Consent: The New Landscape
January 20, 2017
Most practitioners will be familiar with the decision of the Supreme Court in Montgomery v. Lanarkshire Health Board which concerned a pregnant diabetic patient of short stature who was not warned, by her obstetrician, Dr McLellan of the risk of shoulder dystocia (7 – 10%). The evidence suggested that approximately 70% of cases of shoulder dystocia are reduced using the McRobert’s manoeuvre. The risk of unresolved shoulder dystocia was therefore between 2 – 3%. Mrs Montgomery had raised concerns about vaginal delivery but Dr McLellan’s policy was not routinely to advise diabetic women about shoulder dystocia as, in her view, the risk of a grave problem for the baby was very small, but if advised of the risks of shoulder dystocia women would opt for a caesarean section, which, in Dr McLellan’s view, was not in the maternal interest.
Lord Kerr described the risks to the baby of shoulder dystocia as follows:-
“Shoulder dystocia also presents risks to the baby. The physical manoeuvres and manipulations required to free the baby can cause it to suffer a broken shoulder or an avulsion of the brachial plexus – the nerve roots which connect the baby’s arm to the spinal cord. An injury of the latter type may be transient or it may, as in the present case, result in permanent disability, leaving the child with a useless arm. The risk of a brachial plexus injury, in cases of shoulder dystocia involving diabetic mothers, is about 0.2%. In a very small percentage of cases of shoulder dystocia, the umbilical cord becomes trapped against the mother’s pelvis. If, in consequence, the cord becomes occluded this can cause the baby to suffer from prolonged hypoxia, resulting in cerebral palsy or death. The risk of this happening is less than 0.1%”.
The option of caesarean section was not discussed with Mrs Montgomery and she proceeded to a vaginal delivery. The baby’s shoulder became impacted during an attempted forceps delivery. During the 12 minutes between the baby’s head emerging and delivery, the umbilical cord was occluded which caused oxygen starvation resulting in dyskinetic cerebral palsy. He also suffered a brachial plexus injury. If Mrs Montgomery had undergone elective caesarean section her son would have been born uninjured.
In evidence Dr McLellan had stated that she did not routinely warn of shoulder dystocia as nearly all women would chose caesarean section if such a warning was given.
The Supreme Court determined that if Mrs Montgomery had been warned, she would have chosen caesarean section and there would have been no attempt at vaginal delivery. The issue was whether she should have been warned.
The decision of the Supreme Court, abandoning the Bolam test and overruling the view of the majority in Sidaway v Board of Governors of the Bethlem Royal Hospital takes account of recent social and legal developments, substituting a different test, the doctrine of fully informed consent, endorsing the views of Lord Scarman in Sidaway and Lord Woolfe MR in Pearce v United Bristol Healthcare NHS Trust.
…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 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.”
This passage from the judgment in Montgomery should be at the forefront of the mind of all clinicians advising a patient of the risk of any proposed treatment.
The patient is no longer to be considered as a passive recipient of medical treatment. The Supreme Court indicated that the clinician can only withhold information relating to risk in very limited circumstances. Firstly, if she reasonably concludes that its disclosure would be severely detrimental to the patient’s health and secondly, in circumstances of necessity where, for example, the patient requires urgent treatment or is unconscious or otherwise unable to make a decision.
The Supreme Court went on to describe the practical consequences of the re-formulated test, in the clinical setting:
“89. Three further points should be made. First, it follows from this approach 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. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.
90. 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 grasps, let alone by routinely demanding her signature on a consent form.
91. Thirdly, it is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests.”
Some branches of the medical profession have already embraced the judgment in Montgomery by re-drafting treatment guidelines relating to consent.
One example is the British Society of Gastroenterology (BSG). The recently published “Guideline for obtaining valid consent for gastrointestinal endoscopy procedures” quotes the relevant part of the judgment in Montgomery and incorporates all of the recent guidance from the GMC and the Department of Health. The document is a detailed practical guide for the clinician seeking to obtain informed consent for endoscopy procedures.
It is fair to say that the Guideline, if followed, reflects a very high standard of clinical practice. Equally, however, the Guideline places a very heavy burden on those responsible for organising and working within a busy endoscopy unit.
Other branches of the medical profession will no doubt follow the lead offered by the BSG, when updating and re-drafting their guidelines. The Royal College of Surgeons published revised guidelines on 27.10.16 “Consent: Supported Decision-Making”.
From a practical point of view the decision in Montgomery opens the door to a large number of claims based upon a lack of informed consent.
Very many treatment decisions are concerned with risk. The risk of the proposed treatment; the risk of alternative treatment; the risk of no treatment. Montgomery requires the clinician to enter a dialogue with the patient and to participate in a collaborative approach to decision making.
One can imagine very many scenarios where claims arise out of an alleged failure to provide valid consent. By way of example:
- The obstetrician advising on mode of delivery, either electively or when the patient is in labour.
- The surgeon advising a patient before an operation.
- The GP who is deciding whether to admit a patient for assessment or treat conservatively at home (eg. acute low back pain with some positive neurology; headache; acute asthma; abdominal pain suggestive of diverticulitis; chest pain; the elderly diabetic patient with diarrhoea and vomiting (where there is a risk of dehydration and acute kidney injury)).
- Any treatment where there are reasonable alternatives available, whether conservative treatment or interventional treatment.
It remains to be seen whether Bolam re-emerges in claims arising out of inadequate consent. How will the courts decide whether a clinician has taken reasonable care to ensure that a patient is aware of a material risk or whether the clinician acted reasonably in deciding that certain information about risk fell within the therapeutic exception?