Second Circuit Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of [a U.S. Food and Drug Administration] FDA-approved drug." Slip op. at 51. Such speech, according to the court, qualifies as protected commercial expression, id. at 31, including the shield of heightened scrutiny against attempted restrictions, id. at 39. Following this conclusion, the court determined that the legal theory undergirding the government's prosecution failed to withstand this heightened scrutiny and that, therefore, the conviction at issue had to be vacated. See id. This decision has fascinating implications for pharmaceutical manufacturers, their employees and the medical industry as a whole, and it will certainly give federal prosecutors pause before bringing similar cases.1