Second Circuit Issues Long-Anticipated Decision In Caronia – Pharmaceutical Misbranding Conviction Reversed On First Amendment Grounds

Posted On Tuesday, December 4, 2012

Drug manufacturers may not be prosecuted for promoting off-label uses of their products, the U.S. Court of Appeals for the Second Circuit ruled Monday.

The court concluded that federal drug laws do not criminalize off-label promotion, so long as it is truthful and not misleading.  To rule otherwise, the court wrote, “would raise First Amendment concerns” because off-label use of prescription drugs generally is not illegal.

The 2-to-1 decision in United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir., December 3, 2012) has potentially wide-ranging ramifications for pharmaceutical regulation and free-speech law.

In Caronia, a pharmaceutical sales representative promoted to doctors off-label uses for Xyrem, a powerful central-nervous-system depressant with an active ingredient that is classified as a date-rape drug.  The FDA had approved Xyrem for use by narcolepsy patients who suffer either from excessive daytime sleepiness or cataplexy, a condition involving sudden weakening or paralysis of muscles.  But Caronia touted the drug’s benefits for treating other disorders, including insomnia, fibromyalgia and Parkinson’s disease.   Based on this off-label promotion, Caronia was charged with and convicted of conspiring to introduce a misbranded drug into interstate commerce.

On appeal, Caronia argued that the conviction violated his First Amendment right to free speech.  Avoiding the constitutional question, the Second Circuit instead ruled that the criminal ban on misbranding does not cover off-label promotion.  But the court made clear that an interpretation of the law that allowed prosecution for off-label promotion would “run afoul of the First Amendment.”  

“[P]rohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information,” the court wrote.

Judge Debra Ann Livingston dissented, saying the majority’s opinion “calls into question the very foundations of our century-old system of drug regulation.”

A link to the full decision can be found here.