318 F. Supp. 3d 321
D.C. Cir.2018Background
- Alcresta Therapeutics and patient Jonathan Flath sued HHS challenging the agency's denial/refusal to grant a new permanent billing code for Relizorb; they sought a preliminary injunction and later appealed the denial.
- The court denied the preliminary injunction, finding Plaintiffs failed to show irreparable harm and that Flath likely lacked standing; Plaintiffs then filed an Emergency Motion for an injunction pending appeal.
- Plaintiffs sought (a) enforcement of FACA/procedural compliance in considering Alcresta’s 2018 application, (b) a reasoned decision on the 2017 application, and (c) a temporary, usable billing code for Relizorb.
- The government opposed the emergency motion and submitted an unrebutted declaration that code B4035 remains a valid Medicare billing code allowing claims and appeals processing.
- The court applied the standard for an injunction pending appeal (substantially the same as for a preliminary injunction) and concluded Plaintiffs failed to show a likelihood of irreparable harm, so the emergency motion was denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standard: sliding-scale vs. Winter test | Sliding-scale should apply; strong merits could offset weaker irreparable-harm showing | Winter controls; movant must show likely irreparable harm; sliding-scale is doubtful post-Winter | Court: Winter requires likely irreparable harm; need not analyze other factors when irreparable harm lacking |
| Irreparable harm — patient access (Flath) | Flath argues inability to obtain Relizorb/Medicare reimbursement causes irreparable health/financial harm | Changing billing code will not compel government insurers to reimburse; B4035 remains valid for claims and appeals | Court: No irreparable harm—injunctive relief sought would not remedy alleged injury; also found standing problems for Flath |
| Irreparable harm — Alcresta lost profits | Alcresta claims $15M in lost, unrecoverable profits; argues monetary loss justifies injunction pending appeal | Lost profits not shown to be certain, great, and imminent; financial context missing; unrecoverable money alone insufficient | Court: Monetary losses not shown to be irreparable; plaintiffs failed to prove magnitude/certainty required |
| Procedural injury (FACA) | Government’s alleged FACA violation causes procedural injury warranting injunction | Procedural violation alone, without great concrete harm, does not justify injunction; plaintiffs did not show added harm | Court: Procedural FACA claim does not supply irreparable harm absent concrete, great injury; denial affirmed |
Key Cases Cited
- Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008) (plaintiff must demonstrate irreparable injury is likely to obtain preliminary relief)
- Chaplaincy of Full Gospel Churches v. England, 454 F.3d 290 (D.C. Cir. 2006) (failure to show irreparable harm alone supports denial of preliminary injunction)
- FTC v. Weyerhaeuser Co., 648 F.2d 739 (D.C. Cir. 1981) (failure to show irreparable harm warrants denial of injunction pending appeal)
- Nken v. Holder, 556 U.S. 418 (2009) (standards for stays and consideration of harms in appellate context)
- Davis v. Pension Benefit Guar. Corp., 571 F.3d 1288 (D.C. Cir. 2009) (discusses sliding-scale approach and post-Winter analysis)
- Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011) (historical sliding-scale precedent discussed)
- Cardinal Health, Inc. v. Holder, 846 F. Supp. 2d 203 (D.D.C. 2012) (economic losses do not automatically establish irreparable harm; must be great, certain, imminent)
- Ohio Oil Co. v. Conway, 279 U.S. 813 (1929) (historical authority on certain and irreparable monetary injury)