A federal magistrate judge in Sacramento dismissed a lawsuit accusing Walgreens of selling a urinary pain treatment medication without proper federal authorization.
Jessica Argueta filed a putative class action complaint against the retail pharmacy giant on Jan. 17, alleging it sold phenazopyridine hydrochloride over the counter when she claimed it is “unsafe, ineffective and unlawful to sell” because it had not been approved formally by the U.S. Food and Drug Administration. She said the marketing of such products violated California’s Unfair Competition Law along with warranty protections.
Argueta is represented by attorneys Robert Tauler, of Tauler Smith LLP, of Los Angeles, and Kevin J. Cole, of KJC Law Group, of Beverly Hills.
In an opinion filed Dec. 20, Judge Christopher Baker dismissed the complaint.
Walgreens noted the drug, commonly referred to as PhenAzo, was discovered to have analgesic properties in 1932, while Congress approved the Food, Drug and Cosmetic Act in 1938. The FDA has not challenged the legality of PhenAzo, and Walgreens said the drug doesn’t need to undergo either of two approval mechanisms applicable to new drugs before they reach the market.
The company further cited a webpage from the National Center for Advancing Translational Sciences that said the dye was synthesized in 1914 and “adopted by the US Pharmacopoeia in 1928.”
Baker detailed how the FDCA creates a comprehensive regulatory structure for pharmaceutical manufacturers and how Congress gave the FDA investigatory and enforcement authority. That means private citizens can’t lodge lawsuits alleging FDCA violations and can only petition the FDA to engage in administrative action. Further, he explained U.S. Supreme Court precedent limiting state court fraud lawsuits that exist entirely based on allegations of FDCA violation.
Among the cases that established the legal framework for Baker’s conclusion was a 2020 U.S. Ninth Circuit Court of Appeals ruling in Nexus Pharmaceuticals v. Central Admixture Pharmacy Services, its 2013 decision, Perez v. Nidek, and a July 2023 opinion from the Southern District of California, Telebrands v. Luminas International.
Although he conceded Argueta’s claims are not explicitly premised on an alleged FDCA violation, Baker said litigation of her complaint would require determining whether Walgreens violated the FDCA by selling PhenAzo without FDA approval. He rejected Argueta’s attempts to distinguish her complaint from other cases on the record and said courts could reach the conclusion a lawsuit was preempted without an allegation of a particular FDCA violation.
Baker also said it didn’t matter the Nexus plaintiff was a corporation and not a consumer, noting that ruling reaffirmed Perez, which was a putative class action from individual consumers failing to bring California Consumer Legal Remedies Act fraud claims.
“The allegation that the products are illegal to sell as they are not FDA approved and they are not marketed under an established OTC monograph are veiled allegations of an FDCA violation, which are a critical element of each claim,” Baker wrote, adding he took “notice that PhenAzo is indeed a drug approved for the treatment of UTIs. Despite plaintiff’s argument otherwise, the issue of whether ‘PhenAzo is FDA approved’ is not a question of fact. Further, whether PhenAzo may be lawfully sold as a ‘grandfathered’ drug or by the specific avenues described in the complaint is immaterial to the finding that plaintiff’s claims rely upon a violation of the FDCA.”
Baker further found there was no path for Argueta to amend her complaint to avoid dismissal and refused to let her try.
Walgreens did not respond to a request for comment.
Walgreens is represented by attorney James K. Holder, of Gordon & Rees Scully Mansukhani, of San Francisco.