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Inside Medical Devices Updates on Developments for Medical Devices from Covington & Burling LLP

U.S. v. Caronia: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion

Posted in FDA Device Regulation, First Amendment, U.S. Government Investigations and Compliance

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v. Caronia, concerning the application of the First Amendment to off-label promotion.  The court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug,” because such prosecutions “would run afoul of the First Amendment.”   Slip Op. at 33, 51.

Although this case involved pharmaceutical promotion, this decision raises significant questions about the government’s ability to prohibit truthful, non-misleading off-label promotional speech, including with respect to devices.  Caronia represents a significant affirmation of First Amendment principles for speech related to marketing of medical products.  For the first time, a federal court has placed First Amendment limitations on the government’s ability to criminally prosecute off-label promotion of legally marketed medical products.  The case therefore has potentially far-reaching implications for government regulation in this area.

Caronia’s long-term impact is still uncertain, however.  The case currently binds only courts in the Second Circuit.  Also, the government is likely to appeal the decision to the en banc Second Circuit and/or might seek certiorari in the U.S. Supreme Court. The Wall Street Journal noted that the latter option “has its risks, such as the possibility that the Supreme Court might strike down the FDA’s marketing restrictions on a nationwide basis.”

The Caronia opinion is limited in several ways, which could affect how government officials bring enforcement cases against medical product promotion.  The court specifically limited its holding to “FDA-approved drugs for which off-label use is not prohibited.”  Slip Op. at 51.  The court also made clear that the government still can prosecute off-label promotional speech that is false or misleading.  Thus, as former FDA Chief Counsel Jerry Masoudi recently stated to the New York Times, Caronia will “make FDA, in its promotion cases, focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved.”

Despite these open questions, Caronia has established a precedent in favor of First Amendment protection for truthful, non-misleading off-label promotion.  The development of continued jurisprudence around Caronia, as well as the government’s response, bear careful watching.

For a fuller discussion of Caronia, see our client alert.