OTC Preemption Provision
OTC drug manufacturers are protected from civil liability by an express preemption provision that is even stronger than the medical device preemption clause interpreted in Riegel v. Medtronic, Inc. Riegel, 552 U.S. 312 (2008). The express preemption provision reads thus:
Except as provided in subsection . . . (e) . . . , no State or political subdivision of a State may establish or continue in effect any requirement—
(1) that relates to the regulation of a drug that is not subject to the requirements of [prescription drugs] of this title; and
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter.
21 U.S.C. § 379r(a)(1) (emphasis added). By contrast, the Riegel preemption clause for medical devices prohibits only state law requirements that are “different from or in addition to” Food and Drug Administration (FDA) medical device requirements. 21 U.S.C. § 360k(a). Medical device preemption does not require “identity”; OTC drugs do.
By far the most significant exception to OTC drug preemption is § 379r(e), which provides 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.” This provision effectively removes express preemption from suits involving personal injury—but not where the only alleged damage is economic loss. E.g., Kanter v. Warner-Lambert Co., 122 Cal. Rptr. 2d 72, 80–81 (Cal. Ct. App. 2002) (“Under the product liability law of California, injury to the plaintiff from a defective product is an essential element . . . , but if the damage consists solely of economic losses, recovery on a products liability theory is unavailable.”).
Economic-Loss Class Action Litigation
Still, increasing economic-loss class action litigation generates cases like Meza v. Coty, Inc. and Booker v. E.T. Browne Drug Co., which essentially ignore the § 379r(a)(1) preemption clause barring not only “different” or “additional” labeling but also anything “not identical.” Meza, 2023 WL 3082346 (N.D. Cal. Apr. 24, 2023); Booker, 2021 WL 4340489 (S.D.N.Y. Sept. 23, 2021). Despite the relevant FDA regulation specifying that unapproved terminology would create “misbranding,” Meza, which involved sunscreen, allowed plaintiffs to proceed with a claim involving language admittedly not specified by the FDA’s regulation:
Plaintiff alleges the Products violate California state consumer protection laws because the “24/25 HR” claims misleadingly suggest the Products will provide sun protection for that amount of time when . . . FDA regulations do not mandate that sunscreen manufacturers include claims pertaining to the product’s durational capability.
Meza, 2023 WL 3082346, at *5–6. But precisely because the applicable regulation did not cover this subject, Meza held that state law claims attacking the durational statement “would not lead to any additional or different requirements,” and found no preemption. Id. at *6. The preemption clause’s express not identical language was simply ignored.
Booker involved “massage lotion.” 2021 WL 4340489, at *1. Like the sunscreen in Meza, this product was also FDA regulated as an OTC drug. Id. at *5. Instead of relying on FDA regulation of OTC drugs, however, Booker looked to the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) general prohibition against adulteration and misbranding. Id. at *7. Because the plaintiffs claimed that the labeling in question was “false”—absent any indication that any FDA regulation prohibited the claim—it survived preemption as not being “different” from what the FDA required:
A drug is misbranded under the FDCA when “its labeling is false or misleading in any particular.” 21 U.S.C. § 352(a)(1). Consequently, it appears that Plaintiffs’ grievances—i.e., that the Products do not prevent or reduce [what they claimed], despite the claims on their labels—fall squarely within the realm of conduct that would violate the FDCA. . . . [P]laintiffs’ claims would not be different from obligations imposed under the FDCA because they would simply require Defendant to truthfully state efficacy or not sell its products.
Id. (citing Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, 758 (9th Cir. 2015)).
Again, the specific terms of the applicable OTC preemption clause were ignored, this time in favor of the broader, vaguer language of general (non-OTC) sections of the FDCA. A number of similar decisions exist, such as Burchfield v. Prestige Consumer Healthcare, Inc., holding that essentially any claim alleging falsity escapes preemption:
[I]f the language in the labeling is misleading, as the [complaint] alleges, then state law liability based on the product labels merely creates a damages remedy for violation of state law requirements that “parallel,” rather than add to, federal requirements, and hence are not preempted.
534 F. Supp.3d 1192, 1205 (C.D. Cal. 2021) (citing Riegel, 552 U.S. at 330).
Problems with Decisions
There are two problems with decisions, such as these, allowing economic-loss class actions to proceed: (1) they utilize medical device preemption dodges, such as the Riegel parallel claim dictum; (2) and they ignore the different and stronger preemption language of § 379r(a).
Many such cases, particularly by district courts in the U.S. Court of Appeals for the Ninth Circuit, directly or indirectly rely upon Astiana v. Hain Celestial Group, Inc., a cosmetics case that minimized similar preemption language in 21 U.S.C. § 379s (also barring state claims that were “different from or in addition to, or that [are] otherwise not identical with” federal rules) and that first imported the medical device concept of “parallel claims.” Astiana, 783 F.3d 753, 757 (9th Cir. 2015) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)).
Misguided Reliance on a Presumption Against Preemption
But Astiana did more than just quote Lohr without accounting for the additional not identical language of the relevant preemption clause. It also invoked a strong presumption against preemption:
In analyzing express preemption, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. The FDCA proscribes any . . . labeling that is false or misleading in any particular.
Id. at 757. Thus, introduction of the broad, vague false or misleading statutory language from § 352(a)(1) into OTC drug litigation occurred in direct reliance on a now-abolished presumption against preemption in “express preemption” cases.
A year after Astiana was decided, the Supreme Court explicitly rejected any such presumption:
The plain text of the [preemption clause] begins and ends our analysis. . . . And because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.
Puerto Rico v. Franklin Cal. Tax-Free Tr., 579 U.S. 114, 125 (2016) (citations and quotation marks omitted).
Moreover, the Ninth Circuit has repeatedly recognized and broadly applied this abolition of any presumption against preemption in express preemption cases. See Hollins v. Walmart, Inc., 67 F.4th 1011, 1016 (9th Cir. 2023) (“‘[W]e do not invoke any presumption against pre-emption’ where, as here, ‘the statute “contains an express pre-emption clause.”’” (quoting Franklin Cal. Tax-Free Tr.)); Cal. Rest. Ass’n v. City of Berkeley, 65 F.4th 1045, 1050 (9th Cir. 2023) (“[W]e apply [statutory] textual analysis without any presumptive thumb on the scale.” (citation and quotation marks omitted)); Nat’l R.R. Passenger Corp. v. Su, 41 F.4th 1147, 1153 n.1 (9th Cir. 2022) (“[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption.” (quoting Franklin Cal. Tax-Free Tr.)); R.J. Reynolds Tobacco Co. v. County of Los Angeles, 29 F.4th 542, 553 n.6 (9th Cir. 2022) (quoted in Cal. Rest.); Webb v. Trader Joe’s Co., 999 F.3d 1196, 1202 (9th Cir. 2021) (“Where the intent of a statutory provision that speaks expressly to the question of preemption is at issue, we do not invoke any presumption against pre-emption.” (citation and quotation marks omitted)); Connell v. Lima Corp., 988 F.3d 1089, 1097 (9th Cir. 2021) (quoting Franklin Cal. Tax-Free Tr.); In re Bard IVC Filters Prods. Liab. Litig., 969 F.3d 1067, 1073 (9th Cir. 2020) (“When a federal law contains an express preemption clause, we focus on the plain wording of the clause.” (citation and quotation marks omitted)); Atay v. County of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (quoted in Webb).
Thus, continued judicial reliance on Astiana to deny the plain meaning of § 379r(a)’s broad preemption clause amounts to an improper application of a now-abolished anti-preemption presumption. Citing Astiana in derogation of § 379r(a) ignores controlling Supreme Court precedent.
Misguided Reliance on “Parallel” Claim Concepts
As for “misbranding,” given the stronger express terms of OTC preemption, reliance on “parallel claim” concepts developed in medical device litigation is improper. As adverse OTC preemption cases demonstrate, misuse of “misbranding” allegations permits claims that are plainly “not identical” to the language that the FDA allows on OTC drug labels. If there is any room for parallel claims in OTC preemption litigation, it’s certainly not the capacious language of 21 U.S.C. § 352(a)(1), under which plaintiffs argue that anything they claim to be “false” or “misleading” is automatically a “parallel” claim.
Plaintiffs frequently make similar arguments in medical device preemption cases, relying on broadly worded FDA current good manufacturing practice regulations as supposedly creating “parallel” violations. They are usually unsuccessful. “Parallel” claims require “specific violations” of “specific [FDA] regulations.” Godelia v. Doe 1, 881 F.3d 1309, 1319 (11th Cir. 2018).
[A]n alleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations. . . . It is [plaintiff’s] attempt to transform a design specification, which the FDA recognizes the device will not al-ways function in accordance with, into an actionable guarantee, that seeks to impose an additional requirement as precluded under Riegel.
Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012). “[L]ack of specificity . . . means that there is no meaningful baseline against which to compare the requirements of the state common law, and thus . . . whether Plaintiffs’ state common law claims are truly parallel.” Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129, 181 (D.D.C. 2018).
These are all cases construing the less stringent preemption language of § 360k(a), which does not contain the additional not identical language of § 379r(a). Thus, their rejection of claims alleging violations of vague enactments such as the FDCA’s misbranding language should apply a fortiori to purported OTC “parallel” claim allegations—and the minority of cases permitting vague medical device violation claims should, conversely, not apply to more rigorous OTC preemption language.
Conclusion
Thus, defense counsel confronting OTC economic-loss class actions should keep two things in mind in arguing preemption. First, plaintiffs’ anti-preemption arguments probably rely, directly or indirectly, on a presumption against preemption that has been abolished. Second, their supposed “parallel” claims are based on broad, vague violation claims that in most cases would not be allowed even in medical device cases (where “parallel claims” originated) and certainly should not be allowed under the express “not identical” terms of the applicable § 379r(a) preemption clause.
