Change in the law on consent to treatment

On 11 March 2015 the Supreme Court handed down a unanimous judgment in potentially the most significant clinical negligence case of the last 30 years in Montgomery v Lanarkshire Health Board [2015] UKSC 11 on an appeal from the Scottish Courts. This is a binding decision on the law of consent for the lower courts in England and Wales as well as Scotland and has important urgent, ramifications for all clinicians and health bodies.

In the context of a diabetic patient of small stature expecting a large baby in January 1999, who had expressed concern about her ability to deliver vaginally, it was held that the duty to warn about risks would no longer be governed by a doctor-sensitive test, applying principles from well-established jurisprudence in the line of cases from Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 / Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC 871 (i.e. what a responsible body of medical opinion would conclude are the risks that should be disclosed to a patient) because those authorities are now outdated/unsatisfactory and do not reflect the modern doctor-patient relationship and the shift toward patient self-determination/ autonomy.  It did not matter that a responsible body of obstetricians would also not have warned of the risk of shoulder dystocia (the risk was put at about 9 – 10%), that this practice was reasonable and logical on the evidence or that with proper management shoulder dystocia is a complication that does not usually give rise to an injury per se. 

The new test is patient-sensitive and based upon materiality of risk - in other words, a doctor is under a legal duty to take reasonable care to ensure that the patient is aware of any material risk involved in the recommended treatment and of any reasonable alternative or variant in the treatment.  There are only two limited exceptions and these must not be abused.  First, a doctor is entitled to withhold information if he or she reasonably considers that its disclosure would be seriously detrimental to the patient's health (the so-called therapeutic exception); and second, a doctor is also excused from conferring with the patient in circumstances of necessity such as where emergency treatment is required for a patient who is unconscious or otherwise unable to make a decision.

So what are material risks and how does a doctor ensure that he or she has adequately warned a patient about them? The Montgomery test asks whether, in the circumstances of the particular case, either:

• 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.

To comply with the law, a doctor will have to engage in a dialogue with the patient about the nature of the risk, the effect which the occurrence of the risk would have upon the particular patient, the importance to the patient of the benefits of the proposed treatment, any alternatives or variants available, and the risks versus benefits involved in those alternatives/variants. Many doctors do this anyway. As ever, clear notes must be kept contemporaneously and the evidential value of pro-forma consent forms, information leaflets or similar will be limited unless accompanied by a discussion. A different outcome could easily be achieved by applying the same test to two different patients undergoing the same treatment and the analysis cannot be reduced to any 'rule of thumb' based on the percentage of risk. The key legal principles are set out at paragraphs 87 to 91 of the judgment.

Living in a material world

Whilst the judgment was greeted with satisfaction by the GMC (who intervened in the case) and by patient groups, there will be concern that this patient-sensitive test is unpredictable, will be difficult to comply with by busy doctors and nurses and will open the flood-gates to an increase in claims.  The fact that it is retrospective could also lead to some perverse outcomes; Bolam/Sidaway have informed the way that clinicians were trained to obtain consent for 30 years and the Montgomery decision is only saying that things have moved on, not that they were wrongly decided at the time.  However, it was recognised by the Supreme Court that lower courts had not been applying Bolam/Sidaway strictly in consent cases for many years anyway and it could be argued that this decision is no more than a re-statement of the law as it has evolved.  The same alarms were raised about flood-gates following the House of Lords' decision in Chester v Afshar [2004] UKHL 41, only for the decision to be marginalised and largely ignored since then. 

Montgomery aligns the law with guidance on consent by the GMC and the position in other jurisdictions such as Canada or some American States.  Judges may find it difficult many years later to condemn a doctor as negligent for not warning about a small risk when such a warning would have been against contemporaneous guidance from the various Royal Colleges or NICE, for instance.  The decision does also raise the inevitable spectre of a further shift towards defensive medicine.  Whilst the Supreme Court warned that the doctor's duty is not fulfilled by bombarding patients with voluminous technical information which they cannot reasonably be expected to grasp, some clinicians will probably opt to warn of any or every risk routinely (as they do in some other jurisdictions) rather than taking the time (and the risk!) of exploring every fact-sensitive financial, religious, familial, social or other imponderable of the particular patient in order to arrive at a considered decision about what risks to warn of or not.

Further decisions will doubtless add clarity to the decision in Montgomery and illustrate how it will be applied by the lower courts. Inevitably there will be an increase in consent claims or in amendments to existing claims to plead failure to obtain fully informed consent. The Clinical Risk team at Bevan Brittan LLP are keen to discuss the ramifications of this important judgment with you, including the training needs of your clinicians.