Judge Thomas D. Long, Case Number: 23STCV10020, Date: 2024-03-21 Tentative Ruling

On May 3, 2023, Plaintiff Alex Martinez filed this action against Defendant Prestige Consumer Healthcare Inc. for civil penalties and injunctive relief based on violations of Health & Safety Code section 25249.6 et seq.

Exhibit A (Complaint in this case): Denied as unnecessary because this document is already part of the case’s record.

Exhibit B (Final Statement of Reasons 27 CCR (formerly 22 CCR) Safe Drinking Water and Toxic Enforcement Act of 1986): Denied as irrelevant.

Exhibit C (relevant pages from the Federal Register volume 48, dated July 29, 1983, concerning regulations governing warning labeling for products containing Phenazopyridine Hydrochloride): Granted.

Exhibit D (pages on the drug Uristat, including labeling and warning information mandated by the FDA, from the U.S. National Institutes of Health’s “DailyMed” website): Granted. This includes the label that Plaintiff alleges is misleading, and it forms the basis for the allegations in the Complaint. (See Align Technology, Inc. v. Tran (2009) 179 Cal.App.4th 949, 956, fn. 6.) Plaintiff has not opposed the requests and does not dispute its accuracy. (See Ingram v. Flippo (1999) 74 Cal.App.4th 1280, 1285, fn. 3.)

Exhibit E (Office of Environmental Health Hazard Assessment’s 1992 Expedited Cancer Potency Values and Proposed Regulatory Levels for Certain Proposition 65 Carcinogens): Denied as irrelevant and improperly submitted on reply.

A demurrer for sufficiency tests whether the complaint states a cause of action. (Hahn v. Mirda (2007) 147 Cal.App.4th 740, 747.) When considering demurrers, courts read the allegations liberally and in context, accepting the alleged facts as true. (Nolte v. Cedars-Sinai Medical Center (2015) 236 Cal.App.4th 1401, 1406.) “Because a demurrer challenges defects on the face of the complaint, it can only refer to matters outside the pleading that are subject to judicial notice.” (Arce ex rel. Arce v. Kaiser Found. Health Plan, Inc. (2010) 181 Cal.App.4th 471, 556.)

Under Proposition 65, “[n]o person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.”

Plaintiff alleges that Defendant “developed, manufactured, marketed, distributed, and/or sold the Subject Product [“Uristat Urinary Tract Infection Pain Relief Tablets”] containing Phenazopyridine Hydrochloride into the State of California” without a clear and reasonable warning that they have been exposed to chemical known to the State of California to cause cancer, birth defects, and other reproductive harm.” (Complaint ¶¶ 6, 26-30, 32.)

Defendant argues that Plaintiff cannot prove an intentional exposure without a clear and reasonable warning because the Subject Product’s label includes the FDA-required warning. (Demurrer at pp. 10-14.) The FDA-required warning states: “Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.” (Demurrer at p. 11 & Exs. C-D.) Whether this is a compliant “clear and reasonable warning” about the risk of cancer or reproductive toxicity in humans cannot be determined on demurrer.

Defendant also argues that Plaintiff’s claims are preempted by federal law, relying heavily on Dowhal v. SmithKline Beecham Consumer Healthcare (2004) 32 Cal.4th 910 (Dowhal). (Demurrer at pp. 14-17.) According to Defendant, ‘the Dowhal court concluded FDA “established a federal policy prohibiting defendants from giving consumers any warning other than the one approved by the FDA in that letter, and that the use of a Proposition 65 warning would conflict with that policy.’ Id. at p. 929. The same kind of preemption applies here.”

The Dowhal court did not make such a broad pronouncement for all labels. Rather, the court specifically addressed the FDA’s August 17, 2001 letter and the federal policy it established. (Dowhal, supra, 32 Cal.4th at p. 929.) “The apparent conflict arises from the FDA's insistence that defendants must use the warning it has promulgated unless they have data to support a different warning. The FDA has rejected plaintiff’s claim that his data justify a different warning, and defendants do not claim to have any additional data. Thus, if a defendant were to add a warning to its label advising that nicotine can cause fetal harm, it would violate the FDA’s determination and would risk legal sanctions.” (Id. at p. 927.) The letter “specifically rejected plaintiff's proposed ‘can harm your baby’ warning. It did not expressly reject all possible Proposition 65 warnings.” (Ibid., citation omitted.) The court concluded that the FDA’s ruling “reflects the concern that Proposition 65 warnings on product labels might lead pregnant women to believe that NRT products were as dangerous as smoking, or nearly so, and thus discourage the women from stopping smoking. . . . Conflict preemption does not require a direct contradiction between state and federal law; the state law is preempted if state law ‘“stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”’” (Id. at p. 929.)

At the pleading and demurrer stage, it is premature and inappropriate to make a fact-intensive finding of preemption like that made at summary judgment in Dowhal.

Defendant also cites Center for Environmental Health v. Perrigo Co. (2023) 89 Cal.App.5th 1 (Perrigo) as instructive. (Demurrer at pp. 16-17.) The Perrigo court concluded that Proposition 65’s self-exception applied, and the “action against the generic-drug defendants cannot go forward, if federal law governs warning in a manner that preempts state law governing warning.” (Perrigo, supra, 89 Cal.App.5th at p. 24.) The court proceeded to determine “whether the generic-drug defendants could give warnings about their products that comply with both Proposition 65 and federal law,” and “since the manufacturer of a generic drug cannot deviate from the labeling of the brand-name version of the drug, it would be impossible for the generic-drug defendants to give a Proposition 65 point-of-sale warning without violating the federal duty of sameness.” (Id. at pp. 24, 33.)

Here, there is no facial conflict between federal law and Proposition 65 and no showing that adding a Proposition 65 label on the Subject Product would not also comply with federal requirements.

The demurrer is OVERRULED. Defendant is ordered to file an answer within 10 days. (California Rules of Court, rule 3.1320(j)(1).)

Parties who intend to submit on this tentative must send an email to the Court at SMCDEPT48@lacourt.org indicating intention to submit. If all parties in the case submit on the tentative ruling, no appearances before the Court are required unless a companion hearing (for example, a Case Management Conference) is also on calendar.

Hon. Thomas D. Long

Judge of the Superior Court