Tylenol Maker Defeats Lawsuit Over Labeling

NEW YORK (Reuters) – The maker of Tylenol defeated a lawsuit by consumers who said they were deceived into overpaying for “Rapid Release” gelcaps that did not relieve pain faster than cheaper tablets, including those labeled Extra Strength and Regular Strength.

In a decision on Tuesday night, U.S. District Judge Andrew Carter in Manhattan agreed with Kenvue that the federal Food, Drug, & Cosmetic Act preempted the consumers’ claims under New York state law.

Evie Collaza, the Bronx, New York resident who led the proposed class action, had cited a 2018 study that found Rapid Release gelcaps took longer than regular tablets — 3.94 minutes versus 3.56 minutes — to dissolve by at least 80%.

But the judge said it would make no sense to ignore Food and Drug Administration labeling rules for “immediate release” acetaminophen products only because that agency did not use the exact words “rapid release.”

He said some judges have ruled similarly in lawsuits against the grocer Albertsons, though one suggested in a lawsuit against pharmacy chain Rite Aid that “immediate” and “rapid” were not synonymous.

“To hold that the FDA’s regulation of acetaminophen dissolution rates ought not control simply because a drug producer markets or prices several of its qualifying ‘immediate release’ products in varying manners would be to create an end-run around the FDCA’s express preemption clause,” Carter wrote.

Kenvue, based in Skillman, New Jersey, was part of Johnson & Johnson before being spun off in August 2023.

Lawyers for Collaza did not immediately respond to requests for comment. Kenvue and its lawyers did not immediately respond to similar requests.

The case is Collaza v Johnson & Johnson Consumer Inc, U.S. District Court, Southern District of New York, No. 23-06030.

(Reporting by Jonathan Stempel in New York; Editing by Bill Berkrot)