Courts are struggling with how to make liability decisions based on the regulatory regime that Congress and the Food and Drug Administration have established for allowing medical devices into the market. The largest controversy surrounds devices cleared through the 510(k) process as being substantially equivalent in safety and efficacy to an existing device. Congress and FDA created the 510(k) clearance process so devices that represent technological advancements from previous devices can reach the market faster than if they had to go through the full pre-market approval process.
Some courts give deference to this regulatory process and some do not. Some courts allow juries to be provided evidence of what information and criteria the FDA used to clear the devices and some do not. We were joined by two experts in medical device liability who provided the plaintiff and defense perspectives on these judicial decisions and how they can impact America’s health care and the system Congress established to govern medical devices.
This Congressional Civil Justice Academy featured:
Phil Goldberg, Managing Partner, Shook Hardy & Bacon
Jonathan D. Orent, Attorney, Motley Rice LLC
Moderator: Donald Kochan, Professor of Law and Deputy Executive Director of the Law & Economics Center, Antonin Scalia Law School at George Mason University
Please see below for a recording of the event!