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Second Circuit revives limited claims in decongestant class-action lawsuit

A federal appeals panel largely upheld a district court’s dismissal of consumer claims that oral phenylephrine decongestants are ineffective, but it revived a few advertising and labeling allegations.

In Manhattan, a three-judge panel of the Second Circuit largely confirmed a district judge’s ruling that federal law bars most consumer lawsuits alleging oral phenylephrine decongestants fail to work. Senior Judge Denny Chin wrote that the FDA’s labeling requirements shield manufacturers from liability, and the plaintiffs lacked standing for a RICO claim. The court did, however, revive two categories of claims: one accusing companies of falsely advertising products as “maximum strength,” and another questioning whether certain brand-name drugs received approval through the FDA’s new-drug application pathway.

The plaintiffs, led by attorney Jonathan Selbin of Lieff Cabraser, argue that manufacturers knowingly sold ineffective products that have generated roughly $12 billion in revenue. The appeals court sent the remaining claims back to U.S. District Judge Brian Cogan for further action. The FDA has not commented on the decision.

Why it matters

The ruling narrows consumer recourse against major drug makers while leaving some advertising claims alive.

In this story

decongestantoral phenylephrineclass actionSecond CircuitFDA labelingmaximum strengthRICO claimconsumer lawsuitdrug efficacy