NOT FOR PUBLICATION FILED

UNITED STATES COURT OF APPEALS DEC 10 2021

MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS

FOR THE NINTH CIRCUIT

HOPE MEDICAL ENTERPRISES, INC., No. 21-55165 d/b/a Hope Pharmaceuticals, D.C. No. Plaintiff-Appellee, 2:19-cv-07748-CAS-PLA

v.

MEMORANDUM*

FAGRON COMPOUNDING SERVICES,

LLC; et al.,

Defendants-Appellants.

Appeal from the United States District Court for the Central District of California Christina A. Snyder, District Judge, Presiding

Argued and Submitted November 17, 2021 Pasadena, California

Before: RAWLINSON and LEE, Circuit Judges, and KENNELLY,** District Judge.

Defendants Fagron Compounding Services, LLC, JCB Laboratories, LLC,

AnazaoHealth Corporation, and Coast Quality Pharmacy, LLC (collectively,

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3. ** The Honorable Matthew F. Kennelly, United States District Judge for the Northern District of Illinois, sitting by designation. “Fagron”) appeal the district court’s denial of their motion titled “Motion for

Reconsideration of Order Granting Preliminary Injunction.” We dismiss the

appeal for lack of jurisdiction.

Under 28 U.S.C. § 1292(a)(1), we have interlocutory appellate jurisdiction

over orders “refusing to dissolve . . . injunctions.” This Court has previously

explained that an order denying a motion to dissolve an injunction is appealable

only if the motion “in substance is based on new circumstances that have arisen

after the district court granted the injunction.” Credit Suisse First Boston Corp. v.

Grunwald, 400 F.3d 1119, 1124 (9th Cir. 2005). Thus Fagron’s appeal depends on

whether its motion was based on new circumstances that arose after the district

court granted the preliminary injunction.

Fagron presents two “new circumstances” that it contends satisfy the

Grunwald test. First, Fagron cites several decisions issued in the Nexus cases,

including Nexus Pharmaceuticals Inc. v. Central Admixture Pharmacy Services

Inc., No. 8:20-cv-01506-CJC-JDE (C.D. Cal. Oct. 29, 2020), in which a different

judge in the Central District of California concluded that the plaintiff’s state law

claims were preempted by the Food, Drug, and Cosmetics Act. Second, Fagron

points to a declaration, filed in the Nexus cases, from Maria Gozun, the Food and

Drug Administration’s (FDA) Acting Director of the Division of Compounded

Drugs.

2 Neither the Nexus decisions nor the Gozun declaration constitute “new

circumstances” sufficient to meet the Grunwald test. The Nexus decisions were not

controlling authority; they were issued by a different district judge and thus were not

binding on the district judge in this case. See Camreta v. Greene, 563 U.S. 692, 709

n.7 (2011) (“A decision of a federal district court judge is not binding precedent in

either a different judicial district, the same judicial district, or even upon the same

judge in a different case.”) (citation omitted). A non-binding decision by a judge at

the same court level does not amount to a relevant “new circumstance.”

Similarly, an agency declaration is not binding on district courts. Although

the Supreme Court “has recognized that an agency regulation with the force of law

can pre-empt conflicting state requirements,” the Gozun declaration is not such a

regulation. See Wyeth v. Levine, 555 U.S. 555, 576 (2009). “[A]n agency’s mere

assertion that state law is an obstacle to achieving its statutory objectives” is not a

regulation that can preempt conflicting state requirements. Id.

Even if the Gozun declaration were binding, it does not constitute “new

circumstances” that qualify under Grunwald. Part of the declaration addresses a

type of drug compounding that is not at issue in this case. And the part of the

declaration addressing bulk drug compounding facilities, like those operated by

Fagron, states that the FDA has not changed and is not planning to change its

regulations concerning such facilities.

3 Because Fagron’s motion was not based on “new circumstances” satisfying

the Grunwald test, the district court’s decision is not appealable as an order

refusing to dissolve a preliminary injunction under section 1292(a)(1).

DISMISSED.

4