At present’s visitor publish is by Amy McVeigh and Jessica Farmer, who’re companions at Holland & Knight. They touch upon the demise of one other purported class motion towards a producer of hydrogen peroxide, which is an FDA-regulated over-the-counter (“OTC”) drug. As all the time our visitor posters deserve 100% of the credit score (and any blame) for for his or her work.
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At present’s publish dives into the fizz of authorized battles over the adequacy of labeling of over-the-counter (“OTC”) hydrogen peroxide. You may suppose hydrogen peroxide is only a humble brown bottle in your medication cupboard, revered for its old-timey wound-cleaning prowess and its uncanny potential to bleach your hair in moments of teenage riot. However what’s actually behind that label in your bottle of H2O2? And is it deceptive to say that it may be used to “deal with” minor cuts and abrasions?
The Western District of Michigan stated “No” to the latter query within the newest OTC preemption resolution involving a hydrogen peroxide product, Bridges v. Meijer, Inc.,2024 WL 1007883, at *3 (W.D. Mich. Feb. 20, 2024), report and advice adopted sub nom. Lashan Bridges, Plaintiff, v. Meijer, Inc., Defendant, No. 1:22-CV-1112, 2024 WL 1141865 (W.D. Mich. Mar. 15, 2024). Frequent readers might recall a prior publish specializing in the same resolution out of the Northern District of Illinois, Novotney v. Walgreen Co., — F. Supp. 3d —, 2023 WL 4698149 (N.D. Unwell. July 20, 2023). This newest casebuilds on Novotney and likewise will get it proper.
Hydrogen peroxide has lengthy been bought over-the-counter as a primary help antiseptic. Like different OTC merchandise, the FDA regulates hydrogen peroxide merchandise by means of a monograph course of. A “monograph” is an in depth regulation describing the situations underneath which a category of medicine could be marketed with out a prescription. See 21 C.F.R. § 330.1; Nat. Res. Def. Council, Inc. v. U.S. Meals & Drug Admin., 710 F.3d 71, 75 (second Cir. 2013) (describing monograph course of). It is sort of a “recipe” for that individual product which, amongst different issues, units out labeling necessities. NRDC, 710 F.3d at 75.
In Bridges, the plaintiff asserted plenty of state-law claims claiming that Meijer’s private-label hydrogen peroxide answer was “misbranded” as a result of it was promoted “For Therapy of Minor Cuts and Abrasions.” Like different latest hydrogen peroxide instances, plaintiff argued that the phrase “therapy” on the label was deceptive as a result of the phrase “deal with” means to “heal” or “remedy” and hydrogen peroxide couldn’t, truly, heal or remedy cuts or abrasions. She alleged that she paid a premium for the product—of no less than $1.29—primarily based on her understanding of the phrase “deal with” and sought to certify financial loss courses of Illinois, Michigan, Ohio, Indiana, Kentucky, and Wisconsin residents.
After all, Weblog devotees and preemption lovers know that with respect to OTC merchandise, Congress prohibited the states from establishing “any requirement … that’s completely different from or along with, or that’s in any other case not similar with, a requirement” imposed underneath federal regulation. 21. U.S.C. § 379r(a)(2). Plaintiff argued that her state regulation claims weren’t preempted by this provision as a result of the FDA by no means endorsed the labeling of hydrogen peroxide for “therapy” functions and since “hydrogen peroxide doesn’t deal with minor cuts and abrasions as a result of no proof helps a connection between the variety of micro organism and discount in therapeutic time of a clear wound.” However as Defendants identified, the FDA itself used the phrase “deal with” greater than 50 instances within the monograph, and used it to imply “give medical care to” or “apply topically.” See Topical Antimicrobial Drug Merchandise for Over-the-Counter Human Use; Tentative Last Monograph for First Support Antiseptic Drug Merchandise, 56 Fed. Reg. 33651; 33655, 1991 WL 303853 (Jul. 22, 1991).
Finally, relying closely on Novotney’s reasoning, the Court docket held that the product’s labeling complied with FDA requirements, citing Novotney’s conclusion that “by claiming that another terminology is important to make sure that the label is just not deceptive, plaintiff impermissibly claims that state regulation imposes necessities which are completely different from, further to, or in any other case not similar with, the necessities of the FDCA. 2024 WL 1007883 at *3 (citing Novotney v. Walgreen Co., No. 22 C 3439, 2023 WL 4698149, — F. Supp. 3d — (N.D. Unwell. July 23, 2023)). The Court docket subsequently dismissed all of plaintiff’s state regulation claims as expressly preempted underneath 379(r).
Having distributed with the state regulation claims, the Court docket subsequent turned to the lone declare introduced underneath federal regulation: violation of the Magnusson-Moss Guarantee Act (“MMWA”). To state an MMWA declare, nevertheless, a plaintiff wants a viable, underlying state regulation breach of guarantee declare. The Court docket rightly held—like others earlier than it—that when the underlying breach of guarantee claims underneath state regulation are preempted, the MMWA declare should even be dismissed, stating “plaintiff’s MMWA declare fails as a result of she has no state regulation guarantee declare with respect to the Product or its label as a “therapy;” any such state regulation declare is preempted by federal regulation.” 2024 WL 1007883 at *3; see additionally In re Zantac (Ranitidine) Prod. Liab. Litig., 510 F. Supp. 3d 1141, 1172, (S.D. Fla. 2020).
In sum, it isn’t deceptive to say that hydrogen peroxide can be utilized for therapy of minor cuts and abrasions. However the everlasting query stays for one more day: “who’s accountable for my hair turning orange?”
