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JHP Pharms., LLC v. Hospira, Inc.

United States District Court, C.D. California

October 7, 2014

JHP PHARMACEUTICALS, LLC,a Delaware limited liability company, Plaintiff,
HOSPIRA, INC., a Delaware corporation; INTERNATIONAL MEDICATION SYSTEMS, LTD., a Delaware corporation; and AMERICAN REGENT, INC., a New York corporation, Defendants

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[Copyrighted Material Omitted]

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For Par Sterile Products, LLC, a Delaware corporation formerly known as JHP Pharmaceuticals LLC, Plaintiff: Brendan J Hughes, Peter J Willsey, LEAD ATTORNEYS, PRO HAC VICE, Dana J Moss, PRO HAC VICE, Cooley LLP, Washington, DC; John Paul Oleksiuk, LEAD ATTORNEY, Cooley LLP, Santa Monica, CA; Amy P Nickerson, Caldwell Leslie and Proctor PC, Los Angeles, CA; Michael J Freno, PRO HAC VICE, Eric A Lindberg, Harold Storey, Seed Intellectual Property Law Group PLLC, Seattle, WA.

For Hospira Inc, a Delaware corporation, Defendant: Jeffrey A LeVee, Kathleen P Wallace, LEAD ATTORNEYS, Jones Day, Los Angeles, CA.

For International Medication Systems Ltd, a Delaware corporation, Defendant: Jeffrey A LeVee, Kathleen P Wallace, LEAD ATTORNEYS, Jones Day, Los Angeles, CA; Richard Douglas Whitlow, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA.

For American Regent Inc, a New York corporation, Defendant: Bruce G Chapman, Bridgette A Agness, Sheppard Mullin Richter & Hampton LLC, Los Angeles, CA.

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DEAN D. PREGERSON, United States District Judge.

Presently before the court are two motions to dismiss the complaint brought by Par Sterile Products, LLC, against the Defendants American Regent, Inc., Hospira, Inc., and International Medical Systems, Ltd. The complaint alleges false or misleading advertising and labeling, based on the Lanham Act and equivalent state

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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.


A. Factual Background [1]

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 epinephrine products.

In 2012, Par (then known as JHP Pharmaceuticals, LLC) submitted a New Drug Application (" NDA" ) for its 1 mL and 30 mL injectable epinephrine products to the U.S. Food and Drug Administration (" FDA" ) under the brand name ADRENALIN. (Compl. ¶ ¶ 3-4.) On December 7, 2012, the FDA, pursuant to its power under the Food, Drug, and Cosmetic Act (" FDCA" ), granted JHP approval to market and sell the 1 mL version of ADRENALIN. (Id. ¶ ¶ 5-6.)[2] Par alleges that it invested millions of dollars in complying with the FDA approval process. (Id. ¶ ¶ 50-51.)

Par alleges that the Defendants all sell injectable epinephrine products which are not FDA-approved (Compl. ¶ ¶ 55, 57), an allegation which no Defendant denies. Par also alleges that the Defendants mislead the public in four different ways.

First, Par alleges that the Defendants represent to consumers, either overtly or through misdirection, that their products are FDA-approved, when they are not. (Compl. ¶ 71.)

Second, Par alleges that the Defendants misleadingly advertise their products as " safe" and " effective." [3]

Third, Par alleges that the Defendants advertise products that are " illegal" to sell or market under the FDCA (Id. ¶ ¶ 56-57), while representing to wholesalers and the public that they abide by the law. Par thus alleges that the Defendants are misleading wholesalers and the public as to the legality of their products.

Fourth, Par alleges that the Defendants omit from their product labeling certain injection location and adverse reaction information that Par's product must carry as part of its FDA-approved labeling. This,

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Par contends, misleads the public into thinking that Par's product is more dangerous than the generics, because it can only be administered in certain locations and can cause certain adverse reactions.

Par asserts a claim against the Defendants for each of these representations under the Lanham Act, 15 U.S.C. § 1125(a)(1), which forbids false or misleading advertising.[4] Par also alleges actual injury, in the form of both competitive disadvantage and harm to reputation and goodwill.

Defendants counter that Par's Lanham Act claims should be dismissed, either because they are precluded altogether by the FDCA, because Par has failed to exhaust its administrative remedies, or because the FDA has primary jurisdiction over the claims and the case should be referred to the agency for a ruling. (Def. American Regent's Mot. Dismiss, § II; Defs. Hospira and IMS's Reply, § I; Def. American Regent's Reply, " Argument." ) Defendants Hospira and IMS also raise the issue of the factual sufficiency of Par's claims. (Defs. Hospira and IMS's Mot. Dismiss, § I.C.2.)

B. Procedural Background

The initial complaint in this matter was filed on October 8, 2013, and the Defendants filed motions to dismiss on November 27, 2013. On February 3, 2014, Judge Michael Fitzgerald held a hearing on the motions. Ultimately, however, the Court ordered the motions denied without prejudice and the case stayed, pending the resolution of another Lanham Act/FDCA case in the Supreme Court, POM Wonderful LLC v. Coca-Cola Co., 134 S.Ct. 2228, 189 L.Ed.2d 141 (2014).

POM Wonderful was decided June 12, 2014. On June 19, 2014, the Plaintiff in this case filed notice of the decision, and on July 23, 2014, the Defendants filed new motions to dismiss, which are the subject of this order.


A complaint may be dismissed under Rule 12(b)(6) only if it " either (1) lacks a cognizable legal theory or (2) fails to allege sufficient facts to support a cognizable legal theory." Somers v. Apple, Inc., 729 F.3d 953, 959 (9th Cir. 2013). " All allegations of material fact in the complaint are taken as true and construed in the light most favorable to the plaintiff." Williams v. Gerber Products Co., 552 F.3d 934, 937 (9th Cir. 2008). " When there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief." Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009).


A. Failure to Exhaust Administrative ...

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