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 (2026), which held that the Federal Insecticide, Fungicide, and Rodenticide Act preempts a failure-to-warn claim seeking a cancer warning beyond the EPA-approved label. Yousefzadeh, 184 F.4th at 150 n.14 (citing Durnell, 146 S. Ct. at 2009–11). By anchoring its analysis in Durnell, the Second Circuit signaled that Durnell’s reasoning may extend beyond FIFRA to statutes with similarly worded preemption clauses, including the FDCA’s monograph regime.
Yousefzadeh, however, did not affirm dismissal of all claims, narrowing the district court’s preemption analysis. First, the court vacated dismissal of claims against brand-name New Drug Application (“NDA”)-approved PE products because the district court had not considered whether the FDA’s “changes-being-effected” regulation gave manufacturers an independent path to revise labeling. Id. at 153–54. Second, it revived “Maximum Strength” labeling claims, since those statements were voluntary rather than FDA-mandated. Id. at 152–53.
Separately, the Second Circuit in Yousefzadeh joined the Third, Sixth, and Seventh Circuits in holding that the antitrust indirect-purchaser rule of Illinois Brick Co. v. Illinois, 431 U.S. 720 (1977), applies to civil RICO claims, barring recovery by consumers too far removed from the alleged racketeering scheme—an issue of first impression in the circuit. Id. at 156–58.
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