31 March 2023 | Comment | Article by Irfan Mohamed
Informed consent is a legal requirement for any medical treatment, especially surgery. Without which, civil and even criminal liability could arise. The case of Snow v Royal United Hospitals Bath NHS Foundation trust [2023] EWHC 42 (KB) (‘Snow’) recently dealt with the issue of informed consent and whether the injuries sustained by the claimant would have been incurred had proper informed consent been obtained.
The Existing Law
The definitive authority on informed consent has been the 2015 Supreme Court case of Montgomery V Lanarkshire Health Board [2015] UKSC 11 (‘Montgomery’). The Court here held that doctors must take reasonable care to ensure:
- The patient is aware of all material risks of the treatment proposed – this includes any risks which a reasonable person would consider to be significant as well as any risks which the specific patient would consider to be significant, and The patient knows about the reasonable alternatives to this treatment;
- Under the above principles, the Court commented that written consent on the day of the surgery was not evidence of adequate informed consent.
Case Background
In the case of Snow, the claimant alleged that the hospital Trust (the Defendant) did not obtain his fully-informed consent to conduct a laparoscopic low anterior resection of his rectal cancer with a procedure called the Trans-anal (Ta) Total Mesorectal Excision (TME) (‘TaTME’). The Claimant alleged that as a result of this failure, he was not aware of the full extent of the risks attached to the TaTME procedure and his informed consent had not been obtained. The Claimant argued that had he been aware of the risks of the procedure, he would have opted for a Total Mesorectal Excision (TME) and would have avoided the below injuries:
- Permanent total impotence, total inability to ejaculate and anorgasmia
- Urinary incontinence and urgency
- Faecal urgency and incontinence
- Exacerbation of Lower Anterior Resection Syndrome (LARS)
- Moderate prolonged adjustment disorder and depression
The Defendant made some admissions that they had breached a duty of care in not obtaining the Claimant’s informed consent prior to undertaking the TaTME. However, the Defendant argued that even if the Claimant had been advised of reasonable alternatives, he would still have opted for the TaTME procedure in any event. As such, the denied causation.
The Legal Issues to be Considered
The two legal issues for the Court to consider were:
- whether the Claimant, upon being fully-informed, would have instead opted for the less risky TME
- whether the Claimant would have suffered from similar injuries even if he had undergone a TME
The Court’s decision
His Honour Judge Richard Roberts, sitting in the High Court, found that the doctors at the Defendant Trust had not followed the standard guidance on informed consent and specifically the advice recommended to be given to patients undergoing a TaTME. This guidance is set out by the National Institute for Health and Care Excellence (NICE), which is often cited as the key source of clinical guidelines for treatment and patient care. Specifically, Judge Roberts found that the surgeons had failed to:
- Advise that the NICE guidelines had considered the evidence on the safety and efficacy of the TaTME procedure and found that it was limited in both quantity and quality. Patients needed to understand that there was uncertainty
- Provide the Claimant with a copy of the patient guidance on TaTME
- Inform the Claimant that this was only their second time carrying out the TaTME procedure
- Inform the Claimant of the alternative operations he could undergo, namely the less risky TME procedure
Judge Roberts was persuaded by the Claimant’s evidence which was that he would not have let anyone operate on him had he known that there was not much good evidence on how safe the procedure was and the risks attached to the TaTME.
The Court accepted this and found that C would have instead opted for the TME procedure.
The Court also found that had the Claimant undergone the TME procedure, he would not have suffered total impotence, loss of ejaculatory function and anorgasmia.
In a judgement delivered in January 2023, the case was decided in the Claimant’s favour and he was awarded compensation of just under £400,000.
The Impact of Snow
Snow has reconfirmed the principles of informed consent as established in the case of Montgomery. Interestingly, the Court here has gone beyond the typical guidelines to say that it is not enough for a doctor to counsel the patient of the possible risks and consequences of the procedure but that patients need to have information as to the alternative procedures available and their associated risks. This should be supported by providing the NICE guidelines literature as well as information on the experience of the surgeon(s) performing the proposed procedure.
This case is of great significance and it is welcoming to see that the Courts have upheld a patient-centric approach to informed consent.