Kenvue Inc. KVUE, the maker of Tylenol, has reportedly defended itself against a lawsuit in which consumers claimed being misled into overpaying for “Rapid Release” gelcaps, arguing that these gelcaps did not relieve pain any faster than less expensive Tylenol tablets.
The drug is used to treat mild to moderate pain and to reduce fever.
The lawsuit hinged on a 2018 study indicating that the gelcaps took slightly longer to dissolve—3.94 minutes compared to 3.56 minutes for regular tablets.
Citing a ruling issued on Tuesday, Reuters noted that U.S. District Judge Andrew Carter in Manhattan sided with Kenvue, determining that the consumers’ claims were preempted by the federal Food, Drug, & Cosmetic Act (FDCA).
Judge Carter emphasized that ignoring the FDA’s labeling regulations for “immediate release” acetaminophen products would be illogical because the agency did not use the term “rapid release.”
The judge further noted that similar rulings have been made in other cases, such as those against grocer Albertsons Companies, Inc. ACI and pharmacy chain Rite Aid Corp RADCQ.
Carter argued that to disregard the FDA’s regulation of acetaminophen dissolution rates on the basis of marketing or pricing strategies would undermine the FDCA’s express preemption clause.
This decision reflects a consistent judicial approach to interpreting FDA guidelines, reinforcing the agency’s authority to regulate drug labeling and marketing.
Kenvue was formerly a part of Johnson & Johnson JNJ before becoming an independent company in August 2023.
Price Action: KVUE stock is up 0.18% at $21.79 at last check Friday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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