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Over-the-counter (“OTC”) drugs 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., 552 U.S. 312 (2008).  That provision is:

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” FDA medical device requirements.  21 U.S.C. §360k(a).  It does not require “identity.”

The only exception that really matters 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.”  That eliminates express preemption in personal injury suits involving personal injury – but only for personal injury.  E.g., Kanter v. Warner-Lambert Co., 122 Cal. Rptr. 2d 72, 80-81 (Cal. 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”).  So we put personal injury cases to one side.

Still, with economic loss class action litigation out of control in California (and plaintiffs elsewhere seeking to emulate), we see cases like Meza v. Coty, Inc., 2023 WL 3082346 (N.D. Cal. April 24, 2023), and Booker v. E.T. Browne Drug Co., 2021 WL 4340489 (S.D.N.Y. Sept. 23, 2021), that essentially ignore the preemption clause barring not only “different” or “additional” language but also anything “not identical.”  Meza involved sunscreen, and despite the relevant FDA regulation specifying terminology that would create “misbranding,” 2023 WL 3082346, at *5, 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.

Id. at *6.  But precisely because the applicable regulation did not cover this subject, Meza held that state law claims attacking it “would not lead to any additional or different requirements,” and found no express preemption.  Id.  The preemption clause’s “not identical” language was simply ignored.

Booker involved so-called “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 sticking to regulation of OTC drugs, however, Booker relied on the FDCA’s general prohibition against adulteration and misbranding.  Id. at *7.  Because plaintiff claimed that the labeling in question was “false” – even though there is no indication that any FDA regulation prohibited the claim – it survived preemption as a 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 Group., Inc., 783 F.3d 753, 758 (9th Cir. 2015)).

Again, the specific terms of the applicable preemption clause were ignored, this time in favor of broader, vaguer language of general (non-OTC) sections of the FDCA.  There are a lot of these cases, such as Burchfield v. Prestige Consumer Healthcare, Inc., 534 F. Supp.3d 1192, (C.D. Cal. 2021), 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.

Id. at 1205 (citing Riegel, 552 U.S. at 330).

There appear to be two problems with these pro-plaintiff decisions allowing economic loss class actions to proceed:  (1) they adopt medical device preemption dodges, such as the Riegel parallel claim dictum; (2) while ignoring the different and stronger preemption language of §379r(a).

Many of these cases, particularly those in Ninth Circuit district courts, directly or indirectly rely upon Astiana v. Hain Celestial Group, Inc., 783 F.3d 753 (9th Cir. 2015), 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 is otherwise not identical with” federal rules), and which first imported the medical device concept of “parallel claims.”  783 F.3d at 757 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)).  But Astiana did more than just quote Lohr without accounting for the additional “not identical” language of the relevant preemption clause.  It also applied the infamous 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.

783 F.3d at 757.

Thus, the broad, vague “false or misleading” statutory language was introduced in direct reliance on a presumption against preemption in “express preemption” cases – a presumption that no longer exists.  As we pointed out when it happened, the Supreme Court abolished that presumption the year after Astiana was decided:

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 California Tax-Free Trust, 579 U.S. 114, 125 (2016).

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) (“we do not invoke any presumption against pre-emption where, as here, the statute ‘contains an express pre-emption clause”) (quoting PR v. Franklin); California Restaurant Assn. v. City of Berkeley, 65 F.4th 1045, 1050 (9th Cir. 2023) (“we apply [statutory] textual analysis without any presumptive thumb on the scale”) (citation and quotation marks omitted); National Railroad Passenger Corp. v. Su, 41 F.4th 1147, 1153 n.1 (9th Cir. 2022) (“because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption”) (quoting PR v. Franklin); R.J. Reynolds Tobacco Co. v. County of Los Angeles, 29 F.4th 542, 553 n.6 (9th Cir. 2022) (quoted in California Restaurant); Webb v. Trader Joe’s Co., 999 F.3d 1196, 1202 (9th Cir. 2021) (“[w]here 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 PR v. Franklin); In re Bard IVC Filters Products Liability Litigation, 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 is another example of zombie express preemption presumption precedent that we warned about last year.  All too many courts are relying on the no-longer-viable presumption-based derogation of § 379r(a) in favor of purported “parallel claims” based on the misuse of the FDCA’s misbranding prohibition.

And about that misbranding prohibition. . . .

Given the stronger express terms of OTC preemption, we question whether any reliance on “parallel claim” concepts developed in medical device litigation is proper.  As these adverse OTC preemption cases demonstrate, misuse of that concept is resulting in allegations that are plainly “not identical” to the language the FDA allows on OTC drug labels.  But if there is any room for a parallel claim in OTC preemption litigation, it’s certainly not the broad, vague 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 try the same thing in medical device preemption cases all the time, relying on broadly worded FDA current good manufacturing practice regulations as supposedly creating a “parallel” violation.  They usually lose.  “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 to” language of §379r(a).  Thus, their rejection of claims alleging violations of vague enactments such of 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.

So we offer these two pointers to defense counsel confronting OTC economic loss class actions.  The plaintiffs’ anti-preemption arguments are bogus.  They rely, directly or indirectly on a presumption against preemption that has been abolished, and they purport to base parallel claims 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.