United States District Court, D. South Carolina, Florence Division
Bryan Harwell United States District Judge.
Court previously scheduled a hearing on Plaintiff's
“Motion for Preliminary Injunction” and
“Emergency Motion to Stay” for this Friday, June
28, 2019. See ECF No. 36. Having now considered the
recent filings in this matter, the Court finds a hearing is
unnecessary and will deny the motions.
2018, Plaintiff filed this action challenging its removal
from a federal drug pricing program-the 340B
Program-following an audit by the Heath Resources and
Services Administration (“HRSA”). Within a
week, the parties reached an agreement whereby HRSA permitted
Plaintiff to be provisionally readmitted to the 340B Program,
and the Court stayed this case for nearly a year while the
parties attempted to resolve the matter. On May 24, 2019, the
parties filed a status report stating they had not reached a
resolution, and Plaintiff filed a “Motion for
Preliminary Injunction” and an “Emergency Motion
to Stay” both seeking preliminary injunctive relief.
See ECF Nos. 32 & 33.Plaintiff “asks the
Court to restrain the Defendants from enforcing [the] audit
findings” and to “stay the imposition of
HRSA's findings.” ECF No. 32 at p. 6; ECF No. 33 at
p. 23. However, on June 6, 2019, HRSA voided the audit
findings, closed the audit, and determined Plaintiff
“has no further obligations or responsibilities in
regard to the audit.” ECF No. 41-1. Based on HRSA's
recent determination, the Court concludes preliminary
injunctive relief is not warranted and will therefore deny
Plaintiff's motions seeking such.
obtain a preliminary injunction, a plaintiff must show (1) it
is likely to succeed on the merits, (2) it is likely to
suffer irreparable harm without the preliminary injunction,
(3) the balance of equities tips in its favor, and (4) the
injunction is in the public interest. Winter v. Nat. Res.
Def. Council, Inc., 555 U.S. 7, 20 (2008); see
generally Fed. R. Civ. P. 65 (addressing preliminary
injunction motions). A court cannot issue a preliminary
injunction if a plaintiff fails to satisfy any of these four
requirements. Real Truth About Obama, Inc. v. FEC,
575 F.3d 342, 346-47 (4th Cir. 2009), vacated and
remanded on other grounds, 559 U.S. 1089 (2010),
reinstated in relevant part, 607 F.3d 355 (4th Cir.
Court finds Plaintiff has not satisfied the second
Winter factor because it has not made “a clear
showing that it is likely to be irreparably harmed absent
preliminary relief.” Real Truth, 575 F.3d at
347. Although Plaintiff asks the Court to restrain HRSA
“from enforcing its audit findings, ” ECF No. 32
at p. 6, HRSA has voided the audit findings and closed the
audit. Plaintiff itself acknowledges that the audit results
were voided “in their entirety.” See ECF
No. 43 at pp. 1-2. Thus, there is nothing for the Court to
preliminarily enjoin. Moreover, the Court cannot issue a
preliminary injunction “simply to prevent the
possibility of some remote future injury.”
Winter, 555 U.S. at 22; see Roe v.
Shanahan, 359 F.Supp.3d 382, 418 (E.D. Va. 2019)
(“A party seeking a preliminary injunction must make a
clear showing of ‘actual and imminent' irreparable
harm in the absence of injunctive relief.” (quoting
Direx Israel, Ltd. v. Breakthrough Med. Corp., 952
F.2d 802, 812 (4th Cir. 1991))); see generally
Winter, 555 U.S. at 33 (“Congress plainly intended
declaratory relief  to act as an alternative to the strong
medicine of the injunction[.]”). The Court will deny
Plaintiff's motions seeking preliminary injunctive
foregoing reasons, the Court DENIES
Plaintiff's Motion for Preliminary Injunction [ECF No.
32] and Emergency Motion to Stay [ECF No. 33].
IS SO ORDERED.
 The Court decides the motions without a
hearing pursuant to Local Civil Rule 7.08 (D.S.C.).
 “Section 340B of the Public Health
Services Act, 42 U.S.C. § 256b (2006 ed. and Supp. IV),
imposes ceilings on prices drug manufacturers may charge for
medications sold to specified health-care facilities. Those
facilities . . . include public hospitals and community
health centers, many of them providers of safety-net services
to the poor. The § 340B ceiling-price program (340B
Program) is superintended by the Health Resources and
Services Administration (HRSA), a unit of the Department of
Health and Human Services (HHS).” Astra USA, Inc.
v. Santa Clara Cty., 563 U.S. 110, 113 (2011).
“Immediate responsibility for oversight of the 340B
program resides in HRSA's Office of Pharmacy
Affairs.” Cty. of Santa Clara v. Astra U.S.,
Inc., 428 F.Supp.2d 1029, 1031 (N.D. Cal. 2006).
 Plaintiff also filed a “Motion to
Amend Verified Petition for Judicial Review, Emergency Motion
to Stay, and Petition for Declaratory Relief.” ECF No.
31. The Court will grant the motion to amend because it is
not opposed and ...