Materiality

by TheEditor

Categories: Investigative, Law, Rights

The case of Montgomery v Lanarkshire Health Board [2015] UKSC 11 is a landmark decision in the UK law of medical negligence, specifically in relation to the duty of a doctor towards a patient in relation to advice about treatment. It fundamentally altered the legal approach to patient consent and disclosure of risks by healthcare professionals.

Materiality explained

The concept of materiality was brought to the forefront of UK medical law in Montgomery. The Supreme Court held that a risk is considered ‘material‘ if a reasonable person in the patient’s position would likely attach significance to it, or if the doctor is, or should reasonably be, aware that the particular patient would likely attach significance to it. This marked a significant shift from the previous ‘doctor-centred’ approach to a more ‘patient-centred’ approach, emphasising patient autonomy and the right to make informed decisions about one’s own body.

Patient-centred approaches are nothing new. Materiality significantly moved focus deep into the area of patient-centredness. It is no longer ‘we consider the patient but doctor knows best.’

However, the concept of materiality is not without its complexities. It requires a careful balance between ensuring patients are sufficiently informed to make decisions about their treatment and avoiding an information overload that could lead to unnecessary anxiety or confusion. Furthermore, it necessitates a bespoke approach to each patient, considering their individual circumstances, values, and preferences.

In the broader context, materiality continues to be a subject of ongoing debate and evolution, shaping the landscape of medical law and practice. It serves as a reminder of the importance of clear, open, and respectful communication between healthcare professionals and patients, and the central role of patients in decisions about their care.

The case saw importation of the Australian common law principle of patient autonomy and informed consent into UK law, via the case of Rogers v Whitaker (1992) 175 CLR 479. This has had significant implications for medical practice in the UK, placing greater emphasis on patient autonomy and the provision of information about risks.

Key Points in Montgomery:

  1. Lower courts’ decisions: The Lord Ordinary, Lord Bannatyne, rejected both grounds of fault, basing his decision primarily on expert evidence of medical practice, following the approach laid down by the majority in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] AC 871. This decision was upheld by the Inner House (Lord Eassie, Lord Hardie and Lord Emslie). That was the starting point.
  2. Parties involved: The case involved Nadine Montgomery (the appellant) and Lanarkshire Health Board (the respondent). Dr Dina McLellan, a consultant obstetrician and gynaecologist employed by Lanarkshire Health Board, was responsible for Mrs Montgomery’s care during her pregnancy and labour.
  3. Background: Mrs Montgomery, a diabetic, gave birth to a baby boy on 1 October 1999 at Bellshill Maternity Hospital, Lanarkshire. As a result of complications during the delivery, the baby was born with severe disabilities. Mrs Montgomery attributed these injuries to negligence on the part of Dr McLellan.
  4. Claims: Mrs Montgomery advanced two distinct grounds of negligence. The first concerned her ante-natal care. It was contended that she ought to have been given advice about the risk of shoulder dystocia (the inability of the baby’s shoulders to pass through the pelvis) which would be involved in vaginal birth, and of the alternative possibility of delivery by elective caesarean section. The second branch of the case concerned the management of labour. It was contended that Dr McLellan had negligently failed to perform a caesarean section in response to abnormalities indicated by cardiotocograph (“CTG”) traces.

Final Decision of the Supreme Court:

The Supreme Court departed from the decision of the House of Lords in Sidaway and re-considered the duty of a doctor towards a patient in relation to advice about treatment. The court held that a doctor is under a duty to take reasonable care to ensure that a patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. 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 court also held that the doctor is under a duty to answer any specific question posed by the patient as fully as the doctor reasonably can. The doctor’s duty is not fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.

The court concluded that it was incumbent on Dr McLellan to advise Mrs Montgomery of the risk of shoulder dystocia if she were to have her baby by vaginal delivery, and to discuss with her the alternative of delivery by caesarean section. It was held that Dr McLellan’s failure to do so, therefore, amounted to a breach of her duty of care. The court also held that causation was established, since it was clear that, had she been advised of the risk of shoulder dystocia and offered a caesarean section, she would probably have elected to be delivered by caesarean section.

The appeal was allowed and it was declared that Mrs Montgomery was entitled to damages for the injuries to her son caused by the respondent’s negligence, to be assessed.

Damages

Mrs Montgomery was awarded £5.25 million in compensation for damages for the injuries sustained by her son due to the respondent’s negligence. The calculation of damages in personal injury cases, such as this one, is a complex process that takes into account various factors. These factors can include the nature and extent of the injury, the impact of the injury on the individual’s quality of life, any past and future financial losses (including loss of earnings and care costs), and any other expenses incurred as a result of the injury.

In this particular case, the damages would have been calculated based on the severe disabilities that Mrs Montgomery’s son sustained as a result of the complications during his birth. This would likely have included consideration of the costs of his past and future care, any medical expenses, and the impact of his disabilities on his quality of life.

Potential objections addressed

Lords Kerr and Reed acknowledged potential objections to their approach in the Montgomery v Lanarkshire Health Board [2015] UKSC 11 case, but they provided counterarguments to each of these points:

  1. Some patients would rather trust their doctors than be informed of all the ways in which their treatment might go wrong: The Lords acknowledged that some patients might prefer to place their trust in their doctors’ judgement and not be burdened with all the potential risks. However, they argued that this preference does not negate the doctor’s duty to inform the patient. If a patient expresses a clear wish not to be informed of risks, then this wish should be respected. However, unless such a wish is expressed, the presumption should be in favour of full disclosure.
  2. It is impossible to discuss the risks associated with a medical procedure within the time typically available for a healthcare consultation: The Lords recognised the time constraints of medical consultations. However, they argued that the importance of informed consent means that sufficient time must be found to discuss material risks. They suggested that the issue of time could be addressed through better management of resources, and that the constraints of the consultation should not be allowed to undermine the patient’s right to make informed decisions about their treatment.
  3. The requirements imposed are liable to result in defensive practices and an increase in litigation: The Lords acknowledged the concern about defensive medicine and increased litigation. However, they argued that a shift towards patient-centred care and respect for patient autonomy could lead to better medical practice and improved patient satisfaction, which might reduce, rather than increase, the incidence of litigation. They also suggested that the fear of litigation should not prevent doctors from respecting patients’ rights to make informed decisions about their treatment.
  4. The outcome of such litigation may be less predictable: The Lords recognised that their approach might lead to less predictability in the outcomes of litigation. However, they argued that this was not necessarily a bad thing. They suggested that the law should be flexible enough to accommodate the wide range of circumstances in which questions of informed consent arise, and that a degree of unpredictability might be a price worth paying for a legal standard that respects individual autonomy and ensures that patients are properly informed about their treatment options.

In essence, Lords Kerr and Reed placed a strong emphasis on the principles of patient autonomy and informed consent, arguing that these principles should be upheld even if doing so might present certain challenges. They suggested that these challenges could be addressed through better resource management and a shift towards more patient-centred care.

Recap of capacity

The Mental Capacity Act 2005 sets out a two-stage test of capacity:

  1. Diagnostic Test: Is there an impairment of, or disturbance in the functioning of, the person’s mind or brain? [S2(1) of MCA 2005.] This could be due to various conditions such as dementia, significant learning disabilities, mental health problems, concussion from a head injury, the effects of anaesthetics or certain medications, or symptoms of alcohol or drug use.
  2. Functional Test: If so, is the impairment or disturbance sufficient that the person lacks the capacity to make a particular decision? The Act states that a person is unable to make a decision if they cannot do one or more of the following [S3 MCA 2005]:
    1. Understand the information relevant to the decision,
    2. Retain that information,
    3. Use or weigh that information as part of the process of making the decision, or
    4. Communicate their decision (whether by talking, using sign language or any other means).

Contained within ‘understanding’ and ‘retention’ will be the relevant information on material risks.

What does all this mean?

Significance: Many doctors and other capacity/consent assessors will likely become hung up on the issue of ‘significance’. What does that mean? The news is that the law – nor the Supreme Court – will tell us! Why? Because the law is there to set out general principles of application. It does not know ‘your patient’. ‘You’ know your patient and it is up to you to respect what might be significant to the patient. It is about the individual patient – but the Law Lords have the power to put ‘you’ into the ‘envelope’ of duty.

Disclosure: The disclosure of material risks will be expected to add complexity to a patient’s decision-making process. The patient is tasked with weighing the material risks against the potential benefits of the proposed treatment, taking into account their personal circumstances, values, and preferences. This process can be challenging, particularly when the risks are serious, even if they are rare. ‘You’ as the psychiatrist, are charged with various duties and responsibilities. Ignorance of legal requirements is not an excuse.

Complexity: The addition of material risks to the information provided to patients stands to increase the complexity of the decision-making process. This could potentially make it more difficult for some patients to understand, retain, use or weigh the information, which are the criteria used to assess capacity under the Mental Capacity Act 2005 in England and Wales.

Professional roles: The healthcare professional’s role is extended beyond simply providing information. They are responsible for supporting the patient in understanding  information, now to include material risks, in assisting the patient coming to their decision. This can involve explaining the information in clear, understandable terms, answering any questions the patient may have, and providing reassurance and emotional support. The patient may need more time to consider the information. Now after Montgomery – with greater weight being given to autonomy – it means that professionals have to work harder to facilitate a patient’s understanding of complex information.

Time impact: Prior to Montgomery, the assessment of capacity and obtaining consent were already very demanding based on the requirements of the Mental Capacity Act 2005.  After Montgomery, capacity assessments and obtaining consent will foreseeably become  even more demanding.

Potential regulatory consequences: Doctors who cut corners or who are oblivious to the law will be placing their medical registration and/or licence at risk.  It will be no defence to submit that one did not have the time to carry out a proper capacity assessment including the Montgomery requirements. Why? Because the Law Lords dealt with and dismissed that argument. Further the General Medical Council requires all registered doctors to act within the law. Ignorance of the guidance and the law will not be an excuse; nor will be the excuse about your excessive workload. We may not like it – foam at the mouth or throw up our hands. It is what it is.

Potential legal consequences: Keep in mind that damages were compensated to £5.25 million in Montgomery.  Whilst not every case will be equal to Montgomery, compensation in other cases could amount to substantial amounts, depending on the nature and impact of any damages. Do you feel lucky? The choice is yours.

Best interests: In making best interests decisions for patients – only possible on failure of the capacity tests – health professionals will be charged with considering materiality. This will make decision-making more demanding of time and attention.


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