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
 2
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).
 3
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
 4
“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,
 5
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
 6
(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.).
 7
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.
 8
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
 9
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.
 10
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
 11
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.
 13
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).
 14
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.
 15
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
 16
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.