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# Don’t Criminalize Device Truthful Speech: WLF
- URL: https://www.fdaweb.com/dont-criminalize-device-truthful-speech-wlf/
- Published: 2021-07-29T12:00:00.000Z
- Updated: 2026-09-14T17:08:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149821

Washington Legal Foundation (WLF) is asking the 1st Circuit Court of Appeals to reverse on First Amendment grounds the criminal convictions of two former medical device company executives under the Federal Food, Drug, and Cosmetic Act (FFDCA). WLF submitted an *amicus* brief on behalf of the two Acclarent former executives who were convicted of misdemeanor adulteration and misbranding under the FFDCA for distributing a medical device (the Relieva Stratus microflow spacer) for an off-label use.

At trial, WLF [says](https://www.wlf.org/2021/07/29/communicating/wlf-urges-first-circuit-not-to-criminalize-truthful-non-misleading-speech-about-medical-devices/?ref=fdaweb.com), the jury found that no defendant made false or misleading statements, nor had any intent to defraud or mislead, and thus acquitted the two on all charges requiring an intention or knowledge of wrongdoing. “That means,” WLF says, “the primary evidence of guilt supporting the defendants’ misdemeanor convictions was their truthful, non-misleading speech about Stratus’ off-label uses.”

The brief says the conviction cannot stand because 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 FFDCA’s misbranding and adulteration regulations, as applied here, are content-, viewpoint-, and speaker-based restrictions on speech that cannot withstand strict scrutiny,” WLF concludes.