• Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases
  • December 7, 2012 | Authors: David B. Leland; Gregory M. Luce
  • Law Firm: Skadden, Arps, Slate, Meagher & Flom LLP - Washington Office
  • In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a misbranded drug into interstate commerce. In an era in which most investigations of industry off-label promotional activities result in settlements rather than litigation, the Caronia case was widely seen as an important but rare test of the government’s criminal liability theories in off-label promotion cases. In an opinion that will certainly be welcomed by many in the industry, the court rejected the government’s interpretation of the Food, Drug and Cosmetic Act’s (FDCA) misbranding provisions, holding, “We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an FDA-approved drug.” Op. at 51. The court found that “such a construction - and a conviction obtained under the government’s application of the FDCA - would run afoul of the First Amendment.” Op. at 33.