
The manufacturer of Tylenol successfully defended against a legal action filed by consumers who claimed they were misled into paying more for “Rapid Release” gelcaps that did not provide faster pain relief compared to less expensive pills, including those labeled as Extra Strength and Regular Strength.
U.S. District Judge Andrew Carter in Manhattan sided with Kenvue on Tuesday night, ruling that the federal Food, Drug, & Cosmetic Act preempted the customers’ claims under New York state law.
Evie Collaza, the lead plaintiff in the lawsuit and a resident of the Bronx, New York, cited 2018 research that found Rapid Release gelcaps took longer to dissolve at least 80% compared to conventional tablets—3.94 minutes versus 3.56 minutes, respectively.
However, the court noted that it would be unreasonable to dismiss the Food and Drug Administration’s guidelines for labeling “immediate release” acetaminophen products simply because the FDA did not use the term “rapid release.”
Judge Carter mentioned that other judges have made similar rulings in cases filed against the grocery store chain Albertsons. However, in a lawsuit against the drugstore chain Rite Aid, one judge argued that the terms “immediate” and “rapid” are not synonymous.
Carter wrote, “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.”
Formerly a subsidiary of Johnson & Johnson, Kenvue, headquartered in Skillman, New Jersey, was spun off from the company in August 2023.
Requests for comment from attorneys representing Collaza were not immediately returned. Kenvue and its legal team also declined to comment.
J&J has previously stated that the term “rapid release” refers to a comparison with a conventional gelcap rather than a tablet.
According to the company, the price difference between the two products is due to the laser-drilled holes in the gelcap.
This is the latest class-action lawsuit regarding pricing discrepancies to be dismissed without further consequence, following similar lawsuits in California and Massachusetts.
This is not the only recent lawsuit involving Tylenol; the company also successfully defended against autism-related lawsuits in 2022. These lawsuits emerged two years ago when a consortium of doctors and scientists published a letter in a medical journal, alerting the healthcare community to a potential correlation between prenatal Tylenol exposure and increased autism prevalence. As a result, an increasing number of parents initiated legal actions, claiming that their children’s autism was caused by the mother’s excessive use of Tylenol during pregnancy.