United States v. Caronia
703 F.3d 149, 2012 U.S. App. LEXIS 24831, 92 A.L.R. Fed. 2d 721 (2012)
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Rule of Law:
The government cannot prosecute pharmaceutical manufacturers and their representatives under the Federal Food, Drug and Cosmetic Act (FDCA) for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug, as such a prosecution unconstitutionally restricts free speech under the First Amendment.
Facts:
- Orphan Medical, Inc. (later Jazz Pharmaceuticals), a pharmaceutical company, manufactured Xyrem, a powerful central nervous system depressant whose active ingredient is gamma-hydroxybutryate (GHB), federally classified as the “date rape drug.”
- In July 2002 and November 2005, the FDA approved Xyrem for specific medical indications: treating narcolepsy patients experiencing cataplexy, and treating narcolepsy patients with excessive daytime sleepiness (EDS).
- Due to serious safety concerns, the FDA required a “black box” warning for Xyrem, stating its safety and efficacy were not established in patients under 16 years of age and with very limited experience among elderly patients; its distribution was restricted to one centralized pharmacy.
- In March 2005, Orphan hired Alfred Caronia as a Specialty Sales Consultant to promote Xyrem, with his salary based on individual sales performance.
- Caronia initiated Orphan’s “speaker programs” for Xyrem, enlisting physicians, including Dr. Peter Gleason, to speak to other physicians about FDA-approved drug uses.
- In the spring of 2005, the federal government began an investigation of Orphan and Dr. Gleason, focusing on the off-label promotion of Xyrem.
- On October 26, 2005, Caronia was audio-recorded promoting Xyrem to Dr. Stephen Charno (a government cooperator posing as a prospective customer) for unapproved indications like insomnia, fibromyalgia, periodic leg movement, restless leg, Parkinson’s, and MS, and suggested its use for patients as young as fourteen.
- On November 2, 2005, Caronia arranged a meeting where Dr. Gleason also promoted Xyrem to Dr. Charno for unapproved uses, including for patients under age thirteen, and for obesity and chronic fatigue.
Procedural Posture:
- Orphan Medical, Inc. (Caronia's employer) and Dr. Peter Gleason (an Orphan speaker) were charged under the FDCA's misbranding provisions and both pled guilty.
- On July 25, 2007, a grand jury returned its first Indictment against Alfred Caronia.
- On August 19, 2008, the government filed a Superseding Information charging Caronia with two misdemeanor offenses: Count One (conspiracy to introduce a misbranded drug into interstate commerce) and Count Two (introducing a misbranded drug into interstate commerce).
- On October 9, 2007, before trial, Caronia moved to dismiss the charges, arguing they violated his First Amendment free speech rights and were unconstitutionally vague and broad.
- On September 11, 2008, the United States District Court for the Eastern District of New York (Eric N. Vitaliano, J.) denied Caronia's motion to dismiss, holding that the FDCA, to the extent it criminalized speech, passed constitutional muster under the commercial speech doctrine.
- The case proceeded to a jury trial from October 6 to October 16, 2008.
- On October 23, 2008, the jury found Caronia guilty as to the first prong of Count One (conspiracy to introduce a misbranded drug into interstate commerce) and not guilty on the second marketing prong of Count One and on Count Two.
- After the jury verdict, Caronia renewed his Rule 29 motion for acquittal, which the district court denied on December 13, 2008.
- On November 30, 2009, the district court sentenced Caronia to one year of probation, 100 hours of community service, and a $25 special assessment.
- Caronia appealed his judgment of conviction to the United States Court of Appeals for the Second Circuit.
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Issue:
Does the government's prosecution of a pharmaceutical sales representative under the Federal Food, Drug and Cosmetic Act (FDCA) for truthful, non-misleading promotion of an FDA-approved drug for off-label use violate the First Amendment's guarantee of free speech?
Opinions:
Majority - CHIN, Circuit Judge
Yes, the government's prosecution of Alfred Caronia for promoting an FDA-approved drug for off-label use violated his First Amendment right to free speech. The Court vacated the conviction, concluding that the government prosecuted Caronia for his speech alone, not merely using it as evidence of intent. The FDCA and its regulations do not expressly prohibit off-label promotion but rather reference promotion as evidence of a drug's intended use. The Court employed constitutional avoidance, construing the FDCA narrowly to avoid serious First Amendment issues. Applying the Sorrell v. IMS Health, Inc. framework, the Court found the government's construction of the FDCA's misbranding provisions to criminalize off-label promotion to be content- and speaker-based, thus subject to heightened scrutiny. Even under the less rigorous Central Hudson intermediate scrutiny test, the prohibition failed. First, off-label promotion concerns lawful activity and was not deemed false or misleading. Second, while the government's asserted interests in drug safety and the integrity of the FDA approval process are substantial, the prohibition on off-label promotion does not directly advance these interests because off-label use itself is legal and physicians may still prescribe drugs for off-label purposes. Criminalizing manufacturer promotion, while allowing others to speak about it, paternalistically interferes with informed treatment decisions. Third, the prohibition is not narrowly drawn, as numerous less speech-restrictive alternatives exist, such as warning systems, disclaimers, or even prohibiting the off-label use entirely, without resorting to a complete criminal ban on truthful promotion.
Dissenting - DEBRA ANN LIVINGSTON, Circuit Judge
No, Alfred Caronia's conviction should be affirmed because the First Amendment does not prohibit the government from using speech as evidence of motive or intent. Judge Livingston argued that Caronia was convicted of conspiring to introduce a "misbranded" drug into interstate commerce, where "misbranded" means its labeling lacks adequate directions for its intended uses. Promotional speech, like Caronia's, serves as evidence of these "intended uses" under FDA regulations (21 C.F.R. § 201.128), which is a long-settled principle in food and drug law. This is consistent with Wisconsin v. Mitchell, which holds that the First Amendment does not prohibit the evidentiary use of speech to establish elements of a crime or prove intent. The prosecution did not target Caronia's speech directly as the crime itself, but rather used it to prove his intent to distribute a misbranded drug. She contended that allowing off-label marketing would undermine the entire FDA premarket approval process, which is a substantial government interest in ensuring drug safety and efficacy. She maintained that the ban on such promotion is a narrowly drawn and necessary tool to encourage drug manufacturers to seek approval for new uses. She distinguished Sorrell and Thompson by arguing that those cases involved direct regulation of speech, whereas here, speech was evidence of intent for an underlying conduct-based crime, and that the majority's reasoning would invalidate the foundational definitions of "drug" and "device" in the FDCA.
Analysis:
This case significantly strengthens First Amendment protections for commercial speech, particularly concerning pharmaceutical marketing. By ruling that truthful, non-misleading off-label promotion of FDA-approved drugs cannot be criminalized, the Second Circuit limited the FDA's enforcement powers and prompted a reevaluation of how the agency regulates drug promotion. The decision emphasized the distinction between speech as evidence of intent (permissible under Mitchell) and speech as the actus reus of a crime (subject to heightened scrutiny). It underscored the importance of Central Hudson's third and fourth prongs (direct advancement and narrow tailoring) in the context of commercial speech, suggesting that paternalistic bans on information are disfavored, especially when less restrictive alternatives exist. This ruling has broad implications for pharmaceutical companies, potentially allowing them greater latitude in communicating information about drug uses, and could influence future challenges to government regulation of commercial speech across various industries.
