Center for Environmental Health v. Perrigo Company
(Cal. Ct. App., Mar. 9, 2023): A California appellate court affirmed the dismissal of failure-to-warn claims against generic drug manufacturers because it was impossible for the defendants to comply with state labeling requirements regarding known carcinogens while complying with the federal requirement that generic drugs have the same labeling as their brand-name equivalents. Under Proposition 65, which was passed in California in 1986, California requires products containing certain carcinogens to carry label warnings about those carcinogens. The Center for Environmental Health alleged that manufacturers of certain generic drugs were violating Proposition 65 by not labeling the drugs with known carcinogen warnings, but also that adding the required Proposition 65 warnings to drug labels would cause the companies to be in violation of federal law, which severely restricts permissible content on generic drug labels so that those labels are as similar as possible to the labels on brand name equivalent drugs. When the case was filed, the brand name drug labels did not include the Proposition 65 warnings. The court agreed with the manufacturers, finding that federal drug labeling laws preempted the state’s known carcinogen labeling requirement. Read the full decision here.
View all cases in Judicial Trends and Public Health – May 16, 2023