DOJThe Obama Administration has been a faithful friend of the plaintiffs’ bar, particularly regarding federal preemption of State-law tort claim against product manufacturers. The Food and Drug Administration has, for example, proposed a regulation (with direct input from plaintiffs’ lawyers) on labeling of generic drugs that would sweep away a federal preemption defense upheld twice by the U.S. Supreme Court.

A Supreme Court brief filed on May 20 by the Solicitor General of the United States provides another example of just how committed the Administration is to this mutually beneficial friendship. In urging the Court to deny review in a medical device preemption case, the brief urges the Court to ignore an express preemption statute and to effectively overrule its 2008 pro-preemption decision in Riegel v. Medtronic.

The Supreme Court has steered a middle course when previously considering claims that the federal statute at issue, 21 U.S.C. § 360k(a), preempts product liability suits against medical device manufacturers. It held in a 1996 case that federal law does not preempt claims involving the vast majority of medical devices: those devices being marketed based on a determination that they are “substantially equivalent” to devices already on the market as of 1976 (so-called § 510(k) devices).   The Court explained that FDA never undertook a formal review of the safety and effectiveness of such devices, and thus there was no reason to believe that Congress intended to prevent States from imposing their own safety and effectiveness requirements. The Court later held in Riegel that § 360k(a) generally does preempt design defect and failure-to-warn claims involving the small number of Class III devices that FDA has approved for marketing following a safety and effectiveness review undertaken in accordance with the agency’s rigorous pre-market approval (PMA) process.

The Solicitor General’s office submitted its brief in connection with a petition (Medtronic v. Stengel) seeking review of a U.S. Court of Appeals for the Ninth Circuit decision that claims involving a PMA device for delivering pain medication were not preemped. (WLF filed an amicus brief in support of certiorari). Riegel left open the possibility that some State law claims might escape § 360k(a) preemption if they were “parallel” to federal law; i.e., if the State were simply imposing the very same requirements on a device that FDA regulations specific to the device already imposed. Lower courts have struggled in the ensuing years to craft a workable definition of a “parallel claim,” and the Stengel petition asks the Supreme Court to resolve a well-entrenched conflict among the federal appeals courts regarding the meaning of the parallel-claims exception. Last October, the Supreme Court invited the Solicitor General to comment on the petition.

In urging the Court to deny the petition, the Solicitor General said that any conflict over the scope of the parallel-claims exception was largely irrelevant. That is so, he asserted, because § 360k(a) is wholly inapplicable whenever (as here) 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 Solicitor General did not mention that adoption of his position would effectively eliminate federal preemption of tort claims involving PMA devices. 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. The Court explained that Congress adopted § 360k(a) in order to minimize litigation-based obstacles to development of innovative medical devices that would improve public health. It held that the congressional text suggested that “the solicitude for those injured by FDA-approved devices . . . was overcome in Congress’s estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.”

There is nothing inherently improper, of course, about Obama Administration efforts to overrule case law disfavored by the plaintiffs’ bar. But the Solicitor General, in his role as the “Tenth Justice,” at least 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 (principally, the Court’s decision in Wyeth v. Levine) has little or no relevance to medical devices, which are subject to the express preemption mandate of  § 360k(a).

Amazingly, the Solicitor General asserts that all federal appeals courts have erred in their assumption that claims against manufacturers of PMA devices are preempted unless the plaintiff can fit within the parallel-claims exception. He suggests that is a reason to deny review in Medtronic v. Stengel: why waste resources examining the issue when the Ninth Circuit should have ruled that failure-to-unilaterally-update-the-labeling claims are never preempted? To the contrary, if the Solicitor General honestly believes that every federal appeals court has misinterpreted Riegel, that only strengthens the argument for granting review. If, on the other hand, the Court is unwilling to adopt the Solicitor General’s position that Riegel should be rendered meaningless (i.e., effectively overruled), then it ought to grant review in order to address the very real conflict among the federal appeals courts regarding the parallel-claims exception.

Also published at WLF’s contributor page