An update from a regular series written by Mr Robert Wheeler, director, department of clinical law, where he considers various aspects of clinical law that our nursing and medical staff rely on when caring for patients.

In Montgomery v Lanarkshire [2015] UKSC 11, The Supreme Court has provided clinicians with new guidance relating to what we should disclose to patients when seeking their consent for intervention. The changes are significant, and indicate a substantial change to our practice which will likely result in changes to:

what we disclose
how we disclose i
tthe way we record the process of obtaining consent.

Mrs Montgomery was an insulin dependent diabetic lady in the third trimester of her first pregnancy. Educated and articulate, she was concerned about the risks of delivering a large baby vaginally; her obstetrician estimated a birth weight of 3.9 kg at the 36 week scan. At this appointment, the obstetrician noted that Mrs Montgomery was "worried about [the] size of the baby", and her anxiety that it might be too big for vaginal delivery; it was accepted during the hearing that these concerns had been expressed on previous occasions.

But the obstetrician stated that Mrs Montgomery had not asked her "specifically about exact risks". If she had, the obstetrician would have told her of the risks of shoulder dystocia in these circumstances, but since the question was not asked, this risk was not disclosed. This was because the obstetrician viewed the risks of serious injury to this baby as very slight. The obstetrician felt that it was "fair to allow somebody to deliver vaginally", and that if difficulties were encountered, then recourse would be had to a caesarean section. Mrs Montgomery accepted this advice. But if she had requested an elective caesarean section, she would have been given one. The obstetrician gave evidence that diabetic patients who had been advise of the risk of shoulder dystocia would invariably choose caesarean section, and that Mrs Montgomery in particular would have made such an election;

"Since I felt the risk of her baby having significant enough dystocia to cause even a nerve palsy or severe hypoxic damage to the baby was low I didn’t raise it with her, and had I raised it with her then yes, she would have no doubt requested a caesarean section, as would any diabetic today”

During the hearings, Mrs Montgomery confirmed that if these risks had been disclosed, she would have considered dystocia a significant risk, and she would have asked for a caesarean section. During her vaginal delivery, the labour became arrested, and the baby’s shoulder became impacted at a point where half of his head was outside the perineum. He survived delivery, but has dyskinetic cerebral palsy and Erb’s palsy.

The Supreme Court found that Mrs Montgomery had not been informed of her option for a caesarean section; and that it given that option she would have taken it, and delivered a baby without cerebral or Erb’s palsy. In doing so, the court set out the standard for disclosure that we should use when seeking consent from a patient:

"The doctor ... 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 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.”

It should be noted that the "reasonable" man in this context is a fictional creature who embodies those considerations which ordinarily regulate the prudent conduct of human affairs. Such a reasonable man provides an objective standard against which the behaviour of (in this case a patient) is compared.

The judgement confirms that not only must we disclose risks that any reasonable patient would wish to consider; but that we should also disclose risks that this particular patient in question, who was acting reasonably, would need to know. The fact that the obstetrician accepted that Mrs Montgomery would have " … no doubt requested a caesarean section … " indicates that she knew that Mrs Montgomery would have sought a section, even faced with a low risk of harm to the baby. It was for this reason that the court held the disclosure was inadequate, and prompts us to tailor our disclosure of risks to the patient in front of us.

Several further points were made in the judgement. First, it was held that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude, for example: the nature of the risk; the effect which its occurrence would have upon the life of the patient; the importance to the patient of the benefits sought to be achieved by the treatment; the alternatives available and the risks involved in those alternatives.

Secondly, the doctor’s advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor’s duty is not therefore 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”.

For this reason, it seems that we will have to depart from the current convention of basing our consent process around a simple form. Rather, we can anticipate that a record of the advice offered, the questions asked and the decisions made will become necessary. It is clear that this will involve much more time than is currently available when seeing outpatients and patients preoperatively. Improving comprehensibility alone will be a significant challenge. It is inevitable that this will mean we will see fewer patients per hour, to allow this dialogue to conclude before the decision to accept or reject the proffered treatment is made.

Robert Wheeler
Department of clinical law

Disclosure for consent