Federal Judge Dismisses Phenylephrine Decongestant Lawsuit

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A federal judge has dismissed a proposed class action lawsuit that alleged several retailers and manufacturers misled consumers by marketing hundreds of over-the-counter cough and cold medicines as effective nasal decongestants despite evidence that their active ingredient, phenylephrine (PE), is no more than a placebo.

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In a 17-page order, U.S. District Judge Brian M. Cogan granted the defendants’ motion to toss the streamlined complaint, which was filed in May 2024 as part of multidistrict litigation into which nearly 100 cases concerning PE were consolidated in New York federal court.

The avalanche of phenylephrine lawsuits began after the Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) unanimously declared in September 2023 that PE, when taken orally, does not work to relieve nasal congestion.

Named as defendants were Johnson & Johnson, Haleon, Perrigo, Reckitt Benckiser, Bayer Healthcare, Procter & Gamble, Walmart, Target, CVS Pharmacy and Walgreens—all of whom the plaintiffs claimed have known since at least 2016 that their PE cold and allergy medications were ineffective.

The plaintiffs argued that the defendants violated several New York state laws by failing to update their label claims to truthfully describe the products’ efficacy. Judge Cogan, however, found that the plaintiffs’ state law claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA).

Judge Cogan noted that the plaintiffs’ state law claims sought to impose labeling requirements that conflict with those imposed by the FDCA, which is prohibited under the federal law’s preemption clause. According to the judge, the defendants had no obligation under the federal law to remove or update their label indications to state that PE is an ineffective decongestant.

“[W]hether a drug is ‘effective’ is a term of art under the FDCA, and the statute empowers the FDA, not manufacturers, to make that determination,” the judge wrote. “So, even taking plaintiffs’ allegations as true, nothing on the labels was false or misleading – unless and until the FDA amends the monograph in response to the NDAC’s findings, it is not misleading to state that PE is an effective nasal decongestant.”

Judge Cogan also dismissed claims that the manufacturer defendants violated federal racketeering law by engaging in mail and wire fraud to trick the public and the FDA into believing that PE is an effective decongestant. The judge determined that the plaintiffs did not have standing to assert a claim under the Racketeer Influenced and Corrupt Organizations Act because they were “indirect purchasers” of the PE products.

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