According to a recent Department of Justice News Report, Jet Medical Inc. (“Jet”) has agreed to settle violations of the Federal Food, Drug and Cosmetic Act (“FDCA”) and the False Claims Act (“FCA”) involving misbranding of its migraine headache device, Allevio SPG Nerve Block Catheter (“Allevio”)
Per court documents, between April 2014 and April 2019, Jet’s devices were misbranded under the FDCA and FCA because Jet did not seek approval or clearance from the FDA for the device before distributing the device into interstate commerce. Specifically, the documents indicated the company did not seek approval for the intended use. Jet did not conduct studies regarding Allevio’s safety and efficacy for such intended use.
Jet has entered into a deferred prosecution agreement as part of the criminal settlement along with criminal penalties totaling $200,000.
There also was an associated civil settlement of $545,133 in accordance with a whistleblower complaint allegedly stating violations of the False Claims Act by Jet and related companies, Medical Components Inc. and Martech Medical Products Inc. The alleged complaint included the submission of false claims to government programs for procedures using Allevio for such unauthorized FDA uses.
Principal Deputy Assistant Attorney General Brian M. Boynton states in the News Release, “The FDA approval and clearance process serves an important role in ensuring that devices used to treat patients are safe, effective, and medically appropriate. We will not permit companies to circumvent that process and put profits over patient safety.”
A copy of the DOJ News Release is available here.
For more information regarding DOJ enforcement, please see the Government Prosecutions section of the Enforcement Action Database.