Medical device distributors were forced to pay nearly $750,000 to resolve criminal allegations regarding a piece of equipment used for migraine headache treatments.
Jet Medical Inc. paid $200,000 to settle criminal allegations regarding a product used to treat migraine headaches. Jed Medical and two other medical device distributors paid an additional $545,000 for settlements involving the same device.
The two other culprits involved featured Medical Components Inc. (MedComp) and Martech Medical Products Inc. (Martech).
The device in question is the Allevio SPG Nerve Block Catheter (Allevio). It was used to treat migraines by administering nerve blocks to the sphenopalatine ganglion (SPG), a group of nerves deep in the middle of the skull.
Accusations filed in the Southern District of Illinois claim the device used was misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA). Jet Medical never received approval from the FDA for their device nor did they conduct any studies to test Allevio’s efficiency and safety.
U.S. Attorney Rachelle Aud Crowe for the Southern District of Illinois says the medical device companies involved put at-risk patients in danger by not meeting FDA standards.
The resolution was announced last Wednesday, with Jet Medical agreeing to not only pay the $200,000 criminal allegation penalties but also admit its fault in violating the FDCA. Another part of the resolution was a civil settlement with the three device distributors and the federal...
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