Citations
- 235 F. Supp. 3d 892
Full 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 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). Complying with the same Order, they each filed Motions for Preliminary Injunction and concomitant stays of execution' in November (ECF Nos. 714, 715, 718).
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 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 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 not- be successful here. Based particularly on the testimony of Ohio Department of Rehabilitation and Corrections (“ODRC”) Director- Gary Mohr, 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.
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)).
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 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.
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 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), 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 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.
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, followed by a second dose of the same size if the inmate 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.).
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:
[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 evidence 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 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 body, 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 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).
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 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.” 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. 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 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). 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 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 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 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 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 di