Motion for 60 Day Stay, As Filed (Herbert Smulls)

IN THE UNITED STATES DISTRICT COURTFOR THE WESTERN DISTRICT OF MISSOURI

CENTRAL DIVISION

DAVID ZINK, et al., ))

Plaintiffs, )) No. 2:12-CV-4209-BP)

v. ) This is a capital case))

GEORGE A. LOMBARDI, et al., ) Execution of Plaintiff Smulls) scheduled January 29, 2014

Defendants. )

HERBERT SMULLS’ MOTION FOR 60-DAY STAY OF EXECUTIONBASED ON NEW FACTS THAT ESTABLISH THE UNCONSTITUTIONALITY OF

STATE’S EXECUTION METHODS, INCLUDING THEUSE OF A SUBSTANDARD COMPOUNDED DRUG

Charles M. Rogers Cheryl A. PilateWyrsch, Hobbs, Mirakian, PC Lindsay J. Runnels1000 Walnut, Suite 1600 Morgan Pilate LLCKansas City, MO 64106 926 Cherry Street(816) 221-0080 Kansas City, MO 64106

(816) 471-6694

1

Case 2:12-cv-04209-BP Document 285 Filed 01/21/14 Page 1 of 41

TABLE OF CONTENTS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Factual Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

A. History of Proceedings, including Two Executions . . . . . . . . . . . . . . . . . . . . . .9

B. Discovery Delays and Pending Motion for Sanctions . . . . . . . . . . . . . . . . . . . 13

C. Judge Bye’s Dissent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

D. Recent Discovery Concerning Compounded Pentobarbital . . . . . . . . . . . . . . . 16

E. Expert Opinions of Dr. Sasich Concerning Compounded Pentobarbital . . . . . 18

F. Expert Opinions of Dr. Heath Concerning Compounded Pentobarbital . . . . . .29

G. Complaint to Missouri Board of Pharmacy . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

H. Complaint to Oklahoma Board of Pharmacy . . . . . . . . . . . . . . . . . . . . . . . . . . .32

I. Complaint to United States Attorney’s Office . . . . . . . . . . . . . . . . . . . . . . . . . .33

Legal Argument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

I. Standards Governing a Stay of Execution . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

II. Mr. Smulls is Likely to Prevail on the Merits of His Claims . . . . . . . . . . . . . . 36

III. The Relative Harm to the Parties Weighs Heavily in Favor of Mr. Smulls . . . 37

IV. Mr. Smulls and Plaintiffs Have Asserted their Claims Promptly . . . . . . . . . . . 38

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

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INTRODUCTION

Plaintiff Herbert Smulls, by and through his counsel, hereby moves this Honorable Court

for a temporary 60-day stay of execution to allow him to further develop compelling new facts

which show that the Missouri Department of Corrections has failed to take even the most basic

steps to ensure the safety, efficacy and legality of its execution protocol, including its use of

compounded pentobarbital. The Department’s failures have placed Mr. Smulls at grave risk that

he will experience excruciating pain during his execution due to the Department’s administration

of an expired, degraded, and improperly stored drug.

The drug, compounded pentobarbital, is the same drug used in a recent Oklahoma

execution in which the prisoner, after being injected, said: “I feel my whole body burning.” (See

Exh. A, Alter, “Oklahoma Convict Who Felt ‘Body Burning’ Executed with Controversial Drug,”

TIME, Jan. 10, 2014). The same pharmacy that supplied Oklahoma prison officials may also be

supplying the Missouri Department of Corrections. (See Exh. B, McDaniel, “Investigation:

“Missouri’s Execution Drug Source Raises Legal, Ethical Questions,” St. Louis Public Radio,

Dec. 31, 2013; identifying source of Missouri execution drugs as an unnamed Oklahoma

pharmacy).

A review of recent deposition testimony by the Department’s director of adult institutions,

David Dormire, reveals a shocking level of bureaucratic indifference regarding the lethal drug,

including a failure to obtain even the most basic information about the background and reliability

of the compounding pharmacy, including whether it is properly licensed or adheres to industry

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standards called “good manufacturing practices.” (Exh. C at 47, 59-63)1 The pharmacy, never

properly vetted, was secured through a no-bid contract with the only other inquiries being to two

potential “sellers” that clearly could not supply a specialized compounded drug. (Exh. C at 55-

56)

Remarkably, the Department pays cash to all execution team members, totaling about

$17,000 per execution, with the pharmacy receiving $8,000 of that amount. (Exh. C at 127-131)

Mr. Dormire could not verify whether the Department adheres to federal tax law in issuing 1099s

to individuals or businesses receiving these cash payments. (Exh. C at 129)

The testing laboratory, which is supposed to assure the potency and purity of the execution

drug, states that its report does not constitute any type of warranty. (Exh. C at 119-20). Most

shocking, the compounded pentobarbital is stored – at the pharmacy’s direction - at room

temperature. (Exh. C at 105-06) After a Department representative picks up the drug, it is stored

in a locked cabinet in a Department office in the days or even weeks before an execution,

violating nationally recognized USP standards for the storage of “high risk” compounded drugs.

(Exhs. D, E). Such drugs should be maintained at room temperature for no more than 24 hours

because of the risk that they will degrade. (Exh. C at 108; Exh. D at ¶¶ 5-22; Exh. E at 1-4)

Even “low risk” compounded drugs are to be maintained at room temperature for no more than

48 hours. (Exh. E).

The compounded pentobarbital intended to be used to execute Mr. Smulls is already in

the Department’s custody. (Exh. C at 41, 73, 125). It was picked up on January 14, 2014, from

1 Until issues are resolved between the parties or with the court as to which portions ofthe transcript are designated “confidential,” Plaintiffs are filing the entire transcript under seal.

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the compounding pharmacy and transported it to a Department office, where it is being stored until

just before the execution. (Exh. C at 73, 105, 125 ). By the date of Mr. Smulls’ scheduled

execution, the compounded pentobarbital will have been stored for 15 days at room temperature

– in violation of all accepted pharmaceutical standards pertaining to the safety and efficacy of

compounded drugs. (Exh. E, Sasich affidavit of December 6, 2013).

The Department of Corrections’ execution protocol and its handling of the compounded

drug not only violate universally recognized and accepted standards of pharmacy compounding,

but also:

• Violate the regulatory laws of the State of Missouri, including regulations prohibiting

the compounding of drugs that are “essentially copies” of FDA-approved drugs and prohibiting

the administration of compounded drugs beyond their “beyond use date.” See 20 C.S.R. § 2220-

2.200, 2.400. The Department further violates state law by obtaining a drug from an out-of-state

pharmacy that is not licensed in the State of Missouri. See 20 C.S.R. § 2220-2.025(1).

• Violate the regulatory law of the State of Oklahoma, where the compounding pharmacy

is reportedly located, including regulatory law prohibiting the compounding of drugs that are

“essentially copies” of FDA-approved drugs and prohibiting the administration of compounded

drugs beyond their “beyond use date.” See Title 59 O.S. 535:15-10-53, 535:15-10-61.

• Violate a newly passed federal law, the Drug Quality and Security Act, under which the

compounded “copy” of an FDA-approved drug constitutes an illegal and unapproved “new drug

under 21 U.S.C. § 355. See Pub. L. No. 113+54, 127 Stat.587 (Nov. 27, 2013), § 102(a)

(modifying scope of FDCA § 505).

Complaints about Missouri’s use of substandard, dangerous and illegal drugs are currently

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pending with the Missouri Board of Pharmacy, the Oklahoma Board of Pharmacy, and the federal

Food and Drug Administration (FDA). These complaints have all been filed in the past three

weeks, as Plaintiffs have finally obtained some of the necessary information to challenge the

Department’s flagrantly illegal protocol. (See discussion, infra)

A dissenting opinion from the Eighth Circuit’s denial of a stay to Allen Nicklasson,

authored by Judge Bye and joined by Judge Kelly, sharply criticized Missouri’s “ever changing

execution protocol” and its use of “secret compounding pharmacies to concoct copycat versions

of the drug pentobarbital to carry out its executions.” Nicklasson v. Lombardi, Case No. 13-3664,

Amended Order, at 12-13 (Bye and Kelly, J.J., dissenting) (Exh. F)

Mr. Smulls needs a minimum of another 60 days to develop this critical evidence that will

allow him to satisfy the Baze standard and show that executing him by using an expired,

substandard compounded drug creates a substantial risk he will suffer serious harm and needless

suffering during the execution. Baze v. Rees, 553 U.S. 35, 50 (2008), Brewer v. Landrigan, 131

S. Ct. 445 (2010). A recent execution – interestingly, in Oklahoma – demonstrates that the risk

from the use of pentobarbital to kill a human being is not speculative, but is very real. After

being injected with pentobarbital during his execution, the Oklahoma prisoner said, “I feel my

whole body burning.” (Exh. A).

Mr. Smulls requests that he not be condemned to the same fate as the Oklahoma man

without a fair opportunity to develop the facts that would allow him to show that executing him

with degraded and improperly stored pentobarbital violates the Eighth Amendment prohibition

against cruel and unusual punishment.

As the District Court has previously found, the Defendants’ execution protocol has been

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a “frustratingly moving target,” with the protocol changing no less than five times in the past six

months. Zink v. Lombardi, Doc. # 163 at 1-2, 12. Through no fault their own, Plaintiffs have

been unable, to date, to fully develop all available evidence to demonstrate that Defendants’

execution protocol is fundamentally flawed and creates a grave risk that Plaintiffs, including Mr.

Smulls, will suffer immense, indeed excruciating, pain during their executions. See Landrigan,

131 S. Ct. 445. That said, the new facts that have emerged in the past several weeks, including

Mr. Dormire’s deposition and the recently exposed violations of state and federal law, provide

overwhelming support for at least a 60-day stay, and strongly suggest that additional facts, when

developed, will satisfy the Baze standard and will compel changes to Defendants’ dangerous and

hastily concocted protocol.

Throughout discovery in the present case, Defendants have engaged in persistent foot-

dragging and obstruction – failing to respond to discovery requests or supplying patently

inadequate responses or lodging legally baseless objections. Defendants’ conduct has prolonged

and complicated discovery. In the meantime, they have continued to execute Plaintiffs even while

they obstruct or frustrate Plaintiffs’ access to critical evidence they need to support their claims.

Defendants should not be rewarded for their obstructive conduct. Rather, this Court

should grant a stay to Mr. Smulls of no less than 60 days, permitting him to develop evidence

which will show that the substandard preparation and handling of the compounded pentobarbital

is “sure or very likely to cause serious illness and needless suffering.” Landrigan, 131 S. Ct. 445.

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I. FACTUAL BACKGROUND

The factual background of this case cuts a wide swath and requires an

understanding of not only the procedural history and the proceedings to date, but also:

• The recent dissenting opinion issued by Judge Bye that not only criticizes

Missouri’s recent use of “secret compounding pharmacies” and “copycat pharmaceuticals,”

but also criticizes Missouri’s history of missteps in implementing the death penalty,

including its persistent effort to execute prisoners before they have exhausted federal relief

of their claims, (Nicklasson, Case No. 13-3664, Bye and Kelly, J.J., dissenting)(Exh. F);

• The carrying out of the two recent executions, of Joseph Franklin and Allen

Nicklasson, while they had claims for relief pending before the federal courts;

• The Defendants’ ongoing foot-dragging and use of obstructive discovery tactics

in the present case, improperly hindering Plaintiffs’ ability to discover critical facts in

support of their claims;

• The facts obtained just days ago, on January 15, 2014, during the deposition of

David Dormire, which establish that the compounded pentobarbital is being improperly

stored at room temperature, causing grave risk to Plaintiffs that they will suffer severe,

even excruciating pain, as they are executed with the use of a degraded and unsafe drug;

• Plaintiffs’ complaints to government agencies, including the Boards of Pharmacy

of Missouri and Oklahoma and the federal Food and Drug Administration (FDA), upon

discovery of the violation of numerous Missouri and Oklahoma regulatory laws as well as

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violations of the new federal drug compounding law, the Drug Quality and Security Act;

• The January 10, 2014, execution in Oklahoma in which the prisoner reported

feeling his “whole body burning” after being injected with compounded pentobarbital,

possibly acquired from the same source that the State of Missouri uses;

• The ongoing developments in Missouri state government regarding lethal

injection, including a probe by the Missouri Auditor’s Office;2 and,

• The series of affidavits obtained from Plaintiffs’ pharmacy expert, Larry Sasich,

PharmD, whose most recent opinions concern Missouri’s risky use of compounded

pentobarbital that, by the time of Mr. Smulls’ scheduled execution, will have been stored

at room temperature 15 times longer than permissible under the nationally accepted USP

standards, giving rise to the very substantial risk that Mr. Smulls will be injected with a

degraded and contaminated drug.

History of Proceedings, Including Two Executions

The lengthy procedural history of this case is recounted in detail in Allen

Nicklasson’s motion for stay, Doc. #184, and need not be reiterated here. Mr. Smulls

summarizes only central developments that bear directly on this

2 This Missouri auditor’s office announced on January 13, 2014 that it wasconducting an audit of the Missouri Department of Corrections. The deputy state auditor,Harry Otto, noted that the auditor’s office intended to examine whether the Departmenthad followed its own policies and procedures with respect to the execution protocol andwould evaluate whether any violations of state law had occurred. (See Exh. R, “Auditwill prober Corrections Department execution procedures, drug procurement,”Missourinet, Jan. 13, 2014).

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motion for stay.

The present lawsuit was originally filed in June 2012 as a petition in the Circuit

Court of Cole County, Missouri. It asserted claims under the Eighth and Fourteenth

Amendments as well as the Missouri Constitution attacking the now-defunct protocol that

provided for the use of propofol as the lethal agent. In August 2012, Defendants removed

this lawsuit to federal court. (Doc. #184, 8-10)

After the close of discovery, as a previously scheduled trial date in October 2013

drew near, Defendants twice issued new execution protocols. The first revision divided

the propofol into two separate dosages. A second amendment, on September 24, 2013,

reverted to a single dose of propofol, but preceded it with a sedative and an analgesic.

(Id.).

On October 11, 2013, Governor Nixon ordered the Department to delay the

execution of Nicklasson, then scheduled for October 23, 2013, and ordered the Department

to adopt a different method of lethal injection. (Doc. #163 at 2).

Just one week later, the Department issued its protocol calling for the use of

compounded pentobarbital. The Department then announced on October 22, 2013, that an

unnamed compounding pharmacy was added to the execution team and will provide the

pentobarbital necessary for executions under the new protocol. (Doc. #163 at 2). The

District Court referred to Defendants’ execution protocol as a “frustratingly moving target”

and stated that Plaintiffs, through no fault of their own, have been delayed in obtaining the

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information necessary to satisfy standards for an Eighth Amendment claim. (Doc. #163 at

11-14).

On November 19, 2013, the District Court in this case granted Joseph Franklin’s

motion for stay of execution, based on the fact he had been “afforded no time to research

the risk of pain associated with the Department’s new protocol, the quality of the

pentobarbital provided and the record of the source of the pentobarbital.” (Doc. #163 at

14). The District Court found that Plaintiffs had shown a sufficiently strong likelihood of

success on the merits as well as a showing of irreparable harm, to justify a stay of

execution. Id.

The Eighth Circuit subsequently vacated the District Court’s order based on the

Eighth Amendment, and subsequently denied rehearing en banc. (Doc. #183 at 11)

Franklin’s attorneys subsequently sought a stay in the United States Supreme Court. When

that request was denied at 5:18 a.m. on November 20, 2013, Franklin’s attorneys filed

within minutes a subsequent motion for stay with the district court, asking it to consider

grounds left unresolved in its earlier order. (Doc. #183, at 11-12) Franklin’s attorneys

adhered to protocol and the court’s procedures, calling the Court’s emergency number, and

sending emails to both the Court and to opposing counsel. (Doc. #183 at 12). Despite

counsels’ notification of opposing counsel and the court, Mr. Franklin was executed at

6:07 a.m. – while a viable and meritorious motion for stay was pending. (Doc. #183 at 12;

see also Doc. 184 at 12-15).

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Despite the fact that Mr. Nicklasson’s counsel briefed, in detail, the fact that Mr.

Franklin was executed while a motion for stay was pending before the court (Doc. #184

at 12-15), the same thing occurred with regard to Mr. Nicklasson. He was executed while

a request for en banc review was pending before the Eighth Circuit Court of Appeals,

prompting Judge Bye’s sharp criticism: “Missouri put Nicklasson to death before the

federal courts had a final say on whether doing so violated the federal constitution.” (Exh.

F at 2).

When Defendants changed their protocol, discontinuing propofol and adopting

pentobarbital, they moved to dismiss this lawsuit as moot. (Doc. #143). The district court

denied that motion, in the same order that issued a stay of execution to Mr. Franklin. (Doc.

#163).

On November 8, 2013, Plaintiffs moved to file an amended complaint asserting a

variety of federal and state law claims against the new protocol. (Attached exh. A to Doc.

#147). Plaintiffs asserted that the new protocol amounts to cruel and unusual punishment

under the Eighth Amendment, that it violates the Ex Post Facto clause by increasing the

severity and painfulness of the prisoners’ executions, and that it violates the Eighth and

Fourteenth Amendments by shielding the identity of Defendants’ compounding pharmacy,

and thus, conceals critical information concerning the provenance and safety of

Defendants’ lethal drugs. (Doc. #147).

The proposed amended complaint also included state law claims that (1) the

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protocol violates the manner-of-execution statute by designating a supplier of lethal

injection drugs as a member of the “execution team,” which the statute defines as those

who “provide direct support for the administration of lethal gas or lethal chemicals.” Mo.

Rev. Stat. § 546.720.2(b) (emphasis added) and (2) the protocol violates binding state

regulations that govern the practice of compounding pharmacies; and (3) the protocol

violates the state constitutional guaranty of separation of powers by effectively precluding

judicial review of its provisions. (Doc. #147). The District Court granted Plaintiff’s

motion for leave to amend their complaint, and they did so, filing a 116-page complaint

supported by many exhibits. (Doc. #183).

Discovery Delays and Pending Motion for Sanctions

Throughout this litigation, Defendants have engaged in obvious foot-dragging and

obstruction in the discovery process. They have responded to written discovery requests

weeks or months after they were due, or not at all. They have served patently inadequate

responses, and have failed to correct or timely supplement them3.

3 Plaintiff’s Motion and Reply in support of their Motion for Sanctions observes thatDefendants’ foot-dragging and non-responsiveness in discovery has been so pervasive that itsuggests bad faith. As Plaintiffs assert in their Reply:

At no point prior to filing their response to Plaintiffs’ [present]Motion for Sanctions did Defendants make any objection to thesecond and third discovery requests made or assert to the Plaintiffsor to this Court that they were untimely served, improper...or[objectionable] for any reason otherwise. They simply ignoredthem. This is consistent with their tactic throughout this litigationof delaying responses to requests for as long as possible so as todeprive Plaintiffs of information to which they are entitled and

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Because of Defendants’ persistent and egregious failures to comply with their

discovery obligations, Plaintiffs filed in December a Motion for Sanctions, which requests

that this Court, among other remedies, prohibit Defendants from scheduling or carrying out

any further executions until they have fulfilled their discovery obligations. (See Motion

for Sanctions, Doc. #193; Reply to Defendants’ Preliminary Suggestions in Opposition to

Motion for Sanctions, Doc. #228)

Despite the imminence of Mr. Smulls’ execution, scheduled for January 29, 2014,

Defendants still have supplied no documents regarding the drug to be pumped into Mr.

Smulls’ veins. Although Defendants provided these documents with regard to Mr.

Nicklasson and Mr. Franklin – including copies of the prescription for the lethal drug, the

chain of custody log, prescription drug labels and related materials – Plaintiffs have

received no such documents pertaining to Mr. Smulls.

On January 13, 2014, counsel for Mr. Smulls served Plaintiffs’ Fifth Interrogatories

to Mr. Dormire and Plaintiffs’ Fifth Request for Production to all Defendants. (Exhs. G,

H) In light of the pending execution date, Mr. Smulls’ counsel sent an email requesting

that Defendants promptly supplement their prior responses by providing Smulls-related

documents and by serving expedited responses to the new discovery requests. (Exhs. I)

To date, Smulls’ counsel have received no response to their request for the production of

which they need to litigate underlying claims.

(Doc. #228 at 6) (emphasis added).

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these central documents.

Judge Bye’s Dissent

Following the December 11, 2013, execution of Allen Nicklasson, Judge Bye of the

Eighth Circuit Court of Appeals, joined by Judge Kelly, issued a dissenting opinion from

the order addressing Mr. Nicklasson’s motion for a stay, which had been denied as moot

because he had already been executed.

Judge Bye’s opinion provides a blistering critique of Missouri’s execution practices,

which begins with the observation that “Missouri has a well documented history of

attempting to execute death row inmates before the federal courts can determine the

constitutionality of the executions.” (Exh. F at 2). Judge Bye reviewed numerous

executions over the past 30 years, observing that, again and again, Missouri had set

execution dates and attempted to proceed with executions before federal courts had a

meaningful opportunity to review the prisoners’ federal constitutional claims. (Exh. F at

3 - 12). Judge Bye focused his sharpest criticism on the recent execution of Allen

Nicklasson stating:

At approximately 10:52 p.m. on December 11, 2013, Missouriexecuted Allen Nicklasson before this court had completed itsreview of Nicklasson’s request for a stay of his execution, arequest he brought in a pending action challenging theconstitutionality of Missouri’s execution protocol. That bearsrepeating. Missouri put Nicklasson to death before the federalcourts had a final say on whether doing so violated the federalconstitution.

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(Exh. F at 1-2)

Judge Bye also recounted Missouri’s use, for many years, of an “admittedly dyslexic

physician to implement the state’s unwritten protocol, including the responsibility of

correctly mixing the drugs used in execution.” (Exh. F at 9)(emphasis in original).

With regard to Missouri’s recent resumption of executions, Judge Bye observes that

Missouri’s execution protocol has changed no less than five times since August 1, 2013,

and that it is now relying on “secret compounding pharmacies to concoct copycat versions

of the drug pentobarbital to carry out its executions.” (Exh. F at 12). He added:

[Missouri’s] current practice of using shadow pharmacieshidden behin d the hangman’s hood, copycat pharmaceuticals, numerous last-minute changes to itsexecution protocol, and finally, its act of proceeding with anexecution before the federal courts had completed their reviewof an active request for a stay, has committed this judge tosubjecting the state’s future implementation of the penalty ofdeath to intense judicial scrutiny, for the sake of death rowinmates involved as well as adversaries and advocates ofcapital punishment alike.

(Exh. F at 15) (emphasis added).

Recent Discovery Concerning Compounded Pentobarbital

On January 7, 2014, David Dormire executed his interrogatory answers, stating that

the expiration or “use by” date of the compounded pentobarbital was “30 days from being

compounded,” and that the pharmacy had directed the Department to store the

pentobarbital at room temperature. (Exh. M at 10, answer to #9(f)(g)).

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In his deposition testimony, Dormire stated that the pentobarbital intended to be

used to execute Mr. Smulls had been picked up on January 14, 2014, and was being stored

in a locked location by the Department. (Exh. C at 73, 105-08, 110). He stated the drug

was stored at room temperature, and that he had been informed that the drug was “good

for 30 days” after it was compounded. (Exh. C at 106-07). Mr. Smulls’ scheduled

execution is January 29, 2014, which means the drug will have been stored at room

temperature for a minimum of 15 days by that date.

Dormire indicated he knew little about the pharmacy or how it was selected,

including whether it is properly licensed or adheres to industry standards called “good

manufacturing practices.” (Exh. C at 42-47, 59-61) He said he said he had “no idea” what

type of compounding the pharmacy generally did, and also did not know what steps had

been taken by anyone at the Department to determine the quality or reliability of the

pharmacy. (Exh. C at 42-46). He stated that no one from the Department had inspected the

pharmacy, and that he did not know if any government agency had ever inspected it. (Exh.

C at 46-47) He also did not know whether it was registered under the new federal Drug

Quality and Security Act, supra, or whether it planned to register. (Exh. C at 46-47)

Dormire also testified that he did not know whether the pharmacy was licensed in

Missouri. (Exh. C at 49, 56-60). He acknowledged that the laboratory report stated that

it did not warrant its analysis and that he did not know if there was any connection between

the compounding pharmacy and the lab or how the lab was chosen. (Exh. C at 114- 115).

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Expert Opinions of Dr. Sasich Concerning Compounded Pentobarbital

Dr. Sasich’s Initial Affidavit in this Case

After Defendants changed their protocol to adopt the use of compounded

pentobarbital, Plaintiffs retained a pharmacology expert, Dr. Larry Sasich, who specializes

in drug safety and efficacy issues. Dr. Sasich has extensive experience as both a

pharmacology professor and consultant, both throughout the United States and

internationally. Among many other positions, he formerly served as a consumer

representative on the Science Board of the Food and Drug Administration, an advisory

committee to the FDA Commissioner. (Exh. D at 1; see also Exh. J, Sasich, curriculum

vitae attached).

On November 7, 2013, Dr. Sasich issued an affidavit addressing Missouri’s plan to

execute prisoners with pentobarbital compounded by an unknown pharmacy. Dr. Sasich

explains that compounded drugs are unreliable because they are largely unregulated. (Ex.

J at ¶¶ 9, 12, 14). Compounding pharmacies represent “an emerging, substandard drug

industry responsible for making large quantities of unregulated, unpredictable and

potentially unsafe drugs.” Id. ¶ 12. The drugs they make often contain counterfeit or

substandard ingredients, and drug compounders often use poor practices; as a result, the

process of compounding “often results in drugs which are contaminated, sub-potent or

super-potent, or which do not have the strength, quality or purity...required for the safe and

effective treatment of patients.” Id. ¶ 14. Reputable suppliers of pharmaceutical

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ingredients generally sell directly only to FDA-approved manufacturers of finished

products. Id. ¶ 21. That leaves compounding pharmacies to depend on the unregulated

“grey market” in which ingredients may come from China, India, or other countries that

do not reliably inspect pharmaceutical ingredients; the drugs may not even be what they

purport to be, and it is all but impossible to trace the active ingredient to its original

manufacturer in order to verify its quality. Id. ¶¶ 19-23. In light of these hazards, “The

potential harm associated with the use of such contaminated or sub-potent drugs is

extremely high.” Id. ¶ 14. That harm is enhanced by the secrecy concerning the Department

of Corrections’ supplier, which creates even greater uncertainty as to the origins and

quality of the drug’s ingredients. Id. ¶ 18.

Dr. Sasich outlines four specific hazards from the use of compounded pentobarbital

in executions. First, there is a “substantial risk” that the drug may be sub-potent or super-

potent, either from (a) the fact that Missouri’s protocol specifies no means of adjusting the

measurements of the chemical to account for the drug’s hygroscopic (water-absorbing)

nature, (b) chemical degradation caused by impurities or contamination,( c) a compounding

error, or (d) the possibility that Defendants’ drug is not actually pentobarbital. Id. ¶¶ 22,

32-35. Sub-potent pentobarbital risks “acute intoxication, life-threatening but not fatal

respiratory depression, and/or paradoxical stimulation.” Id. ¶ 34. Super-potent

pentobarbital, meanwhile, may result in “suffocation and gasping for breath, before the loss

of consciousness.” Id. ¶ 35.

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A second problem Dr. Sasich identifies is the danger that compounded pentobarbital

will be contaminated with dangerous allergens, toxins, bacteria, or fungus—any of which

could induce severe allergic or blood reactions that are “highly unpredictable, rapidly

evolving and potentially painful and agonizing.” Id. ¶¶ 28-30.

A third danger arises from particle contamination. The compounded pentobarbital

may contain foreign particles that will either contaminate the solution or precipitate out of

it, creating a “substantial risk of pain and suffering” on injection, as well as a risk of

pulmonary embolism. Id. ¶¶ 30, 33.

Fourth, and finally, Dr. Sasich states that the dosage form of the drug may fail to

reach or maintain the proper pH, which risks burning on injection, the precipitation of solid

particles that could cause a pulmonary embolism, or the multiplication of bacteria and

fungus that may “create instability and/or incompatibility with human blood.” Id. ¶ 33. All

told, Dr. Sasich concludes, compounded pentobarbital creates a “substantial risk of serious,

unnecessary and substantial harm and mental anguish.” Id. ¶ 46.

Dr. Sasich’s Supplemental Declarations

On November 15, 2013, Dr. Sasich issued a Supplemental Declaration in response

to documents filed by Defendants which consisted of a statement that the unknown testing

laboratory is accredited by The American Association for Laboratory Accreditation, a

document entitled Scope of Accreditation, and a Certificate of Analysis for pentobarbital

sodium 50 mg/ml solution. (Exh. K at 1-2).

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After reviewing those documents, Dr. Sasich noted that the American Association

for Laboratory Accreditation appears to be in the business of providing programs for

commercial analytical laboratories to become accredited by that Association but that their

qualifications for conducting analytical testing of pharmacy-compounded drugs are

unknown. Significantly, Dr. Sasich also stated that he is “not aware of any drug regulatory

authority . . that recognizes accreditation by The American Association for Laboratory

Accreditation.” Id. ¶ 1.

Dr. Sasich also noted that a Certificate of Analysis produced by Defendants

contained a statement that the method used in the determination of a concentration of

50.490 mg/ml was not validated, which “erodes confidence in the reported concentration.”

Id. ¶ 3. After noting several issues relevant to the safety and efficacy of the secretly-

compounded pentobarbital which were unanswered in the documents he had been provided

and noting problems with commercial analytical laboratories – including five such

laboratories that conduct testing for the vast majority of large compounding pharmacies

in the United States being cited by the FDA for more than 70 safety problems – Dr. Sasich

concluded that the documents provided only indicate that the product tested may contain

pentobarbital sodium but give no indication “that this product was sterile, free from cross-

contamination or other adulterants that could pose a serious risk” to the prisoner receiving

an injection of this product. Id.

On December 2, 2013, Dr. Sasich issued a Second Supplemental Declaration, after

21


reviewing six additional documents filed by Defendants, including three items labeled as

“Certificate of Analysis” and one labeled “Microbiology Report.” (Exh. L at 1-3). He

noted multiple problems with these purported analyses, noting, for instance that in the

“Microbiology Report,” Dr. Sasich noted that it indicated that two syringes were received

on November 7, 2013, and tested that same date, allowing no explanation for how a result

of “no growth after 7 days” could be reported. He also noted a statement on the report

indicating that the testing had not been performed per USP <71> guidelines. With regard

to a two-page document labeled “Certificate of Analysis,” Dr. Sasich noted that the

molecular weight of the substance, which helps identify the chemical being tested, had

been redacted and concluded that the lab did not guarantee that the Active Pharmaceutical

Ingredient being tested was pentobarbital USP. (Exh. L at 1-3)

On December 6, 2013, Dr. Sasich issued a Third Supplemental Declaration,

discussing the compounded drug used to execute Joseph Franklin on November 20, 2013,

and the compounded drug which the state later used to execute Allen Nicklasson on

December 11, 2013. (Ex. E at 1-4). The stability of compounded drugs is not known, and

that, therefore, the expiration dates required on FDA regulated drugs do not apply to

compounded drugs. Dr. Sasich went on to explain that USP Chapter <797> defines the

“Beyond Use Date” (BUD) as the date or time after which a compounded sterile

preparation should not be administered, stored or transported. (Exh. E at 1-4).

Chapter <797> of the USP assigns BUDs for drugs compounded from non-sterile

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Active Pharmaceutical Ingredients (High Risk Compounding). If the drug is stored at

room temperature, the BUD is 24 hours; if refrigerated, 3 days, and if frozen, 45 days. Id.

at 1-2. From documents given him to review, Dr. Sasich learned that quantity of

pentobarbital sodium was received by the laboratory on November 27, 2013, and stored

at room temperature, at least in the laboratory. Dr. Sasich stated: “The storage conditions

under which the sodium pentobarbital injection was subjected from the time of initial

preparation until it is used in an execution is not known.” Id. at 3. He then concluded that

if the drug was compounded November 26, 2013, 16 days before December 11, 2013, the

date scheduled for Mr. Nicklasson’s execution, the BUD would have been exceeded if the

drug was stored at room temperature or in a refrigerator. Id.

After reviewing the discovery available as of December 6, 2013, (which included

the documents related to Mr. Franklin’s execution), Dr. Sasich concluded that there was

“no evidence that Missouri actually knows what will be injected into a condemned

prisoner. The risk of an untoward event is substantial.” Id. at 4.

Dr. Sasich’s Declaration of January 17, 2014

In January 2014, Defendants finally provided documents that Plaintiffs had

requested more than two months earlier.4 Defendants also served signed interrogatory

4 The documents were initially provided on December 27, 2013, but because ofDefendants’ counsel claimed errors in document redactions, they were permitted to withdraw thediscovery and reissue it. Plaintiffs’ counsel finally received the documents on January 10, 2014, and they immediately provided the documents to Dr. Sasich for review.

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responses, which also had been due weeks earlier. The interrogatory responses and new

documents, allowed Dr. Sasich to provide additional opinions, based on new factual

support. (See Exh. M, answer to #9(f)(g)).

On January 17, 2014, Dr. Sasich issued his most recent Declaration. (Exh. D). He

addressed the recently enacted federal Drug Quality and Security Act and news media

reports of Oklahoma’s execution of Michael Lee Wilson, who was injected with

compounded pentobarbital sodium and, after being injected, said he felt like his whole

body was burning. Dr. Sasich also reviewed Mr. Dormire’s interrogatory responses and

a rough draft of Dormire’s recent deposition testimony. (Ex. D, ¶¶ 4, 8).

Noting that media reports strongly suggest that the drug to be used in Mr. Smulls’

scheduled execution was prepared by an unidentified compounding pharmacy in

Oklahoma, Dr. Sasich prepared his Declaration under the assumption that the drug “was

indeed prepared by an Oklahoma compounding pharmacy regulated by the `Oklahoma

State Board of Pharmacy. Id. ¶ 6.

Dr. Sasich stated that the lack of definite knowledge of the name and location of the

compounding pharmacy and the contract testing laboratory used by the pharmacy

prevented him from rendering a full and final opinion at this time. Dr. Sasich stated he

knew nothing about the pharmacy’s physical facility, could not determine whether the

pharmacy has ever been inspected by state or federal authorities, or whether the pharmacy

has ever been disciplined for state or federal violations and, if so, for what violations.

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Because of limitations on discovery, Dr. Sasich does not know for certain what state’s

standards apply, or whether the pharmacy complied with the standards of the United States

Pharmacopeial Convention (USP), Chapter <797> or whether it complies with current

Good Manufacturing Practice (cGMP) standards. Exh. D at ¶5.

Dr. Sasich stated that both Oklahoma and Missouri pharmacy regulations follow

USP compounding standards, which are viewed as the minimum necessary to ensure that

injectable compounded drugs are safe and effective. Id. ¶ 7.

Dr. Sasich particularly focused on Mr. Dormire’s statements that the pentobarbital

was stored at room temperature after it was picked up from the pharmacy, and that, in Mr.

Smulls’ case, this would mean that the pentobarbital would have been stored for a

minimum of 15 days at room temperature. Dr. Sasich stated that the room temperature

storage represented a “very troubling deviation from USP standards.” (Exh. D ¶ 9)

(emphasis added). Dr. Sasich opined that improper storage “creates a very high risk that

the compounded drug will degrade or allow for more rapid growth of bacteria before it

is used for Mr. Smulls’ execution. Id. ¶ 9 (emphasis added).

Dr. Sasich explained that the improper storage could result in growth of bacterial

contamination or the production of endotoxins in the compounded drug. Id. He also

opined that the compounding pharmacy’s “failure to adhere to nationally recognized and

widely accepted standards also suggests that it may lack the equipment, facility, knowledge

or expertise to properly compound sterile pentobarbital sodium injection.” Exh. D ¶ 10.

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Noting that compounded pentobarbital sodium is a “high risk injectable according

to the USP Chapter <797> definition,” Dr. Sasich stated that it should be kept at room

temperature for no more than 24 hours, and that even if refrigerated, compounded

pentobarbital is considered safe and effective for no more than three days, and found the

failure of the pharmacy to instruct the Department of Corrections on proper storage of the

drug to be “deeply troubling.” Id. ¶ 11

After discussing problems resulting from poorly regulated compounding pharmacies

and the laboratories which purport to analyze their products – which “raise great concerns

about the quality and safety of the pentobarbital sodium intended to be used in the

execution of the plaintiffs in this case” – Dr. Sasich stated that:

The failure to properly store the pentobarbital intended for usein executions creates a very substantial, even grave, risk thatthe prisoner will suffer severe pain and/or an immediatesevere allergic reaction.”

Id. ¶ 15 (emphasis added). This is because, in addition to any adulteration or

contamination occurring during the compounding process, room-temperature storage

would encourage growth of any bacterial contamination of the compounded drug. Id.

Dr. Sasich added that, since the stability over time of compounded drugs is not

tested, and is therefore unknown, the standards applicable to the compounding, storage and

administration of the drugs “must be strictly adhered to or a substantial risk of severe pain

or other severe adverse effects may result.”

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Dr. Sasich observed enacted Drug Quality and Security Act, Section 503B, creates

a new optional license category for sterile compounders, called “outsourcing facilities,”

which must comply with FDA cGMP (current Good Manufacturing Practices). The cGMP

standards set a higher bar than USP Chapter <797>, which is the basis of pharmacy

compounding regulations in both Oklahoma and Missouri. Id. ¶ 17. The Drug Quality

and Security Act was enacted in response to the multistate outbreak of fungal meningitis

caused by contaminated compounded drugs that has resulted in the deaths of more than 60

people. Id.

Dr. Sasich stated that of the five pharmacist members of the Oklahoma State Board

of Pharmacy, four are involved in pharmacy compounding and two own compounding

pharmacies. He described Oklahoma’s historical “national advocacy role” in promoting

pharmacy compounding. Id. ¶ 18. Dr. Sasich stated that on a national level, the oversight

of compounding pharmacies by federal and state authorities is haphazard or non-existent.

Moreover, the contract testing labs provide no reliable reassurance about the quality

of compounded drugs. Five contract testing laboratories that dominate testing for large-

scale specialty pharmacies have been cited by the FDA for more than 70 safety problems.

(Exh. D ¶19) Dr. Sasich stated that Oklahoma-based Analytical Research Laboratories

reported favorable test results for medications produced by the now-closed New England

Compounding Center, which produced the drug that killed 64 people and sickened over

700 others last fall. Id. Dr. Sasich also cited DynaLabs, located in Missouri, which

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reported as safe and effective a calcium gluconate solution, dozens of batches of which

were recalled by the pharmacy in August, 2013 after being linked to two deaths and 13

illnesses at two Texas hospitals. Id. ¶ 19.

Dr. Sasich reiterated that Mr. Dormire’s interrogatory responses about the

expiration or “use by” date on compounded pentobarbital and the compounding

pharmacy’s instruction to store the drug at room temperature “were astonishing and, to me,

demonstrated an irresponsible lack of concern about the safety and quality of

compounded pentobarbital sodium purchased by the state for executions.” (Exh. D ¶20)

(emphasis added).

Dr. Sasich stated that the eight days between the receipt of the compounded drugs

and their use in the executions of Joseph Franklin and Allen Nicklasson “clearly falls

outside the requirements of USP Chapter <797> stating that high risk compounded drugs

such as pentobarbital should not be used after one day if stored at room temperature. Id.

¶ 20.

With regard to the January 10, 2014 execution of Oklahoma prisoner Michael Lee

Wilson, who said he felt his “whole body burning” within 20 seconds of receiving the

pentobarbital, Dr. Sasich opined it was possible “that Mr. Wilson’s reaction was due to

contaminated pentobarbital sodium,” that the injection used could have contained cross-

contaminates, bacteria and endotoxins, and that “because of this lack of oversight no one

knows for sure what was injected into Mr. Wilson.” Id. ¶ 21.

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Ultimately, Dr. Sasich concluded that “safe and effective sterile injections” cannot

be produced in compounding pharmacies. Id. ¶22. He stated: “Missouri Department of

Corrections purchased and used an out-of-date pentobarbital sodium injection of unknown

composition that carries a substantial risk of harm when used for executions.” Id. ¶ 22.

Expert Opinions of Dr. Heath Concerning Compounded Pentobarbital

Dr. Michael Heath, a board-certified anesthesiologist retained as an expert by

Plaintiffs, shares Dr. Sasich’s concerns about compounded pentobarbital of unknown

origin, including the concerns about contamination, deviations in pH or concentration, or

the use of a drug that lacks the correct chemical properties—all of which may result in pain

on injection or only a partial or ineffective dosage of the drug. (Exh. M at 10, answer to

#9(f)(g)).

Dr. Heath warns that sub-potent pentobarbital may even disable the prisoner

severely but without actually killing him. It carries a risk that the prisoner “will be

unconscious for an extended period of time while breathing inadequately, before waking

up in a permanently brain-damaged state.” Id. ¶ 9 (emphasis added). At that point, it

would be unthinkable for Defendants to inject more of their product in order to induce

death, because the prisoner’s failure to die would prove that the executioners do not know

the identity or potency of whatever substance they are injecting. Id. Dr. Heath observes

more broadly that the new protocol is “replete with flaws that present a substantial risk of

causing severe and unacceptable levels of pain and suffering during the execution.” Id.

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¶ 17 (emphasis added).

As Dr. Sasich and Dr. Heath have made clear, the risks associated with compounded

pentobarbital are not merely speculative, but are very real - as illustrated by the recent

execution in Oklahoma, in which the prisoner felt his “whole body burning.” (Exh. A).

The concerns about the dangers of improperly stored, compounded pentobarbital

from a secret source are so troubling that Plaintiffs have taken the unusual step of filing

complaints with the Boards of Pharmacy in both Missouri and Oklahoma, and with federal

prosecutors in Missouri. As explained in the next section, the Department of Corrections

is violating numerous state and federal laws and regulations designed to protect the public

from unsafe, contaminated and defective drugs.

Complaint to Missouri Board of Pharmacy

On December 30, 2013, Plaintiffs in this case, including Mr. Smulls, filed a formal

complaint with the Missouri Board of Pharmacy, and subsequently submitted three follow

up letters alleging additional regulatory violations and factual support for their claims.

(Exh. O) The complaint was on the Board’s agenda for meetings on January 16 and 17,

2014, but the outcome of those meetings is unknown at present. Plaintiffs alleged

numerous violations of Missouri regulatory law, including regulations requiring a valid

prescription and prohibiting the compounding of drugs that are essentially copies of FDA-

approved and manufactured drugs. (See Exh. O).

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At the outset, it is also important to note that the compounding pharmacy does not

appear to be licensed in the State of Missouri, as required by 20 C.S.R. § 2220-2.025(1),

which states that “non-resident pharmacies shall not ship, mail or deliver prescription drugs

into Missouri without first obtaining a pharmacy license from the Missouri Board of

Pharmacy.” When asked if the compounding pharmacy was licensed in the State of

Missouri, Mr. Dormire stated in his deposition that he did not know. (Exh. C at 56-57; see

also Exhibit O, attached follow up letter of Jan. 2, 2014.)

The Department of Corrections’ lethal injection protocol also facially violates

several of Board of Pharmacy’s regulations. The Board’s regulations recognize the hazards

of administering expired compounded drugs: “Because compounded preparations are

intended for administration immediately or following short-term storage, their beyond-use

dates must be assigned based on criteria different from those applied to assigning

expiration dates to manufactured drug products.” 20 Mo. C.S.R. § 2220-2.200(1)( c).

Recent evidence shows that the compounded pentobarbital is expired and that the

Department plan to administer it during Mr. Smulls’ execution more than two weeks

beyond the drug’s proper “beyond-use date.” A sworn interrogatory response from the

Department shows that it stores its pentobarbital at room temperature. (See Exhibit M)

The compounding pharmacy specifically advised DOC to store the drug at room

temperature. Id. Moreover, the pharmacy, by agreement, provides the compounded drug

to the Department at least 15 days prior to the date of the execution. Plaintiffs, including

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Mr. Smulls, submitted all of these facts, along with supporting evidence, to the Missouri

Board of Pharmacy. (See Exh. O).

The Department and its pharmacy transgress not only a binding regulation that

carries the force and effect of law, but also United States Pharmacopoeia (USP) standards

governing beyond-use dating for compounded sterile preparations. See Exhibits D, E

(Declarations of Dr. Larry D. Sasich, Dec. 6, 2013) at pp. 1-2 citing USP Chapter <795>

and <797>. The USP standards establish a maximum of 24 hours after compounding, for

any such drug to be administered, if it is stored at room temperature. Id. The Department

and its pharmacy are violating established standards reflecting a consensus of pharmacy

experts and practitioners. (See Exh. O)

Plaintiffs believe their detailed and well-supported allegations to the Missouri Board

of Pharmacy deserve – and will receive – careful review, as the Department is clearly in

violation of not only nationally recognized standards, but also Missouri regulatory law.

Complaint to Oklahoma Board of Pharmacy

On January 17, 2014, counsel for Mr. Smulls filed a formal complaint with the

Oklahoma Board of Pharmacy, which outlined similar violations of Oklahoma law. (See

Exh. P) (Oklahoma Board of Pharmacy Complaint). Mr. Smulls identified several

violations in his complaint. A few of those violations are included here:

· Title 59 O.S. 535:15-10-61 (a) (Beyond-use dates (BUDs) shall be assigned to all

compounded sterile preparations. The shorter of the chemical stability (established

32


by the manufacturer, or listed in a current authoritative reference, or established by

direct testing following USP standards or equivalent) and microbial limits of

sterility (USP <797> requirements shall be used to determine the date.”);

· Title 59 O.S. 535:15-3-13© (“Legitimate purpose. The pharmacy or pharmacist

shall ensure that the prescription drug or medication order, regardless of the means

of transmission, has been issued for a legitimate medical purpose by and authorized

practitioner acting in the usual course of the practitioner’s professional practice.”);

and,

· Title 59 O.S. 535:15-10-53(a) (“compounding a drug that is commercially available

in the marketplace or that is essentially a copy of an available FDA-approved drug

is generally prohibited unless patient therapy is compromised.”).

Both the Missouri and Oklahoma Boards of Pharmacy are charged with

investigating complaints involving unlicensed activity or claims against any licensee or

registrant. A stay of execution is warranted so that these state regulatory authorities may

fulfill their purpose and investigate the complaints submitted by Mr. Smulls and the other

Plaintiffs.

Complaint to United States Attorney’s Office, Western District of Missouri

On December 30, 2013, Plaintiffs in Zink et al. v. Lombardi et al. 2:12-cv-04209-BP

(W.D. Mo.), including Mr. Smulls, filed a formal complaint with the United States

33


Attorney’s Office, Western District of Missouri alleging that the DOC is violating federal

law. (See Exh. Q).

The complaint complaint alleges that Missouri’s lethal injection protocol violates

the federal Food, Drug, and Cosmetic Act (FDCA) as well as the Controlled Substances

Act. The execution protocol violates the FDCA in two ways. First, the Department of

Corrections is obtaining, dispensing, and administering the prescription-only drug

pentobarbital without a medical prescription, in violation of 21 U.S.C. § 353(b). The

“prescription” issued by the Department’s physician is ineffective because it is not

administered in the course of usual medical practice. See, e.g. United States v. Nazir, 211

F.Supp.2d 1372, 1374-76 (S.D. Fla. 2002).

The FDCA, supplemented by the Drug Quality and Security Act, was signed into

law by President Obama on November 27, 2013. Under the new law, the Department of

Corrections’ compounded “copy” of an FDA-approved drug constitutes an illegal and

unapproved “new drug” under 21 U.S.C. § 355. See Pub. L. No. 113-54, 127 Stat. 587

(Nov. 27, 2013), § 102(a) (modifying scope of FDCA § 505).

The Department of Corrections is also violating the Controlled Substances Act.

Pentobarbital is a Schedule III controlled substance. See 21 C.F.R. § 1306.04(a) (“An order

purporting to be a prescription issued not in the usual course of a professional treatment

or in legitimate or authorized research is not a prescription within the meaning and intent

of section 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a

34


purported prescription, as well as the person issuing it, shall be subject to the penalties

provided for violations of the provisions of law relating to controlled substances.”).

LEGAL ARGUMENT

I. Standards governing a stay of execution

Mr. Smulls is requesting a stay of only 60 days, for the purpose of allowing him to

develop the evidence he needs to prove his Eighth Amendment claims. This period of

time will allow additional, and highly productive discovery, and will also allow for

regulatory authorities to investigate Plaintiffs’ complaints. Defendants should not be

rewarded for their constant changes of protocol and continuing delays during discovery,

all of which have combined to prevent Mr. Smulls and the other Plaintiffs from obtaining

the critical evidence they need to show that Defendants’ use of a defective lethal drug

poses an enormous risk that Mr. Smulls will experience severe and unnecessary pain during

the execution.

Because of their own actions, Defendants are not able to safely and legally carry out

their own protocol, in terms of delivering a safe, effective dose of pentobarbital to execute

Mr. Smulls. What they have instead is an illegal, “copycat” drug that will be dangerously

degraded and likely full of bacteria by the date scheduled for Mr. Smulls’ execution.

Defendants’ attempt to use such an illegal and obviously defective drug violates numerous

state and federal laws, as discussed above, and places Mr. Smulls at grave risk for

experiencing excruciating pain or other severe harm during the execution, all in violation

35


of the Eighth Amendment prohibition on cruel and unusual punishment.

The standards for a stay of execution are well-established. Relevant considerations

for granting a stay include the prisoner’s likelihood of success on the merits, the relative

harm to the parties, and the extent to which the prisoner has unnecessarily delayed his or

her claims. See, Hill v. McDonough, 547 U.S. 573, 584 (2006); Nelson v. Campbell, 541

U.S. 637, 649-50; and Nooner v. Norris, 491 F.3d 804, 808 (8th Cir. 2007). All three

factors weigh strongly in Mr. Smulls’ favor.

II. Mr. Smulls is likely to prevail on the merits of his claims.

To prevail on his Eighth Amendment cruel and unusual punishment claim, Mr.

Smulls must show that the use of a secretly compounded drug alleged to be pentobarbital,

which has been produced, handled and stored in violation of widely accepted and

recognized standards, and in violation of state and federal regulatory law, to execute him

creates “a ‘substantial risk of serious harm,’ an ‘objectively intolerable risk of harm,’” in

the form of needless suffering. Baze v. Rees, 553 U.S. 35, 50 (2008) (citing Farmer v.

Brennan, 511 U.S. 825, 842, 846 (1994)).

Mr. Smulls has shown a significant possibility of success on the merits on this issue,

beyond mere speculative allegations, in the form of the January 17, 2014, Declaration of

Dr. Larry Sasich (Exh. D), which not only particularizes the reasons why the Defendants’

secretly compounded purported pentobarbital, having been stored at room temperature for

fifteen days, is likely to have bacterial contamination which has grown during the improper

36


storage of the drug, but also concludes that the nationally publicized reaction of Michael

Lee Wilson, executed by Oklahoma on January10, 2014, that he felt “his whole body

burning,” was possibly due to contaminated pentobarbital sodium. Ex. D ¶¶ 8, 9, 11, 15,

20 21, 22.

III. The relative harm to the parties factor also weighs heavily in Mr. Smulls’

favor.

Mr. Smulls would suffer irreparable harm without a stay. Of course, the death

penalty is “obviously irreversible.” Evans v. Bennett, 440 U.S. 1301, 1306 (1979)

(Rhenquist, J., granting stay as circuit justice.) Executing Mr. Smulls with the secretly

compounded, improperly stored purported pentobarbital creates a substantial risk that Mr.

Smulls’ last conscious memory will be the experience of excruciating pain. That risk is

documented by abundant and persuasive evidence, and there is no way to remedy a painful

and unconstitutional execution after it has occurred.

Moreover, Defendants themselves are responsible for any harm caused by a stay.

As the Court has previously explained:

[A]ny harm to Defendants caused by a stay is entirely self-inflicted. Defendants chose an untested, non-litigated method of execution in 2012. After more than a year of litigation and only after the close of discovery didDefendants change the protocol to address specific concerns raised byPlaintiffs. Defendants issued three different protocols in the three monthspreceding Franklin’s execution date, and as recent as five days before theexecution, Defendants again changed their method of execution. Defendants’ protocol has been a frustratingly moving target. In the face ofsuch a grave consequence as the death penalty, this Court declines to reward

37


Defendants’ attempts to prevent Plaintiffs from fully litigating their claims.

Doc. #163, at 12-13. Since then, Defendants have escalated their strategy of obfuscation

and delay, insisting on impeding discovery through spurious claims of state secrets so that

they can evade resolution of the issues while attempting to accelerate the pace of

executions in Missouri, with Mr. Smulls next in their cross-hairs.

IV. Mr. Smulls and the other Plaintiffs have developed and asserted their claims

as promptly as possible.

Mr. Smulls has been diligent throughout these events. Plaintiffs brought suit only six weeks

after the Department issued its initial propofol protocol on May 15, 2012; they gathered and

presented additional scientific evidence when Defendants twice switched to other propofol-based

methods; and Plaintiffs, including Mr. Smulls, have brought their current claims at the earliest

opportunity. Cf. Hill v. McDonough, 547 U.S. 573, 584 (2006) (noting the "strong equitable

presumption against the grant of a stay where a claim could have been brought at such a time as

to allow consideration of the merits without requiring entry of a stay"). This Court is well aware

of the convoluted procedural history of this litigation, and there is no question that Defendants are

the source of the delays in resolving the issues. Neither Mr. Smulls nor any of his fellow plaintiffs

have been less than diligent in seeking a prompt resolution of the issues in this case.

Moreover, Mr. Smulls does not seek an indefinite stay of execution in this Motion. He

seeks only a stay of sixty (60) days, in which he can overcome the Defendants’ procedural stalling

and gather evidence to show even more clearly the overwhelming likelihood that Plaintiffs will

prevail on the merits of the case. In that sixty-day period, Mr. Smulls and the other Plaintiffs

38


should be able to depose the compounding pharmacist(s) and the testing chemist(s) to ascertain

the procedures they follow and the instructions they give their clients about handling, storage and

administration of the product, and ascertain any disciplinary histories of those entities or

individuals with the agencies which regulate their professional licenses. See. Ex. D at ¶ 5.

Plaintiffs, including Mr. Smulls, also hope to gain substantial additional information about the

pharmacy and its facilities, as well as about the drug itself, including the conditions and manner

in which the drug is compounded and how it is stored at the pharmacy or lab before it is turned

over to the Department. Depending on the outcome of the Eighth Circuit litigation, In re

Lombardi, they may also seek to inspect the pharmacy itself and ascertain the extent to which it

is complying with state and federal laws as well as industry standards for compounding.

What is clear even at present, however, is that the compounding pharmacy and the

Department have acted in careless and dangerous disregard of Mr. Smulls’ Eighth Amendment

rights and that they are preparing to execute him with a drug whose safety, effective and legality

they cannot assure.

CONCLUSION

Based on all of the foregoing arguments and authorities, Mr. Smulls respectfully

requests that this Court grant his motion for a 60-day stay of execution, granting him the

opportunity to obtain the information necessary to developing his claims.

39


Respectfully submitted,

MORGAN PILATE, LLC

/s/ Cheryl A. Pilate

Cheryl A. Pilate Mo. # 42266

Lindsay J. Runnels Mo. # 62075

926 Cherry Street

Kansas City, MO 64106

Telephone: 816-471-6694

E-mail: [email protected]

CERTIFICATE OF SERVICE

I, Cheryl A. Pilate, do hereby certify that a true and accurate copy of the above andforgoing was served on all counsel of record via the ECF system on 21st day of January,2014.

/s/ Cheryl A. Pilate

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mailto:[email protected]

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