Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies to medical devices, branded drugs, and generic drugs equally.
Medford v. Eon Labs, 2021 WL 5204035 (D.N.J. 2021), involved failure-to-warn and consumer-protection claims brought against generic drug manufacturers, specifically, manufacturers of Amiodarone, a generic version of Cordarone, which is used to treat irregular heartbeats.
The plaintiffs alleged that they or they decedents were injured when they were prescribed Amiodarone for treatment of atrial fibrillation. According to the plaintiffs, using Amiodarone to treat atrial fibrillation is an off-label use of the drug, whose FDA-approved label purportedly states that the drug is indicated for treatment of ventricular fibrillation and ventricular tachycardia.
The plaintiffs’ state-law claims rested on the contention that the generic drug manufacturers: 1. failed to distribute federally required Medication Guides; 2. promoted off-label use of Amiodarone; 3. failed to warn of the risks supposedly associated with off-label use of the drug; and 4. failed to submit adverse-event reports to the FDA.
The court held that the plaintiffs’ claims were impliedly preempted by federal law. The court relied—albeit indirectly—on 21 U.S.C. § 337(a) as authoritatively interpreted in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). Section 337(a) declares that all actions to enforce the Food, Drug, and Cosmetic Act “shall be by and in the name of the United States.” This, said Buckman, “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” with the FDCA. Id. at 349 n.4.” That the Medford court relied on Buckman, a device case, in a generic-drug case underscores the fact that § 337(a), the no-private-right-of-action provision, applies equally to all products regulated under the FDCA.
Plaintiffs’ claims were impliedly preempted by § 337(a) insofar as they rested on the manufacturers alleged failure to distribute Medication Guides because, said the court, their complaint did “not identify any state law requiring generic manufacturers to provide a Medication Guide.” 2021 WL 5204035, at *4. “[T]o the contrary,” their complaint “repeatedly reference[d] the FDA regulations on Medication Guides” as the basis for the manufacturers’ purported tort duty. Id. Thus, although the plaintiffs “couch[ed] their failure to warn claims in traditional state tort law, … the gravamen of these claims” was the defendants’ purported violation of “the FDA’s medication guide regulation.” Id. That, the court correctly concluded, is not allowed under Buckman, which held that § 337(a) impliedly preempts all “state law claims that ‘“exist solely by virtue of the FDCA … requirements.”’” Id. (quoting Frei v. Taro Pharms. U.S.A., Inc., 443 F. Supp. 3d 456, 468 (S.D.N.Y. 2020), in turn quoting Buckman, 531 U.S. at 352).
Plaintiffs’ claims were also held impliedly preempted under Buckman insofar as they rested on the manufacturers’ purported promotion of Amiodarone for off-label use. The court explained that because there is no “applicable state law that parallels the FDCA’s” purported prohibition on off-label promotion, the plaintiffs’ off-label promotion claims “rest[ed] solely on federal law.” 2021 WL 5204035, at *4.
The same was true, the court said, insofar as the plaintiffs’ claims rested on the manufacturers’ alleged failure to file adverse-event reports with the FDA because “‘New Jersey is a jurisdiction that “declin[es] to recognize a separate state law duty to warn the FDA.”’” 2021 WL 5204035, at *4.
Notice that everything the court held would be equally true if analogous claims had been asserted against device manufacturers or branded-drug manufacturers. Nothing turns on the fact that a generic drug was at issue. Section 337(a) prohibits all private actions to enforce any provision of the FDCA, regardless of the product in question.
But, as noted at the outset, preemption does often depend on the product at issue. In Medford, the plaintiff’s claim that the generic-drug manufacturers were liable because they had failed to revise their labeling to warn of the risks supposedly associated with off-label use of Amiodarone was impliedly preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), because generic-drug manufacturers are unable to unilaterally change their warning labels, even in response to newly acquired information. The result might have been different under Wyeth v. Levine, 555 U.S. 555 (2009), had the drug in question been a branded drug because FDA regulations allow brandname manufacturers to unilaterally change their labeling under certain circumstances. If the product at issue were a medical device with premarket approval, the claim would not be impliedly preempted because device manufacturers also may unilaterally revise their labels under certain circumstances. But although not impliedly preempted if asserted in connection with a medical device, the claim would nonetheless be expressly preempted under 21 U.S.C. § 360k(a) because—as held in National Meat Association v. Harris, 565 U.S. 452 (2012)—state law may not require that which federal allow merely allows when federal law prohibits state requirements different from or in addition to federal requirements.
So, beware the differences between medical devices, branded drugs, and generic drugs, but also remember that 21 U.S.C. § 337(a) applies to each.