Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications For False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from criminal prosecution in United States v. Caronia, __ F. 3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012). This decision has attracted widespread attention from the government, the FDA, and the pharmaceutical industry, prompting questions as to whether Caronia could be the beginning of the end of the FDA's prohibition on off-label promotion.

The constitutional and regulatory implications of Caronia are significant and it is unclear how this decision will affect civil liability under the False Claims Act ("FCA"),¹ one of the primary tools used by the government to penalize off-label promotion. This Client Alert analyzes the potential FCA implications of Caronia, assessing how this decision may affect defenses available to companies accused of violating