“FDCA prosecutions for truthful speech are denying doctors access to the best available information about FDA-approved drugs and devices, interfering with delivery of state-of-the art medical care.”
— Cory Andrews, WLF General Counsel & Vice President of Litigation

Click here for WLF’s brief.

WASHINGTON, DC— Washington Legal Foundation (WLF) yesterday urged the U.S. Court of Appeals for the First Circuit to reverse, on First Amendment grounds, the criminal convictions of two medical-device company executives under the Food, Drug, and Cosmetic Act (FDCA). WLF’s amicus brief was prepared with substantial pro bono assistance from Joel Kurtzberg, Adam Mintz, John Macgregor, and Jason Rozbruch of Cahill Gordon & Reindel LLP.

Bill Facteau and Patrick Fabian, former executives of medical-device maker Acclarent, were convicted of misdemeanor adulteration and misbranding under the FDCA for distributing a medical device for an “off-label” use. At trial, however, the jury found that no defendant made false or misleading statements, nor had any intent to defraud or mislead, and so acquitted on all charges requiring mens rea. That means the primary evidence of guilt supporting the defendants’ misdemeanor convictions was their truthful, non-misleading speech about Stratus’s off-label uses.

As WLF’s amicus brief explains, the defendants’ convictions cannot stand. Under the First Amendment, a criminal conviction cannot be based on truthful, non-misleading speech about a drug or device’s off-label use. The FDCA’s misbranding and adulteration regulations, as applied here, are content-, viewpoint-, and speaker-based restrictions on speech that cannot withstand strict scrutiny.    

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