Johnson & Johnson Consumer Inc. is among the companies sued last week over a decongestant that’s alleged to be ineffective.
Florida resident Steve Audelo filed his complaint September 13 in the Northern District of Florida federal court accusing Procter & Gamble and Johnson & Johnson Consumer of fraud and deception.
“These products are manufactured, sold and distributed by defendants and have been found by the U.S. Food and Drug Administration (FDA) to lack efficacy,” wrote Audelo’s attorney Jason Richards of the Aylstock, Witkin, Kreis & Overholtz law firm. “The products’ lack of efficacy was not disclosed to plaintiff prior to plaintiff’s purchase of the products and plaintiff would not have purchased the products had he known they did not work as advertised.”
The controversy over the decongestant began in 2007 when the consumer advocacy group Public Citizen expressed concerns to the FDA that among decongestants, phenylephrine was not as effective as pseudoephedrine in many over-the-counter cold medicines, according to the complaint.
Products mentioned in the lawsuit include Sudafed PE, Vicks NyQuil, and Benadryl Allergy Plus Congestion.
“Collectively, defendants J&J and Procter & Gamble marketed and sold the products to consumers in Florida and across the United States as an effective nasal decongestant,” the complaint states.
However, Johnson & Johnson Consumer Inc. is not affiliated with Johnson & Johnson.
“Johnson & Johnson is not named in the lawsuits, which makes sense because it did not manufacture or sell decongestant cold medicines and, following our separation, Johnson & Johnson Consumer Inc. is not a part of Johnson & Johnson,” a J & J spokesperson told the Florida Record.
J & J Consumer Inc., Walgreens and P&G did not immediately reply to requests for comment.
Data from 2018 was confirmed last week by the FDA that phenylephrine-based decongestants are ineffective or work as a placebo, according to media reports.
The FDA briefing document stated that two studies from Elizabeth Biochemical Labs were not only the most positive studies, but also produced near textbook perfect results that could not be duplicated in other similarly designed studies that used the same methodology but were conducted at two other centers by the same sponsor.
“This raises suspicion regarding potential bias and data integrity issues at the Elizabeth site…While we discuss those potential issues in our review, we consider them unsubstantiated," the paper states.
Other lawsuits with similar claims were filed against GSK citing TheraFlu, Reckitt Benckiser citing Mucinex Sinus Max, and Walgreens citing their generic decongestants.