A medical device distributor based in Pennsylvania Jet Medical Inc. (Jet) has agreed to pay a settlement of $200,000 to resolve criminal allegations regarding a migraine headache treatment. Additionally, Jet and two related companies will pay an additional $545,000 in a civil settlement for the same device.
In a criminal information filed today 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 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 announced today 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 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,” said U.S. Attorney Rachelle Aud Crowe for the Southern District of Illinois. “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,” said 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.”
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.
The resolution of this matter illustrates the government’s emphasis on combating health care fraud. The FCA is one of the most powerful tools in this effort. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services at 900-HHS-TIPS (800-447-8477).
The FDA’s Office of Criminal Investigations conducted the investigation.
Assistant U.S. Attorney Luke Weissler for the Southern District of Illinois and Trial Attorney David Hixson of the Civil Division’s Consumer Protection Branch, with assistance from the FDA’s Office of Chief Counsel, represented the government in the criminal case. Assistant U.S. Attorney Laura Barke for the Southern District of Illinois represented the government in the civil case.
Except as to conduct admitted in connection with the deferred prosecution agreement, the claims settled by the civil agreement are allegations only and there has been no determination of civil liability.