DOJ has escalated prosecution of executives in off-label marketing cases
With its May 10, 2007 announcement that three senior Purdue executives were pleading guilty to misdemeanor violations of the Food Drug and Cosmetic Act under a doctrine of vicarious liability, the Department of Justice revived a rarely used, 30-year-old theory of criminal liability to convict individuals. The guilty plea marks a significant escalation of the DOJ’s tactics in the off-label marketing and misbranding arena. In the June 22 edition of Rx Compliance Report, Kirsten Mayer, a litigation associate at Ropes & Gray, reviews the plea and analyzes potential consequences for executives in the pharmaceutical and medical-device industries. To read the article, please "DOWNLOAD PDF."