Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices.
In Stengel v. Medtronic, Inc., the Court ruled that neither the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) nor the U.S. Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee preempted state law tort claims based on a manufacturer's failure to monitor its class III medical devices and failure to disclose adverse events after PMA approval. This decision will directly affect class III medical device manufacturers that find themselves in court in the Ninth Circuit. However, because federal courts are divided on this issue, manufacturers should continue asserting all available preemption defenses until the U.S. Supreme Court resolves the dispute.
The Medical Device Amendments to the FDCA contain an express preemption provision that prohibits state law from imposing requirements on manufacturers of class III medical devices that are different to and/or additional to federal law. In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic, Inc. that while the MDA preempted state law claims that would impose additional and/or different requirements, it did not preempt parallel state law claims – i.e., claims premised on violations of FDA regulations.
In Stengel v. Medtronic, Inc., a class III medical device manufactured by Medtronic allegedly injured plaintiff Richard Stengel and caused him to become a paraplegic. Mr. Stengel and his wife asserted various claims against Medtronic, including claims for negligence and failure to warn based on allegations that Medtronic breached its "continuing duty to monitor the product after pre-market approval and to discover and report to the FDA any complaints about the product's performance and any adverse health consequences of which it became aware and that are or may be attributable to the product." The district court dismissed all of the Stengels' claims, finding them preempted by the MDA. A three-judge panel of the Court of Appeals for the Ninth Circuit affirmed.
The Court of Appeals for the Ninth Circuit, en banc, unanimously reversed the panel decision. The Court first analyzed whether the Stengels' claims based on Medtronic's failure to monitor and disclose adverse events discovered after PMA approval were "parallel" claims that were not preempted under the MDA. The Court ruled that they were parallel claims because they were based on violations of FDA regulations and did not seek to impose any obligations that were in addition to or different from federal law. The Court reasoned that the MDA did not preempt these claims because they did not seek to impose any state law obligations that were in addition to or different from federal law.
The Court further ruled that Stengel's claims were not preempted under the U.S. Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, which dismissed, as preempted, claims based on allegations that a manufacturer committed fraud on the FDA during the PMA approval process. In Stengel, the Court reasoned that the plaintiff's claims "[are] independent of the FDA's pre-market approval process that was at issue in Buckman." In doing so, the Court adopted a very narrow interpretation of Buckman – i.e., that the case involved exclusively federal-based claims. According to the Ninth Circuit, therefore, Buckman preemption bars only federal claims based exclusively on violations of federal law – not state law claims based on fraud-on-the-FDA. The Court used this narrow interpretation of Buckman to rule that state law claims based on failure to monitor devices and disclose adverse events to FDA after PMA approval are not preempted.
The Stengel decision is a victory for plaintiffs as it joins the Fifth Circuit in narrowing the scope of Riegel and Buckman preemption. Federal courts nationwide are divided on whether these types of claims for failure to disclose information to FDA after PMA approval are preempted. Until the Supreme Court addresses this issue, device manufacturers are wise to continue asserting preemption challenges to these claims.