Over-the-counter (“OTC”) medication are shielded from civil legal responsibility by an specific preemption provision that’s even stronger than the medical system preemption clause interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  That provision is:

Besides as offered in subsection . . . (e) . . ., no State or political subdivision of a State could set up or proceed in impact any requirement −

(1) that pertains to the regulation of a drug that isn’t topic to the necessities of [prescription drugs] of this title; and

(2) that’s completely different from or along with, or that’s in any other case not an identical with, a requirement underneath this chapter. . . .

21 U.S.C. §379r(a)(1) (emphasis added).  Against this, the Riegel preemption clause for medical gadgets prohibits solely state-law necessities which can be “completely different from or along with” FDA medical system necessities.  21 U.S.C. §360k(a).  It doesn’t require “identification.”

The one exception that actually issues is §379r(e), which gives that “[n]othing on this part shall be construed to switch or in any other case have an effect on any motion or the legal responsibility of any particular person underneath the product legal responsibility legislation of any State.”  That eliminates specific preemption in private harm fits involving private harm – however just for private harm.  E.g., Kanter v. Warner-Lambert Co., 122 Cal. Rptr. second 72, 80-81 (Cal. App. 2002) (“Below the product legal responsibility legislation of California, harm to the plaintiff from a faulty product is a necessary factor . . ., but when the harm consists solely of financial losses, restoration on a merchandise legal responsibility idea is unavailable”).  So we put private harm circumstances to at least one aspect.

Nonetheless, with financial loss class motion litigation uncontrolled in California (and plaintiffs elsewhere looking for to emulate), we see circumstances 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 basically ignore the preemption clause barring not solely “completely different” or “further” language but in addition something “not an identical.”  Meza concerned sunscreen, and regardless of the related FDA regulation specifying terminology that may create “misbranding,” 2023 WL 3082346, at *5, allowed plaintiffs to proceed with a declare involving language admittedly not specified by the FDA’s regulation:

Plaintiff alleges the Merchandise violate California state client safety legal guidelines as a result of the “24/25 HR” claims misleadingly recommend the Merchandise will present solar safety for that period of time when . . . FDA laws don’t mandate that sunscreen producers embody claims pertaining to the product’s durational functionality.

Id. at *6.  However exactly as a result of the relevant regulation didn’t cowl this topic, Meza held that state legislation claims attacking it “wouldn’t result in any further or completely different necessities,” and located no specific preemption.  Id.  The preemption clause’s “not an identical” language was merely ignored.

Booker concerned so-called “therapeutic massage lotion.”  2021 WL 4340489, at *1.  Just like the sunscreen in Meza, this product was additionally FDA regulated as an OTC drug.  Id. at *5.  As an alternative of sticking to regulation of OTC medication, nonetheless, Booker relied on the FDCA’s normal prohibition towards adulteration and misbranding.  Id. at *7.  As a result of plaintiff claimed that the labeling in query was “false” – regardless that there isn’t a indication that any FDA regulation prohibited the declare – it survived preemption as a not being “completely different” from what the FDA required:

A drug is misbranded underneath the FDCA when “its labeling is fake or deceptive in any explicit.” 21 U.S.C. §352(a)(1).  Consequently, it seems that Plaintiffs’ grievances − i.e., that the Merchandise don’t forestall or cut back [what they claimed], regardless of the claims on their labels − fall squarely inside the realm of conduct that may violate the FDCA. . . .  [P]laintiffs’ claims wouldn’t be completely different from obligations imposed underneath the FDCA as a result of they’d merely require Defendant to honestly state efficacy or not promote its merchandise.

Id. (citing Astiana v. Hain Celestial Group., Inc., 783 F.3d 753, 758 (ninth Cir. 2015)).

Once more, the particular phrases of the relevant preemption clause had been ignored, this time in favor of broader, vaguer language of normal (non-OTC) sections of the FDCA.  There are loads of these circumstances, equivalent to Burchfield v. Status Shopper Healthcare, Inc., 534 F. Supp.3d 1192, (C.D. Cal. 2021), holding that basically any declare alleging falsity escapes preemption.

[I]f the language within the labeling is deceptive, because the [complaint] alleges, then state legislation legal responsibility based mostly on the product labels merely creates a damages treatment for violation of state legislation necessities that “parallel,” moderately than add to, federal necessities, and therefore aren’t preempted.

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

There seem like two issues with these pro-plaintiff selections permitting financial loss class actions to proceed:  (1) they undertake medical system preemption dodges, such because the Riegel parallel declare dictum; (2) whereas ignoring the completely different and stronger preemption language of §379r(a).

Many of those circumstances, significantly these in Ninth Circuit district courts, straight or not directly depend on Astiana v. Hain Celestial Group, Inc., 783 F.3d 753 (ninth Cir. 2015), a cosmetics case that minimized related preemption language in 21 U.S.C. §379s (additionally barring state claims that had been “completely different from or along with, or that’s in any other case not an identical with” federal guidelines), and which first imported the medical system idea of “parallel claims.”  783 F.3d at 757 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)).  However Astiana did extra than simply quote Lohr with out accounting for the extra “not an identical” language of the related preemption clause.  It additionally utilized the notorious presumption towards preemption:

In analyzing specific preemption, we begin with the idea that the historic police powers of the States had been to not be outdated by the Federal Act until that was the clear and manifest objective of Congress.  The FDCA proscribes any . . . labeling that’s false or deceptive in any explicit.

783 F.3d at 757.

Thus, the broad, obscure “false or deceptive” statutory language was launched in direct reliance on a presumption towards preemption in “specific preemption” circumstances – a presumption that not exists.  As we identified when it occurred, the Supreme Court docket abolished that presumption the 12 months after Astiana was determined:

The plain textual content of the [preemption clause] begins and ends our evaluation. . . .  And since the statute accommodates an specific pre-emption clause, we don’t invoke any presumption towards pre-emption however as a substitute give attention to the plain wording of the clause, which essentially accommodates one of the best proof of Congress’ pre-emptive intent.

Puerto Rico v. Franklin California Tax-Free Belief, 579 U.S. 114, 125 (2016).

Furthermore, the Ninth Circuit has repeatedly acknowledged and broadly utilized this abolition of any presumption towards preemption in specific preemption circumstances.  See Hollins v. Walmart, Inc., 67 F.4th 1011, 1016 (ninth Cir. 2023) (“we don’t invoke any presumption towards pre-emption the place, as right here, the statute ‘accommodates an specific pre-emption clause”) (quoting PR v. Franklin); California Restaurant Assn. v. Metropolis of Berkeley, 65 F.4th 1045, 1050 (ninth Cir. 2023) (“we apply [statutory] textual evaluation with none presumptive thumb on the size”) (quotation and citation marks omitted); Nationwide Railroad Passenger Corp. v. Su, 41 F.4th 1147, 1153 n.1 (ninth Cir. 2022) (“as a result of the statute accommodates an specific pre-emption clause, we don’t invoke any presumption towards pre-emption”) (quoting PR v. Franklin); R.J. Reynolds Tobacco Co. v. County of Los Angeles, 29 F.4th 542, 553 n.6 (ninth Cir. 2022) (quoted in California Restaurant); Webb v. Dealer Joe’s Co., 999 F.3d 1196, 1202 (ninth Cir. 2021) (“[w]right here the intent of a statutory provision that speaks expressly to the query of preemption is at subject, we don’t invoke any presumption towards pre-emption”) (quotation and citation marks omitted); Connell v. Lima Corp., 988 F.3d 1089, 1097 (ninth Cir. 2021) (quoting PR v. Franklin); In re Bard IVC Filters Merchandise Legal responsibility Litigation, 969 F.3d 1067, 1073 (ninth Cir. 2020) (“ When a federal legislation accommodates an specific preemption clause, we give attention to the plain wording of the clause”) (quotation and citation marks omitted); Atay v. County of Maui, 842 F.3d 688, 699 (ninth Cir. 2016) (quoted in Webb);

Thus, continued judicial reliance on Astiana to disclaim the plain which means of §379r(a)’s  broad preemption clause is one other instance of zombie specific preemption presumption precedent that we warned about final 12 months.  All too many courts are counting on the no-longer-viable presumption-based derogation of § 379r(a) in favor of purported “parallel claims” based mostly on the misuse of the FDCA’s misbranding prohibition.

And about that misbranding prohibition. . . .

Given the stronger specific phrases of OTC preemption, we query whether or not any reliance on “parallel declare” ideas developed in medical system litigation is correct.  As these adversarial OTC preemption circumstances display, misuse of that idea is leading to allegations which can be plainly “not an identical” to the language the FDA permits on OTC drug labels.  But when there’s any room for a parallel declare in OTC preemption litigation, it’s definitely not the broad, obscure language of 21 U.S.C. §352(a)(1), underneath which plaintiffs argue that something they declare to be “false” or “deceptive” is mechanically a “parallel” declare.

Plaintiffs strive the identical factor in medical system preemption circumstances on a regular basis, counting on broadly worded FDA present good manufacturing apply laws as supposedly making a “parallel” violation.  They normally lose.  “Parallel” claims require “particular violations” of “particular [FDA] laws.”  Godelia v. Doe 1, 881 F.3d 1309, 1319 (eleventh Cir. 2018).

[A]n alleged deviation from manufacturing efficiency specs for a tool that has obtained premarket approval shouldn’t be the identical factor as noncompliance with the FDA or its laws. . . .  It’s [plaintiff’s] try to rework a design specification, which the FDA acknowledges the system is not going to al-ways operate in accordance with, into an actionable assure, that seeks to impose a further requirement as precluded underneath Riegel.

Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012).  “[L]ack of specificity . . . implies that there isn’t a significant baseline towards which to match the necessities of the state frequent legislation, and thus . . . whether or not Plaintiffs’ state frequent legislation claims are really parallel.”  Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129, 181 (D.D.C. 2018).

These are all circumstances construing the much less stringent preemption language of §360k(a), which doesn’t comprise the extra “not an identical to” language of §379r(a).  Thus, their rejection of claims alleging violations of obscure enactments such of the FDCA’s misbranding language ought to apply a fortiori to purported OTC “parallel” declare allegations − and the minority of circumstances allowing obscure medical system violation claims ought to, conversely, not apply to extra rigorous OTC preemption language.

So we provide these two tips to protection counsel confronting OTC financial loss class actions.  The plaintiffs’ anti-preemption arguments are bogus.  They rely, straight or not directly on a presumption towards preemption that has been abolished, they usually purport to base parallel claims on broad, obscure violation claims that typically wouldn’t be allowed even in medical system circumstances (the place “parallel claims” originated) and positively shouldn’t be allowed underneath the specific “not an identical” phrases of the relevant §379r(a) preemption clause.