Tylenol Maker Wins Lawsuit Over ‘Rapid Release’ Claims

By Jonathan Stempel

NEW YORK (Reuters) – The maker of Tylenol defeated a lawsuit by consumers who claimed deception over the efficacy of “Rapid Release” gelcaps, which allegedly did not provide faster pain relief than cheaper Extra Strength and Regular Strength tablets.

U.S. District Judge Andrew Carter in Manhattan ruled on Tuesday night that Kenvue (NYSE:KVUE) was protected by the federal Food, Drug, & Cosmetic Act, which preempted the consumers’ claims under New York state law.

Evie Collaza, a Bronx resident leading the class action, referenced a 2018 study indicating that Rapid Release gelcaps took longer to dissolve (3.94 minutes) than regular tablets (3.56 minutes) by 80%.

Judge Carter stated that it would be illogical to disregard FDA labeling rules for “immediate release” acetaminophen products simply because the agency did not specifically use the term “rapid release.” He noted that some judges had ruled similarly in lawsuits against Albertsons (NYSE:ACI) and expressed differing opinions about the terms “immediate” and “rapid.”

“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 argued.

Kenvue, based in Skillman, New Jersey, was previously part of Johnson & Johnson (NYSE:JNJ) before its spinoff in August 2023.

As of now, attorneys for Collaza and Kenvue have not responded to requests for comment.

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