Silva v. Haleon US Inc.
3:24-cv-04059
N.D. Cal.Dec 2, 2024Background
- Plaintiffs (Silva and Jones) filed a class action alleging misleading marketing of Sensodyne Pronamel toothpaste by Haleon US, particularly claims that the product "Rebuilds," "Restores," or "Repairs" enamel.
- Plaintiffs argued these representations are false because, scientifically, lost enamel cannot be replaced with fluoride toothpaste.
- The toothpaste is regulated as an over-the-counter (OTC) anticaries drug under an FDA monograph that describes allowed labeling and active ingredients (here, sodium fluoride).
- The FDA has previously considered and not prohibited such claims (rebuild, restore, repair) in public warning letters about similar products.
- Plaintiffs brought five state law causes of action, all relating to allegedly false or misleading product labeling.
- Defendants moved to dismiss, claiming Plaintiffs' claims are preempted by federal law and fail to allege actionable misrepresentations.
Issues
| Issue | Plaintiff’s Argument | Defendant’s Argument | Held |
|---|---|---|---|
| Are Plaintiffs’ state law claims preempted by FDA law? | State claims aren't preempted; labels must be truthful/non-misleading | Claims raise a requirement not identical to the FDA monograph | Court: Claims are preempted by federal law |
| Does FDA monograph expressly address product claims? | FDA did not specifically authorize phrases used | FDA addressed similar claims and hasn’t prohibited them | Court: No prohibition; FDA has considered terms |
| Can state law challenge replace FDA’s judgment on labels? | State law may bar misleading language absent FDA prohibition | Only FDA decides what’s misleading for OTC drugs | Court: Only FDA can decide labeling issues |
| Should leave to amend be granted? | (Positioned as futile; no new facts could be pled) | Amendment would not cure preemption | Court: Leave to amend would be futile |
Key Cases Cited
- Eckler v. Neutrogena Corp., 238 Cal. App. 4th 433 (Cal. Ct. App. 2015) (affirmed OTC drug labeling preemption; only FDA can decide what is false/misleading under monograph)
- Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015) (discussed when state labeling requirements are preempted by federal law)