Medical device distributor Jet Medical Inc has agreed to pay the United States government $200,000 to resolve criminal allegations related to misbranding of a migraine treatment, the Department of Justice (DOJ) has announced.
Jet Medical’s device, the Allevio sphenopalatine ganglion (SPG) nerve block catheter, was intended to treat migraine headaches by blocking the SPG, a small structure of neuronal tissue near the sphenopalatine implicated in orofacial pain.
The DOJ alleges that between April 2014 and April 2019, Jet Medical distributed Allevio devices for this intended use without obtaining approval or clearance from the US Food and Drug Administration (FDA), and did not study the safety and effectiveness of the device when used as intended.
As part of the settlement, the company admitted that it distributed misbranded devices in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and agreed to implement enhanced compliance measures.
“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,” principal deputy assistant attorney general Brian Boynton, head of the Justice Department’s civil division, said in a statement.
“Device manufacturers who circumvent the proper regulatory path in bringing their products to market endanger patients and put the public health at risk. We will continue to investigate and bring to justice companies that ignore the law and jeopardize the public health,” added Catherine A. Hermsen, assistant commissioner for criminal investigations at the FDA Office of Criminal Investigations.
Civil Settlement From Whistleblower Suit
The resolution also includes a civil settlement with the federal government under the False Claims Act (FCA) totalling $545,133.
Along with Jet, two related companies — Medical Components Inc. (MedComp) and Martech Medical Products Inc. (Martech) — are parties to the civil settlement.
This settlement resolves allegations in a qui tam (whistleblower) lawsuit that all three companies violated the FCA by causing medical providers to submit false claims to Medicare for procedures using the Allevio device.
The lawsuit alleged the Allevio was not approved or authorized by the FDA for use in SPG nerve blocks for the treatment of headache, and that the procedure was not covered by Medicare.
The suit further 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.
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