Decongestant class action sputters back to life in Second Circuit

Since the FDA requires manufacturers to label oral phenylephrine medications as effective, drug companies profiting billions from their sale can't be blamed for their uselessness, judges said.MANHATTAN (CN) — Makers and distributors of Sudafed, Mucinex and Advil decongestant medications are back on the hook for some claims in a consolidated class action after the Second Circuit largely — but not completely — affirmed a lower court’s dismissal of claims that the products don’t work.Customers sued drugmakers and retailers like Johnson & Johnson, Procter & Gamble, Pfizer, Bayer Healthcare, CVS Pharmacy, Walgreens, Target and Amazon in more than 100 class actions.The plaintiffs claim products like Sudafed PE, Nyquil Severe Cold & Flu, Advil Sinus Congestion & Pain and Mucinex Sinus Max — which contain the ingredient oral phenylephrine — are not effective, citing scientific studies concluding the decongestant is no more effective than a placebo.The FDA, however, requires manufacturers to label oral phenylephrine medications as effective. In the past decade, the drugs have raked in around $12 billion, according to court papers.In the lower court, U.S. District Judge Brian Cogan found the federal Food, Drug, and Cosmetic Act barred the consumers’ state law claims, and that the plaintiffs lacked statutory standing to bring their RICO claim against the drug companies.A three-judge panel of the Second Circuit mostly agreed in a Thursday opinion penned by Senior U.S. Circuit Judge Denny Chin.“We hold that the FDCA expressly preempts the majority of consumer plaintiffs’ state law claims and that Consumer Plaintiffs lack a cause of action to bring their RICO claim. Indeed, defendant manufacturers followed the FDA’s prescribed labeling requirements by designating their decongestants’ purpose as decongestion. Defendant manufacturers cannot now be sued for complying with those FDA specifications,” the Barack Obama appointee wrote.In a footnote, Chin explained the circuit found Cogan’s “statutory standing” analysis to be a misnomer, and said the finding was a question of whether the plaintiffs have a cause of action under the statute.There were two other exceptions to the panel’s concurrence with Cogan, a George W. Bush appointee.The circuit revived claims that certain manufacturers falsely advertised their products as better than others by using the words “maximum strength” on their labels.The appeals court also vacated the dismissal of claims regarding brand-name products that were approved through the Food, Drug, and Cosmetic Act’s new drug application process, which requires the FDA to determine any drug it approves is “generally recognized as safe and effective.”The record isn’t clear, the panel said, which drugs were approved through that regime and which followed the monograph process — where drugmakers can sell over-the-counter drugs without an individualized FDA review if its labels adhere to detailed regulations governing specific drug categories.Plaintiff’s attorney Jonathan Selbin, of the firm Lieff Cabraser, said the consumers aren’t giving up their fight, and are considering their next steps.“For over a decade these manufacturers made billions of dollars selling products with a decongestant (oral phenylephrine) that they long knew — in many cases based on their own studies — were entirely ineffective at decongesting,” Selbin said in a statement emailed to Courthouse News.According to Selbin, “substantial amounts” of medication, including some of the most popular brands, were sold as “maximum strength” or went through the new drug application process — the claims that remain alive and are now remanded to the lower court.“Together with our co-counsel, we look forward to continuing to represent and litigate on behalf of the tens of millions of American consumers who deserve to get their money back. This case is far from over,” Selbin said.Senior U.S. Circuit Judge Reena Raggi, a George W. Bush appointee, and U.S. Circuit Judge Myrna Pérez, a Joe Biden appointee, joined Chin.The FDA did not immediately return a request for comment.Subscribe to our free newslettersOur weekly newsletter Closing Arguments offers the latest about ongoing trials, major litigation and rulings in courthouses around the U.S. and the world, while the monthly Under the Lights dishes the legal dirt from Hollywood, sports, Big Tech and the arts.Additional Reads