Jet Medical Inc., a Pennsylvania-based medical device distributor, has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment.
The agreement, announced by the federal government, follows allegations that between April 2014 and April 2019, Jet Medical 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.
The Allevio SPG Nerve Block Catheter (Allevio), a device 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, was at the center of the allegations. The government alleged that Jet Medical 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.
As part of the agreement, Jet Medical admitted to distributing 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. 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. “We will not permit companies to circumvent that process and put profits over patient safety.”
Jet Medical Inc., a medical device distributor, has agreed to pay a total of $745,133 to resolve allegations relating to the distribution of misbranded medical devices. The agreement includes a $200,000 fine and a $545,133 civil settlement under the False Claims Act (FCA).
Defendant: Jet Medical Inc.
Criminal Charges: Distributing misbranded medical devices in violation of the FDCA.
City and State: Pennsylvania
Exact Date: April 2014 to April 2019
Sentence or Outcome: $745,133 in fines and civil settlements
Dollar Amounts: $200,000 fine, $545,133 civil settlement
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Key Facts
- State: Pennsylvania
- Category: White Collar Crime
- Source: DOJ Press Release â†â€â€
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