United States v. Caronia
703 F.3d 149
| 2d Cir. | 2012Background
- Alfred Caronia, a pharmaceutical sales representative for Orphan (Jazz), was convicted at trial of conspiracy to introduce a misbranded drug (Xyrem) into interstate commerce and of introducing a misbranded drug.
- Xyrem was FDA-approved for narcolepsy with cataplexy and for excessive daytime sleepiness; it carried a black-box warning and centralized distribution due to safety concerns.
- Caronia promoted off-label uses of Xyrem to physicians during recorded meetings in October and November 2005, including unapproved indications and subpopulations.
- The government charged Count One (conspiracy) and Count Two (misbranding) under the FDCA; a jury found him guilty on the conspiracy (first prong) and not guilty on the second prong and on Count Two.
- The district court instructed that misbranding could be shown by promotion for off-label uses, effectively tying speech to criminal liability, and Caronia appealed on First Amendment grounds.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does FDCA misbranding prohibit off-label promotion? | Caronia argued speech promoting off-label uses is criminalized. | Caronia argued the FDCA does not criminalize mere promotion of off-label use. | No; the FDCA does not criminalize simple off-label promotion. |
| Is prosecuting off-label promotion compatible with the First Amendment? | Government contends speech is not the crime; it's evidence of intent. | Caronia contends speech itself was prosecuted as the offense. | Conviction cannot stand where speech was treated as the proscribed conduct. |
| Can speech be used as evidence of intent without violating the First Amendment? | Speech may be used to prove intent under Mitchell and related cases. | Speech used as the sole basis for criminal liability burdens free speech. | Speech may be used as evidence of intent, but cannot support a speech-alone criminal prohibition. |
| What standard applies to regulating speech in this criminal regulatory scheme? | Content-based limits on pharmaceutical marketing may be justified by safety goals. | Uniform limits on off-label promotion by manufacturers are permissible under existing doctrine. | The government’s construction is content- and speaker-based and fails Central Hudson/Sorrell scrutiny; reversed on First Amendment grounds. |
Key Cases Cited
- Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (U.S. 2011) (speech as protected expression; content- and speaker-based restrictions subjected to heightened scrutiny)
- Central Hudson Gas & Electric Corp. v. Public Service Comm’n of N.Y., 447 U.S. 557 (U.S. 1980) (four-part test for commercial speech regulation)
- Brown v. Entertainment Merchants Ass’n, 131 S. Ct. 2729 (U.S. 2011) (content-based restrictions subject to strict scrutiny; applied to commercial speech)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDA labeling and premarket approval context for drug regulation)