Informed Consent: When Is There A Duty To Obtain Consent On Technical Choices?

• Published date: 13 August 2021
• Subject Matter: Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Trials & Appeals & Compensation, Professional Negligence, Biotechnology & Nanotechnology
• Law Firm: Gatehouse Chambers
• Author: Mr Aneurin Moloney

The Supreme Court in Montgomery imposed (or perhaps clarified) a duty to ensure that any patient is aware of the material risks involved in any recommended treatment. They also extended the duty to obtain informed consent to informing the patient of "any reasonable alternative or variant treatments."

Reasonable alternative treatments is a relatively straightforward concept - for example, in a fracture case it may be that there are a menu of reasonable possible treatments e.g. rest and ice, immobilisation in plaster, or surgical fixation. Provided that any option is a reasonable treatment, the patient should be informed of that treatment option, even if the doctor recommends one particular treatment as part of their professional judgement.

But, it remains unclear just how far 'variant treatments' extends. For example, should a patient undergoing biliary surgery be offered a range of different stents that could all be suitable? Should a patient undergoing hip replacement be asked for their preference of a posterior or anterior approach incision?

In Diamond v Royal Devon & Exeter NHS Foundation Trust [2017] EWHC (QB), HHJ Freedman sitting in the High Court found that there was a duty to advise on whether hernia repair surgery would be carried out using mesh or by simple suturing, where the use of mesh would carry serious implications for any future pregnancy. Although the claimant failed to establish causation in circumstances where a simple suture repair carried a high risk of recurrence of the hernia. The causation aspect of this decision was upheld in the Court of Appeal.

(1) Negus (2) Bainbridge v Guy's and St Thomas' NHS Foundation Trust [2021] EWHC 643 (QB)

A similar issue was recently considered by the High Court in Negus. The patient (who died before trial) underwent aortic valve replacement surgery in 2014 with a 19mm mechanical valve. The claimants' case was that a larger valve should have been used together with aortic root enlargement ('ARE'), that the patient should have been advised on the greater risk of cardiac dysfunction with a smaller valve, and that they should have been offered the alternative larger valve with ARE.

The patient experienced cardiac dysfunction with the 19mm valve and later underwent revision surgery using a larger 23mm valve with ARE. Following that surgery, the patient deteriorated. She subsequently died of heart failure which, it was alleged, would have been avoided had a 23mm valve with ARE been used in the first...