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Court rejects man’s suit over medical device he claims paralyzed him

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WASHINGTON – A federal appeals court said Monday that an Arizona man cannot sue a medical device manufacturer under state law for injuries from a pain pump that he said left him paraplegic.

A divided three-judge panel of the 9th U.S. Circuit Court of Appeals upheld a lower court ruling that said Richard Stengel’s state claims against Medtronic Inc. were pre-empted by federal law, even as it conceded that denying him compensation “may seem harsh.”

In a sharp dissent, Judge John Noonan said it appeared that courts had left “individuals injured by the malfunction of such devices without remedy against the manufacturers.”

A spokeswoman for Medtronic said the company was pleased that the 9th Circuit panel had issued a ruling “consistent with other federal circuit court and Supreme Court rulings that have upheld the doctrine of federal pre-emption for devices which have gone through the rigorous premarket approval process for medical devices.” Donna Marquard said the company had no further comment on the case.

Thomas Cotter, an attorney for Richard and Mary Lou Stengel, would not comment on the decision except to say, “We are disappointed.”

Richard Stengel began using a Medtronic pump in 2000. The implanted device delivered medication through a spinal catheter to control pain.

But in 2005, he began developing symptoms of paralysis that were determined to be caused by a granuloma, an inflammation in his spine that grew around the catheter tip. Doctors removed the device and most of the granuloma “but not in time to prevent the granuloma from rendering Stengel permanently paraplegic,” the court said.

Medtronic first won Food and Drug Administration approval for a pain pump in 1998 and won approval in 1999 for the pump Stengel used. But it recalled the pump in 2008.

The Stengels filed suit in Arizona state court against the company, accusing it of negligence, breaches of express and implied warranties and strict liability.

The Stengels subsequently amended their complaint to argue that Medtronic did not have adequate procedures for examining complaints about the device and reporting them to the FDA. They claimed Richard’s paralysis could have been avoided had Medtronic followed the reporting requirements and doctors had learned of the possibility of inflammation sooner.

But the district court ruled that the couple’s claims were pre-empted by federal law and the stringent premarket approval process put in place by the FDA.

The circuit court agreed, saying FDA regulations trump legal claims questioning the safety of medical devices that have already been granted premarket approval.

“The claims generally challenged the safety and effectiveness of Medtronic’s pump without any hint of an allegation that Medtronic’s conduct violated FDA regulations,” the court said. In order for these claims to be legally valid, the Stengels would have had to show that the device should have had a different design or different label warnings from FDA requirements, the court said.

The appellate ruling said Congress established the premarket approval process “as an important balance between getting help to patients who need it as soon as possible and protecting patients who will use the newly proposed help.”

“It is a balance we must observe. Any change must be made by Congress itself,” the appellate ruling said.

But Noonan said that nothing in the law prevents state damages from being awarded for breaking state rules that “parallel” federal ones.

“Nothing in the statute prevents provision by a state of ‘a traditional damages remedy’ for violation of ‘state duties’ that parallel federal requirements,” he wrote.

He asked whether courts were granting “freedom from liability” to all medical manufacturers, except in non-existent cases.