lott motion

8/13/2019 Lott Motion

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IN THE UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

EASTERN DIVISION

IN RE: OHIO EXECUTION ) Case No. 2:11-cv-1016

PROTOCOL LITIGATION )) JUDGE GREGORY L. FROST

)

) Magistrate Judge Mark R. Abel

This document relates to: )

PLAINTIFF GREGORY LOTT ) Death penalty case: Execution

) scheduled for March 19, 2014

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.

Case: 2:11-cv-01016-GLF-MRA Doc #: 418 Filed: 02/03/14 Page: 1 of 43 PAGEID #: 12065


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Respectfully submitted this 3rdday of February, 2014.

FEDERAL DEFENDER SERVICES

OF EASTERN TENNESSEE, INC.

BY: /s/Stephen A. FerrellStephen A. Ferrell (Ohio Reg. No. 0061707)

Assistant Federal Community Defender

Email: [email protected]

Trial Attorney and Counsel for

Plaintiff Gregory Lott

/s/Stephen M. Kissinger (Pro Hac Vice)

Stephen M. Kissinger (WY Bar No. 5-2342)



Co-counsel for Plaintiff Gregory Lott

/s/Dana C. Hansen Chavis (Pro Hac Vice Pending)

Dana C. Hansen Chavis (TN Bar No. 019098)



Federal Defender Services

of Eastern Tennessee, Inc.

800 S. Gay Street, Suite 2400

Knoxville, TN 37929

Phone: (865) 637-7979Fax: (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}

II. Injunctive Relief.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {8}

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {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}

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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.. . . . . . . . . . . . . . . . . {22}

c. Death occurring as much as 45 minutes or more

after the injection of 10 mg of midazolam and 40mg of hydromorphone is lingering and thus

prohibited by the Eighth Amendment. . . . . . . . {23}

d. The disgrace inherent in Defendants handling of



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}

3. Plan B violates the Eighth and Fourteenth Amendments even whenadministered 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 thusprohibited by the Eighth Amendment. . . . . . . . {24}

d. The disgrace inherent in Defendants handling of



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


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.. . . . . {25}

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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}

C. There is a substantial likelihood that Lott will demonstrate that Ohios Protocolrequires 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}

D. Lott will suffer irreparable injury absent a stay of execution.. . . . . . . . . . . . . . {34}

E. The risk that Lott will suffer a cruel and unusual death outweighs Defendants

interest in carrying out his sentence on March 19, 2014. . . . . . . . . . . . . . . . . . {34}

F. The public interest weighs in favor of a stay of execution. . . . . . . . . . . . . . . . {35}

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

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

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INDEX OF ATTACHMENTS

Attachment Description

A Dr. Sasich Declaration dated Jan. 31, 2014

B Response to Phillips Request for Admissions

C Response to Phillips Request for Production of Documents

D Harbison v. Little, No. 3:06-cv-1206 (M.D. Tenn.)

Tennessee Lethal Injection Protocol Committee Minutes, Apr. 9, 2007

E Mitts time line

F Brooks time line

G FDA Inspection Report for Clinical Apothecaries, dated Nov. 20, 2013

H FDA Inspection Report for RC Compounding Services, LLC, dated Feb. 7,

2013

I Ohio State Board of Pharmacy Minutes, May 7-9, 2007

J 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. (SeeDoc. 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,

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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). SeeBalhuin 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 sinceBaldwin, Windsor, andHovey. 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 inMullane 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 alsoLogan 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).

InLogan, 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.

Loganinvolved 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

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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.

1http://www.theguardian.com/world/2014/jan/20/doctor-angry-ohio-executed-inmate-usin

g-untried-untested-procedure-dennis-mcguire.

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http://www.theguardian.com/world/2014/jan/20/doctor-angry-ohio-executed-inmate-using-untried-untested-procedure-dennis-mcguirehttp://www.theguardian.com/world/2014/jan/20/doctor-angry-ohio-executed-inmate-using-untried-untested-procedure-dennis-mcguirehttp://www.theguardian.com/world/2014/jan/20/doctor-angry-ohio-executed-inmate-using-untried-untested-procedure-dennis-mcguirehttp://www.theguardian.com/world/2014/jan/20/doctor-angry-ohio-executed-inmate-using-untried-untested-procedure-dennis-mcguire


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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. InReynolds, 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

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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

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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. SeeBeaty 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. (quotingMich. 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 hisindividual 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 injectedwith 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 stopbreathing. 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 inHarbison 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 havesome 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 themoment 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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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 thusprohibited 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

2Berg 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.

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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.

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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 one-

drug 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?

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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 veryaggressive 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).

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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


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).

4European 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.

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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 hugevariations 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, 36-

37, 61).

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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. ...

5http://www.dispatch.com/content/stories/local/2014/01/16/mcguire-execution.html.

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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 theexecution, 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 forthat 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).

6http://www.theguardian.com/commentisfree/2014/jan/22/ohio-mcguire-execution-untested-letha

l-injection-inhumane.

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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 PlanA-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.

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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


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


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,

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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.

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d. The disgrace inherent in Defendants handling of Lott as if he


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 inBazethat an inmate must show an alternative method of

execution is not supported by the Eighth Amendment. SeeBaze, 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. at63 (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

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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, 655-

56 (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

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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 NinthCause 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 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 , 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

7http://www.washingtonpost.com/politics/labs-that-test-safety-of-custom-made-drugs-fall-under-

scrutiny/2013/10/05/18170a9e-255f-11e3-b3e9-d97fb087acd6_story.html.

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


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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

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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

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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 See21 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 enteredand 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

8Whether this allegation is true may be readily proved through discovery.

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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

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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. SeeWilliams 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)





/s/Stephen M. Kissinger (Pro Hac Vice)

Stephen M. Kissinger (WY Bar No. 5-2342)




/s/Dana C. Hansen Chavis (Pro Hac Vice Pending)

Dana C. Hansen Chavis (TN Bar No. 019098)



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-mailaddress 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. WillePrincipal 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 DefendantsOffice 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


