Bischoff v. Albertsons Companies, Inc.

Background

Christine Bischoff alleged that defendants Albertsons Companies, Inc.; Acme Markets, Inc.; Safeway, Inc.; Better Living Brands, LLC; and LNK International, Inc. marketed two acetaminophen gelcap products under the Signature Care brand using the phrase “Rapid Release.” Bischoff alleged that the products did not work faster than lower-priced Signature Care acetaminophen products without the “Rapid Release” label. An independent study commissioned by Bischoff found that the non-“Rapid Release” products dissolved slightly faster, although both products were fully dissolved within 30 minutes.

Bischoff asserted seven state-law claims: violations of New York General Business Law §§ 349 and 350, breach of express warranty, breach of the implied warranty of merchantability, unjust enrichment, negligent misrepresentation, and fraud. She sought to represent a nationwide class and a New York subclass of purchasers.

Arguments and legal standard

The defendants moved to dismiss the First Amended Complaint under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint plausibly states a claim for relief. They argued that the claims were expressly preempted by the Federal Food, Drug, and Cosmetic Act, that the court should defer to the responsible federal agency under the primary-jurisdiction doctrine, and that the claims were inadequately pleaded.

Bischoff argued that the federal standards did not apply because they addressed acetaminophen tablets rather than gelcaps and used terms such as “immediate release” and “rapidly dissolving,” not “Rapid Release.” She also argued that federal guidance documents lacked the force of law.

Preemption analysis

The court held that the Federal Food, Drug, and Cosmetic Act expressly preempts state requirements for over-the-counter drugs that differ from, add to, or are not identical to federal requirements. The court explained that the federal regulatory framework addresses acetaminophen dissolution standards. The relevant standards treat a product as “immediate release” when at least 80 percent dissolves within 30 minutes, and federal guidance also addresses products described as “rapidly dissolving” or “very rapidly dissolving.”

The court rejected Bischoff’s argument that the federal standards did not apply to gelcaps, reasoning that the Amended Complaint itself described gelcaps as gelatin-coated, capsule-shaped tablets. The court also concluded that the absence of the exact phrase “Rapid Release” from the federal materials did not avoid preemption because the federal rules regulated the subject matter—acetaminophen dissolution standards. In the court’s view, Bischoff’s claims sought additional labeling obligations, such as removing the “Rapid Release” statement or adding a disclosure that other products dissolved faster.

The court therefore concluded that all of Bischoff’s state-law claims were preempted. It stated that it did not need to decide the primary-jurisdiction issue or whether the complaint otherwise adequately pleaded the claims. The court also noted that neither party briefed whether the express-warranty claim fell within a statutory savings clause for state product-liability law, but concluded that Bischoff had abandoned that argument and that the claim would not qualify for the exception.

Leave to amend and disposition

Bischoff requested permission to amend the complaint a second time if the motion was granted. The court declined to grant leave to amend, finding that the problems with the causes of action were substantive and could not be fixed through better pleading. The court also relied on the fact that Bischoff had already amended once after receiving notice of the defendants’ anticipated arguments and had not identified additional facts that would cure the defects.

The court granted the defendants’ motion to dismiss, directed the clerk to terminate the motion, and directed the clerk to close the case.