United States District Court, District of Columbia
ALCRESTA THERAPEUTICS, INC. et al., Plaintiffs,
ALEX M. AZAR II, Secretary of Health and Human Services, Defendant.
MEMORANDUM OPINION AND ORDER
TIMOTHY J. KELLY UNITED STATES DISTRICT JUDGE.
26, Plaintiffs filed an Emergency Motion (the
“Emergency Motion”) for an Injunction Pending
Appeal of the Court's Order denying their Motion for
Preliminary Injunction. See ECF No. 50 (“Emer.
Mot.”). For the reasons set forth below, the Emergency
Motion is denied.
February 2, 2018, Plaintiffs Alcresta Therapeutics, Inc.
(“Alcresta”) and Jonathan Flath filed suit
against the Secretary of Health and Human Services, alleging
that the agency improperly failed to grant Alcresta a new
billing code for one of its products, Relizorb. ECF No. 1.
More than three weeks later, Plaintiffs filed an Amended
Complaint, ECF No. 7, and a Motion for Preliminary Injunction
(the “PI Motion”), ECF No. 8. At the parties'
request, the Court stayed its consideration of the PI Motion
while they discussed a potential settlement.
settlement talks broke down, the Court held oral argument on
the PI Motion and subsequently issued an Order denying the PI
Motion, ECF No. 47, and an accompanying Memorandum Opinion
(“PI Opinion”), ECF No. 48. The instant opinion
assumes familiarity with the facts of the case as described
in the PI Opinion. Id. at 1-9. In denying the PI
Motion, the Court concluded that, based on the record,
Alcresta was not entitled to a preliminary injunction because
it failed to establish that absent an injunction, it would
suffer irreparable harm. Id. at 10-15. The Court
also concluded that Flath, a patient with cystic fibrosis who
had taken Relizorb for a few months, was not entitled to a
preliminary injunction because: (1) he failed to demonstrate
a substantial likelihood of standing, which is necessary to
establish a likelihood of success on the merits; and (2) he
failed to establish irreparable harm because the preliminary
relief sought-including a temporary new billing code for
Relizorb-would not cause government insurers to reimburse for
Relizorb, and thus would not remedy the irreparable harm
Flath had alleged. Id. at 1, 15-24.
26, Plaintiffs appealed the Court's Order, ECF No. 51
(notice of appeal), and filed the instant Emergency Motion.
The Emergency Motion seeks an injunction pending appeal
resembling the preliminary injunction Plaintiffs requested
earlier. Plaintiffs request that this Court order that
Defendant (1) adhere to the Federal Advisory Committee Act
(“FACA”) and other required procedures in
considering Alcresta's 2018 application for a permanent,
unique billing code, (2) issue a “reasoned
decision” on Alcresta's 2017 application, and (3)
issue a “valid, usable temporary code” for
Relizorb in the interim. Emer. Mot. at 1-2; see also
PI Motion at 1. On June 27, Defendant filed his response. ECF
Rule of Civil Procedure 62(c) provides that “[w]hile an
appeal is pending from an interlocutory order . . . that . .
. denies an injunction, the court may suspend, modify,
restore, or grant an injunction on terms for bond or other
terms that secure the opposing party's rights.”
“[Injunction pending appeal is an extraordinary
remedy.” Memphis Publ'g Co. v. FBI, 195
F.Supp.3d 1, 3 (D.D.C. 2012) (citing Cuomo v. U.S.
Nuclear Regulatory Comm'n , 772 F.2d 972, 978 (D.C.
Cir. 1985)). “The standards for evaluating a motion for
an injunction pending appeal are ‘substantially the
same as those for issuing a preliminary
injunction.'” Amgen Inc. v. Azar, No.
17-cv-1006, 2018 WL 1990521, at *1 (D.D.C. Feb. 22, 2018)
(quoting Al-Anazi v. Bush, 370 F.Supp.2d 188, 199
n.11 (D.D.C. 2005)). Plaintiffs “must establish that
[they are] likely to succeed on the merits, that [they are]
likely to suffer irreparable harm in the absence of
preliminary relief, that the balance of equities tips in
[their] favor, and that an injunction is in the public
interest.” Id. (quoting Winter v. Nat.
Res. Def. Council Inc. 555 U.S. 7, 20 (2008)).
their Emergency Motion, Plaintiffs make two broad arguments
for an injunction pending appeal, both of which reflect
disagreement with the Court's reasoning in the PI
Opinion. First, they argue that the D.C. Circuit uses a
“sliding scale” to evaluate motions for
preliminary injunctive relief, and that the Court erred by
failing to apply it in the PI Opinion. Emer. Mot. at 2-3, 5.
Second, Plaintiffs argue that the Court erred by concluding
that they failed to demonstrate irreparable harm.
Id. at 3-4. The Court addresses each argument in
The Sliding Scale
the Supreme Court's decision in Winter, courts
in this circuit applied a ‘sliding-scale' approach
under which ‘a strong showing on one factor could make
up for a weaker showing on another.'”
Amgen, 2018 WL 1990521, at *1 (quoting Sherley
v. Sebelius, 644 F.3d 388, 392 (D.C. Cir. 2011)). In
Winter, the Supreme Court rejected the argument that
“when a plaintiff demonstrates a strong likelihood of
prevailing on the merits, a preliminary injunction may be
entered based only on a ‘possibility' of
irreparable harm.” 555 U.S. at 21. Instead, plaintiffs
seeking preliminary relief must “demonstrate that
irreparable injury is likely in the absence of an
injunction.” Id. at 22. “Some judges of
the D.C. Circuit have expressed the view that . . .
Winter supplants the ‘sliding scale'
approach, and a movant cannot obtain an injunction without
showing ‘both a likelihood of success
and a likelihood of irreparable harm.'”
Soundboard Ass'n v. FTC, 254 F.Supp.3d 7, 9-10
(D.D.C. 2017) (quoting Sherley, 644 F.3d at 392).
But the D.C. Circuit “has not yet needed to decide
th[e] issue.” League of Women Voters of U.S. v.
Newby, 838 F.3d 1, 7 (D.C. Cir. 2016).
this backdrop, Plaintiffs argue that the “sliding
scale” governs the Emergency Motion and that the PI
Opinion misapplied that standard, because it did not conduct
a full analysis of their likelihood of success on the merits
or the balance of equities. Emer. Mot. at 2-3. As an initial
matter, the Court has strong doubts that the sliding-scale
approach survives Winter. See, e.g.,
Nken v. Holder, 556 U.S. 418, 438 (2009)
(“When considering success on the merits and
irreparable harm, courts cannot dispense with the required
showing of one simply because there is a strong likelihood of
the other.” (Kennedy, J., concurring)); Davis v.
Pension Benefit Guar. Corp., 571 F.3d 1288, 1296 (D.C.
Cir. 2009) (“[U]nder the Supreme Court's
precedents, a movant cannot obtain a preliminary injunction
without showing both a likelihood of success
and a likelihood of irreparable harm, among other
things.” (Kavanaugh, J., concurring)); Guttenberg
v. Emery, 26 F.Supp.3d 88, 100 n.5 (D.D.C. 2014)
(“Even a narrow reading of the Court's holding in
Winter supports the view that sliding-scale analysis
“[w]hether or not Winter spelled the end of
sliding-scale analysis, one thing is clear: plaintiffs here
must at least ‘demonstrate that irreparable injury is
likely in the absence of an injunction.'”
Guttenberg, 26 F.Supp.3d at 101 (quoting
Winter, 555 U.S. at 22). “Under
Winter, even a ‘strong likelihood of
prevailing on the merits' cannot make up for a deficient
showing of irreparable injury.” Id. (quoting
Winter, 555 U.S. at 21-22). As the Court explained
in its PI Opinion, Plaintiffs have failed to demonstrate that
they are “likely” to suffer irreparable harm in
the absence of an injunction. PI Opinion at 10-15, 22-24.
Thus, they are not entitled to a preliminary injunction, and
the Court need not analyze the remaining factors to reach
this conclusion. See, e.g., Chaplaincy of Full
Gospel Churches v. England, 454 F.3d 290, 297 (D.C. Cir.
2006) (“A movant's failure to show any irreparable
harm is therefore grounds for refusing to issue a preliminary
injunction, even if the other three factors entering the
calculus merit such relief.”); City Fed Fin. Corp.
v. OTS, 58 F.3d 738, 747 (D.C. Cir. 1995)
(“[Plaintiff] has made no showing of irreparable injury
here, [and] that alone is sufficient for us to ...