The Minnesota Court of Appeals is reviving a lawsuit against Medtronic from the mother of a deceased patient, despite the medical device maker's insistence in court filings that it is all but immune from personal liability in such cases.
The mother of Florida teen Kaitlyn M. Jones sued Medtronic in 2016, arguing that the company's SynchroMed II implantable drug pump became clogged and failed to deliver required doses of a powerful drug to treat Jones' spastic quadriplegia from severe cerebral palsy. Jones died in 2014 from a bowel problem related to her withdrawal from the drug that her pump was supposed to deliver, the lawsuit alleges.
A Hennepin County District judge granted Medtronic's motion to dismiss the case, finding most of its claims "pre-empted" by the federal law that gives the Food and Drug Administration the exclusive authority to regulate the safety of the riskiest devices. This week, a three-judge panel of the state appeals court disagreed, and reinstated many of Patricia Jones' claims against the Minnesota-operated device maker.
The underlying allegations — that Medtronic knowingly sold a bad device that harmed Kaitlyn Jones — have yet to go to trial, which means her mother's legal team would still need to prove that Medtronic was liable for her death in order to win the case.
"We were dismayed to learn of the death in this case and our thoughts are with the patient's family," Medtronic spokesman Eric Epperson said via e-mail. "While we are disappointed that the appellate court has allowed certain claims to move forward, the ruling addresses preliminary issues and is not a decision on the merits of the case. We continue to have strong defenses to the remaining claims and will pursue those defenses vigorously."
Similar patient lawsuits are pending, though it's not clear how many. Medtronic has not disclosed the total to investors in securities filings.
A Medtronic filing with the Minnesota appeals court on Nov. 17 cited seven other SynchroMed II lawsuits that were dismissed in recent years by courts in Ohio, Tennessee, Texas, Louisiana, New York and Illinois because judges found the claims were pre-empted by federal law.
In the medical device litigation context, "pre-emption" refers to Congress' decision to give the FDA exclusive authority to regulate risky Class III medical devices. That means consumer-protection laws in the 50 states cannot impose additional requirements on Class III medical devices, and they cannot be used to enforce federal law in cases where plaintiffs disagree with the FDA's enforcement decisions.