Second Circuit Vacates Misbranding Conviction For Pharmaceutical Representative On First Amendment Grounds

John Brownlee is a Partner in our Northern Virginia office, William Gould a Partner in our Washington, D.C. office and Timothy Taylor an Associate in our Northern Virginia office

The Court's Decision Has Major Implications for the Pharmaceutical Industry

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

A Long Time Coming

The Caronia case represents the latest chapter in the ongoing battle over the regulation of pharmaceutical company speech. As noted by the trial court in this case, the defendant's First Amendment challenge "rais[ed] constitutional issues 'very much unsettled, not only in this circuit but nationwide.'" Caronia, slip. op. at 19–20 (citing United States v. Caronia, 576 F. Supp. 2d 385, 403 (E.D.N.Y. 2008), vacated and remanded by Caronia, No. 09-5006-cr).

The unsettled nature of these issues was highlighted by the case's procedural history on appeal. The Second Circuit heard oral argument in the case over two years ago, on December 2, 2010. However, the court then requested supplemental briefing in light of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011). Sorrell, decided June 23, 2011, struck down a Vermont statute restricting pharmaceutical manufacturers from using prescriber-identifying information for marketing purposes. The court held this to violate the Constitution's free speech protections. The parties completed their supplemental briefing in Caronia on August 29, 2011, and the Second Circuit's decision was published this week.

The Legal Framework: The "Off-Label" Paradox

At issue in Caronia was the government's prosecution premised on a particular construction of the FDCA and its implementing regulations. That legal framework, in a nutshell, is as follows. Before a drug may be distributed in interstate commerce, it must be approved by FDA for a specific use or uses. 21 U.S.C. § 355(a). Such approved uses are the only uses allowed on the drug's labeling. Id. § 321(m), (p). Despite this restriction, physicians may prescribe so-called "off-label" uses for drugs.

Even so, a drug is misbranded if "its labeling fails to bear 'adequate directions for use,' [id.] § 352(f), which FDA regulations define as 'directions under which the lay[person] can use a...