Summary
The United States District Court for the Northern District of California granted Defendants’ motion to dismiss Plaintiff’s claims concerning alleged benzene in CVS-branded guaifenesin products, allowing leave to amend. The court found personal jurisdiction over Amneal and concluded that Plaintiff adequately pleaded Article III standing. It held that the claims were expressly preempted under the Federal Food, Drug, and Cosmetic Act because the products’ formulation and labeling had been approved by the FDA.
Topics
Practice areas
Questions Presented
- Whether the court could exercise specific personal jurisdiction over the nonresident Amneal defendants.
- Whether Plaintiff adequately pleaded Article III standing by alleging that the specific product she purchased contained benzene and was manufactured by Amneal.
- Whether the FDCA's express preemption provision preempted Plaintiff's California claims challenging the FDA-approved formulation and labeling of nonprescription drugs.
- Whether Plaintiff should receive leave to amend after dismissal.
Holdings
- The court had specific personal jurisdiction over Amneal because Amneal sold the products to a distributor whose facilities were located in only four states, including California, making it reasonable to conclude that the products would reach California; Amneal's registration to do business and registered agents in California provided additional support.
- Plaintiff adequately pleaded Article III standing because her allegations reasonably supported an inference that the product she purchased contained benzene and was manufactured by Amneal.
- The FDCA expressly preempted Plaintiff's California claims to the extent they challenged the FDA-approved formulation or required additional or different labeling concerning benzene in the products.
- The court granted Plaintiff leave to amend because it did not determine that the pleading could not possibly be cured by alleging other facts.
Key quotations
“To preserve “[n]ational uniformity for nonprescription drugs,” Section 379r(a)(2) of the FDCA expressly prohibits any state from establishing “any requirement” that “is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter.”” (Discussion § III.C)
“Based on the foregoing, the Court GRANTS Defendants’ motion to dismiss with leave to amend.” (Conclusion)
Factual background
Plaintiff purchased a CVS-branded extended-release guaifenesin product in California in July 2024. She alleged that the products were manufactured by Amneal, sold by CVS, and contained carbomer manufactured using benzene, a known carcinogen. Amneal's abbreviated new drug applications were approved by the FDA in 2018, including the products' formulation, inactive ingredient, manufacturing specifications, and labeling. Plaintiff alleged that Defendants should have disclosed the presence and risks of benzene and asserted economic-loss and consumer-protection claims.
Procedural history
Plaintiff filed the action on September 5, 2024, and later filed a First Amended Complaint asserting five claims: breach of implied warranty, unjust enrichment, fraud, violation of the California Consumer Legal Remedies Act, and violation of California's Unfair Competition Law. Defendants moved to dismiss for lack of subject matter jurisdiction, failure to state a claim, and other grounds. The court granted the motion to dismiss, finding personal jurisdiction and Article III standing adequately alleged but concluding that the claims were expressly preempted, and granted leave to amend by October 20, 2025.
Remand instructions
No remand. Plaintiff may file an amended complaint by October 20, 2025.