U.S. Medical Device Distributors Resolve Allegations

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 government under the False Claims Act (FCA), equaling $545,133.

In a U.S. Department of Justice statement, FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen highlighted the importance of public safety.

“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,” Hermsen said. “We will continue to investigate and bring to justice companies that ignore the law and jeopardize the public health.”

What are SPG blocks?

SPG blocks are growing in popularity for chronic migraines and some severe non-migraine headaches. Commercially available options include the Tx360 and SpenoCath devices, according to information from Blue Cross BlueShield of North Carolina.

Research has been conducted to test the efficiency of the SPG blocks, although it is limited. Clinical trials at the University of California San Francisco Headache Center are evaluating the FDA-approved SphenoCath, with some results still pending.

A study from the Middle East tested the efficiency of the SPG block Sphenocath in 2018. Fifty-five patients were involved in the study, with a sufficient majority of those receiving relief within 24 hours after treatment. Few adverse effects were detected.

What is a migraine?

Migraines are headaches that can cause throbbing pain or a pulsing sensation, in most cases to one side of the head. They are a common condition, with an estimated 15.3% of Americans aged 18 or older reporting migraines in the previous three months, based on data from the CDC.

Four stages of migraines:

  1. Prodrome - Usually occurring one to two days before the onset of a migraine, including symptoms of constipation, mood swings, hunger, neck tightness, repeated yawning, and increased urination.
  2. Aura - Depending on the individual, an aura may occur prior to or during migraines. Aura examples include visual phenomena, vision loss, weakness or numbness in the face or one-half of the body, and trouble communicating verbally.
  3. Attack - Migraine attacks can last from four to 72 hours without medication. The pain usually occurs on side of the head but can occur on both sides. Other symptoms include sensitivity to light, sound, smell, touch, nausea, and vomiting.
  4. Post-drome - Following the pain of an attack, some may feel tired or demented for up to a day while others experience symptoms of elation. It is important to rest following a migraine, as quick head movement may trigger more pain.

Migraines vs. other headaches

Cluster headaches are unique, procuring severe pain and commonly occurring the same way every time. The pain lasts from one to three hours, ranging from every other day or a few times throughout the day.

Tension-type headaches are the most common primary headache disorder that features tightness around the head that can translate into the neck. Both migraines and tension headaches are more common in women, while cluster headaches affect more males. Tension-type headaches usually last for a few hours but can linger on for days.

Medication-overuse headache is caused by the constant use of medication to cure a headache. It is the most common secondary headache disorder, with symptoms occurring at their peak in most cases in the morning. Medication-overuse headaches affect more men than women.

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