A federal appeals court on Thursday revived portions of a broad, nationwide legal challenge in which consumers contend that drugmakers and retailers sold over-the-counter oral decongestants that failed to relieve nasal congestion.
The litigation, which consolidated roughly 100 suits, follows an advisory panel review at the U.S. Food and Drug Administration that concluded in September 2023 that oral phenylephrine - an active ingredient in several popular products - was no more effective than a placebo. Plaintiffs in the litigation alleged that manufacturers and retailers reaped billions of dollars selling products containing the ingredient despite its ineffectiveness.
A three-judge panel of the 2nd U.S. Circuit Court of Appeals in Manhattan said most of the consumers' state-law claims are preempted by the Federal Food, Drug, and Cosmetic Act because the defendants had adhered to FDA labeling requirements. However, the court permitted two categories of claims to proceed.
- Claims tied to "maximum strength" labeling: The panel found that allegations related to the use of the phrase "maximum strength" were not preempted when defendants themselves added that language to product labels.
- Claims tied to certain brand-name drugs approved under the New Drug Application process: The court said those claims could proceed because manufacturers of brand-name products approved through the NDA process could have updated their labels to reflect the most recent scientific findings.
Circuit Judge Denny Chin acknowledged the tension between the legal outcome and the FDA's own review, writing that the limitations on state-law remedies "may appear unfair, particularly when the FDA's own agency review has confirmed that oral PE does not work as a decongestant and when studies have impugned oral PE's efficacy for 20 years." He added, "The fix, however, must flow not from litigation but from the FDA."
The appeals panel also determined that the consumer plaintiffs lacked standing to pursue a civil racketeering claim that accused the defendants of defrauding both the public and the FDA.
Jonathan Selbin, counsel for the consumers, said plaintiffs were "obviously disappointed" by aspects of the ruling and indicated they were reviewing their next steps. He said, "For over a decade these manufacturers made billions of dollars selling products with a decongestant that they long knew - in many cases based on their own studies - was entirely ineffective at decongesting." He added that "This case is far from over."
Named manufacturers and retailers in the litigation include Procter & Gamble, which makes Vicks NyQuil Severe Cold & Flu, and Haleon, maker of Advil Sinus Congestion & Pain. Other defendants listed in the suits include Bayer, GSK, Kenvue, Costco, Target, Walgreens, Walmart and CVS. Lawyers for those companies did not immediately respond to requests for comment.
The appeals court returned the matters to U.S. District Judge Brian Cogan in Brooklyn, who had dismissed the consolidated litigation in October 2024. In November 2024, the FDA proposed removing oral phenylephrine as an ingredient from over-the-counter oral cold medications.