Abstract

The False Claims Act, 31 U.S.C. § 3729, a post-Civil War law inspired by cases of defense contracting fraud, was revitalized in 1986. Since then it has been used to sue both manufacturers and providers of pharmaceuticals. In some cases, these suits were meant to target offlabel marketing of pharmaceuticals. In 2009, the 11th Circuit rendered a decision in Hopper v. Solvay Pharmaceuticals that dramatically limits the ability of private plaintiff whistle-blowers to bring qui tam suits under the FCA for such marketing. In June 2010, the Supreme Court denied certiorari, making the Circuit court decision final. The Solvay decision creates a significant barrier to certain kinds of qui tam suits, requiring the plaintiff to demonstrate the intent to market off-label, including by showing specific prescriptions that were written as a result of efforts to do so.