980 F.3d 123
D.C. Cir.2020Background
- In July 2019 the Department of Justice adopted a one-drug federal lethal-injection "2019 Protocol" using pentobarbital; 13 federal death-row inmates sued challenging the protocol under the Eighth Amendment, the Federal Food, Drug, & Cosmetic Act (FDCA) via the Administrative Procedure Act (APA), and the Federal Death Penalty Act (FDPA).
- Litigation produced multiple district-court injunctions and several emergency stays; this court and the Supreme Court repeatedly reviewed and in many instances vacated or stayed those injunctions during a summer–fall 2020 execution schedule.
- Plaintiffs allege pentobarbital commonly causes "flash pulmonary edema," producing acute drowning/asphyxiation sensations while the prisoner remains sensate; they allege a readily available, feasible alternative (pre-administration of an analgesic) that would materially reduce that risk.
- The district court (post-Supreme Court per curiam rulings) entered judgment finding the protocol violated the FDCA to the extent it permits dispensing/administration of pentobarbital without a prescription, but dismissed plaintiffs’ Eighth Amendment claim at the pleading stage and denied a permanent injunction for the FDCA violation.
- This panel: (1) affirms summary judgment for defendants on the FDPA issues; (2) reverses the dismissal of the Eighth Amendment claim (plaintiffs plausibly pleaded the required elements); and (3) holds the Protocol must be set aside to the extent it permits use of unprescribed pentobarbital, but declines to impose a permanent injunction remanding for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Eighth Amendment method-of-execution claim | Pentobarbital-only protocol creates a virtual medical certainty of severe, needless pain (flash pulmonary edema); plaintiffs proposed a feasible, available alternative (pre-dose analgesic) | Pentobarbital protocol is constitutional; prior high-court decisions and competing expert evidence show no demonstrated unconstitutional risk | Reversed dismissal: plaintiffs plausibly alleged Eighth Amendment claim at pleading stage and may proceed to factfinding |
| FDCA applicability / APA cause of action | FDCA requires prescription for pentobarbital; BOP’s use without prescriptions violates FDCA and agency action is reviewable under the APA | Government contends FDCA does not govern drugs used for executions and that plaintiffs lack a private FDCA cause of action | Protocol must be set aside to the extent it permits dispensing/administration without a prescription; APA provides review (court relied on binding circuit precedent) |
| Permanent injunction for FDCA violation (irreparable harm) | Unprescribed administration creates health risks constituting irreparable injury warranting injunction | Government: plaintiffs did not show likely irreparable harm and public interest favors carrying out executions | Denied injunction: plaintiffs failed to satisfy equitable factors (irreparable harm not established for injunction), so remedy limited to setting aside unlawful portions of the Protocol |
| FDPA claim (incorporation of state procedures) | FDPA requires federal executions be carried out in manner prescribed by state law where sentence imposed; alleged conflicts with 2019 Protocol | Government: no live conflict; in many instances it would comply with state procedures or no plaintiff sought state procedure | Affirmed summary judgment for government; no live controversy shown as to state-procedure claims |
Key Cases Cited
- In re Federal Bureau of Prisons’ Execution Protocol Cases, 955 F.3d 106 (D.C. Cir. 2020) (prior D.C. Cir. decision resolving APA/FDPA preliminary issues and remanding other claims)
- Baze v. Rees, 553 U.S. 35 (2008) (Eighth Amendment lethality/constitutionality framework for lethal-injection protocols)
- Glossip v. Gross, 576 U.S. 863 (2015) (method-of-execution standard: demonstrated risk of severe pain and requirement to identify feasible, readily implemented alternatives)
- Bucklew v. Precythe, 139 S. Ct. 1112 (2019) (as-applied challenge standard and burden to propose alternative)
- Barr v. Lee, 140 S. Ct. 2590 (2020) (per curiam stay analysis in last-minute execution-challenge context)
- Cook v. FDA, 733 F.3d 1 (D.C. Cir. 2013) (circuit precedent applying FDCA principles to lethal-injection drug regulation in import/enforcement context)
- Heckler v. Chaney, 470 U.S. 821 (1985) (agency non-enforcement decisions generally not reviewable under APA)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard for plausibility under Rule 12(b)(6))
- Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008) (standards for preliminary injunction/irreparable harm and balance-of-equities)
- Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139 (2010) (permanent-injunction equitable factors)