Hope Medical Enterprises, Inc. v. Fagron Compounding Services ( 2021 )

NOT FOR PUBLICATION FILED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