FILED

U.S. COURT OF APPEALS

ELEVENTH CIRCUIT

 SEPTEMBER 7, 2011

JOHN LEY

CLERK

 [PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

 FOR THE ELEVENTH CIRCUIT

 ________________________

 No. 11-13891 

 ________________________

 D.C. Docket No. 3:11-cv-00700-MMH-TEM

MANUEL VALLE, 

Plaintiff-Appellant,

versus

STEVEN SINGER, 

in his official capacity as the Warden of Florida State Prison,

TIMOTHY CANNON,

in his official capacity as the Execution Team Leader,

lEDWIN BUSS, 

in his official capacity as the Secretary,

Florida Department of Corrections,

UNKNOWN EXECUTIONERS, 

Defendants-Appellees.
________________________

 Appeal from the United States District Court

 for the Middle District of Florida

 ________________________

(September 7, 2011)

Before CARNES, HULL and WILSON, Circuit Judges.

PER CURIAM:

Manuel Valle is a death row prisoner who is scheduled to be executed by the

State of Florida. The State originally scheduled his execution by lethal injection

for August 2, 2011. The Florida Supreme Court granted a stay to allow a Florida

circuit court to determine whether the State’s use of an altered lethal injection

protocol—one that substituted pentobarbital for sodium thiopental in its three-drug

execution cocktail—violates the Eighth Amendment. Following an evidentiary

hearing, the circuit court denied relief. The Florida Supreme Court affirmed,

lifting its previously issued stay. Valle’s execution was rescheduled for September

6, 2011; this Court’s temporary stay expires September 8, 2011 at 7:00 pm.

Valle also brought suit in federal district court. He filed a complaint under

42 U.S.C. § 1983 and a motion for a temporary restraining order (“TRO”) and

preliminary injunction and to stay his execution. On August 9, the district court

denied his motion, concluding, inter alia, that Valle failed to demonstrate a

2
substantial likelihood of success on the merits of his Eighth Amendment claim—a

prerequisite for injunctive relief.1

 Valle appeals that decision and also asks this

Court to enter a stay of execution so that he can obtain a merits ruling on his

complaint. He concedes that this Court’s recent decisions rejected similar

challenges. Valle seeks to distinguish those cases—allowing Georgia and

Alabama to proceed with executions using pentobarbital instead of sodium

thiopental—because he alleges that Florida, unlike Georgia and Alabama, has a

history of problems with properly effecting executions.2

“A stay of execution is equitable relief which this Court may grant only if

the moving party shows that: (1) he has a substantial likelihood of success on the

merits; (2) he will suffer irreparable injury unless the injunction issues; (3) the stay

would not substantially harm the other litigant; and (4) if issued, the injunction

would not be adverse to the public interest.” DeYoung v. Owens, 646 F.3d 1319,

1324 (11th Cir. 2011) (internal quotation marks omitted). “We review the district

court’s denial of [defendant’s] motions for a TRO and stay of execution for abuse

1

 Valle also filed a second motion for a temporary restraining order seeking to delay his

execution. The district court noted that, except for the procedural history, the motion was

virtually identical to the first motion. Therefore, it denied the second motion for the same

reasons stated in the previous order.

2

 Valle notes in his brief that his complaint before the district court raised four separate

claims. His filing in this court, however, focuses exclusively on the Eighth Amendment claim. 

Accordingly, we do the same.

3
of discretion.” Id. at 1324 n.2. 

“To state an Eighth Amendment claim, [the defendant] must demonstrate

that (1) the State is being deliberately indifferent (2) to a condition that poses a

substantial risk of serious harm to him. In the lethal injection context, this standard

requires an inmate to show an objectively intolerable risk of harm that prevents

prison officials from pleading that they were subjectively blameless for purposes of

the Eighth Amendment.” Id. at 1325 (internal quotations marks and citations

omitted).

We conclude that Valle has not demonstrated that he has a substantial

likelihood of success on the merits of his Eighth Amendment claim for the reasons

set out in Part C.1 of the district court’s thorough and well-reasoned discussion of

the lethal injection issue. We adopt that part of the district court’s opinion as our

own. For the convenience of the reader, we reproduce that part of the opinion, as

well as some introductory parts of it, as an appendix to this one.3

Because Valle has failed to show a substantial likelihood of success on the

merits, we need not address the other three requirements for issuance of a stay of

execution. See DeYoung, 646 F.3d at 1328 (“DeYoung has not demonstrated a

3

 The appendix is part of the district court’s order but with the district court’s Westlaw

citations updated to the Federal Reporter and all quotations checked for accuracy.

4
substantial likelihood of success on the merits of his claims. Therefore, the Court

denies DeYoung’s motion for a stay of execution in this Court.”); Parker v. State

Bd. of Pardons and Paroles, 275 F.3d 1032, 1035 (11th Cir. 2001) (holding that

death row inmate who failed to establish substantial likelihood of success on merits

of his clemency claims was not entitled to temporary restraining order, preliminary

injunction, or stay of execution). 

For the foregoing reasons, we conclude that Valle does not satisfy the first

requirement for the issuance of a stay of execution, and thus we deny Valle’s

motion.4

MOTION FOR STAY OF EXECUTION IS DENIED; DISTRICT

COURT’S ORDER IS AFFIRMED.

4

 Based on the same rationale, we conclude that the district court did not abuse its

discretion in denying Valle’s motion for a stay of execution.

5
APPENDIX

UNITED STATES DISTRICT COURT 

MIDDLE DISTRICT OF FLORIDA 

JACKSONVILLE DIVISION

MANUEL VALLE,

Plaintiff,

v. Case No. 3:11-cv-700-J-34TEM

STEVEN SINGER, 

etc.; et al.,

Defendants.

ORDER

A. Introduction

Plaintiff Manuel Valle, a prisoner sentenced to death by the 

State of Florida, was scheduled to be executed by lethal injection 

on Tuesday, August 2, 2011, at 6:00 p.m. On July 18, 2011, Valle, 

represented by counsel, filed a Complaint (Doc. #1) and Memorandum 

of Law and Argument in Support of the Complaint (Memorandum) (Doc.

#2) pursuant to 42 U.S.C. § 1983. In the Complaint and Memorandum, 

Valle challenges the State of Florida's lethal injection procedures 

and asserts that the Florida Department of Corrections' recent 

change from sodium thiopental to pentobarbital, as the first of 

three drugs used in the lethal injection protocol, constitutes 

cruel and unusual punishment in violation of the Eighth Amendment 

and also violates his rights protected by the Due Process and Equal 

Protection Clauses of the Fourteenth Amendment of the United States 

Constitution. Additionally, he alleges that the Florida Department 

of Corrections' current policies and procedures and its history of 

failing to follow its own written execution procedures, combined
2

with the recent substitution of pentobarbital, will unnecessarily 

cause a risk of the infliction of pain and suffering and will 

create a substantial risk of serious harm to Valle at his upcoming 

execution. As relief, Valle seeks declaratory and injunctive 

relief aimed at stopping the State of Florida from executing him 

using its lethal injection protocol, as well as a stay of execution 

to allow his § 1983 action to be fully and fairly litigated without 

an imminent execution date looming.

* * *

B. Background

Following lengthy state trial court proceedings which included 

two separate trials and three sentencing proceedings, Valle was 

sentenced to death for the 1978 murder of Officer Louis Pena of the 

Coral Gables Police Department.3 Valle appealed his sentence to 

the state supreme court, which denied his direct appeal on May 2,

1991. Valle v. State, 581 So.2d 40 (Fla. 1991). Valle then 

petitioned the United States Supreme Court for a writ of

3 In the trials, Valle was also convicted of other non-capital 

crimes, including the attempted murder of another Coral Gables 

Police Officer, Gary Spell, and possession of a firearm by a 

convicted felon. See Valle v. State

1985), , 474 So.2d 796, 798 (Fla.cert. granted, judgment vacated by Valle v. Florida

U.S. 1102 (1986).

, 476
3

certiorari, which was denied on December 2, 1991. Valle v.

Florida

In 2000, the Florida Legislature established lethal injection 

as the method of execution in the State of Florida.

, 502 U.S. 986 (1991). Thus, Valle's conviction and 

sentence became final on December 2, 1991.

Lightbourne v.

McCollum, 969 So.2d 326, 341-42 (Fla. 2007), cert. denied

1059 (2008). Although the applicable state statute provides for 

the method of execution, it does not set forth the specific 

procedures or drugs to be used. 

, 553 U.S.

Id. at 342. Instead, the 

legislature delegated the responsibility for establishing 

appropriate procedures to the Florida Department of Corrections 

(FDOC). Id. Until recently, lethal injection in the State of 

Florida was accomplished by a three-drug protocol utilizing sodium 

thiopental to render the condemned person unconscious, followed by 

the administration of pancuronium bromide, a neuromuscular blocking 

agent, and finally a dose of potassium chloride. Id. at 345. 

According to the Complaint, the FDOC, on June 9, 2011, released a 

new lethal injection procedure in which it publically advised, for 

the first time, that the State intended to replace sodium 

thiopental with pentobarbital. See

65-67. Additionally, on June 30, 2011, the State announced that 

Valle's execution was scheduled for August 2, 2011.

Complaint at 22-23, paragraphs

See

In this action, pursuant to 42 U.S.C. § 1983, Valle asserts 

that Florida's intention to execute him using pentobarbital in the 

three-drug lethal injection sequence, instead of sodium thiopental,

Motion to 

Dismiss at 2.
4

violates his Eighth Amendment right to be free from cruel and 

unusual punishment. He asserts that, as a result of this 

substitution, he may be conscious after being injected with 

pentobarbital, and thus subjected to significant pain during the 

administration of the final two drugs. In support of his claims, 

Valle points to a report and an affidavit provided by Dr. David B. 

Waisel, M.D. See P. Ex. B, Waisel's Expert Report and Affidavit. 

In his report, Dr. Waisel expresses concern regarding the lack of 

clinical history related to the use of pentobarbital for 

anesthesia. See generally Id.

Valle asserts that "[t]he combination of significant unknowns 

from a lack of clinical history related to using pentobarbital to

Additionally, in his affidavit, Dr. 

Waisel opines that, based on his reviews of descriptions of the 

June 23, 2011 execution of Roy Willard Blankenship, pentobarbital 

may inadequately anesthetize the inmate and subject him to a 

substantial risk of serious harm and extreme, torturous and 

needless pain and suffering. Valle also relies on a position paper 

released by Lundbeck, Inc., the manufacturer of pentobarbital, 

which he contends reflects the manufacturer's judgment that the 

drug is "untested and unsafe for use in judicial lethal 

injections," has not been approved by the Food and Drug 

Administration (FDA) to induce anesthesia, has no relevant clinical 

history, and "no relevant clinical reference doses on which to 

determine what dose would cause a clinically adequate depth of 

anesthesia, much less an adequate lethal injection dose." 

Complaint at 6, paragraph 24.
5

induce anesthesia, inadequate implementation of procedural 

safeguards and a cavalier attitude toward lethal injection puts 

[him] at risk for serious undue pain and suffering." Id. Thus, 

Valle relies not only on the recent substitution of pentobarbital, 

but also upon his concerns regarding the inadequate training and 

experience of execution team members, inadequate monitoring of the 

IV lines, inadequate monitoring of consciousness by unqualified 

individuals, FDOC's failure to conduct meaningful review of its 

processes, as well as its failure to respond to public information 

requests. Id.

Defendants have filed a Motion to Dismiss, in which they 

assert that Valle's claims are barred by the applicable statute of 

limitations, and further that he has failed to state any claim upon 

which relief can be granted. Motion to Dismiss at 3-4, 12-17. In 

Plaintiff's Response, recognizing that many of his arguments have 

been addressed by the decisions of the United States Supreme Court 

in 

at 15-22.

Baze v. Rees, 553 U.S. 35, 50 (2008), and the Florida Supreme 

Court in Lightbourne

It is only within the past year that Mr. Valle 

learned that U.S. prisons across the country 

have been obtaining the drugs used in 

executions illegally. It is only recently 

that Mr. Valle learned that the Defendants 

have failed to comply with even the 

administrative requirements that were written 

into their own procedures. It is only since 

June 9, 2011[,] that Mr. Valle learned that 

the Defendants have substituted an untested 

and non-FDA approved drug for sodium 

thiopental. It has only been since the 

warrant for his execution was signed that he

, Valle contends that his challenges are new 

and different because:
6

learned that the sole manufacturer of 

pentobarbital, Lundbeck, Inc., has issued a 

warning that it cannot guarantee the safety 

and efficacy of the drug in the execution of 

human beings. And it is only in the past week 

that Mr. Valle learned that there have been 

more botched executions around the country 

where pentobarbital was used.

Plaintiff's Response at 7. In sum, Valle asserts that the 

replacement of sodium thiopental with pentobarbital when combined 

with Florida's history and the deficiencies in its procedures 

subjects him to a substantial risk of serious harm. As such, he 

seeks a temporary restraining order and an immediate stay of his 

impending execution.

C. Motion to Stay

Very recently, the Eleventh Circuit Court of Appeals 

reiterated the requirements for a stay of execution:

A stay of execution is equitable relief which 

this Court may grant "only if the moving party 

shows that: (1) he has a substantial 

likelihood of success on the merits; (2) he 

will suffer irreparable injury unless the 

injunction issues; (3) the stay would not 

substantially harm the other litigant; and (4) 

if issued, the injunction would not be adverse 

to the public interest."

DeYoung v. Owens, (DeYoung II4), 646 F.3d 1319,1324 (11th Cir.

2011) (quoting Powell v. Thomas, 641 F.3d 1255, 1257 (11th Cir.

2011) (per curiam), cert. denied, 131 S.Ct. 2487 (2011))

4 In DeYoung II, the Eleventh Circuit affirmed the decision in 

DeYoung v. Owens, Case No. 1:11-cv-2324-SCJ (N.D. Ga. 2011), Order 

(Doc. #27), filed July 20, 2011 (DeYoung I). A copy of DeYoung I

#12).

is appended to Defendants' Notice of Supplemental Authority (Doc.
7

cert. denied, No. 11-5361, 2011 WL 2870756 (U.S. July 20,

2011).

1. Substantial Likelihood of Success on the Merits

As the moving party, Valle bears the burden of establishing 

that he has a substantial likelihood of succeeding on the merits of 

his § 1983 claims raised in this action. Henyard v. Sec'y, Dep't

of Corr

Florida's recent replacement of sodium thiopental with 

pentobarbital in the three-drug lethal injection sequence underlies 

the bulk of Valle's claims in this action.5 Specifically, Valle 

asserts that, under Florida's present protocol, at his upcoming 

execution, he may be conscious after being injected with 

pentobarbital, and thus, able to feel pain during the 

administration of the final two chemicals. Valle's claims brought 

under 42 U.S.C. § 1983 are subject to Florida's four-year personal

., 543 F.3d 644, 647 (11th Cir. 2008) (per curiam). Upon 

review of the record and each of the claims raised in this action, 

the Court determines that Valle's Motion to Stay is due to be 

denied because Valle has failed to meet his burden of establishing 

that he has a substantial likelihood of success on his claims.

injury statute of limitations.6 See Van Poyck v. McCollum, 646 F.3d

5 Florida's June 8, 2011 substitution of pentobarbital for 

sodium thiopental coincides with the substitution made by other 

states within the Eleventh Circuit, both Georgia and Alabama. See

DeYoung I at 4-5 n.2. Indeed, as noted in DeYoung I: "A number of 

states have recently adopted the use of pentobarbital as U.S. 

manufactured sodium thiopental is no longer available following the 

decision of Hospira, Inc., the sole U.S. manufacturer of the drug, 

to discontinue its production." Id.

6 Section 1983 creates a cause of action against any person who 

acts in violation of the constitutional rights of another while
8

865, 866 (11th Cir. 2011) (per curiam) (citing Henyard, 543 F.3d

at 647). Florida adopted lethal injection as a method of 

execution on January 14, 2000. Thereafter, condemned persons, such

as Valle, had thirty days under the statute to select a preferred 

method of execution, or until February 13, 2000. See Henyard

Despite the significant passage of time since February 2004, 

Valle contends that his claims are not barred by the statute of 

limitations, because Florida's substitution of pentobarbital for 

sodium thiopental in the three-drug lethal injection protocol 

constitutes a substantial change in the method of execution. In 

, 543

F.3d at 647. Consequently, to the extent Valle wished to challenge

Florida's intention to execute him by lethal injection, he was

required to bring his § 1983 action within four years of February

13, 2000, i.e., by February 13, 2004, absent a later "significant 

change" in Florida's execution protocol. As previously noted, 

Valle did not file this Complaint until July 18, 2011. Thus, it

appears that Valle's claims in this action would be barred as the

suit was filed well beyond the four- year limitations period.

McNair v. Allen, 515 F.3d 1168, 1174 (11th Cir. 2008), cert. 

denied, 553 U.S. 1098 (2008), the Eleventh Circuit Court of Appeals

acting under color of state law. Here, Valle challenges the 

constitutionality of the execution procedure he is scheduled to 

undergo. Such challenges are appropriately brought under § 1983. 

Hill v. McDonough, 547 U.S. 573, 576 (2006); McNair v. Allen

F.3d 1168, 1176 (11th Cir. 2008) ("[T]he Supreme Court has

, 515

sanctioned the filing of § 1983 claims challenging the 

constitutionality of execution methods."), cert. denied

1098 (2008).

, 553 U.S.
9

concluded that "a method of execution claim accrues on the later of 

the date on which state review is complete, or the date on which

the capital litigant becomes subject to a new or substantially

changed execution protocol." Thus, the Court must consider 

whether Valle has alleged facts supporting a conclusion that

Florida has changed or substantially altered its execution 

protocol.

Not surprisingly, the recent substitution of pentobarbital as 

the first of the three-drug lethal injection protocol used by 

various states has resulted in a flurry of activity in courts 

across the country and within the Eleventh Circuit.7 Of particular 

import to Valle's claims before this Court are a series of recent 

decisions from within the Eleventh Circuit. On May 16, 2011, a 

district court in Alabama denied an inmate's motion to stay his 

execution, which relied on the substitution of pentobarbital for 

sodium thiopental, based on the court's conclusion that the inmate 

failed to meet his burden of demonstrating a substantial likelihood

7 DeYoung I; DeYoung II; Powell (Williams) v. Thomas (Powell

(Williams) I), Case No. 2:11-CV-376-WKW, 2011 WL 1843616 (M.D. Ala. 

May 16, 2011), aff'd, Powell (Williams) v. Thomas (Powell

(Williams) II), 641 F.3d 1255 (11th Cir. 2011) (per curiam), cert. 

denied, Williams v. Thomas, 131 S.Ct. 2487 (2011); Powell v. Thomas

(Powell I), No. 2:11-CV-376-WKW [WO], 2011 WL 2292108 (M.D. Ala. 

June 9, 2011), aff'd, Powell v. Thomas (Powell II), 643 F.3d 1300 

(11th Cir. 2011) (per curiam), petition for cert. filed

11055, 10A1235, (U.S. June 15, 2011), and other courts across the , No. 10-

country. See Pavatt v. Jones, 627 F.3d 1336 (10th Cir. 2010),

cert. denied, 131 S.Ct. 974 (2011); West v. Brewer

PHX-NVW, 2011 WL 2836754 (D. Ariz. July 18, 2011);

, No. CV-11-1409-

Jackson v.

Danberg

(granting a stay of execution), 

, Case No. 06-300-SLR (D. Del. July 12, 2011), (Doc. #148)

vacated, Jackson v. Danberg

No. 11-9000 (3d Cir. July 21, 2011);

, Case

Cooey v. Kasich

1156, 2:09-cv-242, 2:09-cv-823, 2:10-cv-27, 2011 WL 2681193 (S.D.

, Nos. 2:04-cvOhio July 8, 2011).
10

of success given his "heavy burden" to prove an Eighth Amendment 

claim. Powell (Williams) I. The Eleventh Circuit Court of Appeals 

upheld the denial concluding "[t]he replacement of sodium 

thiopental with pentobarbital does not constitute a significant 

alteration in the [Alabama Department of Corrections’] lethal 

injection protocol, and . . . such an amendment does not violate

the Eighth Amendment under the cases cited by [plaintiff]." Powell 

(Williams) II

Thereafter, in reliance on

, 641 F.3d at 1258.

Powell (Williams) II, the district 

court dismissed inmate Powell's § 1983 action challenging Alabama's 

lethal injection protocol based upon a finding that it was barred 

by the statute of limitations. See Powell I. Specifically, the 

district court concluded that the alteration of Alabama's threedrug lethal injection protocol (by the substitution of 

pentobarbital for sodium thiopental) was not a significant or 

substantial change in the execution protocol so as to reset the 

applicable statute of limitations. Id. at *4. Additionally, the 

court rejected Powell's Fourteenth Amendment due process challenge 

based upon the state's secrecy of its processes noting that Powell 

could have challenged the secrecy surrounding the method of 

execution beginning in 2002. Id. As a result, the state's change 

to pentobarbital did not "awaken this long stale claim." Id. On 

review, the Eleventh Circuit Court of Appeals agreed. Powell II. 

On June 15, 2011, in Powell II, the Eleventh Circuit rejected 

Powell's attempt to relitigate the issue of whether Alabama's 

change in the first drug of the lethal injection protocol was a
11

significant change for purposes of restarting the statute of 

limitations. 643 F.3d at 1304-05.8 As such, the court found that

the Eighth Amendment challenge was barred by the statute of 

limitations, and further that the Eighth and Fourteenth Amendment

challenges to the change in execution protocol based upon the

secrecy in which it was accomplished were similarly barred by the 

statute of limitations. Id.

In an effort to distinguish the instant case from the recent 

at 1305.

Powell decisions, Plaintiff asserts that his "case presents claims 

and a factual basis unlike any presented before to seek a stay." 

Motion to Stay at 6. He not only complains about Florida's 

replacement, on June 8, 2011, of sodium thiopental with 

pentobarbital, as the first drug in the three-drug lethal injection 

sequence, but also that Florida has a "broken lethal injection 

process." Id. In support of his assertions, Valle points to the 

following: (1) the June 23, 2011 execution by lethal injection, 

using pentobarbital, of inmate Roy Willard Blankenship in Georgia, 

as detailed in the Affidavit and Expert Report of Dr. David B. 

Waisel, M.D. (P. Ex. B, Waisel's Expert Report and Affidavit); (2) 

the July 1, 2011 pentobarbital manufacturer's position paper 

condemning the use of pentobarbital for executions by lethal 

injection and noting that the drug is not approved for such use; 

and (3) "Florida's unique history of botched executions," 

(exemplified by the 2006 execution of Angel Diaz), the Defendants'

8 [Footnote regarding Westlaw citations omitted.]
12

unchecked discretion in deviating from and not following the 

written execution procedures, and "Florida's already broken lethal 

injection process," including the inadequate training, experience, 

and qualifications of the execution team members. Valle's 

protestations notwithstanding, the purported distinctions upon 

which he relies are neither new nor, based on Eleventh Circuit 

precedent, are they sufficient alone or in combination with one 

another to carry his burden.

Following the filing of the Complaint and the Motion to Stay, 

the Eleventh Circuit Court of Appeals had another opportunity to 

consider the substitution of pentobarbital for sodium thiopental, 

this time in an action by a Georgia inmate who raised claims 

strikingly similar to those of Valle. See generally DeYoung II

20, 2011, arguing that Georgia's lethal injection protocol violated 

his Eighth Amendment right to be free from cruel and unusual 

punishment. 

. 

Inmate DeYoung sought a stay of his execution scheduled for July

DeYoung II, 646 F.3d at 1323. He contended that

the use of pentobarbital subjected him to a substantial risk of 

serious harm because pentobarbital was insufficiently tested for 

use as an anesthetic and that in prior executions using 

pentobarbital, specifically the execution of Roy Blankenship, the 

drug failed to "painlessly anesthesize the prisoners."

The Eleventh Circuit, in rejecting DeYoung's claims, 

unequivocally reiterated its finding that the substitution of 

pentobarbital for sodium thiopental does not result in a 

substantially changed execution protocol.

Id.

Id. at 1325. Moreover,
13

addressing DeYoung's attempt to revisit the statute of limitations 

issue in reliance on evidence regarding the Blankenship execution, 

the court noted, "the mere act of proffering additional reasons not 

expressly considered previously will not open the door to 

reconsideration of the question by a second panel." Id.

(quoting Smith v. GTE Corp., 236 F.3d 1292, 1302 (11th Cir. 2001) 

(quotation marks and ellipsis omitted)). Nevertheless, the 

Eleventh Circuit considered and rejected DeYoung's Eighth Amendment 

claim on the merits, finding the additional proffered evidence did 

not undermine Powell's conclusion. Specifically referencing the 

events surrounding the Blankenship execution, the court determined 

that DeYoung failed to "establish a substantial risk of serious 

harm from the pentobarbital, or even that Blankenship necessarily 

suffered any harm, much less serious harm." DeYoung II

The Eleventh Circuit explained:

, at 1326.

First, as the district court pointed out, "Dr. 

Waisel entirely failed to provide a medical 

explanation for why pentobarbital might have 

caused Blankenship pain. To the contrary, Dr. 

Waisel testified that a patient will not feel 

pain at the moment when a drug is introduced 

intravenously unless it is a drug, such as 

potassium chloride, which causes a burning 

sensation."

Second, the district court noted that Dr. 

Waisel admitted that "any 'suffering' was 

short lived as it clearly ended within a few 

minutes-three minutes at the most-after the 

pentobarbital was injected." The Eighth 

Amendment does not protect against all harm, 

only serious harm; and it does not prohibit 

all risks, only substantial risks. "Simply 

because an execution method may result in 

pain, either by accident or an inescapable 

consequence of death, does not establish the 

sort of 'objectively intolerable risk of harm'
14

that qualifies as cruel and unusual." Baze

553 U.S. at 50, 128 S.Ct. at 1531 (plurality,

opinion). In any event, Dr. Waisel was not

present at the Blankenship execution; rather,

he opines from the witnesses' varied

descriptions of Blankenship's movements that

those movements were a sign of "discomfort,"

which Dr. Waisel termed "suffering." Dr.

Waisel acknowledged that no one reported any

movement by Blankenship after the nurse's

consciousness check. Further, Blankenship's

autopsy revealed no evidence of trauma. The

catheters were inside Blankenship's veins and

the veins were not burst or broken. There was

no infiltration of fluid in the soft tissue of

the right arm near the catheter site.

Notably too, DeYoung presented no 

evidence to show that unconsciousness is not 

achieved after the complete administration of 

a 5000-mg dose of pentobarbital.

All parties agree that the purpose of the 

anesthetic in Georgia's three-drug lethal 

injection protocol is to render the inmate 

unconscious before administration of the

second and third drugs. As the record 

demonstrates, and the district court found, a 

consciousness check was performed on 

Blankenship after he was administered the 

pentobarbital and prior to injection of the 

second drug pancuronium bromide, as Georgia's 

lethal injection protocol requires. It is 

clear that Blankenship's execution did not 

proceed to the second drug until after he was 

fully unconscious. And as the district court 

found, DeYoung's execution, or any other under 

the Georgia protocol, cannot proceed until he 

is unconscious. To the contrary, Georgia's 

protocol specifically provides that GDOC 

officials will not administer the pancuronium 

bromide but will instead administer more 

anesthetic-and conduct more consciousness 

checks-until the inmate has been shown to be 

unconscious.

DeYoung has wholly failed to show that 

pentobarbital, once fully administered and 

allowed to act, is ineffective as an 

anesthetic. As the district court succinctly 

found, Georgia's "use of pentobarbital does
15

not create a substantial risk of serious harm 

to inmates."

DeYoung II, 646 F.3d at 1326-27 (footnote omitted).

Plaintiff's attempt to distinguish his claim from the binding 

Powell precedent, based upon the Blankenship execution and the 

affidavit of Dr. Waisel, is significantly undermined if not 

entirely foreclosed by DeYoung II. Indeed, the affidavit of Dr. 

Waisel relied upon by Valle, see P. Ex. B at 14-18, is identical, 

in substance, to that considered and found to be insufficient by 

the district court and the Eleventh Circuit Court of Appeals in 

DeYoung I and DeYoung II.9 See DeYoung v. Owens

2324-SCJ (N.D. Ga. 2011), Affidavit of Dr. David B. Waisel, M.D. 

(Doc. #3-15), filed July 15, 2011, at 1-5.10 Moreover, Florida's

, Case No. 1:11-cvprotocol, like that of Georgia in DeYoung II,11 calls for 5 grams

9 In Plaintiff's Response to the Motion to Dismiss, Valle also 

argues for the first time, without reference to any affidavit or 

other evidence, that "Powell himself had the unfortunate 

distinction of becoming Alabama's first botched execution by lethal 

injection." Plaintiff's Response at 5. Valle described the start 

of the execution: "[w]itnesses reported that after the start of the 

execution, Mr. Powell violently jerked his head up off the gurney, 

turned his head from side to side, clenched his jaw, . . . appeared 

to be in pain[,] and [h]is eyes remained open for quite a while." 

Id. at 5 n.1. However, when recently faced with such evidence in 

the DeYoung II

. . . Powell's counsel [(who had witnessed the execution)] did not

case, the Eleventh Circuit stated: "DeYoung's 

evidence about the Powell execution does not change our conclusion.

know at what time the various chemical[s] were administered."

DeYoung II, 646 F.3d at 1327 n.5.

10 This exhibit is not available on Westlaw; therefore the Court 

cites to the document that appears on the Pacer Case Locator. See

https://pcl.uscourts.gov/search.

11 See DeYoung II, 646 F.3d at 1323 (noting that

5000 milligrams of pentobarbital is used, as the first drug, in 

the three-drug protocol and stating that the "[l]ack of

sodium thiopental availability led Georgia on May 13, 2011[,]
16

of pentobarbital to be administered as the first drug of the threedrug protocol. P. Ex. A, Execution by Lethal Injection Procedures. 

Florida's protocol also specifically requires a consciousness check 

after the administration of the 5 grams of pentobarbital, and prior 

to the administration of the second drug of the three-drug 

protocol. Id. If, after the consciousness check the individual is 

not unconscious, the procedure is started anew, with a new set of 

chemicals. Id. Thus, as in DeYoung II, under Florida's protocol, 

the execution cannot proceed until the individual is rendered 

unconscious. 

Based on Eleventh Circuit precedent, the undersigned concludes

Id.

that Florida has not made a significant alteration in its lethal 

injection protocol. Plaintiff has failed to support his assertion 

that his case is distinguishable from the Eleventh Circuit's 

decisions in the Powell cases and DeYoung II, and mere speculation 

cannot substitute for evidence that the use of pentobarbital will 

or very likely will cause serious illness and needless suffering. 

Indeed, as the United States Supreme Court has instructed, the fact 

that "an execution method may result in pain, either by accident or 

as an inescapable consequence of death, does not establish the sort 

of 'objectively intolerable risk of harm' that qualifies as cruel 

and unusual." Baze

Nevertheless, Valle also attempts to distinguish his case from 

the

, 553 U.S. at 50.

Powell decisions by asserting that Lundbeck, Inc., the sole

to switch to the use of pentobarbital as the anesthetic in its

lethal injection protocol").
17

manufacturer of pentobarbital, issued a position paper on July 1,

2011, condemning the misuse of that drug for executions by lethal 

injection. Motion to Stay at 11. The pertinent portion of this 

position paper, upon which Valle relies, states:

The use of pentobarbital to carry out the 

death penalty in [United States] prisons falls 

outside its approved indications. Lundbeck 

cannot assure the associated safety and 

efficacy profiles in such instances. Lundbeck 

does not promote pentobarbital for use as part 

of lethal injections and is doing everything 

in its power to put an end to this misuse.

Id. (quoting Lundbeck's Position Regarding the Misuse of 

Pentobarbital in Execution of Prisoners, available at

http://www.lundbeck.com/Media/pentobarbital.asp.).

Lundbeck's July 1, 2011 position paper does not support a 

finding that the substitution of pentobarbital for sodium 

thiopental constitutes a significant change in Florida's execution 

protocol. Notably, as acknowledged by Valle, Hospira, Inc., the 

only manufacturer approved by the FDA to manufacture sodium 

thiopental, also condemned the use of that drug for lethal 

injections. See Motion to Stay at 8. However, this objection did 

not warrant its withdrawal from the various states' lethal 

injection protocols. Indeed, whether or not a manufacturer objects 

to the use of its drug for executions appears to have little, if 

any, evidentiary weight. See Powell (Williams) I, at *8 n.7 

("Williams emphasizes that the manufacturer of pentobarbital has 

pronounced that it is opposed to its drug being used for 

executions, but fails to demonstrate how that fact is in any way 

relevant to the issues and his burden.").
22

Moreover, Lundbeck's statements that the use of pentobarbital 

in lethal injections falls outside its approved indications and 

that it cannot assure pentobarbital's safety and efficacy when used 

in such a fashion, see

the conditions presenting the risk must be 

Complaint at 8-9, paragraph 31, fall short 

of meeting Valle's burden. As the Supreme Court has explained,

sure or very likely to cause serious illness 

and needless suffering, and give rise to 

sufficiently imminent dangers. We have 

explained that to prevail on such a claim[,] 

there must be a substantial risk of serious 

harm, an objectively intolerable risk of harm

that prevents prison officials from pleading 

that they were subjectively blameless for 

purposes of the Eighth Amendment.

Baze, 553 U.S. at 50 (internal citation and quotation marks 

omitted). As such, "[a] stay of execution may not be granted . . . 

unless the condemned prisoner establishes that the State's lethal 

injection protocol creates a demonstrated risk of severe pain. He 

must show that the risk is substantial when compared to the known 

and available alternatives." Id.

Preliminarily, the Court recognizes that other courts have 

rejected claims that the absence of FDA approval of a drug for use 

in lethal injections means that the drug is unsafe or suggests that 

it is sure or very likely to cause serious illness or needless 

suffering.

at 61. The statements by 

Lundbeck do not satisfy this burden.

See Brewer v. Landrigan, 131 S.Ct. 445 (2010) (vacating 

a stay of execution which was based upon a finding that the 

plaintiff had a substantial likelihood of success on the merits of 

his claim that the use of sodium thiopental manufactured by a 

foreign source and not approved by the FDA creates a substantial
23

and unnecessary risk of serious harm in violation of the Eighth 

Amendment); Cook v. Brewer, 637 F.3d 1002, 1006-07 (9th Cir. 2011) 

("Cook relies on his allegations that Arizona's sodium thiopental 

is imported and not approved by the FDA. But Landrigan . . . 

advises that these facts are not sufficient to state a plausible 

Eighth Amendment claim"); Powell (Williams) I

Finally, the Court does not find the 

manufacturer's "warning" against pentobarbital 

use in executions to be persuasive. Although 

the company relayed to the Georgia Department 

of Corrections it could not "assure the 

associated safety and efficacy" of using 

pentobarbital for off-label use, it also made 

clear that it was "adamantly opposed" to the 

use of pentobarbital "or any product for that 

matter, for the purpose of capital punishment" 

because such use "contradicts everything we 

are in business to do—provide therapies that 

improve people's lives." (Doc. 1, Ex. N.) This 

is insufficient evidence to establish a 

substantial risk of harm.

, at *7-8 (finding

that the plaintiff did not have a substantial likelihood of 

success on the merits of his challenge to the lethal injection

protocol based on the substitution of pentobarbital for sodium 

thiopental, which was supported in part by Dr. Waisel's assertion

that the use of pentobarbital as an agent to induce anesthesia is 

not FDA approved). Moreover, Lundbeck's asserted lack of

information as to the efficacy and safety of pentobarbital for 

use in lethal injections does nothing to establish a demonstrated

risk of severe pain or needless suffering. Indeed, the United 

States District Court of Arizona arrived at this same conclusion

when faced with Lundbeck's opposition to the use of pentobarbital 

in the lethal injection process in Arizona:
24

West v. Brewer

Lundbeck's position on the use or misuse of pentobarbital 

simply does not establish that the use of pentobarbital will 

subject Valle to a risk of pain and needless suffering. Valle 

submits no evidence that the administration of 5 grams of 

pentobarbital during the execution process will cause him needless 

suffering in and of itself.

, No. CV-11-1409-PHX-NVW, 2011 WL 2836754, at *8 (D. 

Ariz. July 18, 2011).

See DeYoung II, 646 F.3d at 1326-27.

Additionally, the evidence before the Court fails to support a 

conclusion that Valle is likely to establish an objectively 

intolerable risk that this dosage of pentobarbital will not 

render Valle unconscious. Id.

Dr. Mark Dershwitz, M.D., an anesthesiologist with a Ph.D. in 

pharmacology, states that pentobarbital is and has been commonly 

used to induce a barbiturate coma since the mid-1970s. Def. Ex. D, 

Expert Report of Mark Dershwitz, M.D., Ph.D., at paragraphs 8-10. 

He further explains:

At 1327.

A dose of 5,000 mg of pentobarbital will cause 

virtually all persons to stop breathing. In 

addition, a dose of 5,000 mg of pentobarbital 

will cause the blood pressure to decrease to 

such a degree that perfusion of blood to 

organs will cease or decline such that it is 

inadequate to sustain life. Thus, although 

the subsequent administration of vecuronium 

bromide, a paralytic agent, would have the 

effect of paralyzing the person and preventing 

him or her from being able to breathe, 

virtually every person given 5,000 mg of 

pentobarbital will have stopped breathing 

prior to the administration of vecuronium 

bromide. Thus, even in the absence of the 

administration of vecuronium bromide and 

potassium chloride, the administration of
25

5,000 mg of pentobarbital by itself would 

cause death in almost everyone.

Id.

There is no way to know, in any given case, 

how a massive dose of pentobarbital will 

affect a human patient, because it has not 

been tested to any remotely sufficient degree 

to be able to say. The way Blankenship 

reacted to the injection of pentobarbital 

at paragraph 12. Dr. Waisel, on the other hand, candidly 

admits that he does not know how the State's dosage of 

pentobarbital will affect inmates subjected to execution by lethal 

injection. He explains:

may

be indicative of how many human beings will 

react.

P. Ex. B, Expert Report at 4, paragraph 9 (emphasis added). This 

asserted lack of knowledge simply cannot satisfy Valle's burden of 

affirmatively showing that a substantial risk of serious harm 

exists. Baze

Therefore, neither Lundbeck's July 1, 2011 condemnation of the 

use of pentobarbital for executions by lethal injection, nor its 

position that pentobarbital is not approved for use in executions, 

supports a finding that the substitution of pentobarbital for 

sodium thiopental subjects him to a substantial risk of serious 

harm or constitutes a significant change in Florida's execution 

protocol. Thus, by this assertion, Valle has failed to distinguish

, 553 U.S. at 61 (stating that, in order to obtain a 

stay of execution, a condemned inmate must show that "the State's 

lethal injection protocol creates a demonstrated risk of severe 

pain[]" and that "the risk is substantial when compared to the 

known and available alternatives").
26

his case from the Powell decisions or the more recent decision in

DeYoung II.

Valle presents one further contention in his effort to 

distinguish his claims from other previous cases seeking a stay of 

execution. He argues that his assertions are not premised merely 

on the substitution of pentobarbital for sodium thiopental, but 

also on "the deadly combination of adding an untested drug to 

Florida's already broken lethal injection process." Motion to Stay 

at 6; Plaintiff's Response at 5-6. Referring to what he describes 

as "Florida's unique history of botched executions" and 

specifically citing to the 2006 execution of Angel Diaz as an 

example, Valle asserts that Defendants' history and pattern of 

deviating from and not following execution procedures violates the 

Eighth and Fourteenth Amendments. Motion to Stay at 4-5, 16-17,

33. He alleges that the administration of the three drugs, the 

assessment of IV lines and consciousness, and the continued 

monitoring of the inmate for consciousness throughout the procedure 

are inadequate in that the Defendants do not require that the 

execution team members have adequate training, experience, 

qualifications, and certification to properly perform the multiple 

tasks associated with the execution. Id.

process claims.12

at 12-16, 23-26. These 

latter allegations not only support Valle's Eighth Amendment claim 

but also form the basis of his substantive and procedural due

12 The Court notes that Valle's Complaint also includes various 

allegations regarding illegally obtained drugs and potential black 

market drugs. Any allegations regarding the illegal obtention of
27

Since the facts supporting Valle's claim of an "already 

broken" lethal injection process and "botched" executions "should 

have been apparent to any person with a reasonably prudent regard 

for his rights," McNair, 515 F.3d at 1177, in 2006, Florida's 

"switch to pentobarbital does not awaken this long stale claim." 

Powell I at *4. Accordingly, Valle has not shown that he has a 

substantial likelihood of success on the merits of his claims in 

that "the statute-of-limitations clock did not restart in 2007 when 

Florida adopted additional safeguards in its lethal injection 

protocols." Henyard, 543 F.3d at 647-48. Moreover, the 

substitution of pentobarbital did not reset the statute of 

limitations. Powell II; Powell (Williams) II. Thus, Valle has 

not established a substantial likelihood of success on the merits 

of his claims because the instant § 1983 action was filed beyond 

the applicable statute of limitations.13 Valle became subject to

sodium thiopental are irrelevant given the substitution of 

pentobarbital for sodium thiopental in the three-drug protocol. 

The Complaint contains no allegations of fact whatsoever regarding 

the manner in which FDOC obtains pentobarbital. Valle's allegation 

that "[o]n information and belief, the FDOC has illegally imported 

sodium thiopental and/or pentobarbital[,]" see Complaint at 12, 

paragraph 39, is entirely speculative and lacking in factual 

support. Moreover, Valle submitted no evidence regarding this 

allegation in support of the Motion to Stay.

13 The Court recognizes that Valle also complains that 

Defendants have consistently refused to reveal information about 

the training of the execution team and the source or vendor history 

of the lethal injection drugs, denying him due process of law. 

Motion to Stay at 24, 27. Defendants respond that this claim is 

barred by the statute of limitations, because at the time Florida 

adopted lethal injection, it also adopted the statutes which made 

the information concerning the process confidential. Defendants' 

Response at 10-11. This same contention was made in Powell II, 

643 F.3d at 1305, and was rejected, with the Eleventh Circuit 

finding that the issue of the secrecy surrounding a lethal

injection protocol is not revived by switching one of the drugs.
28

execution by lethal injection on February 14, 2000, and 

consequently had four years to file a federal civil rights claim 

under 42 U.S.C. § 1983. The Complaint was filed on July 18, 2011, 

long after the four-year statute of limitations expired; therefore, 

Valle's claims appear to be untimely. Crowe v. Donald

1290, 1292 (11th Cir.), 

, 528 F.3d

cert. dismissed, 553 U.S. 1077 (2008); 

McNair

Even if Valle's claims were timely filed, for the reasons

, 515 F.3d at 1177-78.

previously discussed, they fail as a matter of law because Valle 

has not met his burden of affirmatively showing that a substantial 

risk of serious harm exists or that the risk is substantial when 

compared to the known and available alternatives. See Baze

U.S. at 61. Indeed, Valle's allegations stop well short of 

complying with the Eighth Amendment standard set forth in 

, 553

Baze in 

that he has failed to show a "substantial risk of serious harm." 

Baze

56 of the Complaint that "available alternatives exist[,]" he has 

failed to proffer any alternative procedure or drug, and failed to 

show that any such alternative procedure or drug is "feasible, 

readily implemented, and in fact significantly reduce[s] a

, 553 U.S. at 50. Moreover, while Valle asserts in paragraph

Additionally, the Eleventh Circuit has declined to find that 

there is "a categorical rule entitling defendants to a lethal 

injection protocol that is legislatively enacted and subjected to 

extensive litigation." Powell (Williams) II, 641 F.3d at 1258. 

Thus, to the extent Valle is claiming that secrecy prevented him 

from litigating his issues up to now, this claim was rejected in 

Powell (Williams) II and the failure to disclose is not

unconstitutional. See Powell (Williams) II, 641 F.3d at 1257-58.
29

substantial risk of severe pain."14 Baze, 553 U.S. at 52; Powell

(Williams) I, at *9 (citation omitted).

Notably, Valle's various objections to the lethal injection 

protocol itself have been rejected on the merits in previous cases. 

See Baze, 553 U.S. at 53-61 (rejecting claims concerning the 

maladministration of the lethal injection protocol, the failure to 

adopt untried and untested alternatives, the risk that the 

procedures will not be properly followed, the absence of additional 

monitoring by trained personnel, inadequate facilities and 

training, the placement and monitoring of IV lines, the lack of 

professional medical experience, and the need for a significant 

consciousness test); Lightbourne, 969 So.2d at 350 n.22 (rejecting 

Lightbourne's claims relating to the sufficiency of the August 2007 

protocol, including that the revised procedures do not meaningfully 

increase the qualifications of executioners; there is no 

requirement that the team warden or executioners have experience in 

conducting executions; the procedures do not specifically indicate 

the qualifications needed by each designated team member; 

phlebotomists are not trained to place catheters in veins; the 

procedures leave inmates to guess if the execution team members are 

adequately experienced and medically qualified; the procedures do 

not provide any method for monitoring the inmate's consciousness 

after administration of the first drug (sodium pentothal); and the

14 It is noteworthy that, in Baze, the inmate petitioners 

proposed a one-drug barbituate-only protocol, using either 

pentobarbital or sodium thiopental as the suggested alternative 

drug. Baze, 553 U.S. at 56-58.
30

contention that pancuronium bromide is used for purely cosmetic 

reasons); Schwab v. State

Valle also complains that the lethal injection protocol was 

not recertified between April 2008 and the signing of the June 8,

, 969 So.2d 318 (Fla. 2007) (per curiam) 

(rejecting similar assertions made by Schwab, focusing primarily on 

whether the protocols adequately ensure the assessment of 

consciousness and whether the use of a paralytic drug during the 

execution is warranted).

2011 procedure, denying him due process of law. Motion to Stay at

28. This assertion does little to advance his claim. No 

certificate of readiness was issued because sodium thiopental was 

unavailable, and the Governor did not sign any death warrants for 

death row inmates during the period of unavailability of sodium 

thiopental. Defendants' Response as 12. It was not until June 8,

2011, that the Secretary of the FDOC represented that the procedure 

had been reviewed, and certified that the Department was prepared 

to accomplish an execution by lethal injection. P. Ex. C, June 8,

2011, Letter from Edwin G. Buss, Secretary, to the Honorable Rick 

Scott. At that time, pentobarbital was substituted for the sodium 

thiopental in the three-drug protocol permitting the State to 

certify that it was prepared to carry out the lethal injection 

protocol. P. Ex. A, Execution by Lethal Injection Procedures, 

dated June 8, 2011. Thus, the lack of recertification of the 

process during this period of unavailability of sodium thiopental 

is not probative of any fact relevant to Valle's claims.

 
31

* * *

In consideration of the foregoing, the Court concludes that

Valle has failed to carry his burden of establishing that he has a

substantial likelihood of succeeding on the claims raised in this 

action. For this reason alone, the Motion to Stay would be due to

be denied.

* * *

DONE AND ORDERED at Jacksonville, Florida, this 9th day of

August, 2011, at 11:20 a.m.