                        RECOMMENDED FOR FULL-TEXT PUBLICATION
                             Pursuant to Sixth Circuit Rule 206
                                    File Name: 09a0414p.06

                UNITED STATES COURT OF APPEALS
                                FOR THE SIXTH CIRCUIT
                                  _________________


                                                 X
                                                  -
 RICHARD WADE COOEY II, et al.,
                                                  -
                                          Plaintiffs,
                                                  -
                                                  -
                                                       No. 09-4474
 KENNETH BIROS (Intervenor),
                                                  ,
                           Plaintiff-Appellant, >
                                                  -
                                                  -
                                                  -
           v.

                                                  -
                        Defendants-Appellees. -
 TED STRICKLAND, Governor, et al.,
                                                 N
                   Appeal from the United States District Court
                  for the Southern District of Ohio at Columbus.
                 No. 04-01156—Gregory L. Frost, District Judge.
                                Submitted: December 7, 2009
                          Decided and Filed: December 7, 2009
                Before: SILER, GIBBONS, and SUTTON, Circuit Judges.

                                     _________________

                                          OPINION
                                     _________________

        JULIA SMITH GIBBONS, Circuit Judge. This appeal presents the question of
whether to stay the execution of Kenneth Biros, scheduled for December 8, 2009, at 10:00
a.m., based on his challenge to the lethal injection procedure by which Ohio intends to carry
out his death sentence. The district court denied Biros’s request for a stay, and, because we
agree that Biros in particular is unable to demonstrate a likelihood of success on the merits
of his Eighth Amendment claim, we affirm.

        When a state permissibly chooses to impose the death penalty on a properly
convicted criminal, the state, not the federal courts, is in charge of carrying out the sentence,
but it may not impose “cruel and unusual” punishment in imposing that sentence. U.S.
Const. amend VIII. This means that the courts will not allow a state to use an execution
procedure that creates an “objectively intolerable risk of harm” or a “demonstrated risk of


                                               1
No. 09-4474           Biros v. Strickland, et al.                                                Page 2


severe pain” that is “substantial when compared to the known and available alternatives.”
Baze v. Rees, 553 U.S. 35, 128 S. Ct. 1520, 1531, 1537 (2008) (plurality opinion).

          Kenneth Biros previously challenged Ohio’s old execution protocol, one that
mirrored the Kentucky execution protocol in all material aspects and was upheld by the
United States Supreme Court. See Baze v. Rees, supra. He now challenges Ohio’s new
execution protocol, which made two relevant changes. Both are designed to render capital
punishment in Ohio more humane.

          One change eliminates Ohio’s use of a three-drug protocol, which allegedly created
a risk that the individual would not be properly anesthetized before the third, painful
injection induced cardiac arrest. Even though the Supreme Court permitted this precise
three-drug protocol in Baze, Ohio sought to address this concern by adopting a one-drug
protocol—the same protocol advanced by the losing plaintiffs in Baze. Id. at 1534. While
Biros understandably does not wish to be the first individual executed with this new drug,
his medical expert, Dr. Mark Heath, acknowledges that Ohio’s change is a positive one and
                                                                               1
that the one-drug protocol is a more humane execution procedure.                   Indeed, his fellow
litigants in the Cooey method-of-execution litigation, ongoing since 2004, have
demanded that Ohio change to this precise procedure.

          The second change in Ohio’s protocol responds to another criticism—that the
Ohio execution team has had difficulty accessing the veins of some individuals, most
recently in the attempted execution of Romell Broom on September 15, 2009. Both in
the Baze litigation and in the Cooey litigation, the claimants have registered complaints
about the training of the EMTs responsible for inserting the intravenous (“IV”) lines
used to deliver the fatal drugs and about their inability to start an IV line promptly on
some individuals. In response to these concerns, Ohio has established a two-drug,
intramuscular injection as a back-up procedure if the execution team cannot obtain IV
access.



          1
           Dr. Heath began his testimony by stating: “[I]t was gratifying to see that Ohio had decided to
renounce the use of pancuronium and potassium. That really is a big step forward, and it’s taken many
years, but I think they really are to be commended for doing that.” Tr. at 35.
No. 09-4474        Biros v. Strickland, et al.                                      Page 3


       In denying Biros’s stay of execution, the district court determined that Biros
failed to produce evidence sufficient to demonstrate a likelihood that his challenge to
Ohio’s new protocol would succeed on the merits. After a thorough and considered
review of the record before the district court, the testimony presented at the December
4, 2009, hearing, the Ohio protocol itself, and the district court’s opinion, we agree that
Biros has not met his burden. He has not demonstrated that, facially or as applied to
him, Ohio’s new protocol “demonstrate[s] risk of severe pain” that is “substantial when
compared to the known and available alternatives.” Id. at 1531, 1537. Although Ohio’s
new protocol may not be perfect, it conforms with the Constitution’s prohibition on cruel
and unusual punishment, and the record indicates that it is a decided improvement on the
protocol that Ohio has utilized in the past.

                                               I.

       Biros’s challenge to Ohio’s lethal injection procedure under 42 U.S.C. § 1983,
in which he argues that the new protocol violates his Eighth Amendment right to be free
from cruel and unusual punishment, follows protracted proceedings in which Biros
sought to overturn his 1991 conviction and death sentence. Biros was convicted of
aggravated murder (with two capital punishment specifications), felonious sexual
penetration, aggravated robbery, and attempted rape in connection with the death of
Tami Engstrom and was sentenced to death. Biros v. Bagley, 422 F.3d 379, 382–85 (6th
Cir. 2005). In the early morning of February 7, 1991, Biros and Engstrom left a bar in
Hubbard, Ohio, together. Eventually, Biros told the police that Engstrom was dead,
signed a waiver of his Miranda rights, and revealed the location of her body. Authorities
recovered several of Engstrom’s body parts in a desolate area of Butler County,
Pennsylvania, and other portions of her body thirty miles north in Venango County.
Engstrom’s ring, two bloodstained knives, and clothing stained with Engstrom’s blood
were found in Biros’s home and car.

       Biros appealed his conviction and death sentence to the Ohio Court of Appeals
and to the Ohio Supreme Court, State v. Biros, 678 N.E.2d 891 (Ohio 1997), and
unsuccessfully sought post-conviction relief in state court, State v. Biros, No. 98-T-0051,
No. 09-4474         Biros v. Strickland, et al.                                      Page 4


1999 WL 391090 (Ohio Ct. App. May 28, 1999). He later filed an application to reopen
his appeal, which the Ohio Supreme Court denied on the merits. State v. Biros, 754
N.E.2d 805 (Ohio 2001). In September 2001, Biros filed a petition for a writ of habeas
corpus in federal district court, which issued the writ as to his death sentence and
withheld it as to his remaining claims. On appeal, we addressed each claim in turn and
rejected them. After careful consideration, we concluded that the jury had imposed the
death penalty after Biros had received the benefit of a fundamentally fair trial as required
by the United States Constitution. See Biros, 422 F.3d at 392.

        In November 2006, Biros intervened in an action initiated in the United States
District Court for the Southern District of Ohio in 2004 challenging Ohio’s three-drug
lethal injection protocol under the Eighth and Fourteenth Amendments. Although the
district court preliminarily enjoined Biros’s execution in December 2006, it vacated its
decision in a 159-page opinion issued in March 2009 after a five-day hearing. The
district court determined that Biros had shown insufficient likelihood of success on the
merits to warrant a stay. Its opinion made clear that Biros was unlikely to demonstrate
a risk of harm that rose to the level of a constitutional violation.

        In September 2009, Governor Ted Strickland postponed the execution of Romell
Broom after an attempt to execute him was halted when the execution team was unable
to access a vein. The Governor temporarily stayed other executions scheduled for
October and November 2009 but left Biros’s December 8 execution in place. On
October 19, 2009, the district court stayed Biros’s execution and scheduled the trial date
of his and his co-plaintiffs’ lawsuit for July 12, 2010. The district court made no
findings with respect to Biros’s likelihood of success on the merits of his challenges. On
October 23, 2009, Ohio notified the district court that it was seeking alternatives to its
execution protocol.     Specifically, the State was considering a “single drug for
intravenous administration . . . [or] the use of two drugs for intramuscular administration
. . . either as primary and secondary alternatives, or as co-existing alternatives.” R. 594
at 3.
No. 09-4474         Biros v. Strickland, et al.                                      Page 5


        On November 13, 2009, the State of Ohio filed a second motion for summary
judgment in district court in which it announced that it had modified the Ohio
Department of Rehabilitation and Correction (“ODRC”) policy directive regarding
executions by lethal injection. An attached affidavit of Terry Collins, director of the
ODRC, explained the changes made to the Ohio protocol in response to the halted
execution of Broom and subsequent inquiry. Collins outlined the two most significant
alterations to the May 14, 2009, protocol that it replaced: the new protocol utilizes a one-
drug, IV injection with a two-drug, intramuscular injection back-up procedure should
the execution team fail to locate veins suitable for IV transmittal. The new protocol took
effect on November 30, 2009, and is to be applied at Biros’s scheduled December 8
execution.

        Because this new protocol, and not its predecessor, which was at issue in Biros’s
original petition for relief, would govern his execution, the State asked the district court
to vacate its October 19 stay of execution as moot. When the district court refused to
vacate the stay, the State urged us to do so. On November 25, we vacated the stay,
finding that the new protocol mooted Biros’s challenge to the old protocol and that the
district court had premised its stay primarily on “concerns related to the old procedure.”
Cooey (Biros) v. Strickland, No. 09-4300, Slip Op. at 3 (6th Cir. Nov. 25, 2009). The
full court denied Biros’s petition for rehearing en banc on December 4. Cooey (Biros)
v. Strickland, No. 09-4300, Slip Op. at 1 (6th Cir. Dec. 4, 2009).

        Meanwhile, on December 3, 2009, Biros filed a motion with the district court to
amend his § 1983 complaint to challenge the new one-drug protocol, and the district
court granted the motion on December 4. Supported by the affidavit of Mark J.S. Heath,
M.D., Biros also asked the court to temporarily restrain the State from executing him.
The State opposed the temporary restraining order, attaching the affidavit and
declaration of Mark Derwshwitz, M.D., Ph.D. On December 4, the district court
conducted an evidentiary hearing in which both Heath and Dershwitz testified by phone.
Biros also introduced photos of Broom, a law review article, and depositions of Broom,
No. 09-4474          Biros v. Strickland, et al.                                   Page 6


corrections officials involved in Broom’s attempted execution, and Broom’s medical
expert.

          The district court denied Biros’s motion in a December 7, 2009, Opinion and
Order. Cooey (Biros) v. Strickland, No. 2:04-cv-1156 (S.D. Ohio Dec. 7, 2009). The
district court first described the testimony offered at its March 23–27, 2009, preliminary
injunction hearing regarding the then-applicable three-drug protocol, the elements of the
November 30, 2009, protocol, and the testimony offered at the December 4, 2009,
hearing on Biros’s motion for an emergency stay. After considering the facts before it,
the district court concluded that Biros had not met his burden of demonstrating a strong
likelihood of success on the merits of his claim of a constitutional violation under any
standard set forth in Baze. Id. at 182. The court found unpersuasive Biros’s contentions
regarding the alleged problems with establishing IV access in light of Ohio’s safeguards,
which largely mirror those employed in Kentucky and approved in Baze. Id. at 155.
Based upon its review of the evidence, the court further could not conclude that medical
team members were “insufficiently trained, incompetent, or unable to perform
competently under the circumstances of an Ohio execution,” or that the new protocol’s
prescription of thiopental sodium through peripheral IV access was “a structural flaw of
the protocol.” Id. at 157. Moreover, the safeguards in place “acceptably mitigated” the
risks of human error involved in the implementation of the protocol. Id. at 171. With
respect to the particular drugs employed in both the IV and intramuscular procedures,
the court determined that there was insufficient evidence that they created a sufficient
risk of harm under Baze. Id. at 171–72, 178, 183.

          The district court then considered Biros’s claims under the Due Process Clause
and the All Writs Act. On the former, the court concluded that Biros failed to present
a strong likelihood of success given the dearth of authority as to the meaning of the Ohio
statutory language regarding the execution of death sentences in Ohio and Biros’s failure
to fashion a complete argument based on the new execution protocol. Id. at 182–83.
With respect to the latter, the court concluded that Biros had not demonstrated that he
No. 09-4474           Biros v. Strickland, et al.                                              Page 7


is entitled to a stay of execution under the All Writs Act because such a stay was not
necessary to preserve jurisdiction over this matter. Id. at 189.

          Biros promptly appealed and moved for a stay of his execution.

                                                  II.

          In reviewing the district court’s order, we apply the following established
standards: (1) whether Biros has demonstrated a strong likelihood of success on the
merits; (2) whether he will suffer irreparable injury in the absence of equitable relief; (3)
whether the stay will cause substantial harm to others; and (4) whether the public interest
is best served by granting the stay. Workman v. Bredesen, 486 F.3d 896, 905 (6th Cir.
2007); Ne. Ohio Coal. for Homeless & Serv. Employees Int’l Union, Local 1199 v.
Blackwell, 467 F.3d 999, 1009 (6th Cir. 2006). “These factors are not prerequisites that
must be met, but are interrelated considerations that must be balanced together.” Mich.
Coal. of Radioactive Material Users, Inc. v. Griepentrog, 945 F.2d 150, 153 (6th Cir.
1991).2

                                                 III.

                                                  A.

          On November 30, 2009, Ohio released the precise language of the new
protocol—No. 01-COM-11—to the public and to Biros’s counsel. The new protocol
closely resembles the May 14, 2009, protocol in most material respects other than the
two alterations mentioned in the Collins affidavit made public on November 13, 2009:
the shift to a one-drug injection and the adoption of an intramuscular back-up procedure.
Consistent with the prior protocol, there remains extensive provision for the training and
qualifications of the medical team that administers the protocol. The execution team

          2
          In requesting a stay, Biros relies heavily on the stay order granted to another Ohio death-
sentenced prisoner by a panel of this court following the halted Broom execution. See Reynolds v.
Strickland, 583 F.3d 956 (6th Cir. 2009). He reasons that because the panel in Reynolds granted a stay,
so should we. However, we find this argument unpersuasive. First, the lethal injection protocol
challenged in Reynolds was that used during the attempted Broom execution—that is, the old protocol.
Second, Biros has had the benefit of an evidentiary hearing before the district court, which included
presentation of deposition testimony, testimony by Heath about the Broom incident, and photos of Broom.
Thus, the situation that prompted the Reynolds stay order is not present here.
No. 09-4474         Biros v. Strickland, et al.                                      Page 8


conducts training exercises no less than weekly for one month prior to an execution, and
each member receives medical training prior to joining the team and annually thereafter.
The execution team must include individuals “who are currently qualified under Ohio
Law to administer and prepare drugs for intravenous and intramuscular injections, and
. . . have at least one year experience as a certified medical assistant, phlebotomist, EMT,
paramedic or military corpsman.” R. 617-1 at 4, 8.

        Ohio also continues to employ several safeguards and checks on each team
member during the dispensing of the drugs, preparation of the syringes and IVs,
administration of the IV, and monitoring of IV flow and pharmacological effects of any
injections. Each step of the protocol is also closely supervised by both the Warden or
ODRC Director and medically trained team members. During use of the IV method, the
medical team member administering the injection and the Warden will observe the
inmate as the drugs are administered to “look for signs of swelling or infiltration at the
IV site, blood in the catheter, and leakage from the lines and other usual signs or
symptoms.” R. 617-1 at 9. Another team member will enter the execution chamber and
inspect the IV sites for problems after each injection.

        One major difference in the new protocol, however, is the combination of drugs
to be used in the execution process. Until November 30, Ohio employed the same three-
drug IV injection that twenty-seven other states and the federal government use: 2 grams
of thiopental sodium (a barbiturate), followed by 100 milligrams of pancuronium
bromide (a muscle paralytic), and then 100 milliequivalents of potassium chloride (a salt
that causes cardiac arrest and rapid death). See Baze, 128 S. Ct. at 1527 (discussing
Kentucky’s three-drug protocol); Workman, 486 F.3d at 902 (describing Tennessee’s
three-drug protocol). The use of pancuronium bromide and potassium chloride formed
the basis of most of the challenges to lethal injection protocols in federal and state
courts, including Biros’s original complaint in the instant case. In fact, in the challenges
to both Kentucky and Tennessee’s three-drug protocol, the prisoners advocated the one-
drug injection adopted by Ohio here as a more humane alternative to the risk of pain
No. 09-4474        Biros v. Strickland, et al.                                      Page 9


arising from the use of the three drugs. See Baze, 128 S. Ct. at 1531–32; Harbison v.
Little, 571 F.3d 531, 538–39 (6th Cir. 2009).

       After reconsidering its protocol in light of the halted execution of Broom, Ohio
decided to switch to what it considers a more humane injection procedure using only
thiopental sodium.     In implementing the new procedure, “a person qualified to
administer and prepare drugs for intravenous and intramuscular injections” will prepare
five labeled syringes containing in total 5 grams of thiopental sodium. An additional
five labeled syringes and 5 grams of thiopental sodium are to be on hand in case the
initial dosage does not produce death.

       When administering the lethal injection via IV, medically trained team members
“evaluate and consider the establishment of one or two viable IV sites.” R. 617-1 at 8.
Then, those team members “shall make such number of attempts to establish IV sites as
may be reasonable under the circumstances and shall take the amount of time necessary
when pursuing this objective” and then test any chosen sites. Id. The protocol notes that
the preferred site for IV injection is the “joint between the upper and lower arm” but that
“a qualified medical person authorized to administer intravenous and intramuscular
drugs may use an alternative site to deliver the drugs as they may be authorized by law.”
Id. Should the team members “question the feasibility of establishing two or even one
site” due to difficulty, passage of time, or any other reason, the team members must
consult with the Warden. Id. At that time, the Warden must consult with the Director
of ODRC and “others as necessary” to determine whether to continue to search for an
IV site, pursue the alternative procedure, or halt the execution. Id. at 9.

       The other significant alteration in the new Ohio protocol, and one that Biros
challenges as untested, is the implementation of a back-up procedure for use if the
prisoner’s veins—like Broom’s—prove difficult to access. “If the Director and Warden
decide IV injections should not be used, or if an IV injection is commenced and
abandoned,” a two-drug injection of 10 milligrams of midazolam and 40 milligrams of
hydromorphone shall be administered in a single syringe intramuscularly. Id. at 8. A
second syringe of the same mixture will be available if necessary as will a third syringe
No. 09-4474        Biros v. Strickland, et al.                                    Page 10


of 60 milligrams of hydromorphone. Id. A medical team member will administer the
first injection and, after five minutes, examine the prisoner for signs of breathing. If
necessary, the medical team member will then administer the second injection and
reexamine the prisoner after five minutes. Id. Should the prisoner still exhibit signs of
breathing, the medical examiner will administer the 60 milligrams of hydromorphone.
Id.

                                             B.

       The plurality opinion in Baze sets the ground rules for gauging Biros’s likelihood
of success in challenging Ohio’s procedure. See Marks v. United States, 430 U.S. 188,
193 (1977) (“When a fragmented Court decides a case and no single rationale explaining
the result enjoys the assent of [the majority], ‘the holding of the Court may be viewed
as that position taken by those Members who concurred in the judgments on the
narrowest grounds.’” (citing Gregg v. Georgia, 428 U.S. 153, 169 n.15 (1976) (plurality
opinion))). To demonstrate that Ohio seeks to impose “cruel and unusual” punishment,
U.S. Const. amend. VIII, Biros must show that its protocol ignores a “sure or very
likely” risk of serious pain “and needless suffering,” Baze, 128 S. Ct. at 1531, which
“creates a demonstrated risk of severe pain” that is “substantial when compared to the
known and available alternatives,” id. at 1537.

       In thinking about what Baze requires, it is helpful to remember what it does not.
The opinion contains several controlling premises within which Biros must formulate
his challenge: Capital punishment is constitutional, see id. at 1529; death-row inmates
cannot use method-of-execution challenges to prohibit what the Constitution allows, id.;
“the Constitution does not demand” a pain-free execution, id. at 1529, 1537; and an
inmate cannot question a state’s execution protocol without providing “feasible, readily
implemented” alternatives that “significantly reduce a substantial risk of severe pain,”
see id. at 1532 (emphasis added); id. at 1531 (“[A] condemned prisoner cannot
successfully challenge a State’s method of execution merely by showing a slightly or
marginally safer alternative.”). Significantly, the Constitution does not allow the federal
courts to act as a best-practices board empowered to demand that states adopt the least
No. 09-4474        Biros v. Strickland, et al.                                    Page 11


risky execution protocol possible. See id. at 1529, 1531. Within this framework, the
Supreme Court has never held that an inmate met the “heavy burden” of demonstrating
that a state’s execution protocol is “cruelly inhumane” in violation of the Constitution.
See id. at 1533 (citing Gregg, 428 U.S. at 175); see also id. at 1529, 1531; Harbison, 571
F.3d at 535 (rejecting a challenge to Tennessee’s lethal injection protocol after Baze).

       Since Baze, this court and other circuits have addressed challenges to various
states’ lethal injection protocols according to this standard—in all cases finding that
Baze prevented the challengers from demonstrating either a violation of the Eighth
Amendment, a genuine issue of material fact regarding the existence of a violation, or
a likelihood of success on the merits for the alleged violation. See Clemons v. Crawford,
585 F.3d 1119, 1128 (8th Cir. 2009) (Missouri); Harbison, 571 F.3d at 535 (Tennessee);
Wellons v. Hall, 554 F.3d 923, 942 (11th Cir. 2009), overruled on other grounds, Cone
v. Bell, 129 S. Ct. 1769 (2009), as recognized in, Owen v. Sec’y for Dep’t of Corrs., 568
F.3d 894, 915 n.23 (11th Cir. 2009) (Georgia); Emmett v. Johnson, 532 F.3d 291, 295
(4th Cir. 2008) (Virginia); Hankins v. Quarterman, 288 F. App’x 952, 961 (5th Cir.
2008) (Texas). Two other circuits addressed similar challenges before Baze and came
to identical conclusions. See Hamilton v. Jones, 472 F.3d 814, 816–17 (10th Cir. 2007)
(Oklahoma); Beardslee v. Woodford, 395 F.3d 1064, 1075 (9th Cir. 2005) (per curiam)
(California).

       In the face of these requirements and this guidance, Biros has little prospect of
being the first inmate to show that an execution protocol is unconstitutional—either with
respect to the primary method of execution (the one-drug IV protocol) or with respect
to the back-up method of execution (the two-drug intramuscular protocol). A thorough
review of the evidence presented regarding Ohio’s new one-drug IV procedure reveals
that the similarities with Baze are considerable and the risk of severe pain no
greater—and likely less—than the risk of pain inherent in any lethal injection procedure
found constitutional by a federal court.         Furthermore, although the two-drug
intramuscular back-up injection differs from the protocol discussed in Baze, it is not
likely “cruelly inhumane” and does not “create[] a demonstrated risk of severe pain.”
No. 09-4474         Biros v. Strickland, et al.                                     Page 12


Baze, 128 S. Ct. at 1533, 1537. Finally, Biros “has not shown a sufficient likelihood that
the administration [of the protocol] will be improper in his case, or that there are specific
risks unique to him that require modification of the protocol.” See Beardslee, 395 F.3d
at 1076.

                                             C.

        Before embarking on a detailed analysis of Ohio’s new protocol, it is appropriate
to briefly outline the historical role of the Eighth Amendment in the context of capital
punishment in the United States. Although the notion of execution is uncomfortable for
many—and abhorrent to some—the Supreme Court has found it to be constitutional. See
Gregg, 428 U.S. at 169 (finding that capital punishment “does not invariably violate the
Constitution”). It is an extreme punishment reserved for “the most extreme of crimes.”
See id. at 187 (“There is no question that death as a punishment is unique in its severity
and irrevocability . . . .”). The Court has struggled for more than a century to articulate
“with exactness the extent” of the Eighth Amendment’s protections. Wilkerson v. Utah,
99 U.S. 130, 135–36 (1878). The Court has said that “[p]unishments are cruel when they
involve torture or a lingering death . . . . [or imply] something inhuman and
barbarous—something more than the mere extinguishment of life,” In re Kemmler, 136
U.S. 436, 447 (1890), when they cause “unnecessary pain” or “wanton infliction of
pain,” Louisiana ex rel. Francis v. Resweber, 329 U.S. 459, 463 (1947) (plurality
opinion), or when they do not “accord with ‘the dignity of man, which is the basic
concept underlying the Eighth Amendment,’” Gregg, 428 U.S. at 173.

        The role of the Eighth Amendment has thus become a check on states’ imposition
of this constitutional punishment and an encouragement to develop more humane
methods of execution. See Baze, 128 S. Ct. at 1537 (“State efforts to implement capital
punishment must certainly comply with the Eighth Amendment, but what that
Amendment prohibits is wanton exposure to ‘objectively intolerable risk,’ not simply the
possibility of pain.” (citation omitted)). The May 14 and November 30 changes to
Ohio’s lethal injection protocol have been in furtherance of this aim. See Governor Ted
Strickland, Warrants of Reprieve, Oct. 6, 2009; cf. Baze, 128 S. Ct. at 1527 n.1 (“[I]t is
No. 09-4474         Biros v. Strickland, et al.                                   Page 13


. . . undisputed that, in moving to lethal injection, the States were motivated by a desire
to find a more humane alternative to then-existing methods.”); Workman, 486 F.3d at
907 (“The whole point of the Tennessee lethal-injection protocol is to avoid the needless
infliction of pain, not to cause it.”). By adopting a one-drug injection, Ohio purposely
ceased using the pancuronium bromide and potassium chloride that had been the focus
of previous Eighth Amendment challenges to lethal injection protocols, including in
Biros’s original complaint. See, e.g., Baze, 128 S. Ct. at 1534–35; Emmett, 532 F.3d at
295, 300; Compl. at 2. Additionally, Ohio’s decision to employ a back-up intramuscular
injection option was a direct response to the difficulties encountered during Broom’s
halted execution. That is, the purpose of the intramuscular injection seeks to avoid an
unduly prolonged search for difficult-to-access veins and to provide a safe, non-IV lethal
injection method.

       In addressing challenges to execution methods, the Supreme Court has
determined that the Eighth Amendment does not require a state to employ a painless
execution method, but rather one free from “needless suffering” and a “demonstrated
risk of severe pain.” Baze, 128 S. Ct. at 1531, 1537; see, e.g., Resweber, 329 U.S. at 464
(“The cruelty against which the Constitution protects a convicted man is cruelty inherent
in the method of punishment, not the necessary suffering involved in any method
employed to extinguish life humanely.”); see also Hamilton, 472 F.3d at 816 (“[T]he
Constitution does not require the use of execution procedures that may be medically
optimal in other contexts. Rather, . . . such procedures [must] ‘not involve the
unnecessary and wanton infliction of pain.’”). The lethal injection protocols are
designed to minimize pain and the likelihood of improper administration of the
procedure. Because “capital punishment is constitutional[, i]t necessarily follows that
there must be a means of carrying it out. Some risk of pain is inherent in any method of
execution—no matter how humane—if only from the prospect of error in following the
required procedure.” Baze, 128 S. Ct. at 1529. “It is clear, then, that the Constitution
does not demand the avoidance of all risk of pain in carrying out executions.” Id.; see
also Emmett, 532 F.3d at 303 (“[I]t is enough to observe that Virginia is not
No. 09-4474         Biros v. Strickland, et al.                                     Page 14


constitutionally required to eliminate every possibility that pain might occur or every
unnecessary risk that may exist.”).

        In considering Ohio’s new lethal injection protocol, therefore, we do not consider
whether it is the best possible procedure, but rather whether the protocol itself presents
a “demonstrated risk of severe pain.” Baze, 128 S. Ct. at 1537; see also Beardslee, 395
F.3d at 1073 (“In the context of this particular challenge [of reviewing the district court’s
denial of a preliminary injunction], the more important consideration may be the
examination of the objective evidence as to the pain caused by the particular method
employed . . . .”); Campbell v. Wood, 18 F.3d 662, 683 (9th Cir. 1994) (en banc)
(holding that judicial review of a method of execution “focuses more heavily on
objective evidence of the pain involved in the challenged method” (internal quotation
marks and citation omitted)).

                                             D.

        Biros raises questions regarding the appropriateness of Ohio’s protocol and
indicates specific elements of that protocol that he alleges present a demonstrated risk
of severe pain sufficient to rise to the level of cruel and unusual punishment. Biros does
not challenge the use of the one-drug IV injection if properly administered, and indeed
his medical expert praises Ohio’s decision to abandon the three-drug injection. His
allegations regarding the unconstitutionality of Ohio’s primary procedure—IV injection
of thiopental sodium—therefore solely address the risk of improper administration of the
drug. These challenged elements of the protocol can be fairly summarized as: (a) the
undue risk of improper implementation of Ohio’s protocol, leading to severe pain;
(b) the employment of untrained and insufficiently competent medical personnel; (c) the
lack of supervision of the execution process by a licensed physician; (d) the lack of a
prescribed limit to the time allowed the execution team to search for accessible veins for
IV administration; and (e) the lack of an explicit ban on the use of cut-down procedures
for accessing veins as an alternative method to the preferred peripheral IV access. His
challenge to Ohio’s new back-up procedure is more substantive but less detailed: (a) the
untested nature of the intramuscular procedure; (b) the slow-acting and unpredictable
No. 09-4474        Biros v. Strickland, et al.                                   Page 15


effect of that procedure; and (c) the existence of a more humane alternative to
intramuscular injection. We will consider first those challenges related to the IV
injection and implementation of the protocol. We will then turn to Biros’s allegations
regarding the back-up procedure.

    1. Challenges to IV Injection and Ohio’s Implementation of the New Protocol

       The majority of the claims regarding the one-drug IV injection are foreclosed by
Baze and its progeny.

       a. Undue Risk of Improper Implementation of Ohio’s Protocol. In Baze, the
Court held that Eighth Amendment challenges to lethal injection protocols on the
grounds that the protocol could be improperly administered are insufficient to
demonstrate a violation. The Court stated:

       Petitioners agree that, if administered as intended, that procedure will
       result in a painless death. The risks of maladministration they have
       suggested—such as improper mixing of chemicals and improper setting
       of IVs by trained and experienced personnel—cannot remotely be
       characterized as “objectively intolerable.” Kentucky’s decision to adhere
       to its protocol despite these asserted risks, while adopting safeguards to
       protect against them, cannot be viewed as probative of the wanton
       infliction of pain under the Eighth Amendment.
Baze, 128 S. Ct. at 1537–38; see also Beardslee, 395 F.3d at 1071–72 (rejecting a
prisoner’s claim that “the lack of specificity” in the protocol leading to many “variables
that can complicate the proper administration of the drugs, such as the use of Valium as
a pre-execution sedative, and the problems in finding acceptable veins for the insertion
of an intravenous tube”). Consequently, Biros’s general claim that the possibility of
maladministration of the IV could lead to severe pain is without merit. To demonstrate
a likelihood of success on this ground, therefore, Biros must distinguish his
maladministration claims from those rejected in Baze. He has failed to do this.
No. 09-4474            Biros v. Strickland, et al.                                               Page 16


         Biros relies heavily on Ohio’s halted execution of Broom to distinguish his case
from that of Baze.3 The Supreme Court has found, however, that evidence of prior
accidents in the administration of an execution protocol does not render the protocol
itself per se unconstitutional. In Resweber, Louisiana attempted to execute a prisoner
by electrocution, but when the executioner flipped the switch, nothing happened. The
Court first noted that “we must and do assume that the state officials carried out their
duties under the death warrant in a careful and humane manner. Accidents happen for
which no man is to blame.” Resweber, 329 U.S. at 462. It then found that a subsequent
execution of the same prisoner by electrocution would not be unconstitutional. See id.
at 464 (“The fact that an unforeseeable accident prevented the prompt consummation of
the sentence cannot, it seems to us, add an element of cruelty to a subsequent execution.
There is no purpose to inflict unnecessary pain nor any unnecessary pain involved in the
proposed execution.”). The Court in Baze affirmed that “an isolated mishap alone does
not give rise to an Eighth Amendment violation, precisely because such an event, while
regrettable, does not suggest cruelty, or that the procedure at issue gives rise to a
‘substantial risk of serious harm.’” Baze, 128 S. Ct. at 1531 (citation omitted).

         Furthermore, in a case similar to the one before us today, the Eighth Circuit
addressed a challenge to Missouri’s lethal injection protocol after a series of mistakes
in administration of the protocol came to light. See Clemons, 585 F.3d at 1119. The
Eighth Circuit rejected the prisoner’s claim that there was a substantial risk of pain due
to incompetent personnel despite the fact that the court had previously found that
medical personnel administering the protocol—since removed—had been incompetent.
Id. at 1127 (“We reject the prisoners’ attempt to distinguish their case from Baze on the
basis of alleged past incompetence on the part of Missouri’s medical personnel.”). For


         3
            Broom’s attempted execution took place on September 15, 2009. The execution team was
unable to find a vein on Broom’s arm after repeated attempts over two hours. They attempted to insert the
IV catheter into the crook of Broom’s elbow, his wrists, over the knuckle of his first finger, and near his
ankles. Twice, the team managed to insert a catheter that was not secured properly and caused bleeding.
Biros contends that the new one-drug protocol is identical to the old protocol in terms of the training and
supervision of the execution team and thus, he could be subjected to a failed execution like Broom’s. Biros
uses little more than speculation and the argument that if failure happened once, it could happen again.
Biros cannot rely upon Broom’s experience without more specific evidence that would show a likelihood
that his own execution would be unsuccessful. Without such evidence, we must, as the Supreme Court
has instructed, assume that the execution team will implement the protocol as specified.
No. 09-4474         Biros v. Strickland, et al.                                    Page 17


the same reasons, we cannot assume that the same misfortunes that befell Broom will
befall Biros, nor can we assume that Ohio’s execution team—if faced with difficulty
administering the lethal injection intravenously—will not cease searching for veins and
turn to the back-up intramuscular protocol. Speculations, or even proof, of medical
negligence in the past or in the future are not sufficient to render a facially
constitutionally sound protocol unconstitutional.

        Permitting constitutional challenges to lethal injection protocols based on
speculative injuries and the possibility of negligent administration is not only
unsupported by Supreme Court precedent but is also beyond the scope of our judicial
authority. See, e.g., Gregg, 428 U.S. at 174–75 (“[W]hile we have an obligation to
insure that constitutional bounds are not overreached, we may not act as judges as we
might as legislators.”). While the Eighth Amendment does provide a necessary and not
insubstantial check on states’ authority to devise execution protocols, its purpose is not
to substitute the court’s judgment of best practices for each detailed step in the procedure
for that of corrections officials. See Baze, 128 S. Ct. at 1537 (“[A]n inmate cannot
succeed on an Eighth Amendment claim simply by showing one more step the State
could take as a failsafe for other, independently adequate measures. This approach
would serve no meaningful purpose and would frustrate the State’s legitimate interest
in carrying out a sentence of death in a timely manner.”); Gregg, 428 U.S. at 175–76
(“We may not require the legislature to select the least severe penalty possible so long
as the penalty selected is not cruelly inhumane or disproportionate to the crime involved.
. . . Caution is necessary lest this court become, ‘under the aegis of the Cruel and
Unusual Punishment Clause, the ultimate arbiter of the standards of criminal
responsibility . . . throughout the country.’” (quoting Powell v. Texas, 392 U.S. 514, 533
(1968) (alteration in original))); Emmett, 532 F.3d at 303 (“While Dr. Henthorn is of the
view that such delay [of administering each subsequent injection] would be a better
practice, we are not at liberty to dictate what is in our judgment or the judgment of any
expert a ‘better’ or ‘less risky’ procedure.”). Indeed the Court has all but foreclosed this
form of Eighth Amendment challenge:
No. 09-4474            Biros v. Strickland, et al.                                              Page 18


         Given what our cases have said about the nature of the risk of harm that
         is actionable under the Eighth Amendment, a condemned prisoner cannot
         successfully challenge a State’s method of execution merely by showing
         a slightly or marginally safer alternative.
         Permitting an Eighth Amendment violation to be established on such a
         showing would threaten to transform courts into boards of inquiry
         charged with determining “best practices” for executions, with each
         ruling supplanted by another round of litigation touting a new and
         improved methodology. Such an approach finds no support in our cases,
         would embroil the courts in ongoing scientific controversies beyond their
         expertise, and would substantially intrude on the role of state legislatures
         in implementing their execution procedures—a role that by all accounts
         the States have fulfilled with an earnest desire to provide for a
         progressively more humane manner of death.
Baze, 128 S. Ct. at 1531. Thus, Biros’s advocacy for modest improvements to the
administration of Ohio’s lethal injection protocol is not sufficient to demonstrate that a
protocol without those improvements is unconstitutional.

         b. Employment of Untrained and Insufficiently Competent Medical Personnel.
Biros’s more specific criticisms of the Ohio protocol with respect to proper training of
personnel, supervision, and lack of guidance on when and how to determine that the
back-up procedure should be used also fail to demonstrate a likelihood of success. Biros
argues that Ohio’s requirement of one year of medical training and the use of medical
assistants, phlebotomists, and EMTs is insufficient to ensure competent execution
personnel.4 In considering Kentucky’s protocol, however, the Baze Court noted the
existence of “important safeguards to ensure that an adequate dose of sodium
thiopental[,] . . . [t]he most significant of [which] is the written protocol’s requirement
that members of the IV team must have at least one year of professional experience as
a certified medical assistant, phlebotomist, EMT, paramedic, or military corpsman . . .


         4
           The presence of a supervising or attending physician at an execution by lethal injection
undoubtedly could help to ensure that executions proceed as smoothly and painlessly as possible. See Atul
Gawande, When Law and Ethics Collide—Why Physicians Participate in Executions, 354 New Eng. J.
Med. 1221, 1223 (2006). However, the majority of doctors refuse to participate in executions in any
meaningful way, see Neil J. Farber et al., Physicians’ Willingness to Participate in the Process of Lethal
Injection for Capital Punishment, 135 Ann. Intern. Med. 884, 886 (2001), and the relevant medical ethics
guidelines prohibit such participation, see Baze, 128 S. Ct. at 1539–40 (Alito, J., concurring). For this
reason, Ohio must rely on non-physicians to implement its lethal injection protocol, and its requirements
of training and qualifications provide adequate supervision in the absence of physicians.
No. 09-4474           Biros v. Strickland, et al.                                              Page 19


[and] participate in at least 10 practice sessions per year.” Baze, 128 S. Ct. at 1533–34;
see also id. at 1528 (explaining the qualifications and training of Kentucky’s execution
team); cf. R. 617-1 at 4, 8. Baze found that the same training and qualification
requirements also “substantially reduce the risk of IV infiltration.” 128 S. Ct. at 1534.

         This court and other circuits that have addressed challenges to the competency
and training of execution personnel have upheld requirements similar to those listed in
Ohio’s protocol. See Harbison, 571 F.3d at 538 (finding that the use of two paramedic
technicians to administer the IV and monthly training sessions of the execution team
provided sufficient safeguards to assume proper administration of Tennessee’s protocol);
Emmett, 532 F.3d at 295 (finding sufficient Virginia’s requirements that the execution
team undergo eight hours of training per month and that at least two team members
“have received training as military corpsmen, cardiac emergency technicians, or should
receive on-the-job training from a physician in receiving and dispensing medications,
to include starting and administering IV fluids” (citation omitted)); Hamilton, 472 F.3d
at 816 (rejecting a similar challenge to Oklahoma’s protocol, which requires that “an
EMT-P or person with similar qualifications and expertise in IV insertion” establish the
IV drips (citation omitted)). Biros’s claim that Ohio’s protocol is constitutionally
deficient on the basis of poorly trained personnel or the ceding of too much discretion
to those personnel is therefore meritless.

         Biros’s medical expert, Dr. Heath, further suggests that Ohio should employ
physicians to implement the new protocol.5 This alternative is not required by
Baze and state law itself would subject any participating physician to severe
discipline by the state medical board. It is undisputed that the American Medical
Association guidelines prohibit physician participation in execution. American
Medical        Association,         Opinion        2.06—Capital           Punishment          (2000),
http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-
ethics/ opinion206.shtml. Ohio permits the state medical board to “limit, revoke or


         5
          Dr. Heath also references Ty Alper, The Truth About Physician Participation in Lethal Injection
Executions, 88 N.C. L. Rev. ___ (forthcoming 2009).
No. 09-4474         Biros v. Strickland, et al.                                     Page 20


suspend an individual’s certificate to practice [medicine in the state for a] . . . violation
of any provision of a code of ethics of the American Medical Association.” Ohio Rev.
Code. Ann. § 4731.22(B)(13). Indeed, so long as the medical board has “reliable,
probative, and substantial” evidence of a violation of the AMA guidelines, a doctor is
subject to its penalty without resort even to the courts. Schechter v. Ohio State Med. Bd.,
No. 04-AP-1115, 2005 WL 1869733, at *19 (Ohio Ct. App. Aug. 9, 2005) (“When the
board’s order is supported by reliable, probative, and substantial evidence and is in
accordance with law, a reviewing court may not modify a sanction authorized by
statute.”). Dr. Heath’s proposed alternative is therefore not feasible.

        c. Lack of Supervision of the Execution Process by a Licensed Physician. For
similar reasons, we find that Biros’s claim that a lack of proper supervision of the IV
injection by a physician constitutes an Eighth Amendment violation also must fail. Like
the Kentucky protocol upheld in Baze, Ohio’s protocol calls for the medical team
members to administer the drug remotely by IV while the Warden and Director of
ODRC remain in the execution room to visually inspect the prisoner to determine if he
is unconscious, needs further injections, or exhibits any problems with the IV catheters
and tubing such as infiltration of the tissue. Compare Baze, 128 S. Ct. at 1528, 1534,
with R. 617-1.      This court and other circuits have rejected allegations of the
unconstitutionality of similar supervisory procedures. See Harbison, 571 F.3d at 536–38
(“Medical experts in Baze testified that identifying signs of possible infiltration
occurring at the IV site would be very obvious to the average person because of the
swelling that would result.” (citing Baze, 128 S. Ct. at 1534)); Emmett, 532 F.3d at
295–96; Hamilton, 472 F.3d at 816 (“[W]hile monitoring of anesthetization level is the
optimal practice appropriate for a surgical operating room . . . , the risk inherent in the
lethal-injection procedure under review is already so attenuated that we cannot say there
is a significant likelihood that a challenge to the protocol under the minimal
requirements imposed by the Eighth Amendment on executions could succeed on our
record.”). Thus Biros cannot demonstrate that Ohio’s supervision procedures are
unconstitutional.
No. 09-4474        Biros v. Strickland, et al.                                    Page 21


       d. Lack of a Prescribed Limit to the Time Allowed the Execution Team to Search
for Accessible Veins for IV Administration. Invoking the experiences of Broom and of
Joseph Clark before him, Biros says that there are no limits on how long the execution
team may “poke and stick” him before moving to the alternative intramuscular injection,
raising the risk that the protocol will cause “unconstitutional pain and suffering” in the
interim. Am. Compl. at 12. As established in Baze, the training and qualifications of the
medical personnel required by the protocol ensure that they can make this determination
competently. See 128 S. Ct. at 1533–34.

       Biros argues that an easy and feasible alternative to the challenged discretion
exists. Biros advocates that Ohio, like Kentucky, adopt a sixty-minute limit on how long
the execution team be allowed to search for an accessible vein. Baze held that “proffered
alternatives must effectively address a ‘substantial risk of serious harm.’ To qualify, the
alternative procedure must be feasible, readily implemented, and in fact significantly
reduce a substantial risk of severe pain.” Id. at 1532 (citation omitted). Therefore, it is
now settled law that “[a] prisoner cannot successfully challenge a method of execution
merely by showing that the method may result in pain, either by accident or as an
inescapable consequence of death, or that a slightly safer alternative is available.”
Harbison, 571 F.3d at 535 (citing Baze, 128 S. Ct. at 1531, 1537); see also Walker v.
Epps, 287 F. App’x 371, 376 (5th Cir. 2008) (finding that the prisoner “ha[d] not
demonstrated irreparable harm ‘through the mere possibility that some unforeseen
complication will result in a lingering death causing [him] to suffer unnecessary pain[;
therefore,] [h]e cannot rely on this possibility as the grounds for substantial risk of
harm’” (citing Lambert v. Buss, 498 F.3d 446, 452 (7th Cir. 2007), and Beardslee, 395
F.3d at 1075) (alterations in original)). In light of the constitutionally adequate medical
supervision, the requirement that Ohio impose a sixty-minute limit on the amount of
time allowed to search for veins for IV injection does not alleviate a “substantial risk of
serious harm.” Furthermore, this proposed amendment to Ohio’s protocol is eminently
the kind of cost–benefit judgment that courts are ill-suited to perform and that Baze
discouraged. See Baze, 128 S. Ct. at 1531.
No. 09-4474         Biros v. Strickland, et al.                                      Page 22


        The unfortunate incident of Ohio’s unsuccessful execution of Broom does not
distinguish Ohio’s protocol from that at issue in Baze. When administered properly,
both protocols are humane and constitutional. Ohio’s protocol, like Kentucky’s, is
regrettably open to the possibility of mistaken application. The complete eradication of
all risk of accident, however, is not yet possible, and the assertion that the mere
possibility of future improper administration of the lethal injection despite the training
and safeguards is too “attenuated” and “speculative”—and certainly not intended—to
constitute cruel and unusual punishment. See id. at 1536–37; United States v. Emerson,
270 F.3d 203, 262 (5th Cir. 2001).

        e. Lack of an Explicit Ban on the Use of Cut-Down Procedures. Biros also
asserts that Ohio’s protocol does not prohibit the use of a cut-down procedure when a
prisoner’s veins prove difficult to locate. A cut-down procedure entails making an
incision into an arm or leg to gain IV access. See Nelson v. Campbell, 541 U.S. 637, 641
(2004). First, generally physicians or nurses are needed to perform this procedure, and
the Ohio protocol does not envision physicians or nurses as members of the execution
team nor has Ohio generally been able to acquire the assistance of either at executions
in the past. Second, Biros presents no evidence that Ohio has previously employed the
cut-down procedure. It was not employed during the attempted execution of Broom, and
there is no evidence that it would be used in the execution of Biros. Furthermore, the
Director of ODRC has stated that the procedure will not be used—an assurance that Dr.
Heath acknowledged and accepted in testimony. Furthermore, Ohio’s protocol indicates
that the alternative intramuscular injection is to be utilized if the execution team finds
the prisoner’s veins difficult to access, and the implication is that it is this intramuscular
procedure—and not cut-down—that will be employed should the execution team find
peripheral IV injection impossible. Finally, because we upheld Tennessee’s lethal
injection protocol, which included cut-down as the approved back-up procedure, we
need not address it in further detail here. See Harbison, 571 F.3d at 539.
No. 09-4474        Biros v. Strickland, et al.                                    Page 23


               2. Challenges to the Back-Up Intramuscular Procedure

       Biros raises a series of distinct challenges to Ohio’s contingency intramuscular
injection of hydromorphone and midazolam. While Baze forecloses Biros’s claims that
Ohio’s use of the one-drug IV injection are unconstitutional, the protocol at issue in Baze
is less factually similar to Ohio’s back-up intramuscular injection procedure. Biros first
asserts that the intramuscular injection is unconstitutional because it has never before
been used in an execution, thereby rendering him “a human guinea pig.” Dr. Heath,
Biros’s medical expert, expresses concern that there is insufficient analysis of what
happens when this combination of drugs is administered to humans. Second, Biros
alleges that the intramuscular injection is cruel and unusual because it is slower—a
matter of minutes rather than seconds—than the IV procedure. The delayed effect of the
drug, Dr. Heath argues, increases the likelihood that the prisoner will experience the
common but unpleasant side effects of the two drugs.

       Before addressing those challenges, however, it bears noting that Biros faces a
threshold problem. The record gives us little reason to think that the execution team will
have to resort to this contingency. Biros has never argued, much less shown, that he has
difficult-to-access veins, and the intramuscular injection comes into play only when an
IV injection is not possible. Furthermore, Biros’s own medical expert concedes that it
is very unlikely that the intramuscular injection protocol will be necessary because
thiopental sodium is likely to work. Indeed, Dr. Heath has explicitly endorsed the
thiopental-sodium protocol. That reality alone diminishes the alleged risks.

       It is also important to note that Ohio’s adoption of a back-up procedure to the IV
injection arose out of concerns regarding the pain that may ensue from attempting to find
veins in prisoners—like Broom—whose veins are difficult to access. That is, the back-
up procedure is patently an attempt by the State of Ohio to render its execution process
more humane, rather than less. The procedure is an improvement on the prior protocol
in two ways. First, it provides an approved alternative method of execution by lethal
injection that medical personnel can turn to quickly should they encounter difficulty in
accessing a prisoner’s veins. The availability of an alternative should curtail the
No. 09-4474            Biros v. Strickland, et al.                                              Page 24


searching and poking that Biros fears. Second, the alternative is less invasive than the
cut-down procedure employed by Tennessee.6                     See Harbison, 571 F.3d at 539
(upholding Tennessee’s procedure, including the cut-down alternative); Workman, 486
F.3d at 903 (outlining Tennessee’s alternative cut-down procedure); see also Nelson, 541
U.S. at 641 (describing the cut-down procedure in detail).

         a. Untested Nature of the Intramuscular Procedure. That the procedure has
never before been used does not itself establish that the procedure is cruel and unusual.
The Supreme Court has previously considered various modes of execution and has yet
to find one violative of the Eighth Amendment. See Baze, 128 S. Ct. at 1530 (“This
Court has never invalidated a State’s chosen procedure for carrying out a sentence of
death as the infliction of cruel and unusual punishment.”). Indeed, the development of
increasingly humane methods of execution is to be encouraged:

         The broad framework of the Eighth Amendment has accommodated this
         progress toward more humane methods of execution, and our approval
         of a particular method in the past has not precluded legislatures from
         taking the steps they deem appropriate, in light of new developments, to
         ensure humane capital punishment. There is no reason to suppose that
         today’s decision will be any different.
Id. at 1538. In determining whether a new execution method is constitutional, we must
analyze it under the same framework as any other alleged Eighth Amendment violation.
See In re Kemmler, 136 U.S. at 447 (considering the constitutionality of New York’s
novel adoption of execution by electrocution and noting that “[t]he courts of New York
[had found] that the mode adopted in this instance might be said to be unusual because
it was new, but that it could not be assumed to be cruel in the light of that common
knowledge which has stamped certain punishments as such”).




         6
           Dr. Heath also alludes to standards promulgated by the American Veterinary Medical
Association for intramuscular euthanasia. The record is not well-developed on this point and the
overwhelming weight of the testimony indicates that the intramuscular injection protocol drugs are not
likely to cause pain and suffering. Furthermore, the Supreme Court addressed a similar claim with respect
to laws prohibiting the use of pancuronium bromide by veterinarians in euthanasia, noting that “veterinary
practice for animals is not an appropriate guide to humane practice for humans.” See Baze, 128 S. Ct. at
1535–36.
No. 09-4474             Biros v. Strickland, et al.                                                  Page 25


         We now turn to whether Biros has presented sufficient evidence to demonstrate
that the intramuscular injection of hydromorphone and midazolam presents a risk of
severe pain. We conclude that he has not.

         b. Slow-Acting and Unpredictable Effect of the Intramuscular Procedure.
According to Dr. Mark Dershwitz, a board-certified anesthesiologist and professor at the
University of Massachusetts and the State’s medical expert, a large dose of
hydromorphone, an opioid most commonly used for pain relief, causes cessation of
breathing.7       Midazolam, the second drug used in the intramusculatory injection
procedure, is commonly used to sedate and relieve the anxiety of patients undergoing
uncomfortable procedures or anesthetization before surgery.                           Both drugs cause
ventilatory depression, and the effect is increased and hastened when the two drugs are
administered together. According to Dr. Dershwitz, an inmate injected with the dosage
required by the Ohio protocol will become sleepy and slow breathing after several
minutes and lose consciousness within two to four minutes. Approximately five minutes
after breathing stops, the heart and brain “will become damaged irreversibly, and death
will occur a few minutes later.” R. 611-1 at 3. Although the “peak pharmacological
effect will occur in about 20–30 minutes,” the State has shown that the loss of
consciousness sets in shortly—and Dr. Dershwitz avers that “perceptible effects” will
“occur within a minute or two”—the inmate will not experience the side effects Biros
fears. Even if death does not occur until several minutes later, the inmate will not be
aware of the delay. Biros has presented no evidence that the pharmacological effect of
the two-drugs would be otherwise. The Federal Drug Administration has approved both
drugs for intramuscular injection, and although this mode of administration acts more
slowly than IV administration, it is used on patients around the country daily.




         7
           At the outset, we note Dr. Dershwitz’s extensive professional experience with pharmacokinetics
and pharmacology. See United States v. Diaz, 25 F.3d 392, 394 (6th Cir. 1994) (“When an expert has been
qualified, other evidence, including the testimony of other experts, that contradicts or undermines the
testimony of the expert affects that expert’s credibility . . . .”). Dr. Dershwitz has a Ph.D. in pharmacology,
has taught the subject for more than thirty years, and has published extensively in the field. He based his
expert opinions of the intramuscular injection protocol on an extensive literature review as well as his own
professional experience.
No. 09-4474         Biros v. Strickland, et al.                                    Page 26


        Biros has presented evidence that hydromorphone and midazolam—like all
pharmaceuticals—can lead to uncomfortable side effects. Specifically, he has identified
side effects such as nausea, vomiting, aspiration, biliary spasm, anxiety, and
combativeness. Dr. Heath testified that the intramuscular injection protocol drugs could
induce nausea and vomiting that could cause pain and violent coughing that could wake
up a prisoner if he is unconscious. Even if a prisoner did not wake up, Dr. Heath
believes it possible that the vomit could enter his airways and lead him to aspirate. He
further testified that it is possible that the drugs could render a prisoner disoriented,
anxious, and intoxicated such that it could provoke a combative fight-or-flight response.

        At the recent hearing, Dr. Heath was unable to quantify the likelihood of any of
these side effects occurring if the State turned to the intramuscular injection method. At
most, he was able to say that “some” prisoners could have an individualized adverse
reaction to the drugs. Tr. at 63. He also pointed out that, because patients in the clinical
context are administered much lower doses of the drugs, the likelihood and intensity of
the side effects is uncertain. Dr. Dershwitz, on the other hand, gave a definite expert
opinion, explaining, “[I]t is my belief beyond a reasonable degree of medical certainty,
if [intramuscular injection] is implemented . . . it is very unlikely that the inmate will
suffer any pain.” Tr. at 219–20. The expert opinion to a reasonable degree of medical
certainty offered by Dr. Dershwitz contrasts sharply with the speculation by Dr. Heath:
“[S]ome prisoners who are exposed [to this intramuscular injection]” may have adverse
reactions that result in a “distasteful” procedure. Tr. at 35. As we have emphasized
repeatedly, the Constitution does not require perfection; it does require Biros to show
more to convince us that he faces a substantial likelihood of pain and suffering.

        Furthermore, according to Dr. Dershwitz, the likelihood of seizure-type activity
is low and midazolam is both an anti-emetic (a drug effective against vomiting and
nausea) and anti-seizure medication that counteracts many of the side effects Dr. Heath
identified as resulting from hydromorphone. The opioids would more likely than not
dull any possible pain and not exacerbate it. Dr. Dershwitz offered testimony that an
individual would lose consciousness within two to four minutes of the first
No. 09-4474            Biros v. Strickland, et al.                                              Page 27


administration of midazolam and would thus be unlikely to aspirate. Even if a person
did vomit, they would not suffer pain because they would be unconscious. Any inter-
individual variation in the absorption rates, and thus the efficacy of the drugs, would be
overwhelmed by the dosage amounts.

         Biros points to an additional uncertainty. If the execution team uses the
intramuscular procedure after injecting thiopental sodium into his bloodstream during
an attempted IV injection, the unintended combination of drugs may exacerbate the side
effects of the intramuscular drugs or reduce their absorption rate. However, even Biros’s
own expert could not give a definitive opinion on whether those were legitimate
possibilities.    Uncertainties built on so many other uncertainties cannot show a
substantial risk of severe pain and needless suffering.

         At best, Biros has pointed to a four minute window within which he could
possibly suffer some discomfort. However, he has neither established any likelihood
that he would experience the side effects of hydromorphone or midazolam nor has he
demonstrated any likelihood that these side effects would cause him pain.8 Dr. Heath
has presented speculative evidence that certain patients in certain circumstances with
certain combinations of risk factors may experience unpleasant side effects. None of his
testimony outweighs the evidence presented by Dr. Dershwitz that midazolam and
hydromorphone will almost certainly have an anti-emetic, anti-seizure, and analgesic
effect on an individual and that the overwhelming doses of these drugs would counteract
any discomfort. In sum, Biros has failed to provide any objective evidence that in the
few minutes during which the prisoner would lapse into unconsciousness after the first
injection, these side effects would pose a substantial risk of severe pain or needless
suffering.




         8
         Dr. Heath’s request for a pharmacokinetic analysis of hydromorphone by Dr. Dershwitz similarly
has no bearing on the likelihood of severe pain during the process. Indeed, it is Dr. Dershwitz’s
uncontradicted testimony that additional studies would not change the fact that a high dose of
hydromorphone would induce death after a prisoner loses consciousness, and thus the ability to sense pain.
Even moderate variability in the effectiveness of the drugs from person to person is irrelevant due to the
overwhelming dosages involved.
No. 09-4474         Biros v. Strickland, et al.                                    Page 28


        c. More Humane Alternative to Intramuscular Injection. Dr. Heath faults the
new protocol for using an intramuscular injection backup instead of instructing the
execution team to insert a “central line,” or long IV catheter, through a vein in the
prisoner’s neck, under the collar bone, or along the femur, so that the catheter rests a few
inches from the heart. He contends that this is the accepted back-up procedure in a
number of other jurisdictions. Yet Heath concedes that “a central line has a far greater
capability of causing severe injury and pain and morbidity and mobility.” Tr. at 110
(emphasis added). The insertion of a central line may be one alternative to peripheral
venous access, but even Biros’s expert’s testimony confirms that the State’s chosen
procedure is less dangerous than the alternative and less likely to cause severe injury and
pain. Dr. Heath also agreed that “in order to avoid substantial risk that the central line
will not be performed effectively,” it would “be necessary to use a physician.” Tr. at
112. Yet Ohio has consistently proven unable to obtain assistance from medical doctors
in the administration of the death penalty.

        Therefore, the use of a central line as an alternative does not satisfy Baze’s
requirements that an alternative “be feasible, readily implemented, and in fact
significantly reduce a substantial risk of severe pain.”         Baze, 128 S. Ct. 1532.
Furthermore, because Biros fails to demonstrate a risk of severe pain in the
intramuscular procedure, and thus no “substantial risk of serious harm” posed by it, see
id., we need not address the relative merits of the two procedures because the mere
existence of an alternative is insufficient to render Ohio’s chosen protocol
unconstitutional.

                                            ***

        Biros argues that Ohio is unduly “rush[ing]” to carry out his death sentence and
unreasonably holding itself to an “arbitrary” execution schedule. R. 610 at 3. However,
many years have elapsed between Biros’s 1991 conviction and the first challenge to
Ohio’s lethal injection protocol in 2004. Still more years have passed between that first
challenge to the protocol and the present. In the meantime, no federal appellate court
has concluded that a state’s lethal injection procedure is unconstitutionally cruel and
No. 09-4474         Biros v. Strickland, et al.                                    Page 29


unusual. Throughout this entire period, states have sought to improve their lethal
injection protocols and to attempt to make executions more comfortable for citizens
sentenced to death. A state’s efforts to reduce the likelihood of discomfort for those
whom it must lawfully execute cannot be seen as unconstitutionally undue haste unless
the condemned prisoner can demonstrate that those procedures present a “sure or very
likely” risk of serious pain “and needless suffering” that “creates a demonstrated risk of
severe pain” that is “substantial when compared to the known and available
alternatives.”   Baze, 128 S. Ct. at 1531, 1537.        Certainly, states should not be
discouraged from attempting to improve their protocols—to obtain a “more humane
manner of death”—“a role . . . [that] the States have fulfilled with an earnest desire” for
more than two hundred years. Id. at 1531. If, however, a state changes its protocol in
pursuit of a more humane punishment and the alteration becomes the subject of
protracted, stay-inducing federal litigation, the change impedes the state’s interest in
swiftly executing those sentenced to death. When that occurs, we risk stifling the
necessary impetus to seek more humane execution methods and insert the courts into a
policy and scientific debate not suited to judicial authority. The standards and inquiries
set out by the Supreme Court in Baze strike a balance between turning the federal courts
into tribunals of best practices and maintaining their rightful function as a constitutional
check on the “wanton infliction of pain” by the state. See Resweber, 329 U.S. at 463.

        Biros further maintains that a stay is necessary to maintain the status quo and
permit him additional time—even a matter of days—to further develop the record. The
evidence presented by the parties and the testimony of both medical experts persuade us,
however, that additional time will not enhance Biros’s likelihood of success on the
merits. Biros’s burden in demonstrating an Eighth Amendment violation is a “heavy”
one, and there is nothing in the record before us to indicate that additional testing and
discovery will reveal a “substantial risk of severe pain” or contradict Dr. Dershwitz’s
testimony regarding the remoteness of a possibility of adverse side effects to the
intramuscular procedure.       Dr. Heath’s concerns are without objective, concrete
evidentiary support, as evidenced by his concession that adverse side effects are
extremely unlikely to occur and, if they do at all, will do so for individualized,
No. 09-4474         Biros v. Strickland, et al.                                       Page 30


unforeseeable reasons. Furthermore, Biros’s assertions that time is needed to conduct
further discovery regarding the halted Broom execution are unavailing. The extensive
depositions of Broom, members of his execution team, and other corrections personnel
were part of the record before the district court and before us. We have reviewed those
depositions   and    conclude      that    further   discovery   regarding     the    Broom
incident—including       deposing         Governor   Strickland,   who       has     declined
questioning—would not bring to light evidence sufficient to enable Biros to demonstrate
a likelihood of success on the merits of his Eighth Amendment claim based on the new
protocol.

       Biros also argues that the State has no legitimate interest in executing him hastily
under a new protocol without discovery or thorough federal court review, so the public
interest factor cuts in his favor. We disagree because this overlooks the state’s “strong
interest in enforcing its criminal judgments without undue interference from the federal
courts.” Hill v. McDonough, 547 U.S. 573, 584 (2006).

       For these reasons, we find that Biros has failed to demonstrate that Ohio’s
decision to adopt an alternative, non-IV method of lethal injection poses any risk of
severe pain. He is therefore unable to demonstrate a likelihood of success on his claim
that it or the one-drug IV administration violate the Eighth Amendment’s prohibition on
cruel and unusual punishments.

                                             IV.

       Biros also claims that the planned execution will violate his right to a “quick and
painless death.” R. 610 at 9. He cites Ohio Revised Code § 2949.22(A), the statute that
provides for a death caused by “a lethal injection of a drug . . . of sufficient dosage to
quickly and painlessly cause death.” But § 2949.22 creates no cause of action to enforce
any right to a quick and painless death. See State v. Rivera, Nos. 08CA009426,
08CA009427, 2009 WL 806819, at *7 (Ohio Ct. App. Mar. 30, 2009) (“There is no
‘action’ for a quick and painless death” under Ohio Reg. Code Ann. § 2949.22(A).). We
are not persuaded by Biros’s assertion that § 2949.22 creates a federal right because the
statute creates “liberty and property interests in a ‘quick and painless execution’”
No. 09-4474         Biros v. Strickland, et al.                                     Page 31


protected by the substantive component of the Due Process Clause of the Fourteenth
Amendment. R. 610 at 9. Biros is unlikely to show that the reach of any such right
extends beyond the incorporation of the Eighth Amendment. Cf. Furman v. Georgia,
408 U.S. 238, 359 n.141 (Marshall, J., concurring).

                                              V.

        Finally, Biros asks us to stay his execution under the All Writs Act. That Act
authorizes us to “issue all writs necessary or appropriate in aid of [our] jurisdiction[] and
agreeable to the usages and principles of law.” 28 U.S.C. § 1651(a). Biros argues that
we can stay his execution without a showing of a likelihood of success on the merits
because the Act looks to our exercise of jurisdiction over this case, which we lose once
Ohio executes him on December 8, rather than to the affect of the litigation on the
parties. Biros’s assertion is unpersuasive and unsupported by precedent. “There is no
reason why the All Writs Act can or should be used to thwart the proper application of
the [TRO] factors,” Lambert, 498 F.3d at 454, and every reason to assume that the use
of the Act in this way would erode the customary grounds for obtaining stays of
execution.

        The All Writs Act provides “a residual source of authority” when no other
provision “addresses the particular issue at hand,” not an alternative to available but
unavailing procedures concerning the matter at hand. See Pa. Bureau of Corr. v. U.S.
Marshals Serv., 474 U.S. 34, 43 (1985). Biros’s interpretation of the Act amounts to
circumvention of the requirements of Federal Rule of Civil Procedure 65, and would do
exactly what U.S. Marshals Service prevents: substitute the Act for the requirements
that Congress provided for obtaining emergency stays.

                                             VI.

        For the foregoing reasons, we affirm.
