In a decisive move, a New York federal judge has dismissed roughly 100 lawsuits filed against consumer giants like Procter & Gamble, Haleon, Bayer, and Johnson & Johnson, where consumers alleged that the companies knowingly marketed ineffective decongestants. The lawsuits came on the heels of a September 2023 FDA advisory panel finding that phenylephrine, a common decongestant in over-the-counter cold medicines, lacked real efficacy.
Judge Brian Cogan ruled that the companies had no legal obligation to update their labels with the FDA’s findings unless directed by the agency itself, thereby closing the door on the plaintiffs’ claims. He also turned down a request from the plaintiffs to pause the dismissals while the FDA considers removing phenylephrine from store shelves altogether.
These lawsuits emerged shortly after the FDA advisory panel’s report, which identified phenylephrine’s impact as essentially indistinguishable from a placebo—despite being present in millions of products and generating $1.76 billion in sales in 2022. The cases, consolidated into a multidistrict litigation (MDL) in late 2023, argued that companies knowingly misled consumers about phenylephrine’s effectiveness, but Cogan’s ruling leaned on federal labeling regulations, affirming that companies were legally compliant under current guidelines.
This ruling is significant as it not only halts litigation in New York but may serve as a precedent for similar cases, reinforcing regulatory agency authority in labeling matters. The FDA has since hinted it may take further action regarding phenylephrine, potentially reshaping the decongestant market.
