Center for Environmental Health v. Perrigo Co.
Annotate this Case
Generic versions of ranitidine-containing antacids are sold under the brand name Zantac. In 2019, after an independent laboratory found “significant quantities of NDMA,” a known carcinogen in ranitidine-containing antacids, the FDA issued a public alert. Some manufacturers voluntarily recalled their products. In 2020, the FDA “request[ed that] manufacturers withdraw all prescription and [OTC] ranitidine drugs from the market immediately.”
CEH, a nonprofit corporation, sued under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code 25249.5, alleging that the generic-drug defendants continued to expose individuals to NDMA without clear and reasonable warnings regarding the carcinogenic hazards. The trial court dismissed the generic defendants without leave to amend, citing preemption by the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301. The court determined that the generic-drug defendants cannot give a Proposition 65 warning without violating the federal requirement that the generic version of a drug have the same “labeling” as the brand-name version. The court of appeal affirmed that dismissal. Although not all methods of publicly communicating a warning about a drug necessarily qualify as “labeling,” CEH fails to identify any method by which the generic-drug defendants could provide a warning that would satisfy both Proposition 65 and the federal duty of sameness.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.