Medtronic (NYSE:MDT) and the FDA have earned significant victories in a Minnesota court related to spinal cord stimulator (SCS) lawsuits.
The medtech giant had faced claims that its SCS systems implanted in four patients caused damages, while the plaintiffs alleged that the company avoided regulatory scrutiny related to updates.
In a decision leveled on Tuesday, Judge Patrick J. Schiltz of the U.S. District Court for the District of Minnesota ruled Tuesday that all claims from three plaintiffs were time-barred. It only allowed claims from one plaintiff to proceed.
The lawsuit relates to Medtronic SCS implants received by plaintiffs Cathryn Keys, Dilly Anderson, Doyle Hayes and Theresa Goodman. They asserted product liability and related claims against Medtronic and sought to sue the FDA, claiming the devices failed to undergo the proper regulatory approval process.
Keys’ case, for example, outlined that Medtronic initially won FDA approval in 1984 for its Itrel II SCS system. Since that initial approval, the company has more than 400 FDA premarket approval (PMA) supplements to expand the system. Changes include updates to pulse generator hardware, leads, software, firmware, stimulation waveforms, battery chemistry, surgical implantation tools and labeling.
Keys herself received the Medtronic Intellis system implant in 2019. The suit said that Medtronic supplemented the system through a series of streamlined FDA processes. These processes didn’t require new clinical testing, including 30-day notices and real-time review pathways.
Decisions favor Medtronic and the FDA, but one remains
Medtronic earned the decisions from the court with respect to Keys’, Anderson’s and Goodman’s complaints, with those dismissed in their entirety.
Schlitz’s decision said that Goodman’s claims of product liability, personal injury, warranty and misrepresentation claims are time-barred. Likewise, Hayes’ claims of the same, which relate to an implant received in 2019, also register as time-barred. Anderson’s fall under the one-year statute of limitations in Kentucky, meaning complaints over the implant received in 2018 are time-barred.
Anderson, Keys and Hayes all received instructions to turn off their devices by mid-2019 because of pain and complications. Schlitz stated that this offered “more than enough to put them on notice” that their devices may cause the injuries they experienced. According to the court, Goodman never received instruction to turn off her device. However, she experienced “dramatic” new symptoms within two weeks of implantation. Schlitz said these symptoms also would have raised alarm early enough to take action.
The court also granted the motion to dismiss Hayes’ claim against the FDA and remaining claims against Medtronic, apart from claims of a manufacturing defect related to the SCS Hayes received in March 2024.
According to the court, Hayes’ claim for strict liability is preempted, based on the process Medtronic followed in manufacturing his device. Hayes claimed Medtronic’s defect included improper assembly, defective battery control firmware, flawed charging telemetry integration and defective anchoring or lead stabilization mechanisms. This “parallel” claim is not preempted.
Medtronic argued insufficiency in the claim, but the court said Hayes’ parallel claim of defects in the 2024 device “is sufficiently pleaded.”
