                           PUBLISHED
                                                Filed: April 20, 2006

UNITED STATES COURT OF APPEALS
                 FOR THE FOURTH CIRCUIT


WILLIE BROWN, JR.,                     
                Plaintiff-Appellant,
                  v.
THEODIS BECK, Secretary, North
Carolina Department of Corrections;                No. 06-9
                                               (5:06-ct-03018-H)
MARVIN POLK, Warden, Central
Prison, Raleigh, North Carolina;
UNKNOWN EXECUTIONERS,
               Defendants-Appellees.
                                       

                             ORDER

   By order dated April 17, 2006, the district court denied the motion
of Willie Brown, Jr. for a preliminary injunction enjoining the defen-
dants from carrying out his execution which is scheduled for Friday,
April 21, 2006. Brown has filed a notice of appeal to this Court from
that order, a motion for preliminary injunction and a brief in support.
Appellees filed a brief opposing appellant’s motion for preliminary
injunction.

   The Court affirms the district court’s denial of a preliminary
injunction and directs the clerk to issue the mandate forthwith.

  Entered at the direction of Judge Luttig with the concurrence of
Judge Traxler. Judge Michael wrote the attached dissent.

                                       For the Court

                                       /s/ Patricia S. Connor
                                               Clerk
2                           BROWN v. BECK
MICHAEL, Circuit Judge, dissenting:

   I respectfully dissent from the majority’s affirmance of the district
court’s denial of a preliminary injunction to temporarily block the
execution of Willie Brown, Jr. Brown is a North Carolina death row
inmate scheduled to be executed by lethal injection on April 21, 2006,
at 2:00 a.m. He filed a § 1983 action seeking to enjoin the warden and
others ("the State") from executing him by lethal injection under the
procedures the State intended to employ. Specifically, Brown con-
tends that the State will use an inadequate protocol for anesthesia as
a precursor to carrying out his death sentence, and that as a result he
faces an unacceptable and unnecessary risk of suffering excruciating
pain during his execution in violation of the Eighth Amendment. See
Gregg v. Georgia, 428 U.S. 153, 173 (1976) (recognizing, in the con-
text of executions, that the Eighth Amendment prohibits punishment
"involv[ing] the unnecessary and wanton infliction of pain"); In re
Kemmler, 136 U.S. 436, 447 (1890) (recognizing that the Eighth
Amendment prohibits "torture or a lingering death"). The district
court, in its final order, denied Brown’s motion for a preliminary
injunction enjoining his execution on the ground that the State’s
revised protocol ensures that Brown will be rendered unconscious
during the execution and will not feel pain. Because this finding is not
supported by the clear weight of the evidence, I would reverse.

   In its April 7, 2006, order the district court determined that there
were "substantial questions as to whether North Carolina’s execution
protocol creates an undue risk of excessive pain." (Order, 13-14, Apr.
7, 2006.) Specifically, the court found that inadequate administration
of anesthesia prior to execution would undisputedly make Brown
"suffer excruciating pain as a result of the administration of
pancuronium bromide and potassium chloride." (Id. at 12.) The court
further determined that any difficulties could be addressed if

    there are present and accessible to [Brown] throughout the
    execution personnel with sufficient medical training to
    ensure that [Brown] is in all respects unconscious prior to
    and at the time of the administration of any pancuronium
    bromide or potassium chloride. Should [Brown] exhibit
    effects of consciousness at any time during the execution,
    such personnel shall immediately provide appropriate medi-
                             BROWN v. BECK                              3
     cal care so as to insure [Brown] is immediately returned to
     an unconscious state.

(Id. at 14.)

   On April 12, 2006, the State responded by proposing a revised pro-
tocol that uses a bispectral index (BIS) monitor, a device that, accord-
ing to the State, can monitor Brown’s level of consciousness during
the execution procedure. Over Brown’s objections, the district court
determined that the revised protocol will ensure that Brown is ren-
dered unconscious prior to and throughout the period during which
lethal drugs are injected into his bloodstream, so that he will not per-
ceive pain during his execution. The court stated,

     [The State] will not administer lethal drugs until after total
     unconsciousness of the plaintiff has been verified through
     use of the BIS monitor. Thus, [Brown’s] concerns about
     human error are greatly mitigated by the use of this indepen-
     dent check on [his] level of consciousness before the poten-
     tially pain-inducing injections . . . begin. Whatever concerns
     might be raised about this "machine" or about the propriety
     of using it in executions, it is apparent to this court that the
     BIS monitor has been used reliably for a decade and is used
     in many anesthesia procedures across the country to deter-
     mine an individual’s level of consciousness.

(Final Order, 6, Apr. 17, 2006). Because these findings are not sup-
ported by the clear weight of the evidence in the record, the district
court abused its discretion in denying Brown’s motion for a prelimi-
nary injunction. See Bryte v. Am. Household, Inc., 429 F.3d 469, 475
(4th Cir. 2005) ("A district court abuses its discretion if its conclusion
. . . rests upon a clearly erroneous factual finding."); Jiminez v. Mary
Washington Coll., 57 F.3d 369, 379 (4th Cir. 1995) (recognizing that
a district court conclusion that is "contrary to the clear weight of the
evidence considered in light of the entire record" is clearly errone-
ous).

   First, the district court’s finding that the BIS monitor alone will
accurately verify Brown’s level of consciousness is contrary to the
clear weight of the evidence considered in light of the entire record.
4                           BROWN v. BECK
Brown presents an impressive array of evidence that although a BIS
monitor may be helpful in assessing the effectiveness of anesthesia,
it is not suitable as the State intends to use it — as the sole indicator
of Brown’s level of consciousness. "It is virtually universally
accepted and understood by all anesthesiologists that the BIS monitor
and other brain function monitors cannot be used as the sole method
for assessing anesthetic depth," but must be used alongside other
markers of consciousness (such as purposeful reflex movement, blood
pressure, and heart rate). (Third Aff. of Dr. Mark Heath ¶¶ 8-9.) In
addition to offering testimony to this effect from three leading medi-
cal experts, Brown offers persuasive evidence from independent,
authoritative sources. For instance, Aspect Medical Systems, the man-
ufacturer of the BIS monitor purchased by the State, warns that
"[c]linical judgment should always be used when interpreting the BIS
in conjunction with other available clinical signs. Reliance on the
BIS alone for intraoperative anesthetic management is not recom-
mended." Aspect Medical Systems, Considerations for Using BIS, at
http://www.aspectmedical.com/resources/proc_cards/or/components_
anesthesia.htm. Likewise, the American Society of Anesthesiologists
(ASA) and the American Association of Nurse Anesthetists have pro-
mulgated standards that counsel against the use of brain functioning
technology, such as BIS monitors, in isolation without other monitor-
ing methods or interpretation by personnel with appropriate training
in anesthesia. Most notably, the ASA has observed:

       The general clinical applicability of [BIS monitors] in the
    prevention of intraoperative awareness has not been estab-
    lished. Although a single randomized clinical trial reported
    a decrease in the frequency of awareness in high-risk
    patients, there is insufficient evidence to justify a standard,
    guideline, or absolute requirement that these devices be used
    to reduce the occurrence of intraoperative awareness in
    high-risk patients [or any other group of patients] undergo-
    ing general anesthesia.

American Society of Anesthesiologists, Practice Advisory for
Intraoperative Awareness and Brain Function Monitoring, 104 Anes-
thesiology 847, 855 (2006) (attached as Ex. 1 to Third Heath Aff.).
Likewise, a recent study on the reliability of BIS monitors in the med-
ical journal Anesthesiology concludes that "[a]nesthesia providers
                            BROWN v. BECK                               5
should not rely exclusively on the BIS reading when assessing depth
of anesthesia." See Dagmar J. Niedhart et al., Intrapatient Reproduc-
ibility of the BISxp® Monitor, 104 Anesthesiology 242, 242 (2006)
(attached as Ex. 2 to Third Heath Aff.)

   The State offers scant evidence to rebut Brown’s compelling prof-
fer. The State relies solely on the conclusory assertion of its expert,
Dr. Mark Dershwitz, that in his opinion, "beyond a reasonable degree
of medical certainty, . . . the utilization of the BIS monitor as part of
the execution protocol . . . will prevent the possibility of [Brown]
being awake during the administration of pancuronium or potassium
chloride." (emphasis added) (Third Aff. of Dr. Mark Dershwitz ¶ 11.)
Even if Dr. Dershwitz opined that Brown would not be conscious
(rather than simply not awake), the basis for his opinion is question-
able: the State offers no evidence to counter Brown’s persuasive argu-
ment that the BIS monitor cannot be used in isolation to determine an
individual’s level of consciousness. Furthermore, Dr. Dershwitz’s
opinion on this point is particularly suspect because just two months
ago he opined in another case that, absent further testing, "it would
not be prudent to recommend the use of the BIS monitor during lethal
injections." Dershwitz Rebuttal Report, Walker v. Johnson, No.
1:05cv934, at 4-5 (E.D. Va. Feb. 3, 2006) (attached as Ex. B to
Brown’s Objection to Def.’s Notice and Response to 7 April 2006
Order). In finding that the BIS monitor will adequately verify
Brown’s unconsciousness during his execution, the district court dis-
regarded substantial evidence, unrebutted by the State, that casts seri-
ous doubt on the reliability of the BIS monitor as the sole means of
assessing consciousness.

   In addition, there is no support in the record for the district court’s
finding that if Brown remains conscious (or regains consciousness)
during the execution, medical professionals will be able to bring
about the injection of additional sodium pentothal until Brown is ren-
dered fully unconscious. Under the revised protocol, only if the BIS
monitor displays a value below 60 will the State proceed to adminis-
ter the pancuronium bromide (the second drug in the lethal injection
protocol which causes paralysis) and the potassium chloride (the third
drug in the lethal injection protocol which causes the heart to stop
beating). (Second Aff. of Marvin Polk ¶¶ 2-4.) In the event the BIS
value reading remains at 60 or above, "additional sodium pentothal
6                          BROWN v. BECK
[will] be given until the value reading on the BIS monitor does fall
below 60." (Id. ¶ 4.) Although the protocol provides that "[t]he BIS
monitor will be located such that it can be observed and its values
read by [the licensed registered nurse and the licensed physician who
observe the Cardiac Monitor Defibrillator]," it makes no provision for
these medical professionals to actually do anything in the event the
reading does not fall below 60. (Def.’s Notice and Response to 7
April 2006 Order, 3.) Thus, if Brown’s BIS reading exceeds 60 or he
otherwise is conscious during the execution, the State will take the
same inadequate steps to secure Brown’s unconsciousness that it
would have taken under the original protocol. Even if the revised pro-
tocol could be construed as requiring the medical professionals to take
some action to ensure Brown’s unconsciousness, undisputed evidence
in the record establishes that, based on the execution chamber’s phys-
ical set-up, neither the warden nor any other member of the execution
team can observe or respond to a malfunction in the lethal injection
process. (First Aff. of Nancy Bruton-Maree ¶ 10.) Moreover, even if
a medical professional could respond, there is no evidence in the
record to support the district court’s finding that the professional
would possess the skills necessary to ensure Brown’s unconscious-
ness.

   Also problematic is the lack of evidence to show that the BIS mon-
itor will accurately measure consciousness after pancuronium bro-
mide and potassium chloride are administered. Dr. Heath opines that
the administration of pancuronium bromide can lead to an inaccurate
indication of anesthetic depth on a BIS monitor. He bases this opinion
on a study finding that BIS readouts far below 60, the value proposed
by the State as indicating an inmate’s unconsciousness, can be
observed in fully conscious individuals who have been administered
paralysis-inducing drugs similar to pancuronium bromide. M. Mess-
ner et al., The Bispectral Index Declines During Neuromuscular
Block in Fully Awake Patients, 97 Anesthesia & Analgesia 488
(2003) (attached as Ex. 5 to Third Heath Aff.) In addition, Dr. Dersh-
witz, the State’s expert, has recently hypothesized that a BIS monitor
cannot assess the level of consciousness once potassium chloride is
administered. See Dershwitz Rebuttal Report, Walker v. Johnson, No.
1:05cv934, at 4-5 (E.D. Va. Feb. 3, 2006) (attached as Ex. B to
Brown’s Objection to Def.’s Notice and Response to 7 April 2006
Order). Indeed, the revised protocol does not indicate whether the BIS
                           BROWN v. BECK                             7
monitor will be used after administration of the second drug,
pancuronium bromide, and nothing else in the record indicates that
Brown’s consciousness will be monitored after this point in the exe-
cution. The district court’s finding that the revised protocol will
ensure that Brown is rendered unconscious "throughout the period
during which lethal drugs are injected into his bloodstream" is there-
fore clearly erroneous. (See Final Order, 2, Apr. 17, 2006.)

   Before the State revised its execution protocol, the district court
concluded that the preliminary injunction hardship-balancing test
favored Brown: that "the likelihood of irreparable harm to Brown far
exceeds the likelihood of harm to Defendants." (Order, 12, Apr. 7,
2006.) If Brown does, in fact, regain consciousness at any point dur-
ing his execution, "there is no dispute that [he] will suffer excrucia-
ting pain as result of the administration of pancuronium bromide and
potassium chloride" and that he, having suffered a tortuous death, will
have no meaningful retrospective relief. (Id. at 11-12.) The district
court conditionally denied Brown’s motion for preliminary injunction
with the requirement that the State add safeguards to ensure that
Brown is in fact unconscious during his execution. In an effort to
comply with the district court’s order, and thereby shift the balance
of hardships, the State incorporated use of the BIS monitor. The clear
weight of evidence, however, reveals that the State’s use of the BIS
monitor will not adequately ensure that Brown will remain uncon-
scious throughout his execution. The balance of hardships therefore
remains weighted in Brown’s favor. Accordingly, I would reverse the
district court’s denial of Brown’s motion for a preliminary injunction
and direct that court to enter the preliminary injunction and conduct
further proceedings, which would allow to State to further revise its
protocol.
