US Appeals Court Overturns Conviction in Off-Label Drug-Marketing Case

December 3, 2012—A three-judge panel of the Second US Circuit Court of Appeals in Brooklyn, New York, overturned the conviction of Alfred Caronia, a sales representative for Orphan Medical, Inc. (Minnetonka, MN), which was subsequently acquired by Jazz Pharmaceuticals Inc. (Palo Alto, CA). Mr. Caronia was convicted in federal court in 2009 for off-label marketing of the narcolepsy drug Xyrem for unapproved purposes, such as treating drowsiness and chronic fatigue.

The appeals court ruled that Mr. Caronia's statements were protected by free speech rights. According to a report by Thomas Burton in The Wall Street Journal, the decision could threaten US Food and Drug Administration rules that prohibit the marketing of drugs for off-label uses or those that are not specifically approved by the US Food and Drug Administration. The decision is also the subject of a Review & Outlook column in the The Wall Street Journal's editorial page and commentary in the paper's online Law Blog. Additional insights on the case are available online in a report by Katie Thomas in The New York Times and another by John Fauber in The Milwaukee Journal Sentinel.