July 28, 2014

Second Circuit Reverses Conviction for Off-Label Promotion Based on First Amendment

In U.S. v. Caronia, the U.S. Court of Appeals for the Second Circuit recently reversed the criminal conviction of a pharmaceutical sales representative for the off-label promotion of a prescription pharmaceutical based on the First Amendment. The court summarized its decision as follows: "We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA approved prescription drugs...We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug."

Albert Caronia was a sales representative for Orphan Medical, Inc. n/k/a Jazz Pharmaceutical. Caronia was responsible for marketing Xyrem, a powerful central nervous system depressant, the active ingredient of which is known as the "date rape drug." Xyrem was approved to treat patients with narcolepsy who experience either excessive daytime sleepiness or cataplexy, a condition associated with weak or paralyzed muscles. Caronia was secretly recorded promoting Xyrem to a physician for treating fibromyalgia, chronic pain, chronic fatigue, and other non-approved, "off-label" uses. Based on this evidence, a jury convicted him of conspiring to introduce a misbranded drug into commerce.

The Court of Appeals reversed the conviction, however, because it was based on speech protected by the First Amendment. Relying on the Supreme Court's 2011 decision in Sorrell v. IMS Health, the Second Circuit found that the prohibition on off-label promotion was a content-based and speaker-based restriction on speech and therefore subject to heightened scrutiny under the First Amendment. Although regulating the safety and effectiveness of medicines is a substantial governmental interest, the Court found the prohibition unconstitutional because it is not narrowly-tailored to directly advance the government's interest.

This ruling is potentially significant because the government has collected billions of dollars in fines and other monetary penalties, primarily from pharmaceutical companies but also from medical device firms, for off-label promotion of drugs and medical devices over the last decade or so. The decision continues a trend of courts relying on the First Amendment to cut back on the government's power to regulate food, drug, device and tobacco firms in certain ways. Other recent cases in this trend are summarized in the book chapter, "The FDA's Regulation of Off-Label Promotion: Has the Supreme Court's Decision in Sorrell v. IMS Health Cracked the Foundation?" which our group leader, Lynn Tyler, contributed to Inside the Minds: Recent Developments in Food and Drug Law by Aspatore Books.

Nonetheless, it would be a mistake for drug and device firms to conclude that it is "open season" for off-label promotion of their products. The Caronia court expressly stated that its decision was narrow and did not address the government's theory that it can use evidence of off-label promotion to show a regulated firm's intended use for a product and, if the intended use is not an approved use, to show that the product is misbranded. In Wisconsin v. Mitchell, the Supreme Court stated that the government can use speech as evidence of a crime. The government's error in Caronia was to treat his speech itself as the crime. Further, the court stated that the off-label use of drugs can lead to malpractice liability for physicians and negligence liability for pharmaceutical manufacturers. Thus, given the severe consequences potentially involved, drug and device firms should continue to be very cautious before engaging in any off-label promotion.


About the Author

Barnes & Thornburg's Food, Drug & Device Law practice group helps pharmaceutical, biotechnology, medical device, diagnostic, food, dietary supplement and cosmetic companies, as well as other healthcare entities, throughout the product lifecycle, from concept, development and approval to manufacturing, marketing, ongoing compliance, investigation, enforcement actions and litigation. We advise clients on the ever-evolving laws and FDA regulations that govern their products and components. Moreover, we have the government experience and industry knowledge necessary to...


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