PI Brief Update

Informed Consent in Clinical Negligence Claims: The New Law Explained and the Consequences Considered - John-Paul Swoboda, 12 King's Bench Walk

23/06/15. On 11th March 2015 the Supreme Court handed down its judgment in Montgomery v Lanarkshire Health Board [2015] UKSC 11 which considered how the courts should determine whether a medical professional had fulfilled their duty to provide disclosure of the risks of a medical procedure to a patient (i.e. informed consent).

2. Nadine Montgomery (a diabetic) had, as shown on ultrasound scans, a large baby in utero. That the baby was large heightened the risk of shoulder dystocia (the shoulders becoming stuck in the birth canal) during birth by 9% to 10% which was a cause for concern in relation to the mother’s health. If shoulder dystocia occurred then there was also a chance of serious injury to the baby, including brachial plexus or cerebral palsy the probability of which was smaller (0.1% to 0.2%). Nadine Montgomery’s obstetrician, Dr McCellan, took the view that if diabetic pregnant women were warned of the possibility of shoulder dystocia they would “invariably choose… delivery by caesarean section” which she judged not to be in the women’s best interests albeit that the health risks of caesarean section are minuscule in comparison. Nadine Montgomery was not informed of the risk of shoulder dystocia which occurred. As a result her baby was born with cerebral palsy and a brachial plexus injury. The Supreme Court decided Nadine Montgomery should have been told of the risks of shoulder dystocia.

The position now and then

3. Before Montgomery practitioners faced a number of overlapping decisions which appeared, at least to this author, not entirely coherent. In Sidaway v Boards of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] AC 871 the Bolam test(whether a body of competent doctors would support the decision not to disclose the risk to the patient) survived by a bare majority but was subject to two exceptions set out by Lord Bridge.

4. Even though Siaway applied Bolam to the issue of informed consent, subject to the two exceptions, it was interpreted in Pearce v United Bristol Healthcare NHS Trust [1999] PIQR P 53 by Lord Wolf in the Court of Appeal in a somewhat surprising way. Lord Wolf judged that Lord Bridge’s first exception meant “if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk…”. This is surprising as it has nothing to do with the Bolam test and appears to undermine the very substance of the rule.

5. In Montgomery the Supreme Court in a unanimous decision, overturned Sidaway, and judged that the doctor’s duty is to:

Take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any 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.

6. All trace of the Bolam test is now vanquished from informed consent. The Montgomery test requires the doctor to take reasonable careto ensure the patient is aware of material risks. Material risks are identified:
   
   

   1. not by reference to whether a group of doctors believe a risk should or should not be discussed; but

   2. by whether a reasonable person in the patient’s position would consider the risk significant; or

   3. if the doctor knows (or should know) that the patient would consider the risk significant
      
      

7. The Supreme Court, endorsing the decision of the Court of Appeal in Pearce, has wrested control, of whether risks of treatment should be disclosed, from doctors and returned such control to judges. As the Supreme Court explained the treating doctor’s role in identifying the risks are judgements subject to professional skill and judgment to which Bolam might apply. However once potential risks are identified it is not a matter of medical judgment as to whether a risk should be disclosed and therefore Bolam (judgment by one’s peers in the medical profession) cannot apply. Whether risks should be disclosed to a patient is, according to the Supreme Court, a legal question to be determined by a judge taking into account the circumstances of the patient.

The two competing models

8. At the heart of the decision to give judges control over which risks should be disclosedis the proposition that a patient is a person with rights who should be provided with sufficient information to make an informed choice. The old paternalistic view that patients are simply passive recipients of care incapable of understanding and making decisions in relation to their medical care is gone. The new view is that in an era of human rights and where patients are to be viewed as consumers there is no room for a legal test which allows the medical profession to justify a restrictive approach to disclosure of risk. It is this change in philosophy which sounds the death knell for Bolam in cases of informed consent.

9. The move to a rights based approach protects the patients’ right to make life-changing decisions on the basis of all significant information and it is surely right that it is not for the medical profession to decide whether a particular risk should be disclosed as it is not a matter which requires the application of clinical judgment.

More work for lawyers

10. The Supreme Court judged, in response to a submission by counsel for the NHS trust that there was no justification for the assertion that there would be an increase in litigation by the change in the law. This author, not without great trepidation, respectfully disagrees with the Supreme Court: the culture change required of the medical profession by the change in the law is unlikely to happen overnight. Many busy surgeons and other medical practitioners are likely to continue to see the issue of informed consent as no more than a form to be signed by the patient in the waiting room before they enter the operating theatre. Such an approach is unlikely to be sufficient in this author’s opinion. My prediction is that litigation will increase, at least in the short and medium term, as Claimants seek to use the uncertainty created by the change in the law (e.g. was the non-disclosed risk material) as a bargaining chip, and as Defendants factor in the uncertainty in their calculation as to how likely the Claimant is to succeed.

John-Paul Swoboda
12 King's Bench Walk

Image ©iStockphoto.com/J-Elgaard