Medical Device Distributor Settles in Misbranding Lawsuit

Sarasota, FL (WorkersCompensation.com) – The Allevio SPG Nerve Block Catheter (Allevio), developed by neurologists, is a device that is used in treatment for chronic migraine and severe non-migraine headache. The sphenopalatine ganglion (SPG) is located by the bony structures of the nose and is connected to the trigeminal nerve which has been directly associated as the primary nerve causing headache disorders. Blocking the SPG as a pain management solution is done through the nose by topical application of local anesthetic to mucosa overlying the SPG. Application of those anesthetics is done through FDA approved catheters, which includes the SphenoCath®, Tx360® Nasal Applicator. 

Medicare and other large payers have developed coverage policies for the block procedure. As the Allevio device had supposedly gained FDA approval, many large payers specifically also included the Allevio device in their medical coverage policies.

However, in a recent news release by the Department of Justice (DOJ), the Allevio device was allegedly misbranded according to the Federal Food, Drug and Cosmetic Act (FDCA).

In fact, the DOJ alleges that between 2014 and 2019, Pennsylvania medical device distributor, Jet Medical, Inc. (Jet) distributed Allevio devices for the nerve block procedures without approval or clearance, and that there was no study for safety and effectiveness when used for the SPG procedure. 

In an effort to resolve these allegations, Jet along with companies MedComp and Martech have agreed to pay out more than $700,000. Jet has agreed to pay out $200,000 to resolve the criminal allegations. MedComp and Martech will pay out $545,000 in a civil settlement.

Filed in the Southern District of Illinois, the civil settlement resolves the allegations made in a qui tam or whistleblower lawsuit alleging that the three companies violated the FCA by causing providers to bill fraudulent claims to Medicare for a device that was not FDA approved. The lawsuit asserted that Jet, along with companies MedComp and Martech educated, coached and encouraged medical providers on the billing of procedures using the Allevio device.

Assistant Commissioner for Criminal Investigations, Catherine A. Hermsen of the FDA Office of Criminal Investigations, states that the FDA process is critical to patient safety stating, “Doctors and their patients rely on FDA oversight to ensure that the medical devices they depend upon are safe and effective for their intended uses. Device manufacturers who circumvent the proper regulatory path in bringing their products to market endanger patients and put the public health at risk.”

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