Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia


On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce by promoting the drug, Xyrem, for off-label use in violation of the federal Food, Drug, and Cosmetic Act (FDCA). Caronia, a former Specialty Sales Consultant for Orphan Medical, Inc., appealed his conviction on the grounds that he was convicted for his speech when promoting Xyrem for off-label uses, in violation of the First Amendment. The Second Circuit agreed, holding that Caronia was convicted in violation of his right to free speech and vacating and remanding Caronia’s judgment of conviction to District Court.

Factual Background -

According to the opinion, the allegations against Caronia centered on his promotion of the drug, Xyrem, which was approved in July 2002 to treat narcolepsy patients who experience cataplexy. The drug’s label contained a boxed warning stating that safety and efficacy were not established in patients under 16. As described in the Second Circuit’s opinion, the federal government began an investigation of Orphan Medical and Dr. Peter Gleason, a paid physician speaker, in spring 2005 for alleged off-label promotion of Xyrem. The government obtained two tape-recorded conversations in which Caronia and Gleason promoted Xyrem for unapproved indications and subpopulations, including muscle disorders, chronic pain, daytime fatigue, excessive sleepiness, fibromyalgia, and patients under 16.

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