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Media Alerts - United States v. Caronia - Second Circuit
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December 4, 2012
  United States v. Caronia - Second Circuit
Headline: Second Circuit Reverses Conviction of Pharmaceutical Sales Representative for Promoting Drug for "Off-Label" Use, Holding that the Government's Interpretation of the FDCA Violates the First Amendment

Area of Law: First Amendment

Issue Presented: Whether the First Amendment is violated by the FDA's interpretation of the FDCA as prohibiting pharmaceutical representatives from promoting drugs for non-FDA approved uses.

Brief Summary: The Food and Drug Administration ("FDA") has interpreted the Food, Drug and Cosmetic Act ("FDCA") as prohibiting representatives from pharmaceutical companies from promoting drugs for non-FDA-approved uses (often referred to as "off-label" uses), even though physicians can ultimately prescribe them for such uses. The defendant, a pharmaceutical sales representative, was convicted of conspiracy to introduce a misbranded drug into interstate commerce due to recordings in which he told a physician about the off-label uses of a narcolepsy drug called Xyrem. He argued that his conviction violated his free speech rights, and the Second Circuit agreed, vacating his conviction. To read the full opinion, please visit

Extended Summary: After a jury trial in the Eastern District of New York, pharmaceutical sales representative Alfred Caronia was convicted of conspiracy to introduce a misbranded drug into interstate commerce, in violation of the Federal Drug and Cosmetic Act ("FDCA"). The FDCA states that before drugs are distributed into interstate commerce, the Food and Drug Administration ("FDA") must approve them for specific uses. Doctors, in turn, can prescribe prescription drugs for both FDA-approved and unapproved (or "off-label") uses. The FDCA does, however, prohibit "misbranding" - i.e., when a drug's labeling fails to bear "adequate directions" regarding the drug's intended uses. Moreover, the FDA has stated that "an approved drug that is marketed for an unapproved use (whether in labeling or not) is misbranded." Under this interpretation, the government has repeatedly prosecuted pharmaceutical companies and their representatives for misbranding based on their promotion of drugs for off-label uses.

The government's prosecution of Caronia, who worked for a pharmaceutical company now known as Jazz Pharmaceutical, stemmed from his promotion of Xyrem, a powerful depressant that is FDA-approved for two types of narcolepsy. During an undercover investigation, the government recorded Caronia telling a doctor (secretly working for the government) that Xyrem might also be useful for conditions including insomnia, fibromyalgia, and restless leg syndrome. He also stated that Xyrem could be used for patients under age sixteen, even though the FDA had not approved it for this population. The government accordingly brought misbranding charges against Caronia. Caronia moved to dismiss the charges, arguing that the application of the FDCA's misbranding provisions to his statements about the drug's potential off-label uses violated his free speech rights. The district court rejected this argument, however, and Caronia was convicted of conspiracy to introduce a misbranded drug. After being sentenced to one year of probation, 100 hours of community service, and a $25 special assessment, he appealed.

On appeal, in a 2-1 split, the Second Circuit overturned Caronia's conviction. The government had argued that the First Amendment was not implicated in this case, contending that Caronia was not prosecuted for his speech itself, and that his speech had instead "served merely as 'evidence of intent'" regarding whether Xyrem had been misbranded. The court rejected this view, stating that "the government clearly prosecuted Caronia for his words - for his speech." The court explained that "the government never suggested, for example, that Caronia conspired to place false or deficient labeling on a drug. Rather, the record makes clear that the government prosecuted Caronia for his promotion and marketing efforts."

Having concluded that the government indeed prosecuted Caronia for his speech, the Second Circuit further held that this was impermissible. The court's analysis relied heavily on a recent Supreme Court case, Sorrell v. IMS Health, which stated that speech in aid of pharmaceutical marketing was protected by the First Amendment, and that regulations on such speech - if those regulations were content-based and speaker-based - would be subject to heightened scrutiny. Here, the Second Circuit held that the government's construction of the FDCA's misbranding provisions as prohibiting the promotion of off-label drug use by pharmaceutical manufacturers was indeed both content-based (distinguishing between favored and disfavored speech on the basis of the ideas expressed) and speaker-based (distinguishing between what pharmaceutical manufacturers and other speakers could say about drugs). Moreover, the court held that the government could not justify its criminal prohibition of off-label promotion under such scrutiny. "As off-label drug use is not itself prohibited, it does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government's goals of preserving the efficacy and integrity of the FDA's drug approval process and reducing patient exposure to unsafe and ineffective drugs," the court reasoned, further describing the prohibition as "paternalistic." Accordingly, the Second Circuit vacated Caronia's conviction.

Judge Livingston dissented. "Alfred Caronia was convicted of conspiring to introduce a prescription drug into interstate commerce with the intent that it be used in ways its labeling neither disclosed nor described," she asserted. "This internet was revealed, inter alia, through his speech." She disagreed with the majority that the government had prosecuted Caronia for his speech itself, instead agreeing with the government's contention that it had simply used his speech as evidence of intent.

Panel: Circuit Judges Raggi, Livingston, and Chin

Argument: 12/2/2010

Date of Issued Opinion: 12/3/2012

Docket Number: 09-5006-cr

Decided: Vacated and Remanded

Case Alert Author: Emily Gold Waldman

Counsel: Douglas Letter and Martin Coffey, for Loretta E. Lynch, U.S. Attorney for the Eastern District of New York, Brooklyn, NY, for Appellee.

Jennifer L. McCann, Law Offices of Thomas F. Liotti, Garden City, New Nork, for Defendant-Appellant.

Eric E. Murphy, Jones Day, for Amicus Curiae Washington Legal Foundation.

Author of Opinion: Judge Chin (majority); Judge Livingston (dissent)

Case alert Circuit Supervisor: Emily Gold Waldman

Edited: 12/12/2012 at 10:15 AM by Media Alerts Moderator

    Posted By: Emily Waldman @ 12/04/2012 03:47 PM     2nd Circuit  

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