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Speaking Engagements

Matt Newcomer Moderates Panel Examining FDA Violations and Liability at FDLI's Enforcement, Litigation, and Compliance Conference on Dec. 8

December 8, 2016

On December 8th, Internal Investigations & White Collar Defense Principal Matthew T. Newcomer served as moderator for the panel session, "Strict Liability Based on FDA Violations: How to Protect Your Company and Yourself," at the Food and Drug Law Institute's (FDLI) Enforcement, Litigation, and Compliance Conference in Washington, D.C.

In July of 2016, two former J&J medical device unit executives were convicted of introducing a misbranded device into interstate commerce. This verdict comes on the heels of the Eighth Circuit’s July 2016 opinion upholding jail sentences for officers of Quality Egg LLC, who pled guilty to Federal Food, Drug, and Cosmetic Act (FDCA) violations in connection with the sale of contaminated eggs. These convictions stem from the Responsible Corporate Officer Doctrine – otherwise known as the Park doctrine – under which officers and executives of food and drug companies can be held liable for FDCA violations even where they had no personal knowledge of wrongdoing.

The panel session explored recent government successes in obtaining criminal convictions under these theories, what factors make prosecution attractive, and what steps the food and drug industry can take to mitigate risk. The panelists also explored how the Yates Memo factors into government prosecutions.