J&J, P&G, Walgreens sued after FDA panel ruling on cold medicine decongestant

[September 15, 2023]  By Jonathan Stempel

(Reuters) -Johnson & Johnson, Procter & Gamble and Walgreens are among several companies accused in lawsuits of deceiving consumers about cold medicines containing an ingredient that a unanimous U.S. Food and Drug Administration advisory panel declared ineffective.

Proposed class actions were filed on Wednesday and Thursday, after the panel reviewed several studies and concluded this week that the ingredient phenylephrine marketed as a decongestant was essentially no better than a placebo.

According to an agency presentation, about 242 million products with phenylephrine were sold in the United States last year, generating $1.76 billion of sales and accounting for about four-fifths of the market for oral decongestants.

The first lawsuit appeared to have been filed in Pensacola, Florida, federal court.

It said Johnson & Johnson's consumer health business and Procter & Gamble should have known by 2018 that their marketing claims about products with phenylephrine were "false and deceptive."

That year was when new FDA guidance for evaluating symptoms related to nasal congestion demonstrated that earlier data about phenylephrine's effectiveness could no longer be relied upon, the complaint said.

The plaintiff Steve Audelo, a Florida resident, said he bought Johnson & Johnson's Sudafed PE and Benadryl Allergy Plus, and Procter & Gamble's Vicks NyQuil, based on the companies' claims that the products worked.

The company logo for Johnson & Johnson is displayed on a screen to celebrate the 75th anniversary of the company's listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid/File photo

Similar lawsuits were filed on Thursday against GSK, which makes TheraFlu; Reckitt Benckiser, which makes Mucinex Sinus Max, and Walgreens, which produces generic decongestants.

Johnson & Johnson's consumer business is known as Kenvue after a May 3 initial public offering. It also makes Tylenol Cold & Flu, whose ingredients include phenylephrine. Kenvue is also a defendant in one of the lawsuits.

The defendant companies did not immediately respond on Thursday to requests for comment.

The FDA generally follows but does not always adopt its advisory panels' recommendations.

On Thursday, the agency said it would seek public comment on whether products with phenylephrine should be pulled from store shelves.

The Florida case is Audelo v Johnson & Johnson Consumer Inc et al, U.S. District Court, Northern District of Florida, No. 23-24250.

(Reporting by Jonathan Stempel in New York; Editing by Aurora Ellis)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.