Patora v. Vi-Jon, LLC

Background

Jeannie Patora and Nancy Kane brought a consolidated putative class action against Vi-Jon, LLC, concerning certain magnesium citrate saline laxative products. The plaintiffs alleged that Vi-Jon recalled product lots after testing identified the bacterium Gluconacetobacter liquefaciens. They alleged that the products’ labels did not list the bacterium as an ingredient or warn about its presence or possible presence. They also alleged that they purchased and ingested the products in New York, became ill afterward, and would not have bought them had they known about the alleged contamination.

The plaintiffs asserted claims under New York General Business Law Sections 349 and 350 for deceptive acts or practices and false advertising. They sought economic damages and equitable relief. The plaintiffs had voluntarily withdrawn breach-of-express-warranty claims under other states’ laws.

Vi-Jon moved to dismiss the consolidated amended complaint under Rule 12(b)(6), which allows dismissal when a complaint does not adequately state a legal claim. The court considered the well-pleaded allegations, documents incorporated into the complaint, and documents integral to the complaint, including product labels and recall press releases.

Federal Preemption

Vi-Jon argued that the federal Food, Drug, and Cosmetic Act, or FDCA, expressly preempted the plaintiffs’ state-law claims. Express preemption occurs when Congress has stated in federal law that conflicting state requirements cannot apply. The FDCA contains such a provision for over-the-counter drugs, including laxatives. It bars states from imposing requirements that are different from, additional to, or not identical to federal requirements.

The court explained that federal law requires over-the-counter drug labels to identify active and inactive ingredients. But the plaintiffs did not allege that Vi-Jon manufactured the products to contain Gluconacetobacter liquefaciens. Under the federal definitions, the bacterium therefore was not an active or inactive ingredient that federal law required Vi-Jon to list.

The court also examined federal warning requirements. The applicable federal rules and the 2023 Food and Drug Administration monograph for laxatives required specific warnings, but did not require a warning about the possible presence of bacteria or Gluconacetobacter liquefaciens in particular. The court concluded that the plaintiffs’ proposed ingredient disclosure and warning duties would have added requirements beyond those imposed by federal law.

Because the plaintiffs’ claims sought to impose labeling requirements that were not identical to federal requirements, the court held that the claims were expressly preempted by the FDCA. The court stated that allowing the claims to proceed would create the inconsistent packaging requirements that Congress sought to prevent.

Disposition

The court held that the plaintiffs’ claims were preempted and therefore dismissed them. It also denied the plaintiffs’ request for leave to file a second amended complaint, finding that further amendment would be futile and noting that the plaintiffs had not offered facts showing how they would correct the deficiencies. Judge Vincent L. Briccetti granted Vi-Jon’s motion to dismiss, directed the clerk to terminate the motion, and ordered the consolidated cases—22-cv-6678 and 22-cv-7061—closed.