People who are suffering from a migraine headache will do just about anything to make it stop, but they often find that nothing helps very much. So, you can imagine the excitement that frequent migraine sufferers felt when they heard about a new device that promised to use new technology to end their pain.
According to the manufacturers, this wasn’t just some phony snake oil promising miracles it couldn’t deliver. They said their device was approved by the FDA.
Unfortunately, this turned out to be false. Whether the device works or not, it has not yet been approved by federal regulators.
The device, Allevio SPG Nerve Block Catheter, is intended to block nerve endings in the skull that contribute to migraines. The manufacturers marketed the device from 2014 through 2019 using claims that it had been approved by the FDA.
This was not true, and so the FDA took action. Recently, the FDA announced that it had reached agreement with Jet Medical and other medical device companies to settle claims that they had mislabeled the device when they claimed it was FDA-approved. The companies will pay a total of $745,000.
Slipping through the cracks
The FDA requires medical device makers to put their products through extensive testing before they can go to market. This arrangement has its bad points: The regulatory process can sometimes drive up prices and make it harder for consumers to get the treatments they need. But the great advantage of the process is that it protects the public from potentially dangerous medical devices.
Of course, even the most rigorous regulatory system in the world can’t catch everything. Sometimes a dangerous device slips through the cracks and enters the marketplace. Sometimes, a company markets a device using false or even deceptive information that can mislead consumers. Sometimes, people get hurt.
Those who have been injured by defective medical devices have rights. Attorneys help the injured and their families assess their legal options.