Collaza v. Johnson & Johnson Consumer Inc.

Background

Evie Collaza filed a putative class action against Johnson & Johnson Consumer, Inc. She asserted claims under New York General Business Law §§ 349 and 350, unjust enrichment, and declaratory relief. The complaint alleged that Johnson & Johnson’s Tylenol Extra Strength Rapid Release Gelcaps cost more than other acetaminophen products and were marketed as working quickly because they contained “laser-drilled holes” and dissolved quickly. Collaza alleged that the gelcaps did not work faster than cheaper tablet alternatives. She relied on a 2018 study reporting that the gelcaps reached 80% dissolution in 3.94 minutes, while Tylenol tablets reached that level in 3.56 minutes.

Johnson & Johnson moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint states a legally sufficient claim. In the alternative, it asked the court to transfer the case to the District of New Jersey. The court treated the complaint’s factual allegations as true for purposes of deciding the dismissal motion.

Preemption Framework

The Food, Drug, & Cosmetic Act gives the Food and Drug Administration authority over the labeling and marketing of over-the-counter drugs. The Act also contains an express preemption provision barring states from imposing requirements concerning covered drugs that differ from, add to, or are not identical with federal requirements.

The court explained that the FDA’s 1988 tentative final monograph for acetaminophen established dissolution standards for “immediate release” tablets. That monograph became a final order when Congress enacted the CARES Act in 2020. The FDA also issued guidance concerning products described as “rapidly dissolving” or “very rapidly dissolving.”

Parties’ Arguments

Johnson & Johnson relied on decisions from the Southern District of New York, the District of Massachusetts, and the Northern District of California holding that similar claims concerning “rapid release” acetaminophen products were preempted. Those decisions treated “immediate release” and “rapid release” as addressing the same subject—how quickly the product dissolves—and concluded that a manufacturer could not avoid federal requirements merely by using different wording.

Collaza argued that “immediate release” and “rapid release” were different terms and that the FDA’s rules did not apply because they did not use the exact phrase “rapid release.” She also argued that the FDA’s regulations governed labeling but not advertising, marketing, or pricing. The court rejected those arguments and declined to follow a contrary decision that had found preemption unsupported by a binding federal regulation.

Ruling

The court held that Collaza’s state-law claims were preempted because they concerned acetaminophen dissolution rates and would impose requirements different from or additional to the federal requirements. The court reasoned that the FDA’s regulation of the subject matter could not be avoided by using the phrase “rapid release” instead of “immediate release,” or by presenting the challenged statements through marketing and pricing practices rather than labeling alone.

The court granted Johnson & Johnson’s motion to dismiss on preemption grounds. The dismissal was granted with prejudice because the court determined that the problems with the claims were substantive and could not be cured through better pleading. Because it resolved the case on preemption grounds, the court did not consider the parties’ arguments about transferring the action to New Jersey.