[1] Montgomery v Lanarkshire Health Board [2015] UKSC 11

[2] McCulloch and others (Appellants) v Forth Valley Health Board (Respondents) [2023] UKSC 26

[3] Bilal v St George’s University Hospital NHS Foundation Trust [2023] EWCA Civ 605

[4] Winterbotham v Shahrak [2024] EWHC 2633 (KB)

[5] SD v (1) AR (2) JT [2024] EWHC 20444

An update on informed consent – MAY 2025

Many clinical negligence claims continue to include allegations relating to the failure to obtain informed consent, following the case of Montgomery [2015][1].  However, recent case law should provide some reassurance to surgeons that a claimant’s inclusion of a consent allegation is no guarantee of their claim succeeding.

Consenting under Montgomery

The case of Montgomery obliges all surgeons to take reasonable care to ensure a patient is aware of any material risks of recommended treatment, and of any reasonable alternative treatments.  When advising a patient, a surgeon is required to consider both (a) what a reasonable person in the patient’s position would consider to be significant, and (b) what this particular patient would consider to be significant.

The obligation imposed by Montgomery can be considered overly burdensome for surgeons, with the risk of overwhelming patients with various treatment options advised with potential litigation in mind.

Does recent case law assist surgeons?

• The cases of McCulloch [2023][2] and Bilal [2023][3] found that there is still a role for clinical judgement in the consent process and the assessment of treatment options, albeit the proposed treatment options must be supported by a responsible body of medical opinion.  However, to comply with Montgomery, the case of McCulloch found that a surgeon must also consider and advise of the risks of any proposed treatment that might be material to the patient.

• In the case of Winterbotham [2024][4], with reference to the judgement in McCulloch, the defendant was found to have breached his duty of care in failing to obtain informed consent in a dental claim.  Both parties’ experts agreed that a coronectomy was a reasonable treatment alternative that ought to have been disclosed to the patient.  Whilst the defendant would not perform this alternative treatment, the fact that the claimant could go elsewhere for this treatment was considered sufficient basis for alternative options to be discussed.

• In the case of SD [2024][5], having allegedly failed to warn of the risk of bowel injury, the defendant successfully argued that he had advised the claimant of this risk on two separate occasions pre-operatively.  Whilst this was not recorded in his notes, and the defendant could not specifically recollect doing so, he successfully relied upon the fact that to warn of the risk of bowel injury was his standard practice.  Whilst this case has demonstrated that there is still scope for surgeons to argue that a risk has been discussed where it is not recorded, it is important to note that the success of such an argument would depend on the quality of each parties’ written and verbal evidence, as well as the quality of a surgeon’s record keeping.

GMC Guidance

The GMC provides detailed guidance on decision making and consent, which includes the following key points:

• All patients have the right to be involved in decisions about their care and treatment.
• Decision making is an ongoing process focused on meaningful dialogue and the exchange of relevant information specific to the individual patient.
• All patients have the right to be given the information they need to make a decision, and the time and support they need to understand it.
• Consent can be written, verbal or implied, but this should be recorded in a patient’s notes.

Summary

It is possible to robustly defend consent claims where surgeons can demonstrate a transparent, well-documented and appropriately communicated consent procedure.  If a surgeon does find themselves to be the subject of a clinical negligence claim relating to alleged failures to obtain informed consent, defending the claim would be greatly assisted by evidence of the following:

• Signed and dated consent forms making explicit reference to each individual risk that is the subject of the claim.
• A clear record of discussions between the surgeon and patient of the risks and alternative treatment options discussed.
• If applicable, a copy of a referral to a patient’s GP or a clinical psychologist when a patient appears to have unrealistic outcome expectations, an apparent disproportionate view of their appearance, or whether there is an existing mental health condition.
• Details of alternative treatment options offered by the advising surgeon, as well as those reasonable and appropriate alternative treatment options that would need to be provided elsewhere.
• Evidence of the patient having been provided sufficient time between consultations and treatment to make an informed decision as to whether to proceed (whilst GMC and BAPRAS guidance suggest a ‘cooling off’ period of two weeks, the PRASIS code of practice recommends a four week period for cosmetic surgical procedures).
• Copies of any literature provided to a patient in advance of treatment, again allowing sufficient time for the patient to have considered the literature in detail to assist in their decision making.
• If applicable, evidence of the surgeon having considered any language barriers or capacity issues that could impact a patient’s decision making.

It is important to note that even if a claimant were to establish that a surgeon had failed to obtain informed consent, they would still need to prove that in those circumstances they would not have proceeded with the index treatment.

Finally, whether a specific risk or alternative treatment option is detailed in a patient’s records can be a determinative factor for a Court in considering whose evidence is preferred.  Therefore, surgeons are encouraged to keep detailed contemporaneous records of all consultations and discussions with patients as to risks and treatment options.