Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia


On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce by promoting the drug, Xyrem, for off-label use in violation of the federal Food, Drug, and Cosmetic Act (FDCA). Caronia, a former Specialty Sales Consultant for Orphan Medical, Inc., appealed his conviction on the grounds that he was convicted for his speech when promoting Xyrem for off-label uses, in violation of the First Amendment. The Second Circuit agreed, holding that Caronia was convicted in violation of his right to free speech and vacating and remanding Caronia’s judgment of conviction to District Court.

Factual Background -

According to the opinion, the allegations against Caronia centered on his promotion of the drug, Xyrem, which was approved in July 2002 to treat narcolepsy patients who experience cataplexy. The drug’s label contained a boxed warning stating that safety and efficacy were not established in patients under 16. As described in the Second Circuit’s opinion, the federal government began an investigation of Orphan Medical and Dr. Peter Gleason, a paid physician speaker, in spring 2005 for alleged off-label promotion of Xyrem. The government obtained two tape-recorded conversations in which Caronia and Gleason promoted Xyrem for unapproved indications and subpopulations, including muscle disorders, chronic pain, daytime fatigue, excessive sleepiness, fibromyalgia, and patients under 16.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© King & Spalding | Attorney Advertising

Written by:


King & Spalding on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.