# In re Ohio Execution Protocol Litigation

> District Court, S.D. Ohio · January 26, 2017 · 235 F. Supp. 3d 892

URL: https://www.frixlaw.com/law-library/cases/7242161

## Case

- **Full name:** IN RE: OHIO EXECUTION PROTOCOL LITIGATION. This Order relates to Phillips, Tibbetts, and Otte
- **Court:** District Court, S.D. Ohio
- **Decided:** January 26, 2017
- **Citations:** 235 F. Supp. 3d 892; 2017 U.S. Dist. LEXIS 11019; 2017 WL 378690
- **Precedential status:** Published
- **Opinion:** Opinion of the court by Merz
- **Judges:** Merz
- **Cited by:** 85 later opinions in the Frix Law Library

## Citator (automated)

- **Red flag:** Vacated by Fears v. Morgan, 860 F.3d 881 (2017).
- Negative treatments: 1
- Distinguished by: 0
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/7242161

## Opinion text

Michael R. Merz, United States Magistrate Judge
DECISION AND ORDER GRANTING IN PART AND DENYING IN PART PLAINTIFFS’ MOTIONS FOR PRELIMINARY INJUNCTION
This consolidated case under 42 U.S.C. § 1983 is brought by Ohio inmates under a sentence of death and seeks relief from a number of asserted constitutional deficiencies in Ohio’s new lethal injection protocol adopted October 7,2016.
The above-named inmates and the State of Ohio unanimously consented to plenary magistrate judge jurisdiction over their cases (ECF No. 732) and Chief Judge Sargus referred these three cases on that basis (ECF No. 734). Hence the Magistrate Judge is authorized to decide the pending motions for temporary injunctive relief even though they are classified as “dispositive” motions under 28 U.S.C. § 636 (b)(1)(A).
This Decision and Order embodies the findings of fact and conclusions of law required for a preliminary injunction decision under Fed. R. Civ. P. 52. They are not binding at trial on. the merits. United States v. Edward Rose & Sons, 384 F.3d 258, 261 (6th Cir. 2004), citing Univ. of Texas v. Camenisch, 451 U.S. 390, 395 , 101 S.Ct. 1830 , 68 L.Ed.2d 175 (1981).
In the most recent preliminary injunction decision in this case, Judge Frost wrote:
The recent history of this litigation and its. .often frustrating' factual developments can be found in the following Opinion and Orders, which this Court expressly incorporates herein by reference: In re Ohio Execution Protocol Litigation (Phillips), No. 2:11-cv-1016, 2013 U.S. Dist. LEXIS 159680 , 2013 WL 5963150 (S.D. Ohio Nov. 7, 2013); In re Ohio Execution Protocol Litigation (Hartman), 906 F.Supp.2d 759 (S.D. Ohio 2012), In re Ohio Execution Protocol Litigation (Wiles), 868 F.Supp.2d 625 (S.D. Ohio 2012), In re Ohio Execution Protocol Litigation (Lorraine), 840 F.Supp.2d 1044 (S.D. Ohio 2012), Cooey (Brooks) v. Kasich, Nos. 2:04-cv-1156, 2:09-cv-242, 2:09-cv-823, 2:10-cv-27, 2011 U.S. Dist. LEXIS 128192 , 2011 WL 5326141 (S.D. Ohio Nov. 4, 2011), and Cooey (Smith) v. Kasich, 801 F.Supp.2d 623 (S.D. Ohio 2011).
In re Ohio Execution Protocol Litigation, 994 F.Supp.2d 906, 908, n.2 (S.D. Ohio 2014).
Rather than incorporate by reference another judge’s writing, this Court states it considers itself bound by the law of the case stated in. these decisions and by decisions of the Sixth Circuit in prior appeals in this case and 2:04-cv-1156.
Current Litigation Context
Most Ohio death row inmates are Plaintiffs in this case which has been pending under the above case number since 2011 and under the prior caption Cooey v. Strickland, 2:04-cv-1156, since shortly after the. Supreme Court authorized use of § 1983 to attack methods of execution in Nelson v. Campbell, 541 U.S. 637 , 124 S.Ct. 2117 , 158 L.Ed.2d 924 (2004).
Each of the above-named three Plaintiffs has an execution date set between February 15 and April 12, 2017. Although execution dates for these three Plaintiffs were first set- some time-ago, they , have been extended by action of Governor. John *895 Kasich several times, most recently by Warrants of Reprieve as to Plaintiffs Phillips and Tibbetts (ECF No. 848).
The intention of the State of Ohio to proceed with three executions in the first quarter of 2017 was announced to Plaintiffs’ counsel in open court on October 3, 2016. At that time- the State also announced its intention to promulgate, on i October 7, 2016, the protocol by which the executions would be carried out (see Minute Entry, ECF No., 655; Transcript, ECF No. 672).
Based on this announcement, the Court vacated the' stay of these proceedings as to the three named Plaintiffs and set a schedule for the filing of a Fourth Amended Complaint to reflect the new protocol and the briefing of motions for preliminary in-junctive relief (Order Partially Vacating Stay and Setting Schedule, ECF No. 658). In compliance with that schedule, each of these Plaintiffs filed a motion for preliminary injunctive relief, including a stay of execution (ECF Nos. 714, 715, 718). As required by the same scheduling order, Defendants filed their consolidated memorandum in opposition a week later (ECF No. 730).
To protect the decisional process of the Sixth Circuit on the then-pending interlocutory appeal in this case, the Court entered a preliminary injunction pendente lite (ECF No. 834) which was appealed by the State (ECF No. 841). The Sixth Circuit then decided the interlocutory appeal on Judge Frost’s protective order. Fears v. Kasich, 845 F.3d 231 (6th Cir. 2016). This obviated the reason for the pendente lite stay and it was dissolved (ECF No. 910). The Court commenced a five-day eviden-tiary hearing on the preliminary injunction motions January 3,2017.
The Pending Motions for Injunctive Relief
As provided in the Court’s scheduling order, each of the above-named Plaintiffs filed a Fourth Amended Complaint on October 26, 2016, to address Ohio’s newly revised execution protocol (ECF Nos. 691, 692, 695). 1 Complying with the same Order, they each filed Motions for Preliminary Injunction and concomitant stays of execution' in November (ECF Nos. 714, 715, 718). 2
Plaintiffs claim that their executions under the new Ohio protocol would violate their constitutional rights as follows:
1. Under the Cruel and Unusual Punishment Clause of the Eighth Amendment because the new protocol embodies a reversion to a “more primitive, less humane execution method” than Ohio has heretofore used. (E.g., Plaintiff Raymond Tibbetts’ First Claim for Relief, denominated Wilkerson-Kemmler Claim and relying on Wilkerson v. Utah, 99 U.S. 130 [ 25 L.Ed. 345 (1878)] (1879); In re Kemmler, 136 U.S. 436 [ 10 S.Ct. 930 , 34 L.Ed. 519 ] (1890); and Trap v. Dulles, 356 U.S. 86 [ 78 S.Ct. 590 , 2 L.Ed.2d 630 ] (1958). Plaintiffs argue separate ' Eighth Amendment claims in their Proposed Findings as an “evolving standards of decency”/“devolution” claim under Trop and an Eighth Amendment claim *896 under Wilkerson-Kemmler in which they are not required to prove an available alternative method of execution.
2. Under the Cruel and Unusual Punishment Clause of the Eighth Amendment because a three-drug execution method which includes midazolam, a paralytic, and potassium chloride creates a substantial risk of serious harms (E.g., Plaintiff Raymond Tibbetts’ Third and Fourth Claims for Relief, denominated Baze-Glossip Claims and relying on Baze v. Rees, 553 U.S. 35 [ 128 S.Ct. 1520 , 170 L.Ed.2d 420 ] (2008), and Glossip v. Gross, 576 U.S. -, 135 S.Ct. 2726 , 192 L.Ed.2d 761 (2015).)
3. Under the Equal Protection Clause on a class-of-one theory and relying on the State of Ohio’s alleged violations of prior execution protocols (E.g., Plaintiff Raymond Tibbetts’ Eighth Claim for Relief).
4. On claims under the doctrines of judicial admissions, judicial estoppel, and promissory estoppel (E.g., Plaintiff Raymond Tibbetts’ Sixth Claim for Relief).
Standard for Preliminary Injunctive Relief
In determining whether preliminary injunctive relief is merited in a capital § 1983 case, a trial or appellate court applies the following established standards:
(1) whether [petitioner] 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); [N.E.]. 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).
Cooey (Biros) v. Strickland, 589 F.3d 210, 218 (6th Cir. 2009). Judge Frost applied these same criteria in a prior preliminary injunction decision in this case. In re: Ohio Execution Protocol Litig.(Lorraine), 840 F.Supp.2d 1044, 1048 (S.D. Ohio 2012). They are consistently applied by the Sixth Circuit to preliminary injunctive relief requests across subject matter areas, Overstreet v. Lexington-Fayette Urban Co. Gov’t, 305 F.3d 566, 573 (6th Cir. 2002); Nightclubs, Inc. v. City of Paducah, 202 F.3d 884, 888 (6th Cir. 2000); Washington v. Reno, 35 F.3d 1093, 1099 (6th Cir. 1994); NAACP v. City of Mansfield, 866 F.2d 162 , 166 (6th Cir. 1989); Frisch’s Restaurant, Inc. v. Shoney’s, Inc., 759 F.2d 1261, 1263 (6th Cir. 1985); In re DeLorean Motor Co., 755 F.2d 1223 , 1228 (6th Cir. 1985).
Supreme Court case law is consistent.
A plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of the equities tips in his favor, and that an injunction is in the public interest.
Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 20 , 129 S.Ct. 365 , 172 L.Ed.2d 249 (2008), citing Munaf v. Geren, 553 U.S. 674, 689-90, 128 S.Ct. 2207 , 171 L.Ed.2d 1 (2008); Amoco Prod. Co. v. Gambell, 480 U.S. 531, 542 , 107 S.Ct. 1396 , 94 L.Ed.2d 542 (1987); Weinberger v. Romero-Barcelo, 456 U.S. 305, 311-12 , 102 S.Ct. 1798 , 72 L,Ed.2d 91 (1982). The Court notes the Supreme Court statement *897 of the standard does not attempt to quantify the degree of likelihood of success.
The purpose of a preliminary injunction is to preserve a court’s power to render a meaningful decision after a trial on the merits. Alabama v. U.S. Army Corps of Engineers, 424 F.3d 1117, 1128 (11th Cir. 2005), quoting Wright, Miller & Kane, Federal Practice and Procedure: Civil, § 2946.
Although the fundamental fairness of preventing irremediable harm to a party is an important factor on a preliminary-injunction application, the most compelling reason in favor of entering a Rule 65(a) order is the need to prevent the judicial process from being rendered futile by defendant’s action or refusal to act.... [T]he preliminary injunction is appropriate whenever the policy of preserving the court’s power to decide the case effectively outweighs the risk of imposing an interim restraint before it has done so.
Id. at § 2947.
In a case such as this, a § 1983 challenge to the constitutionality of an imminently pending execution, failure to enjoin the execution will obviously render the case moot long before trial. Nevertheless, stays of execution are not to be granted routinely. A court must weigh the interest of a State in carrying out a lawful death sentence and its parallel interest in finality of criminal judgments. Workman, supra.
This Decision is divided into four sections paralleling the four factors required to be found:
I. Likelihood of success on the merits with each of Plaintiffs’ claims discussed separately;
II. Irreparable harm;
III. The balance of equities; and
TV. The public interest.
I. The Likelihood of Success on the Merits
Plaintiffs’ Eighth Amendment Claims
Although much prior litigation in this case has focused on Equal Protection claims, here, as in the McGuire preliminary injunction proceeding, the focus is on the Eighth Amendment. Plaintiffs assert they can prevail under any one of three purportedly distinct Eighth Amendment theories. They make what they describe as Baze/Glossip Claims, Wilkerson/Kemmler Claims, and Evolving Standards of Decency/Devolution Claims (Plaintiffs’ Amended Proposed Findings of Fact and Proposed Conclusions of Law (ECF No. 895-1, Pa-gelD 30028).)
The Wilkerson/Kemmler Claim
As the Court understands the Wilkerson/Kemmler Claim, it is based on Justices Thomas and Scalia’s concurrence in Baze . As the Supreme Court in Glossip read that concurrence, it would have upheld any method of execution against an Eighth Amendment challenge “unless it is deliberately designed to inflict pain.” Glossip, 135 S.Ct. at 2738, n. 2 , citing Baze, 553 U.S. at 94 , 128 S.Ct. 1520 . Plaintiffs here assert the Ohio three-drug protocol is so likely to inflict severe pain that its use should be read as a deliberate infliction of pain or at least as recklessly indifferent to that possibility. Success on such a claim, they assert, does not depend on their proof of a readily available alternative method of execution, an element of an Eighth Amendment claim under Baze/Glossip.
This Court is not persuaded that Supreme Court Eighth Amendment jurisprudence recognizes these three disparate theories. The Wilkerson/Kemmler theory is based on a concurrence which did not command a majority of the Court. If that theory were the law, moreover, it would *898 not- be successful here. Based particularly on the testimony of Ohio Department of Rehabilitation and Corrections (“ODRC”) Director- Gary Mohr, 3 the Court concludes that the State’s efforts have been directed toward making executions rpore humane and less painful, and not just minimally constitutional. Plaintiffs did not , prove at the preliminary injunction hearing that an execution under the current protocol would be so likely to inflict serious pain that anyone using it would have to know that fact and intend the result.
Evolving Standards of Decency Claim
The Evolving Standards of Decency/Devolution Claim is also made under the Eighth Amendment. Plaintiffs outline that claim in their Proposed Conclusions of Law as follows:
1. A state’s punishment is assessed un- ' der "the Eighth Amendment against the evolving standards of decency that mark the progress of a maturing society. Trop v. Dulles, 356 U.S. 86, 100-101 , 78 S.Ct. 590 , 2 L.Ed.2d 630 (1958) (plurality opinion).
2. An execution method can be unconstitutional if the method represents “devolution to a more primitive” method that is a “step in the opposite direction” under society’s evolving standards of decency and humanity, Glossip, 135 S.Ct. at 2795-97 (Sotomayor, J., principal dissent), such as if an execution method is less humane than the method used before.
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5. If a method of execution is categorically barred, then it can never be imposed regardless of whether another form of execution is available. See Graham v. Florida, 560 U.S. 48, 59 , 130 S.Ct. 2011 , 176 L.Ed.2d 825 (2010) (the Eighth Amendment prohibits “inherently barbaric punishments under all circumstances.”); Penry v. Lynaugh, 492 U.S. 302, 330 , 109 S.Ct. 2934 , 106 L.Ed.2d 256 (1989) (the “Eighth Amendment categorically prohibits the infliction of cruel and unusual punishments.”).
6. Because the State may not impose a death sentence upon- any inmate us- ' ing an unconstitutional method of execution, there is no requirement to plead an alternative method of execution when claiming the method is categorially unconstitutional. “Irrespective of the existence of alternatives, there are some risks ‘so grave that it violates contemporary standards of decency to expose anyone unwillingly to’ them.” Glossip v. Gross, — U.S. -, 135 S.Ct. 2726, 2793 , 192 L.Ed.2d 761 (2015) (Sotomayor, J., dissenting, joined by Ginsburg, J., Breyer, J., and Kagan, J.) (quoting Helling v. McKinney, 509 U.S. 25, 36 , 113 S.Ct. 2475 , 125 L.Ed.2d 22 (1993) (emphasis in original)).
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8. When Defendants changed their protocol to abandon the three-drug method and to abandon the paralytic drug and potassium chloride, they expressly did so to be more humane, and the courts gave them credit for that. By reintroducing a .three-drug execution method, reintroducing a paralytic drug, reintroducing potassium chloride, and using a first drug that is" demonstrably incapable of protecting the inmate against the *899 torturous pain and suffering associated with the second and third drugs and the process of dying from injection of those drugs, Defendants have now gone backwards, contrary to their expressed purpose of the previous evolution and their promises to this Court and the Sixth Circuit.
9. The key is not the devolution going backwards itself, but that' Defendants evolved for .the purpose of making execution procedures inore humane, and were blessed by the courts - for that evolution, and are now devolving to a markedly less safe and humane execution method. In such circumstances, devolution is not permissible.
10. By intentionally reintroducing the second and third drugs back into DEC Defendants’ execution protocol, and by reintroducing the three-drug execution method, DRC Defendants have intentionally, ■ knowingly or recklessly moved backward to an execution method that is a devolution from the previous protocol.
(ECF No. 895-1, PagelD 30095-96.)
The evolving standards of decency language, though its lineage is fifty years older than Baze , is no firmer a foundation for Plaintiffs’ claims. It finds its source in Trop v. Dulles, supra. In Trap , the Supreme Court held that use of denaturalization as a punishment for wartime desertion from military duty was barred by the Eighth Amendment. Chief Justice Warren wrote:
The [Eighth] Amendment must draw its meaning from the evolving standards of decency that mark the progress of a maturing society.... [U]se of denatural-ization as a punishment is barred by the Eighth Amendment. There may be involved no physical mistreatment, no primitive torture. There is instead the total déstruction of the individual’s status in organized society. It is a form of punishment more primitive than torture, for it destroys for the individual the political existence that was centuries in the development.
356 U.S. at 101 , 78 S.Ct. 590 . 4
Just prior to this passage, however, he wrote:
At the outset, let us put to one side the death penalty as an index of the constitutional limits on punishment. Whatever the arguments may be against capital punishment, both on moral grounds and in terms of accomplishing the purposes of punishment—and they are forceful— the death penalty has been employed throughout our history, and, in a day when it is still widely accepted, it cannot be said to violate the constitutional concept of cruelty.
Id. at 99 , 78 S.Ct. 590 . Thus the Trap plurality expressly excluded the death penalty from its consideration.
Trop makes, its appearance in Furman v. Georgia, 408 U.S. 238 , 92 S.Ct. 2726 , 33 L.Ed.2d 346 (1972), in the concurrence of Justice Douglas and very extensively in *900 the concurrence of Justice Brennan, who noted that Trop left open the future constitutionality of capital punishment. Id. at 285, n. 33, 92 S.Ct. 2726 . He concluded
It is a denial of human dignity for the State arbitrarily to subject a person to an unusually severe punishment that society has indicated it does not regard as acceptable, and that cannot be shown to serve any penal purpose more effectively than a significantly less drastic punishment. Under these principles and this test, death is today a “cruel and unusual” punishment.
Id. at 286 , 92 S.Ct. 2726 . Justice Brennan never deviated from this absolute position, one to which he eventually persuaded Justices Marshall and Souter. But that position never became the law of the land and in Glossip the Court again affirmed the constitutionality of the death penalty against an Eighth Amendment claim.
While the “evolving standards of decency” language from Trop has never been repudiated by the Court, and was relied on by the Court in Atkins v. Virginia, 536 U.S. 304, 311-12 , 122 S.Ct. 2242 , 153 L.Ed.2d 335 (2002), and Roper v. Simmons, 543 U.S. 551, 561 , 125 S.Ct. 1183 , 161 L.Ed.2d 1 (2005), 5 neither has it become the basis for declaring the death penalty per se unconstitutional. In interpreting Trop, this Court is aware of Justice Frankfurter’s dissent where he wrote:
All power is, in Madison’s phrase, “of an encroaching nature.” Federalist, No. 48 (Earle ed. 1937), at 321. Judicial power is not immune against this human weakness. It also must be on guard against encroaching beyond its proper bounds, and not the less so since the only restraint upon it is self-restraint.
Trop, 356 U.S. at 119 , 78 S.Ct. 590 . What is true for Supreme Court Justices is truer still for trial courts, whose business lies in obeying. “Unless we wish anarchy to prevail within the federal judicial system, a precedent of this Court must be followed by the lower federal courts no matter how misguided the judges of those courts may think it to be.” Hutto v. Davis, 454 U.S. 370, 375 , 102 S.Ct. 703 , 70 L.Ed.2d 556 (1982). Following precedent is, of course, an art form, not a matter of blind obedience. Sometimes a district court can accurately anticipate where the Supreme Court is ready to go. See Obergefell v. Kasich, 2013 WL 3814262 , 2013 U.S. Dist. LEXIS 102077 (S.D. Ohio 2013)(Black, J.), affirmed sub nom Obergefell v. Hodges, — U.S. -, 135 S.Ct. 2584 , 192 L.Ed.2d 609 (2015). But because this Court believes neither the Sixth Circuit nor the Supreme Court is prepared to recognize an “evolving standards of decency” claim, it concludes Plaintiffs are unlikely to prevail on this claim.
The Baze/Glossip Claim
In Baze v. Rees, 553 U.S. 35 , 128 S.Ct. 1520 , 170 L.Ed.2d 420 (2008), the Supreme Court upheld Kentucky’s lethal injection protocol which called for an initial injection of sodium thiopental, a second such injection if the first did not render the inmate unconscious, then the paralytic drug pan-curonium bromide and finally potassium chloride to cause cardiac arrest. Petitioners conceded that the protocol itself was humane and constitutional if performed properly, but asserted there was a significant risk the thiopental sodium would not be administered properly and the inmate would suffer severe pain when the other two drugs were administered. Plaintiffs proposed alternatives which they claimed would eliminate an “unnecessary risk” of *901 serious harm. The plurality opinion rejected that standard in favor of the “substantial risk of serious harm” or “objectively intolerable risk of harm” standards adopted in Farmer v. Brennan, 511 U.S. 825 , 114 S.Ct. 1970 , 128 L.Ed.2d 811 (1994). As noted above, Justices Scalia and Thomas concurred in the judgment, but believed the Court’s standard departed inappropriately from the original meaning of the Cruel and Unusual Punishments Clause.
In Glossip v. Gross, 576 U.S. -, 135 S.Ct. 2726 , 192 L.Ed.2d 761 (2015), the Supreme Court considered Oklahoma’s lethal injection protocol which required administration of a 500 milligram dose of midazolam, followed by a paralytic agent and potassium chloride. Justice Alito wrote for a majority and reaffirmed Bale’s requirement that, to prevail, inmates challenging a method of execution must identify “a known and available alternative method of execution that entails a lesser risk of pain, a requirement of all Eighth Amendment method-of-execution claims.” Id. at 2731 citing Base. He wrote that
Our decisions in this area have been animated in part by the recognition that because it is settled that capital punishment is constitutional, “[i]t necessarily follows that there must be a [constitutional] means of carrying it out.” Id., at 47, 128 S.Ct. 1520 , 170 L.Ed.2d 420 . And because some risk of pain is inherent in any method of execution, we have held that the Constitution does not require the avoidance of all risk of pain. Ibid. After all, while most humans wish to die a painless death, many do not have that good fortune. Holding that the Eighth Amendment demands the elimination of essentially all risk of pain would effectively outlaw the death penalty altogether.
Id. at 2732-33. Glossip was before the Court on appeal from denial of a preliminary injunction. In that context, “[t]he preliminary injunction posture of the present case thus requires petitioners, to establish a likelihood that they ean establish both that Oklahoma’s lethal 'injection protocol creates a demonstrated risk of severe pain and that the risk is substantial when compared to the known and available alternatives.” Id. at 2737 . Noting the preliminary injunction standard from Winter, supra, the Court observed that the determining question was likelihood of success on the merits. 6
To prevail on their Baze/Glossip claim, Plaintiffs must show that use of midazolam as the first of three drugs prescribed in Ohio’s lethal injection protocol (1) “creates a demonstrated risk of severe pain” and (2) “that the risk is substantial when compared to known and available alternatives.” To prevail at the preliminary injunction stage, they must show it is likely they can prove these two elements at a trial on the merits.
Midazolam as an Execution Drug
Ohio’s new lethal injection protocol calls for the initial intravenous administration of 500 milligrams midazolam, 7 followed by a second dose of the same size if the inmate *902 appears to be still conscious when a consciousness check is performed. If the consciousness check is negative, the execution will proceed by IV injection of a paralytic drug, followed by potassium chloride, which is intended to precipitate cardiac arrest. The chief focus of the evidentiary hearing was on the first drug, midazolam.
The Dennis McGuire Case
Midazolam made its debut as an American execution drug with Ohio’s execution of Dennis McGuire on January 16, 2014. McGuire was a Plaintiff in this case and Judge Gregory Frost, to whom this case was previously assigned, held an evidentia-ry hearing on McGuire’s constitutional objections to the then-extent Ohio execution protocol which required a single injection of a combination of 10 mg of midazolam and 40 mg of hydromorphone (DX 2: ODRC Ol-COM-11, eff. 10/10/2013).
Although prior litigation in this case had focused on Equal Protection claims.
Today’s challenge returns the focus to the Eighth Amendment so that the question is not whether Ohio can be trusted to do what it says it will do, but whether following the protocol will subject McGuire to an unconstitutional substantial risk of severe pain that constitutes cruel and unusual punishment.
In re: Ohio Execution Protocol Litig. (McGuire), 994 F.Supp.2d 906, 908 (S.D. Ohio 2014)(Frost, D.J.). 8
Judge Frost understood" the standard for judging. McGuire’s Eighth Amendment claims to have been set by the Sixth Circuit:
The Sixth Circuit has explained that “[t]o demonstrate that Ohio seeks to impose ‘cruel and unusual’ punishment, [a plaintiff] must show that its protocol ignores a ‘sure or very likely’ risk of serious pain ‘and needless suffering,’ .. .which ‘creates a demonstrated risk of severe pain’ that is ‘substantial when compared to the known and available alternatives.’ ”
McGuire, 994 F.Supp.2d at 911 , quoting Cooey (Biros), 589 F.3d at 220 (quoting Baze v. Bees, 553 U.S. 35, 128 S.Ct. 1520 , 170 L.Ed.2d 420 (2008). (plurality opinion)).
The State objected that McGuire had not presented an alternative means of execution. Judge Frost concluded that, whether formally “presented” by McGuire or not, “[t]o this Court and no doubt to everyone present in the courtroom during the evidentiary hearing, however, the message was clear. A far greater dose of midazolam would be an alternative.” Id. at 911. Judge Frost declined to find that the suggested alternative would be preferable, noting
“[T]he Constitution does not allow the federal courts to act as a best-practices board empowered to demand that the states adopt the least risky execution protocol possible.” Cooey (Biros), 589 F.3d at 220-21 .' Instead, this Court’s “rightful function [is] as a constitutional check on the ‘wanton infliction of pain’ by the state.” Id. at 233 (quoting Louisiana ex rel Francis v. Resweber, 329 U.S. 459, 463 , 67 S.Ct. 374 , 91 L.Ed. 422 (1947) (plurality opinion)).
Id. at 912.
McGuire’s claim was based directly on the expert testimony of Dr. David Waisel who opined:
*903 [McGuire] possesses physical and medical characteristics that increase his risk of obstructive sleep apnea. This proclivity toward obstruction means that following the administration of midazolam and hydromorphoné, his breathing will be suppressed, he will experience a consequent rise in the amount of carbon dioxide in his system, he will experience a need or sensation to breathe, and he will suffer an obstruction that he will be unable to mitigate through physical manipulation or otherwise. This in turn will lead him to experience ‘“air hunger,” which Waisel characterized as a terrifying inability to obtain a breath to satisfy the ventilatory drive. Waisel testified that this will result because the ventila-tory depressant effects, of the protocol will occur prior to the pain relief or sedative effects. Stated most simply: McGuire asserts that there will be up to a 5-minute window before the drugs alleviate his awareness'of air hunger and that he will suffer air hunger during this time period.
Id. at 912. The State’s expert, Dr. Mark Dershwitz, contradicted Dr. Waisel’s prediction, opining instead that
[T]he timing of the effects of the protocol drugs and the effect of the hydro-morphone dose involved [are such that] the analgesic effect occurs' earlier so that it will precede ventilatory depression. Moreover, because the amount of hydromorphoné administered under the protocol is so massive, its effect must be regarded on a sliding scale that does not track traditional therapeutic dosing. In other words, McGuire will not be experiencing terror but rather possible euphoria, and even in the event of a possible obstruction, he will likely be unconscious by the time that happens. Again attempting to summarize most simply: Defendants assert that the window for experiencing air hunger is so much less than McGuire argues that it is likely non-existent or at worst far less than 5 minutes.
Id. at 912.- Judge' Frost found Dr. Der-shwitz more persuasive and concluded McGuire was unlikely to experience “air hunger,” even assuming arguendo that “the sensation of air hunger sufficiently constitutes severe pain within the Eighth Amendment prohibition.” Id. Nonetheless, Judge Frost had doubts which he expressed as follows:
There is absolutely no question that Ohio’s current protocol presents an experiment in lethal injection processes. The science involved, the new mix of drugs employed at dosés based on theory but understandably lacking actual application in studies,' and the Unpredictable nature of human response make today’s inquiry at best a contest of probabilities. To pretend otherwise, or that either of the experts or this Court truly knows what the outcome of that experiment will be, would be disingenuous. But as odd as it sounds, this is not a problem until it is actually a problem. The law teaches that Ohio is free to innovate and . to evolve its procedures for administer- ' ing capital punishment until such experimentation sufficiently risks running afoul of the constitutional protections afforded every citizen, regardless of his or her status, crime, or punishment. See Cooey (Biros), 589 F.3d at 229-30 .
The evidence before this Court fails to present a substantial risk that McGuire will experience severe pain. This is not to say that the Court is convinced that the execution will be pain free or even complication free. There is always a'possibility of human error or unfortunate ' misadventure. There is also the possibility that in the earliest moments of his execution, McGuire could.experience an obstruction. This Court credits the evi *904 dence that he has characteristics suggesting, if not establishing, a propensity for possible obstruction. The simple possibility of obstruction leading to air hunger of which McGuire would be cognizant does not amount to a sufficient probability, however, and the weight of the evidence leads to the conclusion that the hydromorphone overdose employed in Ohio’s protocol will most likely offset the risk factors and preclude the experience of air hunger. Thus, although the Court is not without concern over what could transpire during McGuire’s execution, the applicable law looks at the degree of risk and the amount of pain involved. The only fair evaluation of the evidence here leads to the conclusion that the degree of risk that Ohio’s protocol presents is acceptable within the contours of the Constitution.
Id. at 913.
Midazolam’s Career as an Execution Drug After Judge Frost’s McGuire Decision
The Actual Dennis McGuire Execution
Judge Frost’s decision was not appealed and McGuire was executed on January 16, 2014, using a single injection which combined 10 mg of midazolam and 40 mg of hydromorphone. During the January evi-dentiary hearing in this case, the Court heard from three eyewitnesses to Dennis McGuire’s execution: ODRC Director Gary Mohr, Execution Team Member No. 10, and Columbus Dispatch reporter Alan Johnson.
Director Mohr described what he saw As the drugs were going in, Mr. McGuire looked over, said—what I think he said was “I love you.” It was not— that was not audible to me, but the mouth was pretty clear that he was. And leaned back down, and his head was kind of straight.
And what I saw for the first five to six minutes was no movement. I saw, you know, after the first minute or so, no movement.
(Evid. Hrg. Tr., ECF No. 925, PagelD 31357.)
Director Mohr’s perception was that McGuire became unconscious faster than had happened with the pentobarbital executions he had witnessed. Id. After McGuire was “at peace and motionless,” “I saw the stomach first. I saw what looked like a knot in his stomach ... and his stomach was moving. I had not seen that before. And then I saw his mouth open, and I heard audible sounds. I don’t know whether it was like a snore or a snort....” Id. at PagelD 31358-59. Director Mohr observed McGuire’s stomach continue to knot up and relax and snort multiple times. Id. at PagelD 31360. Because he had not seen these phenomena before and was concerned, he convened a meeting of the medical team and was assured that McGuire was not aware and “we’ve seen this in our experience.” Id. After a five minute wait recommended by the medical team, the drug administrator told Director Mohr he could detect no heart sounds or breathing sounds. Id. at PagelD 31362. Director Mohr has overseen eleven executions. Id. at PagelD 313784.
Execution Team Member 10 9 testified he was in the death chamber with McGuire during the execution. When the syringe was empty and the execution drugs were in the process of entering McGuire’s *905 body, 10 McGuire had a “dry mouth swallow, which is normal in that case. (Evid. Hrg. Tr., ECF No. 922, PagelD 30672.) He lifted his head and whispered “I love you” to his family and “immediately laid back down.” Id. Team Member 10 was standing at the head of the execution gurney and McGuire tilted his head back toward No. 10. Id. at PagelD 30673. His jaw relaxed and he snored three or four times—“pretty common at that time in the process.” Id. He appeared to Number 10 to be unconscious at 10:31 a.m. One-and-a-half to two minutes later, Team Member 10 noticed a swelling in the belly area, but the IV site appeared normal. Id. at Pa-gelD 306749. There was a wave in the belly followed by a snort which happened eight to ten times. Id. There was no movement after that. Id. at PagelD 30675. Team Member 10 has witnessed approximately forty-nine executions. Id. at Pa-gelD 30694.
Reporter Alan Johnson covers Ohio state government for the Columbus Dispatch and has done so since 1990. Id. at PagelD 30702. He has witnessed twenty Ohio executions, including McGuire’s. Id. at PagelD 30703. He testified:
[Tjypically after five minutes [from the time the drugs begin to flow], things calm down in an execution in my experience. But after the end of five minutes, roughly, inmate McGuire began coughing, gasping, choking in a way that I had not seen before at any execution. And I remember it because I relived it several times. Frankly that went on for 12 to 13 minutes.
Id. PagelD 30706. McGuire gasped fifteen to sixteen times “in a way that would almost seem to be choking. And he attempted to kind of lift up off the table. His hands were clenching and unclenching.” Id. In the other nineteen executions Johnson had witnessed, he had seen “very minor reaction's"—sometimes clenching of the hands, sometimes a chest compression or an eyelid flutter, “but nothing of that intensity or that duration in any of the 19 previous executions.” Id. at PagelD 30708.
Other Midazolam-Involved Executions
Ohio has executed no one since Dennis McGuire. But Plaintiffs presented testimony from eyewitnesses to other executions in which midazolam was the first part of the protocol.
The State objected to the relevance of this testimony and testimony .regarding McGuire’s execution in that (1) the present protocol calls for a different usage and fifty times larger dose of midazolam than that used with McGuire, (2) executions in other States using midazolam involved different protocols, and (3) problems with other executions may have resulted from maladministration of the drugs, e.g., from infiltration into muscle tissue instead of proper intravenous infusion. This concern is well taken as a reservation on how directly probative other executions may be, but does not lead the Court to conclude the evidence has no probative value, particularly in a matter in equity tried to the bench alone.
Ronald Smith was executed.by Alabama on December 8, 2016 (Evid. Hrg. Tr. ECF No. 922, PagelD 30609). Spencer Hahn, an Assistant Federal Defender for the Middle District of Alabama Capital Habeas Unit, was assigned to witness Smith’s execution. Id. at 85. Alabama’s protocol called for a 500 mg dose of midazolam, followed by 600 *906 mg of a paralytic drug and 240 milliequiva-lents of potassium chloride. Id. at PagelD 30611.
At some point after administration of the midazolam, Smith was coughing, clenching and unclenching his fists, “and trying to mouth words that I could not make out.” Id. at PagelD- 30609-10. The attending corrections officer performed several “consciousness checks” on Smith including calling his name, brushing his eyelid, and pinching his arm. Id.. at’Pa-gelD 30616-18. After a second consciousness check, Smith appeared to Hahn to still be conscious and he assumed the execution would be stopped. Id. .at PagelD 30618. At about seventeen minutes from the start of drug flow, it appeared to Hahn that the paralytic was administered. Summarizing, Hahn said:
[T]here were two periods in which be appeared to rest somewhat briefly, as if in .reaction to something. Followed by coughing, heaving, flailing, or attempting to flail arms, clenching and unclench-ing of fists, movement of lips, trouble, almost as if he were' hyperventilated, and then’ doing this asthmatic cough, barking-type cough.
Id. at PagelD 30619.
Sonya Rudenstine, a lawyer in a’ solo practice in Florida who specializes in capital post-conviction work, witnessed the execution of Paul Howell in Florida (Evid. Hrg. Tr. EOF No. 924, PagelD 31199). She-identified the Florida execution protocol in place for the Howell execution as that adopted- September 9, 2013. Id. at PagelD 31202, identifying Plaintiffs Exhibit (hereafter “PX”) 71. That Florida protocol called for injection of 500 milligrams of midazolam in' two separate injections of -250 milligrams each, followed by 200 milligrams of vecuronium bromide in two 100 milligram injections, followed by 240 milliequivalents of potassium chloride. Id. She observed Mr. Howell open his eyes after the consciousness check. Id. at Pa-gelD 31230. From logs produced by the Florida Department of Law Enforcement official witnesses, Ms. Rudenstine understood the midazolam began- to be administered at 6:18 p.m. and was complete by 6:22. Id. at PagelD 31216.
During the very course of the preliminary injunction hearing, to wit, on'January 4, 2017, Florida changed its lethal injection protocol to replace midazolam as the first drug with etomidate. (PX 81, page 6). 11
Dale Baich is supervisor of the Federal Defender Capital Habeas Unit in Arizona. He witnessed the July 2014 execution of Joseph Wood in that State. The protocol called for injection of a mixture of 50 mg of midazolam and 50 mg of hydromorphone. (ECF No. 940, PagelD 31673-74.) In Mr. Wood’s case, this mixture was injected fifteen separate times. Id. at PagelD 31682. Wood continued to gasp and try to breathe until his death at 3:49 p.m., almost two hours after the process began. Id. at .Pa-gelD 31683.
Mr. Baich also identified the settlement agreement and consequent dismissal order he negotiated on behalf of Arizona death row inmates (PX 69 and 70). In the Settlement Agreement, Arizona permanently foreswears the use of “midazolam, or any other benzodiazepine, as part of a drug protocol in a lethal injection execution” (PX 69, page 2).
Terry Alang, who is an attorney employed as an investigator for the Capital Habeas Unit in the Middle District of Alabama, testified she witnessed the execution *907 of Christopher Brooks in Alabama on January 20, 2016. (EOF No. 940, PagelD 31721.) Midazolam was the first drug administered and Mr. Brooks’ chest began heaving a few minutes after it was given. Id. at PagelD 31723.
Dean Sanderford is an attorney with the Federal Public Defender in Denver, Colorado. His office was appointed by the Tenth Circuit Court of Appeals to witness the Oklahoma execution of Clayton Lock-ett. (ECF No. 940, PagelD 13738.) Oklahoma’s protocol calls for the administration of 100 mg of midazolam, followed by a paralytic agent and potassium chloride. Id. at PagelD 31739: Three to four minutes after administration of the paralytic to Mr. Lockett, Sanderford observed Lockett attempt to speak and his body began writhing. Id. at PagelD 31742. On cross-examination, Mr. Sanderford admitted this was thé first execution he had witnessed and it was determined the drugs went into muscle tissue by process of infiltration. Id. at PagelD 31754-55.
After the hearing in this case was completed, Virginia executed Rick Gray using a three-drug protocol with midazolam as the first drug. According to press accounts from his attorneys, he experienced many of the same phenomena testified to in the hearing, to wit, “labored breathing, gasping, snoring, and other audible and visible activity.” 12 While this account is obviously hearsay and not in evidence, the account corroborates admissible testimony the Court did hear.
Witnesses to non-Ohio executions were from legal practices devoted to representing capital clients. Although such witnesses might be expected to be biased in favor of death row inmates, their testimony was carefully confined to ■ observations rather than opinions on what they were seeing. This contrasts with some press characterizations of some of these executions as “botched,” “horrendous,” “barbaric,”, and so forth. These witnesses were carefully professional in not adding advocatory characterizations to their observations.
On the short notice involved with a preliminary injunction hearing, other evidence would have been difficult to obtain, indeed, the State of Alabama moved in the Middle District of Alabama to quash Plaintiffs’ subpoenas for records of the Smith execution and those documents were not produced.
Glossip v. Gross
In addition to its actual use in other executions, midazolam -has received Supreme Court attention since the McGuire execution. In Glossip v. Gross, — U.S. -, 135, S.Ct. 2726, 192 L.Ed.2d 761 (2015), the Court reviewed Oklahoma’s three-drug lethal injection protocol which featured a 500 mg dose of midazolam as the first drug. 13 The district court had denied preliminary injunctive relief and the Tenth Circuit affirmed. The Supreme Court held:
For two independent reasons, we also affirm. First, the prisoners failed to identify a known and available alternative method of execution that entails a lesser risk of pain, a requirement of all Eighth Amendment method-of-execution claims. See Baze v. Rees, 553 U.S. 35, 61 , 128 S.Ct. 1520 , 170 L.Ed.2d' 420 (2008) (plurality opinion).- Second) the District *908 Court did not commit clear error when it found that the prisoners failed to establish that Oklahoma’s use of a massive dose of midazolam in its execution protocol entails a substantial risk of severe pain.
Id. at 2731.
As noted above, after reciting a brief history of execution methods in the United States, the Court reaffirmed its holding in Baze v. Rees, 553 U.S. 35 , 128 S.Ct. 1520 , 170 L.Ed.2d 420 (2008), that
[B]ecause it is settled that capital punishment is constitutional, “[i]t necessarily follows that there must be a [constitutional] means of carrying it out.” Id., at 47 , 128 S.Ct. 1520 , 170 L.Ed.2d 420 . And because some risk of pain is inherent in any method of execution, we have held that the Constitution does not require the avoidance of all risk of pain. Ibid. After all, while most humans wish to die a painless death, many do not have that good fortune. Holding that the Eighth Amendment demands the elimination of essentially all risk of pain would effectively outlaw the death penalty altogether.
Glossip, 135 S.Ct. at 2732-33 . It noted the protocol found constitutional in Baze consisted of
(1) sodium thiopental, “a fast-acting barbiturate sedative that induces a deep, comalike unconsciousness when given in the amounts used for lethal injection,”
(2) a paralytic agent, which “inhibits all muscular-skeletal movements and, by paralyzing the diaphragm, stops respiration,” and (3) potassium chloride, which “interferes with the electrical signals that stimulate the contractions of the heart, inducing cardiac arrest.
Glossip, 135 S.Ct. at 2732 . This protocol was used in 2008 by at least thirty of the thirty-six States executing by lethal injection. Id.
Relying largely on press accounts, the Court majority found that thiopental sodium and pentobarbital had become unavailable, at least to Oklahoma. Id. at 2734 . Florida became the first State to substitute midazolam- for a barbiturate in October 2013. Oklahoma followed suit in 2014 and had already used its new protocol in the executions of Clayton Lockett (April 2014) and Charles Warner (January 2015). 14 The Glossip plaintiffs filed suit in June 2014. After a three-day evidentiary hearing, the District Court denied relief on the two independent bases eventually adopted by the Supreme Court:
[First, the petitioners] fail[ed] to identify a known and available method of execution that presented a substantially less severe risk of pain than the method that the State proposed to use. Second, the court found that petitioners failed to prove that Oklahoma’s protocol “presents a risk that is ‘sure or very likely to cause serious illness and needless suffering,’ amounting to ‘an objectively intolerable risk of harm.’” App. 96 (quoting Baze, 553 U.S. at 50 , 128 S.Ct. 1520 , 170 L.Ed.2d). The court emphasized that the Oklahoma protocol featured numerous safeguards, including the establishment of two IV access sites, confirmation of the viability of those sites, and monitoring of the offender’s level of consciousness throughout the procedure.
Glossip, supra, at 2736 .
As to the second branch of the decision, the Court emphasized it was doing what is appropriate for an appellate court reviewing a district court finding of fact: it found *909 that conclusion was not clearly erroneous. “First, we review the- District Court’s factual findings under the deferential ‘clear error’ standard. This standard does not entitle us to overturn a finding ‘simply because [we are] convinced that [we] would have decided the case differently.’ ” Glos-sip, at 2739, quoting Anderson v. Bessemer City, 470 U.S. 564, 573 , 105 S.Ct. 1504 , 84 L.Ed.2d 518 (1985). As this Court has noted earlier, the affirmance in Glossip does not logically imply that it can never be proven that midazolam presents an objectively intolerable risk of harm. Instead, this Court must evaluate the evidence presented here, rather than the evidence the Oklahoma District Court heard in Glossip , which is not before this Court.
This distinction is necessary because some have read Glossip as holding the three-drug protocol at issue in that case is per se constitutional. ODRC Director Mohr testified he adopted Ohio’s current protocol because he believed that is what Glos-sip held. (Evid. Hrg. Tr., ECF No. 925, PageID 31319.) The Sixth Circuit also opined that “The new [Ohio] protocol mirrors the Oklahoma protocol approbated by the Supreme Court in June 2015.” Fears v. Kasich, 845 F.3d 231, 234 , 2016 WL 7494863, *2 (6th Cir. 2016), citing Glossip v. Gross, 135 S.Ct. at 2734-35. What the Supreme Court held in Glossip was that the District Court was not clearly erroneous, not that it was clearly correct. This Court must therefore evaluate the ■ evidence before it de novo.
Expert Testimony at the Preliminary Injunction Hearing
Given the experience with use of midazo-lam as an execution drug since the McGuire execution, the parties understandably focused their presentations on expert testimony about how that experience should be understood. That testimony is summarized here at length.
Craig Stevens, PhD
Plaintiffs called Dr. Craig Stevens, PhD., a Professor of Pharmacology at the Oklahoma State University. He was asked “to provide expert opinions regarding the use of midazolam, in itself and in comparison to pentobarbital, in the lethal injection procedures employed by the State of Ohio Department of Rehabilitation and Corrections (“DRC”). (ECF No. 836-1, PagelD 24802). Dr. Stevens testified as to his education, employment, and experience in the field of pharmacology (Evid. Hrg. Tr., ECF No. 923, PagelD 30735-44); his Curriculum Vitae is attached to his Expert Declaration' (ECF No. 836-1, PagelD 24834-47). Without objection by Defendants, the Court'accepted Dr. Stevens as an expert witness in the field of pharmacology. (ECF No. 923, PagelD 30744). On cross-examination, Dr. Stevens agreed that he is not an anesthesiologist and has no clinical experience. Id. at PagelD 30917.
Dr. Stevens’ expert opinion is four-fold:
1. Ohio’s decision to use midazolam instead of an anesthetic (such as a barbiturate like pentobarbital) as the first drug in its three-drug lethal injection . protocol is contrary to sound medical or scientific. reasoning, and expert pharmacological' advice.
Midazolam is a benzodiazepine drug while pentobarbital and thiopental are barbiturate drugs. For reasons of pharmacological classification, mechanism of action, ■ therapeutic uses, and FDA scheduling, midazo-lam is NOT equivalent to pentobar-bital or thiopental. to
Midazolam in any amount cannot render and maintain the condemned inmate unaware and insensate to pain. That is the functional state of “General Anesthesia” as used in the *910 medical context. The key consideration in the lethal injection execution context is not,whether there is a formal medical assessment that the inmate is under General Anesthesia, but whether the drug is capable of rendering an inmate unaware and insensate. Midazolam cannot achieve ’ that. Pentobarbital and thiopental can more reliably render the condemned inmate unconscious/unaware and insensate to pain.
4. Use of midazolam as the first drug in the State’s three-drug lethal injection protocol (Ol-COM-11, eff. Date Oct 7, 2016) is highly likely to cause intolerable and severe pain and suffering in the-condemned inmate.
(Declaration, EOF No. 836-1, PagelD 24802-03.)
Dr. Stevens testified that he reviewed not only Ohio’s October 2016 Execution Protocol, but also numerous other research sources, listed in section 5 of his Expert Declaration Id. at PageID 24830-33, and in his Rebuttal Report (EOF No. 900-1, Pa-gelD 30156-57). (EOF No. 923, PagelD 30745). Dr. Stevens explained that midazo-lam is a benzodiazepine, a major class of drugs most commonly used as antianxiety drugs. Id. at PageID 30745-46. He further explained that midazolam is “kind of a special” benzodiazepine because it comes in an intravenous (“IV”) formulation. Id. at PageID 30746. Dr. Stevens testified that midazolam, along with an opioid, is commonly .administered during such procedures as a colonoscopy. Id. He explained that midazolam has a sedative and amnesic effect, while whatever opioid is included would have an analgesic, or pain-blocking, effect. Id. at PagelD 30746-47.
Referencing a table of four diagrams in his Expert Declaration (EOF No. 836-1, PageID 24805), Dr. Stevens laid out the differences between the, chemical structures of benzodiazepines, such as midazo-lam and diazepam, and the. chemical structures of barbiturates, such as pento-barbital and thiopental, (ECF No. 923, PageID 30748-50.) Dr. Stevens noted that pentobarbital used- to be commonly used for everything from sleep, anxiety, and a number of disorders, for which benzo-diazepines are now used because they are safer. Id. at PagelD 30749. The importance of the difference in chemical, structures between these two -drug types, Dr. Stevens continued, is that,they act on totally different targets on the brain or body, which, determines where -they act and how they act—or their “mechanisms of action.” Id. at PageID 30751.
Dr. Stevens next testified about “GABA,” an acronym for gamma-aminobu-tyric acid. According to Dr. Stevens, “[tjhat’s a[n] amino-acid-derived neurotransmitter that is the most common inhibitory neurotransmitter in the brain.” Id. at PageID 30752 (emphasis added). A substance called glutamate, by contrast, is the major excitatory neurotransmitter. Dr. Stevens, explained that neurons connect with other neurons through a synapse—a small- gap between one neuron and the next neuron—such that neurotransmitters from one neuron cross the synapse to another neuron and interact with receptors on that second neuron to either inhibit that second neuron or excite it. Id. at PageID 30752-53. Dr. Stevens used an easel to demonstrate this process. Id. at PageID 30754-56.
GABA, Dr. Stevens explained, acts on a receptor called GABAa, by opening it (as a door) and allowing in chloride ions that bring a negative charge to that neuron, or inhibit it. When midazolam is introduced, it binds to a separate place on the GABAa receptor and increases the flow of chloride ions into the receptor, which increases depression of neural activity. Id. at PagelD *911 30756-57. To that point, Dr. Stevens emphasized that if there is no GABAa on the receptor, midazolam does not open up the channel to inhibit the neurons. In other words, “midazolam can only work when GABAa is present on the receptor.” “Without GABAa present,” Dr. Stevens expounded, “midazolam cannot- open those doors or cause any inhibition of the neuron.” Id. at PageID 30759. Dr. Stevens analogized this concept to “Boy Scouts helping a little old lady crossing the street.” Id.
The little old lady is GABA, and the Boy Scouts were midazolam trying to help her across the street. So that if there is only one little old lady, no matter how many Boy Scouts you have, you are still going to just get one activity there.
Id, at PagelD 30759. During cross-examination, Dr. Stevens did not appear to agree with, or find any significance to, studies indicating midazolam interferes with the “reuptake” of GABA, thereby causing an accumulation of GABA. Id. at PagelD 30930-33.
Dr. Stevens next turned to what happens when a barbiturate such as pentobar-bital is introduced. He testified that even without GABA present, pentobarbital can open up the channel and decrease neuronal activity. Id. at PagelD 30760. That, Dr. Stevens explained, is the key difference between a benzodiazepine such as midazo-lam and a barbiturate such as pentobarbi-tal: barbiturates can work without GABA present, while midazolam is limited by the need for GABA and therefore has a ceiling effect. Id. Dr. Stevens further explained that while midazolam has the effect of opening the channel to allow in inhibiting ions more frequently, pentobarbital has the effect of increasing the duration of the channel staying open. Id.
Dr. Stevens proceeded to testify about a section of his Expert Declaration entitled “Midazolam is a partial agonist, and pento-barbital is a full agonist.” (ECF No. 836-1, PagelD 24807-208.) “An agonist,” Dr. Stevens explained, “is a drug that does something that activates the receptor and turns it on.” By contrast, an “antagonist” hits a receptor and-does not do anything. Id. at PagelD 30762. Dr. Stevens noted that although midazolam and pentobarbital are agonists insofar as they turn on receptors, the effect of turning on the receptors is opening channels (or doors) to allow in ions that inhibit .neural activity. Id. Dr. Stevens proceeded to. explain:
So if you have an assay where you are measuring the effect of midazolam and pentobarbital, what you will see in that assay is that pentobarbital can produce a very potent effect! So let’s just say we are measuring inhibition of a neuron. We have a neuron in a cell dish or something we are dropping the drugs on. So pentobarbital, we will see the full effect, full inhibition of those neurons, whereas ’ midazolam we wouldn’t. It would be limited by the amount of GABA present, for example. And so because we don’t see the full effect, it’s called a partial agonist. It’s just a pharmacological term.
Id. at PageID 30763.
As a partial agonist, Dr. Stevens continued, midazolam will have a ceiling effect. Referring to a figure in his Expert Declaration (ECF No. 836-1, PagelD 24808), Dr. Stevens explained that the X-axis depicts increasing doses of benzodiazepines and barbiturates, while the Y-axis depicts the increasingly different effects of those drugs—sedation, then hypnosis (sleep), then anesthesia, then coma, and finally death. (ECF No. 923, PageID 30764; ECF No. 836-1, PageID 24808.) Dr. . Stevens testified that with barbiturates, as you increase the dose, you increase the potency of inhibiting neurons to the point where *912 the person is sedated, then asleep, then anesthetized, then comatose, and then dead. That line on the graph goes diagonally up from the lower left corner to the upper right corner. Id. at PageID 30765. Dr. Stevens testified that “the greater the dose, the greater the effects along that vertical or Y-axis.” Id.
With respect to benzodiazepines, according to Dr. Stevens:
[A]t some dose this effect does not keep going up along the Y axis. You get a plateau. And in this case, it’s drawn just below anesthesia. So just below anesthesia you start to see it level off. It’s either called a plateau effect or a ceiling effect.
Id. at PagelD 30765-66.
Dr. Stevens agreed during cross-examination that while pentobarbital has a lethal dose range, midazolam does not. Id. at PagelD 30926. When pressed to explain fatalities that had been reported from doses of midazolam ranging from as little as .04 to .07 mg per kilogram, Dr. Stevens expressed his belief that such fatalities are more likely “when there is another drug on board,” and further testified that fatalities from midazolam alone are “very, very rare.” Id. at PageID 30936. Dr. Stevens also agreed on cross-examination that mi-dazolam package inserts include a “black box warning” about the drug’s potential dangers, but noted that “[i]t is not rare to have a black box warning.” Id. at PagelD 30937-38.
Dr. Stevens several times cautioned that his diagram was theoretical, in the sense that he did not assign values or doses, but that “you could take experiments where they have looked at actual assays and cell cultures, for example, and you could come up with values along [the X-axis or dose line].” Id. at PageID 30766. Dr. Stevens thus clarified that although his diagram was illustrative in nature, what that diagram represents has been confirmed through experiments. Id. at PageID 30766-67.
Dr. Stevens next testified about precise (and imprecise) uses of the terms “anesthesia” and/or “general anesthesia.” Relying on the approach taken by the American Society of Anesthesiology (“ASA”), Dr. Stevens explained that “we have to be very careful to only use general anesthesia when we’re talking about the stage of anesthesia that is deep enough to do surgery, for example, where you have loss of awareness, you have loss of consciousness, and no response to noxious stimulus.” Id. at PageID 30767-68; EOF No. 836-1, Pa-gelD 24809-10. Dr. Stevens further explained that although there are different levels of sedation—minimal, moderate, and deep—there is only one level of general anesthesia, which is beyond the deepest level of sedation. (ECF No. 923, PageID 30768-69; ECF No. 836-1, PageID 24810.) Dr. Stevens then opined that because the “responsiveness” associated with general anesthesia is “unarousable even with painful stimulus,” that is the state in which you would want a condemned inmate to be. (ECF No. 923, PageID 30768.)
With respect to the different levels of sedation, Dr. Stevens testified that minimal sedation would be associated with premedication before a root canal; that moderate sedation would be greater premedication; and that deep sedation would be that achieved by IV midazolam. Id. at PageID 30769. On cross-examination, Dr. Stevens agreed that the ASA chart in his report states that, under a level of deep sedation/analgesia, “reflex withdrawal from painful stimulus is NOT considered a purposeful response.” Id. at PageID 30934 (citing ECF No. 836-1, Pa-geID 24810.) Dr. Stevens continued that whereas different levels of sedation can involve drug-induced depression of consciousness, but the ability to respond pur *913 posefully, “only at general anesthesia do we have a drug-induced loss of consciousness.” Id. at PagelD 30770 (emphasis added). Stated another way, Dr. Stevens explained, if a person who is sedated is exposed to increasingly severe stimulation, that person will eventually respond, but a person under general anesthesia would not respond to even the most painful stimulus. Id. at PageID 30770-71 (relying on ECF No. 836-1, PageID 24810 “Continuum of Depth of Sedation”). Ben-zodiazepines, Dr. Stevens testified, cannot bring someone to a level of general anesthesia. (ECF No. 923, PageID 30771.) Dr. Stevens confirmed on cross-examination that he was not aware of any state other than general anesthesia where a patient would lose consciousness. Id. at PageID 30920.
Returning to his Y-axis / X-axis illustrative diagram in his Expert Declaration (ECF No. 836-1, PageID 24808), Dr. Stevens explained that if one were to attempt to assign dose values along the X-axis, one would never plot a dose of 500 mg because “there is no data that exists.” (ECF No. 923, PageID 30772.) “There is no data at the level of dosage,” Dr. Stevens continued, “because it’s way beyond any clinical usage of that drug.” Id. at PageID 30773). Dr. Stevens also testified that there is no evidence to support the proposition that a plot point of 500 mg of midazolam would achieve general anesthesia. Id. Dr. Stevens explained that the highest dosage level of midazolam for which he had seen clinical data was 2 or 3 mg per kilogram. Id. at 30773-74.
Dr. Stevens next returned to the concept of “ceiling effect.” After agreeing that the concept of a ceiling effect is not controversial, Dr. Stevens likened a ceiling effect to the amount of pain relief an over-the-counter analgesic, such as Advil or aspirin, would provide for a severe injury such as the loss of a limb or a gallbladder attack— that is, “[i]t could maybe cause 20 percent decrease in your pain, but it’s going to level off and show a ceiling effect.” Id. at PagelD 30774-75. “[T]he main point,” Dr. Stevens explained, “is that you can’t just give more of a drug and expect the nature of the drug to change.” Id. at PagelD 30776.
Dr. Stevens stated his understanding of Ohio’s current execution protocol:
Yes. I believe the first drug is two syringes full of 250 milligrams each of mi-dazolam. So those are infused IV. And then after a consciousness check, the second drug is a muscle paralytic; pan-curonium, vecuronium, one of paralytic drugs, which, if course, paralyzes muscles so there is no movement, including breathing. And then the third drug is potassium chloride, which basically is an electrolyte that stops the heart. So that’s my understanding.
Id. at PagelD 30777. Dr. Stevens was next asked what is known about how the second and third drugs would feel to someone who is not unaware and not insensate to pain. On the basis of a few papers he had researched concerning cases where patients were administered a paralytic while conscious and without having been sedated (ECF No. 836-1, PageID 24811), Dr. Stevens testified that those patients reported feeling terrible and in severe pain, like being buried alive or already dead, panicked, and as if they were suffocating. (ECF No. 923, PageID 30777-78.) Dr. Stevens agreed on cross-examination that with respect to the complaint of feeling panic or terror, that part of the pharmacological effect of midazolam is, in fact, relief of anxiety. Id. at PagelD 30951. To that point, Dr. Stevens also agreed that mi-dazolam has an anterograde amnesic effect that can suppress a patient’s ability to form memories while under the effect of *914 the. midazolam. Id. at PagelD 30951-52. Dr. Stevens agreed with earlier testimony in this litigation to the effect that the level of fear, pain, and panic associated with the feeling of being buried alive would almost surely break through and overcome the anti-anxiety effect of midazolam. Id. at Pa-geID 30959.
With respect to the third drug, potassium chloride, Dr. Stevens testified about a patient who had reported a severe pain that spread up his arm after the potassium chloride was injected IV and a ringing in his ears, before losing consciousness. Id. at PageID 30779. He cited another study where potassium chloride produced severe pain at the injection site, and .four cases where the patients screamed out in pain. Id. Dr, Stevens testified, “it’s obvious, I think, and accepted that potassium chloride without being in a state of general anesthesia would always cause severe and intolerable pain and suffering.” Id. To that point, Dr. Stevens agreed it would not be acceptable medical’practice to administer the second or third drug'to someone not in a state of general anesthesia, though he qualified that opinion by noting that he is not a medical doctor. Id. at PageID 30780.
Dr. Stevens proceeded to testify about a table in his Expert Declaration labeled “Comparison of therapeutic uses for five benzodiazepines and five barbiturates.” (ECF No. 836-1, PageID 24812.) He testified that what the table ends up demonstrating is that there is not much overlap. “In other words,” he explained, “the FDA has clearly shown that these are separate entities, separate classes of. drugs with separate therapeutic uses.” (ECF No. 923, Pagel# 30781.) He continued, “benzodiaze-pines are not a good pharmacological substitute for barbiturates.” Id. He testified as to his understanding that midazolam is approved for inducing anesthesia, but not for maintaining general anesthesia. Id. at PageID 30781-83; ECF No. 836-1, Pa-gelD 24812. When questioned on cross-examination whether the Seventh Edition of Miller’s Anesthesia states that midazo-lam is the . benzodiazepine of choice to induce anesthesia and is safe in doses oí as little as .2 mg for that purpose, Dr. Stevens answered that he believed a later edition of Miller’s may have been updated on that point. (ECF No. 923, PageID 30948-49.)
Dr. Stevens was asked about a section of his Expert Declaration discussing the Drug Enforcement Agency’s (“DEA”) scheduling of midazolam and pentobarbi-tal. He explained that under- the Controlled Substances Act of 1970, drugs are assigned to schedules ranging from I to V, with Schedule I listing drugs with no medical use and are illicit. Id. at PageID 30783; ECF No. 836-1, PageID 24814. Schedule II drugs are medically used but highly addictive—such as morphine, methamphetamine, and cocaine. Id. Dr. Stevens then explained that another reflection of the differences between barbiturates and ben-zodiazepines is the fact that they are scheduled differently: barbiturates are more susceptible to being abused and are accordingly scheduled higher than are mi-dazolam and other benzodiazepines: mi-dazolam is on Schedule IV, whereas most barbiturates are on Schedule II. (ECF No. 923, PagelD 30785; ECF No. 836-1, Pa-geID 24814.)
Dr. Stevens, testified generally about various calculations he conducted and/or data he relied on. in estimating what level of midazolam in the brain would produce a ceiling effect. (ECF No. 923, PageID 30788 (discussing ECF No. 836-1, PageID 24815-28)). 15 He explained the need to ex *915 amine in-vitro studies—or “cells in petri dishes” in a laboratory setting—because that is the best data available. (ECF No. 923, PageID 30788.) Using that data, Dr. Stevens testified that when those cells reached approximately 100 nanomoles of GABA (a measure of concentration), they leveled off, such that even if GABA were increased, that fact would not show a greater effect in the cell models. Id. at PageID 30788-89. On cross-examination, Dr. Stevens could not confirm at what temperature the various specimens were tested. Id. at PageID 30940. He also attempted to explain variations, means, and true values inherent in these in-vitro studies. Id. at PageID 30940-43. On redirect examination, Dr. Stevens confirmed that no matter what level of drug coneéntration the ceiling effect of midazolam is calculated to be, it would not change Dr. Stevens’ conclusion as to the substantial likelihood of harm from using any amount of the drug as the first in Ohio’s three-drug protocol. Id. at PageID 30959-60. '
In addition to considering in-vitro data, Dt. Stevens also looked at some clinical studies that showed a ceiling effect. Id. at PagelD 30793. Specifically, Dr. Stevens referenced a section in his Expert Declaration titled “Clinical studies of midazolam and BIS.” (ECF No. 836-1, PagelD 24826.) Dr. Stevens explained that “BIS” is an acronym for bispectral index—a proprietary algorithm that takes raw EEG brain waves, filters them through some transformations, and comes up with a single number on a scale from 100 to zero. A reading of 100 means the individual is completely awake and aware, while zero means there is no brain wave activity. (ECF No. 923, PageID 30793-30794.) Dr. Stevens explained that BIS. value is a good proxy for determining how much the brain activity is depressed and can be used during surgical procedures for measuring depths of sedation and determining when general anesthesia.has been reached. Id. at PagelD 30794.
Ultimately, Dr: Stevens concluded that midazolam reaches á ceiling effect at about 228 mg id. at PageID 30800, and that Ohio’s dosage of 500’ mg is 2A92 times higher than the concentration at which midazolam produces a ceiling effect. Id. at PagelD 30799. The relevance of that conclusion to a lethal injection protocol, Dr, Stevens explained, is that because 500 mg is beyond the ceiling effect, greater doses will not .produce,, a greater effect. Id. at PageID 30799. Dr. Stevens clarified that if a dose of 500 mg were administered, a second dose :of ,500 mg would have “[n]o effect.” Id. at PageID 30800. Referring to midazolam’s “mechanism , of action,” Dr. Stevens further explained:
I mean, all the clinical studies support that there is a ceiling effect of midazo-lam. Midazolam cannot get past a deep sedative level, deep sedation, according to ASA, and it hasn’t been ever shown to product general anesthesia. I have found no clihical studies to do that.
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[I] think that’s the key point. As much ■ ■as you might want it to, one cannot .change the nature of - a drug by giving more and more and more of it.
Id. at PagelD 30801. Dr. Stevens agreed on cross-examination, however, that “it’s not possible to experiment on humans administered doses greater than those used clinically.” M at PagelD 30935. He further offered that, despite his view that midazo- *916 lam is not dangerous, he did not belief that any institutional review board would approve a study in which humans were given 500 mg of the drug. Id. PagelD 30935.
Dr. Stevens concluded with his opinion that, to a reasonable degree of scientific certainty, “the use of midazolam as the first drug in a three-drug protocol is highly likely to cause intolerable pain and suffering,” stemming from the administration of the second and third drugs. Id. at Pa-gelD 30802-03.
Dr. Stevens agreed on cross-examination that fast-acting barbiturates such as thiopental and pentobarbital are pharma-cologically more suitable for lethal injection protocols, insofar as they would produce the state of general anesthesia that the first drug is intended to produce. Id. at PagelD 30921-22, 30927. Dr. Stevens was unable to identify any manufacturers or suppliers of thiopental and/or pentobarbi-tal who were willing to sell those drugs, or even those drugs’ active pharmaceutical ingredients, to Ohio for the purposes of conducting lethal injection executions. Id. at PagelD 30924-325. Dr. Stevens also agreed on cross-examination that in an earlier report he had prepared and submitted in a 2015 lethal injection case in Arkansas, he opined that a massive dose of an opioid would be an alternative method of execution. Id. at PagelD 30952-53. Dr. Stevens was unable to recall whether he was aware that Ohio had conducted an execution in 2014 using a mixture of mi-dazolam and the opioid hydromorphone when he wrote his 2015 Arkansas report, but he did state that combining those drugs would render a synergistic effect, which is to say that in combination, each drug would amplify the strength or effect of the other. Id. at PagelD 30954-55.
Sergio Bergese, M.D.
Plaintiffs’ next expert witness was Dr. Sergio Bergese, M.D, a Professor of Anesthesiology and Neurological Surgery, as well as a practicing anesthesiologist, at the Ohio State University Wexner Medical Center. Dr. Bergese testified as to his education, employment, and experience in the field of anesthesiology (Evid. Hrg. Tr., ECF No. 923, PagelD 30812-18); his Curriculum Vitae is attached to his Expert Declaration (ECF No. 844-1, PageID 24992-61.) Without objection by Defendants, the Court ruled that Dr. Bergese was qualified to testify as an expert. (ECF No. 923, PagelD 30819.)
Dr. Bergese’s expert opinions, as set forth in his Expert Declaration, are as follows:
4. There are no clinical data establishing what will happen to an individual upon injection of 500 mg of midazo-lam, nor are there any clinical data establishing what will happen upon injection of 1000 mg of midazolam or any higher doses.
5. There now exists, however, sufficient real-world data taken from lethal injection executions using midazolam to be able to conclude that using midazolam in a lethal injection protocol will not cause immediate death and will cause the inmate to suffer an excruciating and torturous execution while the' inmate experiences and feels that pain and suffering.
6. When there is not an effective chemical mask in place to hide what the inmate is experiencing, the inmate in every execution using midazolam has exhibited bodily movements that demonstrated he was sensate following injection of midazolam. The inmate was aware and therefore experiencing the pain and suffering of noxious stimuli.
7. The painful stimulus in a lethal injection execution using Ohio’s proto *917 col can be in the form of air hunger, which is the sensation of being unable to catch one’s breath, like a fish out of water. Descriptions of movements by Dennis McGuire in Ohio, Joseph Wood in Arizona, and Ronald Smith in Alabama all strongly suggest those individuals experienced air hunger during their executions.
8. While McGuire was injected with 10 mg of midazolam, Mr. Wood was injected with 750 mg of midazolam, and reports suggest Mr. Smith was injected with at least 500 mg' and possibly 1000 mg of midazolam.
9. The painful stimulus using Ohio’s execution protocol can be in the form of feelings of suffocation like being buried alive, which will occur when the respiratory system’s muscles are paralyzed by the paralytic agent. The person will be unable to perform the muscle movements necessary to breathe while aware.
10. The painful stimulus using Ohio’s execution protocol ean be in the form of feeling like being burned alive from the inside, as if fire is being poured into the veins, when potassium chloride is injected into the blood vessels causing irritation.
11. The painful stimulus using Ohio’s execution protocol can be in the form of a searing pain of a massive heart attack as potassium chloride disrupts the electrical activity of the heart and cause cardiac arrest.
12. Reports of executions in which a condemned inmate was first injected with midazolam and then bodily movement such as moving the extremities or opening of one or both eyes was observed following injection of the paralytic drug and/or potassium chloride suggest those individuals were aware or at least able to feel and experience the stimuli associated with the second and third drugs, and were responding to one or more of these stimuli. Further responsive movements were subsequently hidden behind the chemical veil of the paralytic drug taking full effect.
13. Because the inmate will not be rendered and kept unaware and insensate quickly following the initial injection of midazolam in a three-drug protocol using a paralytic agent and potassium chloride, and will not be rendered and kept unaware and insensate throughout the entire process until death occurs, the inmate will experience any or all of those stimuli during his execution.
14. The use of midazolam in Ohio’s three-drug lethal injection protocol creates a substantial and unnecessary risk of a severely painful, torturous death process. There is more than a substantial and unnecessary risk; it is a virtual certainty, based on the only data from real-world applications of midazolam of the amounts used in lethal injection executions.
15. The pain associated with the second and third lethal injection drugs would be excruciating, equivalent or worse than the pain associated with a major surgical intervention with no anesthesia. Similarly, the air hunger caused by respiratory suppression from midazolam would be terrifying and painful. Unless the IV-administered midazolam would induce and maintain a state of being unaware and insensate deep enough to withstand at least the pain of a major surgical intervention, or to not be overcome by *918 the painful stimulus of air hunger, it is ineffective in its intended role in Ohio’s execution protocol No amount of midazolam can do that, however.
16. It is my expert opinion, based in substantial part on reviewing the reports from lethal injection executions, that an IV injection of 500 mg of midazolam, or a 100Q mg IV injection of midazolam, or a greater dose, is incapable of rendering and holding an inmate in an unaware and insensate state through the experience of air hunger and the sensations associated with the second and third lethal injection drugs in Ohio’s protocol.
17. Midazolam’s inability to render and hold an inmate unaware and insensate in the presence of painful stimuli from the second and third drugs makes midazolam unsuitable from use as contemplated by Ohio’s execution protocol.
18. Midazolam’s inability to render and hold an inmate sufficiently unaware and insensate in the presence of painful stimuli from suffering air hunger makes midazolam wholly unsuited for use as contemplated by Ohio’s execution protocol.
19. My opinion is not just based on having administered midazolam (and many other true general anesthetic drugs) many thousands of times over the course Qf my medical career. Leading medical' texts, pharmacological references, and research papers confirm midazolam cannot induce and maintain a sufficiently deep state of unawareness and being insensate in the presence of painful stimuli. An established body of information, therefore, confirms the real-world data we have from lethal injection executions using midazolam.
20. The reason midazolam cannot sufficiently depress electrical activity in the brain to hold an inmate unconscious in the presence of pain stimuli is directly tied to the biochemical mechanism by which mi-dazolam exerts action in the brain. This specific biochemical mechanism places a firm limit on the maximum pharmacological effect that midazolam can have. This specific biochemical mechanism means that midazolam is chemically incapable of depressing neuronal activity to the same extent as general anesthetics such as propofol.
21. Midazolam does not' render and maintain a person unaware and insensate through the application of a painful stimulus. For midazolam to keep a person unaware it would have to work also on the implicit memory, otherwise it only would cause memory dissociation. It does not depress electrical activity to a deeper level than would be provided by, for example, pentobarbital. Midazolam does not produce any analgesic (“pain blocking”) effect.
22. Even the memory dissociation and limited depression in neuronal activity midazolam induces will have a ceiling effect and it will wear off rapidly. It is highly likely the maximum effect of midazolam will begin to wear off, manifested by a measurable increase in neuronal activity, within approximately fifteen minutes following administration.
23. The properties of midazolam limit its ability to fully depress electrical activity in the brain. The lack of any analgesic (pain blocking) properties renders midazolam incapable *919 .of maintaining even that limited level of depressed electrical activity-under the undiminished pain and suffering associated with' the drugs in Ohio’s execution protocol,
24. The “consciousness assessment” called for in Ohio’s protocol is undefined. But if it does not involve the use of. reliable instrumentation-based assessments of awareness and the ability to feel and experience pain, it is not an adequate . means of assessing whether an inmate is unaware and insensate be- ■ .fore administration of the second and third lethal injection drugs. Furthermore, the execution rehearsal documentation I have seen demonstrates that Ohio execution personnel will conduct an extreme: ly short consciousness check, mostly based on the lack of reflex, much too soon after they conclude injecting the first 500 mg of midazolam, and that they will proceed to inject the second and third drugs far too soon after injection of that midazo-lam. A lack of reflex does not constitute a lack of awareness or a lack of pain.
(EOF No. 844-1, PageID 24942-47.)
Dr. Bergese testified that the field in which he primarily practices, anesthesia during surgical procedures on the brain, puts more emphasis on managing a patient’s brain before, during,, and after surgery. When asked whether consciousness is the same thing as awareness, Dr. Berg-ese answered, “No, they are concepts that clearly cross paths, but you can be unconscious and be aware.” 16 (EOF No. 923, PagelD 30819.) Dr, Bergese further testified that “we can make the same assumption from pain. So you can be unconscious and you can have pain.” Id. at PagelD 30820. He explained, that a patient who is unconscious but experiencing pain might exhibit such signs as hypertension, tachycardia, high blood pressure, increased heart rate, sweating, or movement. Id. at PagelD 30821.
Dr. Bergese defined general anesthesia as the state at which a patient can undergo surgery, and is defined by achieving (1) immobility, (2) lack of consciousness, and (3) lack of pain. Id. at PagelD 30821. Dr. Bergese testified that as a general rulé, anesthesiologists use multiple drugs for a surgical procedure, using One drug to induce anesthesia and another drug or drugs to maintain anesthesia. Id. at PagelD 30821-22. Dr. Bergese proceeded to explain the nature and use of Bispectral Index (“BIS”) as a proprietary algorithm that measures EEG and other data to produce an index that provides an understanding of the depth of anesthesia of a patient. He continued that oh a scale from zero to 100, the range of forty to sixty would reflect a state of general anesthesia. Id. at PagelD 30823.
When asked whether midazolam has analgesic properties, Dr. Bergese answered, “[cjlinically I will say no.” Dr. Bergese then clarified that' BIS monitors have nothing to do with treating or gauging pain. Id. at PagelD 30824. Dr. Bergese denied that he would ever use midazolam by itself as the sole anesthetic for a procedure. 17 Id. at PagelD 30825. When asked *920 during cross-examination whether midazo-lam is ever used alone to sedate a patient before intubation, Dr. Bergese stated that midazolam is not “commonly used alone, but you can use it alone, true.” Id. at PagelD 30901. He also allowed that in certain circumstances such as a patient in distress during an emergency, midazolam might be used alone. Id. at PagelD 30900. Dr. Bergese explained that although mi-dazolam is “very commonly” used for colo-noscopies, midazolam is never used alone, and is instead used with an opioid which treats the pain. Id. at PagelD 30825-26. Dr. Bergese testified that one would typically give the opioid followed by midazolam because due to pharmacokinetics, if the patient’s pain is treated first, he or she can then be given a lower dose of a sedative to achieve the degree of sedation desired. 18 Dr. Bergese also testified that a person undergoing a colonoscopy “absolutely” actually experiences the pain as the procedure is happening. Id. at PagelD 30826-27. He explained that midazolam also has an amnesic effect, such that a patient could feel a painful experience as it is happening but not remember that later. (Id. at Pa-gelD 30828-29.
Dr. Bergese testified that the amnesic quality of injected midazolam would not have the ability to stop an inmate from actually experiencing any pain associated with his execution by lethal injection. Id. at PagelD 30829-30. He clarified that the pain experienced would depend on how much the inmate’s consciousness is depressed, noting that consciousness is not an all-or-nothing proposition, but rather, is a spectrum of different grades. Id. at Pa-gelD 30830. Dr. Bergese then testified that if an inmate’s consciousness were not depressed enough, that inmate would not only feel, but would react to, pain, which could not be relieved by midazolam’s amnesic effect. (Id. at PagelD 30830. Explaining this concept in the context of a routine colonoscopy, during which a combination of an anesthetic and an opioid would be used, Dr. Bergese testified that a patient’s inability to remember the procedure or any attendant pain does not mean that the patient did not actually experience the pain. Id. at PagelD 30831-32.
Dr. Bergese next testified that movements) sometimes occur after a patient has been sedated. As a preliminary matter, Dr. Bergese testified that movements while under sedation mean that the anesthesiologist is “not doing a very good job,” in view of the fact that one of the three goals of anesthesia is immobility. Id. at PagelD 30834. While acknowledging a theoretical difference between movements that are reflexive and movements that might indicate some level of consciousness or awareness, Dr. Bergese testified that if a patient exhibited movement during surgery, he as the anesthesiologist would immediately give more anesthetic because as soon as the patient moves, consciousness is going to follow. Id. at PagelD 30835. Dr. Bergese noted that this is an example of *921 where a BIS monitor can be valuable because it would show whether a patient’s EEG is becoming more active, indicating a return to consciousness. Id. at PagelD 30836. Dr. Bergese appeared to agree on cross-examination that even if it would be difficult to draw any conclusions from reports of movements such as eye movements alone, when such movements happen frequently, “it makes me believe that that involuntary movement may have a lot to do with consciousness.” Id. at PagelD 30892.
Applying these principles to an execution context, Dr. Bergese agreed that it is very important with a three-drug protocol that the first drug works to render the inmate fully unaware, fully insensate, and unconscious. Id. at PagelD 30837. When asked why that is so important, Dr. Berg-ese answered, “[w]e know, for instance, rocuronium, [the] second drug[ ] that you are going to use, is painful on injection.” Id. at PagelD 30837-38. Dr. Bergese further testified that the pH of potassium chloride, the third drug in Ohio’s three-drug execution protocol, is caustic and would cause pain. Id. at PagelD 30838. He added “there are things that we don’t know,” such as whether the process of dying is something that might cause an inmate being executed react differently than a patient undergoing surgery. Id. at PagelD 30838. He also explained that it would never be medically acceptable to paralyze a fully conscious patient because it is absolutely terrifying not being able to move and being aware of not being able to move. Id. at PagelD 30840-41.
When asked whether, hypothetically, he could have offered any opinion three years ago about an execution protocol involving a mixture of 50 mg of hydromorphone and 50 mg of midazolam, Dr. Bergese answered that he would not have offered an opinion because there was no scientific or real-world data upon which to rely. Id. at PagelD 30842-44. By contrast, he testified that he was now in a position to offer opinions about Ohio’s three-drug execution protocol because “[n]ow we have real data that we cannot ignore,” referring to eyewitness accounts of midazolam-involved executions. Id. at PagelD 30844-45. He continued:
We just cannot ignore the people are gasping, the people are going 20 minutes, that people are going 40 minutes. It’s your responsibility as a citizen to act on this.
I was in Europe last time that I hear this. People talk to you like we are inhumane, that we are just having people 20 minutes, 30 minutes, 40 minutes. So clearly we are here today because we have a problem, and clearly we have to address this problem. So that’s why I accepted this time and say yes, I will do a report.
Id. at PagelD 30845. Dr. Bergese explained that for science to reach valid conclusions, it must consider “every single piece of data.” Id. at PagelD 30845. In this context, Dr. Bergese continued, while it is important to consider pharmacology, phar-macodynamics, and clinical data, “I think that the strongest data that you have is what happened in those executions.” Id. at PagelD 30846. Dr. Bergese explained during cross-examination that although it is important to consider every piece of available data, he respectfully did not place much stock in what findings any court might have made about something as complex as “consciousness.” Id. at PagelD 30894-95.
Dr. Bergese was asked about the recent executions to which he was referring, beginning with Alabama’s execution of Ron Smith. Testimony and evidence demonstrated that Smith was executed with a three-drug protocol that began with an IV *922 administration of 500 mg of midazolam, followed by a paralytic and then potassium chloride. Dr.- Bergese testified that he had reviewed news stories of eyewitness accounts, as well as a sworn declaration by Spencer Hahn. Id. at PagelD 30849. Dr; Bergese found significance in accounts that Smith appeared be speaking for several minutes after the injection of midazolam. Id. at PagelD 30850; Dr. Bergese explained:
I think it’s telling us that here we have something that is different, that we haven’t seen [with] other type of hypnotics. I do anesthesia every day, and when you put somebody else asleep—and I’m talking- about smaller doses, people just don’t talk. People just don’t do - those kind of things. So .here to me what- it’s signaling, what it’s telling me is that it’s a higher recruiting on the brain of consciousness for this person to be able to do this kind of thing, to be able to speak, to be able to think.
So it’s, very difficult. Like I said before, we work in a black box. We don’t know what happened in the middle. It’s no different than when we do general anesthesia. So sometimes it’s very difficult to get conclusions when you see a little movement in here, a little movement in there. You can argue either way. But, here, clearly, the state of consciousness of this patient is much, much higher than you will expect for somebody else to just move a muscle, who has a twitch.
Id. at PagelD 30849-50. Dr. Bergese continued that talking requires a significant amount of brain activity. Id. at PagelD 30850. Later, during cross-examination, Dr. Bergese agreed that although he was aware of one or two executions during which the inmate(s) purportedly spoke, he was aware that there have been quite a few: more executions during which the inmates did not speak. Id. at PagelD 30890. Dr. Bergese explained that the fact that midazolam has appeared to “work” for some people does not invalidate his opinion as to the inmates on whom it did not appear to work as expected with respect to depressing- those inmates’ level of awareness. Id. at PagelD 30896-97. When asked about the validity of an opinion based on one or two isolated incidents, Dr. Bergese explained that the unusual occurrences of people exhibiting any kind of movement or speaking validated his reaching an opinion based on the few cases in which inmates moved or spoke during their executions: “When [I] put a patient asleep, people don’t do those kinds of things..... and since we are not measuring electrical function of the brain [during executions], we just don’t know the answer. That’s my concern.” .Id. at PagelD 30898.
Later during cross-examination, Dr. Bergese agreed that it would be very difficult to conduct research on the effects of the dosage level of midazolam prescribed by Ohio’s current execution protocol because that dosage level far exceeds a clinical level. Id. at PagelD 30908-09. He also agreed that although data extrapolations about high dosages could “[g]o either way,” he maintained that “there is data,sufficient data [that] led me to believe that some of those inmates were conscious beyond what I expected with the dose.” Id. at PagelD 30909,
Continuing with the Smith execution, Dr. Bergese also found significance in accounts that five minutes after béing injected with midazolam, Smith was pinched on the back of the arm and yanked away from that pinch. Id. at PagelD 30851. Dr. Berg-ese explained that withdrawing from pain is a complex thing and that a person who is unconscious will not withdraw from pain. Id. at PagelD 30851. Dr. Bergese explained that there is a difference between involuntary movement and voluntary *923 movement, and that voluntary movement requires a much higher state of consciousness. Id. at PagelD 30851.
When asked about accounts that Smith lifted his head, looked around, and moved his arms, Dr. Bergese continued:
That is not normal by any means. I was thinking about this this morning when I put two patients asleep. And I counted and I never do and I counted this morning and 18, 20 seconds later it tells patients, they were gone. They did not move. They did not do anything else. So clearly the quantity of midazolam that was used is not working as my propofol that I used this morning. So is something quite different here. Those drugs are affecting consciousness in a different way. So that’s my conclusion.
Id. at PagelD 30852. Such purposeful movements such as the clenching and un-clenching of one’s fists, as opposed to perhaps the opening and closing of the eyes. requires a more active brain. Id. at Pa-gelD 30852. Dr. Bergese stated that, with a high degree of certainty, a person exhibiting such purposeful movements is- not insensate. Id. at PagelD 30852. And given that Smith was actually injected with a second dose of 500 mg of midazolam, Dr. Bergese stated again that “that’s where science goes wrong.... So clearly, again, I[’m] going to insist, my observation is that this drug is not working as we thought it would,” Id. at PagelD 30853.
Dr. Bergese was next asked about the January 16, 2014, execution of Dennis McGuire in Ohio. He testified that accounts that McGuire was opening and closing his fists after being injected with a mixture of 10 mg of midazolam and 40 mg of hydromorphone indicated “that the brain is working to the point that the inmate can do purposeful movement[s]” and that the inmate “[i]s not fully unconscious for sure.” Id. at PagelD 30855. With respect to accounts that after administration of the two-drug mixture, McGuire said “I love you” toward his children, Dr. Berg-ese testified that “speaking is even a more elaborate function.” Id. at PagelD 30855. He also offered that “[sjomebody else who [is] speak[ing] -will feel pain for sure.” Id. at PagelD 30855, That McGuire was injected with an opioid in addition to the midazolam did not change Dr. Bergese’s assessment as to the use of midazolam as it relates to consciousness as the first drug in a three-drug protocol. Id. at PagelD 30855-56. He reiterated that conclusion during cross-examination, testifying that although a lower dose of midazolam was used than that now prescribed by - Ohio’s execution protocol, Dr. Bergese would have expected the midazolam to have a “higher effect,” given the fact that opioids and midazolam have a synergistic effect. Id. at PagelD 30899. Dr. Bergese explained that what happened during the McGuire execution, followed by what happened during the Ronald Smith execution in Alabama, begins to establish a pattern showing that midazolam is not having the expected effect during executions. Id. at PagelD 30857. •
Dr. Bergese was asked about the execution of Clayton Lockett in Oklahoma. Referring first to the autopsy report, Dr. Bergese noted that there were 1400 nano-grams of midazolam per gram of tissue, “which is above and beyond what you need for general anesthetic, .for instance.” Id. at PagelD 30858. Asked to comment on evidence that following the injection of lethal injection drugs and - originally appearing unconscious, Lockett proceeded to speak, writhe, clinch his fists, and try to lift himself off the table, Dr. Bergese responded, that if Lockett’s brain was still active enough to perform those actions after administration of the drugs, then the drugs *924 were not having the intended effect. Id. at PagelD 30858.
Turning to the execution of Joseph Wood in Arizona, Dr. Bergese was asked about accounts that Wood was injected with a total of 750 mg of midazolam and 750 mg of hydromorphone over the course of two hours, but attempted to breathe and gasped over 640 times. Id. at PagelD 30859. Dr. Bergese stated:
I think it’s more or less what we were talking about. It’s a long period of time. Two hours is a long time. You don’t expect that hiatus. I mean, it is a long period. There [are] a lot of drugs that were given and still they are not doing what you think [they’re] supposed to do.
Id. at PagelD 30859. Dr. Bergese could not give a definitive answer as Wood’s state of consciousness during his lengthy execution. Id. at PagelD 30860. Similarly, he could not say whether the movements and breathing actions that Ohio inmate Dennis McGuire exhibited during his execution were incident to the act of dying or an indication that his brain still had some level of functioning. Id. at PagelD 30861.
Dr. Bergese was next asked about evidence from Florida executions indicating that following an injection of 500 mg of midazolam followed within a minute or two by an injection of a paralytic agent, certain inmates exhibited minimal movements such as eye opening. Id. at PagelD 30862. Dr. Bergese appeared to question the application of the paralytic so quickly, noting the importance of being very sure that the inmate was insensate and unconscious before receiving the paralytic. Id. at PagelD 30862-63. During cross-examination, Dr. Bergese did not dispute that as of April 15, 2015, Florida had conducted a total of eleven lethal injection executions using 500 mg of midazolam as the first drug in a three-drug protocol. Id. at PagelD 30886-87. Dr. Bergese acknowledged that he considered how quickly the paralytic agent follows the administration of the midazolam in Florida, and the manner in which Florida immobilizes inmates’ hands during executions in forming his opinion, to the extent that he did, about the Florida midazolam-in-volved executions. Id. at PagelD 30887.
Dr. Bergese continued that an immediate injection of the paralytic would mask movements such as were witnessed in the McGuire (Ohio), Wood (Arizona), and Lockett (Oklahoma) executions, but would not guarantee that the inmate was unconsciousness and insensate. Id. at PagelD 30863. A person fully paralyzed and fully conscious, would experience considerable terror. Id. at PagelD 30863. Dr. Bergese continued that nothing about consciousness should be gleaned from the absence of movements during executions in which the paralytic drug was injected very quickly after the first drug. Id. at PagelD 30863-64.
Dr. Bergese testified that what occurred during the four executions he was asked about indicate to him- that for whatever reason, midazolam “is not doing what you thought it would.” 19 Id. at PageJD 30864. Dr. Bergese “absolutely” agreed,'to a reasonable degree of medical certainty, that *925 Plaintiffs Tibbetts, Phillips, and Otte would be subjected to a substantial risk of experiencing the pain and suffering of an execution is they were executed using Ohio’s current protocol. Id. at PagelD 30865.
Dr. Bergese agreed on cross-examination, however, that he was not testifying that there were no circumstances under which the dosage of midazolam set forth in Ohio’s current execution protocol could render an inmate sufficiently sedated to not be aware of the noxious stimuli of the second and third drugs. Id. at PagelD 30873. Dr. Bergese also agreed on cross-examination that if midazolam administered during an execution does not appear to have the effect desired it could be because the midazolam was not properly administered. (Id. at PagelD 30874. Dr. Bergese stated that he is 100 percent certain that the dosage level of midazolam called for in Ohio’s execution protocol will not render the inmate insensate to the noxious stimuli of the second and third drugs in the protocol. 20 Id. at PagelD 30875.
Dr. Bergese next testified about conclusions he set forth in a Supplemental Expert Declaration—specifically with respect to the six different types of “consciousness checks” that could be used during executions under Ohio’s current protocol. (EOF No. 897-1). Dr. Bergese explained:
So the problem with this kind of quote-unquote consciousness check is that they are not truly consciousness check. All you doing is... checking a reflex or ... checking pain. So if I touch your eye, all I am doing is ... monitoring the trige-minal nerve and the facial manner and seefing] their response.
If I pinch you and you move your arm, all I know is you are withdrawing [from] pain but that doesn’t talk about consciousness.
So as general rule, if you do not have consciousness, you are not going to have reflex. But the opposite is not true. You can have no reflex and be fully conscious, as we talkfed about] in the beginning of my declaration when I said, well, people who’[re] undergoing surgery sometimes do remember but don’t have reflex.
So, again, did we use that in anesthesia? Sure, we used that, but it is very rudimentary way to measure consciousness. That’s why now we use EEG-based technology because you truly see what the brain is doing and that is not even 100 percent full [sic] proof. But, still, this is very rudimentary, number one.
Id. at PagelD 30866-67. Dr. Bergese further testified that it matters who is performing a consciousness check, such that a neurologist or other similarly trained professional would be better capable of interpreting what any movements might mean. Id. at PagelD 30867. Dr. Bergese agreed that although a response would indicate consciousness, a lack of response does not *926 indicate a lack of consciousness. Id. at PagelD 30868.
Dr. Bergese strenuously denied cross-examination suggestions that he considered only data that supported his opinions, and did not consider data inconsistent with his opinions. Id. at PagelD 30888-89, 30907-08. Dr. Bergese denied that he is opposed to capital punishment as a matter of public policy. Id. at PagelD 30904-05.
Joseph Antognini, M.D.
Defendants’ first expert witness, Dr. Joseph Antognini, testified that he attended the University of Southern California, and performed his residency in anesthesiology at the University of California, Davis (“UCDavis”). (Evid. Hrg. Tr., ECF No. 924, PagelD 31020.) After being in private practice for five years assisting in a variety of surgical procedures, Dr. Antognini joined the faculty at UCDavis where he performed clinical work, conducted research, and taught medical students and residents. Id. at PagelD 31020-21. He has been retired from the' active practice of anesthesiology for approximately one year and now volunteers as a clinical professor. M at PagelD 31101.
In his clinical research, Dr. Antognini focused on the how anesthetics produced immobility, with a further concentration on the relationship between anesthesia and autonomic responses such as an increase in heart rate or blood pressure upon application of noxious stimulation. Id. at PagelD 31022. He testified that in his work, he sought to determine where in the subject’s body the anesthetics were producing their effects to result in immobility. Id. at Pa-gelD 31022-23. He acknowledged that most of his research in that area was performed using animal models. Id. at Pa-gelD 31023. His research did not include studying the consciousness of the animals, nor did he study the effects of midazolam or other benzodiazepines. Id. at PagelD 31102-3, 31033.
In addition to his clinical work and teaching duties, Dr. Antognini’s curriculum vitae lists over 160 articles in professional journals, 127 of which were peer reviewed; case reviews; and chapters in books he has authored. (Curriculum Vitae of Joseph F. Antognini, M.D.; DX 4, ECF No. 924, PagelD 31020-33, 31102.) In addition, he has reviewed other authors’ papers and served as an associate editor for the journal “Anesthesiology.” Id. at PagelD 31024. He has recently retired from teaching at UCDavis and from the active practice of anesthesiology. Id. at PagelD 31026, 31150. He was permitted by the Court to testify as an expert witness without objection from Plaintiffs. Id. at PagelD 31026.
Dr. Antognini identified three essential goals of anesthesia: amnesia, unconsciousness, and immobility. Id. at PagelD 31026-27. To illustrate the order in which the three goals are reached when anesthesia is administered, Dr. Antognini drew a graph 21 showing that first the anesthetic affects memory, thus the amnesia goal is achieved; then consciousness, achieving the second goal; and finally movement, completing the third goal of immobility. Id. at PagelD 31029-30. He made it clear, however, that when referring to “movement,” it was gross purposeful movement he was talking about, not a simple withdrawal reflex from noxious stimulus. 22 Id. *927 at PagelD 31031-32. He acknowledged that there is. an element of arbitrariness in interpreting movements by a patient or subject of a study; where some practitioners or researchers will interpret reflexive movements as indicative of consciousness, others will not. Id. at PagelD 31032. Although Dr. Antognini stated that he has not performed any studies of midazolam or on anesthesia as it relates to memory or consciousness, he acknowledged that memory and consciousness are more sensitive to anesthetics than mobility. Id. at PageID 31028, 31134.
Dr. Antognini. testified that anesthesia acts on the spinal cord to .achieve immobility. Id. at PagelD 31133, 31138. It is not uncommon for patients to move during surgery, even though they are unconscious. Id. at PagelD 31027-28. He noted that even brain-dead humans have demonstrated spontaneous movement or movement in response to noxious stimuli by sitting up in bed, crossing their arms over their chest, or turning their head, which is referred to as the Lazárus Phenomenon. 23 Id. at PagelD 31035. He himself has witnessed some such movements in his' work as an anesthesiologist assisting in harvesting organs from individuals declared brain dead. Id. at PagelD 31036. In such circumstances, he observed the individual’s blood pressure or heart rate increase, and such occurrences have been reported in the literature as well. Id.
Contrary to Dr. Bergese’s testimony, Dr. Antognini denied that complex physical movements are always indicative of consciousness. Id. Referring to his graph, he explained that consciousness is affectéd by anesthesia before gross purposeful movement is, and therefore an unconscious individual can exhibit complex movements while unconscious. Id. at PagelD 31037. In fact, in the surgical context, patients can move their arms around, attempt to sit up, cough, and move quite violently when an incision is made even though they are unconscious. Id. Dr.' Antognini appeared to qualify that statement somewhat, however, by immediately stating that it is difficult to achieve the correct level of anesthetization, and that sometimes misjudgment of the amount necessary for a particular patient does happen. Id. When asked how such complex movements are possible from an anesthetized patient, Dr. Antognini responded that
I believe, again, based on the work that I’ve done and also the work that’s documented, complex neurocircuitry in the spinal cord and brain stem ... lead me to believe, and I think others, that the complex movements occur because of the—or the circuitry is there to generate those movements. So just because the patients are unconscious does not mean that they cannot move in a complex way.
Id. at PageID 31038. Dr. Antognini gave a further example of his point describing “the frog wiping reflex,” in which a frog will use his back leg to wipe away a noxious stimulus applied to his front leg even after the connection between the brain and spinal cord has been surgically severed. Id. at PageID 31038-39.
In surgery Dr. Antognini would expect to see a variety of movements from the patients. Id. at PagelD 31043. There could be violent thrashing about or “bucking,” vigorous coughing, or movement of the arms and legs, and that is one of the reasons patients are strapped down during operations. Id. at PagelD 31043-44. In addition, patients’ eyes can remain open *928 during surgery and dry out, which is why the eyes are almost always taped closed during surgery. Id. at PagelD 31044. Movement during surgery can indicate the return of consciousness, the emergence from the anesthesia. Id. at PagelD 31160. Dr. Antognini’s first response to such movement would be to administer additional anesthetic. Id.
Other responses would vary according to the circumstances of each case. Id. at Pa-gelD 31159. He might administer an opiate, an analgesic, or a muscle relaxant, depending upon whether the patient has suffered trauma, and if so the extent of the trauma, and the status of the patient’s blood pressure. Id. at PagelD 31159-60. The anesthesiologist must be cognizant of the risks presented by each of those options. Sometimes giving the patient a muscle relaxant is preferred because even though the patient may be moving, he or she may be sufficiently anesthetized to prevent the formation of memories and remain unconscious. Id. at PagelD 31159.
Dr. Antognini was asked to explain the difference between a noxious stimulus and pain. In responding, he testified that a stimulus threatens to or causes damage to normal tissue whereas pain is “the conscious awareness or that unpleasant sensory and emotional experience associated with that noxious stimulation.” Id. at Pa-gelD 31040. For instance, if one were struck in the knee with a hammer, he would experience pain, he would have a painful experience following the application of the noxious stimulus of the hammer. Id. But if one were anesthetized and a procedure equally as painful as a hammer strike to the knee were performed, upon awaking the patient would report having felt no pain. Id. at PagelD 31041. In other words, Dr. Antognini believes any discussion of the experience of pain should be restricted to those individuals who are awake and conscious. Id. There is, however, no generally accepted objective measurement of pain. Id. at PagelD 31098.
In determining the proper dosage of inhaled anesthetic for a particular patient, anesthesiologists are guided by the minimal alveolar concentration (MAC), which is the dose at which fifty percent of the population would display gross purposeful movement and fifty percent would not. Id. at PagelD 31041. Of course, that; dose varies with the degree of pain the procedure would be expected to inflict on a conscious person. Id. at PagelD 31042. Obviously, the greater the noxious stimulus, the greater the need for more of or a stronger anesthetic, and a patient in poorer condition may not be able to receive the dose that might be given to a healthier or younger individual. Id. at PagelD 31043.
Dr. Antognini’s attention was directed to a figure in Miller’s Anesthesia that duplicates, for the most part, the information on the graph he drew in Court and which appears in his declaration, which attempts to explain in what order anesthesia affects amnesia, unconsciousness, and gross purposeful movement. (Plaintiffs’ Expert Exhibit 9, Bates No. 1079; ECF 852-1, PageID 25790.) Dr. Antognini testified that although the graph relates to inhaled anesthetics, it is a conceptual drawing and therefore it has application to intravenous anesthetics as well. (ECF No. 924, PagelD 31128.) He recognized that the three separate trajectories for amnesia, unconsciousness, and gross purposeful movement might very well appear different in relation to each other in a graph dedicated to intravenous anesthetics rather than the one for inhaled anesthetics. Id. at PagelD 31128. The paucity of data on intravenous anesthetics’ effect on memory, consciousness, and mobility is a result of the relative ease of conducting studies and measuring the results of inhaled anesthetics. Id. at *929 PagelD 31135. Rather than having to perform analyses on the concentration of the anesthetic in blood, the concentrations can be measured in exhalations from the lungs when inhaled anesthetics are studied. Id. Thus, there is no data from which to reliably conclude that the graph diagraming inhaled anesthetics’ actions on memory, consciousness, and mobility is illustrative of the actions of injected anesthetics. Id. at PagelD 31135-36.
Dr. Antognini testified that he is familiar with the benzodiazepine midazolam and described it as a short- and fast-acting drug used in his specialty for sedation in therapeutic doses. Id. at PagelD 31045. As one might expect, dosage depends on the individual characteristics of the patient and the purpose for which the drug is being used. Id. The primary purpose of administering midazolam prior to surgery is to relieve anxiety and produce some level of sedation, but it is also used during procedures such as colonoscopies, and as a beginning of the process of putting a patient under anesthesia. Id. at PagelD 31045-46. For a colonoscopy, for instance, Dr. Antog-nini might give one to five milligrams of midazolam to the patient with elderly patients generally receiving the lower dose and younger patients receiving a larger dose. Id. at PagelD 31046. Beginning the process of anesthetization is called the “induction of anesthesia” and requires more of the drug than in the colonoscopy scenario. Id. at PagelD 31047 Midazolam takes effect within one to two minutes in almost everyone. Id. at PagelD 31048.
One of midazolam’s most potent effects is to prevent the formation of memories, satisfying the first goal of anesthesia, amnesia. Id. While some drugs that cause amnesia can ablate memories formed prior to the administration of the drug, midazo-lam cannot. In that regard, midazolam causes anterograde amnesia rather than a retrograde amnesia. Id.
Midazolam can also cause unconsciousness and can, among other similar drugs, play a part in the induction of anesthesia, as noted above. Id. at PagelD 31049. Mi-dazolam may be used during the intubation procedure, which is a very “stimulating” procedure, meaning that it is extremely uncomfortable if performed without an anesthetic, but other drugs such as thiopen-tal, propofol, etomidate, or ketamine, are preferred. Id. at PagelD 31049-50. Other procedures in which midazolam may be used are endotracheal intubations, various endoscopies, cardioversions, and induction for Cesarean sections. Id. at PagelD 31052.
Pertinent to Cesarean sections, Dr. An-tognini cited a study which compared the effects of midazolam to thiopental during those procedures. Id. at PagelD 31120, citing Michael Crawford, et al., A Randomized Comparison Between Midazolam and Thiopental for Elective Cesarean Section Anesthesia, DX. 76 at 1130-34. He recalled that the study concluded the two drugs were “essentially equivalent” in terms of the effects of the drugs on blood pressure, etc. Id. at PagelD 31056. That study, however, and by Dr. Antognini’s own admission, did not consider any analgesic or anesthetizing effects of midazolam or thiopental, and he did not state in his testimony what those effects were, 24 only that whatever effects were observed were equivalent or nearly so. Id. Dr. Antognini *930 pointed out that during the first minute or so of the Cesarean sections given the women-in the study, of those who received midazolam, it was the only anesthetic they received, although they did receive a muscle relaxant to facilitate intubation as well. Id. at PagelD 31056, 31127. Again, however, the focus of the study was on the drugs’ effect on blood pressure, heart rate, etc., not on the anesthetic effect of either drug.
In a cardioversion, an electrical shock is .administered to the patient to normalize the heart rhythms. , During the procedure, the patient is sedated, not anesthetized. Id. at PagelD 31151. Dr. Antognini questioned whether the patient actually feels the pain and emotional aspects that go along with that sensation when a noxious stimulus such as the electric shock is applied and the patient.wakes up without any memory of the stimulating event. Id. at PagelD 31152. Many times, the electrical stimulation will awaken the patient from sedation, but if he or she were under general anesthesia; which is to say unarousable, the stimulation would not wake them up. Id. at PagelD 31155, 31157. Beyond general anesthesia is coma which is a level of consciousness Dr. Antognini would not want to induce in a normal person using anesthesia. Id. at PageID 31156.
Dr. Antognini identified some of the signs a patient emerging from general anesthesia may exhibit: swallowing, gagging, coughing, grimacing, defensive postfiring,' and the return of muscle tone. Id. at Pa-gelD 31157-58. Continued emergence may produce eye opening, response to verbal commands, and patterns on the electroencephalogram indicating waking. Id. at Pa-gelD 31158. On redirect examination, Dr. Antognini denied that these movements and responses are always indicative of emergence, however. Id. at PagelD 31178. He. explained that the patient may be shifting from a deeper level of anesthesia to a lighter level, id. at PagelD 31178. In an attempt to clarify the distinction between that expression and the word “emergence,” Dr. Antognini explained that a person exhibiting the signs mentioned above is not as deep in terms of their brain depression. Id. at PagelD 31179. 25
It is not clinically warranted to administer a massive dose of midazolam to determine whether it is suitable to be the sole dru

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/7242161. Public record. Not legal advice.
