Kenvue, Procter & Gamble, GlaxoSmithKline, and Walgreens among defendants named in lawsuit following FDA advisory panel vote
CHICAGO—The nation’s largest pharmaceutical companies and pharmacies violated state consumer protection laws, defrauded consumers, and wrongly enriched themselves by selling and marketing products containing a common ingredient in over-the-counter cold medicines they knew to be ineffective, according to a class action lawsuit filed today in New Jersey federal court. The complaint is among the first to be filed following a U.S. Food and Drug Administration advisory panel’s unanimous finding that the ingredient, phenylephrine, is ineffective in oral medication. In the last year alone, nearly $1.8 billion in sales of such phenylephrine-containing purported decongestants were made in the United States across 250 products. Filed by DiCello Levitt LLP with co-counsel, the suit names Kenvue, Inc. (formerly Johnson & Johnson’s Consumer Healthcare Division), GlaxoSmithKline, Procter & Gamble, and Walgreens among defendants who knowingly misled the public about the ingredient’s efficacy.
“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,” said Adam Levitt, founding partner of DiCello Levitt. “Particularly in the years following the pandemic, the pharmaceutical industry’s cynical willingness to peddle bogus cold and flu medication is deeply troubling.”
The lawsuit, brought by DiCello Levitt, Seeger Weiss LLP, Robbins Geller Rudman & Dowd LLP, and Carella, Byrne, Cecchi, Brody & Agnello PC, alleges the defendants have long known phenylephrine to be ineffective, an understanding backed up by multiple, well-known scientific studies.
In a 2006 report published in the Journal of Allergy and Clinical Immunology, researchers found that “Phenylephrine…is unlikely to provide relief of nasal congestion. It has poor oral bioavailability because of extensive first-pass metabolism in the gut and liver…Moreover, in a randomized, double blind, placebo-controlled, crossover study of 3 oral decongestants in 20 patients with chronic nasal stuffiness, phenylephrine was no more effective than placebo in reducing nasal airway resistance.” Further, in an FDA Advisory Committee report issued earlier this week, the committee described a 2017-2018 Johnson & Johnson trial, which “suggest[ed] no beneficial effect [of phenylephrine] when compared with placebo.”
Brought on behalf of plaintiffs who purchased products containing phenylephrine across the country, the complaint charges the defendants with violating consumer protection statutes in New Jersey, Florida, Ohio, and Oklahoma. It further alleges a breach of implied warranty of merchantability and that the companies committed fraud, stating the defendants “intentionally and knowingly falsely concealed, suppressed and/or omitted material facts including as to the standard, quality or grade” of the products they marketed and sold. As the Complaint makes clear, “Defendants knew these products were ineffectual. They marketed and sold them anyway.”
Among other demands, the lawsuit seeks to require the defendants to make full disclosure of their knowledge of the efficacy of the decongestant products and disgorge profits from the sale of said profits. The case is Barton et al. v. Reckitt Benckiser LLC et al. in the United States District Court of New Jersey, Case No. 2:23-cv-20370.
A copy of the complaint is available upon request, and attorneys from DiCello Levitt are available for media interviews.
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