IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MISSOURI CENTRAL DIVISION

DAVID ZINK, et al., Plaintiffs, v.

GEORGE A. LOMBARDI, et al., Defendants.

) ) ) ) ) ) ) ) ) ) )

No. 2:12-CV-4209-BP This is a capital case

Execution of Plaintiff Smulls scheduled January 29, 2014

HERBERT SMULLS MOTION FOR 60-DAY STAY OF EXECUTION BASED ON NEW FACTS THAT ESTABLISH THE UNCONSTITUTIONALITY OF STATES EXECUTION METHODS, INCLUDING THE USE OF A SUBSTANDARD COMPOUNDED DRUG

Charles M. Rogers Wyrsch, Hobbs, Mirakian, PC 1000 Walnut, Suite 1600 Kansas City, MO 64106 (816) 221-0080

Cheryl A. Pilate Lindsay J. Runnels Morgan Pilate LLC 926 Cherry Street Kansas City, MO 64106 (816) 471-6694

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TABLE OF CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Factual Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 A. B. C. D. E. F. G. H. I. History of Proceedings, including Two Executions . . . . . . . . . . . . . . . . . . . . . .9 Discovery Delays and Pending Motion for Sanctions . . . . . . . . . . . . . . . . . . . 13 Judge Byes Dissent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Recent Discovery Concerning Compounded Pentobarbital . . . . . . . . . . . . . . . 16 Expert Opinions of Dr. Sasich Concerning Compounded Pentobarbital . . . . . 18 Expert Opinions of Dr. Heath Concerning Compounded Pentobarbital . . . . . .29 Complaint to Missouri Board of Pharmacy . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Complaint to Oklahoma Board of Pharmacy . . . . . . . . . . . . . . . . . . . . . . . . . . .32 Complaint to United States Attorneys Office . . . . . . . . . . . . . . . . . . . . . . . . . .33

Legal Argument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 I. II. III. IV. Standards Governing a Stay of Execution . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35 Mr. Smulls is Likely to Prevail on the Merits of His Claims . . . . . . . . . . . . . . 36 The Relative Harm to the Parties Weighs Heavily in Favor of Mr. Smulls . . . 37 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 Departments failures have placed Mr. Smulls at grave risk that he will experience excruciating pain during his execution due to the Departments 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:

Missouris 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 Departments 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. 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 (Exh. C at 55-

shocking, the compounded pentobarbital is stored at the pharmacys 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 Departments custody. (Exh. C at 41, 73, 125). It was picked up on January 14, 2014, from

Until issues are resolved between the parties or with the court as to which portions of the transcript are designated confidential, Plaintiffs are filing the entire transcript under seal. 4

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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. 22202.200, 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 Missouris use of substandard, dangerous and illegal drugs are currently 5

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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 Departments flagrantly illegal protocol. (See discussion, infra) A dissenting opinion from the Eighth Circuits denial of a stay to Allen Nicklasson, authored by Judge Bye and joined by Judge Kelly, sharply criticized Missouris 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 6

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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. Dormires deposition and the recently exposed violations of state and federal law, provide ov erwhelming 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 footdragging 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 Missouris recent use of secret compounding pharmacies and copycat pharmaceuticals, but also criticizes Missouris 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 Auditors Office;2 and, The series of affidavits obtained from Plaintiffs pharmacy expert, Larry Sasich, PharmD, whose most recent opinions concern Missouris 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 Nicklassons motion for stay, Doc. #184, and need not be reiterated here. Mr. Smulls summarizes only central developments that bear directly on this This Missouri auditors office announced on January 13, 2014 that it was conducting an audit of the Missouri Department of Corrections. The deputy state auditor, Harry Otto, noted that the auditors office intended to examine whether the Department had followed its own policies and procedures with respect to the execution protocol and would evaluate whether any violations of state law had occurred. (See Exh. R, Audit will prober Corrections Department execution procedures, drug procurement, Missourinet, Jan. 13, 2014).
9
2

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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 Franklins motion for stay of execution, based on the fact he had been afforded no time to research the risk of pain associated with the Departments 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 Courts order based on the Eighth Amendment, and subsequently denied rehearing en banc. (Doc. #183 at 11) Franklins 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, Franklins 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) Franklins attorneys

adhered to protocol and the courts procedures, calling the Courts 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. Nicklassons 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 Byes 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 Plaintiffs

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.
Plaintiffs Motion and Reply in support of their Motion for Sanctions observes that Defendants foot-dragging and non-responsiveness in discovery has been so pervasive that it suggests 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 the second and third discovery requests made or assert to the Plaintiffs or to this Court that they were untimely served, improper...or [objectionable] for any reason otherwise. They simply ignored them. This is consistent with their tactic throughout this litigation of delaying responses to requests for as long as possible so as to deprive Plaintiffs of information to which they are entitled and 13
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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). 14

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these central documents. Judge Byes 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. Nicklassons motion for a stay, which had been denied as moot because he had already been executed. Judge Byes opinion provides a blistering critique of Missouris 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, Missouri executed Allen Nicklasson before this court had completed its review of Nicklassons request for a stay of his execution, a request he brought in a pending action challenging the constitutionality of Missouris execution protocol. That bears repeating. Missouri put Nicklasson to death before the federal courts had a final say on whether doing so violated the federal constitution.

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(Exh. F at 1-2) Judge Bye also recounted Missouris use, for many years, of an admittedly dyslexic physician to implement the states unwritten protocol, including the responsibility of correctly mixing the drugs used in execution. (Exh. F at 9)(emphasis in original). With regard to Missouris recent resumption of executions, Judge Bye observes that Missouris 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: [Missouris] current practice of using shadow pharmacies hidden behi n d the hangmans hood, copycat pharmaceuticals, numerous last-minute changes to its execution protocol, and finally, its act of proceeding with an execution before the federal courts had completed their review of an active request for a stay, has committed this judge to subjecting the states future implementation of the penalty of death to intense judicial scrutiny, for the sake of death row inmates involved as well as adversaries and advocates of capital 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. Sasichs 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 Missouris 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.
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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 drugs 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 superpotent, either from (a) the fact that Missouris protocol specifies no means of adjusting the measurements of the chemical to account for the drugs 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 fungusany 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. Sasichs 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 secretlycompounded 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 crosscontamination 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
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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. Nicklassons 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. Franklins 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. Sasichs 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

The documents were initially provided on December 27, 2013, but because of Defendants counsel claimed errors in document redactions, they were permitted to withdraw the discovery and reissue it. Plaintiffs counsel finally received the documents on January 10, 2014, and they immediately provided the documents to Dr. Sasich for review. 23

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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 Oklahomas 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. Dormires interrogatory responses and a rough draft of Dormires 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 pharmacys 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 states 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. Dormires 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 pharmacys 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 use in executions creates a very substantial, even grave, risk that the prisoner will suffer severe pain and/or an immediate severe 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 Oklahomas 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 largescale 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. Dormires interrogatory responses about the

expiration or use by date on compounded pentobarbital and the compounding pharmacys 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. Wilsons reaction was due to contaminated pentobarbital sodium, that the injection used could have contained crosscontaminates, 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. Sasichs 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 propertiesall 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 prisoners 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 Boards 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 FDAapproved 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 Pharmacys regulations. The Boards 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 drugs 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
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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 practitioners 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 Attorneys 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

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Attorneys Office, Western District of Missouri alleging that the DOC is violating federal law. (See Exh. Q). The complaint complaint alleges that Missouris 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 Departments 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
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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
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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 prisoners 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
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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. 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 did Defendants change the protocol to address specific concerns raised by Plaintiffs. Defendants issued three different protocols in the three months preceding Franklins execution date, and as recent as five days before the execution, Defendants again changed their method of execution. Defendants protocol has been a frustratingly moving target. In the face of such a grave consequence as the death penalty, this Court declines to reward
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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

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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.

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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: cpilate@morganpilate.com CERTIFICATE OF SERVICE I, Cheryl A. Pilate, do hereby certify that a true and accurate copy of the above and forgoing 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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