In re: FBOP Execution Protocol Cases

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued November 16, 2020 Decided November 18, 2020

No. 20-5329

IN RE: IN THE MATTER OF THE FEDERAL BUREAU OF PRISONS'

EXECUTION PROTOCOL CASES,

JAMES H. ROANE , JR., ET AL.,

APPELLANTS

v.

WILLIAM P. BARR, ATTORNEY GENERAL, ET AL.,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 1:19-mc-00145)

Alexander C. Drylewski argued the cause for appellants.

With him on the briefs were Jonathan L. Marcus, Shawn

Nolan, Jonathan C. Aminoff, Paul F. Enzinna, Ginger D.

Anders, Jonathan S. Meltzer, Brendan Gants, Amy Lentz,

Matthew Lawry, Gerald W. King, Jr., Jeffrey Lyn Ertel, and

Evan Miller.

Melissa N. Patterson, Attorney, U.S. Department of

Justice, argued the cause for the appellees. With her on the

brief were Jeffrey Bossert Clark, Acting Assistant Attorney

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General, Sopan Joshi, Senior Counsel to the Assistant Attorney

General, and Amanda L. Mundell, Attorney.

Before: MILLETT , PILLARD and RAO, Circuit Judges.

Opinion for the Court filed PER CURIAM.

Opinion concurring in part and dissenting in part by

Circuit Judge PILLARD.

Opinion concurring in part, concurring in the judgment,

and dissenting in part filed by Circuit Judge RAO.

PER CURIAM: In July 2019, eight years after federal

executions were put on hold due to the government’s inability

to acquire one of the drugs for its then existing lethal injection

protocol, the Department of Justice announced a revised

protocol for execution by lethal injection using a single drug,

pentobarbital. Plaintiffs, thirteen federal death row inmates,

promptly raised statutory and constitutional challenges to the

government’s revised protocol. In November 2019, the district

court preliminarily enjoined the four then-scheduled

executions while it (and, in turn, we) considered a pair of

baseline legal challenges to the government’s lethal injection

protocol. When we held that the 2019 Protocol is exempt from

notice and comment requirements under the Administrative

Procedure Act (APA) and that the Federal Death Penalty Act

(FDPA) does not require the federal government to follow

execution procedures set forth in state execution protocols that

are less formal than state statutes and regulations, we vacated

those injunctions and remanded for the district court to

consider the balance of plaintiffs’ challenges. See In re

Federal Bureau of Prisons’ Execution Protocol Cases (In re

FBOP), 955 F.3d 106 (D.C. Cir. 2020).

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During the pendency of the litigation on those remaining

claims, the government scheduled executions to take place

within days or weeks of one another through the summer and

fall. At the behest of plaintiffs with execution dates and

unresolved challenges, the district court issued a series of

injunctions barring the federal government from executing

inmates whose pending claims it held were likely to succeed.

Each of those injunctions was vacated by either this court or

the Supreme Court, and the government has since executed

seven inmates, six of whom were plaintiffs in this case at the

time of their execution. In September, the district court

resolved the plaintiffs’ remaining claims. On November 3,

2020, the district court denied the Plaintiffs’ motion to alter or

amend the judgment under Rule 59(e).

The Plaintiffs then sought expedited review in this court of

three of the district court’s rulings, and two plaintiffs with

upcoming execution dates moved for stays of execution

pending appeal. We affirm the district court’s grant of

summary judgment to the defendants based on plaintiffs’ new

challenges to the FDPA, but we reverse its dismissal of the

plaintiffs’ Eighth Amendment challenge for failure to state a

claim. We also hold that the district court should have ordered

the 2019 Protocol to be set aside to the extent that it permits the

use of unprescribed pentobarbital in a manner that violates the

FDCA. But we affirm the district court’s denial of a permanent

injunction to remedy the FDCA violation.

I.

A.

In 1988, Congress reinstated the federal death penalty

without specifying how executions were to be implemented.

Five years later, in 1993, the Attorney General issued

regulations to fill that gap. Those regulations provide that the

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“method of execution” for a sentence of death is to be

“intravenous injection of a lethal substance or substances in a

quantity sufficient to cause death.” 28 C.F.R. § 26.3(a)(4). The

regulations include no details regarding the specific substances

to be used or how those substances are to be chosen or

administered. In 1994, Congress enacted the Federal Death

Penalty Act (FDPA), which states that federal executions are

to be implemented “in the manner prescribed by the law of the

State in which the sentence is imposed.” 18 U.S.C. § 3596(a).

The FDPA and the Attorney General’s regulations remain the

federal law governing executions by the United States. See

Manner of Federal Executions, 854 Fed. Reg. 47,324, 47,325-

26 (2020).

Between 2001 and 2003, the federal government carried

out its first three executions since the death penalty was

reinstated. See In re Federal Bureau of Prisons’ Execution

Protocol Cases (In re FBOP), 955 F.3d 106, 110 (D.C. Cir.

2020). The method of execution for each was lethal injection

using a combination of three substances—sodium thiopental,

pancuronium bromide, and potassium chloride. Id. In 2005,

three death row inmates filed suit in the District Court for the

District of Columbia alleging they were to be executed under a

protocol that violated the Constitution and the APA. See

Complaint at 30-36, Roane v. Gonzales, 05-cv-2337 (D.D.C.

Dec. 6, 2005); see also Amended Complaint at 28-32, Roane,

05-cv-2337 (July 10, 2006) The court granted motions by the

three original plaintiffs and several plaintiffs who intervened

for preliminary injunctions barring their executions. See, e.g.,

Order at 1, Roane, 05-cv-2337 (D.D.C. June 30, 2006); Minute

Order, Roane, 05-cv-2337 (D.D.C. Feb. 14, 2007); Order at 1,

Roane, 05-cv-2337 (D.D.C. Feb. 21, 2007). During the

litigation, the government produced a 50-page protocol, first

adopted in 2004, detailing the procedures for carrying out

executions, including admitting witnesses to the execution,

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providing for the prisoner’s final meal, and permitting

statements, among many other things. In re FBOP, 955 F.3d

at 110. In 2008, the government produced an addendum to the

2004 Protocol specifying that the method of execution would

be by lethal injection using the same three-drug protocol the

government used in the executions between 2001 and 2003.

See In re FBOP, 955 F.3d at 110. That same year, the Supreme

Court rejected an Eighth Amendment challenge to Kentucky’s

use of the same three substances for execution by lethal

injection. See Baze v. Rees, 553 U.S. 35, 53-54 (2008). In

2011, however, the government announced it was unable to

procure sodium thiopental, one of the drugs required to carry

out an execution under its existing protocol. At that point, at

least two cases involving method-of-execution challenges were

pending in the district court and two more were filed shortly

thereafter. See Roane, 05-cv-2337; Robinson v. Mukasey, 05-

cv-2145 (D.D.C.); Bourgeois v. Dep’t of Justice, 12-cv-782

(D.D.C.); Fulks v. Dep’t of Justice, 13-cv-938 (D.D.C.). All

four were put on hold pending the government’s issuance of a

revised protocol.

On July 25, 2019, eight years after announcing the

unavailability of sodium thiopental, the Department of Justice

announced its revised protocol, referred to in this litigation as

the 2019 Protocol. A two-page addendum to the 2019 Protocol

makes pentobarbital, a barbiturate, the sole drug to be used in

federal executions. See In re FBOP, 955 F.3d at 110. On the

same day that it announced the 2019 Protocol, the government

also announced scheduled execution dates in December 2019

and January 2020 for five inmates on death row.

In response to the government’s notification of its revised

protocol, the district court scheduled a status conference in the

four pending cases for August 15 of last year and consolidated

the cases five days later. See Minute Order, Roane, 05-cv-2337

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(Aug. 5, 2019). Because the execution date of one of the

plaintiffs before the court, Alfred Bourgeois, had been

scheduled for January 13, 2020, the district court asked the

government at the scheduling conference if it was willing to

stay Bourgeois’s execution pending the resolution of his case.

See Status Hr’g Tr. 6, supra. The government stated that it did

not intend to stay the execution date, so the district court

proceeded to set an expedited schedule, requiring an amended

complaint by the end of March. Id. at 19; see Fed. R. Civ. P.

30(b)(6). On March 18, the parties jointly requested that the

court extend by 60 days the deadline for plaintiffs’ amended

complaint because of the disruptions the COVID-19 outbreak

had caused in plaintiffs’ efforts to complete pre-amendment

discovery. The court granted that request the next day and set

a briefing schedule for dispositive motions extending from July

to December. See Minute Order, In re FBOP, No. 19-mc-145

(D.D.C. Mar. 18, 2020).

In the meantime, plaintiffs with execution dates in

December and January sought to enjoin their executions until

their pending claims could be resolved. Three of the inmates

with scheduled execution dates—Daniel Lee, Wesley Purkey,

and Dustin Honken—had intervened in the master case in the

months after the protocol was announced. Those three

plaintiffs and Bourgeois all moved for preliminary injunctions,

which the district court granted in November 2019. See

Memorandum Opinion, In re FBOP, No. 19-mc-145 (D.D.C.

Nov. 20, 2019), ECF No. 50. The court found that plaintiffs

had shown a likelihood of success on their claim that the 2019

Protocol exceeded the government’s statutory authority under

the FDPA but it did not reach any of the plaintiffs’ other claims.

Id. at 13, 15. Both this court and the Supreme Court denied the

government’s motion to stay the district court’s preliminary

injunction. See Order, In re FBOP, No. 19-5322 (D.C. Cir.

Dec. 2, 2019); Barr v. Roane, 140 S. Ct. 353 (2019) (mem.).

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On April 6, 2020, in a divided opinion, this court vacated the

district court’s injunction and reversed its FDPA ruling on the

merits. See In re FBOP, 955 F.3d 106. We denied plaintiffs’

petition for rehearing en banc on May 15, and the Supreme

Court denied their petition for writ of certiorari on June 29. See

Bourgeois v. Barr, No. 19A1050, 2020 WL 3492763 (U.S.

June 29, 2020) (mem.).

On June 15, with the preliminary injunction on the FDPA

claim vacated, but prior to briefing on the merits of plaintiffs’

other claims, the government set new execution dates in July

and August for four of the plaintiffs in this case—Lee, Purkey,

Honken, and Keith Nelson. Four days later, those same

plaintiffs moved for a preliminary injunction. See Plaintiffs’

Motion for a Preliminary Injunction, In re FBOP, No. 19-mc-

145 (D.D.C. June 19, 2020), ECF No. 102. On July 13, the day

the first of these four plaintiffs, Lee, was scheduled to be

executed, the district court preliminary enjoined the

executions, concluding that plaintiffs were likely to succeed on

the merits of their Eighth Amendment challenge to the 2019

Protocol. See Memorandum and Opinion, In re FBOP, No. 19-

mc-145, 2020 WL 3960928 (D.D.C. July 13, 2020). Later that

day, this court denied the government’s motion for a stay of the

injunction, concluding it had not demonstrated a likelihood of

success on its claim that the district court abused its discretion.

See Order, No. 20-5199 (D.C. Cir. July 13, 2020). We ordered

that the appeal be expedited and set a briefing schedule with a

final deadline of July 24. In the early morning hours of July

14, however, the Supreme Court vacated the district court’s

preliminary injunction, holding that the plaintiffs had failed to

establish a likelihood of success on the merits of their Eighth

Amendment claim. Barr v. Lee, 140 S. Ct. 2590 (2020). The

government executed Lee that same day.

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The second of the four plaintiffs with a scheduled

execution date, Purkey, was scheduled to be executed the next

day, July 15, and the third of the four plaintiffs, Honken, was

scheduled to be executed on July 17. Plaintiffs thus requested

on July 15 that the district court issue a preliminary injunction

on the remaining grounds they had asserted in their June 19

motion. See Plaintiffs’ Emergency Notice Requesting Ruling

on Pending Motion, In re FBOP, No. 19-mc-145 (D.D.C. July

15, 2020), ECF No. 144. On July 15, prior to Purkey’s

execution, the district court issued another preliminary

injunction, finding that plaintiffs were likely to succeed on the

merits of their claim that the 2019 Protocol violates the FDCA.

See Order, In re FBOP, No. 19-mc-145 (D.D.C. July 15, 2020),

ECF Nos. 145, 146. Late on July 15, this court denied the

government’s motion for a stay pending appeal, holding that

the government had not demonstrated a likelihood of success

on the merits of its claim that the 2019 Protocol comports with

the FDCA. See Order, In re FBOP, No. 20-5210 (D.C. Cir.

July 15, 2020). In the early morning hours of July 16, however,

the Supreme Court vacated the district court’s injunction

without addressing the merits of the FDCA claim or this court’s

order. See Barr v. Purkey, No. 20A10, 2020 WL 4006821

(U.S. July 16, 2020) (mem.). Purkey was executed later that

day. Honken was executed on July 17, after this court denied

his motion for a stay of execution pending appeal of the district

court’s denial of a preliminary injunction on several other

claims. See Order, In re FBOP, No. 19-mc-145 (D.D.C. July

16, 2020), ECF No. 166; In re FBOP, No. 5206 (D.C. Cir. July

17, 2020).

Alongside the litigation over the stays of the executions

that summer, proceedings on the merits continued. In

accordance with the district court’s briefing schedule, the

plaintiffs filed an amended complaint on June 1, and the

government filed its dispositive motions on July 31. But

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Nelson—then the only plaintiff left with a scheduled execution

date (August 28)—filed an emergency motion to expedite a

trial on the Eighth Amendment claim (on July 31) and for

summary judgment on the FDCA claim (on August 4). The

district court then changed course from its prior briefing

schedule, which did not require plaintiffs to file any opposition

and cross motions until the end of September, and instead

required that by August 10 plaintiffs respond to the

government’s dispositive motions and the government respond

to Nelson’s emergency motion for summary judgment on the

FDCA claim. On August 15, the district court granted the

government’s motion to dismiss the Eighth Amendment claim

in light of the Supreme Court’s July 15 decision, Barr v. Lee,

vacating the preliminary injunction the district court had earlier

issued on the Eighth Amendment claim. Order, In re FBOP,

No. 19-mc-145 (D.D.C. Aug. 15, 2020), ECF No. 193.

On August 25, this court denied Nelson’s motion for a stay

of execution pending appeal of the district court’s dismissal,

concluding that the record before the court contained no

findings of fact that could distinguish Nelson’s request for

equitable relief from the request the Supreme Court rejected in

Lee. See Order, In re FBOP, No. 20-5210 (D.C. Cir. July 15,

2020). On August 27, a day before Nelson’s execution, the

district court granted summary judgment to Nelson on the

FDCA claim, enjoining the government from executing him.

See Memorandum Opinion, In re FBOP, No. 19-mc-145

(D.D.C. Aug. 27, 2020), ECF No. 213. Later that same day

this court granted the government’s motion to vacate the

district court’s injunction, noting the court failed to include

findings that irreparable injury would result from the FDCA

violation. See Order, In re FBOP, No. 20-5260 (D.C. Cir. Aug.

27, 2020). On August 28, the district court denied Nelson’s

motion to clarify or amend its prior order. The government

executed Nelson later that same day.

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The district court’s August decision granting judgment on

the FDCA claim was limited to Nelson; on September 9 the

remaining plaintiffs moved for summary judgment on the same

ground. Included among the plaintiffs were Christopher

Andrew Vialva and William LeCroy, who the government had

announced on July 31 would be executed on September 22 and

24, respectively. In their September 9 motion, the plaintiffs

argued that violations of the FDCA would subject them to

irreparable harm, noting that the rush of litigation before

Nelson’s execution had prevented him from making the same

showing. See Plaintiffs’ Motion for Partial Summary

Judgment and Permanent Injunction, In re FBOP, No. 19-mc-

145 (D.D.C. Sept. 9, 2020), ECF No. 236. The district court

held an evidentiary hearing on September 18 and 19 on the

FDCA claim.

On September 20, the district court issued an order

entering final judgment on the remaining claims in the case.

See Memorandum Opinion, In re FBOP, No. 19-mc-145

(D.D.C. Sept. 20, 2020), ECF No. 261. The court granted

summary judgment to the plaintiffs on the FDCA claim, as it

had to Holder in August, but denied a preliminary injunction,

holding that plaintiffs failed to establish irreparable harm. The

court ruled in favor of the government on all other claims,

including a claim that the 2019 Protocol violated the FDPA. It

also vacated preliminary injunctions that it had issued between

2005 and 2007, during challenges to the prior three-drug

protocol, that continued to bar the executions of several

plaintiffs in this case. LeCroy was executed on September 22

and Vialva was executed on September 24.

Four days later, on September 30, the government set

November 19 as the execution date for Orlando Hall, one of the

plaintiffs whose execution the court had previously enjoined.

On October 16, it set December 10 as the execution date for

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Brandon Bernard. On November 4, the day after the district

court denied their motions to alter or amend its judgment on

their Eighth Amendment, FDCA, and FDPA claims, plaintiffs

filed this appeal. They moved to expedite briefing and oral

argument two days later, noting the upcoming executions of

Hall and Bernard. On November 10, Hall and Bernard filed an

emergency motion for stay of execution pending appeal. We

expedited briefing on both the merits appeal and the stay

motion and heard oral argument on November 16.

B.

The Bureau of Prisons developed its 2019 Protocol

through review of state practices and in consultation with

medical professionals. See Administrative Record at PDF 6, In

re FBOP, No. 19-mc-145 (D.D.C. Nov. 13, 2019), ECF No.

39-1. Like the federal government, at least 30 states previously

had lethal injection protocols in place that used three drugs:

sodium thiopental, “a fast-acting barbiturate sedative that

induces a deep, comalike unconsciousness when given in the

amounts used for lethal injection,” pancuronium bromide, “a

paralytic agent that inhibits all muscular-skeletal movements

and, by paralyzing the diaphragm, stops respiration,” and

potassium chloride, which “interferes with the electrical signals

that stimulate the contractions of the heart, inducing cardiac

arrest.” See Baze v. Rees, 553 U.S. 35, 44 (2008). When

sodium thiopental became unavailable, states began using

pentobarbital, another barbiturate, instead. See Glossip v.

Gross, 576 U.S. 863, 871 (2015). Some states use

pentobarbital as part of a three-drug protocol, but others use it

as a single-drug protocol. Administrative Record at PDF 6.

The Bureau of Prisons also decided to use pentobarbital

after locating “a viable source” for the drug. Id. at PDF 9. It

elected a single-drug protocol because of the “complications

12

inherent in obtaining multiple drugs,” the superior “effien[cy]”

of acquiring and storing a single drug, and the “reduce[d] . . .

risk of errors” in administration of a single drug. Id. at PDF 7.

The protocol provides for three injections—two containing 2.5

grams of pentobarbital in 50 milliliters of diluent and the third

containing 60 milliliters of a saline flush. Id. at PDF 1075.

According to the Bureau, two medical experts whom it asked

to review its protocol concluded that it “would produce a

humane death.” Id. at PDF 8. The Supreme Court rejected an

as-applied challenge to Missouri’s one-drug pentobarbital

protocol last year. See Bucklew v. Precythe, 139 S. Ct. 1112

(2019). The Court held that the inmate at issue, who had a

medical condition he argued would prevent the drug from

working properly, failed to present a viable alternative to the

protocol, as required by its precedent. Id. at 1129-33; see also

id. at 1135-36 (Kavanaugh, J., concurring).

Plaintiffs in this case have presented evidence indicating

that use of pentobarbital in executions causes inmates to

experience “flash pulmonary edema,” a medical condition in

which fluid rapidly accumulates in the lungs, causing

respiratory distress and “sensations of drowning and

asphyxiation,” which in turn induce “extreme pain, terror and

panic” comparable to death by drowning. J.A. 346. Medical

experts cited by the plaintiffs have concluded based on autopsy

reports that it is very likely inmates will experience such pain

and distress before they are rendered insensate. Plaintiffs also

point to many autopsies revealing froth or foam trapped in the

airways, which they say demonstrates that edema began while

the deceased was still attempting to draw breath. J.A. 346-48.

And one of the plaintiffs’ experts found it is a “virtual medical

certainty that most, if not all, prisoners executed with a single

dose of pentobarbital . . . experienced ‘immediate, flash

pulmonary edema.’” J.A. 347.

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Plaintiffs have bolstered their claims with witness reports

from executions, J.A. 348, including those of Lee, Honken, and

Purkey, J.A. 122, as well as the results of an autopsy of Purkey,

concluding that all suggest those plaintiffs experienced

symptoms of pulmonary edema. The government has not

contested that most individuals who are executed through the

lethal injection of pentobarbital experience flash pulmonary

edema but they have submitted competing expert testimony

suggesting that the condition occurs only after the inmate has

been rendered insensate. One of its experts has stated that

“[t]here is no way to determine based on autopsy findings how

quickly the pulmonary edema occurred.” J.A. 121.

Allegations regarding flash pulmonary edema were not, we

note, before the Supreme Court in Bucklew.

II.

A.

The Plaintiffs challenge the district court’s dismissal

under Federal Rule of Civil Procedure 12(b)(6) of their Eighth

Amendment claims. Order at 5 n.1, In re FBOP, No. 19-mc-

145-TSC (D.D.C. Aug. 15, 2020), ECF No. 193; Order at 14–

15, In re FBOP, No. 19-mc-145-TSC (D.D.C. Sept. 20, 2020),

ECF No. 261. To survive a motion to dismiss under Rule

12(b)(6), the complaint must allege “sufficient factual matter,

accepted as true, to ‘state a claim to relief that is plausible on

its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting

Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). That

standard is met if the complaint’s factual allegations support a

“reasonable inference” that the defendant is liable for the

challenged conduct. Id. In evaluating the complaint, the court

must take as true all plausible factual allegations and

reasonable inferences drawn from them. Banneker Ventures,

LLC v. Graham, 798 F.3d 1119, 1129 (D.C. Cir. 2015).

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The Eighth Amendment sets a “high bar” for challenges to

the government’s mode of implementing the death penalty.

Barr v. Lee, 140 S. Ct. 2590, 2591 (2020) (per curiam). So to

properly make out an Eighth Amendment claim that the

government’s chosen method of execution is “cruel and

unusual,” U.S. CONST. AMEND. VIII, plaintiffs first must allege

that the execution method is “sure or very likely to cause

serious illness and needless suffering,” and “give rise to

sufficiently imminent dangers.” Glossip v. Gross, 576 U.S.

863, 877 (2015) (formatting modified; quoting Baze v. Rees,

553 U.S. 35, 50 (2008) (opinion of Roberts, C.J.)).

Specifically, the complaint must allege either a “substantial

risk of serious harm” that is “objectively intolerable,” or a

“demonstrated risk of severe pain.” Id. at 877–878 (internal

quotation marks omitted).

In addition, the complaint must show that the risk of this

harm is “substantial when compared to the known and

available alternatives.” Glossip, 576 U.S. at 878 (quoting Baze,

553 U.S. at 61 (opinion of Roberts, C.J.)). The Supreme Court

has described this inquiry as comparative—it is necessary to

identify when pain caused by a method of execution is

“gratuitous” given other methods available to the government.

Bucklew v. Precythe, 139 S. Ct. 1112, 1126 (2019).

Finally, the complaint must “identify an alternative”

method that “is feasible, readily implemented, and in fact

significantly reduce[s] a substantial risk of severe pain.”

Glossip, 576 U.S. at 877 (internal quotation marks omitted)

(quoting Baze, 553 U.S. at 52 (opinion of Roberts, C.J.)). If

the complaint makes each of those showings, the government

cannot refuse to implement the plaintiffs’ suggested alternative

without a legitimate penological reason. Bucklew, 139 S. Ct.

at 1125.

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Taking the factual allegations as true, the Plaintiffs’

amended complaint meets that strict test. The complaint and

incorporated declarations allege that, in the “vast majority, if

not all” executions using only pentobarbital, the large dosage

injected will cause flash pulmonary edema—the rapid

accumulation of fluid in the lungs. J.A. 345 ¶ 76, 347 ¶ 79.

More specifically, because of its high pH, pentobarbital is

corrosive. J.A. 345–346 ¶ 76. So when it makes physical

contact with the lungs, it dissolves natural barriers in the body,

causing bodily fluid to course into the airways. J.A. 346 ¶ 76.

As these fluids flood into the lungs, and as the individual

struggles to breathe, the edema creates a foam that fills and

blocks the airways. J.A. 346 ¶ 77. The body’s efforts to

dislodge the painful obstruction only compounds the

problem—the lungs’ effort to dislodge the foam merely causes

them to suck in even more fluid. J.A. 346 ¶ 77.

The complaint further alleges that the pulmonary edema

will occur “virtually instantaneously” upon administration of

the pentobarbital, J.A. 345 ¶ 76 (formatting modified), at a time

when the inmate is still “capable of feeling pain, terror, and

suffocation,” J.A. 347 ¶ 80. As a result, it is “extremely likely,”

to the point of “virtual medical certainty,” that “most, if not all,

prisoners will experience excruciating suffering, including

sensations of drowning and suffocation” during the lethal

injection process. J.A. 347 ¶ 80. That is so, the complaint

alleges, because barbiturates like pentobarbital “‘do not

guarantee lack of consciousness,” but instead can “produce[]

only unresponsiveness, not unconsciousness or lack of

awareness.” J.A. 345 ¶ 74. In that way, the lethal injection

procedure causes “extreme pain, terror and panic,” because

“[n]ot being able to breathe during drowning or asphyxiation is

one of the most powerful, excruciating feelings known” to

humans. J.A. 346 ¶ 78. While not necessary at the pleading

stage, the amended complaint plausibly substantiates its

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allegations with the declarations of multiple expert witnesses

and eyewitness testimony from executions that employed the

pentobarbital-only execution method. See, e.g., J.A. 345–350,

360–361.

The complaint adds that this extreme suffering could

easily be avoided by providing the inmate a pre-pentobarbital

dose of a pain-relieving anesthetic drug, such as, for example,

fentanyl, which is alleged to be readily available to the

government. J.A. 360–361 ¶ 114. According to the complaint,

the Bureau of Prisons itself has acknowledged that many

companies manufacture fentanyl in the United States and could

provide the drug for executions. J.A. 361 ¶ 114(a). In fact,

Plaintiffs allege that the Bureau of Prisons has located a

lawfully licensed compounding pharmacy that is both “able

and willing” to compound fentanyl for the Bureau as needed.

J.A. 361 ¶ 114(a).

Equally importantly, the complaint does not invoke a

novel or “untried and untested” mode of execution. Bucklew,

139 S. Ct. at 1130 (internal citations omitted). The

combination of drugs as part of lethal injection protocols has

been used by both states and the federal government, and is still

used in a number of jurisdictions. See, e.g., J.A. 384–388;

Glossip, 576 U.S. at 869. The two-drug protocol also fits

squarely within the plain text of the federal execution protocol,

which provides that the method of execution is the

“intravenous injection of a lethal substance or substances[.]”

28 C.F.R. § 26.3(a)(4). To be sure, Plaintiffs propose using

two drugs rather than the three drugs used in many capital-

punishment jurisdictions. But that change eases the logistics

of known protocols, and does so by adding a commonly used

and available pain reliever.

17

By pleading that the federal government’s execution

protocol involves a “virtual medical certainty” of severe and

torturous pain that is unnecessary to the death process and

could readily be avoided by administering a widely available

analgesic first, the Plaintiffs’ complaint properly and plausibly

states an Eighth Amendment claim. See Glossip, 576 U.S. at

877–878.

Whether Plaintiffs will ultimately be able to climb the

Eighth Amendment’s high constitutional mountain of proof is

not the question for today. See Bucklew, 139 S. Ct. at 1124

(noting that the Supreme Court “has yet to hold that a State’s

method of execution qualifies as cruel and unusual”). The only

issue before us it whether the Plaintiffs have plausibly alleged

the critical elements of a successful Eighth Amendment claim.

Plaintiffs’ complaint hurdles that bar.

B.

The district court’s dismissal of the complaint rested on

two critical legal errors.

First, the district court misread the Supreme Court’s per

curiam decision in Lee, 140 S. Ct. 2590, as holding that,

“absent particular medical circumstances, the use of

pentobarbital will withstand Eighth Amendment scrutiny, no

matter the evidence of excruciating pain.” Order at 5, Fed.

Bureau. of Prisons’ Execution Protocol Cases, No. 19-mc-

145-TSC (D.D.C. Aug. 15, 2020), ECF No. 193; see also Order

at 2, Fed. Bureau of Prisons’ Execution Protocol Cases, No.

19-mc-145-TSC (D.D.C. Nov. 3, 2020), ECF No. 305. The

district court, in other words, ruled that whatever pain is caused

by pulmonary edema arising from pentobarbital injections is a

type of pain that is categorically permissible under the Eighth

Amendment. The court added that, under its reading of Lee,

“no amount of new evidence will suffice to prove that the pain

18

pentobarbital causes reaches unconstitutional levels.” Order at

4, In re FBOP, No. 19-mc-145-TSC (D.D.C. Aug. 15, 2020),

ECF No. 193; Order at 14, In re FBOP, No. 19-mc-145-TSC

(D.D.C. Sept. 20, 2020), ECF No. 261.

Lee did not hold that the Eighth Amendment turns its back

on needless and extreme suffering as long as it is caused by

flash pulmonary edema. For starters, Lee involved an entirely

different legal question. The Supreme Court’s decision there

arose not out of a motion to dismiss, but Lee’s motion for a

preliminary injunction, which is “an extraordinary remedy that

may only be awarded upon a clear showing that plaintiffs are

entitled to such relief.” Winter v. Natural Res. Def. Council,

555 U.S. 7, 22 (2008). To obtain a preliminary injunction, Lee

had to show that he was “likely to succeed on the merits, that

he [was] likely to suffer irreparable harm in the absence of

preliminary relief, that the balance of equities tip[ped] in his

favor, and that an injunction [was] in the public interest.” Id.

at 20.

That is a decidedly far more searching inquiry than the

question of whether a complaint properly alleges a claim for

relief. There is nothing “extraordinary” about surviving a Rule

12(b)(6) motion to dismiss. Quite the opposite, the plaintiff

enjoys the benefit of having all plausible allegations and

reasonable inferences from those facts taken in favor of

sustaining the complaint. See Warth v. Seldin, 422 U.S. 490,

501 (1975); see Iqbal, 556 U.S. at 678. Nor must plaintiffs

show a likelihood of success at this stage. They simply must

show that their claim is plausible. Iqbal, 556 U.S. at 678.

That means that all we are deciding at this stage is whether

the complaint contains the necessary factual allegations to state

a legal claim for relief, and so to open the courthouse doors to

the Plaintiffs. That is a far distant inquiry from Lee’s request

19

that a court take the extraordinary step of affirmatively

proscribing a party’s behavior before adjudicating its rights.

Second, and relatedly, the court erred in concluding that

Lee forevermore categorically exempted the federal

government’s execution protocol from Eighth Amendment

scrutiny even if it were found to unnecessarily and

unreasonably inflict an “excruciating” death. Order at 5, Fed.

Bureau of Prisons’ Execution Protocol Cases, No. 19-mc-145-

TSC (D.D.C. Aug. 15, 2020), ECF No. 193. Indeed, the district

court went so far as to say that the Supreme Court in Lee “found

no viable Eighth Amendment challenge.” Order at 3, Fed.

Bureau of Prisons’ Execution Protocol Cases, No. 19-mc-145-

TSC (D.D.C. Nov. 3, 2020), ECF No. 305.

Not so. Nothing in the Supreme Court’s decision

purported to vastly overshoot the question of whether a stay of

execution should issue and entered a final ruling on the merits

of the case. Rather, all that the Supreme Court said in Lee was

that, under the demanding preliminary-injunction standard and

before any conclusive factual findings could be made in the

case, “competing expert testimony” over whether pulmonary

edema occurs before or after the inmate is rendered insensate

would not by itself support a “last-minute” stay of execution.

Lee, 140 S. Ct. at 2591. Nothing in that ruling addressed the

ability of a well-pleaded complaint to go forward for discovery

and fact finding in the normal course, and it certainly did not

sua sponte enter final judgment in the case. More to the point,

if the government’s pentobarbital protocol were constitutional

as a matter of law no matter what facts and science might show

and regardless of whether every element of an Eighth

Amendment violation were proven, there would have been no

need for the Court to even mention the government’s

competing evidence.

20

The government points to Baze, Glossip, and Bucklew as

establishing the constitutionality of its protocol as a matter of

law. But none of these cases involved the federal government’s

execution scheme see Baze, 553 U.S. at 40–41 (opinion of

Roberts, C.J.) (Kentucky death-penalty protocol); Glossip, 576

U.S. at 872–873 (Oklahoma death-penalty protocol), and

therefore those cases do not predetermine the outcome here.

Bucklew was an as-applied challenge to Missouri’s death-

penalty protocol arguing that the inmate’s unique medical

condition rendered the use of pentobarbital cruel and unusual

even in the absence of a viable alternative form of execution.

139 S. Ct. at 1121.

To be sure, those cases collectively mark out the difficult

task ahead for Plaintiffs on the merits. And the government is

correct (Br. 21) that, if all that Plaintiffs can produce at

summary judgment is a “scientific controvers[y]” between

credible experts battling between “marginally safer

alternative[s],” their claim is likely to fail on the merits. See

Baze, 553 U.S. at 51 (opinion of Roberts, C.J.). But not one of

those cases altered the rules governing a motion to dismiss and,

in fact, each one allowed the complaints to proceed past the

pleading stage. See Bucklew, 139 S. Ct. at 1129 (granting

summary judgment for the government after discovery);

Glossip, 576 U.S. at 874 (rejecting claim after discovery and

evidentiary hearing); Baze, 553 U.S. at 46 (opinion of Roberts,

C.J.) (rejecting claim after a “7-day bench trial”). Applying

settled law, we do the same.

Contrary to the district court’s suggestion, at this early

procedural stage of litigation, the Plaintiffs do not need to

prove entirely uniform scientific consensus or that every

execution carried out using pentobarbital in the past was

unconstitutional. See Order at 7, Fed. Bureau of Prisons’

Execution Protocol Cases, No. 19-mc-145-TSC (D.D.C. Nov.

21

3, 2020), ECF No. 305. Nor do they need to show a likelihood

of success on the merits. They only need to plausibly allege

that the government’s execution protocol will, without relevant

penological justification, impose a substantial risk of severe

pain and suffering that is needless given a readily available,

administrable, and known alternative. This complaint does

that. The Supreme Court has not said otherwise. The order of

dismissal is reversed.

C.

Plaintiffs Hall and Bernard also request that their stay be

granted on the grounds that they are likely to succeed on the

merits of their Eighth Amendment claim. Plaintiffs argue that

the holding in Lee was limited only to last-minute stays of

execution. This Court declined to enjoin a previous execution

based on the exact same Eighth Amendment claim Plaintiffs

put forward here. Order, In the Matter of the Fed. Bureau of

Prisons’ Execution Protocol Case, No. 20-5252 (D.C. Cir.

Aug. 25, 2020). Because Plaintiffs are unable to distinguish

that precedent, their request for a stay of execution based on

the Eighth Amendment claim is denied.

III.

A.

The district court granted the Plaintiffs partial summary

judgment on their claim that the government’s execution

protocol is contrary to law in violation of the Administrative

Procedure Act to the extent that it allows the dispensing and

injection of pentobarbital without the prescription required by

the FDCA, 21 U.S.C. § 353(b)(1)(B); see also Memorandum

Opinion at 32-33, In re FBOP, No. 19-mc-145 (D.D.C. Sept.

20, 2020), ECF No. 261; Memorandum Opinion at 6-10, In re

FBOP, No. 19-mc-145 (D.D.C. Aug. 27, 2020), ECF No. 213.

22

At the same time, the district court denied Plaintiffs’ motion to

enjoin their executions pending the government’s compliance

with the FDCA on the ground that they had not shown a

likelihood of suffering irreparable harm due to the absence of

a prescription. On appeal, the Plaintiffs argue that the court

erred in failing both to set aside the Protocol and to enjoin the

government from conducting plaintiffs’ executions without

first complying with the FDCA. The government, for its part,

argues that the FDCA does not apply to the dispensing and

administration of drugs for lethal injection and that the

Plaintiffs lack a cause of action to enforce the FDCA. We agree

that the district court should have ordered the protocol set aside

only to the extent that it permits the dispensing and

administration of pentobarbital without a prescription. But we

deny the Plaintiffs’ request for an injunction and the

government’s arguments, without having filed a cross-appeal,

that the district court’s FDCA holding should be reversed.

There is no dispute that pentobarbital is a drug regulated

under the FDCA. See 21 U.S.C. § 321(g)(1). Nor is there any

dispute that pentobarbital is the type of drug that the FDCA

requires to be dispensed only through a prescription issued by

a licensed medical professional. 21 U.S.C. § 353(b)(1)(B); see

21 C.F.R. Part 1306.1 There likewise is no question that

prisoners are generally entitled to the protections of the

FDCA’s prescription requirement. See 21 C.F.R. § 1301.23

(exempting Bureau of Prisons officials from registration

requirement, while recognizing their obligations to comply

1

A number of state laws protect their medical professionals

who write prescriptions for FDCA-covered drugs to be used as part

of an execution protocol. See, e.g., GA. CODE ANN. § 42-5-36(d)(2);

TENN. CODE ANN. § 10-7-504(h)(1); TEX. CRIM. PRO. CODE

§ 43.14(b).

23

with regulations governing the issuance and filling of

prescriptions under 21 C.F.R. Part 1306).

The government nevertheless argues that when

pentobarbital is dispensed and administered to a prisoner as

part of a lethal injection, the FDCA falls away, invoking the

Supreme Court’s decision in Gonzales v. Oregon, 546 U.S. 243

(2006), and FDA v. Brown & Williamson Tobacco Corp., 529

U.S. 120, 133 (2000). The Supreme Court has never resolved

“the thorny question of the FDA’s jurisdiction” over the drugs

used in lethal injections. Heckler v. Chaney, 470 U.S. 821, 828

(1985). But binding precedent in this circuit has. See Cook v.

FDA, 733 F.3d 1 (D.C. Cir. 2013) (applying the FDCA’s

regulation of drug imports to a lethal injection drug); Chaney

v. Heckler, 718 F.2d 1174, 1179-1182 (D.C. Cir. 1983), rev’d

on other grounds, 470 U.S. 821 (1985); Beaty v. FDA, 853 F.

Supp. 2d 30, 42-43 (D.D.C. 2012) (holding that the Food and

Drug Administration’s failure to apply the FDCA to lethal

injection drugs “undermined the purpose of the [statute] and

acted in a manner contrary to the public health,” with the

consequence that “prisoners on death row have an unnecessary

risk that they will not be anesthetized properly prior to

execution”), aff’d in relevant part, 733 F.3d 1 (D.C. Cir. 2013).

That precedent binds this panel. See LaShawn A. v. Barry, 87

F.3d 1389, 1395 (D.C. Cir. 1996) (en banc).

The government also argues that the FDCA does not

provide the inmates a right of action. That may well be true.

But the Plaintiffs have sued under the APA, which entitles any

person “suffering legal wrong because of agency action” to

judicial review. 5 U.S.C. § 702. And binding circuit precedent

recognizes that the APA provides a cause of action to review

agency action in violation of the FDCA. See Cook, 733 F.3d

at 10-11; Purepac Pharm. Co. v. Thompson, 354 F.3d 877,

884–885 (D.C. Cir. 2004) (quoting Purepac Pharm. Co. v.

24

Thompson, 238 F. Supp. 2d 191, 212 (D.D.C. 2002)). The

government also argues that 21 U.S.C. § 337 allows only the

government to bring an enforcement proceeding. An APA suit

to review agency action unlawfully taken against an individual

is not a civil enforcement action, and that provision does not

provide the type of comprehensive review scheme for those

adversely affected by agency action that would displace the

APA. See Cook, 733 F.3d at 10-11. See generally Guerrero-

Lasprilla v. Barr, 140 S. Ct. 1062, 1069 (2020) (“Consider first

a familiar principle of statutory construction: the presumption

favoring judicial review of administrative action.”) (citation

and internal quotation marks omitted).

The Bureau of Prisons does not dispute that it fails to

obtain prescriptions for the pentobarbital used in executions,

nor does it deny that it does not intend to obtain prescriptions

for the upcoming executions. Because, under binding circuit

precedent, the FDCA applies when already-covered drugs like

pentobarbital are used for lethal injections, the execution

protocol as administered by the Federal Bureau of Prisons is

“not in accordance with law” to the extent that it allows the

dispensation and administration of pentobarbital without a

prescription and must be “set aside” in that respect. 5 U.S.C. §

706(2).

B.

The district court, however, was correct to deny the entry

of a permanent injunction. Success on an APA claim does not

automatically entitle the prevailing party to a permanent

injunction. Instead, the party must demonstrate that (i) “it has

suffered an irreparable injury,” (ii) “remedies available at law

* * * are inadequate to compensate for that injury,” (iii) the

balance of hardships weighs in favor of an injunction, and (iv)

“the public interest would not be disserved by a permanent

25

injunction.” Monsanto Co. v. Geertson Seed Farms, 561 U.S.

139, 156-157 (2010) (quoting eBay Inc. v. MercExchange,

L.L.C., 547 U.S. 388, 391 (2006)). To obtain an injunction,

then, the prevailing party must demonstrate that it actually “has

suffered,” id., or is “likely to suffer irreparable harm,” Winter

v. Natural Resources Defense Council, Inc., 555 U.S. 7, 20

(2008). The district court specifically found, however, that

“the evidence in the record does not support Plaintiffs’

contention that they are likely to suffer flash pulmonary edema

while still conscious,” Order at 39, In re FBOP, 1:19-mc-145-

TSC (D.D.C. Sept. 20, 2020), ECF No. 261. The Plaintiffs

have not identified before the district court or this court any

other type of irreparable harm that would likely be suffered due

to the unprescribed use of pentobarbital.

IV.

We hold that the district court did not err in granting

summary judgment for the government on Plaintiffs’ Federal

Death Penalty Act (“FDPA”) claim. 2 Plaintiffs had pointed to

several alleged discrepancies between the 2019 Protocol and

state statutes dictating different methods of execution or

aspects of the execution process. Memorandum Opinion at 27-

28, In re FBOP, 19-mc-145 (D.D.C. Sept. 20, 2020). The

district court concluded that there was no conflict in this case,

2

The government maintains that this court lacks jurisdiction to

review the district court’s order granting summary judgment because

the district court had not, at the time of the notice of appeal, entered

final judgment on its FDPA ruling. The district court has since

entered partial final judgment on Plaintiffs’ FDPA claim. Order, In

re FBOP, No. 19-mc-145-TSC (D.D.C. Nov. 16, 2020), ECF No.

315. A Rule 54(b) judgment rendered after notice of appeal is filed

is jurisdictionally permissible under our precedents. See, e.g., Outlaw

v. Airtech Air Conditioning & Heating Inc., 412 F.3d 156 (D.C. Cir.

2005).

26

either because the government had committed to complying

with the state statutes at issue or because no plaintiff had

requested to be executed in accordance with them. Id. at 30-

31. Upon a motion for reconsideration, the district court

affirmed that decision, pointing out that Hall’s request to be

executed after 6 p.m. in accordance with Texas law had been

granted so “Plaintiffs [had] failed to identify a statutory

violation.” Order at 9, In re FBOP, 19-mc-145 (D.D.C. Nov.

11, 2020). We agree.

In this expedited process, we are particularly mindful to

decide no more than what is necessary to resolve the appeal.

The government here argues that the district court erred in

concluding that the Texas time-of-day provision is

incorporated under the FDPA because this provision is not a

“procedure[] that effectuate[s] the death.” Appellee Br. 48

(quoting In re FBOP, 955 F.3d 106, 151 (D.C. Cir. 2020)

(Tatel, J., dissenting)). As we agree with the district court that

there is no live controversy, we find it unnecessary here to

engage in a line-drawing exercise about whether a statute

setting the time of execution is a procedure that implements

“the sentence in the manner prescribed by the law of the State

in which the sentence is imposed.” 18 U.S.C. § 3596(a).

Plaintiffs are correct that non-binding statements by a

defendant are generally insufficient to moot an otherwise active

controversy. See United States v. W. T. Grant Co., 345 U.S.

629, 633 (1953) (“Such a profession does not suffice to make

a case moot although it is one of the factors to be considered in

determining the appropriateness of granting an injunction

against the now-discontinued acts.”). But here we have not

only a governmental agreement to comply, but also the absence

of any concretely aggrieved plaintiff. Nonetheless, the

government has affirmed it will comply with the Texas statute

at issue and so Hall’s request to be executed after 6 p.m. has

27

been granted. J.A. 135. It does not appear that Bernard has

made the same request, but the government has indicated it will

consider the request if made. In a case where no plaintiff has

asserted a present denial of a desired state procedure, the mere

possibility that the government may not comply with state

procedures, without more, is insufficient to establish a statutory

violation of the FDPA. Cf. United States v. Mitchell, 971 F.3d

993, 999 (9th Cir. 2020) (“It is not enough to show a ‘mere

possibility’ that the Bureau of Prisons might use protocols

inconsistent with [state] procedures.” (citation omitted)).

* * *

For the foregoing reasons, the judgment of the district

court is affirmed in part, reversed in part, and remanded for

further proceedings consistent with this opinion.

So ordered.

PILLARD , Circuit Judge, concurring in part and dissenting

in part: The court correctly holds that, because the 2019

Protocol calls for the use of pentobarbital unaccompanied by

an FDCA-mandated prescription, it must be set aside as

contrary to law under the APA. That conclusion alone requires

a stay of the pending executions until the government complies.

It is the government’s prerogative to execute the plaintiffs by a

method of its choosing. But if it elects a method subject to

statutory requirements, the government must then abide by

those requirements. The government could choose to execute

plaintiffs by firing squad, for instance, assuming the method

remained permissible under the Eighth Amendment. But if a

federal statute required that members of a firing squad first be

certified marksmen, the government could not execute a death

row inmate until it ensured that the members of its firing squad

were so certified.

Even if equitable relief is not necessary to pause the

upcoming executions, however, it is my view that the district

court also erred in denying plaintiffs an injunction preventing

defendants from continuing to violate the FDCA. The district

court denied the injunction for want of irreparable harm, and

my colleagues affirm. Because I believe that error is of

continued importance, I dissent from Part III.B of the opinion.

The FDCA is protective legislation. See POM Wonderful

LLC v. Coca-Cola Co., 573 U.S. 102, 115 (“[T]he FDCA

protects public health and safety.”). Its statutory safeguards

exist to ensure that drugs are correctly administered and their

potential adverse effects minimized, in light of current medical

knowledge and the circumstances of the individual. See Brown

& Williamson, 529 U.S. at 134 (noting FDA’s mission includes

“protect[ing] the public health by ensuring that . . . drugs are

safe and effective” (citation omitted)). Its applicability does

not depend on specific vulnerabilities of the recipients of

controlled substances. Rather, it categorically imposes safety

procedures to mitigate risk of bodily harm from the

2

administration of powerful medications with complex

characteristics. Included among the statute’s protections is its

requirement that some drugs be dispensed only with a

prescription from a medical professional. The government’s

decision to ignore such statutory protections subjects those

affected to substantial and unnecessary risks of bodily injury,

illness, and suffering. Unlike commercial harms, which are

readily remedied by damages, harms to the body have long

been treated as irreparable. Set aside for a moment the fact that

the Plaintiffs here are on death row and that the medication at

issue is intended to be used in lethal injections. A plan by the

government to inject anyone with therapeutic, non-lethal drugs

disbursed and administered in violation of the FDCA would

pose precisely the type of health risks that the FDCA is

intended to prevent. The fact that the government here

proposes to engage in this conduct in the context of executions

does not change the calculus—there remains the irreparable

harm that is inherent in the administration of barbiturates

without medical guidance. Certain risks against which the

FDCA’s requirements would ordinarily shield, like those to

future health, are not relevant once an inmate is executed. But

risks of potential physical degradation and a painful and

prolonged dying process could be minimized were the

government to follow the FDCA’s mandates.

The district court did not question the type of harm in this

case; after all, the Plaintiffs painted quite a clear picture of the

damage flash pulmonary edema can do to an inmate during

execution, and presented expert evidence that that damage is

done while an inmate is still sensate. What the district court

questioned was the likelihood of that harm. At one point in the

court’s order denying Plaintiffs their injunction, it faulted them

for failing to show “that they will suffer irreparable injury,”

Order at 35, In re FBOP, 19-mc-145 (D.D.C. Sept. 20, 2020)

(quoting Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139,

3

162 (2010)). Later it suggested the problem was that they had

not shown the harm was sufficient likely. But “[i]n the context

of safety regulations, risk is itself the harm prohibited by law.

Exposure to that harm thus is irreparable injury.” Nat’l Ass’n

of Farmworkers Orgs. v. Marshall, 628 F.2d 604, 614 & n. 39

(D.C. Cir. 1980). Consider an official agency policy of sending

truck drivers out onto the roads without seatbelts, or of serving

meats to employees stored at a temperature below what federal

regulations require. In either of these cases the agency would

be subject to an injunction without a further evidentiary

showing of how likely it was that the drivers or diners were to

be injured. Where a legal mandate protecting bodily health and

safety is concerned, the law itself reflects the regulatory or

legislative judgment that the driver and the diner are likely to

suffer harm if that mandate is ignored.

I thus disagree that a certain showing of any one specific

risk is required before a court can enjoin the government from

continuing to disregarding health- and safety-related mandates.

But assuming the Plaintiffs did have to show that the risks they

expect to face from the government’s refusal to comply with

the FDCA, the record suggests the district court may

erroneously equated the showing of irreparable harm sufficient

to enjoin a violation of the FDCA with the showing needed to

support injunctive relief on Eighth Amendment grounds.

Before the Supreme Court’s July decision in Barr v. Lee, 140

S. Ct. 2590 (2020), the district court found that Plaintiffs’

evidence on the complaint alone “overwhelmingly indicate[d]

that the 2019 Protocol is very likely to cause Plaintiffs extreme

pain and needless suffering during their executions.”

Memorandum Opinion at 9-10, In re FBOP, 19-mc-145

(D.D.C. July 13, 2020), ECF No. 135. The court cited

Plaintiffs’ experts’ declarations demonstrating “that the

majority of inmates executed via pentobarbital injection

suffered flash pulmonary edema during the procedure.”

4

Memorandum Opinion at 9-10, In re FBOP, 19-mc-145

(D.D.C. July 13, 2020), ECF No. 135. Recognizing the key

issue as timing—whether the inmates could feel the effects of

flash pulmonary edema, as Plaintiffs alleged, or whether they

were insensate when it occurred, as the government argued—

the district court concluded the Plaintiffs had the better of the

evidence. Id. at 12. Only after the Supreme Court vacated a

preliminary injunction on Plaintiffs’ Eighth Amendment claim

did the district court find that Plaintiffs had failed to show

irreparable harm. The court did initially enter an injunction on

the FDCA violation, but it failed in that order to discuss

irreparable harm, and we remanded its order on that ground that

same day. The court then held an evidentiary hearing on the

issue of irreparable harm and denied the injunction for want of

a showing that Plaintiffs were “likely” to suffer flash

pulmonary edema. Memorandum Opinion at 36, In re FBOP,

19-mc-145 (D.D.C. Sept. 20, 2020), ECF No. 261. Even then,

however, the court “continue[d] to be concerned at the

possibility that inmates will suffer excruciating pain during

their executions.” Id. at 36.

If the district court treated as interchangeable the

evidentiary requirements for an injunction under the

Constitution and the statute, that was legal error. According to

Supreme Court precedent, the Eighth Amendment sets a

constitutional floor on the pain and degradation to which a

death row inmate may be subjected during an execution; it does

not guarantee a prisoner a painless death. Bucklew v. Precythe,

139 S. Ct. 1112, 1124 (2019). The purpose of the statutory

protections of the FDCA, in contrast, is to guard patients from

various risks that medical guidance and supervision might

eliminate. Thus, even where harms are not unconstitutional

under the Eighth Amendment, they may nonetheless give rise

to statutory violations under the FDCA entitling plaintiffs to

redress. On their Eighth Amendment claim, plaintiffs must

5

demonstrate that their method of execution involves a

“substantial risk of severe pain.” Glossip v. Gross, 576 U.S.

863, 882 (2015). This necessarily means the Eighth

Amendment permits at least methods of execution that impose

a less-than-substantial risk of pain. But no similar threshold

applies under the FDCA. Thus, while the evidence of flash

pulmonary edema the plaintiffs brought to bear on their Eight

Amendment claim may also bear on their FDCA claim, the

statute guards against the risks of avoidable pain at lower levels

as well.

I believe that the risk of harm flowing from the FDCA

violation in this case readily meets the threshold for irreparable

injury. In any event, the record suggests that the district court

may have applied the threshold of expected harm required for

an Eighth Amendment injunction to deny the injunction under

the FDCA. Rather than affirming the denial of the FDCA

injunction, we should have clarified the distinction and

remanded to give the court an opportunity to reconsider

whether the record supports enjoining the FDCA violation.

The government further asserts that, even assuming

Plaintiffs have shown irreparable harm, the balance of equities

and public interest weigh against an injunction barring them

from executing additional Plaintiffs pending compliance with

the FDCA. The district court did not reach these equities, but

they merit comment as an important and recurring aspect of the

plaintiffs’ method-of-execution challenges.

The public interest as the government contends sees it

requires adherence to the current execution schedule. Appellee

Br. 39-40. It is our responsibility as courts “to ensure that

method-of-execution challenges to lawfully issued sentences

are resolved fairly and expeditiously.” Barr v. Lee, 140 S. Ct.

2590, 2591 (2020) (citation omitted). But Plaintiffs have thus

6

far pressed their concededly nonfrivolous claims with dispatch,

and the government has made no showing of delay that will

result if they comply with the FDCA.

The government suggests that Plaintiffs’ challenges “have

already been the subject of multiple rounds of litigation,” id. at

7, but the “rounds of litigation” to which it refers were the result

of a series of individual plaintiffs each seeking to enjoin

executions scheduled to take place before resolution of the

merits of their promptly and plausibly pleaded claims.

Plaintiffs sought those injunctions precisely so that they would

have an opportunity to litigate their claims. The particular

method of execution plaintiffs would face—including the

extent to which it would be determined by state law—was only

quite recently determined, see In re FBOP Protocol Cases, 955

F.3d at 110-11, and we recognized when we resolved those

claims under the FDPA and APA that, “regardless of our

disposition, several claims would remain open on remand.” Id.

at 113. Three of those claims are now before us. It is difficult

to see what more plaintiffs might have done to obtain earlier

rulings on the merits of their claims. Time that the government

and the courts have reasonably required cannot weigh against

plaintiffs’ entitlement to a permanent injunction. And, for its

part, the government has not introduced any evidence that it

would be unable promptly to obtain a prescription if it sought

to do so.

The public interest that the sentences be promptly carried

out must be weighed against the public interest in adhering to

applicable legal requirements, including the FDCA’s controls

on drug administration. And the Plaintiffs have aligned

interests in avoiding the elevated risks of severe and gratuitous

pain from administration of pentobarbital absent the requisite

statutory safeguards. On this record, it would appear that

Plaintiffs’ interest in avoiding those elevated risks outweighs

7

the government’s interest in proceeding with the executions as

scheduled without obtaining the required prescriptions.

For these reasons, I would have reversed and remanded the

district court’s decision to deny injunctive relief for the FDCA

violation.

RAO, Circuit Judge, concurring in part, concurring in the

judgment, and dissenting in part: The district court held that the

government’s decision to administer pentobarbital for lethal

injections without a prescription violates the Federal Food,

Drug & Cosmetic Act (“FDCA”) and so is contrary to law

under the Administrative Procedure Act (“APA”). The district

court also dismissed Plaintiffs’ Eighth Amendment claim for

failure to state a claim and granted summary judgment to the

government on Plaintiffs’ Federal Death Penalty Act

(“FDPA”) claim. The majority properly vacates the district

court’s dismissal of the Eighth Amendment claim and affirms

the grant of summary judgment on the FDPA claim. The

majority then concludes that binding circuit precedent

mandates the application of the FDCA to drugs administered

for capital punishment and orders the district court to set aside

the Protocol under the APA until the government procures

prescriptions for the lethal injection drugs. I disagree that this

conclusion is required by our precedent. Moreover, application

of the FDCA to drugs used in lethal injections is inconsistent

with the statutory text and the Supreme Court’s decision in

FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120

(2000). In any event, Plaintiffs have no authority to challenge

the Food and Drug Administration’s decision not to enforce the

FDCA in this context. See Heckler v. Chaney, 470 U.S. 821,

837–38 (1985). Accordingly, I respectfully concur in part,

concur in the judgment, and dissent in part.

***

I agree with the majority that the district court correctly

granted summary judgment for the government on the FDPA

claim. I also concur in the judgment that the district court erred

when it dismissed Plaintiffs’ Eighth Amendment claim for

failure to state a claim, FED. R. CIV. P. 12(b)(6). Plaintiffs

needed only to plead factual allegations, accepted as true,

sufficient to state a plausible claim that the government’s

protocol violates the Eighth Amendment. See Ashcroft v. Iqbal,

2

556 U.S. 662, 678 (2009); accord Bell Atl. Corp. v. Twombly,

550 U.S. 544, 555 (2007). To constitute a violation of the

Eighth Amendment based on the method of execution, the

Supreme Court has held a plaintiff must establish that the

method creates “a demonstrated risk of severe pain” and

propose “an alternative that is feasible, readily implemented,

and in fact significantly reduces a substantial risk of severe

pain.” Glossip v. Gross, 576 U.S. 863, 877–78 (2015) (cleaned

up).

Plaintiffs’ pleadings, taken as true, plausibly support the

claim that the use of pentobarbital poses a demonstrated risk of

severe pain. Yet after the Supreme Court held that Plaintiffs

were unlikely to succeed on the merits of this claim in the

context of preliminary injunctive relief, see Barr v. Lee, 140 S.

Ct. 2590 (2020) (per curiam), the district court took that as a

suggestion that the claim would fail and dismissed it. To be

sure, Plaintiffs face an exceptionally high bar to succeed on the

merits of their method-of-execution claim, as no such claim has

yet to succeed at the Supreme Court. See Bucklew v. Precythe,

139 S. Ct. 1112, 1124 (2019); see also Glossip, 576 U.S. 877;

Baze v. Rees, 553 U.S. 35 (2008). The Court has warned

against “transform[ing] courts into boards of inquiry charged

with determining ‘best practices’ for executions, with each

ruling supplanted by another round of litigation touting a new

and improved methodology.” Baze, 553 U.S. at 51. In the

current round of this litigation, it remains to be seen whether

Plaintiffs can prevail on the merits of their Eighth Amendment

claim, but the district court erred by dismissing the claim at the

pleading stage. Because little more need be said on this error, I

concur only in the judgment with respect to this issue.

3

***

I dissent with respect to the majority’s holding that the

2019 Protocol should be set aside to the extent that it permits

the use of pentobarbital for executions without a prescription.

While we are bound by previous decisions of our circuit, no

case conclusively holds that the FDCA regulates drugs when

used for lethal injection in the course of an otherwise lawful

execution. The majority relies on Cook v. FDA, 733 F.3d 1

(D.C. Cir. 2013); however, that case did not resolve the

question of whether the FDCA applies to lethal injection drugs.

Rather in Cook, the court accepted the FDA’s concession that

an imported lethal injection drug was an “unapproved new

drug,” and used that concession to conclude that the FDA was

required to refuse admission to any foreign drug that appeared

to violate FDCA provisions on misbranded and unapproved

new drugs. See id. at 11 (cleaned up). Thus, we merely assumed

the applicability of the FDCA to lethal injection drugs in the

context of the FDA’s enforcement obligations over foreign

drugs imported to the United States. An assumption cannot

bind us on this important question of statutory interpretation.1

See, e.g., Cooper Indus., Inc. v. Aviall Servs., Inc., 543 U.S.

157, 170 (2004) (“Questions which merely lurk in the record,

neither brought to the attention of the court nor ruled upon, are

1

Neither am I persuaded by the district court’s analysis of the

question in Cook’s underlying proceeding, Beaty, 853 F. Supp. 2d at

42. The district court’s holding that, by declining to apply the FDCA

to lethal injection drugs, the FDA had “undermined the purpose of

the [statute] and acted in a manner contrary to the public health,” id.,

significantly expanded the agency’s jurisdiction, but did not explain

how application of the FDCA to drugs obtained for lethal injection

is consistent with the text of the FDCA and Supreme Court

precedent.

4

not to be considered as having been so decided as to constitute

precedents.”) (quoting Webster v. Fall, 266 U.S. 507, 511

(1925)). Earlier in this litigation, this court concluded that the

applicability of the FDCA was a necessary premise of the Cook

decision. See In re Federal Bureau of Prisons’ Execution

Protocol Cases, No. 20-5206, slip op. at 3 (D.C. Cir. July 15,

2020). The district court had stayed Plaintiffs’ executions,

holding that they had demonstrated a likelihood of success on

the merits of their FDCA claims; we refused to allow one of

the executions to move forward, denying the government’s

motion for a stay pending appeal. Id. at 2. This court did not

explicitly hold that the FDCA applies to drugs used in lethal

injections. Instead, in the context of assessing whether the

government had established a likelihood of success on the

merits, we suggested that the government had not met the high

bar to establish that Brown & Williamson should prevent the

application of the FDCA. Id. at 3. The next day, the Supreme

Court vacated the district court’s injunction without comment.

Barr v. Purkey, No. 20A10, 2020 WL 4006821, at *1 (U.S.

July 16, 2020).

The majority also relies on this court’s holding in Chaney

v. Heckler for the proposition that the FDA has jurisdiction

over drugs used for lethal injection. 718 F.2d 1174, 1179–82

(D.C. Cir. 1983), rev’d, 470 U.S. at 838. Even if the Supreme

Court declined to resolve this question explicitly in Heckler,

470 U.S. at 828, our court’s jurisdictional finding was based on

the understanding that “Congress clearly intended that the

[FDCA’s] ‘coverage be as broad as its literal language

indicates,’” Chaney, 718 F.2d at 1179 (citation omitted). Our

literal and expansive reading of the FDA’s jurisdiction in

Chaney conflicts with the Supreme Court’s later decision in

Brown & Williamson, which rejected a broad assertion of

jurisdiction by the FDA over tobacco products and cautioned

courts to read statutes in the context of other enacted laws to

5

ensure “a symmetrical and coherent regulatory scheme.”

Brown & Williamson, 529 U.S. at 133 (citation omitted). In

sum, none of our earlier decisions mandate that we interpret the

FDCA to require a prescription for the government’s use of

pentobarbital for lethal injections.

Therefore, I would proceed to address the statutory

question directly. The government vigorously contests the

applicability of the FDCA to drugs used in lethal injections, a

question with significant implications for the administration of

the death penalty by federal and state governments. The

government maintains that, when a drug’s intended use is to

effectuate capital punishment by the federal government or a

state, it is not subject to regulation under the FDCA. Appellees’

Br. 26 (citing Whether the FDA Has Jurisdiction over Articles

Intended for Use in Lawful Executions, slip op. O.L.C., 2019

WL 2235666 (May 3, 2019)). Squarely faced with a dispute

over the meaning of the statute, I would proceed to interpret

the text of the FDCA in a manner that comports with its

structure and history, other significant laws enacted by

Congress, and binding Supreme Court precedent. See Brown &

Williamson, 529 U.S. at 133.

First, the FDCA grants the FDA the authority to regulate

all “drugs” and “devices,” which include, among other things,

any “articles (other than food) intended to affect the structure

or any function of the body.” 21 U.S.C. § 321(g)(1)(C). While

the FDA’s authority is expansive, it is not without limit. The

Supreme Court has explained that we must understand this

broad authority in light of specific provisions of the FDCA, as

well as other statutory frameworks that might preclude

jurisdiction even when it would otherwise appear to be

included in the literal meaning of the FDCA. See Brown &

Williamson, 529 U.S. at 133 (“[T]he meaning of one statute

may be affected by other Acts, particularly where Congress has

6

spoken subsequently and more specifically to the topic at

hand.”).

Here, applying the requirements of the FDCA to lethal

injection drugs does not cohere with the text and structure of

the whole statute. In particular, Plaintiffs seek to require the

government to obtain a prescription for the use of execution

drugs. Section 353 of the FDCA, which requires an oral or

written prescription for “[a] drug intended for use by man

which (A) because of its toxicity or other potentiality for

harmful effect, or the method of its use, or the collateral

measures necessary to its use, is not safe for use except under

the supervision of a practitioner licensed by law to administer

such drug; or (B) is limited by an approved application under

section 355 of this title to use under the professional

supervision of a practitioner licensed by law to administer such

drug.” 21 U.S.C. § 353(b)(1)(A)–(B) (emphasis added). This

language makes clear that the prescription requirement is

designed with the therapeutic benefit of the patient in mind.

The other relevant provisions identified by the district court—

premarket approval by the FDA and labeling requirements—

share this focus. Each of these provisions serves to protect the

public by ensuring that a product is safe for its intended

therapeutic use. Indeed, the Supreme Court has recognized that

the FDCA “generally requires the FDA to prevent the

marketing of any drug or device where the potential for

inflicting death or physical injury is not offset by the possibility

of therapeutic benefit.” Brown & Williamson, 529 U.S. at 134

(cleaned up); see also United States v. Rutherford, 442 U.S.

544, 555 (1979) (“[T]he Commissioner generally considers a

drug safe when the expected therapeutic gain justifies the risk

entailed by its use.”).

By contrast, drugs used for the purpose of lethal injection

have a certainty of inflicting death. There is no corresponding

7

therapeutic benefit of a drug used to administer a lethal

injection in the context of capital punishment. To apply the

FDCA’s careful balancing of therapeutic risks and benefits to

execution drugs would distort the Act’s framework.

Moreover, such an expansive application of the FDCA

would run headlong into the numerous statutes Congress has

enacted providing for capital punishment. Since 1790,

Congress has authorized the death penalty for various

violations of federal law. See, e.g., An Act for the Punishment

of Certain Crimes § 33, 1 Stat. 112, 119 (Apr. 30, 1790); see

also Act of June 19, 1937, ch. 367, 50 Stat. 304, 304 (repealed

1984). Most recently, Congress enacted the Federal Death

Penalty Act of 1994, which reestablished the federal death

penalty and provides for the U.S. marshal to “supervise

implementation of the sentence in the manner prescribed by the

law of the State in which the sentence is imposed.” 18 U.S.C.

§ 3596(a). In 1994, as today, lethal injection is one of the most

common methods of execution and, in many States, the

exclusive method of execution. The 1994 Act unambiguously

assumes the continued availability of drugs necessary for

execution by lethal injection.

The general terms of the FDCA cannot be reconciled with

this separate and distinct scheme for capital punishment,

reenacted by Congress against a background of expanding use

of lethal injection by the States. See Brown & Williamson, 529

U.S. at 137 (finding relevant to the analysis that Congress had

“foreclosed the removal of tobacco products from the

market”). The majority’s interpretation of the FDCA creates a

significant and entirely novel impediment to this method of

capital punishment, not only for federal executions, but also for

State executions. Yet the Supreme Court has repeatedly upheld

lethal injection as a constitutional method of execution. See,

e.g., Baze v. Rees, 553 U.S. 35, 40–41 (2008) (explaining that

8

the progress of states towards a more humane method of capital

punishment “has led to the use of lethal injection by every

jurisdiction that imposes the death penalty”).

Furthermore, the FDA’s longstanding policy of declining

jurisdiction over lethal injection drugs reinforces the propriety

of not extending the FDCA’s requirements here. See Brown &

Williamson, 529 U.S. at 146. The FDCA was enacted in 1938,

Act of June 25, 1938, ch. 675, 52 Stat. 1040, and lethal

injection has been used as a method of execution since the

1970s. From the first use of otherwise FDA-approved drugs in

capital punishment, the FDA has not attempted to exercise

jurisdiction over drugs or devices intended to carry out lawful

sentences of capital punishment.2 This commonsense approach

is consistent with the overarching purpose of the FDCA—to

ensure that drugs and devices in interstate commerce are safe

and effective for their intended uses. The intended use of a drug

or device in the capital punishment context is to end human

life. It is “implausible … that the FDA is required to exercise

its enforcement power to ensure that States only use drugs that

2

After Beaty entered an injunction requiring the FDA to block

foreign shipments of sodium thiopental, in 2015, the FDA blocked

Texas’s attempt to import the drug for use in capital punishment. See

Letter from Todd W. Cato, Director, Southwest Import District

Office at 1–2 (Apr. 20, 2017). The FDA expressly asserted

jurisdiction over lethal injection drugs for the first time, but its

decision was premised on the fact that Texas conceded that the

sodium thiopental was a “drug” within the meaning of the FDCA,

and that the “FDA is bound by the terms of the order issued” in

Beaty. Id. The government’s more recent, considered position is

reflected in the 2019 Office of Legal Counsel Memorandum,

Whether the FDA Has Jurisdiction over Articles Intended for Use in

Lawful Executions, slip op. O.L.C., 2019 WL 2235666 (May 3,

2019).

9

are ‘safe and effective’ for human execution.” Heckler, 470

U.S. at 827.

The district court here held that when “the government

argues that a lethal injection drug is legally and constitutionally

permissible because it will ensure a ‘humane’ death, it cannot

then disclaim a responsibility to comply with federal statutes

enacted to ensure that the drugs operate humanely.” J.A. 558.

This appears to conflate the general requirement that

executions comport with the Eighth Amendment with the

purpose of the FDCA to ensure that a product’s anticipated

therapeutic benefit outweighs its risk of harm. See Brown &

Williamson, 529 U.S. at 140. The fact that executions should

be carried out in a humane manner does not mean the FDCA

applies. I express no opinion on the policy arguments regarding

the purported advantages of requiring a prescription for lethal

injection drugs—I simply do not think the FDCA includes such

a requirement. Therefore Congress, rather than the courts, must

decide how to resolve such policy questions in the sensitive

area of capital punishment.

***

Even if the FDCA applied in this case, these Plaintiffs

cannot challenge the FDA’s nonenforcement decision. As the

Court held in Heckler, the “FDA’s decision not to

take … enforcement action[]” to prevent the use of drugs

intended for use in lethal injection is “not subject to judicial

review under the APA.” 470 U.S. at 837–38. The FDCA

specifically confers such enforcement authority on the

government. See 21 U.S.C. § 337(a) (“[A]ll such proceedings

for the enforcement, or to restrain violations, of this chapter

shall be by and in the name of the United States.”) (emphasis

added). This is not an enforcement proceeding, but it is an

10

attempt by the Plaintiffs to restrain violations of the FDCA.

Section 337 gives that authority to the government.

Despite the absence of a private right of action in the

FDCA, the district court held that the APA provides a private

right of action for agency actions “not in accordance with law”

under 5 U.S.C. § 706(2)(A). Mem. Op., Roane v. Barr, No. 19-

mc-145, at *5 (ECF No. 213) (D.D.C. Aug. 27, 2020).

Acknowledging that the FDCA does not contain a private right

of action, the district court relied on Chrysler Corp. v. Brown,

441 U.S. 281, 316–18 (1979), to find that the APA could

nonetheless supply what the statute lacked: a right to enforce

the FDCA’s premarketing, labeling, and prescription

requirements against the federal government. Mem. Op. at *5.

The district court’s holding appears to conflict with the

Supreme Court’s acknowledgement that an APA action is

precluded by federal statutory schemes that foreclose private

party enforcement. The APA confers a general cause of action

upon persons “adversely affected or aggrieved by agency

action within the meaning of a relevant statute,” 5 U.S.C.

§ 702, but withdraws that cause of action to the extent the

relevant statute “preclude[s] judicial review,” 5 U.S.C.

§ 701(a)(1). See Block v. Cmty. Nutrition Inst., 467 U.S. 340,

352–53 (1984) (holding that Congress intended to preclude

consumer challenges to milk marketing orders and such a

holding would not frustrate the statute’s objectives). “Whether

and to what extent a particular statute precludes judicial

review” is by necessity a fact specific inquiry that turns on the

express statutory language, structure, purpose, and history, and

the nature of the administrative action involved. Id. at 345. It is

not enough to assume, as the district court did, that the APA

can provide the right of action here. Such an assumption is

unwarranted under the FDCA, which places enforcement

authority exclusively with the government. Cf. Buckman Co. v.

11

Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001); Perez

v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (“Although

citizens may petition the FDA to take administrative

action … private enforcement of the statute is barred.”).

Because enforcement of the FDCA is committed to the

government, private litigants cannot sue to enforce its

provisions.