This one appears fairly simple to us, however that didn’t cease plaintiff in Argueta v. Walgreens Firm, 2024 WL 5186825 (E.D. Cal. Dec. 20, 2024), from attempting to make a declare primarily based on allegations that the product was unlawful to promote as a result of it was not FDA permitted. No allegation that the product precipitated any bodily hurt. No allegation that the product didn’t work as meant or was ineffective. The court docket hardly wanted to dig deep to succeed in the conclusion that plaintiff was bringing a prohibited non-public explanation for motion to implement the Meals, Drug, and Beauty Act (“FDCA”). What may very well be extra FDCA-enforcement than a call on whether or not a product is permitted or not?
The product is an over-the-counter drug, phenazopyridine hydrochloride (“PhenAzo”), used to deal with signs of urinary tract infections. Id. at *1. Plaintiff’s claims, introduced on behalf of herself and a putative class, for breach of specific and implied guarantee and unfair competitors had been all premised on allegations that the product was not FDA-approved and subsequently it was not lawfully in the marketplace. Id. at *1-2. Allegations that it seems are usually not factually supported.
Defendant requested the court docket to take judicial discover of a Nationwide Institutes of Well being (“NIH”) web site, which the court docket concluded it might as a result of the web site is a matter of public document “that may be precisely and readily decided from sources whose accuracy can’t be fairly questioned.” Id. at *4. In response to the NIH, the drug at subject was first synthesized in 1914 and was permitted on the market in 1928 – ten years earlier than the FDCA was enacted. Id. at *4. Which means that PhenAzo is a grandfathered drug that needn’t bear the FDCA approval course of and that the FDA itself has not challenged. Subsequently, separate and other than preemption, the court docket took judicial discover that PhenAzo is in actual fact permitted for the therapy of UTI signs. It isn’t a query of reality, however slightly a press release of reality. Id. at *8.
However the coronary heart of the opinion activates preemption and the court docket had ample Ninth Circuit precedent on which to rely:
Plaintiff’s complete criticism is premised upon the lawfulness of Defendant’s sale of the Merchandise underneath the FDCA, whether or not they’re FDA-approved or are marketed underneath a longtime OTC drug monograph. This squarely triggers implied preemption underneath the FDCA as articulated in Perez and Nexus Prescribed drugs.
It didn’t matter that plaintiff’s claims weren’t premised on a particular FDCA violation. Id. at *7. Plaintiff claims the defendant violated the FDCA by promoting PhenAzo with out correct FDA approval. Subsequently, plaintiff’s claims rise or fall on whether or not there was an FDCA violation making them prohibited non-public FDCA-enforcement actions and impliedly preempted.
Plaintiff made a half-hearted request for go away to amend however didn’t assist her argument with any indication of how she might remedy her criticism. Depart to amend was denied as regardless of how plaintiff dressed up her claims, they might be “veiled allegations of an FDCA violation.” Id. at *6.
