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,

l EDWIN 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 w ho 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 C ourt granted a stay to allow a Florida

circuit court to determine whether the Stat e’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 distri ct court. He filed a complaint under

42 U.S.C. § 1983 and a motion for a tempor ary 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 C ourt’s recent decisions rejected similar

challenges. Valle seeks to disti nguish those cases—allowing Georgia and

Alabama to proceed with executions using pentobarbital instead of sodium

thiopental—because he alleges that Flor ida, 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, fo cuses 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 dem onstrated 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 c ourt’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 s ubstantial likelihood of success on the

merits, we need not address the other th ree 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 establis h 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 inje ction 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, combined2 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

rel ief 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.

cer t

. granted

, judgment vacated by Valle v. Florida

U.S. 1102 (1986). , 4763 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 th e Florida Department of Corrections

(FDOC). Id. Unti l r ecently, 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 fr ee 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 hi s 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 R oy 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, ha s 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. Vall e learned that

the Defendants have substituted an untested

and non

**-** FDA approved drug for sodium

thiopental. It has only bee n sinc e 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 seriou s 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 t he other litigant; and (4)

if issued, the injunction would not be adverse

to the public interest."

DeYoung v. Owens

, ( DeYoung II 4 )

, 646 F.3d 1319,1324 (11th Cir.

2011) (quoting Powell v. Thoma s

, 641 F.3d 1255 , 1257 (11th Cir.

2011) (per curiam), cer t

. 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 V alle' s claim s 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 while8 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 th e statut e 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

.

den ied

, 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. Alle n

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."), cer t

. 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 E levent h C ircuit. 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 bur den 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

- cv

Ohio 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 [Al abama Department of Corrections’ ] lethal

injection protocol, and . . . suc h a n amendm e nt does not violate

the Eighth Amendme nt 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 three

drug 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 pro tocol was a11 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 rec ent at 130 5.

Powell decisions, Plaintiff asserts that his "case presents claims

and a factual basis un l ike 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 pent o barbital manufacturer's p osition paper

condemning the use of pentobarbital for executions by lethal

injection and notin g tha t th e 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 omitt ed.]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 combin ation 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 act ion 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 , 64 6 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 t o "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 protoc ol. 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

reconsideratio n 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 "establis h 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 introduc ed

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

a ll 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 t he 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 r equires. 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 unconsciou s. 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

unconsciou s.

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 does15 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

- cv

protocol, like that of Georgia in DeYoung II

, 1 1 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 three

drug 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 I I

, 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 oppose d to its drug being used for

executions

, bu t fail s t o 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 substantial23 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

matt er, 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. I ndeed

, th e United

States District Court of Arizona arrived at this same conclusion

when faced with Lundbeck's oppos i tion 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 do se 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 of25 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 in jection of pentobarbital at paragraph 12. Dr. Waisel, on the othe r 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 ri sk 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 subj e cts 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 exe cution procedures violates the

Eighth and Fourteenth Amendments. Motion to Stay at 4

- 5, 16

- 17,

33. He alleges that the admin istratio n o f 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 of27 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

"switc h 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

, Vall e has

not est ablished a substantial likelihood of success on the merits

of his claims becaus e th e 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.

1 3 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 le thal 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 i nformation 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 claim s appear to be untimely. Crowe v. Donald

1290, 1292 (11th Cir.), , 528 F.3d

cer t

. 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, whi le 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); Lig htbourne

, 969 So.2d at 3 50 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

1 4 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.