United States v. Caronia

Alfred Caronia (defendant) was a pharmaceutical sales representative for Orphan Medical, Inc. (Orphan). Orphan produced the drug Xyrem, a central nervous system depressant whose active ingredient was gamma-hydroxybutyrate. Gamma-hydroxybutyrate—also known as GHB—could cause serious side effects and medical problems and was also classified as a drug used by perpetrators of date rapes. The Food and Drug Administration (FDA) approved Xyrem to treat narcolepsy patients with certain symptoms. The FDA also required Orphan to put a black-box warning on Xyrem explaining that Xyrem should not be taken by patients younger than 16 years of age or certain elderly patients. Caronia, whose salary was based on his sales of Xyrem, developed a speaker program for specialist physicians to promote Xyrem to other physicians. Among the specialist physicians hired by Orphan was Dr. Peter Gleason. Under Orphan’s procedures, Caronia was not allowed to specifically promote unapproved, or off-label, uses of Xyrem. Gleason, on the other hand, was allowed to describe his own experience prescribing Xyrem for off-label uses to other physicians. The United States government (plaintiff) opened an investigation into Orphan, believing that Orphan and its employees were promoting Xyrem for off-label uses. The government recorded Caronia and Gleason promoting Xyrem for unapproved uses and for use by unapproved patients. The government charged Caronia, Gleason, and Orphan with off-label promotion of Xyrem in violation of the Federal Food, Drug, and Cosmetic Act. Gleason and Orphan pleaded guilty, but Caronia pleaded not guilty. At trial, Caronia was convicted. Caronia appealed his conviction, arguing that his off-label promotion of Xyrem was speech protected by the First Amendment to the United States Constitution. The government argued that it used Caronia’s speech promoting Xyrem for off-label uses as proof of his intent to violate the law by introducing a misbranded pharmaceutical into interstate commerce (an offense that included marketing the pharmaceutical for an unapproved use), not as the cornerstone of his prosecution.