This one seems pretty straightforward to us, but that did not stop plaintiff in Argueta v. Walgreens Company, 2024 WL 5186825 (E.D. Cal. Dec. 20, 2024), from trying to make a claim based on allegations that the product was illegal to sell because it was not FDA approved.  No allegation that the product caused any physical harm.  No allegation that the product did not work as intended or was ineffective.  The court hardly needed to dig deep to reach the conclusion that plaintiff was bringing a prohibited private cause of action to enforce the Food, Drug, and Cosmetic Act (“FDCA”). What could be more FDCA-enforcement than a decision on whether a product is approved or not? 

The product is an over-the-counter drug, phenazopyridine hydrochloride (“PhenAzo”), used to treat symptoms of urinary tract infections.  Id. at *1.  Plaintiff’s claims, brought on behalf of herself and a putative class, for breach of express and implied warranty and unfair competition were all premised on allegations that the product was not FDA-approved and therefore it was not lawfully on the market.  Id. at *1-2.  Allegations that it turns out are not factually supported.

Defendant asked the court to take judicial notice of a National Institutes of Health (“NIH”) website, which the court concluded it could because the website is a matter of public record “that can be accurately and readily determined from sources whose accuracy cannot be reasonably questioned.”  Id. at *4.  According to the NIH, the drug at issue was first synthesized in 1914 and was approved for sale in 1928 – ten years before the FDCA was enacted.  Id. at *4.  Meaning that PhenAzo is a grandfathered drug that need not undergo the FDCA approval process and that the FDA itself has not challenged.  Therefore, separate and apart from preemption, the court took judicial notice that PhenAzo is in fact approved for the treatment of UTI symptoms.  It is not a question of fact, but rather a statement of fact.  Id. at *8.

But the heart of the opinion turns on preemption and the court had ample Ninth Circuit precedent on which to rely:

Plaintiff’s entire complaint is premised upon the lawfulness of Defendant’s sale of the Products under the FDCA, whether they are FDA-approved or are marketed under an established OTC drug monograph. This squarely triggers implied preemption under the FDCA as articulated in Perez and Nexus Pharmaceuticals.

It did not matter that plaintiff’s claims were not premised on a specific FDCA violation.  Id. at *7.  Plaintiff claims the defendant violated the FDCA by selling PhenAzo without proper FDA approval.  Therefore, plaintiff’s claims rise or fall on whether there was an FDCA violation making them prohibited private FDCA-enforcement actions and impliedly preempted.   

Plaintiff made a half-hearted request for leave to amend but did not support her argument with any indication of how she could cure her complaint.  Leave to amend was denied as no matter how plaintiff dressed up her claims, they would be “veiled allegations of an FDCA violation.”  Id. at *6.