Like having a primary youngster, while you assume new obligations in caring for aged mother and father, you get a crash-course schooling in subjects you in any other case by no means would have thought of.  Have your first youngster, and also you probably will develop a new-found curiosity—if not firmly-held opinions—on ideas like sleep coaching and breast feeding.  Tackle a task in offering look after aged mother and father and also you would possibly develop a new-found curiosity in scintillating subjects like compression socks and wound care. 

Which is how we got here to know a little bit bit about hydrogen peroxide.  We had been schooled by a wound care doctor that hydrogen peroxide is finest used as a primary help therapy when a lower or scrape initially occurs—however not over time because the wound heals, as a result of it’d impede the expansion of latest pores and skin cells.  At the least that was our take-away.  (Be aware: Don’t take medical recommendation from attorneys.  We’re not docs, we simply play them on TV.)

Which brings us round to Novotney v. Walgreen Co., — F. Supp. 3d –, 2023 WL 46998149 (N.D. Sick. July 20, 2023) involving, sure, hydrogen peroxide.  In Novotney, the claims stemmed from the labeling of three% hydrogen peroxide resolution as a “first help antiseptic” for use for “therapy of minor cuts and abrasions.”  Plaintiff asserted varied fraud and breach of guarantee claims, and alleged that “hydrogen peroxide is ineffective in treating minor cuts and abrasions as a result of, opposite to standard perception, it doesn’t scale back charges of wound an infection… and does extra hurt than good as a result of it additionally destroys useful micro organism and wholesome cells that promote therapeutic.”

Hydrogen peroxide is an FDA-regulated over-the-counter (OTC) drug, so Novotney addressed whether or not plaintiff’s claims had been barred by federal preemption.  And we’re happy to report the court docket got here out the best approach.

In case you have learn this weblog for any size of time, you recognize that OTC medication have an categorical preemption provision, 21 U.S.C. § 379r(a), offering that no state might “set up … any requirement … that’s totally different from or along with, or that’s in any other case not an identical with, a requirement” of the Meals, Drug, and Cosmetics Act (FDCA).  (You additionally know that OTC categorical preemption doesn’t attain product legal responsibility claims, however it does cowl non-product legal responsibility claims looking for financial loss damages.)

Furthermore, the FDA established federal labeling for 3% hydrogen peroxide.  As a part of a long-history of regulating antimicrobial drug merchandise, the FDA issued a 1991 “tentative closing monograph” on First Assist Antiseptic Drug merchandise, and that grew to become closing in 2020.  See 21 U.S.C. § 355h(b)(8)(A). 

The defendant famous that its hydrogen peroxide carried virtually precisely the labeling the FDA had thought-about in its First Assist Antiseptic Drug Product monograph, and the court docket in Novotney agreed.  As a result of “[t]he gravamen of plaintiff’s claims is that this very labeling, which is regulated by the FDA, is deceptive as a result of hydrogen peroxide will not be efficient as a primary help antiseptic for therapy of minor cuts and abrasions” plaintiff’s claims inherently contemplated that the hydrogen peroxide label ought to have mentioned one thing totally different than the FDA required.  Meaning categorical preemption.

Subsequent, the court docket rejected arguments by the plaintiff that attacked the soundness of the science behind the FDA’s judgment that hydrogen peroxide was appropriately-labeled as a primary help antiseptic for minor cuts and abrasion.  The court docket discovered plaintiff’s references irrelevant to the soundness of the FDA’s conclusion, and agreed that preemption utilized.  (Certainly, it might have acknowledged that underneath implied preemption and Buckman Co. v. Plaintiffs Authorized Committee, 531 U.S. 341 (2001), state tort claims are inappropriate automobiles for criticizing what the FDA thought-about in making a regulatory determination or the conclusion it reaches.)

Lastly, the court docket rejected plaintiff’s grievance that the label in query used a phrase (“therapy”) that wasn’t within the FDA monograph.  “[W]hether the FDA particularly permitted using the phrase “therapy” is irrelevant. The content material of the product’s label because it pertains to its security or effectiveness is a matter of federal regulation, and by claiming that another terminology is important to make sure that the label will not be deceptive, plaintiff impermissibly claims that state regulation imposes necessities which might be totally different from, extra to, or in any other case not an identical with, the necessities of the FDCA.”

Rounding out a superb determination, the Courtroom dismissed the case with prejudice, discovering that any modification of the grievance could be futile given the OTC categorical preemption clause.