SUPREME COURT OF THE UNITED STATES

Syllabus

BRNOVICH, ATTORNEY GENERAL OF ARIZONA, et al. v. DEMOCRATIC NATIONAL COMMITTEE et al.

certiorari to the united states court of appeals for the ninth circuit

No. 19–1257. Argued March 2, 2021—Decided July 1, 2021[1]

Arizona law generally makes it very easy to vote. Voters may cast their ballots on election day in person at a traditional precinct or a “voting center” in their county of residence. Ariz. Rev. Stat. §16–411(B)(4). Arizonans also may cast an “early ballot” by mail up to 27 days before an election, §§16–541, 16–542(C), and they also may vote in person at an early voting location in each county, §§16–542(A), (E). These cases involve challenges under §2 of the Voting Rights Act of 1965 (VRA) to aspects of the State’s regulations governing precinct-based election-day voting and early mail-in voting. First, Arizonans who vote in person on election day in a county that uses the precinct system must vote in the precinct to which they are assigned based on their address. See §16–122; see also §16–135. If a voter votes in the wrong precinct, the vote is not counted. Second, for Arizonans who vote early by mail, Arizona House Bill 2023 (HB 2023) makes it a crime for any person other than a postal worker, an elections official, or a voter’s caregiver, family member, or household member to knowingly collect an early ballot—either before or after it has been completed. §§16–1005(H)–(I).

The Democratic National Committee and certain affiliates filed suit, alleging that both the State’s refusal to count ballots cast in the wrong precinct and its ballot-collection restriction had an adverse and disparate effect on the State’s American Indian, Hispanic, and African-American citizens in violation of §2 of the VRA. Additionally, they alleged that the ballot-collection restriction was “enacted with discriminatory intent” and thus violated both §2 of the VRA and the Fifteenth Amendment. The District Court rejected all of the plaintiffs’ claims. The court found that the out-of-precinct policy had no “meaningfully disparate impact” on minority voters’ opportunities to elect representatives of their choice. Turning to the ballot-collection restriction, the court found that it was unlikely to cause “a meaningful inequality” in minority voters’ electoral opportunities and that it had not been enacted with discriminatory intent. A divided panel of the Ninth Circuit affirmed, but the en banc court reversed. It first concluded that both the out-of-precinct policy and the ballot-collection restriction imposed a disparate burden on minority voters because they were more likely to be adversely affected by those rules. The en banc court also held that the District Court had committed clear error in finding that the ballot-collection law was not enacted with discriminatory intent.

Held: Arizona’s out-of-precinct policy and HB 2023 do not violate §2 of the VRA, and HB 2023 was not enacted with a racially discriminatory purpose. Pp. 12–37.

(a) Two threshold matters require the Court’s attention. First, the Court rejects the contention that no petitioner has Article III standing to appeal the decision below as to the out-of-precinct policy. All that is needed to entertain an appeal of that issue is one party with standing. Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania, 591 U. S. ___, ___, n. 6. Attorney General Brnovich, as an authorized representative of the State (which intervened below) in any action in federal court, fits the bill. See Virginia House of Delegates v. Bethune-Hill, 587 U. S. ___, ___. Second, the Court declines in these cases to announce a test to govern all VRA §2 challenges to rules that specify the time, place, or manner for casting ballots. It is sufficient for present purposes to identify certain guideposts that lead to the Court’s decision in these cases. Pp. 12–13.

(b) The Court’s statutory interpretation starts with a careful consideration of the text. Pp. 13–25.

(1) The Court first construed the current version of §2 in Thornburg v. Gingles, 478 U.S. 30, which was a vote-dilution case where the Court took its cue from §2’s legislative history. The Court’s many subsequent vote-dilution cases have followed the path Gingles charted. Because the Court here considers for the first time how §2 applies to generally applicable time, place, or manner voting rules, it is appropriate to take a fresh look at the statutory text. Pp. 13–14.

(2) In 1982, Congress amended the language in §2 that had been interpreted to require proof of discriminatory intent by a plurality of the Court in Mobile v. Bolden, 446 U.S. 55. In place of that language, §2(a) now uses the phrase “in a manner which results in a denial or abridgement of the right . . . to vote on account of race or color.” Section 2(b) in turn explains what must be shown to establish a §2 violation. Section 2(b) states that §2 is violated only where “the political processes leading to nomination or election” are not “equally open to participation” by members of the relevant protected group “in that its members have less opportunity than other members of the electorate to participate in the political process and to elect representatives of their choice.” (Emphasis added.) In §2(b), the phrase “in that” is “used to specify the respect in which a statement is true.” New Oxford American Dictionary 851. Thus, equal openness and equal opportunity are not separate requirements. Instead, it appears that the core of §2(b) is the requirement that voting be “equally open.” The statute’s reference to equal “opportunity” may stretch that concept to some degree to include consideration of a person’s ability to use the means that are equally open. But equal openness remains the touchstone. Pp. 14–15.

(3) Another important feature of §2(b) is its “totality of circumstances” requirement. Any circumstance that has a logical bearing on whether voting is “equally open” and affords equal “opportunity” may be considered. Pp. 15–21.

(i) The Court mentions several important circumstances but does not attempt to compile an exhaustive list. Pp. 15–19.

(A) The size of the burden imposed by a challenged voting rule is highly relevant. Voting necessarily requires some effort and compliance with some rules; thus, the concept of a voting system that is “equally open” and that furnishes equal “opportunity” to cast a ballot must tolerate the “usual burdens of voting.” Crawford v. Marion County Election Bd., 553 U.S. 181, 198. Mere inconvenience is insufficient. P. 16.

(B) The degree to which a voting rule departs from what was standard practice when §2 was amended in 1982 is a relevant consideration. The burdens associated with the rules in effect at that time are useful in gauging whether the burdens imposed by a challenged rule are sufficient to prevent voting from being equally “open” or furnishing an equal “opportunity” to vote in the sense meant by §2. Widespread current use is also relevant. Pp. 17–18.

(C) The size of any disparities in a rule’s impact on members of different racial or ethnic groups is an important factor to consider. Even neutral regulations may well result in disparities in rates of voting and noncompliance with voting rules. The mere fact that there is some disparity in impact does not necessarily mean that a system is not equally open or that it does not give everyone an equal opportunity to vote. And small disparities should not be artificially magnified. P. 18.

(D) Consistent with §2(b)’s reference to a States’ “political processes,” courts must consider the opportunities provided by a State’s entire system of voting when assessing the burden imposed by a challenged provision. Thus, where a State provides multiple ways to vote, any burden associated with one option cannot be evaluated without also taking into account the other available means. P. 18.

(E) The strength of the state interests—such as the strong and entirely legitimate state interest in preventing election fraud—served by a challenged voting rule is an important factor. Ensuring that every vote is cast freely, without intimidation or undue influence, is also a valid and important state interest. In determining whether a rule goes too far “based on the totality of circumstances,” rules that are supported by strong state interests are less likely to violate §2. Pp. 18–19.

(ii) Some factors identified in Thornburg v. Gingles, 478 U.S. 30, were designed for use in vote-dilution cases and are plainly inapplicable in a case that involves a challenge to a facially neutral time, place, or manner voting rule. While §2(b)’s “totality of circumstances” language permits consideration of certain other Gingles factors, their only relevance in cases involving neutral time, place, and manner rules is to show that minority group members suffered discrimination in the past and that effects of that discrimination persist. The disparate-impact model employed in Title VII and Fair Housing Act cases is not useful here. Pp. 19–21.

(4) Section 2(b) directs courts to consider “the totality of circumstances,” but the dissent would make §2 turn almost entirely on one circumstance: disparate impact. The dissent also would adopt a least-restrictive means requirement that would force a State to prove that the interest served by its voting rule could not be accomplished in any other less burdensome way. Such a requirement has no footing in the text of §2 or the Court’s precedent construing it and would have the potential to invalidate just about any voting rule a State adopts. Section 2 of the VRA provides vital protection against discriminatory voting rules, and no one suggests that discrimination in voting has been extirpated or that the threat has been eliminated. Even so, §2 does not transfer the States’ authority to set non-discriminatory voting rules to the federal courts. Pp. 21–25.

(c) Neither Arizona’s out-of-precinct policy nor its ballot-collection law violates §2 of the VRA. Pp. 25–34.

(1) Having to identify one’s polling place and then travel there to vote does not exceed the “usual burdens of voting.” Crawford, 553 U. S., at 198. In addition, the State made extensive efforts to reduce the impact of the out-of-precinct policy on the number of valid votes ultimately cast, e.g., by sending a sample ballot to each household that includes a voter’s proper polling location. The burdens of identifying and traveling to one’s assigned precinct are also modest when considering Arizona’s “political processes” as a whole. The State offers other easy ways to vote, which likely explains why out-of-precinct votes on election day make up such a small and apparently diminishing portion of overall ballots cast.

Next, the racial disparity in burdens allegedly caused by the out-of-precinct policy is small in absolute terms. Of the Arizona counties that reported out-of-precinct ballots in the 2016 general election, a little over 1% of Hispanic voters, 1% of African-American voters, and 1% of Native American voters who voted on election day cast an out-of-precinct ballot. For non-minority voters, the rate was around 0.5%. A procedure that appears to work for 98% or more of voters to whom it applies—minority and non-minority alike—is unlikely to render a system unequally open.

Appropriate weight must be given to the important state interests furthered by precinct-based voting. It helps to distribute voters more evenly among polling places; it can put polling places closer to voter residences; and it helps to ensure that each voter receives a ballot that lists only the candidates and public questions on which he or she can vote. Precinct-based voting has a long pedigree in the United States, and the policy of not counting out-of-precinct ballots is widespread.

The Court of Appeals discounted the State’s interests because it found no evidence that a less restrictive alternative would threaten the integrity of precinct-based voting. But §2 does not require a State to show that its chosen policy is absolutely necessary or that a less restrictive means would not adequately serve the State’s objectives. Considering the modest burdens allegedly imposed by Arizona’s out-of-precinct policy, the small size of its disparate impact, and the State’s justifications, the rule does not violate §2. Pp. 25–30.

(2) Arizona’s HB 2023 also passes muster under §2. Arizonans can submit early ballots by going to a mailbox, a post office, an early ballot drop box, or an authorized election official’s office. These options entail the “usual burdens of voting,” and assistance from a statutorily authorized proxy is also available. The State also makes special provision for certain groups of voters who are unable to use the early voting system. See §16–549(C). And here, the plaintiffs were unable to show the extent to which HB 2023 disproportionately burdens minority voters.

Even if the plaintiffs were able to demonstrate a disparate burden caused by HB 2023, the State’s “compelling interest in preserving the integrity of its election procedures” would suffice to avoid §2 liability. Purcell v. Gonzalez, 549 U.S. 1, 4. The Court of Appeals viewed the State’s justifications for HB 2023 as tenuous largely because there was no evidence of early ballot fraud in Arizona. But prevention of fraud is not the only legitimate interest served by restrictions on ballot collection. Third-party ballot collection can lead to pressure and intimidation. Further, a State may take action to prevent election fraud without waiting for it to occur within its own borders. Pp. 30–34.

(d) HB 2023 was not enacted with a discriminatory purpose, as the District Court found. Appellate review of that conclusion is for clear error. Pullman-Standard v. Swint, 456 U.S. 273, 287–288. The District Court’s finding on the question of discriminatory intent had ample support in the record. The court considered the historical background and the highly politicized sequence of events leading to HB 2023’s enactment; it looked for any departures from the normal legislative process; it considered relevant legislative history; and it weighed the law’s impact on different racial groups. See Arlington Heights v. Metropolitan Housing Development Corp., 429 U.S. 252, 266–268. The court found HB 2023 to be the product of sincere legislative debate over the wisdom of early mail-in voting and the potential for fraud. And it took care to distinguish between racial motives and partisan motives. The District Court’s interpretation of the evidence was plausible based on the record, so its permissible view is not clearly erroneous. See Anderson v. Bessemer City, 470 U.S. 564, 573–574. The Court of Appeals concluded that the District Court committed clear error by failing to apply a “cat’s paw” theory—which analyzes whether an actor was a “dupe” who was “used by another to accomplish his purposes.” That theory has its origin in employment discrimination cases and has no application to legislative bodies. Pp. 34–37.

948 F.3d 989, reversed and remanded.

Alito, J., delivered the opinion of the Court, in which Roberts, C. J., and Thomas, Gorsuch, Kavanaugh, and Barrett, JJ., joined. Gorsuch, J., filed a concurring opinion, in which Thomas, J., joined. Kagan, J., filed a dissenting opinion, in which Breyer and Sotomayor, JJ., joined.

SUPREME COURT OF THE UNITED STATES
No. 21A23

ALABAMA ASSOCIATION OF REALTORS, ET AL. v.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ET AL.

ON APPLICATION TO VACATE STAY

[August 26, 2021]

 PER CURIAM.

The Director of the Centers for Disease Control and Prevention (CDC) has imposed a nationwide moratorium on
evictions of any tenants who live in a county that is experiencing substantial or high levels of COVID–19 transmission and who make certain declarations of financial need.
86 Fed. Reg. 43244 (2021). The Alabama Association of
Realtors (along with other plaintiffs) obtained a judgment
from the U. S. District Court for the District of Columbia
vacating the moratorium on the ground that it is unlawful.
But the District Court stayed its judgment while the Government pursued an appeal. We vacate that stay, rendering the judgment enforceable. The District Court produced
a comprehensive opinion concluding that the statute on
which the CDC relies does not grant it the authority it
claims. The case has been thoroughly briefed before us—
twice. And careful review of that record makes clear that
the applicants are virtually certain to succeed on the merits
of their argument that the CDC has exceeded its authority.
It would be one thing if Congress had specifically authorized the action that the CDC has taken. But that has not
happened. Instead, the CDC has imposed a nationwide
moratorium on evictions in reliance on a decades-old statute that authorizes it to implement measures like fumigation and pest extermination. It strains credulity to believe that this statute grants the CDC the sweeping authority
that it asserts.

I
A
In March 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act to alleviate burdens caused
by the burgeoning COVID–19 pandemic. Pub. L. 116–136,
134 Stat. 281. Among other relief programs, the Act imposed a 120-day eviction moratorium for properties that
participated in federal assistance programs or were subject
to federally backed loans. §4024, id., at 492–494.
When the eviction moratorium expired in July, Congress
did not renew it. Concluding that further action was
needed, the CDC decided to do what Congress had not. See
85 Fed. Reg. 55292 (2020). The new, administratively imposed moratorium went further than its statutory predecessor, covering all residential properties nationwide and imposing criminal penalties on violators. See id., at 55293,
55296.
The CDC’s moratorium was originally slated to expire on
December 31, 2020. Id., at 55297. But Congress extended
it for one month as part of the second COVID–19 relief Act.
See Consolidated Appropriations Act, 2021, Pub. L. 116–
260, §502, 134 Stat. 2078–2079. As the new deadline approached, the CDC again took matters into its own hands,
extending its moratorium through March, then again
through June, and ultimately through July. 86 Fed. Reg.
8020, 16731, 34010.
The CDC relied on §361(a) of the Public Health Service
Act for authority to promulgate and extend the eviction
moratorium. See 58 Stat. 703, as amended, 42 U. S. C.
§264(a). That provision states:
“The Surgeon General, with the approval of the [Secretary of Health and Human Services], is authorized to
make and enforce such regulations as in his judgment 
are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign
countries into the States or possessions, or from one
State or possession into any other State or possession.
For purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to
be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures,
as in his judgment may be necessary.”
See also 42 CFR §70.2 (2020) (delegating this authority to
the CDC). Originally passed in 1944, this provision has
rarely been invoked—and never before to justify an eviction
moratorium. Regulations under this authority have generally been limited to quarantining infected individuals and
prohibiting the import or sale of animals known to transmit
disease. See, e.g., 40 Fed. Reg. 22543 (1975) (banning small
turtles known to be carriers of salmonella).

B

Realtor associations and rental property managers in Alabama and Georgia sued to enjoin the CDC’s moratorium.
The U. S. District Court for the District of Columbia
granted the plaintiffs summary judgment, holding that the
CDC lacked statutory authority to impose the moratorium.
Alabama Assn. of Realtors v. Department of Health and Human Servs., 2021 WL 1779282, *10 (May 5, 2021).
But the court stayed its order pending appeal. It reasoned that even though the Government had not shown a
substantial likelihood of success, it did make a lesser showing of a “serious legal question on the merits,” which the
court said warranted granting a stay when the remaining
stay factors weighed in the Government’s favor. Alabama
Assn. of Realtors v. Department of Health and Human
Servs., 2021 WL 1946376, *4–*5 (May 14, 2021) (citation 
omitted); see also Nken v. Holder, 556 U. S. 418, 434 (2009)
(listing the four traditional stay factors: “(1) whether the
stay applicant has made a strong showing that he is likely
to succeed on the merits; (2) whether the applicant will be
irreparably injured absent a stay; (3) whether issuance of
the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest
lies” (citation omitted)). The D. C. Circuit agreed, though it
rated the Government’s arguments more highly. Alabama
Assn. of Realtors v. Department of Health and Human
Servs., 2021 WL 2221646 (June 2, 2021).
This Court declined to vacate the stay. Alabama Assn. of
Realtors v. Department of Health and Human Servs., post,
p. ___. JUSTICE KAVANAUGH concurred, explaining that he
agreed with the District Court that the CDC’s moratorium
exceeded its statutory authority. But because the CDC
planned to end the moratorium in only a few weeks, and
because that time would allow for additional and more orderly distribution of congressionally appropriated rentalassistance funds, he concluded that the balance of equities
justified leaving the stay in place. JUSTICE THOMAS,
JUSTICE ALITO, JUSTICE GORSUCH, and JUSTICE BARRETT
noted that they would vacate the stay.
The moratorium expired on July 31, 2021. Three days
later, the CDC reimposed it. See 86 Fed. Reg. 43244. Apart
from slightly narrowing the geographic scope, the new moratorium is indistinguishable from the old.
With the moratorium once again in place, the plaintiffs
returned to the District Court to seek vacatur of its stay.
The District Court agreed with the plaintiffs that the stay
was no longer warranted for two reasons. First, the Government was unlikely to succeed on the merits, given the
four votes to vacate the stay in this Court and JUSTICE
KAVANAUGH’s concurring opinion. 2021 WL 3577367, *6
(Aug. 13, 2021). Second, the equities had shifted in the
plaintiffs’ favor: Vaccine and rental-assistance distribution had improved since the stay was entered, while the harm to
landlords had continued to increase. Ibid., n. 3. But the
court concluded that its hands were tied by the law of the
case, in light of the D. C. Circuit’s earlier decision not to
vacate the stay. Ibid. That denial was followed by one more
stop at the D. C. Circuit, where that court again declined to
lift the stay. 2021 WL 3721431 (Aug. 20, 2021).
Having passed through the lower courts twice, the plaintiffs return as applicants to this Court to again ask us to
vacate the District Court’s stay.

II

The District Court concluded that its stay is no longer
justified under the governing four-factor test. See Nken v.
Holder, supra, at 434. We agree.

A

The applicants not only have a substantial likelihood of
success on the merits—it is difficult to imagine them losing.
The Government contends that the first sentence of §361(a)
gives the CDC broad authority to take whatever measures
it deems necessary to control the spread of COVID–19, including issuing the moratorium. But the second sentence
informs the grant of authority by illustrating the kinds of
measures that could be necessary: inspection, fumigation,
disinfection, sanitation, pest extermination, and destruction of contaminated animals and articles. These measures
directly relate to preventing the interstate spread of disease
by identifying, isolating, and destroying the disease itself.
The CDC’s moratorium, on the other hand, relates to interstate infection far more indirectly: If evictions occur, some
subset of tenants might move from one State to another,
and some subset of that group might do so while infected
with COVID–19. See 86 Fed. Reg. 43248–43249. This
downstream connection between eviction and the interstate spread of disease is markedly different from the direct targeting of disease that characterizes the measures identified
in the statute. Reading both sentences together, rather
than the first in isolation, it is a stretch to maintain that
§361(a) gives the CDC the authority to impose this eviction
moratorium.
Even if the text were ambiguous, the sheer scope of the
CDC’s claimed authority under §361(a) would counsel
against the Government’s interpretation. We expect Congress to speak clearly when authorizing an agency to exercise powers of “vast ‘economic and political significance.’”
Utility Air Regulatory Group v. EPA, 573 U. S. 302, 324
(2014) (quoting FDA v. Brown & Williamson Tobacco Corp.,
529 U. S. 120, 160 (2000)). That is exactly the kind of power
that the CDC claims here. At least 80% of the country, including between 6 and 17 million tenants at risk of eviction,
falls within the moratorium. See Response in Opposition
26, 29. While the parties dispute the financial burden on
landlords, Congress has provided nearly $50 billion in
emergency rental assistance—a reasonable proxy of the
moratorium’s economic impact. See 86 Fed. Reg. 43247.
And the issues at stake are not merely financial. The moratorium intrudes into an area that is the particular domain
of state law: the landlord-tenant relationship. See Lindsey
v. Normet, 405 U. S. 56, 68–69 (1972). “Our precedents require Congress to enact exceedingly clear language if it
wishes to significantly alter the balance between federal
and state power and the power of the Government over private property.” United States Forest Service v. Cowpasture
River Preservation Assn., 590 U. S. ___, ___–___ (2020) (slip
op., at 15–16).
Indeed, the Government’s read of §361(a) would give the
CDC a breathtaking amount of authority. It is hard to see
what measures this interpretation would place outside the
CDC’s reach, and the Government has identified no limit in
§361(a) beyond the requirement that the CDC deem a measure “necessary.” 42 U. S. C. §264(a); 42 CFR §70.2.
Could the CDC, for example, mandate free grocery delivery
to the homes of the sick or vulnerable? Require manufacturers to provide free computers to enable people to work
from home? Order telecommunications companies to provide free high-speed Internet service to facilitate remote
work?
This claim of expansive authority under §361(a) is unprecedented. Since that provision’s enactment in 1944, no
regulation premised on it has even begun to approach the
size or scope of the eviction moratorium. And it is further
amplified by the CDC’s decision to impose criminal penalties of up to a $250,000 fine and one year in jail on those
who violate the moratorium. See 86 Fed. Reg. 43252; 42
CFR §70.18(a). Section 361(a) is a wafer-thin reed on which
to rest such sweeping power.

B

The equities do not justify depriving the applicants of the
District Court’s judgment in their favor. The moratorium
has put the applicants, along with millions of landlords
across the country, at risk of irreparable harm by depriving
them of rent payments with no guarantee of eventual recovery. Despite the CDC’s determination that landlords
should bear a significant financial cost of the pandemic,
many landlords have modest means. And preventing them
from evicting tenants who breach their leases intrudes on
one of the most fundamental elements of property ownership—the right to exclude. See Loretto v. Teleprompter
Manhattan CATV Corp., 458 U. S. 419, 435 (1982).
As harm to the applicants has increased, the Government’s interests have decreased. Since the District Court
entered its stay, the Government has had three additional
months to distribute rental-assistance funds to help ease
the transition away from the moratorium. Whatever interest the Government had in maintaining the moratorium’s original end date to ensure the orderly administration of
those programs has since diminished. And Congress was
on notice that a further extension would almost surely require new legislation, yet it failed to act in the several
weeks leading up to the moratorium’s expiration.
It is indisputable that the public has a strong interest in
combating the spread of the COVID–19 Delta variant. But
our system does not permit agencies to act unlawfully even
in pursuit of desirable ends. Cf. Youngstown Sheet & Tube
Co. v. Sawyer, 343 U. S. 579, 582, 585–586 (1952) (concluding that even the Government’s belief that its action “was
necessary to avert a national catastrophe” could not overcome a lack of congressional authorization). It is up to Congress, not the CDC, to decide whether the public interest
merits further action here.

* * *

If a federally imposed eviction moratorium is to continue,
Congress must specifically authorize it. The application to
vacate stay presented to THE CHIEF JUSTICE and by him referred to the Court is granted.
 So ordered. 

_________________
_________________

BREYER, J., dissenting
SUPREME COURT OF THE UNITED STATES
No. 21A23
ALABAMA ASSOCIATION OF REALTORS, ET AL. v.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ET AL.
ON APPLICATION TO VACATE STAY
[August 26, 2021]

 JUSTICE BREYER, with whom JUSTICE SOTOMAYOR and
JUSTICE KAGAN join, dissenting.
The Centers for Disease Control and Prevention (CDC)
has issued an order that, in light of the rise of the COVID–
19 Delta variant, temporarily prohibits certain evictions in
high-transmission counties through October 3. Today, this
Court, as an emergency matter, without full briefing or argument, blocks that order by vacating a lower court’s stay.
I think the Court is wrong to do so, and I dissent.
“We may not vacate a stay entered by a [lower] court . . .
unless that court clearly and ‘demonstrably’ erred in its application of ‘accepted standards.’” Planned Parenthood of
Greater Tex. Surgical Health Servs. v. Abbott, 571 U. S.
1061 (2013) (Scalia, J., concurring in denial of application
to vacate stay) (quoting Western Airlines, Inc. v. Teamsters,
480 U. S. 1301, 1305 (1987) (O’Connor, J., in chambers)).
Those accepted factors are “(1) whether the stay applicant
has made a strong showing that he is likely to succeed on
the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will
substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.” Nken v.
Holder, 556 U. S. 418, 426 (2009) (internal quotation marks
omitted). In my view, the courts below did not clearly err
for three reasons. 

First, it is far from “demonstrably” clear that the CDC
lacks the power to issue its modified moratorium order. The
CDC’s current order is substantially more tailored than its
prior eviction moratorium, which automatically applied nationwide. Justified by the Delta-variant surge, the modified
order targets only those regions currently experiencing skyrocketing rates. 86 Fed. Reg. 43244, 43245, 43250 (2021).
If a covered county “no longer experiences substantial or
high levels of community transmission,” the order “will no
longer apply” there. Id., at 43250. To illustrate the difference, when we denied applicants’ last motion, fewer than
20% of counties would have been covered under the modified moratorium order’s criteria. See CDC, COVID–19
State Profile Report 476 (June 25, 2021). Today, however,
that figure is over 90%. See infra, at 7.
To be protected from eviction, a tenant must reside in a
covered area and attest that he or she:
(1) has “used best efforts to obtain all available governmental assistance for rent or housing”;
(2) satisfies certain income requirements;
(3) is unable to pay rent “due to substantial loss of
household income, loss of compensable hours of
work or wages, a lay-off, or extraordinary out-of-pocket
medical expenses”;
(4) continues to “us[e] best efforts to make timely partial rent payments that are as close to the full rent payment as . . . permit[ted]”; and
(5) has “no other available housing options.” Id., at
43245.
Unlike under New York’s moratorium, see Chrysafis v.
Marks, post, at 1, landlords remain free to “challeng[e]” in
court “the truthfulness of a tenant’s . . . declaration” that
he or she qualifies for the order’s protection. 86 Fed. Reg. 
43251.
The CDC issued this modified moratorium order (like its
prior moratorium order) pursuant to its powers under
§361(a) of the Public Health Service Act. That provision
“authorize[s]” the CDC:
“[T]o make and enforce such regulations as in [its] judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases [interstate]. For purposes of carrying out and enforcing such
regulations, the Surgeon General may provide for such
inspection, fumigation, disinfection, sanitation, pest
extermination, destruction of animals or articles found
to be so infected or contaminated as to be sources of
dangerous infection to human beings, and other
measures, as in his judgment may be necessary.”
42 U. S. C. §264(a).
The statute’s first sentence grants the CDC authority to
design measures that, in the agency’s judgment, are essential to contain disease outbreaks. The provision’s plain
meaning includes eviction moratoria necessary to stop the
spread of diseases like COVID–19. When Congress enacted
§361(a), public health agencies intervened in the housing
market by regulation, including eviction moratoria, to contain infection by preventing the movement of people. See,
e.g., 5,589 New Cases in One Day Break Influenza Record,
N. Y. Times, Jan. 29, 1920, section 1, pp. 1–2, col. 1 (“‘[T]he
Health Department . . . instruct[s] all landlords that no person suffering from [influenza and pneumonia] can be removed under any condition whatever without the sanction
of the Health Department . . . ’”). If Congress had meant to
exclude these types of measures from its broad grant of authority, it likely would have said so.
Section 361(a)’s second sentence is naturally read to expand the agency’s powers by providing congressional authorization to act on personal property when necessary. See 
FTC v. American Tobacco Co., 264 U. S. 298, 305–306
(1924). It could also be read to provide emphasis regarding
particular enforcement measures. See Ali v. Federal Bureau of Prisons, 552 U. S. 214, 226 (2008).
Applicants urge, and today’s per curiam agrees, that the
second sentence should instead be read to cabin the CDC’s
authority. Not only does that reading lack a clear statutory
basis but the second sentence goes on to empower the CDC
to take “other measures, as in [its] judgment may be necessary.” 42 U. S. C. §264(a). Furthermore, reading the provision’s second sentence to narrow its first would undermine Congress’ purpose. As a key drafter explained, “[t]he
second sentence of subsection (a)” was written not to limit
the broad authority contained in the first sentence, but to
“expressly authorize . . . inspections and . . . other steps necessary in the enforcement of quarantine.” Hearings on
H. R. 3379 before the Subcommittee of the Committee on
Interstate and Foreign Commerce, 78th Cong., 2d Sess.,
139 (1944).
The per curiam also says that Congress must speak more
clearly to authorize the CDC to address public health crises
via eviction moratoria. But it is undisputed that the statute
permits the CDC to adopt significant measures such as
quarantines, which arguably impose greater restrictions on
individuals’ rights and state police powers than do limits on
evictions. Indeed, the current Congress did not bristle at
the Government’s reading of the statute. In 2020, Congress
extended the CDC’s moratorium “issued . . . under section
361 of the Public Health Service Act.” Consolidated Appropriations Act, 2021, Pub. L. 116–260, §502, 134 Stat. 2078–
2079.
In any event, lower courts have split on this question.
Compare Alabama Assn. of Realtors v. Department of
Health and Human Servs., 2021 WL 2221646, *2 (CADC,
June 2, 2021), with Tiger Lily, LLC v. United States Dept.
of Housing and Urban Development, 5 F. 4th 666, 669–670 
(CA6 2021). Given the split among the Circuits, it is at least
hard to say that the Government’s reading of the statute is
“demonstrably wrong.” See Coleman v. Paccar Inc., 424
U. S. 1301, 1304 (1976) (Rehnquist, J., in chambers). At
minimum, there are arguments on both sides.
 Certainly this Court did not resolve the question by denying applicants’ last emergency motion, whatever one Justice might have said in a concurrence. The scope of that
challenged moratorium, the balance of the equities, and the
public interest were all different. As is typical in this
Court’s emergency orders denying extraordinary relief, we
said almost nothing about our reasons for declining to act.
Second, the balance of equities strongly favors leaving
the stay in place. Applicants say they have lost “thousands
of dollars” in rental income. See Application 32. That injury is lessened by the moratorium order’s directive that
tenants have an obligation to make “as close to the full rent
payment” as possible. 86 Fed. Reg. 43245. And to compensate for the shortfall, Congress has appropriated more than
$46.5 billion to help pay rent and rental arrears. See §501,
134 Stat. 2070–2078 (appropriating $25 billion); American
Rescue Plan Act, 2021, Pub. L. 117–2, §3201(a)(1), 135 Stat.
54 (appropriating $21.5 billion more). It may, as applicants
say, take time to get that money—and that is an injury.
But compare that injury to the irreparable harm from vacating the stay. COVID–19 transmission rates have spiked
in recent weeks, reaching levels that the CDC puts as high
as last winter: 150,000 new cases per day. 

To date, the CDC estimates that 38,150,911 Americans
have been sickened. Ibid. 629,139 have died. Ibid. This
week, the CDC calculates average new daily hospital admissions at 12,209. See CDC, New Admissions of Patients
with Confirmed COVID–19, https://covid.cdc.gov/coviddata-tracker/#new-hospital-admissions. The number of
patients hospitalized with COVID–19 is up 13.3% from last
week. See CDC, Prevalent Hospitalization of Patients With
Confirmed COVID–19, https://covid.cdc.gov/covid-datatracker/#hospitalizations.
Look back at the order’s criteria for temporary eviction
relief. The CDC targets only those people who have nowhere else to live, in areas with dangerous levels of community transmission. These people may end up with relatives,
in shelters, or seeking beds in other congregant facilities
where the doubly contagious Delta variant threatens to
spread quickly. See CDC, Delta Variant: What We Know
About the Science, https://www.cdc.gov/coronavirus/2019-
ncov/variants/delta-variant.html (Delta variant is “more
than 2x as contagious as previous variants” and may “cause more severe illness than previous strains in unvaccinated
persons”). Absent the current stay, the CDC projects a
strong “likelihood of mass evictions nationwide” with
public-health consequences that would be “difficult to reverse.” 86 Fed. Reg. 43247, 43252.
Third, the public interest is not favored by the spread of
disease or a court’s second-guessing of the CDC’s judgment.
The CDC has determined that “[a] surge in evictions could
lead to the immediate and significant movement of large
numbers of persons from lower density to higher density
housing. . . when the highly transmissible Delta variant is
driving COVID–19 cases at an unprecedented rate.” Id., at
43248. The CDC cites models showing up to a 30% increased risk of contracting COVID–19 for some evicted people and those who share housing with them after displacement. Ibid. The CDC invokes studies finding nationally
over 433,000 cases and over 10,000 deaths may be traced to
the lifting of state eviction moratoria. Ibid.
The public interest strongly favors respecting the CDC’s
judgment at this moment, when over 90% of counties are
experiencing high transmission rates. See CDC, COVD–19
Integrated County View, https://covid.cdc.gov/covid-datatracker/#county-view. That figure is the highest it has been
since at least last winter. See CDC, COVID–19 State Profile Report 372 (Aug. 20, 2021). It was in the single digits
when we considered the CDC’s previous moratorium order
and denied applicants’ earlier motion. See CDC, COVID–
19 State Profile Report 476 (June 25, 2021).
On applicants’ last trip to this Court, they argued that
the “downward trend in COVID–19 cases and the effectiveness of vaccines” left “no . . . public-health rationale for the
[CDC’s then-operative eviction] moratorium.” Application
in No. 20A169, p. 4. These predictions have proved tragically untrue. Today they show just how little we may presume to know about the course of this pandemic. 
Applicants raise contested legal questions about an important federal statute on which the lower courts are split
and on which this Court has never actually spoken. These
questions call for considered decisionmaking, informed by
full briefing and argument. Their answers impact the
health of millions. We should not set aside the CDC’s eviction moratorium in this summary proceeding. The criteria
for granting the emergency application are not met. I respectfully dissent. 

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 

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
(Death Penalty Act) 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). 

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 government based on Plaintiffs’ new
challenges to the Death Penalty Act, 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 Federal Food, Drug, and Cosmetic Act
(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
“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 Death Penalty
Act, 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 Death Penalty
Act 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 (D.D.C. 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, 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 threedrug protocol the government used in the executions between
2001 and 2003. See id. 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 
(D.D.C. 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 Death Penalty Act 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.). On April 6, 2020, in a divided opinion, this
court vacated the district court’s injunction and reversed its
Death Penalty Act 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 Death
Penalty Act 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) (per
curiam). The government executed Lee that same day. 
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 
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. 20-5252 (D.C. Cir. Aug. 25,
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. 
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-mc145 (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 Nelson 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 Death
Penalty Act. 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 
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 Death Penalty Act
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
inherent in obtaining multiple drugs,” the superior
“efficien[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. 
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-mc145-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).

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.

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 
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 capitalpunishment jurisdictions. But that change eases the logistics
of known protocols, and does so by adding a commonly used
and available pain reliever.

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, In re
FBOP, No. 19-mc-145-TSC (D.D.C. Aug. 15, 2020), ECF No.
193; see also Order at 2, In re FBOP, 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 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. Nat. 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 
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, In re
FBOP, 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, In re FBOP, 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. 

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 deathpenalty 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, In re FBOP, No. 19-mc-145-
TSC (D.D.C. Nov. 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 re FBOP, 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.
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
with regulations governing the issuance and filling of
prescriptions under 21 C.F.R. Part 1306).
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).

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.
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 GuerreroLasprilla 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
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. Nat. Res. Def. 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’ Death
Penalty Act 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), ECF No. 261. The
district court concluded that there was no conflict in this case,
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-
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 Death Penalty Act ruling. The district court has
since entered partial final judgment on Plaintiffs’ Death Penalty Act
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).

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.
3, 2020), ECF No. 305. 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 Death Penalty Act 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
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 Death Penalty Act. 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
the government 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 (2014) (“[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 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
134 (2000) (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 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,” 
Memorandum Opinion at 35, In re FBOP, 19-mc-145 (D.D.C.
Sept. 20, 2020), ECF No. 261 (quoting Monsanto Co. v.
Geertson Seed Farms, 561 U.S. 139, 162 (2010)). Later it
suggested the problem was that they had not shown the harm
was sufficiently 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, 613 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 disregard health- and safety-related mandates.
But assuming the Plaintiffs did have to show the risks they
expect to face from the government’s refusal to comply with
the FDCA, the record suggests the district court may have
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, 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.” Id. at 9-10.
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.
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 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 some 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 Eighth 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 sees it requires
adherence to the current execution schedule. Appellees Br. 39-
40. It is our responsibility as courts “to ensure that method-ofexecution challenges to lawfully issued sentences are resolved
fairly and expeditiously.” Barr v. Lee, 140 S. Ct. at 2591
(citation omitted). But Plaintiffs have thus 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,”
Appellees Br. 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, 955 F.3d 106, 110-
11 (D.C. Cir. 2020), and we recognized when we resolved
those claims under the Death Penalty Act 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
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 (“Death
Penalty Act”) claim. I agree to vacate the district court’s
dismissal of the Eighth Amendment claim and affirm the grant
of summary judgment on the Death Penalty Act claim. My
colleagues conclude that binding circuit precedent mandates
the application of the FDCA to drugs administered for capital
punishment and order 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 that the district court correctly granted summary
judgment for the government on the Death Penalty Act 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, 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. at
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.

* * *
I dissent with respect to Part III.A, which holds 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. My colleagues rely 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 30
(D.D.C. 2012). 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. at 42, 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. 

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).
My colleagues also rely 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 
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 
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 
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”). My colleagues’ 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. at 40–41 (explaining that 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).

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 
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 (D.D.C. Aug. 27, 2020), ECF No. 213.
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,” id. § 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 that 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. Block, 467 U.S. 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. 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.

SUPREME COURT OF THE UNITED STATES

_________________
No. 20A8
_________________
WILLIAM P. BARR, ATTORNEY GENERAL, ET AL. v.
DANIEL LEWIS LEE, ET AL.

ON APPLICATION FOR STAY OR VACATUR

[July 14, 2020]

PER CURIAM.
The application for stay or vacatur presented to THE
CHIEF JUSTICE and by him referred to the Court is granted.
The District Court’s July 13, 2020 order granting a preliminary injunction is vacated.
The plaintiffs in this case are all federal prisoners who
have been sentenced to death for murdering children. The
plaintiffs committed their crimes decades ago and have long
exhausted all avenues for direct and collateral review. The
first of their executions was scheduled to take place this afternoon, with others to follow this week and next month.
To carry out these sentences, the Federal Government
plans to use a single drug—pentobarbital sodium—that “is
widely conceded to be able to render a person fully insensate” and “does not carry the risks” of pain that some have
associated with other lethal injection protocols. Zagorski v.
Parker, 586 U. S. ___, ___ (2018) (Sotomayor, J., dissenting
from denial of application for stay and denial of certiorari)
(slip op., at 2).
Hours before the first execution was set to take place, the
District Court preliminarily enjoined all four executions on
the ground that the use of pentobarbital likely constitutes
cruel and unusual punishment prohibited by the Eighth
Amendment. Vacatur of that injunction is appropriate because, among other reasons, the plaintiffs have not established that they are likely to succeed on the merits of their 
Eighth Amendment claim. That claim faces an exceedingly
high bar. “This Court has yet to hold that a State’s method
of execution qualifies as cruel and unusual.” Bucklew v.
Precythe, 587 U. S. ___, ___ (2019) (slip op., at 12). For good
reason—“[f]ar from seeking to superadd terror, pain, or disgrace to their executions, the States have often sought more
nearly the opposite,” developing new methods, such as lethal injection, thought to be less painful and more humane
than traditional methods, like hanging, that have been uniformly regarded as constitutional for centuries. Ibid. The
Federal Government followed this trend by selecting a lethal injection protocol—single-dose pentobarbital—that
has become a mainstay of state executions. Pentobarbital:
• Has been adopted by five of the small number of
States that currently implement the death penalty.
• Has been used to carry out over 100 executions, without incident.
• Has been repeatedly invoked by prisoners as a less
painful and risky alternative to the lethal injection
protocols of other jurisdictions.
• Was upheld by this Court last year, as applied to a
prisoner with a unique medical condition that could
only have increased any baseline risk of pain associated with pentobarbital as a general matter. See
Bucklew, 587 U. S. ___.
• Has been upheld by numerous Courts of Appeals
against Eighth Amendment challenges similar to
the one presented here. See, e.g., Whitaker v. Collier, 862 F. 3d 490 (CA5 2017); Zink v. Lombardi,
783 F. 3d 1089 (CA8 2015); Gissendaner v. Commissioner, 779 F. 3d 1275 (CA11 2015).

Against this backdrop, the plaintiffs cite new expert declarations suggesting that pentobarbital causes prisoners to
experience “flash pulmonary edema,” a form of respiratory
distress that temporarily produces the sensation of drowning or asphyxiation. But the Government has produced
competing expert testimony of its own, indicating that any
pulmonary edema occurs only after the prisoner has died or
been rendered fully insensate. The plaintiffs in this case
have not made the showing required to justify last-minute
intervention by a Federal Court. “Last-minute stays” like
that issued this morning “should be the extreme exception,
not the norm.” Bucklew, 587 U. S., at ___ (slip op., at 30).
It is our responsibility “to ensure that method-of-execution
challenges to lawfully issued sentences are resolved fairly
and expeditiously,” so that “the question of capital punishment” can remain with “the people and their representatives, not the courts, to resolve.” Id., at ___–___ (slip op., at
29–30). In keeping with that responsibility, we vacate the
District Court’s preliminary injunction so that the plaintiffs’ executions may proceed as planned.

It is so ordered.

BREYER, J., dissenting
SUPREME COURT OF THE UNITED STATES

_________________
No. 20A8
_________________
WILLIAM P. BARR, ATTORNEY GENERAL, ET AL. v.
DANIEL LEWIS LEE, ET AL.

ON APPLICATION FOR STAY OR VACATUR

[July 14, 2020]

JUSTICE BREYER, with whom JUSTICE GINSBURG joins,
dissenting.
Today, for the first time in 17 years, the Federal Government will execute an inmate, Daniel Lewis Lee. I have previously described how various features of the death penalty
as currently administered show that it may well violate the
Constitution. See Glossip v. Gross, 576 U. S. 863, 908–946
(2015) (dissenting opinion). The Federal Government’s decision to resume executions renders the question of the
death penalty’s constitutionality yet more pressing.
Given the finality and seriousness of a death sentence, it
is particularly important to ensure that the individuals sentenced to death are guilty, that they received full and fair
procedures, and that they do not spend excessively long periods of time on death row. Courts must also ensure that
executions take place through means that are not inhumane.
This case illustrates at least some of the problems the
death penalty raises in light of the Constitution’s prohibition against “cruel and unusual punishmen[t].” Amdt. 8.
Mr. Lee was sentenced to death in 1999 and has now spent
over 20 years on death row. Such lengthy delays inflict severe psychological suffering on inmates and undermine the
penological rationale for the death penalty. See Glossip,
576 U. S., at 923–935 (BREYER, J., dissenting). Moreover,
the death penalty is often imposed arbitrarily. Id., at 915–
923. Mr. Lee’s co-defendant in his capital case was sentenced to life imprisonment despite committing the same
crime. Amended Judgment in Lee v. United States, No. 20–
2351 (CA 8), pp. 3–4 (July 12, 2020) (Kelly, J., dissenting
from denial of stay of execution); id., at 5–7 (explaining that
Mr. Lee’s execution “raises real concerns about the arbitrary application of the death penalty”).
Moreover, there are significant questions regarding the
constitutionality of the method the Federal Government
will use to execute him. The Government announced on
July 25, 2019, that it planned to resume federal executions,
after nearly two decades, pursuant to a new single-drug
protocol using pentobarbital. See Press Release, Dept. of
Justice, Federal Government to Resume Capital Punishment After Nearly Two Decade Lapse, https://www.justice.gov/opa/pr/federal-government-resume-capital-punishment-after-nearly-two-decade-lapse. In an opinion
preliminarily enjoining the execution of Mr. Lee and three
other plaintiffs, the U. S. District Court for the District of
Columbia explained that the “scientific evidence before [it]
overwhelmingly indicates that the [Government’s] 2019
Protocol is very likely to cause Plaintiffs extreme pain and
needless suffering during their executions.” Memorandum
Opinion in No. 19–mc–145, In the Matter of the Federal Bureau of Prison’s Execution Protocol Cases, Doc. 135, pp. 9,
11 (July 13, 2020). That court also explained that Mr. Lee
and the other plaintiffs had “identified two available and
readily implementable alternative methods of execution
that would significantly reduce the risk of serious pain.”
Id., at 18.
In short, the resumption of federal executions promises
to provide examples that illustrate the difficulties of administering the death penalty consistent with the Constitution.
As I have previously written, the solution may be for this
Court to directly examine the question whether the death
penalty violates the Constitution. See Glossip v. Gross, 576 
U. S., at 946 (dissenting opinion). 

SOTOMAYOR, J., dissenting

SUPREME COURT OF THE UNITED STATES

_________________
No. 20A8
_________________
WILLIAM P. BARR, ATTORNEY GENERAL, ET AL. v.
DANIEL LEWIS LEE, ET AL.

ON APPLICATION FOR STAY OR VACATUR

[July 14, 2020]

JUSTICE SOTOMAYOR, with whom JUSTICE GINSBURG and
JUSTICE KAGAN join, dissenting.
The Court hastily disposes of respondents’ Eighth
Amendment challenge to the use of pentobarbital in the
Federal Government’s single-drug execution protocol. In
doing so, the Court accepts the Government’s artificial
claim of urgency to truncate ordinary procedures of judicial
review. This sets a dangerous precedent. The Government
is poised to carry out the first federal executions in nearly
two decades. Yet because of the Court’s rush to dispose of
this litigation in an emergency posture, there will be no
meaningful judicial review of the grave, fact-heavy challenges respondents bring to the way in which the Government plans to execute them.

I

Respondents’ original complaint in this case dates back
to 2005. Since then, the Government has modified its execution protocol in significant part, most recently in July
2019 when it replaced the three-drug protocol with a single
drug: pentobarbital sodium. App. to Application for Stay or
Vacatur 5a. In light of this change, respondents alleged
that the Government’s planned use of pentobarbital could
result in needless pain and suffering in violation of the
Eighth Amendment. Among other things, respondents
proffered expert evidence that the majority of those injected 
with pentobarbital suffer flash pulmonary edema, which
can lead to a sensation akin to drowning and “‘extreme
pain, terror, and panic.’” Id., at 10a. Respondents first focused their litigation efforts on the claim that the 2019 protocol exceeds statutory authority, although they also alleged that the protocol violated the Administrative
Procedure Act, the Controlled Substances Act, the Food,
Drug, and Cosmetic Act, and the Constitution. The Court
of Appeals issued a final ruling on the statutory-authority
claim in April 2020, expressly declining to rule on respondents’ remaining claims on the ground that they were “‘neither addressed by the district court nor fully briefed.’” Id.,
at 7a. This Court denied review two weeks ago.
On June 15, 2020, the Government announced respondents’ new execution dates. Four days later, respondents
filed a joint motion for a preliminary injunction on their remaining claims and filed a motion for expedited discovery
the following day. The parties submitted hundreds of pages
of briefing and exhibits over two weeks. The District Court
decided this record-heavy motion within two weeks, and
during a time when two sister courts independently stayed
two of the executions. The District Court evaluated respondents’ Eighth Amendment challenge and stayed their
executions to permit full consideration by the District Court
and the Court of Appeals of their claims. The Court of Appeals denied the Government’s motion for a stay, noting
that respondents’ claims involve “novel and difficult constitutional questions” that require the benefit of “further factual and legal development.” The court sua sponte set an
expedited briefing schedule to resolve the appeal. Mere
hours later, however, this Court now grants the Government’s last-minute application to vacate the stay, allowing
death-sentenced inmates to be executed before any court
can properly consider whether their executions are unconstitutionally cruel and unusual. 

II

That outcome is hard to square with this Court’s denial
of a similar request by the Government seven months ago
in this very litigation. See Barr v. Roane, 589 U. S. ___
(2019). That order prohibited the Government to proceed
with executions before the Court of Appeals could address
respondents’ different, but equally serious statutory challenge to the federal execution protocol. And in a separate
statement, three Members of this Court contemplated that
respondents here would not be executed before “the merits
of their Administrative Procedure Act [APA] claim [are] adjudicated.” Id., at ___ (statement of ALITO, J., respecting
denial of stay or vacatur) (slip op., at 2). They maintained
that “in light of what is at stake, it would be preferable for
the District Court’s decision to be reviewed on the merits by
the Court of Appeals for the District of Columbia Circuit
before the executions are carried out.” Ibid.
These statements now ring hollow. By overriding the
lower court’s stay, this Court forecloses any review of respondents’ APA claims and bypasses the appellate court’s
review of a novel challenge to the federal execution protocol.
It does so despite the fact that, whatever may have been
true on the records presented in previous cases, see, e.g.,
Zagorski v. Parker, 586 U. S. ___ (2018), the parties here
introduced conflicting expert evidence about the likelihood
that pentobarbital causes pain and suffering before rendering a person insensate, which no factfinder has adjudicated.

III

Once again, the Court has chosen to grant an emergency
application from the Government for extraordinary relief.
Wolf v. Cook County, 589 U. S. ___, ___ (2020) (SOTOMAYOR,
J., dissenting from grant of stay) (slip op., at 5). The dangers of that practice are particularly severe here, where the
grant of the Government’s emergency application inflicts
the most irreparable of harms without the deliberation such 
an action warrants. See id., at ___ (slip op., at 6) (entertaining last-minute stay applications from the Government
“upend[s] the normal appellate process” and “force[s] the
Court to consider important statutory and constitutional
questions that have not been ventilated fully in the lower
courts, on abbreviated timetables and without oral argument”).

* * *

Today’s decision illustrates just how grave the consequences of such accelerated decisionmaking can be. The
Court forever deprives respondents of their ability to press
a constitutional challenge to their lethal injections, and prevents lower courts from reviewing that challenge. All of
that is at sharp odds with this Court’s own ruling mere
months earlier. In its hurry to resolve the Government’s
emergency motions, I fear the Court has overlooked not
only its prior ruling, but also its role in safeguarding robust
federal judicial review. I respectfully dissent.

In the Matter of the 
Federal Bureau of Prisons’ Execution 
Protocol Cases, 

LEAD CASE: Roane et al. v. Barr 

THIS DOCUMENT RELATES TO: 

Bourgeois v. U.S. Dep’t of Justice, et al., 
12-cv-0782

Lee v. Barr, 19-cv-2559

Purkey v. Barr, et al., 19-cv-03214

MEMORANDUM OPINION

On July 25th of this year, the U.S. Department of Justice (“DOJ”) announced plans to
execute five people. See Press Release, Dep’t of Justice, Federal Government to Resume Capital
Punishment After Nearly Two Decade Lapse (July 25, 2019), https://www.justice.gov/opa/
pr/federal-government-resume-capital-punishment-after-nearly-two-decade-lapse. The DOJ
intends to execute Daniel Lewis Lee on December 9, 2019; Lezmond Mitchell on December 11,
2019; Wesley Ira Purkey on December 13, 2019; Alfred Bourgeois on January 13, 2020; and
Dustin Lee Honken on January 15, 2020. Id. To implement these executions, the Federal
Bureau of Prisons (“BOP”) adopted a new execution protocol: the “2019 Protocol.” Id; (ECF No.
39-1 (“Administrative R.”) at 1021–1075).
Four of the five individuals with execution dates1 (collectively, “Plaintiffs”), have filed
complaints against the DOJ and BOP (collectively, “Defendants”), alleging that the 2019
 1 Mitchell has not filed a complaint in this court.


Protocol is unlawful and unconstitutional on numerous grounds.2 See Purkey v. Barr, 19-cv03214 (D.D.C.), Doc. # 1 (Oct. 25, 2019); Lee v. Barr, 1:19-cv-02559 (D.D.C.), Doc. #1 (Aug.
23, 2019); Bourgeois v. U.S. Dep’t of Justice, et al., 1:12-cv-00782 (D.D.C.), Doc. # 1 (May 5,
2012); ECF. No. 38 (“Honken Compl.”). The court consolidated the cases and ordered Plaintiffs
to complete the necessary 30(b)(6) depositions on or before February 29, 2020 and to amend
their complaints on or before March 31, 2020. (See ECF No. 1 (“Consolidation Order”); Min.
Entry, Aug. 15, 2019.) Because Plaintiffs are scheduled to be executed before their claims can
be fully litigated, they have asked this court, pursuant to Federal Rule of Civil Procedure 65 and
Local Rule 65.1, to preliminarily enjoin the DOJ and BOP from executing them while they
litigate their claims. (ECF No. 34 (“Purkey Mot. for Prelim. Inj.”); ECF No. 29 (“Honken Mot.
for Prelim. Inj.”); ECF No. 13 (“Lee Mot. for Prelim. Inj.”); ECF No. 2 (“Bourgeois Mot. for
Prelim. Inj.”)) Having reviewed the parties’ filings, the record, and the relevant case law, and for
the reasons set forth below, the court hereby GRANTS Plaintiffs’ Motions for Preliminary
Injunction.

I. BACKGROUND

Beginning in 1937, Congress required federal executions to be conducted in the manner
prescribed by the state of conviction. See 50 Stat. § 304 (former 18 U.S.C. 542 (1937)),
recodified as 62 Stat. § 837 (former 18 U.S.C. 3566). After the Supreme Court instituted a de

2 Bourgeois’ complaint was filed in 2012 and relates to a separate execution protocol. See
Bourgeois v. U.S. Dep’t of Justice, et al., 1:12-cv-00782 (D.D.C.), Doc. # 1 (May 5, 2012). In
addition, his Motion for Preliminary Injunction (ECF. No. 2 (“Bourgeois Mot. for Prelim. Inj.”))
does not articulate his bases for a preliminary injunction, but instead argues that a preliminary
injunction is warranted because the plaintiffs in the Roane litigation were granted a preliminary
injunction. Despite the shortcomings of Bourgeois’ briefing, this court has determined that he
meets the requirements of a preliminary injunction, as do the three other plaintiffs in the
consolidated case, whose motions are fully briefed.

facto moratorium on the death penalty in Furman v. Georgia, 408 U.S. 238, 239–40 (1972), and
then lifted it in Gregg v. Georgia, 428 U.S. 153, 187 (1976), Congress reinstated the death
penalty for certain federal crimes but did not specify a procedure for implementation. See AntiDrug Abuse Act of 1988, Pub. L. 100–690, § 7001, 102 Stat. 4181 (enacted Nov. 18, 1988).
Four years later, under the direction of then-Attorney General William Barr, the DOJ published a
proposed rule to establish a procedure for implementing executions. Implementation of Death
Sentences in Federal Cases, 57 Fed. Reg. 56536 (proposed Nov. 30, 1992). The proposed rule
noted that the repeal of the 1937 statute “left a need for procedures for obtaining and executing
death orders.” Id. The final rule, issued in 1993, provided a uniform method and place of
execution. See 58 Fed. Reg. 4898 (1993), codified at 28 C.F.R. pt. 26 (setting method of
execution as “intravenous injection of a lethal substance.”)
But a year later, Congress reinstated the traditional approach of following state practices
through passage of the Federal Death Penalty Act (“FDPA”). See Pub. L. No. 103–322, 108
Stat. 1796 (1994), codified at 18 U.S.C. §§ 3591–3599. The FDPA establishes that the U.S.
Marshal “shall supervise implementation of the sentence in the manner prescribed by the law of
the State in which the sentence is imposed.” Id. § 3596(a). The FDPA provides no exceptions to
this rule and does not contemplate the establishment of a separate federal execution procedure.
Plaintiffs’ cases are governed by the FDPA because when the death penalty portions of the
ADAA were repealed in 2006, the FDPA was “effectively render[ed] . . . applicable to all federal
death-eligible offenses.” United States v. Barrett, 496 F.3d 1079, 1106 (10th Cir. 2007).
Given the conflict between the FDPA’s state-by-state approach and the uniform federal
approach adopted by DOJ’s 1993 rule (28 C.F.R. pt. 26), the DOJ and BOP supported proposed
legislation to amend the FDPA to allow them to carry out executions under their own procedures.

One bill, for example, would have amended § 3596(a) to provide that the death sentence “shall
be implemented pursuant to regulations prescribed by the Attorney General.” H.R. 2359, 104th
Cong. § 1 (1995). In his written testimony supporting the bill, Assistant Attorney General
Andrew Fois wrote that “H.R. 2359 would allow Federal executions to be carried out . . .
pursuant to uniform Federal regulations” and that “amending 18 U.S.C. § 3596 [would] allow for
the implementation of Federal death sentences pursuant to Federal regulations promulgated by
the Attorney General.” Written Testimony on H.R. 2359 Before the Subcomm. on Crime of the
H. Comm. on the Judiciary, 104th Cong. 1 (1995) (Statement of Andrew Fois, Assistant Att’y
Gen. of the United States). None of the proposed amendments were enacted, and the FDPA
continues to require the federal government to carry out executions in the manner prescribed by
the states of conviction.
In 2005, three individuals facing death sentences sued, alleging that their executions were
to be administered under an unlawful and unconstitutional execution protocol. Roane v.
Gonzales, 1:05-cv-02337 (D.D.C.), Doc. #1 ¶ 2. The court preliminarily enjoined their
executions. Roane, Doc. #5. Three other individuals on death row intervened, and the court
enjoined their executions. See Roane, Doc. #23, 27, 36, 38, 67, 68. A seventh individual on
death row subsequently intervened and had his execution enjoined as well. See id. Doc. #333.
During this litigation, the government produced a 50-page document (“2004 Main Protocol”)
outlining BOP execution procedures. Roane, Doc. #179–3. The 2004 Main Protocol cites 28
C.F.R. pt. 26 for authority and does not mention the FDPA. See id. at 1. The government then
produced two three-page addenda to the 2004 Main Protocol. See Roane, Doc. #177-1
(Addendum to Protocol, Aug. 1, 2008) (the “2008 Addendum”); Roane, Doc. #177-3
(Addendum to Protocol, July 1, 2007) (“2007 Addendum”). In 2011 the DOJ announced that the

BOP did not have the drugs needed to implement the 2008 Addendum. See Letter from Office of
Attorney General to National Association of Attorneys General, (Mar. 4, 2011),
https://files.deathpenaltyinfo.org/legacy/documents/2011.03.04.Holder.Letter.pdf. The
government told the court that the BOP “has decided to modify its lethal injection protocol but
the protocol revisions have not yet been finalized.” Roane, Doc. #288 at 2. In response, the
court stayed the Roane litigation.
No further action was taken in the cases for seven years, until July of this year, when
DOJ announced a new addendum to the execution protocol (“2019 Addendum”) (Administrative
R. at 870–871), that replaces the three-drug protocol of the 2008 Addendum with a single drug:
pentobarbital sodium. See id at ¶ C. In addition to the 2019 Addendum, the BOP adopted a new
protocol to replace the 2004 Main Protocol (the 2019 Main Protocol). (Administrative R. at
1021–1075.)
The court held a status conference in the Roane action on August 15, 2019. (See Min.
Entry, Aug. 15, 2019). In addition to the Roane plaintiffs, the court heard from counsel for three
other death-row inmates, including Bourgeois, all of whom cited the need for additional
discovery on the new protocol. (See ECF No. 12 (“Status Hr’g Tr.”)). The government
indicated that it was unwilling to stay the executions, and the court bifurcated discovery and
ordered Plaintiffs to complete 30(b)(6) depositions by February 28, 2020 and to file amended
complaints by March 31, 2020. (See Min. Entry, Aug. 15, 2019.)
Lee filed a complaint challenging the 2019 Addendum on August 23, 2019 (see Lee v.
Barr, 1:19-cv-02559 (D.D.C.), Doc. 1), and a motion for a preliminary injunction on September
27, 2019, (Lee Mot. for Prelim. Inj.). On August 29, 2019 Bourgeois moved to preliminarily
enjoin his execution. (Bourgeois Mot. for Prelim. Inj.) Honken filed an unopposed motion to

intervene in Lee v. Barr, which was granted. (ECF No. 26. (“Honken Mot. to Intervene”).) He
then filed a motion for a preliminary injunction on November 5, 2019. (Honken Mot. for Prelim.
Inj.) Purkey filed a complaint and a motion for preliminary injunction under a separate case
number, 1:19-cv-03214, which was consolidated with Roane. Thus, the court now has before it
four fully briefed motions to preliminarily enjoin the DOJ and BOP from executing Lee, Purkey,
Bourgeois, and Honken.

II. ANALYSIS

A preliminary injunction is an “extraordinary remedy” that is “never awarded as of
right.” Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 24 (2008) (citing Munaf v. Geren, 553
U.S. 674, 689–90 (2008)). Courts consider four factors on a motion for a preliminary injunction:
(1) the likelihood of plaintiff’s success on the merits, (2) the threat of irreparable harm to the
plaintiff absent an injunction, (3) the balance of equities, and (4) the public interest. Id. at 20
(citations omitted); John Doe Co. v. Consumer Fin. Prot. Bureau, 849 F.3d 1129, 1131 (D.C.
Cir. 2017). The D.C. Circuit has traditionally evaluated claims for injunctive relief on a sliding
scale, such that “a strong showing on one factor could make up for a weaker showing on
another.” Sherley v. Sebelius, 644 F.3d 388, 392 (D.C. Cir. 2011). It has been suggested,
however, that a movant’s showing regarding success on the merits “is an independent, freestanding requirement for a preliminary injunction.” Id. at 393 (quoting Davis v. Pension Ben.
Guar. Corp., 571 F.3d 1288, 1296 (D.C. Cir. 2009) (Kavanaugh, J., concurring)). Here,
Plaintiffs’ claims independently satisfy the merits requirement.
A. Likelihood of Success on the Merits
Plaintiffs allege, inter alia, that the 2019 Protocol exceeds statutory authority and
therefore under the Administrative Procedure Act (“APA”), it must be set aside. Under the APA,

a reviewing court “shall . . . hold unlawful and set aside agency action, findings, and conclusions
found to be . . . in excess of statutory jurisdiction, authority, or limitations, or short of statutory
right.” 5 U.S.C. § 706(2)(C). Plaintiffs argue that the 2019 Protocol exceeds statutory authority
by establishing a single procedure for all federal executions rather than using the FDPA’s stateprescribed procedure. (Purkey Mot. for Prelim. Inj. at 16; Honken Mot. for Prelim. Inj. at 34–35;
Lee Mot. for Prelim. Inj. at 5–6, 17). Given that the FDPA expressly requires the federal
government to implement executions in the manner prescribed by the state of conviction, this
court finds Plaintiffs have shown a likelihood of success on the merits as to this claim.
Defendants argue that the 2019 Protocol “is not contrary to the FDPA” because the
authority given to DOJ and BOP through § 3596(a) of the FDPA “necessarily includes the
authority to specify . . . procedures for carrying out the death sentence.” (ECF No. 16 (“Defs.
Mot. in Opp. To Lee Mot. for Prelim. Inj.”) at 34.) Section 3596(a) states:
When the [death] sentence is to be implemented, the Attorney
General shall release the person sentenced to death to the custody of
a United States marshal, who shall supervise implementation of the
sentence in the manner prescribed by the law of the State in which
the sentence is imposed. If the law of the State does not provide for
implementation of a sentence of death, the court shall designate
another State, the law of which does provide for the implementation
of a sentence of death, and the sentence shall be implemented in the
latter State in the manner prescribed by such law.
18 U.S.C. § 3596(a) (emphasis added). Because a United States Marshal is to
“supervise” the process, it does appear that at least some authority is granted to the Marshal. But
it goes too far to say that such authority necessarily includes the authority to decide procedures
without reference to state policy. The statute expressly provides that “the implementation of the
sentence” shall be done “in the manner” prescribed by state law. Id. Thus, as between states and
federal agencies, the FDPA gives decision-making authority regarding “implementation” to the

former. Accordingly, the 2019 Protocol’s uniform procedure approach very likely exceeds the
authority provided by the FDPA.
Defendants contest the meaning of the words “implementation” and “manner.” As they
interpret § 3596(a), Congress only gave the states the authority to decide the “method” of
execution, e.g., whether to use lethal injection or an alternative, not the authority to decide
additional procedural details such as the substance to be injected or the safeguards taken during
the injection. The court finds this reading implausible. First, the statute does not refer to the
“method” of execution, a word with particular meaning in the death penalty context. See id.
Instead, it requires that the “implementation” of a death sentence be done in the “manner”
prescribed by the state of conviction. Id. “Manner” means “a mode of procedure or way of
acting.” Manner, MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY 756 (11th ed. 2014.) The
statute’s use of the word “manner” thus includes not just execution method but also execution
procedure. To adopt Defendants’ interpretation of “manner” would ignore its plain meaning. As
one district court concluded, “the implementation of the death sentence [under the FDPA]
involves a process which includes more than just the method of execution utilized.” United
States v. Hammer, 121 F. Supp. 2d 794, 798 (M.D. Pa. 2000). 3
 3 Defendants cite three cases to suggest that “manner” means “method”: Higgs v. United States,
711 F. Supp. 2d 479, 556 (D. Md. 2010); United States v. Bourgeois, 423 F.3d 501 (5th Cir.
2005); and United States v. Fell, No. 5:0-cr-12-01, 2018 WL 7270622 (D. Vt. Aug. 7 2018).
Higgs interpreted the FDPA to require the federal government to follow a state’s chosen method
of execution but not to follow any other state procedure. 711 F. Supp. 2d at 556. This
interpretation, however, was stated in dicta and is not supported by persuasive reasoning. Id.
Bourgeois did not reach the question of what the words “implementation” and “manner” mean in
18 U.S.C. § 3596(a). 423 F.3d 501 (5th Cir. 2005). Instead, it evaluated only whether the
sentence violated Texas law. Id. at 509. The opinion appeared to assume that § 3596(a) only
requires the federal government to follow the state-prescribed method of execution, but it
provided no basis for that assumption. Id.at 509. In Fell, the district court held that the creation
of a federal death chamber does not violate the FDPA. Fell, slip op., at 4. This holding affirms
the notion that the federal government has some authority in execution procedure (such as the

Moreover, legislative efforts to amend the FDPA further support this court’s
interpretation of the terms “manner” and “implementation.” As noted above, in 1995, the year
after the FDPA became law, the DOJ supported bills amending the statute to allow the DOJ and
BOP to create a uniform method of execution, indicating that the FDPA as drafted did not permit
federal authorities to establish a uniform procedure. The amendments were never enacted.
Defendants argue that reading the FDPA as requiring adherence to more than the state’s
prescribed method of execution leads to absurd results. (See, e.g., Defs. Mot. in Opp. to Purkey
Mot. for Prelim. Inj. at 28.) They contend that if the state’s choice of drug is to be followed, the
federal government would have to “stock all possible lethal agents used by the States.” Id. But
the FDPA contemplates and provides for this very situation: it permits the United States Marshal
to allow the assistance of a state or local official and to use state and local facilities. 18 U.S.C.
§ 3596(a). Moreover, the practice of following state procedure and using state facilities has a
long history in the United States. Before the modern death penalty, the relevant statute provided
that the:
manner of inflicting the punishment of death shall be the manner
prescribed by the laws of the State within which the sentence is
imposed. The United States marshal charged with the execution of
the sentence may use available State or local facilities and the
services of an appropriate State or local official . . .
50 Stat. § 304 (former 18 U.S.C. 542 (1937)), recodified as 62 Stat. § 837 (former 18 U.S.C.
3566) (1948). The federal government carried out executions in accordance with this statute for
decades, including those of Julius and Ethel Rosenberg in New York’s Sing Sing prison, and
Victor Feguer in the Iowa State Penitentiary. See Feguer v. United States, 302 F.2d 214, 216

place of execution), but it does not conflict with the proposition that the FDPA requires the
federal government to follow state procedure as to more than simply the method of execution.

(8th Cir. 1962) (noting sentence of death by hanging imposed pursuant to § 3566 and Iowa law);
Rosenberg v. Carroll, 99 F. Supp. 630, 632 (S.D.N.Y. 1951) (applying § 3566 to uphold state
law confinement prior to execution). Thus, far from creating absurd results, requiring the federal
government to follow more than just the state’s method of execution is consistent with other
sections of the statute and with historical practices. For all these reasons, this court finds that the
FDPA does not authorize the creation of a single implementation procedure for federal
executions.
Defendants argue that the 2019 Protocol derives authority from 28 C.F.R. § 26.3(a),
which provides that executions are to be carried out at the time and place designated by the
Director of the BOP, at a federal penal or correctional institution, and by injection of a lethal
substance or substances under the direction of the U.S. Marshal. (Defs. Mot. in Opp. to Lee Mot.
for Prelim. Inj. at 31.) However, this argument is undercut by the fact that, as with the 2019
Protocol itself, 28 C.F.R. Pt. 26 also conflicts with the FDPA. As noted above, 28 C.F.R. Pt. 26
was promulgated in 1993 (before the FDPA was enacted) to implement the Anti-Drug Abuse Act
of 1988, 21 U.S.C. § 848(e) (the “ADAA”), which does not specify how federal executions are
to be carried out. 28 C.F.R. § 26.3(a) filled that gap by providing an implementation procedure.
But when Congress passed its own requirements for the implementation procedure in the FDPA,
those requirements conflicted with 28 C.F.R. § 26.3(a).
Defendants concede that “where a regulation contradicts a statute, the latter prevails.”
(Defs. Mot. in Opp. to Lee Mot. for Prelim. Inj. at 31.) They argue instead that the regulation
does not conflict with the FDPA as applied to Plaintiffs because lethal injection (the method
required by 28 C.F.R. § 26.3(a)(4)) is either permitted or required in the Plaintiffs’ states of

conviction (Texas, Arkansas, Missouri, and Indiana4
). (ECF No. 37 (“Defs. Mot. in Opp. to
Purkey Mot. for Prelim. Inj.”) at 26–27; ECF No. 36 (“Defs. Mot. in Opp. to Honken Mot. for
Prelim. Inj.”) at 19–20; Defs. Mot. in Opp. to Lee Mot. for Prelim. Inj at 31–32.)5 Two of those
states—Texas and Missouri—use a single dose of pentobarbital for executions. (Administrative
R. at 99, 104.)
But this overlap does not, in and of itself, reconcile 28 C.F.R. pt. 26 with the FDPA. 28
C.F.R. Pt. 26 remains inconsistent with the FDPA because it establishes a single federal
procedure, while the FDPA requires state-prescribed procedures. In addition, 28 C.F.R. §
26.3(a)(2) requires use of a federal facility, while the FDPA permits the use of state facilities.
Compare 28 C.F.R. § 26.3(a)(2) with 18 U.S.C. § 3597. There are also inconsistencies between
the FDPA’s required state procedures and the 2019 Protocol. For example, states of conviction
establish specific and varied safeguards on how the intravenous catheter is to be inserted.6
 The
2019 Protocol, however, provides only that the method for insertion of the IV is to be selected
based on the training, experience, or recommendation of execution personnel. (Administrative
R. at 872.) Thus, the fact that the states of conviction and 28 C.F.R. § 26.3(a) all prescribe lethal
injection as the method of execution is not enough to establish that the regulation is valid as
applied to Plaintiffs.
 4 Honken was convicted in Iowa, which does not have a death penalty. The FDPA requires a
court to designate a death penalty state for any individual convicted in a state without the death
penalty, and the court designated Indiana. (Honken Mot. for Prelim. Inj. at 37.)
5 Defendants do not assert this argument as to Bourgeois (likely because he did not raise 28
C.F.R. Part 26 in his motions), but does include Texas’ execution protocol—which requires
lethal injection—in the Administrative Record. (Administrative R. at 83-91.)
6 See, e.g., Administrative R. at 90-91 (Texas); Administrative R. at 70-71 (Missouri); Honken
Mot. for Prelim. Inj. Ex. 6 at 16–17 (Indiana).

Defendants further argue that even if 28 C.F.R. § 26.3(a) did not conflict with the FDPA
by requiring lethal injection, the DOJ would still adopt lethal injection as its method of execution
for these Plaintiffs. (See e.g., Defs. Mot. in Opp. to Lee Mot. for Prelim. Inj at 32–33.) On this
basis, they ask the court to sever section 26.3(a)(4)—which establishes lethal injection as the
federal method—and affirm the rest of 28 C.F.R. § 26.3(a). Id. Defendants cite Am. Petroleum
Inst. V. EPA, 862 F.3d 50 (D.C. Cir. 2017), for the proposition that the court “will sever and
affirm a portion of an administrative regulation” if it can say “without any substantial doubt that
the agency would have adopted the severed portion on its own.” Id. at 71 (emphasis added). The
court declines to take this approach for several reasons. First, it is premised on the strained
reading of the FDPA that this court has already rejected. Moreover, the court cannot say
“without any substantial doubt” that DOJ “would have adopted the severed portion on its own.”
Id. Even were the court to engage in such speculation, it seems plausible that if 28 C.F.R. §
26.3(a) instructed the BOP to follow state procedure, rather than to implement lethal injection,
that BOP would in fact adopt whatever specific procedures were required by each state. Finally,
even if the court severed the language in 28 C.F.R. § 26.3(a) that conflicts with the FDPA,
another problem would arise: that is the very language that purportedly authorizes the creation of
a single federal procedure. If the court severs it, then 28 C.F.R. § 26.3(a) would no longer
contain the support for a single federal procedure that Defendants claim it does.
More importantly, Defendants’ arguments regarding the regulation’s applicability to
these Plaintiffs take us far afield from the task at hand. The arguments do not control the court’s
inquiry of whether the 2019 Protocol exceeds statutory authority. Based on the reasoning set
forth above, this court finds that insofar as the 2019 Protocol creates a single implementation
procedure it is not authorized by the FDPA. This court further finds that because 28 C.F.R. §

26.3 directly conflicts with the FDPA, it does not provide the necessary authority for the 2019
Protocol’s uniform procedure. There is no statute that gives the BOP or DOJ the authority to
establish a single implementation procedure for all federal executions. To the contrary,
Congress, through the FDPA, expressly reserved those decisions for the states of conviction.
Thus, Plaintiffs have established a likelihood of success on the merits of their claim that the 2019
Protocol exceeds statutory authority. Given this finding, the court need not reach Plaintiffs’
other claims.
B. Irreparable Harm
To constitute irreparable harm, “the harm must be certain and great, actual and not
theoretical, and so imminent that there is a clear and present need for equitable relief to prevent
irreparable harm,” and it “must be beyond remediation.” League of Women Voters of U.S. v.
Newby, 838 F. 3d 1, 7–8 (D.C. Cir. 2016) (citing Chaplaincy of Full Gospel Churches v.
England, 454 F.3d 290, 297 (D.C. Cir. 2006)) (internal quotation marks and brackets omitted).
Here, absent a preliminary injunction, Plaintiffs would be unable to pursue their claims,
including the claim that the 2019 Protocol lacks statutory authority, and would therefore be
executed under a procedure that may well be unlawful. This harm is manifestly irreparable.
Other courts in this Circuit have found irreparable harm in similar circumstances. See,
e.g., Damus v. Nielsen, 313 F. Supp. 3d 317, 342 (D.D.C. 2018) (finding irreparable injury where
plaintiffs faced detention under challenged regulations); Stellar IT Sols., Inc. v. U.S.C.I.S., Civ.
A. No. 18-2015 (RC), 2018 WL 6047413, at *11 (D.D.C. Nov. 19, 2018) (finding irreparable
injury where plaintiff would be forced to leave the country under challenged regulations); FBME
Bank Ltd. v. Lew, 125 F. Supp. 3d 109, 126–27 (D.D.C. 2015) (finding irreparable injury where
challenged regulations would threaten company’s existence); N. Mariana Islands v. United

States, 686 F. Supp. 2d 7, 19 (D.D.C. 2009) (finding irreparable injury when challenged
regulations would limit guest workers).
Plaintiffs have clearly shown that, absent injunctive relief, they will suffer the irreparable
harm of being executed under a potentially unlawful procedure before their claims can be fully
adjudicated. Given this showing, the court need not reach the various other irreparable harms
that Plaintiffs allege.
C. Balance of Equities
Defendants assert that if the court preliminarily enjoins the 2019 Protocol they will suffer
the harm of a delayed execution date. (See, e.g., Def. Mot. in Opp. to Purkey Mot. for Prelim.
Inj. at 43.) While the government does have a legitimate interest in the finality of criminal
proceedings, the eight years that it waited to establish a new protocol undermines its arguments
regarding the urgency and weight of that interest. Other courts have found “little potential for
injury” as a result of a delayed execution date. See, e.g., Harris v. Johnson, 323 F. Supp. 2d 797,
809 (S.D. Tex. 2004). This court agrees that the potential harm to the government caused by a
delayed execution is not substantial.
D. Public Interest
The public interest is not served by executing individuals before they have had the
opportunity to avail themselves of legitimate procedures to challenge the legality of their
executions. On the other hand, “[t]he public interest is served when administrative agencies
comply with their obligations under the APA.” N. Mariana Islands, 686 F. Supp. 2d at 21.
Accordingly, this court finds that the public interest is served by preliminarily enjoining the
execution of the four Plaintiffs because it will allow them to determine whether administrative
agencies acted within their delegated authority, and to ensure that they do so in the future.

III. CONCLUSION

This court finds that at least one of Plaintiffs’ claims has a likelihood of success on the
merits and that absent a preliminary injunction, they will suffer irreparable harm. It further finds
that the likely harm that Plaintiffs would suffer if this court does not grant injunctive relief far
outweighs any potential harm to the Defendants. Finally, because the public is not served by
short-circuiting legitimate judicial process, and is greatly served by attempting to ensure that the
most serious punishment is imposed lawfully, this court finds that it is in the public interest to
issue a preliminary injunction. Accordingly, each of Plaintiffs’ motions for preliminary
injunctions is hereby GRANTED.

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