Medtronic has prevailed in a personal injury lawsuit over a deep-brain stimulation implant approved by the FDA to treat neurological disorders.
A federal judge in Philadelphia on Monday granted the company’s motion to dismiss the lawsuit filed by Edward Walls and his wife, Tonya Chavis-Walls. The couple had claimed in Pennsylvania state court that two Activa deep-brain stimulators and one deep brain stimulator lead surgically implanted in Edward Walls were defective, lacked adequate instructions and warnings and were negligently designed and produced, according to the complaint. The FDA approved Activa in 1997.
Medtronic had the case moved to federal court, where it argued that it complied with the FDA’s stringent premarket approval (PMA) process, in which the agency approves a device only if it finds there is a reasonable assurance of its safety and effectiveness.
The company also argued that it satisfied the standard set by the U.S. Supreme Court in a 2008 case, Riegel v. Medtronic. Riegel preempts claims made in state courts that would require a judge or jury to impose different requirements than those imposed by the PMA process.
Judge Gerald McHugh of U.S. District Court for Eastern Pennsylvania dismissed the Walls’ lawsuit on the grounds that it could not overcome the standards set by Riegel. But he left the door open to the couple to pursue another case against Medtronic “because I cannot definitively conclude that allowing Plaintiffs to amend the Complaint would be futile on the record before me,” he wrote.
Medtronic did not respond to repeated requests for comment.
