The U.S. Court of Appeals for the Second Circuit issued a 2-1 opinion invalidating the conviction of Alfred Caronia, a former sales consultant for Orphan Medical, Inc., now known as Jazz Pharmaceuticals. In 2008, a New York jury found Caronia guilty of conspiracy to introduce a misbranded drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (“FDCA”). In its case, the government alleged that Caronia promoted the drug Xyrem for off-label use.
According to the Opinion, Xyrem is a powerful central nervous system depressant that can cause serious side effects including seizures, dependence, coma, and death. Xyrem was approved by the Food and Drug Administration (“FDA”) to treat narcolepsy patients who experience cataplexy and those with excessive daytime sleepiness. In addition, the FDA required that a black box warning be placed on the drug stating it had not been established as safe and effective for patients under 16 years old.
The FDCA prohibits the promotion of drugs for uses or at doses not approved by the FDA. At trial, the government alleged that Caronia had told potential physician-customers that Xyrem could be used to treat fibromyalgia, chronic fatigue and chronic pain and in patients under 16, even though it had not been approved by the FDA for treatment of those conditions or in patients that young.
The jury found Caronia guilty of conspiracy to introduce a misbranded drug into interstate commence under 18 U.S.C. § 371(a) and 21 U.S.C.§ 331(a) and sentenced him to one year of probation and 100 hours of community service. On appeal, Caronia argued that the misbranding provisions of the FDCA prohibit off-label promotion and, as such, restrict free speech in violation of the First Amendment.
In the Opinion, Circuit Judges Raggi and Chin agreed with Caronia and found that the government could not prosecute pharmaceutical representatives under the FDCA for speech promoting the lawful, off-label use of an FDA approved medication. Circuit Judge Livingston issued a dissenting opinion. The Opinion can be found here.