Alcresta Therapeutics, Inc. v. Azar
Alcresta Therapeutics, Inc. v. Azar
Opinion of the Court
On June 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.
I. Background
On 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.
After 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.
On June 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 No. 53.
II. Legal Standard
Federal Rule of Civil Procedure 62(c) provides that "[w]hile an appeal is *324pending 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." "[I]njunction pending appeal is an extraordinary remedy." Memphis Publ'g Co. v. FBI ,
III. Analysis
In 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 turn.
A. The Sliding Scale
"Before 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 ,
Against 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 ,
But "[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 ,
In fact, the D.C. Circuit has upheld the denial of a motion for an injunction pending appeal where the plaintiff has failed to establish irreparable harm. See FTC v. Weyerhaeuser Co. ,
*326B. Irreparable Harm
Plaintiffs also argue that an injunction pending appeal is justified because the Court purportedly "disregarded" three arguments that they are suffering irreparable harm: (1) Flath's inability to obtain Relizorb and the alleged inability of patients taking Relizorb generally to submit claims under Medicare; (2) Alcresta's alleged loss of $15 million in profits, which Plaintiffs claim are not recoverable; and (3) the procedural injury related to the government's alleged failure to comply with FACA. Emer. Mot. at 3. But none of these alleged harms is sufficient to demonstrate irreparable harm.
First, the Court explained in the PI Opinion that Flath failed to establish irreparable harm because the injunction he sought would not remedy the harm he alleged. PI Opinion at 22-24. Flath's alleged harm stems from the fact that government insurers do not fully reimburse for Relizorb. But the injunctive relief he seeks would only order Defendant to take various actions regarding Relizorb's billing code. Emer. Mot. at 1-2. As the Court has already explained, there is a "fundamental disconnect" between the irreparable harm alleged and the injunctive relief sought because changing the billing code used for Relizorb will not lead government insurers to provide additional reimbursement for the product. PI Opinion at 2, 22-24. For similar reasons, the Court also concluded that Flath failed to establish a substantial likelihood of standing. Id. at 15-22.
Plaintiffs also have not established irreparable harm resulting from patients' inability to submit a Medicare claim for Relizorb. As noted in the PI Opinion, Defendant has submitted a sworn and unrebutted declaration establishing that billing code B4035 remains a valid Medicare billing code for Relizorb and provides patients access to the claims and appeals process. See id. at 9; ECF No. 34-1 ¶¶ 14-15 ("[C]ode B4035 is a valid code for Medicare claims processing purposes.... If a Medicare claim is processed, then there is an initial determination regarding Medicare payment on the claim. Initial determinations are subject to administrative and judicial review in accordance with the Medicare statute and applicable rules, regulations, guidance, and procedures."). In addition, to the extent Plaintiffs now invoke this theory as to "patients" other than Flath, injuries to third parties are not a basis to find irreparable harm. See Cardinal Health, Inc. v. Holder ,
Second, the Court explained in detail in the PI Opinion why the lost profits Alcresta alleges do not demonstrate irreparable harm. PI Opinion at 10-15. Plaintiffs suggest that, despite the Court's conclusion, an injunction pending appeal would be proper because there is a "split" in this Circuit on whether irrecoverable monetary losses constitute irreparable harm, and that this "difficult legal question" justifies an injunction pending appeal. Emer. Mot. at 4 (citing Wash. Metro. Area Transit Comm'n v. Holiday Tours, Inc. ,
Third, on the record before the Court, Plaintiffs have not shown that their claimed procedural injury-"the government's failure to comply with FACA in considering Alcresta's pending application," Emer. Mot. at 3-is sufficient to demonstrate irreparable harm.
*328Accordingly, Plaintiff's claimed procedural harm does not add sufficient weight to establish irreparable harm."). That is precisely the situation here regarding Alcresta. As explained above, the Court cannot conclude that Alcresta's lost profits are "great" without information concerning Alcresta's finances, which it declined to place in the record. And the antecedent FACA-based procedural injury alleged by Plaintiffs, which in and of itself is also not "great," does not alter that analysis.
For all of the above reasons, and those specified in the PI Opinion, Plaintiffs have failed to establish that they will suffer irreparable harm absent an injunction pending appeal, and Flath has failed to demonstrate a likelihood of success on the merits because he has not established a substantial likelihood that he has standing.
IV. Conclusion
Plaintiffs' Emergency Motion for an Injunction Pending Appeal, ECF No. 50, is therefore DENIED .
SO ORDERED.
Plaintiffs seem to suggest that even if the sliding-scale approach does not apply to a motion for a preliminary injunction, it nevertheless applies to a motion for injunction pending appeal. See Emer. Mot. at 2-3. There is no reason to believe this is the case. The tests for both motions are "substantially the same." Amgen ,
"[M]otions for an injunction pending appeal are governed by the same standard as motions for stay pending appeal ...." McCammon v. United States ,
Plaintiffs assert that the D.C. Circuit "has made clear that, even assuming 'the showing of irreparable harm to the movant [is] very low,' the court [must] proceed[ ] to consider the other three factors." Emer. Mot. at 3 (quoting Davis ,
Plaintiffs argue that Ohio Oil Co. v. Conway ,
The Court notes that Plaintiffs did not raise procedural injury as a basis for irreparable harm in their brief or reply brief supporting their PI Motion. See ECF Nos. 10, 21.
In the PI Opinion, the Court concluded that Flath cannot rely on procedural injury to demonstrate standing because the asserted harm to his health is not traceable to a procedural injury. PI Opinion at 21 n.4. For similar reasons, any argument that he is suffering irreparable harm due to a procedural injury fails as well.
Case-law data current through December 31, 2025. Source: CourtListener bulk data.