Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

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.

Please see full alert below for more information.

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