Bailey v. Rite Aid Corporation

Background

Thomas Bailey brought a proposed class action against Rite Aid Corporation asserting eight claims arising from Rite Aid’s sale and marketing of over-the-counter rapid-release acetaminophen gelcaps. The court had previously granted in part and denied in part Rite Aid’s motion to dismiss. In that earlier order, the court rejected Rite Aid’s argument that federal law preempted Bailey’s claims.

Rite Aid then asked the court to certify the federal-preemption question for an immediate, mid-case appeal under 28 U.S.C. § 1292(b). This type of appeal is available only when the order involves a controlling legal question, an immediate appeal could materially advance the case, and there is substantial ground for disagreement about the legal question. The parties disputed only the third requirement.

Rite Aid’s Arguments

Rite Aid argued that the court’s preemption ruling involved two substantial disagreements. First, Rite Aid argued that the court’s conclusion that certain Food and Drug Administration guidance documents did not create requirements under the Food, Drug, and Cosmetic Act conflicted with the Ninth Circuit’s decision in Degelmann v. Advanced Medical Optics, Inc. Second, Rite Aid argued that federal standards for “immediate release” acetaminophen covered the “rapid release” product challenged by Bailey.

Court’s Analysis

The court concluded that Rite Aid had not shown a substantial ground for disagreement about whether the FDA guidance created a federal requirement. The guidance at issue did not serve the same purpose as the guidance discussed in Degelmann, which provided comprehensive directions for showing that a contact-lens-care product was equivalent to a legally marketed product. Rite Aid also did not provide authority showing that the treatment of a different FDA publication determined whether the guidance in this case qualified as a federal requirement.

The court also rejected Rite Aid’s argument about “immediate” and “rapid” release. The court explained that Bailey’s claims concerned whether the acetaminophen dissolved quickly enough to support marketing the product as “rapid release.” The FDA materials cited by Rite Aid suggested that “rapid” and “immediate” were not synonymous and that rapid-release drugs were, at most, a subset of immediate-release drugs. Therefore, regulation of immediate-release acetaminophen did not establish that federal law covered the rapid-release marketing designation challenged in the case.

Ruling

Judge Yvonne Gonzalez Rogers denied Rite Aid’s motion to certify the federal-preemption question for appeal. The court also denied the request to continue the case management conference and stated that the order terminated Docket Numbers 61 and 69. This order addressed whether an immediate appeal should be allowed; it did not resolve the underlying claims on their merits.