Pennsylvania-based medical device distributor Jet Medical Inc. (Jet) agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment, and Jet and two related companies agreed to pay another $545,000 in a civil settlement involving the same device. In a criminal information filed Wednesday in the Southern District of Illinois, the government alleged that, between April 2014 and April 2019, Jet introduced into interstate commerce devices that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distributing the devices. Jet’s device, the Allevio SPG Nerve Block Catheter (Allevio), was intended to treat migraine headaches by administering nerve blocks to the sphenopalatine ganglion (SPG), a collection of nerves located deep in the midface of the skull. The information alleges that Jet never sought approval or clearance from FDA to distribute the Allevio for this intended use, nor did Jet conduct an investigational study regarding the Allevio’s safety and effectiveness when used as intended.
The resolution includes a deferred prosecution agreement and criminal penalties totaling $200,000. As part of the deferred prosecution agreement, which must be approved by the court, Jet admitted that it distributed misbranded devices in violation of the FDCA and agreed to implement enhanced compliance measures. The resolution also includes a civil settlement with the federal government under the False Claims Act (FCA) totaling $545,133. Along with Jet, related companies Medical Components Inc. (MedComp) and Martech Medical Products Inc. (Martech) are parties to the civil settlement. The civil settlement resolves a lawsuit filed under the qui tam or whistleblower provision of the False Claims Act in the Southern District of Illinois. That lawsuit alleged that Jet, MedComp, and Martech violated the FCA by causing medical providers to submit false claims to the Medicare Program for procedures using the Allevio. The lawsuit alleged the Allevio was not approved or authorized by the FDA for use in SPG nerve blocks for the treatment of headaches, and that the procedure was not covered by Medicare. The suit alleged that Jet, MedComp, and Martech instructed, coached, and encouraged medical providers to submit improper billing codes to Medicare for reimbursement of services using the Allevio device.
