Can Truthful Statements Be a Crime? Liability for Off-Label Marketing

September 4, 2015  |  New York Law Journal

In recent years, the U.S. Department of Justice has brought a series of high-profile cases against pharmaceutical companies for “off-label marketing” of prescription drugs, resulting in corporate guilty pleas and billions of dollars of criminal fines, forfeitures and civil penalties. In our latest column, we discuss a recent decision by Southern District of New York Judge Paul A. Engelmayer in Amarin Pharma v. FDA, which interprets the Second Circuit’s decision in United States v. Caronia broadly and rejects liability for truthful off-label marketing.

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