WLF: Obama Sides with Plaintiffs’ Bar on Medical Device Preemption

Posted in Regulatory and Compliance by Jamie Hartford on June 27, 2014

The Washington Legal Foundation (WLF) says a recent Supreme Court brief filed by the solicitor general “provides another example of just how committed the administration is” to the mutually beneficial relationship between the government and the plaintiffs’ bar.

The WLF says the government’s position urging the court to deny review in a medical device preemption case ignores an express preemption statute and asks the court to effectively overrule its 2008 propreemption decision in Riegel v. Medtronic, in which the court affirmed the doctrine of preemption protection for PMA devices.

The solicitor general’s office submitted its brief in connection with a petition seeking review of a 9th Circuit Appeals Court decision that claims involving a PMA device for delivering pain medication were not preempted. The petition notes that appeals courts have had difficulty determining the meaning of the possibility left open in Riegel that some state law claims might escape preemption if they were “parallel” to federal law.

“In urging the court to deny the petition, the [s]olicitor [g]eneral said that any conflict over the scope of the parallel claims exception was largely irrelevant,” the WLF says, because that section of the law is wholly inapplicable when, as in this case, the plaintiffs’ failure-to-warn claim asserts that the manufacturer failed to make unilateral labeling changes to warn of safety concerns that came to light only after FDA approved the device for marketing.

“The [s]olicitor [g]eneral did not mention that adoption of his position would effectively eliminate federal preemption of tort claims involving PMA devices,” the WLF says. “Failure-to-warn claims are always based on an assertion that the manufacturer failed to warn of newly-discovered safety risks. His position would also effectively overrule Riegel, which was premised on the court’s conclusion that Congress intended to preempt most tort claims involving PMA devices.”

WLF says the solicitor general “ought to openly admit what the administration is attempting to do. Instead, his brief disingenuously asserts that his position is consistent with Riegel. But his argument—that federal law should not preempt those failure-to-warn claims based on assertions that a manufacturer failed to make unilateral labeling changes to warn of newly discovered safety concerns—is drawn from cases addressing implied preemption claims. That case law … has little or no relevance to medical devices, which are subject to the express preemption mandate.”

—Jim Dickinson is MD+DI's contributing editor. 



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plaintiff's bar?

Perhaps the administration is also committed to injured parties being able to have their day in court, something denied to them by preemption.