Key facts
- A U.S. appeals court revived some consumer claims against drugmakers and retailers regarding over-the-counter decongestants.
- Claims related to "maximum strength" labels and drugs approved via the New Drug Application process were allowed to proceed.
- Most state law-based claims were preempted due to FDA labeling compliance.
- A civil racketeering claim was dismissed for lack of standing.
- The FDA proposed removing oral phenylephrine as an ingredient in November 2024.
A federal appeals court has revived portions of nationwide litigation accusing drugmakers and retailers of selling ineffective over-the-counter decongestants. The consumers' lawsuits were filed after a U.S. Food and Drug Administration advisory panel found in September 2023 that oral phenylephrine, an ingredient in products like Vicks NyQuil Severe Cold & Flu and Advil Sinus Congestion & Pain, was no more effective than a placebo.
The 2nd U.S. Circuit Court of Appeals in Manhattan ruled that while most state law-based claims were preempted because the defendants followed FDA labeling requirements, claims related to decongestants labeled "maximum strength" could proceed. The court also revived claims concerning brand-name drugs approved through the New Drug Application process, as defendants could have updated labels to reflect current scientific understanding.
Circuit Judge Denny Chin noted that the limitations on consumer remedies might seem unfair given the FDA's findings and long-standing studies questioning oral phenylephrine's efficacy, but stated that any fix must come from the FDA, not litigation. The court also dismissed a civil racketeering claim against the defendants due to a lack of standing.