On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two related companies also agreed to pay $545,000 in a civil settlement involving the same device. The device, Allevio SPG Nerve Block Catheter, was intended to treat migraine headaches by administering nerve blocks to a collection of nerves located in the midface of the skull.
The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution. The government also alleged that Jet Medical did not conduct an investigational study regarding the device's safety and effectiveness when used as intended. Violations of this nature constitute criminal charges under the FDCA. As part of a deferred prosecution agreement, which must be approved by the court, Jet Medical admitted that it distributed misbranded devices and agreed to implement enhanced compliance measures.
In addition to the criminal charges, a civil lawsuit filed under the qui tam or whistleblower provision of the False Claims Act alleged that Jet Medical and two related companies, Medical Components Inc. and Martech Medical Products Inc., violated the...
WASHINGTON, D.C., DC, UNITED STATES, May 6, 2026 /EINPresswire.com/ -- Brown, LLC, a nationally recognized whistleblower law firm and leader in False Claims Act (FCA) litigation, today announced t...