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 making an attempt to make a declare based mostly on allegations that the product was unlawful to promote as a result of it was not FDA authorised. No allegation that the product brought on any bodily hurt. No allegation that the product didn’t work as supposed or was ineffective. The court docket hardly wanted to dig deep to succeed in the conclusion that plaintiff was bringing a prohibited personal explanation for motion to implement the Meals, Drug, and Beauty Act (“FDCA”). What might be extra FDCA-enforcement than a call on whether or not a product is authorised 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 due to this fact it was not lawfully available on the market. Id. at *1-2. Allegations that it seems aren’t 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 report “that may be precisely and readily decided from sources whose accuracy can’t be fairly questioned.” Id. at *4. In keeping with the NIH, the drug at situation was first synthesized in 1914 and was authorised 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. Due to this fact, separate and aside from preemption, the court docket took judicial discover that PhenAzo is the truth is authorised for the remedy of UTI signs. It isn’t a query of reality, however reasonably an announcement 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 below the FDCA, whether or not they’re FDA-approved or are marketed below a longtime OTC drug monograph. This squarely triggers implied preemption below 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. Due to this fact, plaintiff’s claims rise or fall on whether or not there was an FDCA violation making them prohibited personal FDCA-enforcement actions and impliedly preempted.
Plaintiff made a half-hearted request for depart 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.