In a key legal development, a federal judge in New York dismissed nearly 100 lawsuits accusing major corporations, including Procter & Gamble, Haleon, and other industry giants, of selling over-the-counter medications containing the decongestant phenylephrine, which was recently declared ineffective. U.S. District Judge Brian Cogan ruled on Tuesday that the plaintiffs’ claims lacked sufficient grounds, clearing the way for drug manufacturers in a case that has captured significant attention following a 2023 FDA review.
The lawsuits, filed by consumers, centered on the claim that these companies knowingly marketed medications containing phenylephrine, despite growing evidence that it does not work as advertised. The litigation stemmed from a September 2023 decision by a U.S. Food and Drug Administration (FDA) advisory panel, which reviewed extensive scientific data and concluded that phenylephrine, widely used in cold and allergy medications, was essentially no more effective than a placebo.
Judge Cogan’s ruling dismissed the claims based on the argument that companies were not legally required to alter their product labels unless explicitly instructed to do so by the FDA. The judge also rejected the plaintiffs’ request for a delay in the case while the FDA considers removing phenylephrine as an active ingredient from over-the-counter cold medications.
The decision is a setback for consumers who were hoping for legal accountability after spending billions of dollars on products containing phenylephrine, which was included in over 242 million products in 2022, generating sales of $1.76 billion. The plaintiffs had argued that these companies, including Walgreens, Bayer, and Johnson & Johnson’s former consumer health division, knew about the ingredient’s lack of efficacy but continued to sell the products, misleading the public in the process.
Following the filing of these lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized the cases in New York federal court to streamline proceedings. In December 2023, Judge Cogan addressed a class action lawsuit brought on behalf of New York consumers, which sought to challenge the product labels under state law. However, in October 2024, Cogan sided with the defendants, ruling that federal law governed the labeling requirements for over-the-counter medications and precluded state law challenges.
Judge Cogan’s most recent ruling extended this decision to the other lawsuits in the multidistrict litigation, concluding that the plaintiffs could not challenge the drug labeling unless the FDA required changes.
Despite the legal setback, the issue is far from resolved. On November 7, 2024, the FDA announced that it was actively considering whether phenylephrine should continue to be used as an ingredient in over-the-counter oral cold medications. The review follows growing concerns about the effectiveness of the ingredient, which has been the subject of numerous scientific studies.
If the FDA decides to remove phenylephrine from the market, it could prompt changes to product labeling, drug formulations, and industry practices. This regulatory action would likely impact millions of consumers who rely on these medications for relief during cold and flu season.
The dismissal of these lawsuits underscores the legal complexities surrounding consumer protection and regulatory oversight. While the judge’s ruling removes the immediate threat of legal consequences for the companies involved, it highlights the significant role of the FDA in shaping the future of the cold medicine market. If the FDA acts to ban or alter phenylephrine’s use, it could lead to further legal challenges and regulatory changes that may affect both companies and consumers alike.
For now, the legal battle over phenylephrine has been largely halted, leaving many to watch closely as the FDA’s decision unfolds. Consumers, however, remain wary of continued reliance on ineffective decongestants, while industry players prepare for potential changes to their product lines.
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