On July 28, 2021, WLF urged the First Circuit to reverse, on First Amendment grounds, the criminal convictions of two medical-device company executives under the FDCA.  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 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. As WLF’s amicus brief explains, the defendants’ convictions cannot stand. As applied here, the FDCA’s misbranding and adulteration regulations, are content-, viewpoint-, and speaker-based restrictions on speech that cannot withstand strict scrutiny. 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.


WLF brief