WASHINGTON – The U.S. Supreme Court rejected an appeal Monday from medical device manufacturer Medtronic challenging an Arizona man’s lawsuit that claimed the company’s pain-medication pump left him paralyzed below the waist.
Medtronic argued that federal rules pre-empt Arizona law, which should have prevented Richard and Mary Lou Stengel from suing the company under state law. But the high court, without comment, declined to hear the case and let a lower court ruling against Medtronic stand.
Thomas Cotter, the Stengels’ attorney, was not immediately available for comment. But Scott Nelson, an attorney with the Public Citizen Litigation Group, who helped prepare the Stengels’ case to the Supreme Court, said he was pleased with Monday’s decision and hopes other courts will now be willing to hear cases of injuries caused by medical devices.
Medtronic’s attorneys declined to comment, but the company said in an emailed statement that it was disappointed with the denial. The company still maintains that exclusive Food and Drug Administration oversight is necessary to maintain safe and effective medical devices.
“Without pre-emption, there would be no central standard for device safety, effectiveness, testing, labeling and marketing,” the statement said.
The case began in 2000, when Richard Stengel had a Medtronic medication pump surgically implanted, according to court records. In 2005, he began to suffer paralysis in his lower limbs caused by a granuloma, a type of inflammation that he said formed in his spine at the tip of the pump, according to court documents.
Doctors removed the pump, but Stengel eventually lost the use of his legs. He has since died.
The Stengels charged that Medtronic knew about the risks associated with the pump, but did not reveal that information until the FDA inspected its facilities in 2006 and 2007 and issued a warning letter to Medtronic. The company recalled the device in March 2008.
The Stengels sued in 2010, alleging strict liability, breach of warranty and negligence. They subsequently claimed the company had violated Arizona’s negligence law by failing to warn the FDA about the pump’s risks.
A district court found that federal law pre-empted the state-law claim, since the pump had met the FDA’s pre-market approval. That ruling was upheld by a three-judge panel of the 9th U.S. Circuit Court of Appeals in 2012.
But the full circuit court unanimously reversed that decision in 2013, writing that Arizona law “parallels” federal laws and that Stengel deserved a chance to sue.
In its petition to the U.S. Supreme Court, Medtronic argued that the FDA regulations are exclusive to the federal government and cannot be enforced by states.
“Private enforcement … would jeopardize the public health by permitting lay juries to second-guess the FDA’s expert regulatory judgment,” the company said in its petition to the high court.
That was echoed in several briefs in support of Medtronic. The Defense Research Institute said the Supreme Court should weigh in to clarify the case’s pre-emption issues and the extent of federal control over manufacturers.
Eric Magnuson, who co-wrote the institute’s brief, said he was disappointed by the high court’s denial, but would not speculate on what it means.
“It’s kind of like reading tea leaves,” he said. “When they say no, you can think of a hundred different ways they may justify that.”
The Stengels’ attorneys had argued that Medtronic’s arguments were “overblown and incorrect,” pointing to three previous Supreme Court cases – two involving Medtronic – that support the circuit court’s ruling.
The U.S. Solicitor General also urged the high court not to take Medtronic’s appeal, saying the 2012 ruling by the circuit court panel misinterpreted federal pre-emption laws.
“Most prominently, the correct analysis of the express pre-emption question would not be available to this Court because it would result in a more favorable judgment for” the Stengels, the solicitor general’s brief said.