Documenting Device Complications in Electrophysiology: A Checklist for Solicitors

Understanding the Scope of Electrophysiology Claims

In cardiac rhythm management, clinical negligence claims involving ICDs or pacemakers often hinge on whether an adverse outcome represents a recognised risk of the procedure or a deviation from expected standards of care. For solicitors, managing these claims requires a structured approach to expert instruction to ensure that clinical evidence maps accurately to the legal tests of duty, breach, and causation.

Electrophysiological procedures, including device implantation, involve complex clinical judgments regarding patient selection, procedural technique, and long-term management. Claims typically arise within three domains:

• Procedural Complications: Such as pneumothorax, cardiac tamponade, lead displacement, or vascular injury during venous access.
• Device Management Failures: Involving issues such as inappropriate shock therapy, failure to detect ventricular arrhythmias, or sub-optimal programming strategies.
• Informed Consent: Following Montgomery v Lanarkshire Health Board [2015], focusing on whether the patient was provided with sufficient information regarding material risks, irrespective of the technical performance of the procedure.

Each domain requires an expert with relevant sub-specialty experience. A consultant with specific expertise in electrophysiology and device implantation is generally best positioned to assist the court under CPR Part 35 in these matters.

The Evidential Threshold for Breach and Causation

The claimant bears the burden of proof. The court assesses breach of duty through the principles established in Bolam v Friern Hospital Management Committee [1957] and Bolitho v City and Hackney Health Authority [1998]. Bolitho is particularly relevant in device litigation; if an expert maintains that a specific programming strategy or surgical approach was standard, they must be prepared to demonstrate that such an opinion has a logical, defensible basis in clinical practice.

Regarding causation, the ‘but-for’ test remains the standard approach. Solicitors must instruct experts to address whether the patient’s outcome would have been avoided ‘but for’ the alleged breach. While cases involving catastrophic events may occasionally raise questions of material contribution, the ordinary ‘but-for’ test remains central, and experts should distinguish between speculative outcomes and medically probable ones.

Structuring the Expert Instruction

To ensure a report is compliant with CPR 35.10, solicitors should provide a chronological bundle, which may include:

• Complete device interrogation reports (printouts from the device programmer).
• Fluoroscopy images or procedural logs, particularly where the claim concerns lead placement or structural perforation.
• Pre-operative risk stratification, including comorbidities and any relevant device-related history.
• Documentation of the consent process, detailing discussions regarding device-related complications or limitations.

When drafting questions under CPR 35.6, focus on whether clinical decision-making was consistent with practice at the material time. Per CPR 35.3, the expert’s overriding duty is to the court, not to the instructing party; avoid phrasing questions that might be perceived as inviting the expert to advocate for a specific outcome.

Common Pitfalls in Device Litigation

A frequent error in device litigation is the conflation of an adverse outcome with negligence. Not all device-related complications indicate a failure in the standard of care. For instance, lead dislodgement may occur in the absence of technical error. A critical element of an expert’s report is the differentiation between an inherent complication and a failure to identify or timely manage that complication post-operatively.

Additionally, where the court directs a discussion between experts under CPR 35.12, the purpose is to narrow the issues by producing a joint statement. This process does not require an expert to abandon their independent clinical opinion. If the court directs the appointment of a single joint expert under CPR 35.7, they should be instructed in accordance with CPR 35.8.

The Role of the Expert Witness

The role of the consultant cardiologist is to provide the court with the ‘Bolam’ standard of practice. Their task is to translate complex waveforms, device logs, and surgical techniques into a narrative that the court can apply to the legal test for negligence. When selecting an expert, confirm their active involvement in the implantation and follow-up of the specific devices in question, as both hardware and programming protocols evolve.