Thursday, October 5, 2023

No Boo Boos in OTC Preemption Case


Photo of Lisa Baird

Like having a primary kid, whilst you think new tasks in taking good care of aged folks, you get a crash-course training in subjects you another way by no means would have considered.  Have your first kid, and also you most likely will expand a new-found pastime—if now not firmly-held critiques—on ideas like sleep coaching and breast feeding.  Tackle a job in offering maintain aged folks and chances are you’ll expand a new-found pastime in scintillating subjects like compression socks and wound care. 

Which is how we got here to grasp a bit bit about hydrogen peroxide.  We have been schooled via a wound care doctor that hydrogen peroxide is absolute best used as a primary assist remedy when a reduce or scrape to start with occurs—however now not through the years because the wound heals, as a result of it will hinder the expansion of latest pores and skin cells.  No less than that used to be our take-away.  (Word: Don’t take scientific recommendation from legal professionals.  We’re now not medical doctors, we simply play them on TV.)

Which brings us round to Novotney v. Walgreen Co., — F. Supp. 3d –, 2023 WL 46998149 (N.D. Unwell. July 20, 2023) involving, sure, hydrogen peroxide.  In Novotney, the claims stemmed from the labeling of three% hydrogen peroxide resolution as a “first assist antiseptic” for use for “remedy of stripling cuts and abrasions.”  Plaintiff asserted quite a lot of fraud and breach of guaranty claims, and alleged that “hydrogen peroxide is useless in treating minor cuts and abrasions as a result of, opposite to widespread trust, it does now not scale back charges of wound an infection… and does extra hurt than excellent as it additionally destroys recommended micro organism and wholesome cells that advertise therapeutic.”

Hydrogen peroxide is an FDA-regulated over the counter (OTC) drug, so Novotney addressed whether or not plaintiff’s claims have been barred via federal preemption.  And we’re happy to record the courtroom got here out the best means.

You probably have learn this weblog for any period of time, that OTC medication have an specific preemption provision, 21 U.S.C. § 379r(a), offering that no state might “identify … any requirement … this is other from or along with, or this is another way now not equivalent with, a demand” of the Meals, Drug, and Cosmetics Act (FDCA).  (You additionally know that OTC specific preemption doesn’t achieve product legal responsibility claims, nevertheless it does quilt non-product legal responsibility claims in quest of financial loss damages.)

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

The defendant famous that its hydrogen peroxide carried nearly precisely the labeling the FDA had thought to be in its First Help Antiseptic Drug Product monograph, and the courtroom in Novotney agreed.  As a result of “[t]he gravamen of plaintiff’s claims is this very labeling, which is regulated via the FDA, is deceptive as a result of hydrogen peroxide isn’t efficient as a primary assist antiseptic for remedy of stripling cuts and abrasions” plaintiff’s claims inherently pondered that the hydrogen peroxide label must have stated one thing other than the FDA required.  That implies specific preemption.

Subsequent, the courtroom rejected arguments via the plaintiff that attacked the stability of the science in the back of the FDA’s judgment that hydrogen peroxide used to be appropriately-labeled as a primary assist antiseptic for minor cuts and abrasion.  The courtroom discovered plaintiff’s references beside the point to the stability of the FDA’s conclusion, and agreed that preemption carried out.  (Certainly, it might have identified that beneath implied preemption and Buckman Co. v. Plaintiffs Prison Committee, 531 U.S. 341 (2001), state tort claims are beside the point cars for criticizing what the FDA thought to be in creating a regulatory resolution or the belief it reaches.)

In the end, the courtroom rejected plaintiff’s criticism that the label in query used a phrase (“remedy”) that wasn’t within the FDA monograph.  “[W]hether the FDA particularly authorized using the phrase “remedy” is irrelevant. The content material of the product’s label because it pertains to its protection or effectiveness is an issue of federal regulation, and via claiming that any other terminology is essential to make sure that the label isn’t deceptive, plaintiff impermissibly claims that state regulation imposes necessities which can be other from, further to, or another way now not equivalent with, the necessities of the FDCA.”

Rounding out a excellent resolution, the Courtroom disregarded the case with prejudice, discovering that any modification of the criticism could be futile given the OTC specific preemption clause. 


Please enter your comment!
Please enter your name here

Related Stories