A Kentucky woman is suing Medtronic and the FDA alleging that the devicemaker’s spinal cord stimulator made her pain worse and that the agency didn’t diligently review updates to the implant.
Angela Yates had a Medtronic spinal cord stimulator implanted in June 2015 when the device had its original FDA premarket approval granted in 1984, according to her lawsuit filed April 18 in the U.S. District Court for Minnesota. Since then, Medtronic submitted hundreds of PMA supplements to upgrade the stimulator’s software and capabilities.
The lawsuit alleges that Medtronic “avoided the rigorous scientific review, public comment, and clinical trial requirements intended by Congress for Class III medical devices” through the PMA supplement process.
Ms. Yates alleges that these updates “materially altered” the original PMA configuration of her implant, and she suffered complications traceable to its upgrades.
She is seeking compensatory, statutory and punitive damages, along with attorney’s fees. The lawsuit also seeks declaratory relief that the FDA’s continued approval of device modifications without a new premarket approval is unlawful.
Medtronic did not respond to an April 22 request for comment.
“While Medtronic has deep sympathy for Ms. Yates, we believe this case lacks merit,” a spokesperson for Medtronic said in an April 23 email to Becker’s. “Patient safety is a top priority at Medtronic and we stand by quality of our device.”
A spokesperson for the FDA said the agency doesn’t comment on ongoing litigation.
