A class-action lawsuit has been filed against pharmaceutical giants Johnson & Johnson and Procter & Gamble in a US federal court in Florida. The plaintiff, Steve Audelo, alleges that these companies were aware that their over-the-counter cold and flu products, including Sudafed PE, Vicks NyQuil, and Benadryl Allergy Plus Congestion, which contain phenylephrine as an active ingredient, did not deliver the promised results.
The lawsuit contends that due to the defendants’ false and deceptive marketing practices, Audelo and other class members suffered financial losses, including the cost of purchasing these ineffective products.
Similar class-action claims have been filed against other drug manufacturers that produce phenylephrine-containing products. In a New Jersey federal court, GlaxoSmithKline (GSK), Walgreens, Procter & Gamble, and Kenvue (formerly J&J’s consumer health unit) have all been named in a filing.
The catalyst for these legal actions is an FDA advisory committee’s unanimous vote of 16-0, which occurred on Tuesday. The committee concluded that products containing phenylephrine are ineffective in treating congestion. Consequently, the FDA will determine whether to ban such products. In 2022, sales of products containing phenylephrine, totaling 242 different items, reached $1.76 billion, as reported by the FDA.
“There’s a serious problem when a ‘decongestant’ doesn’t ‘decongest,’ and the FDA’s recent findings are a prime example of how the pharmaceutical industry makes billions by knowingly selling questionable products to consumers who are suffering from specific ailments.”
– Adam Levitt, founding partner of DiCello Levitt
Data presented to the panel revealed that phenylephrine performed no better than a placebo in relieving congestion. Phenylephrine is intended to reduce blood vessel swelling, but the committee determined that when taken orally, insufficient amounts reach the nasal passages to produce the desired effect.
The FDA’s scrutiny of phenylephrine dates back to 2007 when the Nonprescription Drugs Advisory Committee arrived at a similar conclusion about its ineffectiveness. Although subsequent studies supported this finding, some variability in the results raised questions about study methodology.
The Florida lawsuit, filed on Wednesday, alleges that J&J and Procter & Gamble were aware or should have been aware of phenylephrine’s ineffectiveness, based on FDA guidance issued in 2018.
Adam Levitt, founding partner of DiCello Levitt, commented on these legal actions, highlighting concerns about the pharmaceutical industry selling products that knowingly provide little relief to consumers suffering from specific ailments.