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IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE: OHIO EXECUTION PROTOCOL LITIGATION ) ) ) ) ) ) ) ) Case No. 2:11-cv-1016 JUDGE GREGORY L. FROST Magistrate Judge Mark R. Abel Death penalty case: Execution scheduled for March 19, 2014

This document relates to: PLAINTIFF GREGORY LOTT

PLAINTIFF GREGORY LOTTS MOTION FOR A TEMPORARY RESTRAINING ORDER AND/OR PRELIMINARY INJUNCTION

Plaintiff Gregory Lott, having filed his Complaint in the above-captioned case, submits this motion, pursuant to Federal Rule of Civil Procedure 65(a) and (b), for a temporary restraining order (TRO), a preliminary injunction and a stay of execution. Mr. Lott seeks injunctive relief barring Defendants, and each of them and/or their agents, from acting jointly or severally to execute him on March 19, 2014, by means that will deprive him of his rights in violation of the Eighth and Fourteenth Amendments to the United States Constitution and 42 U.S.C. 1983. In light of the scheduled execution date, a temporary restraining order and a preliminary injunction are necessary to allow Lott to litigate his claims before he is unconstitutionally executed. Lott requests expedited discovery, oral argument and an evidentiary hearing with post-hearing briefing as the Court deems necessary on his motion. The reasons supporting this request are explained in the attached memorandum in support.

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Respectfully submitted this 3rd day of February, 2014. FEDERAL DEFENDER SERVICES OF EASTERN TENNESSEE, INC. BY: /s/Stephen A. Ferrell Stephen A. Ferrell (Ohio Reg. No. 0061707) Assistant Federal Community Defender Email: Stephen_Ferrell@fd.org Trial Attorney and Counsel for Plaintiff Gregory Lott /s/Stephen M. Kissinger (Pro Hac Vice) Stephen M. Kissinger (WY Bar No. 5-2342) Assistant Federal Community Defender Email: Stephen_Kissinger@fd.org Co-counsel for Plaintiff Gregory Lott /s/Dana C. Hansen Chavis (Pro Hac Vice Pending) Dana C. Hansen Chavis (TN Bar No. 019098) Email: Dana_Hansen@fd.org Co-counsel for Plaintiff Gregory Lott Federal Defender Services of Eastern Tennessee, Inc. 800 S. Gay Street, Suite 2400 Knoxville, TN 37929 Phone: (865) 637-7979 Fax: (865) 637-7999

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MEMORANDUM IN SUPPORT

Table of Contents I. Summary of the Argument.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {1} A. Timing of the instant request. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {1} B. The merits of the instant request. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {4} Injunctive Relief.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {8} Lott is entitled to a temporary restraining order and/or a preliminary injunction staying his execution until such time as the merits of the claims raised in his individual complaint are adjudicated. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {9} A. There is a substantial likelihood that Lott will prevail on the merits of each claim raised in the Eighth Cause of Action in his individual complaint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {9} 1. Plan A-1 violates the Eighth and Fourteenth Amendments even when administered without error or deviation. (Eighth Cause of Action, A.). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {9} a. There is a substantial risk that, if Lott is executed under Plan A-1, he will not die for 45 minutes after he has been injected with 5 grams of pentobarbital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {9} b. Death occurring as much as 45 minutes or more after the administration of lethal injection drugs is lingering and thus prohibited by the Eighth Amendment. . . . . . . . . . . . . . . . . . . . . . . . . . . . {12} c. The disgrace inherent in Defendants handling of Lott as if he were dead, while he is still alive, violates the Eighth Amendment.. . . . . . . . . . . . {14} d. Because Lotts sentence will be satisfied upon Defendant Wardens pronouncement of his death, yet Lott will remain alive, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment. . . . . . . . . . . . . . . . . . . {15} 2. Plan A-2 violates the Eighth and Fourteenth Amendments even when administered without error or deviation. (Eighth Cause of Action, B.).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {17} a. Plan A-2 creates a substantial risk that Lott will experience unnecessary pain and suffering. . . . {17}

II. III.

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3.

4.

There is a substantial risk that, if Lott is executed under Plan A-2, he will not die for 45 minutes after he has been injected with 10 mg of midazolam and 40 mg of hydromorphone.. . . . . . . . . . . . . . . . . {22} c. Death occurring as much as 45 minutes or more after the injection of 10 mg of midazolam and 40 mg of hydromorphone is lingering and thus prohibited by the Eighth Amendment. . . . . . . . {23} d. The disgrace inherent in Defendants handling of Lott as if he were dead, while he is still alive, violates the Eighth Amendment.. . . . . . . . . . . . {23} e. Because Lotts sentence will be satisfied upon Defendant Wardens pronouncement of death, yet Lott will remain alive, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment. . . . . . . . . . . . . . . . . . . {23} Plan B violates the Eighth and Fourteenth Amendments even when administered without error or deviation. (Eighth Cause of Action, C.). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {23} a. Plan B creates a substantial risk that Lott will experience unnecessary pain and suffering. . . . {23} b. There is a substantial risk that, if Lott is executed under Plan B, he will not die for 45 minutes after he has been injected with 10 mg of midazolam and 40 mg of hydromorphone. . . . . . . . . . . . . . . . . . . . {24} c. Death occurring over as much as 45 minutes or more after the injection of 10 mg of midazolam and 40 mg of hydromorphone is lingering and thus prohibited by the Eighth Amendment. . . . . . . . {24} d. The disgrace inherent in Defendants handling of Lott as if he were dead, while he is still alive, violates the Eighth Amendment.. . . . . . . . . . . . {25} e. Because Lotts sentence will be satisfied upon Defendant Wardens pronouncement of Lotts death, yet Lott will remain alive, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment.. . . . . . . . . . . . {25} To the extent Lott is required to demonstrate the existence of a feasible readily-implemented alternative to Ohios 2013 Execution Protocol that significantly reduces that protocols substantial risk of unnecessary pain, a lingering death, gratuitous disgrace, and denial of necessary medical care, such alternatives exist.. . . . . {25}

b.

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B.

There is a substantial likelihood that Lott will demonstrate that Defendants use of compounded drugs to carry out his execution as set forth in the Ninth Cause of Action in his individual complaint will violate the Eighth and Fourteenth Amendments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {27} There is a substantial likelihood that Lott will demonstrate that Ohios Protocol requires Defendants to violate federal and state law and that he is entitled to an injunction requiring Defendants to abide by federal and state drug laws during any attempt to execute Plaintiff such violations. (Lotts Tenth Cause of Action) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {31} 1. Lott can already demonstrate violations of state and federal law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {31} 2. There exists a substantial likelihood Lott will be able to demonstrate further violations of state and federal law should a stay be entered and he be permitted full discovery. . . . . . . . . . {32} Lott will suffer irreparable injury absent a stay of execution.. . . . . . . . . . . . . . {34} The risk that Lott will suffer a cruel and unusual death outweighs Defendants interest in carrying out his sentence on March 19, 2014. . . . . . . . . . . . . . . . . . {34} The public interest weighs in favor of a stay of execution. . . . . . . . . . . . . . . . {35}

C.

D. E.

F. IV.

Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {36}

CERTIFICATE OF SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {37}

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INDEX OF ATTACHMENTS Attachment A B C D E F G H I J Description Dr. Sasich Declaration dated Jan. 31, 2014 Response to Phillips Request for Admissions Response to Phillips Request for Production of Documents Harbison v. Little, No. 3:06-cv-1206 (M.D. Tenn.) Tennessee Lethal Injection Protocol Committee Minutes, Apr. 9, 2007 Mitts time line Brooks time line FDA Inspection Report for Clinical Apothecaries, dated Nov. 20, 2013 FDA Inspection Report for RC Compounding Services, LLC, dated Feb. 7, 2013 Ohio State Board of Pharmacy Minutes, May 7-9, 2007 Compounding in Ohio, Ohio State Board of Pharmacy, Rev. Dec. 2013

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I.

Summary of the Argument The Supreme Court has stated unambiguously that it is unconstitutional to execute a

condemned prisoner when there is a substantial risk that he will be aware while suffocating to death under an execution protocol. Baze v. Rees, 553 U.S. 35, 53 (2008). It is also unconstitutional to employ a method of execution that unnecessarily produces a lingering death, In re Kemmler, 136 U.S. 436, 447 (1890), humiliation or disgrace. Wilkerson v. Utah, 99 U.S. 130, 134-35 (1879). Lott has set forth facts in his supplemental individual complaint (Doc. No. 402), and within this motion, demonstrating that Ohios 2013 Execution Protocol violates these principles. He has demonstrated a likelihood that his execution presents a substantial risk of unnecessary pain, lingering death, humiliation and disgrace. He has further demonstrated that Defendants use of compounded drugs and further acts, in contravention of federal and state drug laws, will unnecessarily increase the risk of such harm. Thus, Lott is likely to prevail on the merits and he should be afforded the opportunity to litigate his claims before he is executed. He therefore requests this Court to grant injunctive relief preventing Defendants from executing him under Ohios Execution Protocol on March 19, 2014. A. Timing of the instant request

Plaintiff Lott filed his complaint on January 23, 2014, and requested that Defendants be required to expedite the answer to the complaint. (Doc. No. 402, PageID# 11977). On January 27, 2014, Defendants notified Lott and this Court that there is currently an investigation into Dennis McGuires execution because things occurred that hadnt before. (See Doc. No. 405). Defendants represented they had no knowledge of the substance of the investigation and did not know if it would be completed before the week of February 10, 2014. Defendants, however, {1}

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stated they would inform Lott 30 days before his execution date about whether changes would be made to Ohios lethal injection protocol for his execution. Although 30 days notice may be sufficient in other contexts, here, it fails to satisfy due process because the impending execution date establishes a strict time limitation, and if Lott were to wait to file this motion, it would deny him a meaningful opportunity to be heard. See Boddie v. Connecticut, 401 U.S. 371, 379-80 (1971) ([A] generally valid notice procedure may fail to satisfy due process because of the circumstances of the defendant[.]). The reasonableness of any notice procedure must be considered in the light of the circumstances of each particular case. Palmer v. Columbia Gas of Ohio, Inc., 479 F.2d 153, 167 (6th Cir. 1973), holding on other grounds modified by, Turner v. Impala Motors, 503 F.2d 607 (6th Cir. 1974). Because Lott faces an execution date of March 19, 2014, every day that passes awaiting Defendants announcement is a day denied Lott for a full and fair hearing on this motion. The Supreme Court has made clear that Due Process is of fundamental importance, especially when a persons life is at stake. Early in our jurisprudence, this Court voiced the doctrine that (w)herever one is assailed in his person or his property, there he may defend, Windsor v. McVeigh, 93 U.S. 274, 277 (1876). See Balhuin v. Hale, 1 Wall. 223 (1864); Hovey v. Elliott, 167 U.S. 409 (1897). The theme that due process of law signifies a right to be heard in ones defence, Hovey v. Elliott, supra, 417, has continually recurred in the years since Baldwin, Windsor, and Hovey. Although (m)any controversies have raged about the cryptic and abstract words of the Due Process Clause, as Mr. Justice Jackson wrote for the Court in Mullane v. Central Hanover Bank & Trust Co., 339 U.S. 306 (1950), there can be no doubt that at a minimum they require that deprivation of life, liberty or property by adjudication be preceded by notice and opportunity for hearing appropriate to the nature of the case. Id., at 313.

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Boddie, 401 U.S. at 377-78 (footnote omitted). See also Logan v. Zimmerman Brush Co., 455 U.S. 422, 429 (1982) (the Due Process Clauses of the Fifth and Fourteenth Amendments protect civil litigants seeking recourse in the courts). In Logan, 455 U.S. at 432-34, the Supreme Court made clear that minimum procedural requirements are a matter of federal law and cannot be diminished by acts of the State that would deprive an aggrieved party the opportunity to present his case and have its merits fully judged. Logan involved an employment discrimination suit that was dismissed after a state hearing board scheduled a hearing outside of the time period permitted under state law. Id. at 426-28. The Court held it was an impermissible due process violation for: the state system itself [to] destroy[] a complainants [fundamental] interest, by operation of law, whenever the Commission fails to convene a timely conference--whether the Commissions action is taken through negligence, maliciousness, or otherwise. Id. at 436. Thus, the Court reiterated that the Fourteenth Amendment requires an opportunity to be heard that is granted at a meaningful time and in a meaningful manner. Id. at 437 (citation omitted). In this case, Defendants state there is an investigation into McGuires execution which may or may not be complete 30 days before Lotts scheduled execution date. Thirty days before March 19, say Defendants, they will give Lott notice about how they intend to execute him. Defendants investigation is laudable. However, Defendants actions should not place Lott and this Court in limbo and reduce the remaining amount of time Lott has; the effect of which will be that he cannot fully present his case for injunctive relief. Due process principles dictate that

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Lotts fundamental interest in his life and the right not be executed in a cruel and unusual manner entitle him to a fair opportunity to present his case and have its merits fully judged. Any decision by Defendants regarding the lethal injection protocol they intend to use on Lott will not materially change the circumstances of this case. By law, he remains subject to death by lethal injection alone. Ohio Rev. Code 2949.22(A) (a death sentence shall be executed by causing the application to the person, upon whom the sentence was imposed, of a lethal injection of a drug or combination of drugs of sufficient dosage to quickly and painlessly cause death.). Lott has challenged the 2013 Execution Protocol on the following bases: (a) it causes a lingering death; (b) it imposes gratuitous disgrace; (c) there is a substantial risk Lott will suffer the horror of death by suffocation; (d) the use of compounded drugs increases the risk of harm; and, (e) it requires Defendants to violate federal and state laws and thus deprives Lott protection under those laws that all other persons receive. Should Defendants decide to change dosages or switch to a different controlled substance or substances, the majority, if not all, of his challenges remain the same. Though the name of the drug may change, Lott has a good faith basis to believe that the constitutional infirmities in the 2013 Execution Protocol will not change. Accordingly, the instant motion for preliminary injunctive relief should be heard at this time. B. The merits of the instant request

In order to prevail on a 1983 claim, Plaintiff must show that, while acting under color of state law, Defendants deprived or will deprive him of a right secured by the Federal Constitution or laws of the United States. Alkire v. Irving, 330 F.3d 802, 813 (6th Cir. 2003). Prior to the execution of Dennis McGuire, there was a dispute over what would happen when a human being was injected with midazolam and hydromorphone in the manner required {4}

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under Ohios never-before-used Execution Protocol, Plan A-2. Plan A-2 has been seriously called into question by the disturbing events which occurred during McGuires execution and demonstrates the likelihood that Lott could ultimately succeed on the merits of his 1983 claim and the likelihood that, if injunctive relief is not granted, Lott will be harmed irreparably. See Reynolds v. Strickland, 583 F.3d 956, 957-58 (6th Cir. 2009) (Cole, J., concurring). McGuire died in the manner that his expert, Dr. David Waisel, said he would die save for two distinctions. The pain McGuire suffered was far more prolonged than anticipated by Dr. Waisel, and McGuires execution produced the degrading and lingering death prohibited by the Eighth Amendment, even in the absence of unnecessary pain and suffering. Prior to the execution, Dr. Waisel testified that Plan A-2 would not anesthetize McGuire to the sensation of suffocation or air hunger. (Testimony of Dr. Waisel, Transcript of Motion Hearing, Jan. 10, 2014, Vol. 1, pp. 31-32, 34-35, 54-55, 74). The details of McGuires execution have not yet fully emerged but it is known that he physically reacted to the execution drugs for up to 15 minutes. Dr. Waisel recently stated, I told them this would happen. Doctor Angry Ohio Executed Inmate Despite Horror Warning, The Guardian (Jan. 20, 2014)).1 He said, I told them that he [McGuire] was going to suffer the horror of suffocation for five minutes in fact, it appears to have been much longer than that. (Id., p. 3). McGuires execution, and what occurred during that 25-minute-time-span, showed the world what happens under Ohios experimental Execution Protocol, Plan A-2.

http://www.theguardian.com/world/2014/jan/20/doctor-angry-ohio-executed-inmate-usin g-untried-untested-procedure-dennis-mcguire. {5}

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In considering the instant motion for injunctive relief, the Court will balance both the likelihood that Lott will prevail on the merits and the likelihood that, if no stay is granted, irreparable harm will occur. In Reynolds, the Court of Appeals addressed injunctive relief for a condemned Ohio inmate after the botched execution of Romell Broom. The concurring opinion remarked, where allowing the process to run its course could result in the severest of consequences, it is more prudent to allow the district court to take these new circumstances into consideration. Reynolds, 538 F.3d at 958 (Cole, J., concurring). The new circumstances surrounding McGuires execution demonstrate a substantial likelihood that Lott can demonstrate that Plan A-2, poses a substantial risk (currently 100%) that he will experience unnecessary pain and suffering. There is a substantial risk of lingering death, of degradation, and of unnecessary pain and suffering under all three methods contained in the 2013 Execution Protocol. For over a century, the Eighth and Fourteenth Amendments have prohibited a method of execution that results in a substantial risk of a lingering death. In re Kemmler, 136 U.S. at 447. Dr. Mark Dershwitz, has testified that execution protocols which effectuate death through suffocation, such as Ohios 2013 Execution Protocol, the condemned prisoner would exhibit a normal ECG for 30 minutes, 45 minutes, or even longer. (Harbison v. Little, No. 3:06-cv-1206 (M.D. Tenn.) Deposition of Dr. Dershwitz, Doc. No. 104-1, PageID# 2828). For an even longer period of our history, the Constitution has prohibited the government from disgracing a prisoner as punishment, Wilkerson v. Utah, 99 U.S. at 134-35 (1879), and for over a half-century such disgrace has included denying their humanity. Trop v. Dulles, 356 U.S. 86, 103-04 (1958). Ohios 2013 Execution Protocol, however, specifies that an inmate be treated as dead as soon as ten minutes after the injection of {6}

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the execution drugs, and at a time where there exists a substantial risk that the inmates heart continues to display a normal ECG. For almost four decades, the Eighth and Fourteenth Amendments have required the States to provide necessary medical care to prisoners in serious need. Estelle v. Gamble, 429 U.S. 97, 104-05 (1976). Defendants know or should have known that they could revive inmates after they are declared dead under the 2013 Execution Protocol (thus fulfilling their capital sentence) but Defendants have failed to provide for such necessary care. Because the law is clear and the facts are established, there is a substantial likelihood that Lott will prevail on these claims. There is a substantial likelihood that Lott can demonstrate further grounds entitling him to relief. Lott has shown the substantial, statistical risk that any pharmacy from which Defendants obtain compounded drugs for use in carrying out Lotts execution under Plan A-1, will compound those drugs from Active Pharmaceutical Ingredients (APIs) which are contaminated, impure, adulterated, or otherwise pose a substantial risk to Lott, and/or that the pharmacy itself is incapable of compounding drugs that will not pose a substantial risk of unnecessary pain to Lott. (Attachment A, Dr. Sasich Declaration, pp. 3-5). Lott should be granted preliminary injunctive relief so that he may conduct discovery and supplant this statistical evidence with direct evidence that the actual API used to compound the drugs for Lotts execution, and/or the actual pharmacy in which those drugs will be compounded, create a substantial risk that Lott will experience unnecessary pain and suffering during his execution. Defendants have already admitted that they obtain the controlled substances they will use to carry out Lotts execution without a prescription, a violation of federal drug laws. (Attachment B, Response to Phillips Request for Admissions #13, #14; Attachment C, Response {7}

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to Phillips Request for Production of Documents). There is a substantial likelihood that, with adequate discovery and a meaningful opportunity to be heard, Lott can show that Defendants violations of federal drug, health, and safety laws are rampant, will deprive Lott from the protection of those laws, and that Lott has standing to seek mandatory injunctive relief prohibiting Defendants from violating those laws. See Beaty v. FDA, 853 F. Supp. 2d 30, 36 (D.D.C. 2012), affd sub nom. Cook v. FDA, 733 F.3d 1 (D.C. Cir. 2013). Because the law is clear and the facts are established, there is a substantial likelihood that Lott will prevail on these claims. II. Injunctive Relief The purpose of a TRO and preliminary injunctive relief is to preserve the status quo until the rights of the parties can be fairly and fully litigated through a final hearing or trial on the merits of a request for a permanent injunction. See Texas v. Camenisch, 451 U.S. 390, 395 (1981) (The purpose of a preliminary injunction is merely to preserve the relative positions of the parties until a trial on the merits can be held); Performance Unlimited v. Questar Publishers, 52 F.3d 1373, 1378 (6th Cir. 1995) (citations omitted). In considering whether injunctive relief staying Lotts execution is warranted, this Court will consider: (1) whether Lott has demonstrated a strong likelihood of success on the merits; (2) whether Lott will suffer irreparable injury in the absence of equitable relief; (3) whether a stay would cause substantial harm to others; and (4) whether the public interest is best served by granting a stay. Cooey v. Strickland, 589 F.3d 210, 218 (6th Cir. 2009). These factors are not prerequisites that must be met, but are interrelated considerations that must be balanced

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together. Id. (quoting Mich. Coal. of Radioactive Material Users, Inc. v. Griepentrog, 945 F.2d 150, 153 (6th Cir. 1991)). III. Lott is entitled to a temporary restraining order and/or a preliminary injunction staying his execution until such time as the merits of the claims raised in his individual complaint are adjudicated. A. There is a substantial likelihood that Lott will prevail on the merits of each claim raised in the Eighth Cause of Action in his individual complaint. 1. Plan A-1 violates the Eighth and Fourteenth Amendments even when administered without error or deviation. (Eighth Cause of Action, A.). a. There is a substantial risk that, if Lott is executed under Plan A-1, he will not die for 45 minutes after he has been injected with 5 grams of pentobarbital.

When administered in accordance with Plan A-1, 5 grams of pentobarbital causes death by suppressing the inmates breathing, thereby depriving the heart (and, accordingly, the other organs in the body) of oxygen. In an affidavit filed with this Court, Dr. Mark Dershwitz, explains: A dose of 5,000 mg of pentobarbital will cause virtually all persons to stop breathing. In addition, a dose of 5,000 mg of pentobarbital will cause the blood pressure to decrease to such a degree that perfusion of blood to organs will cease or decline such that it is inadequate to sustain life. (Affidavit of Mark Dershwitz, M.D., Ph.D. at 10, Doc. No. 146-2, PageID # 6650). What is meant by Dr. Dershwitzs use of the phrase or decline such that it is inadequate to sustain life is revealed in his 2007 deposition testimony given in Harbison v. Little, where he discussed the effect of the then-available drug thiopental, which also causes death by suppressing breathing when used as part of a one-drug protocol.

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So if Thiopental is used by itself, the mechanism of death will be two physiological processes working in tandem. A large dose of Thiopental dramatically decreases the blood pressure and circulation. After five grams, the blood pressure may actually be undetectable. By virtue of stopping the circulation, oxygen delivery to the tissues will be stopped. In addition, a large dose of Thiopental will cause someone to stop breathing. Even if they do have some circulation, the blood that circulates will be deficient in oxygen. A final common pathway will be hypoxia, the decreased delivery of oxygen to tissues, and critical tissues like the heart and the brain will then die. In order to determine when an efficient time frame that this is happening would require someone to perform physical examination on the inmate typically with a stethoscope. Because if one only relies on the electrocardiogram, incredible as it may seem, even after circulation ceases, in a person who has a previously normal and healthy heart, the electrical activity may take a very long time; meaning, half hour, 45 minutes or longer to cease. I actually have personal experience watching this happen in the process of taking care of organ donors in the operating room where we are confident of the moment that circulation ceases because the surgeon clamps the aorta and we can watch the electrocardiogram remain normal for many, many minutes; if the person was previously healthy before, for example, their car or motorcycle accident. So I pointed out to them that they would have to come up with a different way of pronouncing death, assuming that they didnt want to sit there for many, many minutes waiting for the electrocardiogram to go flat. Because I thought that would be very difficult especially on the witnesses to have to sit there for half hour, 45 minutes or longer. (Harbison v. Little, No. 3:06-cv-1206 (M.D. Tenn.), Deposition of Mark Dershwitz, M.D., Ph.D., Aug. 6, 2007, Doc. No. 104-1, PageID# 2827-29 (emphasis added)). In the predecessor to the instant action, Dr. Dershwitz, stated very nearly the same thing: Okay. So, I want to make sure that whenever we use numbers were comparing apples and apples and not apples with oranges. It is true I testified in the past that a protocol using thiopental and nothing else may take as long as 30 to 40 minutes to pronounce death. That was in the jurisdiction where the definition of death was flatline on the ECG monitor. I also said that if they used a physical examination to assess the absence of breathing and circulation, they could do so many, many minutes before that, because electrical activity in the heart persists for about a half hour after the heart stops beating.

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(Cooey v. Strickland, No. 2:04-cv-1156 (S.D. Ohio), Transcript of Motion Hearing, Dec. 4, 2009, Doc. No. 625, PageID# 13907 (emphasis added)). Dr. Dershwitzs proposed solution of using a stethoscope to declare death in this predicament, however, fails to account for the Eighth Amendments prohibition against a lingering death. A lingering death cannot be changed to a certain death by how an execution protocol defines death. To be sure, the States have a right to declare death insofar as whether their state capital sentence has been satisfied. Ohio is thus free to say that, insofar as Lotts sentence of death is concerned, he is dead when the Drug Administrator and the County Coroner no longer hear heart or lung sounds and the Warden announces a time of death. Kipen v. Renico, 65 Fed. Appx. 958, 959 (6th Cir. 2003) (citing Estelle v. McGuire, 502 U.S. 62, 68 (1991)). However, Ohio may not determine by similar fiat when death occurs for the purpose of the Eighth Amendment. A lingering death is defined the same in every jurisdiction. Thus, an inmate executed in Ohio and declared dead via a stethoscope cannot be treated differently than an inmate experiencing the same method of execution in a jurisdiction where the definition of death was flatline on the ECG monitor. In all jurisdictions presently retaining capital punishment, death occurs at the point in time when the heart is stopped. Jurisdictions that want a more efficient time frame because witnesses dont want to sit there for many, many minutes waiting for the electrocardiogram to go flat[,] came up with using a stethoscope to determine, through heart sounds, when the heart has stopped. This is a different way of pronouncing death than using an ECG to measure when rhythmic electrical output of the heart has stopped. The Eighth Amendment question thus becomes, which determination of death is more accurate? If both a stethoscope and an ECG {11}

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measure when the heart stops, yet an ECG is able to detect that the heart has not been stopped when a stethoscope cannot, it is an ECG that more accurately answers the question. In fact, Dr. Dershwitz told the 2007 Tennessee Lethal Injection Protocol Committee that the ECG is a definite interpretation of the end of life. (Attachment D, Harbison v. Little, No. 3:06-cv-1206 (M.D. Tenn.), Tennessee Lethal Injection Protocol Committee Minutes, Apr. 9, 2007). In the emergency medical care field, the absence of heart and lung sounds is not indicative of death but of the need for resuscitation.2 To declare death as soon as heart and lung sounds are no longer heard may make Lotts execution more pleasant for witnesses or may expedite the completion of Lotts sentence. However, it is beyond cavil that Lotts heart will not have stopped until long after he has been declared dead by the Warden. Lott will continue to display a normal ECG for as long as 45 minutes after administration of the lethal injection drugs and that constitutes a lingering death, prohibited by the Eighth Amendment. b. Death occurring as much as 45 minutes or more after the administration of lethal injection drugs is lingering and thus prohibited by the Eighth Amendment.

The Supreme Court has long-recognized that the Eighth Amendment prohibits not just methods of execution that inflict unnecessary pain and suffering, but also those that cause lingering death. In re Kemmler, 136 U.S. at 447 (Punishments are cruel when they involve torture or a lingering death.). Though the term lingering death has not been specifically

Berg RA, Hemphill R, Abella, BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: Adult Basic Life Support, 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, http://circ.ahajournals.org/content/122/18_suppl_3/S685.full. {12}

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defined, courts note when upholding various methods of execution that the method is designed to be quick, see Taylor v. Crawford, 487 F.3d 1072, 1084 (8th Cir. 2007); Walker v. Johnson, 448 F. Supp. 2d 719, 724 (E.D. Va. 2006) (finding that 4 minutes and 20 seconds is not lingering), swift, see McKenzie v. Day, 57 F.3d 1461, 1469 (9th Cir. 1995), cert. denied, 514 U.S. 1104 (1995), or rapid Campbell v. Wood, 18 F.3d 662, 687 (9th Cir. 1994) (en banc);3 Cooey v. Strickland, No. 2:04-cv-1156, 2010 WL 1610608, at *3 (S.D. Ohio Apr. 16, 2010). Ohio law requires a lethal injection execution to quickly and painlessly cause death. Ohio Rev. Code 2949.22(A). Forty-five minutes or more is not quick, swift, or rapid. According to the time line of last years execution of Harry Mitts, 45 minutes after Mitts was injected with pentobarbital, the IV lines had been removed from his arms, he had been placed in a hearse, the hearse had been driven from prison grounds, and the victim witnesses, inmate witnesses, and execution team members had all left the death house. (Attachment E, Mitts time line). Mitts experience was typical for Ohio executions. The participants in, and witnesses to, Lotts execution will have gone on about their business as Lotts heart clings to life even as he is being transported in a hearse. Under these circumstances, Lott has shown that execution under Ohios Execution Protocol will consist of a lingering death in violation of the Eighth Amendment.

Though it upheld the practice of hanging, the court in Campbell did so only after noting that Mr. Campbell had failed to show a substantial risk that he would die as a result of being deprived of oxygen, as opposed to injury to vascular, spinal, and nervous function. Campbell v. Wood, 18 F.3d at 683, 687. {13}

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c.

The disgrace inherent in Defendants handling of Lott as if he were dead, while he is still alive, violates the Eighth Amendment.

Defendants have chosen a method of determining death that they know, or should have known, results in Lott being declared dead for the purposes of his sentence up to 45 minutes before his heart has stopped. For this reason, Defendants actions subsequent to Lott being declared dead, regardless of how appropriate they are in terms of handling an actual corpse, will deny his very humanity. Using the Mitts time line as a reference, the participants, witnesses, and media will be told that he is dead. Approximately seven minutes later, after the witnesses have left, medical will remove the IV catheters from Lotts arms and will leave. A minute later, the execution team will remove the restraints and assist the funeral director in loading Lott onto a gurney. Another minute later, only 21 minutes after he is injected with pentobarbital and as much as 25 minutes or more before his heart finally stops, he will be taken from the prison in the back of a hearse. (Attachment E, Mitts time line). In Trop v. Dulles, the United States Supreme Court condemned the destruction of a persons political existence: We believe, as did Chief Judge Clark in the court below, that use of denationalization as a punishment is barred by the Eighth Amendment. There may be involved no physical mistreatment, no primitive torture. There is instead the total destruction of the individuals 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 (footnote omitted). Under Ohios 2013 Execution Protocol, and in violation of the Eighth Amendment, Lott will be denied his actual existence as his heart struggles to preserve the last remnants of his humanity.

{14}

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d.

Because Lotts sentence will be satisfied upon Defendant Wardens pronouncement of his death, yet Lott will remain alive, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment.

Defendants premature declaration of Lotts death hides the fact that the 2013 Execution Protocol causes a lingering death and Defendants subsequent denial of the fact that Lott remains alive humiliates him as he struggles for life. The declaration of death, however, also means that the sentence has been satisfied. As noted above, Ohios Execution Protocol is free to declare Lott dead when the Drug Administrator and the County Coroner no longer hear heart or lung sounds and the Warden announces a time of death. Kipen v. Renico, 65 Fed. Appx. at 959 (citing Estelle v. McGuire, 502 U.S. at 68). However, because Lott is, in reality, not dead and remains a prisoner of the State of Ohio, Defendants must provide him with necessary medical care. Estelle v. Gamble, 429 U.S. at 104-05. Dr. Dershwitzs interaction with the 2007 Tennessee Lethal Injection Committee informs that a person whose breathing has been chemically suppressed and whose heart and lung sounds can no longer be heard can, in fact, be resuscitated. Dr. Dershwitz: The advantages of using the three-drug protocol are the overall rapidity- using an EKG [ECG] is a definite interpretation of the end of life, and the appearance to lay witnesses is not objectionable. The paralytic drug is a disadvantage. If it is removed there is still a rapid end of life. Without it, Potassium Chloride is more likely to promote involuntary muscle contractions. Pancuronium Bromide can mitigate that effect. The advantage of using the onedrug protocol (Thiopental) is that much of the objections of the other side are greatly removed. The disadvantage is that there is no generally applicable definition of the moment death occurs. Using only this drug you cannot rely solely on the EKG [ECG]. Death could take 30 to 45 minutes. You would need another alternative to determine death. You would need a stethoscope-an expert to lay hands on the inmate to pronounce death. Julian Davis: What are the advantages of using a pulse oxymeter? {15}

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Dr. D.: An oxymeter is of no help. Ricky Bell: What is a lethal dose of Sodium Pentathol? Dr. D: The definition of a lethal dose of Sodium Pentothal varies from person to person, but one dose is lethal. Five grams falls into the category of needing very aggressive methods of resuscitation. (Attachment D, Harbison v. Little, No. 3:06-cv-1206 (M.D. Tenn.), Tennessee Lethal Injection Protocol Committee Minutes, Apr. 9, 2007) (emphasis added). Because a person whose heart and lung sounds have been chemically suppressed to the point that they are no longer detectable can be resuscitated by very aggressive methods, the next question becomes whether Lott can still be resuscitated after Defendant Warden has declared him dead. The history of Ohio executions using 5 grams of pentobarbital, and the expert advice of Dr. Dershwitz, demonstrate that there is a substantial likelihood that Lott can be resuscitated after Defendant Warden has declared him dead. Based on the Mitts time line, Defendant Warden will declare Lott dead approximately ten minutes after he is injected with pentobarbital. Given Dr. Dershwitzs testimony about how quickly 5 grams of pentobarbital will suppress a persons breathing, there is a substantial likelihood the Warden will announce a time of death between two to four minutes after heart and lung sounds are no longer detected. (Cooey v. Strickland, No. 2:04-cv-1156 (S.D. Ohio), Transcript of Motion Hearing, Dec. 4, 2009, Doc. No. 625, PageID# 13831) (Inmate will stop breathing six to eight minutes after pentobarbital injections).

{16}

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The resuscitation of an individual who has been without air or heartbeat for two to four minutes is a commonplace occurrence. More significantly, with aggressive treatment, even a person whose breathing has been chemically suppressed may be resuscitated.4 Defendants have chosen to declare that Lotts execution will have served its purpose when they know, or should know, that Lott is not dead. The policy reasons for that choice are not open to debate in this lawsuit. Kipen v. Renico, supra. That choice, however, does not obviate Defendants Eighth Amendment duty to provide Lott with adequate medical care. Estelle v. Gamble, supra. Even though Defendants know that care will be needed and know the nature of care required, Defendants will violate the Eighth and Fourteenth Amendments by failing to provide for Lotts post-declaration-of-death care. 2. Plan A-2 violates the Eighth and Fourteenth Amendments even when administered without error or deviation. (Eighth Cause of Action, B.). a. Plan A-2 creates a substantial risk that Lott will experience unnecessary pain and suffering.

Dennis McGuires motion for stay of execution and memorandum alleged that under Plan A-2 he was: at substantial, palpable, objectively intolerable risk of experiencing the agony and horrifying sensation of unrelenting air hunger during the midazolam/hydromorphone execution under Ohios execution protocol. (Doc. No. 383, PageID# 11626).
4

European Resuscitation Council Guidelines for Resuscitation 2010, Section 8. Cardiac arrest in special circumstances: Electrolyte abnormalities, poisoning, drowning, accidental hypothermia, hyperthermia, asthma, anaphylaxis, cardiac surgery, trauma, pregnancy, electrocution, Soar, J., Perkins, G., Abbas, G., et al., Resuscitation Volume 81, Issue 10, October 2010 (2010) 1400-33. http://www.hcs.gr/admin/spaw/uploads/files/8%20Full_ERC_2010_Guidelines-Special.pdf. {17}

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Defendants filed an opposition, stating that McGuire would not perceive this experience as uncomfortable. (Doc. No. 385, PageID# 11680). This Court heard expert testimony from both sides. Dr. Dershwitz offered his opinion on how McGuire would react to the midazolam/hydromorphone injection required under Plan A-2: Q. Now, when someone is administered an I.V. injection of 40 milligrams of hydromorphone, would you expect to see air hunger? A. No.

... Q. Okay. That being said, will the dosages of hydromorphone and midazolam used by Ohio in conducting executions result in the symptoms of air hunger? A. No.

... A. Well, if they were suffering from air hunger, they might do things like, you know, cough and sputter or try to move or even tell me I can't breathe. ... Q. Dr. Dershwitz, do you expect a 115-kilogram man with a neck size of 19 inches to suffer severe air hunger pain as a result of the administration of ten milligrams of midazolam and 40 milligrams of hydromorphone? A. No. And it is true that all of the experiments on which these pictures are based were done in perfectly normal people. It is also true that 40 milligrams of hydromorphone is such an enormous overdose that could account for huge variations from normalcy in terms of body weight and size and whatever. Its still going to be a huge overdose in somebody whos 115, or 150, kilograms. Q. And, based on that same question, besides air hunger, do you expect that same person to experience any pain? A. I do not expect them to experience anything that they would perceive as noxious. (Testimony of Dr. Dershwitz, Transcript of Motion Hearing, Jan. 12, 2014, Vol. 2, pp. 28-30, 3637, 61).

{18}

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David Waisel, M.D., offered a different opinion: A. Benzodiazepine crosses fairly quickly, but hydromorphone does not cross quickly. And, so, it will take the peak effect of hydromorphone is generally around 15 minutes, but the onset is earlier. And, in fact, what we know is the ventilatory depression effects of the onset occur before the analgesic effect. In other words, your breathing slows before you have pain relief. So, for the first five minutes or so, you will have ventilatory depression without an effective pain dose in you. ... Q. Would it be -- you know, weve colloquially used the term suffocation. How is that -- I mean, does suffocation accurately describe what you're talking about when you say air hunger? A. Air hunger is the inability to take a breath to satisfy the ventilatory drive we all have. As your carbon dioxide increases -- that is, carbon dioxide is the waste of your body. As it increases, the drive to breathe increases. And if youre unable to satisfy that, that causes an amazing amount of terror and fear and horror. That is what air hunger is. ... Q. Doctor, if you could, could you describe for us kind of in detail what you believe is, in your words, substantially likely to happen to Mr. McGuire if he is subjected to the execution dose or the doses in Ohios execution policy? A. Presuming he receives the medication intravenously and it is a proper medication and dose, he will appear quiet for maybe up to 30 seconds, and then he will start to obstruct, and he will try to sit up. Hell try to turn over. He will try to move around. He might try to stand up. And typically -- when I say sit up, I mean to more than 90 degrees. I mean they go all the way over. And hell be in that state, since the injection, for about five minutes. This -- he will feel the sensation of suffocation, and it will be horrible for him. I can't describe how horrible it will be. (Testimony of Dr. Waisel, Transcript of Motion Hearing, Jan. 10, 2014, Vol. 1, pp. 35-36, 49). The contrast could not have been more stark between Dr. Waisels testimony that hydromorphone would cause respiratory suppression before it provided pain relief and Dr. Dershwitzs testimony that the two effects would occur simultaneously and McGuire would not experience anything perceived as noxious. This Court observed:

{19}

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But let no one pretend for even a moment that this analysis is without potential cracks. There is absolutely no question that Ohios current protocol presents an experiment in lethal injection processes. The science involved, the new mix of drugs employed at doses based on theory but understandably lacking actual application in studies, and the unpredictable nature of human response make todays inquiry at best a contest of probabilities. (Opinion & Order, Doc. No. 390, PageID# 11732-33). On January 16, 2014, Ohio went forward with its experiment on McGuire. Alan Johnson, a reporter for the Columbus Post-Dispatch who had witnessed a number of prior Ohio executions offered his eyewitness account: The chemicals began flowing about 10:29 a.m., and for a while, McGuire was quiet, closing his eyes and turning his face up and away from his family. However, about 10:34 a.m., he began struggling. His body strained against the restraints around his body, and he repeatedly gasped for air, making snorting and choking sounds for about 10 minutes. His chest and stomach heaved; his left hand, which he had used minutes earlier to wave goodbye to his family, clenched in a fist. McGuire eventually issued two final, silent gasps and became still. He was pronounced dead at 10:53 a.m. Inmates death called horrific under new, 2-drug execution, Columbus Post-Dispatch, (January 17, 2014).5 Father Lawrence Hummer also witnessed McGuires execution. This is his account: Ive seen people die many times before: in nursing homes, families Ive known, my own mother. In most settings Ive found death to be a very peaceful experience. But this was something else. By my count it took 26 minutes for McGuire to be pronounced dead. ... At about 10.15am he was brought in and strapped to the gurney. ...

http://www.dispatch.com/content/stories/local/2014/01/16/mcguire-execution.html. {20}

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He made his final statement. ... They began to put lines into him. That was unsettling, as from what I could observe they seemed to find it hard to get insert the IV and there seemed to be blood coming from his right arm. At 10.27am, the syringe containing the untested concoction of midazolam and hydromorphone was injected into him. At 10.30am, three minutes into the execution, he lifted his head off the gurney, and said to the family who he could see through the window: I love you, I love you. Then he lay back down. At about 10.31am, his stomach swelled up in an unusual way, as though he had a hernia or something like that. Between 10.33am and 10.44am I could see a clock on the wall of the death house he struggled and gasped audibly for air. I was aghast. Over those 11 minutes or more he was fighting for breath, and I could see both of his fists were clenched the entire time. His gasps could be heard through the glass wall that separated us. Towards the end, the gasping faded into small puffs of his mouth. It was much like a fish lying along the shore puffing for that one gasp of air that would allow it to breathe. Time dragged on and I was helpless to do anything, sitting helplessly by as he struggled for breath. I desperately wanted out of that room. For the next four minutes or so a medical tech listened for a heart beat on both sides of his chest. That seemed to drag on too, like some final cruel ritual, preventing us from leaving. Then, at 10.53am, the warden called the time of death, they closed the curtains, and that was it. I witnessed Ohios execution of Dennis McGuire. What I saw was inhumane. The Guardian (Jan. 22, 2014).6 Although permitted by Plan A-2, Defendants did not administer additional doses of midazolam or hydromorphone to McGuire. Instead, Defendants decided to wait an additional period of time to see if McGuire would eventually become still. McGuires execution is not the first where Defendants have decided to forgo administering additional drug doses in favor of waiting an additional period of time. (Attachment F, Reginald Brooks time line).

http://www.theguardian.com/commentisfree/2014/jan/22/ohio-mcguire-execution-untested-letha l-injection-inhumane. {21}

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Considering the circumstances of McGuires death, circumstances that Defendants concede have not occurred in an Ohio execution before, there is a substantial likelihood that Lott can demonstrate that Plan A-2 poses a substantial risk (which at this point is 100%) that he will experience unnecessary pain and suffering. [W]here allowing the process to run its course could result in the severest of consequences, it is more prudent to allow the district court to take these new circumstances into consideration. Reynolds, 538 F.3d at 958 (Cole, J., concurring). Thus, an order providing the time necessary for this Courts review of Lotts claims should be entered. b. There is a substantial risk that, if Lott is executed under Plan A-2, he will not die for 45 minutes after he has been injected with 10 mg of midazolam and 40 mg of hydromorphone.

The combination of 10 mg of midazolam and 40 mg of hydromorphone called for in Plan A-2, like the 5 grams of pentobarbital used in Plan A-1, causes death by suppressing the inmates breathing, thereby depriving the heart (and, accordingly, the other organs in the body) of oxygen. (Declaration of Mark Dershwitz, M.D., Ph.D., Doc. No. 146-2, at 23-27, PageID# 6652). Accordingly, as with Plan A-1, there is a substantial risk that Lott will not die for up to 45 minutes after he is injected with the lethal drug combination required under Plan A-2. See III(A)(1)(a), supra.

{22}

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c.

Death occurring as much as 45 minutes or more after the injection of 10 mg of midazolam and 40 mg of hydromorphone is lingering and thus prohibited by the Eighth Amendment.

Death under Plan A-2, like death under Plan A-1, occurs over 45 minutes or more. A death that occurs over such a time period is a lingering death. Plan A-2 thus also violates the Eighth Amendment. See III(A)(1)(b), supra. d. The disgrace inherent in Defendants handling of Lott as if he were dead, while he is still alive, violates the Eighth Amendment.

Death under Plan A-2, like death under Plan A-1, occurs over 45 minutes. Accordingly, as under Plan A-1, Lott will be subjected to disgrace and humiliation under Plan A-2 in violation of the Eighth Amendment. See III(A)(1)(c), supra. e. Because Lotts sentence will be satisfied upon Defendant Wardens pronouncement of death, yet Lott will remain alive, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment.

Under Plan A-2, Lott will be declared dead in satisfaction of his sentence long before he is actually dead. As under Plan A-1, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment. See III(A)(1)(d), supra. 3. Plan B violates the Eighth and Fourteenth Amendments even when administered without error or deviation. (Eighth Cause of Action, C.) a. Plan B creates a substantial risk that Lott will experience unnecessary pain and suffering.

The only difference between death under Plan A-2 and Plan B is that the onset of the pharmacological effect of 10 mg of midazolam and 40 mg of hydromorphone when injected intramuscularly is slower. (Declaration of Mark Dershwitz, M.D., Ph.D., Doc. 146-2, at 24, {23}

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PageID# 6652; Testimony of Dr. Waisel, Transcript of Motion Hearing, Jan. 10, 2014, Vol. 1, p. 50). Accordingly, Plan B, like plan A-2, creates a substantial risk of unnecessary pain. See III(A)(2)(a), supra. b. There is a substantial risk that, if Lott is executed under Plan B, he will not die for 45 minutes after he has been injected with 10 mg of midazolam and 40 mg of hydromorphone.

The combination of 10 mg of midazolam and 40 mg of hydromorphone called for in Plan B, like the 5 grams of pentobarbital used in Plan A-1, causes death by suppressing the inmates breathing, thereby depriving the heart (and, accordingly, the other organs in the body) of oxygen. (Declaration of Mark Dershwitz, M.D., Ph.D., Doc. No. 146-2, at 23-27, PageID# 6652). Accordingly, as with Plan A-1 and Plan A-2, there is a substantial risk that Lott will not die for up to 45 minutes after he is injected with the drug combination required under Plan B. See III(A)(1)(a), supra. c. Death occurring over as much as 45 minutes or more after the injection of 10 mg of midazolam and 40 mg of hydromorphone is lingering and thus prohibited by the Eighth Amendment.

Death under Plan B, like death under Plan A-1 and Plan A-2, occurs over 45 minutes or more. In fact, because Plan B involves an intramuscular injection it will take longer than Plans A-1 and A-2. (Declaration of Mark Dershwitz, M.D., Ph.D., Doc. 146-2, at 24, PageID# 6652; Testimony of Dr. Waisel, Transcript of Motion Hearing, Jan. 10, 2014, Vol. 1, p. 50). Plan B violates the Eighth Amendment. See III(A)(1)(b), supra.

{24}

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d.

The disgrace inherent in Defendants handling of Lott as if he were dead, while he is still alive, violates the Eighth Amendment.

Death under Plan B, like death under Plan A-1 and Plan A-2, occurs over 45 minutes. Accordingly, as under Plans A-1 and A-2, Lott will be subjected to disgrace and humiliation under Plan B in violation of the Eighth Amendment. See III(A)(1)(c), supra. e. Because Lotts sentence will be satisfied upon Defendant Wardens pronouncement of Lotts death, yet Lott will remain alive, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment.

Under Plan B, Lott will be declared dead in satisfaction of his sentence long before he is actually dead. As under Plans A-1 and A-2, Defendants denial of the medical care necessary to resuscitate him violates the Eighth Amendment. See III(A)(1)(d), supra. 4. To the extent Lott is required to demonstrate the existence of a feasible readily-implemented alternative to Ohios 2013 Execution Protocol that significantly reduces that protocols substantial risk of unnecessary pain, a lingering death, gratuitous disgrace, and denial of necessary medical care, such alternatives exist.

Lott submits that the statement in Baze that an inmate must show an alternative method of execution is not supported by the Eighth Amendment. See Baze, 553 U.S. at 52. That statement is based on the pluralitys conclusion that the constitutionality of the death penalty is settled and that, accordingly, there must be some constitutional means of carrying it out. Id. at 47. As Justice Alito observed, however, the Court merely assumed the constitutionality of the death penalty because the question was not before the Court. Id. at 63 (Alito, J., concurring). The death penalty violates the evolving standards of decency to which the Framers of the Constitution looked when drafting the Eighth Amendment. Trop v. Dulles, supra. Though this Court is

{25}

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bound by the decisions of the United States Supreme Court, Lott submits that on review of this Courts decision the Supreme Court should revisit this issue and reverse, abrogate, or modify existing law. Moreover, no method of execution utilized in the United States has ever been held unconstitutional by the Supreme Court. Baze, 553 U.S. at 48. Of those methods of execution which have been approved, death by poisonous gas arguably produces a lingering death like that caused by the 2013 Execution Protocols chemical suffocation of the condemned inmate. See Gomez v. United States District Court for the Northern District of California, 503 U.S. 653, 65556 (Stevens, J., dissenting from order vacating stay of execution). As noted, the Court of Appeals in Campbell v. Wood, 18 F.3d at 683, 687, specifically found that judicial hanging, properly carried out, causes death by injury to vascular, spinal, and nervous function. The firing squad approved in Wilkerson v. Utah, supra, causes death by the immediate physical destruction of the heart. These methods of execution would eliminate the lingering death caused by all three methods in Ohios 2013 Execution Protocol. As for the gratuitous disgrace that will be visited upon Lotts still-living body, Ohio need only refrain from declaring him dead until he no longer exhibits a regular heartbeat on an ECG. Further, as to the refusal to resuscitate Lott, Ohio may either practice the afore-mentioned restraint or provide him with the medical care they know is necessary to revive him. Finally, as to the pain and suffering caused by the use of midazolam and hydromorphone required under Plan A-2 and Plan B, as illustrated by the execution of Dennis McGuire, the afore-mentioned judicially approved methods of execution are feasible and readily implemented

{26}

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and each results in substantially less pain and suffering than the conscious suffocation caused by Ohios 2013 Execution Protocol. B. There is a substantial likelihood that Lott will demonstrate that Defendants use of compounded drugs to carry out his execution as set forth in the Ninth Cause of Action in his individual complaint will violate the Eighth and Fourteenth Amendments.

The use of compounded drugs to carry out Lotts execution creates a substantial risk of unnecessary pain and suffering. Until recently, Defendants represented they would not use imported drugs due to the concern that the drugs would lack FDA approval. Cooey (Brooks) v. Kasich, Nos. 2:04-cv-1156, 2:09-cv-242, 2:09-cv-823, 2:10-cv-27, 2011 WL 5326141, at *8-9 (S.D. Ohio Nov. 4, 2011); Cooey (Smith) v. Kasich, 801 F. Supp. 2d 623, 640-41 (S.D. Ohio 2011). Defendants had also rejected the option of compounding drugs for use in executions. (Opinion & Order, Doc. No. 363, PageID# 10418-19). Compounded drugs also lack FDA approval. (Attachment A, Dr. Sasich Declaration, p. 2 9). Ohios new 2013 Execution Protocol, however, provides for the use of compounded drugs and Defendants have newly stated they will seek to obtain and use imported drugs for executions. (D.C. Policy 01-COM-11, Doc. No. 323, PageID# 9575, 9578; Opinion & Order, Doc. No. 363 PageID# 10417-19). Defendants sudden loss of concern for the danger posed by the use of non-FDA-approved drugs in Ohios 2013 Execution Protocol follows their well-know difficulties in obtaining FDA-approved drugs for that purpose. By placing their desire to move forward with Lotts execution without delay, ahead of avoiding the dangers they have already acknowledged, Defendants act with deliberate indifference to the substantial risk created by the use of compounded.

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Defendants former concerns about non-FDA drugs, however, were warranted. There is a substantial risk that compounded drugs are not sterile or mixed at the proper strength. That risk comes from: the use of APIs of unknown quality from an unknown source; compounding pharmacies that dont employ Good Manufacturing Practice (GMP) guidelines nor comply with Chapter <797> of the United States Pharmacopeial Convention (USP); compounding pharmacies that are non-sterile, that introduce contaminants into what are supposed to be sterile drugs, and that fail to properly store compounded drugs; and, a lack of oversight of both compounding pharmacies and laboratories used by those pharmacies to test the purity and quality of compounded drugs. (Attachment A, Dr. Sasich Declaration, p. 3 14, 17-19). Such risks are widespread, occurring even in Ohio. Each compounding pharmacy recently inspected in the United States by the FDA was non-compliant in several areas thus compromising the safety, sterility and strength of the drugs produced. Of those pharmacies inspected, two were located in Ohio. One Ohio compounding pharmacy failed to test for purity, strength, and quality of raw materials and finished sterile drug products were not tested for sterility and endotoxins nor tested for potency. (Attachment G, FDA Inspection Report for Clinical Apothecaries dated Nov. 20, 2013). The other Ohio compounding pharmacy did not perform assay and identity testing nor sterility testing of a re-packed drug. (Attachment H, FDA Inspection Report for RC Compounding Services, LLC, dated Feb. 7, 2013). In addition, an Ohio compounding pharmacy investigated by the Ohio State Board of Pharmacy was found to have produced compounded drugs with potency ranging between 27% to 85% of the amounts of active ingredients listed on the products labels. The Board further noted no sterility, fungal or

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endotoxin testing was requested on several compounded drugs. (Attachment I, Ohio State Board of Pharmacy Minutes, May 7-9, 2007). These risks are not significantly reduced by voluntary testing. The FDA also inspected each of the five testing laboratories that are employed by 90% of compounding pharmacies in the United States and found those laboratories were not using GMPs, were not in compliance with USP Chapter <797>, and/or were not using scientifically sound testing procedures. At bottom, these laboratories could not reliably assess the strength, quality and purity of the products tested. (Attachment A, Dr. Sasich Declaration, p. 4 23, p. 6 37; Labs that test safety of custom-made drugs fall under scrutiny, The Washington Post (Oct. 5, 2013).7 It is likely that any compounder chosen by Defendants to provide them with lethal injection drugs will fail to employ and maintain the practices required to produce sterile and potent drugs. The lack of meaningful oversight of the testing laboratory, if one is used by the compounder, increases the risk of harm. (Attachment A, Dr. Sasich Declaration, p. 5 30). Despite the fact that the trend toward using compounded drugs is of fairly recent origin, the risk of using compounded drugs has arguably already been realized. In two of the eight (i.e., 25% of) executions carried out with compounded drugs in the United States, errors have occurred. During the South Dakota execution of Eric Robert, it took him 20 minutes to be declared dead. According to reports, during the course of the execution, Robert gasped for air, turned purple/blue, and he opened his eyes and they remained open until his death. His heart

http://www.washingtonpost.com/politics/labs-that-test-safety-of-custom-made-drugs-fall-underscrutiny/2013/10/05/18170a9e-255f-11e3-b3e9-d97fb087acd6_story.html. {29}

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continued to beat for ten minutes after he stopped breathing. (Attachment A, Dr. Sasich Declaration, p. 7 41, 42). After the Oklahoma execution of Michael Lee Wilson began, using compounded pentobarbital as the first of a three-drug protocol, he stated, I feel my whole body burning. A burning sensation is indicative of the fact that the compounded drug was contaminated. (Attachment A , Dr. Sasich Declaration, p.6 39, 40). A 25% error rate in compounded drug executions constitutes a substantial risk of serious harm. Moreover, just a few days ago before the Missouri execution of Herbert Smulls, the compounded execution drug was tested by one of the five laboratories previously mentioned. The Oklahoma laboratory, ARL, report notes that an unknown residual solvent was found in the sample that was tested, yet the report indicated that the sample passed. Zink v. Lombardi, No. 2:12-cv-04209, Doc. No. 299-8, Page 17 of 26 (W.D. Mo. Jan. 26, 2014). It is unacceptable by any standard to inject an unknown substance into a human subject. (Attachment A, Dr. Sasich Declaration, p. 7 43). Furthermore, assuming (see, however, Plaintiff Lotts Tenth Cause of Action) that Defendants compounder complies with compounded drug rules, there is a substantial risk Lott will not be executed in accordance with the 2013 Execution Protocol. The protocol specifies that the inmate is to be injected with 100 mL of pentobarbital, in a 50 mg/mL solution, for a total of 5 grams of pentobarbital (D.C. Policy 01-COM-11 (Oct. 10, 2013), Doc. No. 323, PageID# 9578). However, under compounded drug rules, Defendants compounder cannot provide pentobarbital with a concentration of 50 mg/mL because that is the concentration which is commercially available and thus, cannot be compounded. (Attachment J, Compounding in Ohio, Ohio State {30}

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Board of Pharmacy, Rev. Dec. 2013). Defendants use of pentobarbital with a concentration of less than 50 mg/mL, increases the already substantial risk that Lott will not receive an adequate dose of pentobarbital, and that the cessation of electrical activity in the heart (i.e., death) will occur only after a lingering death. Moreover, if Defendants vary from the 2013 Execution Protocol by using pentobarbital in a different concentration they will treat Lott differently from others executed under the same protocol, thus violating his rights under the Equal Protection Clause. Given the above facts demonstrating a substantial risk of unnecessary harm caused by the use of compounded drugs, there is a substantial likelihood that Lott will prevail on his Ninth Cause of Action. C. There is a substantial likelihood that Lott will demonstrate that Ohios Protocol requires Defendants to violate federal and state law and that he is entitled to an injunction requiring Defendants to abide by federal and state drug laws during any attempt to execute Plaintiff such violations. (Lotts Tenth Cause of Action). 1. Lott can already demonstrate violations of state and federal law.

The status quo should be preserved until Lotts Tenth Cause of Action can be fairly and fully litigated. There is a substantial likelihood Lott will prevail on the merits because Lott has demonstrated the Defendants will intentionally violate state and federal drug laws. Under Ohios 2013 Execution Protocol, Defendants will import, manufacture, distribute, possess, dispense, and/or administer to Lott pentobarbital or midazolam and hydromorphone in order to kill Lott. (D.C. Policy 01-COM-11, Doc. No. 323, PageID# 9570, 9574-75, 9578-79, 9582-85). Because Ohios execution drugs are controlled substances, all of these actions are governed by federal and state drug laws. First, Defendant Warden is not authorized by the {31}

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Controlled Substances Act to procure and use controlled substances. No other Defendant charged with procuring and or using controlled substances under Ohios 2013 Protocol has claimed he/she is authorized to do so.8 See 21 U.S.C. 841(a). Second, Defendants have admitted that the execution drugs are not dispensed pursuant to a valid prescription. Instead, Defendant Warden makes a written request for the drugs. This is a direct violation of 21 U.S.C. 353(b)(1)(A); C.F.R. 1306.04(a), 1306.06; Ohio Rev. Code 3719.06; and, Ohio Admin. Code 4729-5-21 & 30, 4729-19-02(A). (Attachment B, Response to Phillips Request for Admissions #13, #14; Attachment C, Response to Phillips Request for Production of Documents). Third, Defendants (Pharmacies and/or Pharmacists) will provide controlled substances without a valid prescription and outside the usual course of practice. This is a direct violation of 21 U.S.C. 842; 21 C.F.R. 1306.04(a), 1306.06; Ohio Admin. Code 4729-19-02(A); and, Ohio Rev. Code 3719.05(A)(3). 2. There exists a substantial likelihood Lott will be able to demonstrate further violations of state and federal law should a stay be entered and he be permitted full discovery.

A substantial likelihood Defendants (Pharmacies and/or Pharmacists) are acting in violation of licensing and registration laws is demonstrated by the fact that there is no valid prescription for the drugs and may further may be readily proved through discovery. 21 U.S.C. 802(10), 822(a)(1) & (2); 21 C.F.R. 1301.11(a); Ohio Rev. Code 3719.02, 3719.021. A substantial likelihood Defendants (Pharmacies and/or Pharmacists) are violating compounding laws and standards is demonstrated by the fact that there is no valid prescription
8

Whether this allegation is true may be readily proved through discovery. {32}

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for the drugs and may further may be readily proved through discovery. Ohio Admin. Code 4729-19-04. A substantial likelihood Defendants (Drug Administrator(s) and Medical Team) are acting in violation of licensing and registration laws when they distribute, deliver, dispense and/or administer controlled substances to Lott is demonstrated by the fact that there is no valid prescription for the drugs and may further be readily proved through discovery. 21 U.S.C. 822(a)(1) & (2), 844; 21 C.F.R. 1301.11(a); and, Ohio Rev. Code 3719.09(C), 3719.02, 3719.021. Furthermore, a substantial likelihood Defendants are attempting to obtain, or have obtained, an unlawful supply amount of the execution drugs and will use the drugs beyond the lawful beyond use date may be readily proved through discovery. Ohio Admin. Code 4729-9-25(B), 4729-9-25(E)(2)(a)-(c) The afore-described Defendants, and such other Defendants as may become known through discovery, are required by the 2013 Execution Protocol to attempt or to conspire to commit federal offenses in order to obtain controlled substances for executions. Those laws were enacted for the specific purpose of preventing the use of controlled substances except in a manner, and/or by persons, authorized by federal law. Defendants are, by their actions, denying Lott the protection afforded by those laws and inflicting upon him a unique and extreme harm by increasing the already substantial risk that he will suffer unnecessary pain during his execution. State laws and regulations mandating that state actors violate federal law are not permitted under the Supremacy Clause. Maryland v. Louisiana, 451 U.S. 725 (1981). Because no effective remedy exists to protect Lott from the increased risk of harm caused by Defendants violations of {33}

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law, equitable relief enjoining defendants from violating those laws when carrying out Ohios 2013 Protocol is required. D. Lott will suffer irreparable injury absent a stay of execution.

Lott will suffer irreparable harm without injunctive relief enjoining his execution because the only way to preserve Lotts constitutional and civil rights is to provide him with adequate time to present the merits of his case. A stay of execution is essential to the realization of his rights because the execution would occur prior to the time Lott could present his claims and receive this Courts meaningful review. See Williams v. Missouri, 463 U.S. 1301 (1983); Barefoot v. Estelle, 463 U.S. 880, 888-89 (1983) (If a court is unable to resolve the merits of a viable issue before the scheduled date of execution, the condemned inmate is entitled to a stay of execution to permit due consideration of the merits.). Once Lott is executed, those rights can never be restored. Under these circumstances and where a prisoner is scheduled to be executed, irreparable harm is deemed to be self-evident. In re Holladay, 331 F.3d 1169, 1176-77 (11th Cir. 2003) (granting stay of execution); In re Morris, 328 F.3d 739, 741 (5th Cir. 2003) (same). E. The risk that Lott will suffer a cruel and unusual death outweighs Defendants interest in carrying out his sentence on March 19, 2014.

The risk that Lott will be subjected to a cruel and unusual death outweighs the States interest in carrying out his death sentence on March 19, 2014. Regardless of the State of Ohios interest in seeing Lotts sentence of death carried out, it has no interest in conducting an execution in violation of its own constitution, laws, rules, and regulations, or in violation of the constitution and laws of the United States. In re Holladay, supra; In re Morris, supra. Moreover, the State will not suffer substantial harm if injunctive relief is granted because

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Defendants will not forever be prohibited from executing Lott, the execution will only be delayed for a brief period of time until the merits of Lotts supplemental individual complaint can be heard. Should Defendants prevail at a hearing on the merits then the execution will move forward. However, should Lott prevail, then delay in his execution will have been wholly justified and will have preserved Lotts constitutional and civil rights. Even if Lott prevails, Defendants still will not suffer substantial harm because they will not be prohibited from carrying out Lotts sentence. Defendants may do so, but only in a constitutional and lawful manner. Because Defendants will only be delayed in carrying out Lotts sentence, injunctive relief will not cause them to suffer substantial harm. F. The public interest weighs in favor of a stay of execution.

Where, as here, a constitutional violation is likely, the public interest militates in favor of injunctive relief because it is always in the public interest to prevent violation of a persons constitutional rights. Miller v. City of Cincinnati, 622 F.3d 524, 540 (6th Cir. 2010) (quotation and citation omitted). Assuming Ohios death penalty reflects the will of the people, the public interest can only benefit from this Courts meaningful review of Defendants acts and the 2013 Execution Protocol to ensure that Defendants comply with the Constitution and federal and state laws. A governments compliance with the law is always in the best interest of the public. Especially in light of the public spectacle created by the execution of Dennis McGuire, this Courts careful consideration of Lotts claims serves the public interest and lends legitimacy to the death penalty system in Ohio. An order providing the time necessary for that review should be entered.

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IV.

Conclusion Wherefore, Plaintiff respectfully requests this Court preserve the status quo, grant

injunctive relief, and enjoin the State of Ohio from executing him under the procedure set forth in Ohios 2013 Execution Protocol. FEDERAL DEFENDER SERVICES OF EASTERN TENNESSEE, INC. BY: /s/Stephen A. Ferrell Stephen A. Ferrell (Ohio Reg. No. 0061707) Assistant Federal Community Defender Email: Stephen_Ferrell@fd.org Trial Attorney and Counsel for Plaintiff Gregory Lott /s/Stephen M. Kissinger (Pro Hac Vice) Stephen M. Kissinger (WY Bar No. 5-2342) Assistant Federal Community Defender Email: Stephen_Kissinger@fd.org Co-counsel for Plaintiff Gregory Lott /s/Dana C. Hansen Chavis (Pro Hac Vice Pending) Dana C. Hansen Chavis (TN Bar No. 019098) Email: Dana_Hansen@fd.org Co-counsel for Plaintiff Gregory Lott Federal Defender Services of Eastern Tennessee, Inc. 800 S. Gay Street, Suite 2400 Knoxville, TN 37929 Phone: (865) 637-7979 Fax: (865) 637-7999

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CERTIFICATE OF SERVICE I hereby certify that on February 3, 2014, I electronically filed the foregoing Plaintiff Gregory Lotts Motion for Temporary Restraining Order and/or Preliminary Injunction with the Clerk of the United States District Court for the Southern District of Ohio using the CM/ECF system, which will send notification of such filing to the following at the e-mail address on file with the Court: Mr. Christopher P. Conomy Principal Assistant Attorney General Trial Counsel for all Defendants Office of the Ohio Attorney General Court of Claims Defense 150 E. Gay Street, 18th Floor Columbus, OH 43215 Mr. Charles L. Wille Principal Assistant Attorney General Mr. Thomas Madden Senior Assistant Attorney General Mr. David M. Henry Assistant Attorney General Mr. Christopher L. Bagi Assistant Attorney General Co-Counsel for all Defendants Office of the Ohio Attorney General Criminal Justice Section, Capital Crimes Unit 150 E. Gay Street, 16th Floor Columbus, OH 43215

/s/Stephen A. Ferrell Stephen A. Ferrell Trial Attorney and Counsel for Plaintiff Gregory Lott

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