The United States Supreme Court’s most recent pronouncement on federal preemption, decided in the context of generic prescription drugs, appears destined to be at the forefront in future battles over unsettled questions regarding preemption in the context of nonprescription, over-the-counter (OTC) drugs. In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law preempted state law failure to warn claims asserted against generic drug manufacturers. The Court’s preemption holdings, couched in terms of “impossibility” borne out of federal regulatory requirements of “sameness,” could arguably have similar applicability in the context of OTC drugs regulated under the FDA’s “monograph” regime.

The doctrine of federal preemption is based on the Supremacy Clause of the United States Constitution. The Supremacy Clause provides that federal law is “the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. As such, any state law that conflicts with the exercise of federal power is preempted and has no effect. See Maryland v. Louisiana, 451 U.S. 725, 747 (1981).

State law is preempted under the Supremacy Clause where Congress has expressly preempted state law. See, e.g., Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, (1992). Preemption may also be implied to the extent that state law actually conflicts with federal law. English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). “Implied” or “conflict” preemption exists where (1) it is impossible for a private party to comply with both state and federal requirements, or (2) state law obstructs accomplishing and executing Congress’ full purposes and objectives. See Mensing, 131 S. Ct. 2567 (citing Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). In Mensing, the Supreme Court addressed implied preemption based on impossibility.

 Impossibility-Based Federal Preemption as Articulated by Supreme Court in Mensing

Mensing involved state law failure to warn claims asserted against generic prescription drug manufacturers, and alleged the manufacturers failed to provide adequate warning labels. Plaintiffs claimed that state law required the manufacturers to use a different, safer label.

However, the Mensing Court determined that, under FDA regulations, generic drug manufacturers have an ongoing federal duty of “sameness” regarding their labels – namely, that the generic drug’s labeling must at all times be the same as the brand name drug’s labeling because the brand name drug is the basis for generic drug approval. Specifically, the Court found that the generic drug manufacturers could not strengthen their labels through the FDA’s “changes-being-effected” (CBE) process, as such action would constitute a unilateral change by the generic drug manufacturers violating federal regulations requiring a generic drug’s label to match its brand name counterpart. 131 S. Ct. at 2575.

The Court distinguished its prior 2009 decision in Wyeth v. Levine (holding that state law failure to warn claims were not preempted against a brand name prescription drug manufacturer) based on this difference in availability of the CBE process. The Court explained that Wyeth turned on its finding that it was not impossible for Wyeth to strengthen its product warnings because Wyeth could take advantage of CBE provisions applicable to brand name prescription drugs approved under the New Drug Application (NDA) procedure and change its labeling without first seeking FDA approval. Id. at 2581. Thus, the Mensing Court reasoned that, unlike the case before it, the availability of the CBE regulations permitted the brand name drug manufacturer to “unilaterally strengthen its warning” without prior FDA approval, and therefore “allowed the company, on its own volition, to strengthen its label in compliance with its state tort duty.” Id.

The Mensing plaintiffs nonetheless argued against a finding of impossibility by contending that, despite the federal requirement of “sameness” and lack of CBE availability, the generic drug manufacturers were still able to (or even were required to) propose stronger warning labels to the FDA if they believed such warnings were needed. Id. at 2575. The Mensing Court, however, reasoned that simply proposing label changes “would not have satisfied the requirements of state law,” but rather “federal law would permit the Manufacturers to comply with the state labeling requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name label.” Id. at 2578. This, according to the Court, “raise[d] the novel question of whether conflict preemption should take into account these possible actions by the FDA . . . .” Id. The Mensing Court held that it should not:

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it. . .

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If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express preemption, the Supremacy Clause would have any force. We do not read the Supremacy Clause to permit an approach to preemption that renders conflict preemption all but meaningless . . .

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To consider in our preemption analysis the contingencies inherent in these cases – in which the Manufacturer’s ability to comply with state law depended on uncertain federal agency and third-party decisions – would be inconsistent with the non obstante provision of the Supremacy Clause . . .

Id. at 2579-80. The Mensing Court summarized the test for “impossibility” as follows:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for [preemption] purposes.

Id. at 2581.

Impact of Mensing’s Test for Impossibility in Context of OTC Drugs Preemption

The Mensing articulation of impossibility arguably provides compelling grounds for finding impossibility-based preemption in the context of failure to warn claims asserted against OTC drug manufacturers. Specifically, manufacturers of OTC drugs regulated under the FDA’s “monograph” system could persuasively argue that, similar to the generic prescription drug manufacturers in Mensing, their product labeling is subject to federal requirements of “sameness” that cannot be unilaterally changed without FDA permission and assistance.

Lack of Express Preemption for OTC Drugs Does Not Foreclose Arguing Implied Preemption

An initial hurdle facing OTC drug manufacturers asserting implied preemption lies in reconciling the fact that Congress specifically carved out state product liability claims (including presumably, failure to warn claims) from the reach of an express preemption clause applicable to OTC drugs. The Federal Food, Drug and Cosmetic Act (FDCA) governing OTC nonprescription drugs contains an express preemption clause, but then sets forth a “saving clause” stating that “[n]othing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.” 21 U.S.C. § 379r(a), (e).

Nevertheless, the Supreme Court has recognized that the existence of an express preemption provision and saving clause does not foreclose application of the doctrine of implied conflict preemption. In Buckman v. Plaintiffs’ Legal Committee, the Court recognized that “neither an express preemption provision nor a savings clause bars the ordinary working of conflict preemption principles.” 531 U.S. 341, 352 (2001) (citing Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000)).

“Monograph” Regulation of OTC Drugs

The FDA regulates most OTC drugs under its “monograph” regime. A monograph is a set of regulations promulgated by the FDA through notice and comment rulemaking that describes the conditions under which a category of drugs may be marketed without a prescription.

The Final Monograph for a class of OTC drugs includes labeling requirements. The manufacturer of an OTC drug must use the warning language authored by the FDA. 21 C.F.R. § 330.1(c)(2). The FDA’s labeling requirements are designed to provide warnings reflecting known risks based on reliable scientific evidence. See generally 21 C.F.R. § 330.10(a) (procedure for establishing OTC monograph). Adequate warnings are those that, in the judgment of the FDA, are “clear and truthful in all respects, not misleading in any particular,” and that accurately communicate the benefit to risk ratio and the proper use of the product in terms “likely to be read and understood by the ordinary individual.” 21 C.F.R. § 330.10(a)(4)(v).

Compliance with the Final Monograph by the OTC drug manufacturer is mandatory. “Any product which fails to conform to an applicable monograph after its effective date is liable to regulatory action.” 21 C.F.R. § 330.10(b). Therefore, once a Final Monograph goes into effect, it is illegal to sell a drug described therein unless it conforms to the monograph. 21 U.S.C. §§ 332-334. If a drug is marketed without prior FDA approval or without complying with an applicable monograph, the United States may bring an enforcement action under the FDCA. Enforcement measures include seizure of the drug product, civil injunction against its sale and criminal penalties against the violator.

“Sameness” of Labeling Imposed on Final Monograph OTC Drugs

Mensing’s articulation of impossibility arguably provides compelling grounds for finding impossibility-based preemption in the context of failure to warn claims asserted against Final Monograph OTC drug manufacturers. Specifically, manufacturers of Final Monograph OTC drugs could persuasively argue that, similar to the generic prescription drug manufacturers in Mensing, their product labeling is subject to federal requirements of “sameness” that cannot be unilaterally changed without FDA permission and assistance.

Final Monograph OTC drug manufacturers could assert that federal regulations, providing for specific product labeling and making it illegal to sell an OTC drug unless it conforms to the monograph, make it impossible for the manufacturer to comply with the federal law and also provide the additional or different labeling sought under the state law failure to warn claims. Moreover, the OTC drug manufacturers would assert that the monograph regime does not contain any directly applicable CBE provision—a critical distinction made by the Mensing Court in distinguishing its holding from Wyeth.

Finally, the OTC drug manufacturers could argue that under Mensing, the fact that FDA regulations provide a mechanism to amend or repeal any final monograph based on consideration of new information related to the safety or effectiveness of OTC products in the category does not change the impossibility preemption result. As Mensing held, impossibility preemption does not take into account possible actions by the FDA. As such, the OTC drug manufacturer could argue that the mechanism for potential amendment or repeal of a final monograph does not allow it to “satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency,” and thus it “cannot independently satisfy those state law duties for [preemption] purposes” through such means. 131 S. Ct. at 2581.

Conclusion

The law of federal preemption regarding claims against drug manufacturers—whether brand name or generic, prescription or over-the-counter—is constantly evolving, and promises to remain in flux in the immediate wake of Mensing. Key holdings in Mensing provide OTC drug manufacturers with plausible, though far from certain to prevail, impossibility-based preemption arguments to challenge failure to warn claims. Whether Mensing ultimately provides a path to preemption for OTC drug manufacturers should become more clear in the future as courts across the country begin to interpret Mensing’s impact in non-generic OTC drug contexts.