June 27--WASHINGTON -- The U.S. Supreme Court has declined to hear an appeal from Medtronic Inc. to stop a liability lawsuit stemming from a medical device that allegedly left an Arizona man paralyzed.
Medtronic wanted the case thrown out based on a legal concept that severely limits the ability to sue for injuries caused by devices approved by the U.S. Food and Drug Administration. The concept is called pre-emption.
A federal district judge initially disallowed the suit, but a federal appeals court reinstated it. The Supreme Court's refusal to hear Medtronic's challenge to the appeals court decision means the case can go forward.
Richard Stengel was left paralyzed in 2005 after the alleged malfunction of a Medtronic device that surgeons implanted in 2000. The device delivered pain drugs to his spinal cord. An inflammatory mass grew on the end of the catheter that delivered the pain drugs.
In 2005, Stengel collapsed because of the malfunctioning device. But by the time doctors removed it, he was paralyzed from the waist down.
Stengel sued, saying Medtronic learned the device was prone to such problems, but never told the FDA.
Stengel has since died, his lawyers told the courts. His wife continues to pursue the case. The Stengels' attorneys could not be reached for comment.
In an e-mail statement to the Star Tribune, Medtronic said it "will continue to vigorously defend the case."
The company also maintained that the case should not have been allowed to proceed, despite the Supreme Court's refusal to hear the company's appeal.
"FDA experts and the FDA's premarket approval (PMA) process are best suited to oversee and regulate medical devices and determine if a product is safe and effective," the company said. "Without pre-emption, there would be no central standard for device safety, effectiveness, testing, labeling and marketing, which would ultimately be detrimental to patients, their safety, and their access to medical innovation."
Stuart Goldenberg, a Minneapolis lawyer who is trying to overcome pre-emption in several cases involving another Medtronic device, Infuse, said the Supreme Court decision was important because it did not expand its interpretation of pre-emption. But Goldenberg noted that the appeals court decision in the Stengel case does not force any other federal courts to follow its lead.
For victims of bad devices, said Goldenberg, the best hope is that other courts will voluntarily adopt the standard "that a company has to report any adverse events to the FDA."
Jim Spencer -- 1-202-383-6123
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