NOT FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

HOPE MEDICAL ENTERPRISES, INC., 

d/b/a Hope Pharmaceuticals,

Plaintiff-Appellee,

 v. 

FAGRON COMPOUNDING SERVICES, 

LLC; et al.,

Defendants-Appellants.

No. 21-55165

D.C. No. 

2:19-cv-07748-CAS-PLA

MEMORANDUM*

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.

FILED

DEC 10 2021

MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS
2 

“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.
3 

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. 
4 

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.