Like having a first child, when you assume new responsibilities in caring for elderly parents, you get a crash-course education in topics you otherwise never would have thought about. Have your first child, and you likely will develop a new-found interest—if not firmly-held opinions—on concepts like sleep training and breast feeding. Take on a role in providing care for elderly parents and you might develop a new-found interest in scintillating topics like compression socks and wound care.
Which is how we came to know a little bit about hydrogen peroxide. We were schooled by a wound care physician that hydrogen peroxide is best used as a first aid treatment when a cut or scrape initially happens—but not over time as the wound heals, because it might impede the growth of new skin cells. At least that was our take-away. (Note: Don’t take medical advice from lawyers. We’re not doctors, we just play them on TV.)
Which brings us around to Novotney v. Walgreen Co., — F. Supp. 3d –, 2023 WL 46998149 (N.D. Ill. July 20, 2023) involving, yes, hydrogen peroxide. In Novotney, the claims stemmed from the labeling of 3% hydrogen peroxide solution as a “first aid antiseptic” to be used for “treatment of minor cuts and abrasions.” Plaintiff asserted various fraud and breach of warranty claims, and alleged that “hydrogen peroxide is ineffective in treating minor cuts and abrasions because, contrary to popular belief, it does not reduce rates of wound infection… and does more harm than good because it also destroys beneficial bacteria and healthy cells that promote healing.”
Hydrogen peroxide is an FDA-regulated over-the-counter (OTC) drug, so Novotney addressed whether plaintiff’s claims were barred by federal preemption. And we are pleased to report the court came out the right way.
If you have read this blog for any length of time, you know that OTC drugs have an express preemption provision, 21 U.S.C. § 379r(a), providing that no state may “establish … any requirement … that is different from or in addition to, or that is otherwise not identical with, a requirement” of the Food, Drug, and Cosmetics Act (FDCA). (You also know that OTC express preemption doesn’t reach product liability claims, but it does cover non-product liability claims seeking economic loss damages.)
Moreover, the FDA established federal labeling for 3% hydrogen peroxide. As part of a long-history of regulating antimicrobial drug products, the FDA issued a 1991 “tentative final monograph” on First Aid Antiseptic Drug products, and that became final in 2020. See 21 U.S.C. § 355h(b)(8)(A).
The defendant noted that its hydrogen peroxide carried almost exactly the labeling the FDA had considered in its First Aid Antiseptic Drug Product monograph, and the court in Novotney agreed. Because “[t]he gravamen of plaintiff’s claims is that this very labeling, which is regulated by the FDA, is misleading because hydrogen peroxide is not effective as a first aid antiseptic for treatment of minor cuts and abrasions” plaintiff’s claims inherently contemplated that the hydrogen peroxide label should have said something different than the FDA required. That means express preemption.
Next, the court 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 first aid antiseptic for minor cuts and abrasion. The court found plaintiff’s references irrelevant to the soundness of the FDA’s conclusion, and agreed that preemption applied. (Indeed, it could have recognized that under implied preemption and Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), state tort claims are inappropriate vehicles for criticizing what the FDA considered in making a regulatory decision or the conclusion it reaches.)
Finally, the court rejected plaintiff’s complaint that the label in question used a word (“treatment”) that wasn’t in the FDA monograph. “[W]hether the FDA specifically approved the use of the word “treatment” is beside the point. The content of the product’s label as it relates to its safety or effectiveness is a matter of federal law, and by claiming that some other terminology is necessary to ensure that the label is not misleading, plaintiff impermissibly claims that state law imposes requirements that are different from, additional to, or otherwise not identical with, the requirements of the FDCA.”
Rounding out a good decision, the Court dismissed the case with prejudice, finding that any amendment of the complaint would be futile given the OTC express preemption clause.