Jet Medical, Related Firms Fined $700K to Settle Allegations

Jet Medical, a Penn.-based medical device distributor, will pay $200,000 to settle criminal allegations concerning a migraine headache treatment. Jet and two related firms will also pay $545,000 in a civil settlement involving the same device.
 
In criminal information filed today in the Southern District of Illinois, the government alleged between April 2014 and April 2019 Jet introduced misbranded devices into interstate commerce because the company didn’t gain approval or clearance from the FDA before distributing them.
 
The device, the Allevio SPG nerve block catheter, aimed to treat migraines via nerve blocks to the sphenopalatine ganglion (SPG), a collection of nerves deep in the skull’s midface. Jet is alleged to never have sought approval or clearance from the FDA to distribute Allevio for this use, nor did the company conduct an investigational study on Allevio’s safety and effectiveness.
 
Jet admitted that it distributed misbranded devices in violation of the Federal Food, Drug and Cosmetic Act (FDCA) and agreed to enact enhanced compliance measures. Related companies Medical Components Inc. (MedComp) and Martech Medical Products Inc. are also parties to the civil settlement.
 
“The FDA approval and clearance process serves an important role in ensuring that devices used to treat patients are safe, effective, and medically appropriate,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will not permit companies to circumvent that process and put profits over patient safety.”
 
“Medical device companies put vulnerable patients at risk when they fail to follow FDA’s standards and requirements,” U.S. Attorney Rachelle Aud Crowe for the Southern District of Illinois told the press. “This resolution reflects our commitment to holding companies accountable for violating the integrity of the FDA approval process and placing profits over people.”
 
“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,” added Assistant Commissioner for Criminal Investigations Catherine A. Hermsen of the FDA Office of Criminal Investigations. “We will continue to investigate and bring to justice companies that ignore the law and jeopardize the public health.”
 
“This medical device distributor undermined the integrity of the FDA approval process and disregarded patient safety for personal profit,” said Special Agent in Charge Curt L. Muller of the Department of Health and Human Services, Office of Inspector General (HHS-OIG). “Working closely with our law enforcement partners, we will continue to investigate and hold accountable those who put the health and safety of patients at risk and waste valuable taxpayer dollars.”
 
Specifically, the whistleblower lawsuit alleged Jet, MedComp, and Martech violated the FCA by causing medical providers to submit false claims to Medicare for procedures using Allevio. The lawsuit alleged Allevio wasn’t approved or authorized by the FDA for SPG nerve blocks to treat headaches, and the procedure wasn’t covered by Medicare. The suit alleged Jet, MedComp, and Martech instructed, coached, and encouraged medical providers to submit improper billing codes to Medicare for reimbursement of services using Allevio.