Life Sciences

The Ninth Circuit recently issued a key Prop 65 decision that could have broader implications for businesses subjected to its regulatory regime. 

Enacted via a ballot initiative, Prop 65 requires a company to warn consumers when one of its products contains a chemical known to the state of California to be carcinogenic or harmful to reproductive health.  In 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) placed glyphosate on its list of chemicals requiring a warning after the International Agency for Research on Cancer (IARC) concluded that the herbicide was “probably carcinogenic.”  Shortly after, a group of agricultural and business groups sued to enjoin California from requiring glyphosate warnings, arguing that the requirement violated the First Amendment.  The Ninth Circuit agreed.  See Nat’l Ass’n of Wheat Growers v. Bonta,– F.4th–, 2023 WL 7314307, at *2 (9th Cir. Nov. 7, 2023).Continue Reading Citing First Amendment Issues, Ninth Circuit Kills Prop 65 Glyphosate Warning Requirement

Recently, there has been a proliferation of putative class actions targeting allegedly misleading statements (or omissions) on the FDA-approved labels for over-the-counter (“OTC”) drugs.  Last year, we explained how these types of claims are vulnerable to a strong federal preemption defense.  In short, because the Federal Food, Drug, and Cosmetic Act (“FDCA”) explicitly forbids states from imposing OTC labeling requirements that are “different from,” “in addition to,” or “otherwise not identical” with those provided under federal law, 21 U.S.C. § 379r(a), state-law claims that directly challenge or conflict with the FDA’s decision-making for OTC drug labels are expressly preempted.Continue Reading Another Win for Preemption in Over-The-Counter Drug Labeling Case

On October 17, the District of Massachusetts added to the growing line of federal courts that have held a mere data breach, without additional harm, is insufficient to grant customers Article III standing.  See Webb v. Injured Workers Pharmacy, LLC, 2022 WL 10483751, at *1 (D. Mass. Oct. 17, 2022).  In February 2022, a home delivery pharmacy notified over 75,000 affected customers that hackers broke through its defenses and accessed patients’ personal data.  Two of these customers filed a putative class action against the pharmacy, alleging various tort and contract theories.  The court dismissed their claims for lack of standing, holding that plaintiffs had failed to allege any actionable harm stemming from the data breach despite their allegations that the breach caused them significant emotional harm.Continue Reading Data Breach, Without Allegations of Misuse, Isn’t Enough for Article III Standing

Manufacturers of over-the-counter (OTC) medications often move to dismiss consumer class actions based on federal preemption.  The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption clause that forbids states from enforcing laws relating to OTC drugs that are “different from or in addition to, or that [are] otherwise not identical with, a requirement under” the FDCA.  21 U.S.C. § 379r(a).  (Section 379r also contains a savings clause that exempts product liability actions from its preemptive scope.  See id. § 379r(e).)  Similar preemption provisions exist for food and cosmetics.  Id. §§ 343-1(a), 379s(a).  Although most courts have interpreted the FDCA’s express preemption provisions broadly, a minority have limited their application.  As discussed below, the minority view involves distinguishable circumstances and is inconsistent with the FDCA’s statutory text.Continue Reading A Closer Look: Express Federal Preemption for OTC Medications Subject to Monographs