The DOJ just announced that medical device companies Jet Medical Inc. (Jet), Medical Components Inc. (MedComp), and Martech Medical Products Inc. (Martech) agreed to pay $545,133 to settle allegations of violating the False Claims Act (FCA) by distributing misbranded medical devices. Jet will also receive deferred prosecution and pay $200,000 to resolve related criminal allegations.
According to court information, between April 2014 and April 2019, Jet introduced the Allevio SPG Nerve Block Catheter (Allevio) into interstate commerce without FDA clearance or approval. Instead, Jet misbranded the devices under the Federal Food, Drug and Cosmetic Act (FDCA) without seeking proper approval. Jet marketed that Allevio treated migraines by administering nerve blocks to a collection of nerves located in the deep midface of the skull. However, Jet never conducted investigational studies regarding Allevio’s effectiveness or safety.
The FCA civil lawsuit alleged Jet, MedComp, and Martech coached medical providers to submit false claims to Medicare for procedures using Allevio. Medical procedures using Allevio were not covered by Medicare as the devices were not authorized for their intended use by the FDA. This suit was initiated under the qui tam provisions of the FCA, which allow individuals to bring lawsuits against companies who defraud the federal government.
The criminal and civil matters were brought in the United States District Court for the Southern District of Illinois. In addition to paying $200,000, Jet also agreed to implement enhanced compliance measures and admitted to misbranding the Allevio devices. U.S. Attorney Rachelle Aud Crowe for the Southern District of Illinois noted that “[t]his resolution reflects our commitment to holding companies accountable for violating the integrity of the FDA approval process and placing profits over people.”
The attorneys at Chilivis Grubman represent clients of all types and sizes in connection to health care fraud and False Claims Act litigation. If you need assistance with such a matter, please contact us today.