Legal and Health Care Compliance Best Practices

The Importance of FDA Compliance Evidence During a Jury Trial

Tuesday, September 28, 2021

4:00 PM – 5:00 PM ET

Location: Virtual

Virtual Moderator(s)

Sean Burke, Sean Burke

Partner and Vice Chair Products Liability and Toxic Tort Trial Division
Duane Morris, LLP

Virtual Speaker(s)

John F. Brenner, J.D.

Senior VP, Senior Legal Advisor
BD
David Cooner

Senior Vice Presidet, Chief Counsel
BD
Zane Riester

Senior Counsel
Johnson & Johnson
Pamela White , JD

Chief Legal Counsel
Stryker

This panel will focus on the importance of FDA compliance evidence at trial. The COVID-19 pandemic has profoundly changed public attitudes, perceptions and expectations of the life sciences industry in numerous ways. The average juror is more educated about the FDA, clinical trials, manufacture to market timelines, and regulatory compliance than ever before. With this knowledge comes an expectation that medical device and pharmaceutical companies have - at the very least - complied with FDA regulations before marketing their products to the public. Therefore, at a trial involving medical devices, it is paramount to a fair trial that device manufacturers are permitted to introduce evidence of their compliance with FDA pre-market requirements.