A federal judge in New York dismissed threshold consumer claims brought in a test complaint over decongestants, such as Sudafed PE and NyQuil Severe Cold & Flu, that a regulatory body found last year did not work.
In a Tuesday order, U.S. District Judge Brian Cogan, of the Eastern District of New York, found that federal law preempted claims that the decongestants, sold to treat nasal or sinus congestion, were mislabeled. The U.S. Food and Drug Administration, he wrote, through the Federal Food, Drug, and Cosmetic Act, regulates medications.
“The FDCA empowers the FDA, not drug manufacturers, to determine whether a drug is effective,” Cogan ruled.
The judge also struck separate racketeering allegations, concluding that the plaintiffs lacked standing because they were indirect consumers.
The ruling leaves doubt about the future prospects of the multidistrict litigation, created less than a year ago. Plaintiffs’ lawyers planned to file a master complaint following the ruling, which is limited to New York law as part of a streamlined complaint the judge ordered to be filed.
Nearly 100 class actions followed a unanimous vote last year by an FDA advisory committee that the decongestants did not actually work.
Andrew Soukup, of Washington, D.C.’s Covington & Burling, and Jay Lefkowitz, of Kirkland & Ellis in New York, argued for the defendants. Soukup represents Procter & Gamble Manufacturing Co., which makes Vicks NyQuil brands, and Lefkowitz is the attorney for Haleon U.S. Holdings LLC, maker of Advil, Robitussin and Theraflu.
Neither responded to requests for comment.
Other defendants include drug manufacturers Bayer HealthCare LLC, which makes Alka-Seltzer Plus; Johnson & Johnson Consumer Inc., now Kenvue Inc., maker of Sudafed and Tylenol; Perrigo Company plc, which makes the Good Sense brand; and RB Health (USA) LLC, which sells Delsym and Mucinex.
Retailers CVS Pharmacy Inc., Target Corp., Walgreen Co. and Walmart Inc., which sell generic brands of the decongestants, also are defendants.
Attorneys for other defendants in the case did not respond.
Plaintiffs’ lawyers Michael London, of New York’s Douglas & London, who is co-lead counsel in the multidistrict litigation, and Michael Sacchet, of Minneapolis-based Ciresi Conlin, and Jonathan Selbin, of Lieff Cabraser Heimann & Bernstein in New York, who both argued with him at a Sept. 23 hearing, did not respond, either.
‘Serious and Substantial Ramifications’
In an April 16 order, Cogan, who is in Brooklyn, instructed plaintiffs’ lawyers to file a New York complaint that alleged, “representative examples of the conduct and claims they allege to be at issue.” Among those was preemption, he wrote. His order on dismissal, he wrote, “will apply to all cases in this multidistrict litigation.”
Plaintiffs’ lawyers argued that defendants knew since 2016 that their oral phenylephrine-containing products were not more effective at decongesting than a placebo. Given the new scientific studies that prompted the FDA advisory committee’s review, the defendants had a duty to change the labels on the medications that were false and misleading, the complaint says. They cited federal preemption decisions by federal judges in multidistrict litigation over acetaminophen’s use during pregnancy and recalled heartburn medication Zantac.
Plaintiffs also alleged that the defendants conspired, through the Consumer Health Product Association, to mislead consumers in violation of the U.S. Racketeer Influenced and Corrupt Organizations Act.
However, the defendants insisted that changing the label would violate federal law. Moreover, the FDA hasn’t actually changed its official position that oral phenylephrine-containing products are effective.
“Allowing plaintiffs’ claims to proceed would have serious and substantial ramifications,” defense lawyers wrote in a June 3 motion to dismiss. “It would clear the way for the judgment of lay juries to override the FDA’s expert determinations about when medicine is safe and effective. It would also throw the door open for each of the 60 states to adopt 50 different approaches about when medicine is safe and effective and what information must be shared with consumers. In short, the uniform federal regulatory regime governing over-the-counter drugs created by Congress would be thrown in disarray. This court should bring this litigation to an end.”
The judge agreed, citing the U.S. Court of Appeals for the Second Circuit’s 2020 decision in Critcher v. L’Oreal USA Inc., which found claims about the amount of cream in cosmetics were preempted by the FDCA.
“Critcher rests on a straightforward application of administrative law,” Cogan held. “The FDCA generally commands that a drug’s label cannot be false or misleading and, in turn, vests authority in the FDA to determine whether a label is false or misleading. And, so long as there is an applicable preemption clause, that authority is exclusive.”