On December 14, 2023, the First Circuit affirmed the criminal convictions of two medical-device company executives under the FDCA. The decision was a disappointment for WLF, which filed an amicus brief in the case urging reversal. Bill Facteau and Patrick Fabian, former executives of 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 also 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. WLF’s amicus brief argued that the FDCA’s misbranding and adulteration regulations, are content-, viewpoint-, and speaker-based restrictions on speech that cannot withstand strict scrutiny. WLF’s brief was prepared with substantial pro bono assistance from Joel Kurtzberg, Adam Mintz, John MacGregor, and Jason Rozbruch of Cahill Gordon & Reindel LLP.


WLF brief