Products Liability: Medical Devices and Patient Safety with Brian Moher

Gluckstein Lawyers' 4th Annual Risky Business Conference: Case Updates and Practical Tips took place using a hybrid model, on November 29, 2022, from 9:00 AM to 4:00 PM. Our Risky Business conference aims to educate lawyers, law clerks, health care practitioners, and others who wish to understand the nuanced aspects of medical negligence claims. The conference provides tips and guidance on meeting the challenges of medical malpractice litigation, ensuring clients get all they deserve.

Litigation arising out of medical devices requires a sound understanding of the various systems at play. The concepts of product safety and patient safety are related but distinct concepts. Product safety is primarily concerned with whether a medical device meets the relevant regulatory criteria for safety and efficacy. Adverse patient outcomes require consideration of two additional factors beyond regulatory approval: (a) context for use, including environmental and human factors; and (b) safe use, management, and adverse event monitoring.

This presentation proposes a three-step framework for assessing liability relating to medical devices. By approaching medical device liability through a systems based framework, lawyers will be better equipped to identify how and why an adverse medical device outcome occurred.