Individual Liability in the Drug and Device Sectors and the Resurgence of the Park Doctrine
Michael A. Rogoff, Co-Chair of the Complex Commercial Litigation Department and Chair of the White Collar Litigation and Internal Investigations group conducted a one-hour webcast titled “Individual Liability in the Drug and Device Sectors and the Resurgence of the Park Doctrine” at 1:00 p.m. ET on March 17, 2011.
Recently, the U.S. government has increasingly focused on individual accountability in the drug and device sectors. As a result, pharmaceutical and medical device manufacturers need to understand the new enforcement climate and assess their risks and compliance systems.
Topics covered in the webcast included:
- Recent individual prosecutions in the drug and device sector
- The “Responsible Corporate Officer” or Park Doctrine: Where it comes from and how it is now being used
- Recent CIA certification requirements and OIG guidance on the exclusion of individuals
- FDA guidance on individual Park-based prosecutions
- Guidance on how drug and device companies and their employees could address the risks posed by the Park doctrine