(Editor's note: This article has been corrected to reflect CHPA's statements that the FDA has not yet made a final decision on the effectiveness of oral phenylephrine.)
EAST ST. LOUIS - Companies that made and sold remedies for nasal congestion with government approval for 16 years find themselves defending fraud and misrepresentation claims now that the government in considering reversing its position.
Daryl Means of Granite City sued them on Sept. 21, nine days after the Food and Drug Administration announced that it found active ingredient phenylephrine ineffective, according to the complaint.
However, officials with the Consumer Healthcare Products Association (CHPA) told the Record that the FDA has not yet made a determination on oral phenylephrine after an advisory committee submitted its recommendation. Until the FDA makes its determination, oral phenylephrine remains a Category 1 over-the-counter ingredient, which is generally recognized as safe and effective.
"Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision. FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine," the FDA stated.
Means’s counsel Benjamin McIntosh of St. Louis proposed a class action for Illinois residents who bought phenylephrine products “during the fullest period allowed by law.”
McIntosh named Johnson & Johnson, Glaxo Smith Kline, Rickett Benckiser, Bayer, Procter & Gamble, Walmart, Target, CVS, Walgreen, and Amazon as defendants.
He filed the complaint in Madison County Circuit Court, but Bayer removed it to U.S. district court on Oct. 25.
Bayer counsel Eric Roberts of Chicago claimed the amount in controversy exceeded a $5 million limit on class actions in state courts.
According to the complaint, defendants made and sold at least 250 phenylephrine products including Nyquil, Tylenol, Sudafed, Mucinex, and generic products of retailers.
McIntosh claimed defendants knew or should have known at least since 2018 that their marketing claims were false and misleading.
He alleged consumer fraud, negligent misrepresentation, breach of express warranty, design defect, and fraudulent misrepresentation.
McIntosh requested judgment in favor of Means and class members “in the sum of the purchase price of the phenylephrine products.”
He also requested a permanent injunction against sales of phenylephrine products in Illinois.
He claimed defendants marketed it for relief of nasal congestion and sinus pressure associated with colds, allergies, and other respiratory conditions.
“According to defendants it constricts blood vessels in nasal passages, which reduces swelling and congestion,” he wrote.
“Defendants knew these representations were false,” he added.
McIntosh claimed the Food and Drug Administration reviewed phenylephrine research in 2007 and concluded it could be considered effective at recommended doses.
However, he claimed the agency’s recent review found problems with design and methodology of studies for the review in 2007.
“All used a highly variable end point in a setting of a highly variable disease state that is no longer used as a primary end point to evaluate congestion in trials,” he wrote.
“Further, all the positive studies and most of the negative studies were unpublished and therefore never peer reviewed,” he added.
McIntosh claimed six positive studies came from a manufacturer’s study center and the manufacturer’s other study centers couldn’t duplicate the results.
He added that clinical trials since 2007 provided evidence of absence of decongestant effect.
“These studies show that the phenylephrine products are no more effective than placebo in decreasing nasal congestion,” he wrote.
McIntosh proposed to certify a class action and appoint Means as class representative.
He proposed to appoint Benjamin Schmickle, Sophie Zavaglia, and himself as class counsel.
They practice at SWMW in St. Louis.
The district court clerk randomly assigned Magistrate Judge Mark Beatty, who will preside unless a party declines consent to magistrate jurisdiction.
If that happens the clerk will assign a district judge.