ARTICLE · 15 OCTOBER 2026
Second Circuit Delivers A Mixed Verdict On Phenylephrine Preemption
This monthly newsletter examines significant legal trends and landmark cases in product liability and mass torts, including recent court decisions on phenylephrine preemption, BIOCELL implant litigation, AI-directed court filings, EPA hazardous substance designations, and climate superfund laws. The analysis provides strategic insights for businesses navigating complex tort litigation and regulatory challenges across multiple industries.
United StatesLitigation, Mediation & Arbitration
Key Takeaways
- The Second Circuit held that the FDCA preempts most consumer claims against monograph-compliant decongestant makers, while leaving open narrower claims tied to brand-name New Drug Application products and voluntary “Maximum Strength” labeling.
- Yousefzadeh confirms that the FDCA preempts state-law claims against monograph-compliant manufacturers, but leaves open the possibility of claims involving NDA-approved products or voluntary labeling.
In Yousefzadeh v. Johnson & Johnson Consumer Inc., 184 F.4th 130 (2d Cir. 2026), the Second Circuit largely affirmed dismissal of consumer claims against manufacturers of over-the-counter oral phenylephrine (“PE”) decongestants, holding that the Food, Drug, and Cosmetic Act (“FDCA”) express preemption provision, 21 U.S.C. § 379r, bars most state-law claims against monograph-regulated PE products. Yousefzadeh, 184 F.4th at 138–39. The court found its analysis “consistent with” Monsanto Co. v. Durnell, 146 S. Ct. 2001
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