CVS, Albertson’s, and Rite Aid are among the drug stories that were sued in the Central District of California federal court last month over a decongestant ingredient that’s alleged to be ineffective.
California residents Kenneth Levi Pack and Min Ji Jung filed their lawsuit on Sept. 12 accusing the drug stores of fraud, negligent misrepresentation, and unfair business practices involving phenylephrine.
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“Defendants had the duty to legally and truthfully represent to Plaintiffs the facts concerning the ineffectiveness of phenylephrine and phenylephrine products,” the complaint states. “Instead, Defendants aggressively (and falsely) advertised the effectiveness of phenylephrine and the phenylephrine products.”
The lawsuit further states that the consumer advocacy group Public Citizen first raised concerns to the FDA in 2007 that among decongestants, phenylephrine is not as effective as pseudoephedrine in many over-the-counter cold medicines.
Data from 2018 was confirmed last week by the Federal Drug Administration (FDA) that phenylephrine-based decongestants are ineffective or work as a placebo, according to media reports.
“It is the drug manufacturers’ responsibility—not plaintiff lawyers or the public—to monitor and ensure the continued safety and efficacy of their own drugs, and it doesn’t appear they did in this case,” said Jason Richards of Aylstock, Witkin, Kreis, & Overholtz PLLC in Pensacola, FL, who is among the attorneys that filed complaints in the various states.
A second lawsuit was filed in the Central District of California by plaintiff Jennifer Baughman against Johnson & Johnson Consumer Inc. (JJCI), Kenvue Inc., Procter & Gamble, and Reckitt Benckiser.
“Consumers are using Defendants’ Products without knowledge that they lack efficacy,” the lawsuit states. “This conduct has caused and continues to cause substantial injury to consumers because consumers would not have paid for nasal decongestant Products that do not work as advertised but for Defendants’ false labeling, advertising, and promotion.”
An FDA briefing document states 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,” the report states. “While we discuss those potential issues in our review, we consider them unsubstantiated.”
The complaint alleges $5 million or more is at issue but Richards told OrangeCountyLawyers.com that the number of claims submitted for refunds, and how much money in damages are at stake will be determined after a class is certified.
Products mentioned in the two lawsuits include Sudafed PE, Vicks NyQuil, Benadryl Allergy Plus Congestion, Vick’s DayQuil, Vicks Nyquil Severe Cold & Flu, Vicks Nyquil Cold + Flu plus Congestion and Mucinex Sinus Max.
“Because the ingredient phenylephrine had previously been approved by the FDA as safe and effective, the drug’s efficacy was not really on the public’s mind until an FDA advisory panel issued its report last week and said that phenylephrine actually doesn’t work as a nasal decongestant,” Richards added.
Thirteen other complaints were filed in federal courts in Louisiana, New York, North Dakota, Maryland, New Jersey, Florida, Minnesota, and Illinois.
*Photo courtesy Myriams Fotos
Juliette Fairley covers legal topics for various publications including the Southern California Record, the Epoch Times and Pacer Monitor-News. Prior to discovering she had an ease and facility for law, Juliette lived in Orange County and Los Angeles where she pursued acting in television and film.