Sample Case: Medical Device Failure Expert Coordination
Sample Scenario
In this sample scenario, a 52-year-old patient suffers severe complications when an implanted cardiac device malfunctions six months after implantation. The manufacturer claims the device was functioning within normal parameters and that the complications were due to the patient's underlying condition and improper management by the healthcare team.
LNC Approach
In a case like this, a legal nurse consultant would:
- Review the patient's complete cardiac history and medical records
- Analyze device monitoring data and malfunction reports
- Research the device's FDA approval process and any reported adverse events
- Identify the specific expertise needed to address all aspects of the case
- Create detailed case summaries for potential expert witnesses
- Develop targeted questions for each expert based on their specialty
Expert Witness Team
For this type of case, the legal nurse consultant might recommend assembling a team including:
- Cardiac Electrophysiologist: To address the medical aspects of the device's function and the patient's cardiac condition
- Biomedical Engineer: To analyze the device design, testing protocols, and potential failure modes
- FDA Regulatory Expert: To review compliance with regulatory requirements and reporting obligations
- Medical Device Quality Systems Expert: To evaluate the manufacturer's quality control and risk management processes
Potential Impact on the Case
Effective expert witness coordination in this type of case can provide comprehensive testimony that addresses both the medical and technical aspects of the device failure. The legal nurse consultant can help bridge the communication gap between the legal team and medical experts, ensuring that complex technical information is presented clearly and effectively.
In similar cases, this coordinated approach has helped legal teams establish causation between device malfunction and patient injury, counter defense arguments about patient factors, and demonstrate manufacturer liability through multiple lines of expert testimony.