CAN ‘MATERIAL RISK’ EVER BE DEFINED?

[ MONTGOMERY v LANARKSHIRE HEALTH BOARD has been a landmark case concerning the rights of patients and the responsibilities of clinicians in the consent process. Although the case provides some guidance for both patients and clinicians regarding the process of consent, many clinicians have felt that more issues have been raised than solved.

The term ‘material risk’ was born from the case and is deemed to be any risk that the consenting clinician felt the patient would attach significance to. There have been several cases since Montgomery which have put the issue back in the spotlight. Two cases stand out for having implications for clinicians.

Spencer v Hilingdon Hospitals NHS Trust 2015 relates to information provided to a patient post procedure and the potential implications of a lack of suitable post-procedure information. In that case the claimant underwent a hernia operation after which he was discharged from hospital. He was provided with a discharge leaflet which advised him to contact the hospital switchboard if he had any problems after surgery.

Three days later he developed calf pain and breathlessness, both of which he attributed to his recent inactivity. He was subsequently admitted to hospital with bilateral pulmonary emboli. The question asked was whether the hospital trust had given adequate information following discharge about the possibility of deep vein thrombosis and pulmonary embolism post hernia repair and the signs and symptoms of each.

The judge ruled that the trust was liable in that case, relating that the fatal nature of the complication, the improved prognosis with early treatment, the ease of giving the patient oral or written warnings as well as hospital and national guidelines on venous thromboembolism risk for such procedures, were relevant factors in ruling against the trust. The case brings to light the fact that information provided post-procedure is as important as the pre-surgery consent and can lead to negligence claims if deemed inadequate.

In Tasmin v Barts NHS Trust 2015 , the claimant developed cerebral palsy after sustained hypoxia during delivery. The claimant argued that she ought to have been delivered earlier by Caesarean section (C-section) in light of a pathological cardiotocography (CTG) trace during delivery.

The judge ruled against the claimant, suggesting that, in fact, rather than a C-section, a foetal blood sample was reasonable obstetric practice in that situation – in light of guidance from both the Royal College of Obstetrics and Gynaecology and the National Institute for Clinical Standards. Furthermore, the judge deemed that the risk of severe neurological injury from an abnormal CTG was approximately 1:1,000, which was deemed to be too low to be material; and thus such a risk was not obligated to be disclosed at that point, as per Montgomery. The claimant’s case was rejected on those grounds.

Those cases highlight that there is no specific test or standard, either written or numerical, by which doctors can appraise the details that any consenting process requires in a given situation. In Montgomery, the risk of shoulder dystocia was 1:10, with subsequent prolonged hypoxia causing disability at approximately 1:1,000, which was ruled to have been a material risk.

However, in Tasmin, the same risk of 1:1,000 of neurological injury from an abnormal CTG trace was not deemed material. There is an interesting confoundment here suggesting that there is significant contextual judgment in every case which is not apparent when looking at numbers alone.

The question arises, therefore, as to whether Montgomery has raised more questions than it has answered for clinicians? Was the Bolam Principle a more standardised method of thinking about such problems? That is undoubtedly a complex area, and no single judgment will be able to cover the breadth and complexity of everyday clinical encounters between clinicians and patients.

It is certainly the case that every consent process needs to be tailored for every patient. It is, unfortunately, only test cases in the legal system which can bring on-going clarification of the principles underlying Bolam and Montgomery pertaining to material risk. q