By: Gayle S. Putrich
June 30, 2014
WASHINGTON — The U.S. Supreme Court has refused take on an appeal from medical device maker Medtronic Inc. in a liability lawsuit filed by an Arizona man allegedly left paralyzed by a device.
The refusal means that a lawsuit against the Minneapolis-based Medtronic can go forward in state courts.
The company had sought to have the original case, Stengel v. Medtronic, thrown out based on a legal concept that strictly limits the ability of individuals to sue for injuries allegedly caused by medical devices if those devices have been approved by the U.S. Food and Drug Administration, commonly called pre-emption.
A U.S. District Court judge initially shut down the lawsuit, citing preemption, but the 9th Circuit Court of Appeals, which is based in San Francisco, reinstated it. The Supreme Court’s refusal to hear Medtronic’s challenge to the appeals court’s decision means the original case can go forward.
Richard Stengel was left paralyzed in 2005 after the Medtronic SynchroMed EL pump and catheter surgeons implanted in 2000 allegedly malfunctioned. The pump was meant to deliver pain medication directly to his spinal cord but a mass grew on the end of the catheter. In 2005, Stengel collapsed because of the malfunctioning device and was left paralyzed from the waist down by the time doctors were able to remove it. Stengel, who has since died, sued, saying Medtronic learned the device was prone to such problems, but never told the FDA. His wife is pursuing the case.
Medtronic has argued that patients are not allowed use a state law to sue device makers for allegedly violating a duty under federal law.
Previous Supreme Court decisions have interpreted the federal law that governs medical device approval as limiting the types of suits patients can pursue. A trio of previous rulings, including two cases involving Medtronic — Medtronic v. Lohr in 1996 and Reigel v. Medtronicin 2008 — helped form that foundation of federal preemption and parallel claims for medical devices under the Food, Drug and Cosmetic Act.