Distributor of migraine devices settles DOJ misbranding claims

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Medical device distributor Jet Medical Inc has agreed to pay the United States government $200,000 to resolve criminal allegations related to the misbranding of a migraine treatment, the Department of Justice announced (DOJ ).

Jet Medical’s device, the Allevio Sphenopalatine Ganglion (SPG) Nerve Block Catheter, was intended to treat migraines by blocking the SPG, a small neural tissue structure near the sphenopalatine involved 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 United States Food and Drug Administration (FDA), and did not not studied the safety and effectiveness of the device when used as intended.

As part of the settlement, the company admitted to distributing mislabeled devices in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act) and agreed to implement enhanced compliance measures.

“The FDA’s approval and clearance process plays an important role in ensuring that devices used to treat patients are safe, effective, and medically appropriate. Brian Boynton, head of the Justice Department’s Civil Division, said in a statement.

“Device makers who circumvent the proper regulatory pathway in bringing their products to market endanger patients and put public health at risk. We will continue to investigate and bring to justice companies that ignore the law and endanger public health,” added Catherine A. Hermsen, assistant commissioner for criminal investigations in the FDA’s Office of Criminal Investigations.

Civil whistleblower lawsuit settlement

The resolution also includes a civil settlement with the federal government under the False Claims Act (FCA) totaling $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 the three companies violated the FCA by requiring healthcare providers to submit false claims to Medicare for procedures using the Allevio device.

The lawsuit alleged that Allevio was not approved or cleared by the FDA for use in SPG nerve blocks for the treatment of headaches, and that the procedure was not covered by Medicare.

The lawsuit further alleged that Jet, MedComp, and Martech instructed, coached, and encouraged medical providers to submit incorrect billing codes to Medicare for reimbursement for services using the Allevio device.

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