October 09, 2013 Articles

The Intersection of Off-Label Promotion and Free Speech

First Amendment protection may extend to "truthful" off-brand promotional activities, but the issue then becomes what qualifies as "truthful."

By Gerard T. Leone Jr., Hannah Bornstein, and Conor S. Harris

Two recent developments in free-speech protection reflect a shifting environment for prosecutors investigating pharmaceutical and medical-device companies for potential off-label promotional activities. In December 2012, the Second Circuit held that the First Amendment protected a pharmaceutical sales representative’s truthful off-label promotional speech in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). And in March 2013, the defendant in United States v. Harkonen, 510 F. App'x. 633 (9th Cir. Mar. 4, 2013), petitioned the Supreme Court to overturn his wire-fraud conviction on the theory that statements contained in a press release describing the results of a clinical trial were protected by the First Amendment as scientific opinion.Prosecutors have generally downplayed the significance of Caronia, noting that the decision did not address the constitutionality of the government’s usual theory of liability—that a defendant’s off-label promotion is merely evidence of the drug’s intended use for unapproved indications. Nevertheless, as the Harkonen petition demonstrates, defendants are now sure to invoke the First Amendment in cases involving off-label and other allegedly improper promotional claims or activities. As a result, the government likely will be more selective in identifying cases for prosecution, pursuing those that involve allegations of fraud or false and misleading statements while passing on those based on truthful off-label speech.

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