Kenvue Prevails in Tylenol 'Rapid Release' Gelcap Class Action Lawsuit

Kenvue Inc., the manufacturer of Tylenol, has successfully defended itself against a lawsuit claiming consumers overpaid for "Rapid Release" gelcaps due to alleged misleading marketing. The gelcaps were found to have a slightly longer dissolve time than tablets. The court ruled that the FDA's regulations on acetaminophen dissolution rates preempted the claims, as the FDA did not recognize the term "rapid release." Kenvue, formerly a part of Johnson & Johnson, is now an independent company.

Introduction

Kenvue Inc. (NYSE: KVUE), the newly independent global leader in consumer health, has recently secured a significant legal victory against a consumer lawsuit claiming overpayment for Tylenol's "Rapid Release" gelcaps [1]. The lawsuit, which alleged misleading marketing due to the gelcaps' slightly longer dissolve time than tablets, was dismissed based on the preemption of FDA regulations.

Preemption of FDA Regulations

The U.S. Food and Drug Administration (FDA) has established regulations on acetaminophen dissolution rates, which are the timeframes within which a medication must dissolve to be considered effective [2]. In the case of Kenvue's Tylenol "Rapid Release" gelcaps, the FDA did not recognize the term "rapid release" as a specific category within these regulations [3]. Consequently, the court ruled that the plaintiff's claims were preempted by the FDA's regulations, as they relied on a term not recognized by the regulatory agency.

Implications of the Legal Victory

The legal victory is significant for Kenvue as it reinforces the company's focus on delivering science-backed and effective care solutions to consumers [1]. The ruling also highlights the importance of understanding and complying with FDA regulations in the development and marketing of pharmaceutical products.

As the world's largest pure-play consumer health company, Kenvue is well-positioned to continue its growth and innovation, with a portfolio of iconic brands that are trusted by healthcare professionals and consumers worldwide.

References

[1] Kenvue Inc. "Kenvue Becomes a Fully Independent Company." August 23, 2023. https://www.kenvue.com/media/kenvue-becomes-a-fully-independent-company
[2] U.S. Food and Drug Administration. "Test Methods for Evaluating the Dissolution Rate of Solid Oral Dosage Forms: Final Guidance for Industry." April 2012. https://www.fda.gov/media/115232/download
[3] Reuters. "Kenvue Says U.S. Court Dismisses Tylenol Rapid-Release Lawsuit." August 23, 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/kenvue-says-us-court-dismisses-tylenol-rapid-release-lawsuit-2023-08-23/