Documenting Informed Consent in Transcatheter Procedures: A Solicitor’s Evidence Guide

In cardiac clinical negligence litigation, the adequacy of informed consent often becomes the primary focus in claims involving transcatheter procedures, such as Transcatheter Aortic Valve Implantation (TAVI) or percutaneous structural interventions. For instructing solicitors, understanding how an expert cardiologist interprets the adequacy of the consent process is essential for evaluating the merits of a claim and framing the instructions for a report compliant with CPR Part 35.

The Clinical and Legal Framework for Informed Consent

Since the Supreme Court decision in Montgomery v Lanarkshire Health Board [2015], the standard for informed consent has shifted from the traditional ‘reasonable body of medical opinion’ test established in Bolam v Friern Hospital Management Committee [1957] to a patient-centred approach. The law requires that a patient is made aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.

In cardiology medico-legal practice, this necessitates a review of whether the clinician discussed risks specific to the patient—including their comorbidities, frailty status, and life expectancy—rather than relying solely on generic procedural statistics. For complex structural procedures, the ‘materiality’ of a risk is judged by whether a reasonable person in the patient’s position would be likely to attach significance to it.

Evidentiary Burden and Documentation

The absence of contemporaneous documentation presents a significant challenge in cardiac litigation. Where the medical records are silent on the discussion of specific risks, the expert must consider the totality of the evidence. CPR Part 35.3 requires that an expert’s report be objective and unbiased, providing the court with the necessary clinical context to determine if the standard of care was met. Relevant evidentiary areas for review include:

• Evidence of pre-procedure multidisciplinary team (MDT) discussion regarding eligibility and risk profile.
• Records of the patient’s baseline functional status and frailty assessment.
• Documented evidence of a discussion regarding conservative management or alternative surgical options.
• Use of visual aids or consent forms that differentiate between common procedural complications and rare but catastrophic outcomes.

Common Pitfalls in Litigation

Disputes in this area often arise when the claimant asserts that they would not have proceeded with the intervention had they been fully informed of specific complications. An expert opinion may address whether the alleged failure to inform caused the injury, applying the ‘but-for’ test. If the clinician argues that the patient would have proceeded regardless of the information provided, the expert must analyse this in the context of the clinical alternatives available at the time, reflecting the principles discussed in Chester v Afshar [2004].

Another challenge involves the interpretation of ‘reasonable alternatives’. Cardiology experts may provide a retrospective assessment of whether a patient was a suitable candidate for alternative treatments. This requires a nuanced analysis of the patient’s individual clinical profile, including imaging and structural anatomy, against the prevailing standards of the time.

The Role of the Expert Witness

An expert witness in cardiology provides the court with the technical framework required to evaluate the clinical decisions made. Under CPR 35.3, the expert’s overriding duty is to the court. Their role is to assist by identifying whether the information provided was consistent with the standard expected of a reasonably competent cardiologist and whether the clinical assessment was robust. When disagreements exist between experts regarding the adequacy of the consent process, the court may direct a discussion under CPR 35.12 to narrow the issues. This process often produces a joint statement, which remains subject to the court’s determination of the facts.

Practical Guidance for Solicitors

When instructing a cardiologist, solicitors should ensure the following documentation is available for review: the full chronological clinical record, including outpatient correspondence and MDT minutes; patient-specific imaging; and any patient information leaflets provided. When the court directs that evidence be provided by a single joint expert under CPR 35.7, solicitors must be mindful that instructions provided to that expert are governed by CPR 35.8. Seeking early specialist input can be pivotal in determining whether the consent process was robust or whether there was a failure to inform the patient of material risks, thereby establishing the necessary components of a claim.