571 F.Supp.3d 1079
E.D. Mo.2021Background
- In November 2021 CMS issued an Interim Final Rule (the "mandate") requiring COVID-19 vaccination for nearly all employees, volunteers, trainees, students, and contractors at 15 categories of Medicare- and Medicaid-certified facilities.
- Ten States (including Missouri and Nebraska) sued for declaratory and injunctive relief and moved for a preliminary injunction against enforcement within their borders.
- The District Court found it had jurisdiction and evaluated the Dataphase preliminary injunction factors.
- The court held plaintiffs were likely to succeed on the merits, finding CMS likely lacked clear congressional authorization under the major-questions/clear-statement principles, and that the rule violated APA procedures and was arbitrary and capricious.
- The court found plaintiffs would suffer irreparable sovereign, quasi-sovereign, proprietary, and healthcare-access harms (staff losses, facility closures, rural impacts) and that the balance of equities and public interest favored an injunction.
- The court preliminarily enjoined enforcement of the CMS rule in the ten plaintiff States and required no bond.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether CMS had statutory authority to impose a broad vaccine mandate on Medicare/Medicaid-certified facilities | CMS lacks clear congressional authorization; major questions and federalism concerns require express authorization | Secretary has general regulatory authority to set health/safety requirements for Medicare/Medicaid participation | Held for plaintiffs: likely lack of clear congressional authorization; major-question and federalism principles weigh against CMS authority |
| Whether CMS lawfully bypassed APA notice-and-comment (good-cause exception) | CMS improperly invoked "good cause"; delay and available alternatives undercut emergency justification; controversial health rule demanded comment | CMS invoked exigency/public-health urgency and implementation timing to justify IFC and limited comment | Held for plaintiffs: CMS failed to show good cause; notice-and-comment likely required |
| Whether the mandate is arbitrary and capricious under the APA | Rule rests on inadequate record, overbroad scope, failed to consider alternatives (testing, natural immunity), contradicted prior policy, and ignored reliance interests | CMS relied on LTC data, overall public-health objectives, and asserted vaccination is the most effective infection-control measure | Held for plaintiffs: agency action likely arbitrary and capricious for lack of rational connection, failure to consider alternatives and reliance interests, and overbreadth |
| Whether plaintiffs will suffer irreparable harm and balance/public interest favors injunction | States will suffer sovereign and quasi-sovereign harms (nullified state laws; harm to residents), proprietary harms, and imminent healthcare-access harms (staff departures, closures—especially rural) | Government argued injunction would increase COVID risk to patients and staff and hinder public health objectives | Held for plaintiffs: irreparable harms likely; balance of equities and public interest favor preserving status quo via preliminary injunction |
Key Cases Cited
- La. Pub. Serv. Comm’n v. FCC, 476 U.S. 355 (1986) (agency has no power to act absent congressional delegation)
- Ala. Ass’n of Realtors v. Dep’t of Health & Hum. Servs., 141 S. Ct. 2485 (2021) (major-questions principle requires clear congressional authorization for rules of vast significance)
- Util. Air Reg. Grp. v. EPA, 573 U.S. 302 (2014) (clear-statement/major-questions framework)
- Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29 (1983) (arbitrary-and-capricious review; rational-connection requirement)
- Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109 (8th Cir. 1981) (four-factor preliminary injunction test)
- Fox Television Stations, Inc. v. FCC, 556 U.S. 502 (2009) (agency must supply reasoned explanation when changing course)
- Dep’t of Commerce v. New York, 139 S. Ct. 2551 (2019) (courts may scrutinize agency justifications and pretext)
- Regents of the Univ. of Cal. v. DHS, 140 S. Ct. 1891 (2020) (consideration of reliance interests when changing policy)
- Shalala v. Ill. Council on Long Term Care, 529 U.S. 1 (2000) (limitations on judicial review under certain statutory schemes)
- BST Holdings, L.L.C. v. OSHA, 17 F.4th 604 (5th Cir. 2021) (context on workplace vaccine-or-test regulatory challenges)
- NFIB v. Sebelius, 567 U.S. 519 (2012) (federalism considerations in limits on federal power)
- Jacobson v. Massachusetts, 197 U.S. 11 (1905) (state police power and compulsory vaccination precedent)