Dan Jarcho was a featured speaker at this conference and presented “Strict Liability Based on FDA Violations: How to Protect Your Company and Yourself.” In July 2016, two former J&J medical device unit executives were convicted of introducing a misbranded device into interstate commerce. 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 when they had no personal knowledge of wrongdoing. This 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.
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December 7-8, 2016
The Mayflower Hotel / Washington, D.C.