The aftermath of Caronia in pursuing off-label cases

In U.S. v. Caronia, the court vacated the conviction of Alfred Caronia, finding that his conviction violated his free speech rights

In December 2012, the 2nd Circuit issued a groundbreaking 2-1 decision, holding that the First Amendment protects the truthful, non-misleading off label promotion of pharmaceutical products. In U.S. v. Caronia, the court vacated the conviction of Alfred Caronia, a pharmaceutical sales representative found guilty of conspiring to introduce a misbranded drug into commerce in violation of the Food, Drug and Cosmetic Act (FDCA), finding that his conviction, premised solely on his promotion of the drug for off label use, violated his free speech rights under the First Amendment. The court held that the FDCA does not prohibit “the truthful off-label promotion of FDA-approved prescription drugs.”

Although the decision was significant because of the First Amendment protection it extended to defendants facing allegations of off label marketing in certain instances, it was not clear whether it would actually affect the government’s future prosecution of these cases.

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Michael Rogoff

Michael Rogoff is a partner in and co-chair of Kaye Scholer’s Complex Commercial Litigation Department and Head of the firm’s White Collar Litigation & Internal...

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Manvin Mayell

Manvin Mayell is a partner in Kaye Scholer’s White Collar Litigation & Internal Investigations Practice in New York. He is an experienced litigator whose practice...

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Paula Ramer

Paula Ramer is counsel in Kaye Scholer’s White Collar Litigation & Internal Investigations Practice in New York. Her practice includes representing pharmaceutical and medical device...

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