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Law Prohibits Arizona Man from Filing Suit Against Medtronic

An Arizona man has been denied permission to file suit against Medtronic for a pain pump gone bad. The pump, which had been implanted into Richard Stengel’s spine for pain relief in 2000, eventually was involved in him becoming a paraplegic, Stengel alleges.

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. Despite this ruling, the panel conceded the ruling seemed dispassionate.

Medtronic is distancing itself slightly from this case. Donna Marquard, spokesperson for the company, told Medical product Outsourcing, “Medtronic is pleased with the court’s decision, which is consistent with other federal circuit court and Supreme Court rulings that have upheld the doctrine of federal preemption for devices which have gone through the rigorous premarket approval process for medical devices.” There was no further comment.

"To the extent the Stengels’ claims are based on the theory that state law required Medtronic to warn consumers about the dangerous condition of its pain pumps without first receiving an order to do some from the [U.S.] Food and Drug Administration (FDA), the state law establishes a requirement different of the [federal Food, Drug and Cosmetic Act]," wrote Senior Judge John Wallace.

Judge John Noonan was critical of the law, stating that the courts had left “individuals injured by the malfunction of such devices without remedy against the manufacturers.”

The problem with Stengel’s claims was that they insisted on a problem with the device rather than targeting Medtronic and possible company violations of FDA regulation. Because he questioned the device, and because the device had already been approved for market by the FDA, he was unable to proceed with the suit. In order to legally validate the claims he did make, Stengel would have had to demonstrate that the device should have had a different design or different label warnings from FDA requirements, the court said.

The device worked by providing a controlled delivery of pain medication via and implanted catheter. In 2005, five years after implantation, Stengel began showing signs of paralysis. By the time the pump was removed, it was too late, and his condition devolved into paraplegia rendering him unable to move his lower body in at all. His physicians confirmed that a granuloma had formed around the catheter tip – an inflammation of the spine.

Although law prohibits Stengel from suing based on the device’s malfunction itself because it was FDA-approved, the device was recalled in 2008. It had been on the market for ten years. Critic Judge Noonan wrote in his dissent with the ruling that should there be more applicable cases raised, Stengel’s case would be able to move forward.

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