89 Cal.App.5th 1
Cal. Ct. App.2023Background
- CEH sued manufacturers and retailers of ranitidine OTC antacids (generic and brand) under California’s Proposition 65, alleging failure to warn that products contained NDMA, a listed carcinogen.
- FDA alerted the public in 2019 and in 2020 requested withdrawal of ranitidine products after testing found NDMA contamination; some manufacturers recalled products.
- Defendants demurred, arguing federal law (FDCA and the Hatch‑Waxman duty of sameness for ANDA holders) preempts Proposition 65 warnings for generic OTC drugs.
- The trial court sustained demurrers of the generic-drug defendants without leave to amend and dismissed CEH’s claims against them; CEH appealed.
- The Court of Appeal affirmed: although section 379r of the FDCA contains a savings clause preserving Prop 65, impossibility (conflict) preemption applies because generics cannot independently add Proposition 65 warnings without violating the federal duty of sameness unless brand‑name manufacturers first change their labeling.
- The opinion notes practical limits: NDMA is an unintended contaminant (reformulation/removal is a more realistic remedy), and CEH’s claims against brand‑name manufacturers remain pending because those manufacturers may be able to use FDA’s CBE process to add warnings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether CEH’s Prop 65 warning claim against generic ranitidine manufacturers is preempted by federal law (impossibility preemption) | Prop 65 is preserved by FDCA §379r’s savings clause and Prop 65’s self-exception; generics could comply by warning or by reformulating to eliminate NDMA | Federal duty of sameness for ANDA holders prevents generics from unilaterally changing labeling or giving warnings that would differ from the brand label, so complying with both laws is impossible | Held preempted: generics cannot give Prop 65 warnings without violating federal duty of sameness; dismissal affirmed |
| Scope of Proposition 65’s self-exception (§25249.10(a)) — does it require impossibility of all compliance methods before applying? | Self-exception should not be read to preempt Prop 65 unless compliance is impossible by any means; reformulation should preserve state remedy | Self-exception applies where federal law governs warning in a way that preempts state authority to require warnings; if no permissible warning method exists, Prop 65 liability is barred | Court adopts defendants’ view: self-exception applies if federal law governs warnings so as to preempt state warning authority; CEH’s suit barred if no warning method satisfies both laws |
| Whether point-of-sale warnings and similar in-store materials are “labeling” under the FDCA (so subject to the duty of sameness) | Point-of-sale signs are not product labeling and thus not barred by federal sameness duty | Under Kordel and Leeman, materials designed for distribution/sale (including point-of-sale) “accompany” the product and qualify as labeling | Held: point-of-sale warnings qualify as labeling under the FDCA; generics cannot unilaterally provide them without violating duty of sameness |
| Whether public advertising or other public communications can convey a Proposition 65 warning without being "labeling" under federal law | Public advertising (press releases, website posts, social media) can satisfy Prop 65 and fall outside FDCA “labeling” | Kordel and agency practice show advertising that performs the function of labeling or is part of an integrated distribution program can be “labeling”; any advertising likely to be seen at purchase/use would qualify | Held: advertising that would actually satisfy Prop 65 would likely be ‘‘labeling’’ under Kordel and therefore is preempted for generics; CEH did not identify any non‑labeling method that would comply with both laws |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic manufacturers’ duty of sameness can make state-law failure-to-warn claims impossible to satisfy)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (state-law design-defect/warning claims preempted where federal duties prevent independent compliance)
- Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal.4th 910 (2004) (FDCA express-preemption savings clause preserves Prop 65 but does not foreclose conflict preemption relevant to consumer health)
- Kordel v. United States, 335 U.S. 345 (1948) (materials that "accompany" a drug—e.g., in‑store literature—can constitute FDCA "labeling")
- American Meat Institute v. Leeman, 180 Cal.App.4th 728 (2009) (point-of-sale warnings may be "labeling" under federal statutory definitions)