17 F.4th 793
8th Cir.2021Background
- The OPTN is a congressionally authorized private non-profit charged with allocating donated organs nationwide under the National Organ Transplant Act; UNOS operates as OPTN under HHS oversight.
- For decades OPTN allocation prioritized candidates within Donation Service Areas (DSAs) and OPTN Regions; critics argued DSAs/Regions produced geographic inequities and violated the Final Rule’s prohibition on prioritizing candidate location.
- OPTN developed and, on December 3, 2019, adopted a 250-nautical-mile “Fixed Circle” kidney-allocation policy to replace DSA/Region preferences; implementation was announced for late 2020.
- Hospitals and a waitlist patient filed suit days before implementation (Dec. 2020), alleging procedural APA violations (failure to follow 42 C.F.R. § 121.4(b)(2) referral/publish procedures) and that the Fixed Circle rule was arbitrary and capricious; district court denied a TRO/PI.
- The district court found (1) plaintiffs unlikely to succeed on procedural and substantive APA claims, (2) plaintiffs waited too long before suing or filing critical comments, undermining irreparable-harm claims, and (3) the public interest and equities favored denying injunctive relief; the Eighth Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Procedural APA claim under 42 C.F.R. § 121.4(b)(2) (referral to ACOT & Federal Register for "significant" policies) | The Fixed Circle policy is "significant" and HHS was required to refer it to ACOT and publish it; failure mandates vacatur under 5 U.S.C. § 706(2)(D) | §121.4(b)(2)’s referral/publication is discretionary and applies only in the specific circumstances listed; Eleventh Circuit precedent rejects blanket "significant" rule | Denied — plaintiffs unlikely to succeed; Secretary’s referral duty is discretionary and was not violated |
| Whether §121.8(f) makes all allocation proposals matters the Secretary "directs" (triggering §121.4(b)(2)) | Because OPTN must transmit allocation proposals to the Secretary under §121.8(f), every allocation proposal is "as the Secretary directs" and thus subject to §121.4(b)(2) procedures | §121.8(f) governs supporting materials for proposals to aid Secretary review; it does not invoke or eliminate Secretary discretion under §121.4(b)(2) | Denied — §121.8(f) does not convert all allocation proposals into "matters the Secretary directs" |
| Substantive arbitrary-and-capricious challenge to the Fixed Circle policy | OPTN/HHS began with the predetermined conclusion that DSAs/Regions must be eliminated, ignored contrary SRTR modeling (showing fewer transplants/greater wastage), and therefore acted arbitrarily | Agency relied on SRTR modeling, extensive committee work, public comment, and provided reasoned explanations; review is highly deferential on technical matters | Denied — agency examined relevant data and provided a satisfactory explanation; not arbitrary or capricious |
| Irreparable harm, delay, balance of equities, public interest (preliminary injunction factors) | Hospitals face irreparable monetary and operational harms and filed before implementation; delay should not defeat irreparable-harm showing | Plaintiffs delayed a year after adoption and submitted late critical comments; harms are largely monetary/mitigable; public interest favors maintaining the policy already implemented and relied upon | Denied — plaintiffs failed to show irreparable harm; unreasonable delay and public interest/equities favor denial |
Key Cases Cited
- Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109 (8th Cir. 1981) (standard and factors for preliminary injunction)
- Callahan v. U.S. Dep’t of Health & Human Servs., Through Alex Azar II, 939 F.3d 1251 (11th Cir. 2019) (interpretation of §121.4(b)(2) — referral/publication not automatic for all "significant" policies)
- Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary-and-capricious review requires reasoned explanation and consideration of relevant data)
- FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009) (deference to agency where it examines relevant data and explains changes)
- Wise v. Dep’t of Transp., 943 F.3d 1161 (8th Cir. 2019) (standard of review for denial of preliminary injunction)
- Benisek v. Lamone, 138 S. Ct. 1942 (2018) (plaintiff must show diligence; delay affects irreparable-harm inquiry)