Preemption holds that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval. But the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.
In 2000, plaintiff Richard Stengel began using Medtronic’s SynchroMed EL pain pump, an implanted device that delivers medication directly to the spine via an intrathecal catheter. In 2005, Stengel began developing symptoms of paralysis from an inflammation in his spine around the catheter tip. The device and most of the inflammation were removed, "but not in time to prevent the granuloma from rendering Stengel permanently paraplegic," according to court documents.
The FDA approved the first SynchroMed pump in 1998 and later granted approval for the iteration used to treat Stengel. Medtronic recalled that device in 2008.
The U.S. Court of Appeals for the 9th Circuit upheld a lower court’s ruling dismissing Stengel’s case on preemption grounds, but the 3-judge panel’s decision earned a sharp rebuke from a lone dissenter.
"Has Congress or the Supreme Court created such freedom from liability for the manufacturers of such sensitive devices that only in nonexistent cases are the manufacturers subject to suit for damages?" wrote Judge John Noonan, according to court documents. "Are individuals injured by the malfunction of such devices without remedy against the manufacturers of them? That appears to be the conclusion of this court today with its holding that the [Medical Device Act] explicitly preempts and implicitly preempts any state remedy of damages for violation of a state requirement paralleling the MDA."
Judge J. Clifford Wallace, writing for the majority, said the law is clear on the issue of pre-emption.
"We recognize that it may seem harsh to deny compensation to a person who alleges serious injury from a medical device," Wallace wrote. "But such is the direction from the Supreme Court for cases like the one before us. We are required to follow the Court."
Noonan argued that the Stengel’s lawsuit ought to stand because it presents a parallel claim.
"Nothing in the statute prevents provision by a state of ‘a traditional damages remedy’ for violation of ‘state duties’ that parallel the federal requirements," Noonan wrote. "The Stengels have alleged a valid parallel state law cause of action. Arizona law imposes requirements that parallel the requirements under federal law, and Arizona law provides a remedy in damages for the violation of the state requirement."
Medtronic Donna Marquard spokeswoman said the company is pleased that the appeals court’s decision was "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 pre-market approval process for medical devices," according to Cronkite News.
"We are disappointed," Stengel lawyer Thomas Cotter told the news site, declining to comment further.
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