Today’s post is a report on Jazmine Harris v. Topco Associates, LLC, 2021 WL 1885981 (N.D. Ill. 2021), which dismissed on preemption grounds a putative class action that challenged as fraudulent the marketing of acetaminophen for infants. The decision, whose result departs from earlier decisions in the area, highlights the importance of a provision in last year’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

The Harris defendant packages and distributes liquid acetaminophen products. The packaging of one indicates that it is intended for “infants” while the packaging of another indicates that it is intended for “children.” Following an FDA recommendation, the concentration of both products is 160 mg/5 mL. Aside from their packaging, there are only two differences between the two products. The “infant” product comes with a dispensing syringe while the product for “children” comes with a small dosing cup, and the “infant” product costs twice as much per ounce as the product for “children.”

The Harris plaintiff purchased acetaminophen for her then one-year old infant. She purchased the defendant’s product for “infants.” In her complaint, she alleged that she purchased the “infant” product because she believed, in light of its packaging, that it was specially formulated for infants, differing in composition from the less-expensive product for “children.” Asserting a claim under Pennsylvania’s Unfair Trade Practices and Consumer Protection Law, the plaintiff alleged that the defendant’s packaging of its “infant” product is misleading.

The defendant argued that the plaintiff’s claim is preempted by the FDCA. Relying on the CARES Act, the court agreed.

Acetaminophen is an over-the-counter (OTC) medication designed to relieve pain and reduce fever. The general federal labeling requirements for OTC drugs are set forth in 21 C.F.R. § 201.66. Under 21 C.F.R. § 330.1, an OTC drug “is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in” 21 C.F.R. Part 330 “and each of the conditions contained in any applicable monograph.” The FDA explains that “an OTC monograph is a ‘rule book’ for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, route of administration, labeling, and testing under which an OTC drug is generally recognized as safe and effective.” FDA, Over-the-Counter (OTC) Drug Review: OTC Monograph Reform in the CARES Act, https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. In 1988, the FDA issued a “tentative final monograph” addressing OTC drugs that “includes requirements for disclosures and mandatory labeling of acetaminophen products.” 2021 WL 1885981, at *3.

OTC drugs are governed by 21 U.S.C. § 379r, which provides that no state may impose any requirement on an OTC drug “that is different from or in addition to, or that is otherwise not identical with,” a federal requirement applicable to the drug. 21 U.S.C. § 379r(a).

The Harris plaintiff claimed that Pennsylvania’s consumer-protection law required the defendant to disclose on its product labeling that the “infant” product and the product for “children” are pharmacologically identical. She argued that such a requirement was not different from or in addition to the federal labeling requirements, and thus not preempted, because federal misbranding law prohibits “false or misleading” labels. 21 U.S.C. § 352(a).

The plaintiff did not claim that the defendant’s labeling violated any condition in an applicable FDA monograph (or any condition imposed by 21 C.F.R. Part 330). She nonetheless maintained that the disclosure supposedly required by state law was neither different from nor in addition to the federal labeling requirements, and thus not preempted, because, according to the plaintiff, there is no FDA monograph applicable to acetaminophen products and thus no relevant federal labeling requirements from which the purported state-law requirement would diverge.

The court rejected the plaintiff’s argument, concluding that her claim is expressly preempted by § 379r(a).

First, the court dismissed the plaintiff’s contention that her claim survived § 379r(a) because the state prohibition on consumer deception is the same as the FDCA’s prohibition on false or misleading labels. While the state and federal prohibitions might be equivalent in the abstract, that was immaterial, said the court, because the plaintiff’s claim was “based on the labeling of the products themselves, not on a legal theory.” 2021 WL 1885981, at *3. In other words, a state-law claim is preempted by § 379r(a) if it would impose a specific requirement “different from or in addition to” the specific federal requirements applicable to the drug in question, even if the state requirement is derived from a state-law duty that is, at a high level of generality, arguably the same as an overarching federal duty.

Next, the court dispensed with the plaintiff’s assertion that the FDA’s 1988 “tentative final monograph”—which includes disclosure requirements for acetaminophen products—was irrelevant to the preemption issue. The plaintiff argued that because the tentative final monograph was merely tentative, it “does not have the force of law and no controlling final monograph exists that concerns acetaminophen products.” Id. The court held that whatever merit the argument might once have had evaporated upon last year’s enactment of the CARES Act, which declared that the tentative final monograph “shall be deemed to be a final administrative order.” 21 U.S.C. § 355h(b)(8)(A). Because the tentative final monograph has “the force of law as a final monograph” under the CARES Act, the court found that it “sets forth federal labeling requirements for acetaminophen products.” 2021 WL 1885981, at *3.

The court then compared the disclosure that the plaintiff claimed was required by state law to the federal labeling requirements set forth in the tentative final monograph. Examining the monograph, the court found no prohibition on labeling acetaminophen products appropriate for infants as “infant” products and no requirement that the pharmacological equivalence of acetaminophen for “infants” and acetaminophen for “children” be disclosed. Therefore, the court concluded, the plaintiff’s claim is “preempted because she seeks to impose additional obligations” under state law that are “not imposed by” federal law. 2021 WL 1885981, at *4.