In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz Pharmaceuticals whom a federal district court jury found guilty of conspiring to introduce a "misbranded" drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act ("FDCA").[1] A copy of the full opinion is available here.[2] In this case, the majority held that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their employees for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug.

This Client Alert reviews the holding of the case and assesses the potential impact that this case may have for the industry.