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Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.

A bit of background first.

In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by and in the name of the United States”—impliedly preempts any private suit seeking to enforce the FDCA. Thus, under Buckman, a state-law tort claim is barred by federal law if it “exist[s] solely by virtue of the FDCA.” 531 U.S. at 353.

In PLIVA, Inc., v. Mensing, 564 U.S. 604 (2011), the Supreme Court held that federal law impliedly preempts state-law failure-to-warn claims based on a generic drug manufacturer’s failure to give warnings different from those given by the drug’s brand-name manufacturer on its FDA-approved labeling. Such claims are impliedly preempted, the Court explained, because it is impossible for a generic manufacturer to simultaneously comply with a purported state-law duty to provide additional warnings and the federal requirement that generic labels be identical to their brand-name equivalents.

Ever since Buckman and Mensing were issued, the plaintiff’s bar has attempted to evade their holdings. A recently decided case, Bennett v. Teva Pharma. USA, Inc., 2021 WL 797834 (D. Del. 2021), involves one such attempt. More accurately, it involves three such attempts. The Bennett plaintiffs claimed that the defendant generic drug manufacturer was liable on three different failure-to-warn theories. The court rejected each as impliedly preempted.

In the course of doing so, the court made several statements that can be usefully cited not only by generic drug manufacturers but also by their brand-name competitors and medical-device manufacturers.

Claiming to have been injured by the generic version of a drug, the Bennett plaintiffs alleged that its manufacturer had failed to adequately warn of the risks associated with the drug. In particular, the plaintiffs alleged that the manufacturer had: (1) failed to distribute sufficient quantities of the FDA-mandated medication guides to ensure that a guide reached every patient; (2) failed to report adverse events to the FDA as required by the FDCA; and (3) misrepresented the drug as safe for a particular off-label use in purported violation of the FDCA’s misbranding prohibition.

Despite acknowledging that each theory of liability was premised on an “alleged violation[] of the FDCA,” the Bennett plaintiffs maintained that their claims were “not barred by Buckman because the claims” supposedly did “not exist solely by virtue of the FDCA.” 2021 WL 797834, at *2–3. Specifically, the plaintiffs argued that their claims were based on “pre-existing state duties” because the defendant’s alleged conduct purportedly violates Delaware’s misbranding statute and the Restatement (Second) of Torts § 388, which the state’s courts have adopted.

The court was not convinced. And rightly so.

The fact that the defendant’s alleged conduct might violate Delaware’s misbranding statute did not save the claims from preemption under Buckman because the state statute expressly incorporates the FDCA’s definition of misbranding. Thus, the duties that it imposes neither “predate nor exist independent of the FDCA.” 2021 WL 797834, at *3. Accordingly, the court concluded that even if based on a violation of Delaware’s misbranding statute, the plaintiffs’ claims were “prohibited by § 337(a) and preempted under Buckman.” Id.

That holding is relevant to all manufacturers regulated under the FDCA—whether they manufacture generic drugs, branded drugs, or medical devices.

As in Bennett, plaintiffs frequently assert negligence-per-se claims predicated on an alleged violation of the FDCA. Many courts properly reject such claims, either because state law does not recognize negligence-­per-se claims where the statute allegedly violated does not contain a private right of action or because they understand such claims to be preempted under Buckman. Other courts, however, have allowed such claims to proceed, reasoning that they are not preempted under Buckman because state negligence-per-se law does not depend on the existence of the FDCA. That of course ignores the fact that negligence per se is necessarily predicated on the violation of a statute or regulation that imposes substantive requirements. As the Bennett court recognized, when a particular negligence-per-se claim is based on the alleged violation of the FDCA, that particular claim “exist[s] solely by virtue of the FDCA” and is therefore impliedly preempted by § 337(a). Buckman, 531 U.S. at 353.

The plaintiffs’ reliance on Restatement (Second) of Torts § 388 fared no better. Although the provision requires manufacturers to give adequate warnings, it does not, the Bennett court noted, “refer[] to, let alone impose[] an obligation on drug manufacturers to distribute, Medication Guides,” which are “a creature of the FDA.” 2021 WL 797834, at *3. Similarly, “Section 388 … says nothing about an obligation to report adverse events to the FDA.” Id. at *4. Thus, the duty to distribute Medication Guides and the duty to file adverse-event reports “arise” not from § 388 but from the FDCA and its implementing regulations. Id. Accordingly, any private action based on an alleged failure to fulfill those duties is “barred by § 337(a) and Buckman.Id. In other words, a plaintiff cannot rely on a general state-law duty to warn to impose liability for violation of the FDCA. Given that 21 U.S.C. § 337(a) applies to all aspects of the FDCA, that is true whether the claim at issue implicates a generic drug, a branded drug, or a medical device.

The final piece of the Bennett decision is limited to generic drugs, but no less welcome.

Despite the plaintiffs’ insistence that they were not seeking a labeling change, the Bennett court concluded that they did seek such a change and that their claims were therefore preempted under Mensing. Given their insistence that the alleged failure to submit adverse-event reports and alleged failure to warn against a particular off-label use constituted failures to warn under state law, the plaintiffs were, the court found, contending that the defendant’s labeling was inadequate and therefore had to be changed as a matter of state law. As recognized in Mensing, however, “[g]eneric manufactures … are prohibited by federal law from changing their labels to meet state-law warning requirements.” 2021 WL 797834, at *4. Because it was impossible for the defendant generic drug manufacturer to simultaneously comply with the purported state-law duty to change its label and the federal duty to “keep the label the same” as the corresponding branded label, the plaintiffs’ claims did not “escape preemption under Mensing.Id.