JHP Pharmaceuticals, LLC v. Hospira, Inc.

ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTIONS TO DISMISS

Presently before the court are two motions to dismiss the complaint brought by Par Sterile Products, LLC, against the Defendants American Regent, Inc., Hospi-ra, Inc., and International Medical Systems, Ltd. The complaint alleges false or misleading advertising and labeling, based on the Lanham Act and equivalent state *996 statutes. The Defendants’ motions essentially argue that this Court, in deciding the case, would intrude on matters Congress has left exclusively to the discretion of the FDA. The Plaintiff, on the other hand, argues that its complaint does not rest on matters requiring the expertise and authority of the FDA to resolve, and dismissal is not appropriate.

For reasons discussed below, the Court grants the motions in part and denies them in part.

I. BACKGROUND

A. Factual Background

Par Sterile Products, LLC (“Par”) is a manufacturer of injectable epinephrine under the brand name ADRENALIN. Defendants American Regent, Inc. (“American Regent”), Hospira, Inc. (“Hospira”), and International Medical Systems, Ltd. (“IMS”) (collectively, “Defendants”) are manufacturers of other injectable…