Becker’s reported on two spine-related lawsuits since April 23, and both focused on spinal cord stimulator devices.
1. 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. 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.
2. A woman who had a spinal cord stimulator implanted in 2020 is suing devicemaker Boston Scientific and the FDA over complications she experienced with the device. Dena Lawler received the Spectra WaveWriter spinal cord stimulator to manage chronic lumbar postlaminectomy syndrome and refractory back pain, according to the lawsuit filed May 1 in the U.S. District court for Central California. Within a month of her initial surgery, she began experiencing new and worsening symptoms. The lawsuit alleged that substantial modifications to Ms. Lawler’s original implant affected its safety and efficacy and that Boston Scientific improperly used the premarket approval supplement pathway to implement updates instead of a new PMA review.
