“A Perfect Storm: Prosecutors’ Increasing Focus on Individual Liability In the Drug and Device Sectors and the Responsible Corporate Officer Doctrine,” BNA’s Pharmaceutical Law & Industry Report

Michael A. Rogoff, Co-Chair of the Complex Commercial Litigation Department and Chair of the White Collar Litigation and Internal Investigations group, and Paula Ramer, Associate in the White Collar Litigation and Internal Investigations group, co-authored the article, “A Perfect Storm: Prosecutors’ Increasing Focus on Individual Liability In the Drug and Device Sectors and the Responsible Corporate Officer Doctrine” in the November 19, 2010 issue of BNA’s Pharmaceutical Law & Industry Report. The article examines the U.S government’s increasing focus on individual liability and prosecuting executives at pharmaceutical and device companies for violations ranging from misbranding under the federal Food, Drug and Cosmetic Act (‘‘FDCA’’) to wire fraud and obstruction of justice. With respect to misbranding violations in particular, prosecutors wield a potent weapon: the ‘‘Responsible Corporate Officer’’ (‘‘RCO’’) or Park doctrine. The Park doctrine provides for strict liability of individuals under the misdemeanor provisions of the FDCA.