Kenvue Inc. (KVUE), the manufacturer of Tylenol, has won a legal battle against consumers who claimed to have been misled into overpaying for ‘Rapid Release’ gelcaps. The lawsuit alleged that these gelcaps did not provide pain relief any faster than regular, less expensive Tylenol tablets.
The case hinged on a 2018 study that showed the gelcaps took slightly longer to dissolve (3.94 minutes) compared to regular tablets (3.56 minutes). However, U.S. District Judge Andrew Carter in Manhattan sided with Kenvue, ruling 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, as the agency does not use the term ‘rapid release.’ He also pointed to similar rulings in other cases against companies like Albertsons Companies and Rite Aid.
Carter argued that disregarding the FDA’s regulation of acetaminophen dissolution rates based on marketing or pricing strategies would undermine the FDCA’s express preemption clause. This decision underscores the consistent judicial approach to interpreting FDA guidelines and reinforces the agency’s authority to regulate drug labeling and marketing.
Kenvue, formerly a part of Johnson & Johnson (JNJ), became an independent company in August 2023. KVUE stock rose by 0.18% to $21.79 at the end of trading on Friday.