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What is Informed Consent? Putting Emphasis on what the Patient sees as Significant

Informed consent has always been a difficult topic in Clinical Negligence Law. The reason is that in order to succeed in such a claim the Claimant must show firstly that their doctor failed to advise them of their treatment options, and the advantages and disadvantages involved, and secondly that if they had received such advice they would have opted for a different course of treatment to the one they actually received.

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Since 1957 the rules in relation to breach of duty in Clinical Negligence claims and the law to be applied when assessing every case has been laid down by the case of Bolam v Friern Hospital Management Committee. This test sets out the standard of care that a patient can expect from their treating doctor and if the care received falls below that standard there will have been a breach of duty. The standard applied is the standard of the ordinary skilled man exercising his particular skill and if it can be supported by a responsible body of medical opinion it would not be held to be negligent. For example, if you are treated by a General Practitioner, the standard of care that you can expect is the standard of an ordinary skilled General Practitioner exercising that particular role.

However, in a recent landmark decision the Courts have applied a different test in relation to informed consent that will now be the authority, and the appropriate test to be applied to cases going forward.

The change to the law comes from the case of Montgomery v Lanarkshire Health Board [2015]. Mrs Montgomery suffered from insulin dependent diabetes. It is known that women who suffer from diabetes are likely to carry larger than normal babies, which brings with it an increased risk of shoulder dystocia during delivery (shoulder dystocia is an emergency because if the baby cannot be delivered promptly there is risk of oxygen deprivation, brain damage and sometimes death). Due to her diabetes Mrs Montgomery received a greater level of monitoring during her pregnancy and was under the care of a consultant. The risk of shoulder dystocia was considered to be around 10%, but the doctor did not warn Mrs Montgomery about that risk or discuss alternatives, such as a caesarean section. The reason for not warning her was because the doctor decided that the risk of serious injury from shoulder dystocia was small and that Mrs Montgomery would choose a caesarean if she was warned when, in the doctor’s view, that would not be in her best interests or the baby’s best interests. Mrs Montgomery had a vaginal delivery on 1 October 1999, during which shoulder dystocia did occur and delivery took 12 minutes, resulting in oxygen deprivation and her son now suffers from cerebral palsy.

Initially, the courts rejected the claimant's claim on the basis that a reasonable body of medical opinion would not have advised Mrs Montgomery of the risk of dystocia. The courts applied the Bolam test to the issue of consent i.e. would the doctor’s failure to warn of the risk of shoulder dystocia be supported by a responsible body of medical opinion. The question of what information should be provided to a patient was a matter falling within the expertise of members of the medical profession.

However, Mrs Montgomery appealed and the decision on appeal was that “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 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, either a reasonable person in the patient’s position would be likely to attach significance to the risk (objective test) or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it (subjective test).

Previously, when investigating clinical negligence claims, solicitors seek input from medical experts on whether the treatment received satisfied the Bolam test. Now, such expert evidence will not be sufficient to assess the strength of the case when dealing with the issue of informed consent. It will now be much more fact and patient specific and will ultimately be a matter for the Court to decide. The large majority of clinical negligence cases are settled out of court, with the responsibility of proving the case resting on the Claimant. This recent change begs the question, will more claims have to go to Court before they can be concluded, and how can the Claimant prove their case to avoid always relying upon the ultimate interpretation of the Court at a final hearing?

The effects of this recent decision will, undoubtedly, be further tested and commented on going forward, but it is certainly an important decision that significantly changes the way Clinical Negligence cases are to be dealt with.