Leonard v. CVS Pharmacy, Inc.

Background

Cheri Leonard sued CVS Pharmacy, Inc., Amneal Pharmaceuticals of New York, LLC, and Amneal Pharmaceuticals LLC over five CVS-branded, over-the-counter guaifenesin products. She alleged that Amneal manufactured the products, CVS sold them, and the products contained a carbomer manufactured with benzene. She claimed that the defendants should have disclosed the benzene’s presence and asserted claims for breach of the implied warranty of merchantability, unjust enrichment, fraud, violation of California’s Consumer Legal Remedies Act, and violation of California’s Unfair Competition Law.

Leonard alleged that she purchased one of the products at a CVS retail location in Felton, California, in July 2024. She claimed that she would not have purchased it, or would have paid less for it, if the alleged benzene content had been disclosed. The products were subject to FDA approval, and the FDA approved Amneal’s applications in 2018. The approvals authorized the products’ labels and the use of the listed carbomer.

Personal Jurisdiction and Standing

Amneal argued that the court lacked personal jurisdiction over it because it did not sell or advertise the products directly in California. The court rejected that argument. Amneal sold the products to a distributor that had facilities in only four states, including California, and the court concluded that Amneal should have expected the products to reach California. Amneal’s registration to do business in California and its maintenance of registered agents there also supported personal jurisdiction, although those facts were insufficient on their own.

The defendants also argued that Leonard lacked Article III standing because she did not allege facts showing that the particular product she purchased contained benzene or that Amneal manufactured it. The court rejected that argument as well. At the motion-to-dismiss stage, the court accepted Leonard’s allegations that Amneal had admitted that finished doses of the products contained benzene and that Amneal manufactured the products. The court held that those allegations sufficiently established a particularized injury.

Preemption

The defendants argued that the Federal Food, Drug, and Cosmetic Act preempted Leonard’s state-law claims. Federal preemption means that federal law displaces or bars a conflicting state-law requirement. The court agreed.

The court relied on 21 U.S.C. § 379r, which prohibits states from imposing requirements on over-the-counter drugs that differ from, add to, or are not identical with federal requirements. The court concluded that the FDA had approved the products’ formulation and labeling, including the carbomer manufactured using benzene. Leonard did not allege that Amneal manufactured the products in a way that deviated from the FDA-approved applications.

The court therefore held that claims alleging that the products were adulterated, misbranded, not equivalent to Mucinex, or illegal to sell under California law were expressly preempted. The court also rejected Leonard’s arguments that preemption was improper at the motion-to-dismiss stage, that a product-liability exception applied, and that her California Unfair Competition Law claim could not be preempted because it relied on the California Sherman Law. The court stated that challenging FDA-approved content and labeling would impose a requirement different from or additional to the federal requirement.

Disposition

The court did not reach the defendants’ remaining arguments. Judge Edward J. Davila granted Defendants’ motion to dismiss with leave to amend. The court set October 20, 2025, as the deadline for Leonard to file an amended complaint if she chose to do so.