. For example, in cases where a doctor reasonably considers that disclosure of the information may cause serious harm to the patient’s health, the GMC says that this may be appropriate. Importantly, doctors should not take this action merely because they think the patient might become upset, refuse treatment, or choose an alternative.
The Supreme Court established that this ‘therapeutic exception’ is limited and should not be abused. The GMC adds that doctors should seek legal advice if considering withholding information from a patient and always keep an accurate record of the discussion with the patient.
Doctors should presume a patient has capacity to make decisions about their care, unless it can be established otherwise (by assessment of capacity, in line with legal requirements, for a specific decision at a specific time). However, if a patient is unconscious or lacks capacity to decide when they need urgent treatment, the GMC states that doctors ‘can provide treatment that is immediately necessary to save their life or to prevent a serious deterioration of their condition’. The given treatment ‘should be the least restrictive of the patient’s rights and freedoms, including their future choices’.
Applying Montgomery standards in daily general practice
Informed consent is a core principle of the legal and ethical standards for all healthcare professionals and, in the wake of Montgomery, the law in all four countries of the UK is consistent with the GMC’s guidance on Decision making and consent.
GPs should be mindful that in the event of a consent-based claim against them, the courts may apply the ‘Montgomery test’ and assess any evidence of dialogue with the patient while obtaining consent. Cases have succeeded based on the Montgomery ruling, highlighting the lasting implications of this case for clinicians today.
Therefore, investing time in the consent process is worthwhile to improve patients’ experiences and outcomes and to avoid their dissatisfaction and consequent complaints and claims.
Yet, the reality of general practice means that having a full discussion with a patient about their options or determining which risks are ‘material’ may sometimes be challenging because of time and resource constraints.
According to the GMC, if these constraints create a delay in disclosing pertinent information, the patient should be told the reasons and arrangements should be made for the information to be shared as soon as possible, with medical notes updated to record what needs to happen. GPs can also consider other sources of support, including other healthcare professionals, patient support groups, or patient information leaflets.
When factors outside a GP’s control seriously compromise a patient’s ability to make an informed decision, the GMC says to consider raising a concern and think about whether it is appropriate to proceed. In these difficult situations, it is important to seek legal advice.
At Medical Defense Society, we will provide the advice you need about informed consent. Whether you simply need clarity on the guidelines or you are facing a claim, our team is here to support you.
