App. No.

___

--------------------

In The

Supreme Court of the United States

--------------------

Christopher Sepulvado,

Petitioner,

v.

Bobby Jindal et al.,

Respondents.

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APPLICATION FOR STAY OF EXECUTION PENDING
DISPOSITION OF PETITION FOR A WRIT OF CERTIORARI

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ii

TABLE OF CONTENTS
TABLE OF AUTHORITIES ......................................................................................... iv
I. INTRODUCTION .................................................................................................. 1
II. BACKGROUND ..................................................................................................... 3
A. The National Drug Shortage And Its Effect On Execution Protocols. ........ 3
B. Louisianas Continued Administration Of Executions................................. 5
C. Louisianas Refusal To Disclose Its Execution Protocol ............................... 7
D. Summary Of The Proceedings Below ............................................................ 8
E. Subsequent Events Establishing That The State Will Have To Revise Its
Protocol ......................................................................................................... 12
III. REASONS FOR GRANTING THE STAY .......................................................... 17
IV. PETITIONERS MOTION FOR A STAY OF EXECUTION WAS TIMELY ..... 23
V. THIS COURT HAS NEVER CONFRONTED THE QUESTION
PRESENTED IN THE PROCEDURAL POSTURE OF THIS CASE ............... 27
VI. CONCLUSION..................................................................................................... 32
APPENDIX .................................................................................................................. 1a
Appendix A, Lundbeck Pentobarbital Distribution Program Press Release .... 1a
Appendix B, Lundbeck Pentobarbital Divestment Press Release ..................... 4a
Appendix C, First Request for Public Records ................................................... 7a
Appendix D, Response to First Request for Public Records ............................ 11a
Appendix E, Second Request for Public Records .............................................. 15a
Appendix F, Response to Second Request for Public Records ......................... 22a
Appendix G, Request for Administrative Remedies ......................................... 29a
Appendix H, Response to Request for Administrative Remedies .................... 32a
iii

Appendix I, Nembutal Inventory ...................................................................... 34a
Appendix J, January 16, 2014 E-mail from Carlos Finalet, III, General
Counsel, Louisiana Board of Pharmacy ............................................................ 36a
Appendix K, January 16, 2014 E-mail from Jeffrey K. Cody, Counsel for
Louisiana ............................................................................................................ 38a
Appendix L, January 21, 2014 Letter from Gary Clements, Counsel for
Petitioner ........................................................................................................... 40a
Appendix M, January 22, 2014 E-mail from James L. Hilburn, Counsel for
Louisiana ............................................................................................................ 43a
Appendix N, January 24, 2014 Letter from James L. Hilburn, Counsel for
Louisiana ............................................................................................................ 45a
Appendix O, Supplemental Responses to Plaintiffs First Set of
Interrogatories to Defendants ........................................................................... 47a
Appendix P, Affidavit of Larry D. Sasich, PharmD, MPH, FASHP ................ 57a

iv

TABLE OF AUTHORITIES
Cases
Ake v. Oklahoma,
470 U.S. 68 (1985) .................................................................................................... 19
Arthur v. Thomas,
No. 2:11-CV-0438-MEF, 2013 WL 5434694 (M.D. Ala. Sept. 30, 2013) ................... 5
Baze v. Rees,
553 U.S. 35 (2008) ............................................................................................ passim
Beardslee v. Woodford,
395 F.3d 1064 (9th Cir. 2005) .................................................................................. 23
Beaty v. Brewer,
131 S. Ct. 2929 (2011) .............................................................................................. 29
Beaty v. Brewer,
649 F.3d 1071 (9th Cir. 2011), cert. denied, 131 S. Ct. 2929 .................................. 29
Beaty v. Brewer,
791 F. Supp. 2d 678 (D. Ariz. 2011), affd, 649 F.3d 1071 (9th Cir.), cert.
denied, 131 S. Ct. 2929 ............................................................................................ 29
Brewer v. Landrigan,
131 S. Ct. 445 (2010) .......................................................................................... 27, 28
Code v. Cain,
No. 138,860 (1st J.D.C. Mar. 23, 2011), writ denied, No. 09-0113 (La. Oct. 8,
2010); 46 So. 3d 1258. .............................................................................................. 22
Cooey v. Taft,
430 F. Supp. 2d 702 (S.D. Ohio 2006) ..................................................................... 21
Ford v. Wainright,
477 U.S. 399 (1986) .................................................................................................. 18
Gomez v. U.S. Dist. Court for the N. Dist. of Cal.,
503 U.S. 653 (1992) .................................................................................................. 23
Gomez v. U.S. Dist. Court for the N. Dist. of Cal.,
966 F.2d 460 (9th Cir. 1992) .................................................................................... 21
Graves v. Barnes,
405 U.S. 1201 (1972) ................................................................................................ 17
Gregg v. Georgia,
428 U.S. 153 (1976) .................................................................................................. 18
Hamdi v. Rumsfeld,
542 U.S. 507 (2004) .................................................................................................. 11
v

Hobbs v. Jones,
412 S.W.3d 844 (Ark. 2012) ....................................................................................... 5
Holtzman v. Schlesinger,
414 U.S. 1304 (1973) ................................................................................................ 17
In re Holladay,
331 F.3d 1169 (11th Cir. 2003) ................................................................................ 21
In re Ohio Execution Protocol Litig.,
840 F. Supp. 2d 1044 (S.D. Ohio 2012), motion to vacate stay denied, 671
F.3d 601 (6th Cir.), motion to vacate stay denied sub nom. Turner v. Epps,
132 S. Ct. 1306 ......................................................................................................... 22
In re Roche,
448 U.S. 1312 (1980) ................................................................................................ 17
Jones v. Bock,
549 U.S. 199 (2007) .................................................................................................. 24
Jones v. Hobbs,
No. 5:10CV00065JLH, 2010 WL 1417976 (E.D. Ark. Apr. 5, 2010), affd sub
nom., Williams v. Hobbs, 658 F.3d 842 (8th Cir. 2011) .......................................... 31
Landrigan v. Brewer,
625 F.3d 1132 (9th Cir. 2010), vacated, 131 S. Ct. 445 .................................... 21, 27
Landrigan v. Brewer,
No. CV-10-2246-PHX-ROS, 2010 WL 4269559 (D. Ariz. Oct. 25, 2010), affd,
625 F.3d 1144 (9th Cir.), vacated, 131 S. Ct. 445 ............................................. 22, 27
Mathews v. Eldridge,
424 U.S. 319 (1976) .................................................................................................. 19
Nelson v. Campbell,
541 U.S. 637 (2004) ............................................................................................ 10, 20
Oken v. Sizer,
321 F. Supp. 2d 658 (D. Md. 2004), stay vacated, 524 U.S. 916. ...................... 19, 30
Reid v. Covert,
354 U.S. 1 (1957) ...................................................................................................... 20
Rostker v. Goldberg,
448 U.S. 1306 (1980) ................................................................................................ 17
Sims v. Dept of Corr. & Rehab.,
157 Cal. Rptr. 3d 409 (Cal. Ct. App. 2013) ................................................................ 5
Sizer v. Oken,
542 U.S. 916 (2004) ............................................................................................ 29, 30
State v. Sepulvado,
No. 13-0098 (La. Jan. 23, 2013); 105 So.3d 59 .................................................... 8, 26
vi

University of Texas v. Camenisch,
451 U.S. 390 (1981) .................................................................................................. 11
Wainwright v. Booker,
473 U.S. 935 (1985) .................................................................................................. 20
Whitaker v. Livingston,
732 F.3d 465 (5th Cir. 2013), cert. denied sub nom., Yowell v. Livingston, 134
S. Ct. 417 (2013) ................................................................................................. 28, 29
Wilkinson v. Dotson,
544 U.S. 74 (2005) .................................................................................................... 24
Williams v. Hobbs,
133 S. Ct. 97 (2012) .................................................................................................. 31
Williams v. Hobbs,
658 F.3d 842 (8th Cir. 2011) .................................................................................... 32
Woodson v. North Carolina,
428 U.S. 280 (1976) .................................................................................................. 20
Yowell v. Livingston,
134 S. Ct. 417 (2013) .......................................................................................... 28, 29

Statutes
21 U.S.C. 841 ............................................................................................................. 14
42 U.S.C. 1983 ................................................................................................... passim
42 U.S.C. 1997 ........................................................................................................... 24
La. Rev. Stat. Ann. 37:1285 (2007) ........................................................................... 14

Regulations
21 C.F.R. 1306.04 ...................................................................................................... 14
La. Admin. Code tit. 46, 1817 (2012) ........................................................................ 13
La. Admin. Code tit. 46, 2309 (2012) ........................................................................ 15
La. Admin. Code tit. 46, 2501 (2012) ........................................................................ 13
La. Admin. Code tit. 46, 2535 (2012) ........................................................................ 15




vii

Other Authorities
Anticipatory Motion to Lift Stay, Landrigan v. Trujillo,
131 S. Ct. 445 (No. 10-A416) .................................................................................... 27
Commission Implementing Regulation 1352/2011,
2011 O.J. (L 338) 31 ................................................................................................... 4
Compounding and the FDA: Questions and Answers,
U.S. Food & Drug Admin.,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Phar
macyCompounding/ucm339764.htm#approved ...................................................... 15
Deborah W. Denno, Lethal Injection Chaos Post-Baze,
102 Geo. L.J. (forthcoming 2014) ........................................................................... 3, 4
Emergency Application to Chief Justice to Vacate Stay of Execution,
Sizer v. Oken, 542 U.S. 916 (2004) (No. 03-A1023) ................................................. 30
FDA Approved Drug Products, U.S. Food & Drug Admin.,
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm ......................... 12
Manny Fernandez, Executions Stall as States Seek Different Drugs,
N.Y. Times, Nov. 8, 2013, at A1 ................................................................................ 4
First Amended and Supplemental Reconventional Demand for Declaratory
Judgment,
Code v. Dept. of Pub. Safety and Corr., No. C585410 (19th J.D.C. Jan. 22,
2010) ........................................................................................................................... 6
Frequently Asked Questions, Nembutal,
http://www.nembutal.net/faqs.php ...................................................................... 4, 13
Judgment, Code v. Dept. of Pub. Safety and Corr.,
No. C585410 (19th J.D.C. Mar. 10, 2011) ................................................................. 6
La. State Penitentiary, Louisiana Execution Protocol (2013) .............................. 15, 16
Motion to Compel, Hoffman v. Cain,
No. 12-796-JJB-SCR (M.D. La. Oct. 21, 2013) ........................................................ 10
Notice of Disclosure, Schad v. Brewer,
No. 13-02001-ROS (D. Ariz. Oct. 5, 2013) ................................................................. 5
Number of Executions by State and Region Since 1976,
Death Penalty Info. Center, http://www.deathpenaltyinfo.org/number-
executions-state-and-region-1976 .............................................................................. 5
Opinion on Preliminary Injunction, Whitaker v. Livingston,
No. H-13-2901 (S.D. Tex. Oct. 5, 2013) ................................................................... 29
Order, Baze v. Thompson,
No. 06-CI-574 (Franklin Cir. Ct. Dec. 5, 2013) ......................................................... 5
viii

Order, Hill v. Owens,
No. 2013-CV-233771 (Ga. Sup. Ct. July 18, 2013), appeal docketed, No.
S14A0092 (Ga.) ................................................................................................... 21, 22
Order, State v. Irick,
No. M1987-00131-SC-DPE-DD (Tenn. Dec. 11, 2013) .............................................. 5
Petition for a Writ of Certiorari, Yowell v. Livingston,
134 S. Ct. 417 (2013) (No. 13-6809) ......................................................................... 28
Plaintiff Christopher Sepulvados Second Set of Requests for Production,
Hoffman v. Jindal, No. 3:12-cv-00796 (M.D. La. Jan. 7, 2014) .............................. 26
Press Release, Hospira, Hospira Statement Regarding Pentothal (Sodium
Thiopental) Market Exit (Jan. 21, 2011) ................................................................... 4
Respondents Brief in Opposition to Petition for Writ of Certiorari and
Application for Stay of Execution,
Yowell v. Livingston, 134 S. Ct. 417 (2013) (No. 13-6809) ...................................... 28
Ruling on Motion for Protective Order, Hoffman v. Cain,
No. 12-796-JJB-SCR (M.D. La. June 4, 2013) .......................................................... 9
Josh Sanburn, Ohios Lethal-Injection Experiment,
Time (Jan. 17, 2014), http://nation.time.com/2014/01/15/ohios-lethal-
injection-experiment .................................................................................................. 4
Supplemental Response to Motion to Vacate Stay, Brewer v. Landrigan,
131 S. Ct. 445 (No. 10-A416) .................................................................................... 27
Transcript, Code v. Dept. of Pub. Safety and Corr.,
No. C585410 (1st J.D.C. Feb. 22, 2011) ..................................................................... 7



1
To the Honorable Justice Antonin Scalia, as Circuit Justice for the United
States Court of Appeals for the Fifth Circuit:
Petitioner Christopher Sepulvado (petitioner) respectfully requests a stay of
his execution, presently scheduled for February 5, 2014, pending this Courts
disposition of his petition for a writ of certiorari, filed on January 27, 2014. In the
alternative, petitioner requests that the Court issue an order directing that the
execution not be conducted in a manner that materially deviates from the execution
protocol previously disclosed to petitioner.
I. INTRODUCTION
The Fifth Circuit held that petitioner has no due process right to know the
states protocol for executing him. Louisiana has separately produced a protocol in
June 2013 (the 2013 Protocol), but the state has already violated it. There is
moreover compelling evidence that the state will abandon its protocol altogether
because pentobarbital the sole drug specified is unavailable for use in
executions. Petitioner has asked the state to notify him of any changes it makes to
the protocol prior to his execution, but the state has not agreed to do so. To the
contrary and remarkably the state has gone back on its representation that it
would provide discovery regarding the nature and origin of the drugs that will be
used in the execution, stating that it is not required to provide that information to
petitioner until the day after he is executed.



2
This Courts four-part standard for granting a stay of execution is satisfied in
this case. First, there is a reasonable probability that four Justices will vote to
grant certiorari. As explained in petitioners parallel Petition for a Writ of
Certiorari, the Question Presented whether and to what extent the Due Process
Clause of the Fourteenth Amendment entitles a condemned inmate to timely notice
of the method by which he will be executed is a frequently arising legal question
that is the subject of significant disagreement among federal judges. Second, there
is a fair prospect that this Court will reverse the decision below. The Fifth Circuits
resolution of that question is irreconcilable with this Courts precedents. Due
process protects a condemned inmates interest in a humane death and affords him
the concomitant right to obtain the protocol by which he will be executed so that a
federal court may determine whether the execution will comport with the Eighth
Amendment. Without this protection, a state could make a last-minute decision to
use constitutionally unacceptable drugs, Baze v. Rees, 553 U.S. 35, 53 (2008)
(plurality opinion), that subject the inmate to excruciating pain in violation of the
Eighth Amendment. Third, petitioner will suffer irreparable harm if this stay
request is denied. And finally, the countervailing government interests are
minimal: the state does not have any legitimate interest in preventing courts from
reviewing the constitutionality of its execution protocol.



3
II. BACKGROUND
Petitioner is a condemned inmate, whose execution has been set for February
5, 2014. He was convicted of first-degree murder and sentenced to death in
Louisiana in 1993, and his conviction and sentence became final in 1996. Petitioner
timely sought information about the protocol that the state would use to execute
him. After the state repeatedly refused to disclose the protocol, including the drugs
it plans to use, petitioner joined this 1983 action alleging that the states
recalcitrance violates his due process rights. The district court agreed and granted
him a stay of execution, but the court of appeals reversed.
A. The National Drug Shortage And Its Effect On Execution
Protocols
While every state that imposes the death penalty does so by lethal injection,
the landscape of lethal-injection protocols nationwide has changed dramatically
since this Court decided Baze v. Rees, 553 U.S. 35 (2008). At the time of Baze, every
death-penalty state used a protocol that called for lethal injection by a combination
of three drugs, including sodium thiopental. See Deborah W. Denno, Lethal
Injection Chaos Post-Baze, 102 Geo. L.J. (forthcoming 2014) (manuscript at 12),
available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2328407. In
January 2011, Hospira Inc., the sole U.S. manufacturer of sodium thiopental,



4
ceased manufacturing the drug entirely.
1
As a result, at least seventeen states
switched to pentobarbital by 2013, either as part of a three-drug cocktail or as a
single dose. Id. at 31. In January 2011, Lundbeck, Inc., the only domestic
manufacturer of pentobarbital, adopted a policy prohibiting its distributors from
selling the drug to departments of corrections for use in executions. Stay App. 2a.
The last supplies of FDA-approved pentobarbital in possession of state departments
of correction therefore expired by the end of 2013. See Frequently Asked Questions,
Nembutal, http://www.nembutal.net/faqs.php (last visited Jan. 21, 2014) (listing
pentobarbitals shelf life at twenty-four months).
Given these drug shortages, states have repeatedly revised their execution
protocols often without substantial medical supervision, and without determining
whether any new drugs will be effective and humane. Manny Fernandez,
Executions Stall as States Seek Different Drugs, N.Y. Times, Nov. 8, 2013, at A1;
Josh Sanburn, Ohios Lethal-Injection Experiment, Time (Jan. 17, 2014),
http://nation.time.com/2014/01/15/ohios-lethal-injection-experiment. Many states

1
Press Release, Hospira, Hospira Statement Regarding Pentothal (Sodium Thiopental)
Market Exit (Jan. 21, 2011), available at http://phx.corporate-ir.net/phoenix.zhtml?c=175550&p=irol
-newsArticle&ID=1518610&highlight; see Denno, supra, at 29. The United Kingdom and the
European Union likewise enacted export restrictions to prevent the shipment of sodium thiopental to
the United States. See Commission Implementing Regulation 1352/2011, 2011 O.J. (L 338) 31,
available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:338:0031:0034:EN
:PDF.



5
facing this conundrum have suspended executions in the interim,
2
while other
states are attempting to proceed with executions by using new drug protocols.
B. Louisianas Continued Administration of Executions
Louisiana resolved to proceed with executions, despite the national drug
shortages. Through 2010, the states execution protocol provided for the traditional
three-drug cocktail: sodium thiopental (a sedative), pancuronium bromide (a
paralytic), and potassium chloride (which causes cardiac arrest). See Pet. App. 38a.
3

This Court held in Baze that sodium thiopental eliminates unnecessary pain and
thus renders the three-drug cocktail constitutional, but that, failing a proper dose
of sodium thiopental that would render the prisoner unconscious, there is a
substantial, constitutionally unacceptable risk of suffocation from the
administration of pancuronium bromide and pain from the injection of potassium
chloride. 553 U.S. at 53 (plurality opinion).

2
These states include Alabama, see Arthur v. Thomas, No. 2:11-CV-0438-MEF, 2013 WL
5434694 (M.D. Ala. Sept. 30, 2013) (allowing Eighth Amendment claims against execution protocol
to proceed); Arizona, see Notice of Disclosure, Schad v. Brewer, No. 13-02001-ROS (D. Ariz. Oct. 5,
2013) (disclosing that state supply of pentobarbital expired in November 2013); Arkansas, Hobbs v.
Jones, 412 S.W.3d 844 (Ark. 2012) (finding execution protocol in violation of state constitution);
California, Sims v. Dept of Corr. & Rehab., 157 Cal. Rptr. 3d 409 (Cal. Ct. App. 2013) (finding
execution protocol in violation of state law); Kentucky, Order, Baze v. Thompson, No. 06-CI-574
(Franklin Cir. Ct. Dec. 5, 2013) (denying states motion to lift injunction against executions);
Tennessee, Order, State v. Irick, No. M1987-00131-SC-DPE-DD (Tenn. Dec. 11, 2013) (staying
execution so constitutionality of new execution protocol could be evaluated). These states have not
executed anyone since. See Number of Executions by State and Region Since 1976, Death Penalty
Info. Center, http://www.deathpenaltyinfo.org/number-executions-state-and-region-1976 (last
updated Jan. 16, 2014).
3
Citations to Pet. App. refer to the appendix to the accompanying petition for a writ of
certiorari; citations to Pet. refer to the petition itself.



6
On January 22, 2010, in a lawsuit brought by another inmate, the Louisiana
Department of Public Safety and Corrections (Department) named petitioner as a
defendant in a reconventional demand (a state procedure equivalent to a
declaratory judgment action), seeking a ruling that all of its rules, regulations,
protocols, policies, and directives in support of lethal injection executions are valid
and enforceable and fully comply with all constitutional, statutory, and
administrative procedures. First Amended and Supplemental Reconventional
Demand for Declaratory Judgment, Code v. Dept. of Pub. Safety and Corr., No.
C585410 (19th J.D.C. Jan. 22, 2010). Attached to the demand was a copy of the
Departments then-current lethal-injection protocol, which specified that all
executions would use sodium thiopental, pancuronium bromide, and potassium
chloride. Id. at Ex. 2.
On October 28, 2010, the Department acknowledged that it had no sodium
thiopental in stock, Court of Appeals Record (C.A. R.) 107, making it impossible to
carry out the states then-current execution protocol, given that Hospira had
announced that it would no longer produce the drug, id. at 210. Therefore, the state
district court dismissed the Departments reconventional-demand suit insofar as it
sought a judgment evaluating the execution protocol. Judgment, Code, No.
C585410 (19th J.D.C. Mar. 10, 2011). The court found that any ruling on the merits
would be premature, as the protocol would need to be changed due to the
unavailability of sodium thiopental. See id.; Transcript at 9, Code, No. C585410



7
(1st J.D.C. Feb. 22, 2011) (There may very well have been a change in
circumstances now that make [the question] premature. . . . The protocol does
mention three drugs[,] only one is identified by name[,] and thats the one that I
think this court can take judicial notice of the fact that nobody in the United States
is manufacturing anymore.). The Department appealed to the Louisiana First
Circuit Court of Appeals on other grounds, and the state refused during oral
argument on April 25, 2012, to confirm whether it had changed its execution
protocol or to disclose any changes that had occurred. See C.A. R. 2021.
C. Louisianas Refusal To Disclose Its Execution Protocol
Though Louisiana had no sodium thiopental, it steadfastly refused to disclose
a new execution protocol. The states obstinacy prompted petitioner and other
condemned inmates in the state to seek disclosure of the protocol using the
remedies available to them. This dispute involving petitioner and other
condemned inmates has been ongoing for years, but has produced little in the way
of transparency.
On April 16, 2012, counsel for petitioner filed a request for the protocol under
the Louisiana Public Records Act. See Stay App. 8a10a. The Department refused
this request, citing security concerns and repeatedly stating that DOC has no
public records responsive to this request. Id. 12a; see also id. 12a14a.
On December 12, 2012, the state district court issued a death warrant for
petitioner to be executed on February 13, 2013, over petitioners objections that he



8
had not yet been provided with the execution protocol. See C.A. R. at 289. On
January 11, 2013, petitioner sought a writ in the Louisiana Supreme Court on the
issue of whether he could be executed without notice and a hearing as to the
execution protocol. Id. at 249. This writ was denied on January 23, 2013. State v.
Sepulvado, No. 13-0098 (La. Jan. 23, 2013); 105 So. 3d 59.
On December 18, 2012, counsel for petitioner filed a second request under the
Louisiana Public Records Act, again asking the Department to disclose its execution
protocol. Stay App. 16a. The Department refused this request on January 7, 2013.
Id. 23a.
Petitioner simultaneously filed a request seeking disclosure of the protocol
pursuant to Louisianas Administrative Remedy Procedure (ARP). Id. 30a31a.
Almost a month later, on January 14, 2013, the Department rejected the ARP
request, explaining to petitioner that as of this date nothing has personally
happened to you. Id. 33a.
D. Summary Of The Proceedings Below
Having exhausted his state remedies, on January 23, 2013, petitioner
promptly moved to intervene in a 1983 lawsuit filed by inmate Jessie Hoffman in
the United States District Court for the Middle District of Louisiana. C.A. R. at 67
70. Petitioner alleged, inter alia, that Louisianas refusal to provide him with its
execution protocol violates the Due Process Clause of the Fourteenth Amendment.
Id. at 68.



9
Petitioner moved for a preliminary injunction requiring the state to disclose
its lethal-injection protocol. Id. at 11237. After a hearing, the district court
granted the preliminary injunction and stayed petitioners execution. Pet. App. 16a.
The court recognized that [t]here is no question that [petitioner] has a right to
raise [the Eighth Amendment claim] that the method of execution does inflict cruel
and unusual pain. Id. 17a. The court reasoned that [i]t is axiomatic that . . . an
inmate who is to be executed cannot challenge a protocol as violative of the 8th
Amendment until he knows what that protocol contains. Id.
The court also rejected the states argument that petitioners motion for a
stay of execution is an 11th hour appeal. Id. 18a. The court found it obvious that
there was a satisfactory explanation for the delay because Sepulvado has been
trying to determine what the protocol is for years and the state will not provide this
information. Id. See also id. 20a (The intransigence of the State Defendants in
failing to produce the protocol requires the Court to issue this order.).
The state appealed. While the appeal was pending before the Fifth Circuit, a
magistrate judge adjudicating the due process claim ordered Louisiana to disclose
its then-current lethal-injection protocol in discovery. Ruling on Motion for
Protective Order, Hoffman v. Cain, No. 12-796-JJB-SCR (M.D. La. June 4, 2013).
The state complied on June 17, 2013. The disclosed protocol, dated January 10,
2013, calls for the use of a single drug: pentobarbital. Pet. App. 24a. The state
made no representation that it would definitely use that protocol in petitioners



10
execution, however. Indeed, in further discovery responses, the state objected to
disclosing information about its execution protocol on the ground that there were no
currently scheduled executions. See Motion to Compel, Hoffman v. Cain, No. 12-
796-JJB-SCR (M.D. La. Oct. 21, 2013). The state moreover continued to insist in
the Fifth Circuit that petitioner had no due process right to the protocol.
A panel of the Fifth Circuit reversed the district courts grant of the
preliminary injunction. The panel reasoned that petitioner had failed to identify a
cognizable liberty interest for purposes of the Due Process Clause. Pet. App. 10a.
Perhaps the states secrecy masks a substantial risk of serious harm, but it does
not create one. Id. 11a12a (quoting Baze, 553 U.S at 52 (plurality opinion)). In
the panels view, [a]dopting the district courts reasoning would frustrate the
States significant interest in enforcing its criminal judgments. Id. 10a (quoting
Nelson v. Campbell, 541 U.S. 637, 650 (2004)). The panel also discounted the
importance of petitioners asserted due process right because, [d]espite Louisianas
concealment of its protocol, Sepulvado has managed to assert a litany of specific
cruel-and-unusual-punishment claims. Id. 11a.
The panel also reversed the stay of execution. Id. 15a. In addition to finding
that there was no basis for a stay because petitioner had no cognizable liberty
interest, id. 10a, the panel concluded that his motion was untimely because he has
not explained his failure to bring a claim until two years after Louisianas repeal
of its lethal-injection protocol in December 2010, id. 14a. The panel deemed it



11
irrelevant that during that period petitioner had pursued his state law remedies,
and it did not explain how he could have asserted a due process right to the protocol
until the state finally refused to provide it to him.
Petitioners request for rehearing en banc was denied over the dissent of four
judges, three of whom authored a separate opinion. In describing the facts of the
case, the dissenters observed that [t]he State repeatedly refused to furnish
Sepulvado with . . . notice and adamantly insisted before the district court that it is
under no obligation to officially release the details of the execution protocol. Id.
23a. But, citing this Courts opinion in University of Texas v. Camenisch, 451 U.S.
390 (1981), the dissenters argued that the panel decision was moot because the
State complied fully with the terms of the preliminary injunction by turning over
its revised lethal-injection protocol to Sepulvado before the panel of this Court
issued its decision. Pet. App. 27a. The dissenters also argued that the panel erred
on the merits:
If a State does not officially release the details of its execution protocol, a
court would have no way of verifying whether the State planned to use
pentobarbital or another substance, such as expired or contaminated sodium
thiopental, or an entirely different chemical whose properties could very well
cause an unconstitutional degree of pain and suffering. If Sepulvado were
not given such notice before his execution takes place, there is absolutely no
possibility of a post-deprivation hearing or any opportunity to be heard at a
meaningful time and in a meaningful manner.
Id. 31a (quoting Hamdi v. Rumsfeld, 542 U.S. 507, 533 (2004)).
After the case was remanded, on January 10, 2014, the district court
dismissed petitioners due process claim, finding that the Fifth Circuits panel



12
decision mandated that result. Id. 43a44a. The court denied the states motion to
dismiss petitioners Eighth Amendment challenges to the disclosed execution
protocol. Id. 44a46a. Those claims remain pending.
Petitioner filed a timely petition for a writ of certiorari seeking review of the
Fifth Circuits judgment on January 27, 2014.
E. Subsequent Events Establishing That The State Will Have To
Revise Its Protocol
While petitioners execution remains scheduled for February 5, 2014,
ostensibly to be conducted using pentobarbital, it is highly unlikely that Louisiana
will be able to implement the 2013 Protocol. Like sodium thiopental, manufactured
pentobarbital is unavailable for executions in the United States because the only
manufacturer blocks its sale or transfer for that purpose. Nembutal is currently the
only commercially available pentobarbital in the United States. See FDA Approved
Drug Products, U.S. Food & Drug Admin., http://www.accessdata.fda.gov/scripts
/cder/drugsatfda/index.cfm (last visited Jan. 21, 2014). On January 7, 2011,
Lundbeck the then-producer of Nembutal announced a restricted distribution
program designed to deny distribution of pentobarbital to prisons in U.S. states
currently carrying out the death penalty by lethal injection. Stay App. 2a. On
December 22, 2011, Akorn Inc. acquired the patent for Nembutal and agreed to
continue with Lundbecks restricted distribution programme for Nembutal. Id.
5a.



13
Although the state did have pentobarbital during 2013, and affirmed by
affidavit that this pentobarbital was purchased from Lundbeck, C.A. R. 38687,
those supplies have expired, Stay App. 35a. The prison pharmacy, in compliance
with state pharmacy regulations, discarded them as verified by the state Board of
Pharmacy on December 19, 2013. Id. Indeed, the entire supply of Nembutal
potentially available for use in executions (namely, the supply that was distributed
before the restricted distribution program) has expired, see Frequently Asked
Questions, supra, so the prison pharmacy is prohibited from dispensing or storing it,
see La. Admin. Code tit. 46, 2501(D) (2012) (Expired drugs shall not be dispensed
and shall be removed from the pharmacy drug inventory.); see also id. 1817(A)(3)
(In the event expired drugs are received by a penal pharmacy, the pharmacist-in-
charge shall destroy them as required by law.).
The Louisiana State Penitentiary (LSP) Pharmacy has acknowledged that, as
of January 16, 2014, it did not have the drug in stock. Stay App. 37a. On that day,
the General Counsel of the Louisiana Board of Pharmacy stated that one of the
Boards compliance officers visited the LSP Pharmacy and confirmed that the
pharmacy does not have any pentobarbital in stock nor has the pharmacy obtained
any pentobarbital from any compounding pharmacy. Id. The Pharmacist-in-
Charge informed the officer that she has not been directed by anyone with the
Department of Public Safety and Corrections to obtain any pentobarbital. Id.



14
That same day, and again on January 24, 2014, counsel for respondents in
this case informed petitioner that the Department is in the process of procuring
pentobarbital, thereby acknowledging that it does not yet have the drug. Id. 39a;
see also id. 49a. And despite the states assertion that it is procuring the
pentobarbital, it has never explained from where it plans to obtain the drug, and in
fact there is no lawful mechanism by which the state could do so.
Louisiana has informed petitioner that Jonathan A. Roundtree, M.D., will
write the prescription ordering the drug. Id. 51a. However, a doctor is prohibited
from prescribing pentobarbital to petitioner to cause his death, because [a]
prescription for a controlled substance to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual course of his
professional practice. 21 C.F.R. 1306.04; see also 21 U.S.C. 841(a)(1)
(criminalizing the dispensing of a controlled substance without a legitimate medical
purpose); La. Rev. Stat. Ann. 37:1285(A)(6) (2007) (The board may refuse to issue,
or may suspend or revoke any license or permit, or impose probationary or other
restrictions on any license or permit issued under this Part for . . . [p]rescribing,
dispensing, or administering legally controlled substances . . . without legitimate
medical justification therefor . . . .).
Additionally, because there are no commercially available, unexpired
supplies from the manufacturer, the only possible way for the state to acquire the



15
pentobarbital is from a compounding pharmacy.
4
However, under La. Admin. Code
tit. 46, 2535, compounded drugs may be dispensed only if there is a patient
specific prescription, id. 2535 (cmt.), or if the drug is administered by the
prescriber and not dispensed to the patient, id. 2535(D)(2).
5
As discussed above,
it would be illegal for Dr. Roundtree to write petitioner a prescription for
pentobarbital. And compounded pentobarbital cannot be administered by the
prescriber, who must be a doctor, pursuant to Louisianas execution protocol, which
calls for the I.V. Team to be composed of phlebotomists, emergency medical
technicians, paramedics, or Military Corpsmen with training in phlebotomy, not
doctors. La. State Penitentiary, Louisiana Execution Protocol 26 (2013) [hereinafter
Louisiana Execution Protocol]. Louisiana has disclosed the members of its I.V.
team, none of whom have medical licenses. Stay App. 51a52a.
If Louisiana were to illegally use compounded pentobarbital, the execution
would carry a substantial risk of serious harm to petitioner. Baze, 553 U.S at 52
(plurality opinion). Essential chemical properties of compounded pentobarbital

4
A compounding pharmacy mixes drugs in small batches under custom orders. Unlike
manufacturers, compounding pharmacies generally are not subject to the drug approval process and
rigorous checks and regulatory procedures required under federal law. See Compounding and the
FDA: Questions and Answers, U.S. Food & Drug Admin., http://www.fda.gov/Drugs
/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm#approved (las
t updated Dec. 2, 2013).
5
Louisianas pharmacy regulations apply regardless of whether the compounding pharmacy is
located within the state. See La. Admin. Code tit. 46, 2309 (Louisiana pharmacy laws and
regulations shall be applicable to regulate the practice of pharmacy for that portion of the out-of-
state pharmacys Louisiana pharmacy practice or operation.).



16
such as pH, osmolarity, or concentration may be sufficiently different from those
of manufactured pentobarbital that they pose unique risks. See Stay App. 74a, 78a
81a. Such differences may result in a drug that is painful when injected or is
partially or completely ineffective, such that the prisoner will not be killed by the
drug, but will instead be unconscious for an extended period of time while breathing
inadequately, before waking up in a permanently brain-damaged state. See id. 81a.
It is therefore substantially likely that the state will substitute an unknown,
different drug or combination of drugs at the last minute, and that petitioner will be
executed using a procedure that he and the courts will never have the
opportunity to subject to constitutional scrutiny.
Indeed, by failing to acquire pentobarbital in a timely fashion, Louisiana has
already violated the 2013 Protocol. The 2013 Protocol requires the prison pharmacy
at all times to [m]aintain the following stock ensuring chemicals have not
exceeded expiration date: 15 grams pentobarbital 50mg/ml solution. Louisiana
Execution Protocol, supra, at 38. 30 days prior to execution, the LSP Pharmacist
is required to [v]erify execution drugs are in stock as above and expiration dates
will not be exceeded prior to execution date. Id. But as of January 24, 2014 a
mere twelve days before the scheduled execution the state did not possess any
pentobarbital. Stay App. 39a, 49a. That confirmed violation of the 2013 Protocol
strongly suggests that the state will modify its procedures and thus impose an
unnecessary and unconstitutional risk of inhumane punishment on petitioner.



17
III. REASONS FOR GRANTING THE STAY
A stay of execution is appropriate if an applicant makes a four-part showing:
first, that there is a reasonable probability that four Justices of the Court will vote
to issue a writ of certiorari, Rostker v. Goldberg, 448 U.S. 1306, 1308 (1980)
(Brennan, J., opinion in chambers) (quoting Graves v. Barnes, 405 U.S. 1201, 1203
04 (1972) (Powell, J., opinion in chambers)) (internal quotation marks omitted);
second, that there is a fair prospect that a majority of the Court will reverse the
decision below, id.; third, that irreparable harm will likely result if the stay is not
granted, id.; and fourth, that, if it is a close case, the balance [of] the equities
weighs in favor of a stay, based on the relative harms to the applicant and
respondent, as well as the interests of the public, id. (quoting Holtzman v.
Schlesinger, 414 U.S. 1304, 130809 (1973) (Marshall, J., opinion in chambers)).
Where a stay is sought in conjunction with a petition for a writ of certiorari, rather
than on direct appeal, the consideration of prospects for reversal dovetails, to a
greater extent, with the prediction that four Justices will vote to hear the case. In
re Roche, 448 U.S. 1312, 1314 n.1 (1980) (Brennan, J., opinion in chambers).
1. Petitioner meets both the reasonable probability and fair prospect
prongs of the standard. This Court is likely to grant certiorari and reverse the
decision below for two reasons, discussed in detail in petitioners parallel petition
for a writ of certiorari. First, this case presents an ideal vehicle to resolve a legal
question of great national importance. See Pet. Part I. The Question Presented is a



18
pure question of law whether a condemned inmate has a due process right to
know the protocol by which he will be executed that is essential for courts ability
to assess whether an execution comports with the Eighth Amendment. This
question arises with great frequency in capital litigation and is the subject of
substantial disagreement among jurists. This Court likely will intervene to resolve
this fully developed disagreement and prevent continuing disruption of execution
proceedings.
Second, the Fifth Circuits holding that the Constitution permits states to
withhold the information necessary for courts to enforce the Eighth Amendment is
irreconcilable with this Courts precedents. See Pet. Part II. The Eighth
Amendments prohibition against cruel and unusual punishments extends to
methods of execution that produce an unnecessary and wanton infliction of pain,
Gregg v. Georgia, 428 U.S. 153, 173 (1976) (plurality opinion). The condemned
inmates interest in avoiding an inhumane death in turn gives rise to a procedural
due process right to have a court assess whether the states execution protocol
comports with the Eighth Amendment. See, e.g., Ford v. Wainright, 477 U.S. 399,
410, 41314 (1986) (plurality opinion) (establishing that the Eighth Amendment
prohibits execution of inmates who are insane and concluding that inmates claiming
insanity are entitled to procedural due process). But, of course, judicial review of a
states execution protocol is impossible unless that protocol is timely disclosed. See
Oken v. Sizer, 321 F. Supp. 2d 658, 664 (D. Md. 2004) (Obviously, the fact of court



19
review of the protocols presupposes their production.), stay vacated, 524 U.S. 916.
Absent such disclosure, the condemned inmate faces a substantial risk of an unduly
painful execution.
This Court has held that even though lethal injection may be humane, the
Eighth Amendment forbids states from using combinations of drugs that inflict
unnecessary pain and suffering concluding, for example, that without the prior
administration of a sedative, the injection of pancuronium bromide and potassium
chloride would present a substantial, constitutionally unacceptable risk of
suffocation. Baze v. Rees, 553 U.S. 35, 53 (2008) (plurality opinion). However,
under the Fifth Circuits decision, Louisiana may decide at the eleventh hour to use
such constitutionally unacceptable drugs without notifying anyone, and, even
though substantially less painful alternatives may be available, no court would
have the opportunity to review the protocols constitutionality. Weighed against the
inmates almost uniquely compelling interest, Ake v. Oklahoma, 470 U.S. 68, 78
(1985), in avoiding undue suffering during his execution, and the grave risk of
irreversible erroneous deprivation if the execution protocol is not disclosed, the
countervailing governmental interests are minimal. See Mathews v. Eldridge, 424
U.S. 319, 335 (1976). The state simply does not have any substantial interest in
precluding courts from ensuring that its execution protocol comports with the
Eighth Amendment, and the states undisputed interest in enforcing its criminal
judgments is not threatened, since all delay can be avoided by timely disclosure.



20
2. With respect to the third prong, petitioner will suffer irreparable harm if
the stay is not granted. [D]eath is a punishment different from all other sanctions
in kind rather than degree. Woodson v. North Carolina, 428 U.S. 280, 30304
(1976) (plurality opinion). As a consequence, the requirement of irreparable harm .
. . if a stay is not granted . . . is necessarily present in capital cases. Wainwright v.
Booker, 473 U.S. 935, 935 n.1 (1985) (Powell, J., concurring). Louisiana has refused
to tell petitioner the protocol by which he will be executed in nine days. Unless this
Court stays his execution, petitioner will forever lose the opportunity to vindicate
his Eighth Amendment right in court and will face a grave risk of enduring
excruciating pain during his execution.
3. With respect to the balance of the equities prong, the harm to the state
that will result from the entry of a stay of execution is slight in comparison with the
irreparable, unconstitutional harm that petitioner would likely suffer if a stay were
denied. In capital cases, the balance of conflicting interests must be weighed most
heavily in favor of the procedural safeguards of the Bill of Rights. Reid v. Covert,
354 U.S. 1, 46 (1957) (Frankfurter, J., concurring in the result); see also id. at 45
46. To be sure, the state has a strong interest in the prompt execution of its
judgments. See Nelson v. Campbell, 541 U.S. 637, 650 (2004). However, petitioners
due process claim itself poses no obstacle to Louisianas enforcement of the
judgment against him. A stay of execution is necessary in this case only because of
the prospect that the state will execute petitioner according to a different protocol



21
than the one it has disclosed. Had the state timely disclosed and committed to
using a protocol that is consistent with the Eighth Amendment, petitioners
execution would have proceeded without delay. Cf. Landrigan v. Brewer, 625 F.3d
1132, 1133 (9th Cir. 2010) (Wardlaw and Fletcher, JJ., concurring in the denial of
rehearing en banc), vacated, 131 S. Ct. 445.
In any event, the substantial risk that petitioner will be executed in a
manner that violates the Eighth Amendment, without any opportunity to vindicate
his rights in court, far outweighs the harm of a delay in carrying out an execution.
See Gomez v. U.S. Dist. Court for the N. Dist. of Cal., 966 F.2d 460, 462 (9th Cir.
1992) (Noonan, J., dissenting) (The state will get its man in the end. In contrast, if
persons are put to death in a manner that is determined to be cruel, they suffer
injury that can never be undone, and the Constitution suffers an injury that can
never be repaired.); see also In re Holladay, 331 F.3d 1169, 1177 (11th Cir. 2003)
([W]e perceive no substantial harm that will flow to the State of Alabama or its
citizens from postponing petitioners execution to determine whether that execution
would violate the Eighth Amendment.); Cooey v. Taft, 430 F. Supp. 2d 702, 708
(S.D. Ohio 2006); Order at 3, Hill v. Owens, No. 2013-CV-233771 (Ga. Sup. Ct. July
18, 2013), appeal docketed, No. S14A0092 (Ga.). The balance tips even further in
favor of granting a stay in light of the states own interest in ensuring that its
execution protocol comports with the Eighth Amendment, which is evident from the
fact that Louisiana itself sought a declaratory judgment affirming the lawfulness of



22
its former protocol. Code v. Cain, No. 138,860 (1st J.D.C. Mar. 23, 2011), writ
denied, No. 09-0113 (La. Oct. 8, 2010); 46 So. 3d 1258.
6

The interest of the public also strongly favors staying petitioners execution.
[T]he public interest is served only by enforcing constitutional rights and by the
prompt and accurate resolution of disputes concerning those constitutional rights.
In re Ohio Execution Protocol Litig., 840 F. Supp. 2d 1044, 1059 (S.D. Ohio 2012),
motion to vacate stay denied, 671 F.3d 601 (6th Cir.), motion to vacate stay denied
sub nom. Turner v. Epps, 132 S. Ct. 1306. In particular, the public has a strong
interest in ensuring that the state executes its condemned inmates without
subjecting them to excruciating pain in violation of the Eighth Amendment. See
Order at 4, Hill, No. 2013-CV-233771 ([T]he public has a clear interest in ensuring
that the Constitutions, both Federal and State, are followed by Defendants with
regard to protections afforded individuals against cruel and unusual punishment.);
Landrigan v. Brewer, No. CV-10-2246-PHX-ROS, 2010 WL 4269559, at *11 (D. Ariz.
Oct. 25, 2010), affd, 625 F.3d 1144 (9th Cir.), vacated, 131 S. Ct. 445. By contrast,
the public interest has never been and could never be served by rushing to
judgment at the expense of a condemned inmates constitutional rights. Ohio
Execution Protocol Litig., 840 F. Supp. 2d at 1059.

6
To minimize any delay, if the Court grants certiorari, petitioners counsel is prepared to brief
the case according to the schedule applicable to cases granted on Friday January 17, 2014, so that
the case is available for argument and decision in the Courts October Term 2013.



23
IV. PETITIONERS MOTION FOR A STAY OF EXECUTION WAS TIMELY
There is no merit to the Fifth Circuits suggestion that petitioner was
untimely in requesting a stay of execution. See Pet. App. 14a15a. In fact, as the
district court recognized, petitioner has diligently pursued his rights in compliance
with required procedures.
A court may consider the last-minute nature of an application to stay
execution in deciding whether to grant equitable relief. Gomez v. U.S. Dist. Court
for the N. Dist. of Cal., 503 U.S. 653, 654 (1992) (per curiam). However, there is no
general rule that a claim [i]s dilatory if first filed at the time when the possibility
of execution bec[omes] imminent. Beardslee v. Woodford, 395 F.3d 1064, 1070 (9th
Cir. 2005) (per curiam). Instead, the court should conduct[] a fact-specific inquiry
to ascertain whether the claims could have been brought earlier, and whether the
petitioner had good cause for delay. Id.
Petitioners motion for a stay was timely. Indeed, petitioner has been seeking
information about the protocol by which he will be executed for almost two years.
Petitioners counsel, Gary Clements, twice sought to obtain the execution
protocol under the Louisiana Public Records Act, but the state adamantly refused
these requests. Mr. Clements made the first request on April 16, 2012, Stay App.
8a10a, almost eight months before a judge lifted the stay in petitioners state-court



24
case
7
and signed a death warrant for his execution, see C.A. R. 28690.
8
In its reply,
sent more than three months later, the Department refused to provide the protocol,
citing security concerns and repeatedly stating, DOC has no public records
responsive to this request. Stay App. 12a14a. On December 18, 2012, Mr.
Clements filed a second public records request. Id. 16a19a. The Department
refused this request on January 7, 2013, on similar grounds. Id. 23a28a.
The Fifth Circuits suggestion that petitioner disentitled himself to a stay of
execution by initially instituting state rather than federal proceedings is genuinely
inexplicable. Petitioner had no federal constitutional right to information until it
was clear that the state would not provide it. Further, under the Prison Litigation
Reform Act (PLRA), a prisoner cannot bring a 1983 action without first
exhausting his administrative remedies. See 42 U.S.C. 1997e(a) )(No action shall
be brought with respect to prison conditions under section 1983 of this title . . . until
such administrative remedies as are available are exhausted.). This Court has
affirmed that the PLRAs exhaustion requirement is mandatory, see Jones v. Bock,
549 U.S. 199, 211 (2007), and that it is a precondition to any 1983 action,
Wilkinson v. Dotson, 544 U.S. 74, 84 (2005) (emphasis added). To comply with this

7
In July 2008, a state district court had stayed all proceedings in petitioners case due to
ongoing litigation regarding the constitutionality of Louisianas then-current lethal-injection protocol
under Baze. See C.A. R. 289.
8
The Fifth Circuit suggested that petitioner did not act before his death warrant was signed in
December 2012, see Pet. App. 14a & n.19, whereas, in fact, petitioners counsel filed the first public
records request in April 2012.



25
requirement, petitioner filed a request pursuant to Louisianas ARP on December
18, 2012. Petitioner requested that he be provided with a copy of the current
protocol for his execution. See Stay App. 30a31a. Almost a full month later, on
January 14, 2013, the Department rejected petitioners request, explaining that as
of this date nothing has personally happened to you. Id. 33a.
Petitioner also sought relief in state court, repeatedly objecting to the states
refusal to provide him with the protocol on due process grounds. In a memorandum
filed with the state district court on November 30, 2012, petitioner argued that the
stay of his state-court proceedings should not be lifted because the state had refused
to reveal its execution protocol:
The State of Louisiana has no currently publicized execution process. To the
extent that the State has secretly adopted an amended protocol, the States
secrecy violates Mr. Sepulvados due process rights and leaves open the
possibility that the State will execute him in an inhumane, constitutionally
unsound manner.
C.A. R. at 188. Petitioner reiterated his concerns in a motion for stay of execution
after the state court issued his death warrant:
Petitioner knows of no currently publicized execution process in Louisiana.
Louisiana cannot execute Christopher Sepulvado with the same method it
used in its eight previous executions. If the State has secretly adopted an
amended execution protocol, the very secrecy of that amendment would
violate Mr. Sepulvados due process rights and leaves open the very real
possibility that the State will execute him in an inhumane, constitutionally
unsound manner.
C.A. R. at 218. After the state district court denied this motion, petitioner filed an
application for writ of review in the Supreme Court of Louisiana, once again



26
objecting that the state had not provided him with a current execution protocol in
violation of his due process rights. C.A. R. 263. The Supreme Court of Louisiana
denied the writ on January 23, 2013. State v. Sepulvado, No. 13-0098 (La. Jan. 23,
2013); 105 So. 3d 59. Petitioner intervened in this 1983 action on the same day.
While petitioner has actively sought the execution protocol, the state has
continued to drag its feet in related discovery following the Fifth Circuits decision,
causing petitioner to delay his filing in this Court, and making it increasingly likely
that petitioner will be put to death without knowing the method of his
execution. On January 7, 2014 petitioner filed a set of discovery requests seeking
information regarding the nature and origin of the drug by which he would be
executed. Plaintiff Christopher Sepulvados Second Set of Requests for Production,
Hoffman v. Jindal, No. 3:12-cv-00796 (M.D. La. Jan. 7, 2014). The state promised
to comply by January 24, 2014, Stay App. 44a, causing petitioner to delay his filing
with this Court in anticipation of the new documents. But on January 24, 2014, the
state reversed course and refused to produce the requested documents, instead
alleging that it would do so within the applicable delay, i.e., by February 6, 2014
the day after petitioners scheduled execution date. Id. 46a.
Petitioner has moved expeditiously to file this petition. On January 7, 2014,
the state issued a death warrant specifying an execution date of March 7, 2014. On
January 10, the state moved the execution date up to February 5.



27
V. THIS COURT HAS NEVER CONFRONTED THE QUESTION
PRESENTED IN THE PROCEDURAL POSTURE OF THIS CASE
A handful of condemned inmates have raised similar issues in the past. But
none of those cases properly raised the Question Presented.
In Brewer v. Landrigan, 131 S. Ct. 445, 445 (2010) (mem.), by the time the
case reached this Court, the inmate had almost complete information about the
protocol by which he would be executed; he had secured (1) the names of the drugs
that would be used in his execution, (2) their expiration dates, (3) information that
the sodium thiopental that would be used was not obtained from or manufactured
by Hospira, Inc., (4) the states avowal that a sufficient quantity of the drugs was
lawfully obtained with the approval of U.S. Customs and FDA officials, and (5) the
states avowal that it would not depart from the stated protocol. See Landrigan v.
Brewer, No. CV-10-2246-PHX-ROS, 2010 WL 4269559, at *1, *4 (D. Ariz. Oct. 25,
2010); Anticipatory Motion to Lift Stay at 1, Landrigan v. Trujillo, 131 S. Ct. 445
(No. 10-A416). Moreover, the plaintiff had learned that the sodium thiopental that
would be used in his execution was imported from Great Britain. See Landrigan v.
Brewer, 625 F.3d 1132, 1143 (9th Cir. 2010) (Kozinski, J., dissenting from the denial
of rehearing en banc); Supplemental Response to Motion to Vacate Stay at 3,
Landrigan, 131 S. Ct. 445 (No. 10-A416) (admitting knowledge that the state
obtained its sodium thiopental from Britain). The inmates claim was limited to
the narrow assertion that the states refusal to provide a single piece of information
the source of the sodium thiopental that would be used in his execution violated



28
his right to due process. This Court vacated the district courts stay of execution by
a vote of five to four, finding that, given all the other information already available
to the plaintiff about the execution protocol, he had failed to show that the use of
the drug was sure or very likely to cause serious illness and needless suffering in
violation of the Eighth Amendment. Landrigan, 131 S. Ct. at 445 (quoting Baze v.
Rees, 553 U.S. 35, 50 (2008) (plurality opinion)) (internal quotation marks omitted).
In Yowell v. Livingston, 134 S. Ct. 417 (2013) (mem.), the condemned inmate
knew the identity, source, and potency of the drug that Texas would use to execute
him.
9
There was no indication that Texas would change its protocol. The inmate
argued instead that the states failure to disclose information in a timely manner
regarding the method of his execution violated his constitutional right of access to
courts. Whitaker v. Livingston, 732 F.3d 465, 467 (5th Cir. 2013). The district court
denied his stay request, finding that Texas notified the public on one of its websites
that it uses pentobarbital more than a year before Mr. Yowells scheduled
execution and that Texas promptly disclosed information about the drugs source to
Mr. Yowell upon request. Opinion on Preliminary Injunction at 4, Whitaker v.

9
See Petition for a Writ of Certiorari at 10, Yowell, 134 S. Ct. 417 (No. 13-6809) ([I]nformation
from three different sources revealed that TDCJ intended to use compounded pentobarbital from
Woodlands Compounding Pharmacy to execute Mr. Yowell . . . .); see also Respondents Brief in
Opposition to Petition for Writ of Certiorari and Application for Stay of Execution at 1, Yowell, 134 S.
Ct. 417 (No. 13-6809) (The state intends to execute Yowell by administering a lethal injection of 5
grams of pentobarbital in accordance with the execution protocol adopted by [TDCJ] and utilized for
twenty-three [executions] since July 10, 2012. When the states supply of pentobarbital was
exhausted in September 2013, the state obtained compounded pentobarbital with a potency of 98.8%
for use in executions beginning with Yowell.).



29
Livingston, No. H-13-2901 (S.D. Tex. Oct. 5, 2013); see also id. at 45. The Fifth
Circuit affirmed, agreeing with the district court that the state complied with
requests for information about how it intended to execute Yowell promptly after the
plaintiffs requested that information. Whitaker, 732 F.3d at 467. This Court
denied Mr. Yowells petition for a writ of certiorari and application for a stay of
execution. Yowell, 134 S. Ct. at 417.
In Beaty v. Brewer, 131 S. Ct. 2929 (2011) (mem.), the inmate asserted that
the state had violated due process by changing its protocol soon before the planned
execution. As in Yowell, the constitutional claim thus went to the timing of the
states disclosure, rather than to its existence. The district court denied the stay
request, Beaty v. Brewer, 791 F. Supp. 2d 678, 686 (D. Ariz. 2011), and the Ninth
Circuit affirmed, Beaty v. Brewer, 649 F.3d 1071, 1072 (9th Cir. 2011). Seven
judges dissented from the courts denial of rehearing en banc, arguing that Mr.
Beaty has a protected interest in knowing and being given an opportunity to be
heard about the States use of pentobarbital in his execution, in contrast to its
protocol in past executions. Were it otherwise, the capital defendants due process
right to review such protocols would be meaningless. Id. at 1073 (dissent from the
denial of rehearing en banc). This Court denied Mr. Beatys petition for a writ of
certiorari and application for a stay of execution. Beaty, 131 S. Ct. at 2929.
In Sizer v. Oken, 542 U.S. 916 (2004) (mem.), the condemned inmate asserted
that the state had unduly delayed in providing him with a copy of its execution



30
protocol three days before his scheduled execution. See Oken v. Sizer, 321 F. Supp.
2d 658, 66061 (D. Md. 2004). Again, the inmates objection related to the timing of
the disclosure. The district court
[was] not prepared to say that Oken [was] likely to prevail in establishing
that the manner in which the State of Maryland would administer a lethal
injection to him constitutes a cruel and unusual punishment or even, as he
might argue hereafter, that the issue he raises [was] sufficiently serious and
substantial as to merit a further stay.
Id. at 667. Nonetheless, the court granted a stay of execution after concluding that
Defendants themselves contributed to this state of affairs by their last minute
amendment of the Execution Protocol and by their even later delivery of a copy of
that Protocol (moreover, incomplete Protocol) to Okens counsel. Id. The state
sought vacatur in this Court, explaining that Mr. Oken was not entitled to a stay of
execution to have his Eighth Amendment claim heard because he purposely waited
until the last minute to raise it. Emergency Application to Chief Justice to Vacate
Stay of Execution at 4, Oken, 542 U.S. 916 (No. 03-A1023). Mr. Oken had not
requested or challenged the states lethal injection protocol for over a decade, even
though there was no mystery as to the basic procedure for execution by lethal
injection to be used in Maryland and across the country. Id. at 4. Mr. Oken first
requested a copy of the protocol a month and four days before his scheduled
execution, and there was strong evidence that his 1983 claim was a mere tactic for
delay. This Court vacated the stay by a vote of six to three. Oken, 542 U.S. at 916.



31
This case is entirely unlike those in which similar issues have previously
come before this Court. In prior cases, the inmate possessed all the material
information he would need for a court to assess whether his execution would
comport with the Eighth Amendment. The state had irrevocably committed to
refrain from changing its protocol and there was no evidence in the record to
suggest that the drug obtained from a foreign source is unsafe and no showing
that the drug was unlawfully obtained. Landrigan, 131 S. Ct. at 445. By contrast,
here, Louisiana has made no such commitment to refrain from changing its protocol
and there is substantial evidence that Louisianas protocol will change. In earlier
cases, the information available meant that the courts were able to determine
whether the method of execution was consistent with the Eighth Amendment; here,
the states secrecy altogether prevents courts from making that determination.
Further, to the extent that Louisiana has represented an intent to procure
pentobarbital, it has not provided any information about the provenance of the
drug, and its commercial unavailability renders that representation highly suspect.
Petitioner thus faces a serious risk of suffering excruciating pain during his
execution, without any opportunity to challenge Louisianas protocol in court.
10


10
In Williams v. Hobbs, 133 S. Ct. 97 (2012) (mem.), inmates brought a 1983 challenge to the
Arkansas Method of Execution Act, arguing, inter alia, that the statute violated their due process
right of access to courts by preventing them from learning how their executions would be carried out.
Jones v. Hobbs, No. 5:10CV00065JLH, 2010 WL 1417976, at *1 (E.D. Ark. Apr. 5, 2010). The district
court

dismissed the case for failure to state a claim upon which relief could be granted, finding that
the inmates in fact had access to the states current execution protocol, that they could submit a
request to obtain information about future protocols pursuant to the Arkansas Freedom of



32
VI. CONCLUSION
For the foregoing reasons, petitioner respectfully requests that this Court
grant him a stay of execution, now scheduled for February 5, 2014, pending
resolution of his petition for a writ of certiorari and, if the writ is granted, further
order of the Court. In the alternative, petitioner requests that the Court issue an
order directing the state to refrain from conducting the execution in a manner that
materially deviates from the execution protocol previously disclosed to petitioner.
Respectfully submitted,



Kathleen Kelly
Gary Clements
CAPITAL POST-CONVICTION PROJECT
OF LOUISIANA
1340 Poydras St.
Suite 1700
New Orleans, LA 70112


Jonathan Massey
MASSEY & GAIL LLP
1325 G St., N.W.
Suite 500
Washington, DC 20005

Thomas C. Goldstein
Counsel of Record
Tejinder Singh
GOLDSTEIN & RUSSELL, P.C.
5225 Wisconsin Ave. N.W.
Suite 404
Washington, DC 20015
(202) 362-0636
tg@goldsteinrussell.com


January 27, 2014


Information Act, and that their argument that the Director of the Arkansas Department of
Corrections would unilaterally depart from the protocol was speculative. Id. at *3*4. The Eighth
Circuit affirmed. Williams v. Hobbs, 658 F.3d 842, 852 (8th Cir. 2011). After the inmates sought
certiorari, the state stayed all executions and the inmates dismissed their petition. Williams, 133 S.
Ct. at 97. No stay of execution was sought in this Court.
APPENDIX A
1a

Lundbeck overhauls pentobarbital distribution program to restrict misuse

Release date: 01-07-2011
Release time: 06:00
New specialty pharmacy drop ship program will deny distribution of pentobarbital to prisons in U.S. states
currently carrying out the death penalty by lethal injection.
Lundbeck today announced that the company has moved to alter the distribution of its medicine Nembutal

(pentobarbital
sodium injection, USP) in order to restrict its application as part of lethal injection in the U.S. Going forward, Nembutal will be
supplied exclusively through a specialty pharmacy drop ship program that will deny distribution of the product to prisons in U.S.
states currently active in carrying out the death penalty by lethal injection. The company notified its distributors of the plan in
late June.
The new distribution program ensures that hospitals and treatment centers will continue to have access to Nembutal for
therapeutic purposes. Under the program, Lundbeck will review all Nembutal orders before providing clearance for shipping the
product and deny orders from prisons located in states currently active in carrying out death penalty sentences.
Prior to receiving Nembutal, the purchaser must sign a form stating that the purchase of Nembutal is for its own use and that it
will not redistribute any purchased product without express written authorization from Lundbeck. By signing the form, the
purchaser agrees that the product will not be made available for use in capital punishment.
"Lundbeck adamantly opposes the distressing misuse of our product in capital punishment. Since learning about the misuse we
have vetted a broad range of remedies - many suggested during ongoing dialogue with external experts, government officials,
and human rights advocates. After much consideration, we have determined that a restricted distribution system is the most
meaningful means through which we can restrict the misuse of Nembutal," says Ulf Wiinberg, Chief Executive Officer of H.
Lundbeck A/S and continues: "While the company has never sold the product directly to prisons and therefore can't make
guarantees, we are confident that our new distribution program will play a substantial role in restricting prisons' access to
Nembutal for misuse as part of lethal injection."
Lundbeck has initiated a thorough investigation of the distribution of Nembutal to assess ways of restricting prisons' access to
the medicine. Based on the initial findings, the company believes its new distribution program is the best way to achieve this.
The investigation will be completed, and any possible further options that may be discovered will be evaluated.
Prior to the implementation of the drop ship program, Nembutal was sold through a more standard process utilizing several
distributors to fulfill orders based on whether customers held the appropriate federal and state licenses for ordering controlled
substances.
Meets important medical need
Nembutal represents less than one percent of Lundbeck's global sales but the company chose not to withdraw the product from
the market because the product continues to meet an important medical need in the U.S. Nembutal is used to treat serious
conditions such as a severe and life threatening emergency epilepsy.
In a recent survey of more than 200 U.S. physicians and pharmacists conducted by independent third-party research
companies, 90 percent of the respondents stated that options for treating patients requiring emergency control of certain acute
convulsive episodes would be compromised if Nembutal were no longer available for use. Furthermore, 95 percent of
respondents reported that it is very important for their institution to have access to Nembutal for potential use in the medical
care of patients. All survey respondents were from academic institutions, large community hospitals or epilepsy centers in the
U.S.
Contacts
2a


Mads Kronborg, Media Relations Manager
Telephone (direct): +45 36 43 28 51
Simon Augustesen, Media Relations
Telephone (direct): +45 36 43 49 80
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the
quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the
research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders such as
depression and anxiety, schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded by Hans Lundbeck in 1915 in Copenhagen, Denmark, and today employs 5,900 people worldwide.
Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2010, the company's revenue
was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.
3a
APPENDIX B
4a
H. Lundbeck A/S

Ottiliavej 9 Tlf +45 36 30 13 11 E-mail information@lundbeck.com
DK-2500 Valby, Denmark Fax +45 36 43 82 62 www.lundbeck.com





Press release

Valby, 22 December 2011

Lundbeck divests several products in the US as part of long-
term business strategy

The divestiture of a portfolio of products, including Nembutal

supports Lundbecks
long-term strategy to focus on newer, strategic products in its US subsidiary portfolio.

H. Lundbeck A/S (Lundbeck) today announced that the company has entered into an
agreement with Akorn Inc. (Akorn) whereby Akorn has acquired a portfolio of products
comprising Nembutal

(pentobarbital sodium injection, USP), Cogentin

(benztropine
mesylate injection) and Intravenous Sodium Diuril

(chlorothiazide sodium). This transaction

is part of Lundbecks long-term strategy to focus on newer, strategic products in its portfolio.
As part of the agreement, Akorn will continue with Lundbecks restricted distribution
programme for Nembutal

, which was implemented to restrict the use of the product in the

US.

The three products became part of Lundbecks product portfolio through the acquisition
of Ovation Pharmaceuticals, Inc. in 2009, and the medicines have never been of
strategic importance to Lundbeck. Moving forward, Lundbeck will focus on newer
therapies within its product portfolio that predominantly address central nervous system
(CNS) disorders. In the coming years, Lundbeck US plans to launch Onfi
TM
for the
treatment of Lennox-Gastaut syndrome, aripiprazole depot formulation for the treatment of
schizophrenia and Lu AA21004 for the treatment of major depressive disorder.

The US market is a key growth driver for Lundbeck. This transaction allows us to focus on
newer, strategic products with significant revenue potential, such as Onfi
TM
, aripiprazole depot
and Lu AA21004, says Ulf Wiinberg, President & Chief Executive Officer at Lundbeck.

Under the terms of the agreement, Akorn has acquired and retains all of Lundbecks rights
and responsibilities for the manufacturing, distribution and sale of the three products included
in the agreement. The agreement concerns Lundbecks US rights for Nembutal

and global
rights, including US, for Cogentin

and Diuril
.
.

According to the agreement, Akorn will upfront and as a milestone payment after three years
pay a maximum of $60 million in cash. Lundbeck will not receive any royalties based on future
Nembutal

sales. The transfer of the product portfolio is immediate, although certain filings
will still need to be made with the applicable regulatory authorities to reflect the transfer. For a
specified time period, Lundbeck will perform certain services on behalf of Akorn to ensure that
these products will continue to be available to meet the unmet medical needs of patients.






22 December 2011 Press release Page 1 of 2

5a

Lundbeck contacts

Mads Kronborg Simon Mehl Augustesen
Media Relations Manager International Media Specialist
mavk@lundbeck.com smeh@lundbeck.com
+45 36 43 28 51 +45 36 43 49 80

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company
highly committed to improve the quality of life for people suffering from central nervous
system (CNS) disorders. For this purpose Lundbeck is engaged in the research and
development, production, marketing and sale of pharmaceuticals across the world, targeted at
disorders like depression and anxiety, schizophrenia, insomnia, Huntington's, Alzheimer's and
Parkinson's diseases.
Lundbeck was founded by Hans Lundbeck in 1915 in Copenhagen, Denmark, and today
employs 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical
companies working with CNS disorders. In 2010, the company's revenue was DKK 14.8
billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit
www.lundbeck.com.



22 December 2011 Press release Page 2 of 2

6a
APPENDIX C
7a
CAPITAL POST-CONVICTION PROJECT OF LOUISIANA
1340 POYDRAS, SUITE 1700
NEW ORLEANS, LOUISIANA 701 1 2
PHONE: (504) 212-2110 / FAX: (504) 212-2130
GARY CLEMENTS, ESQ.
DIRECTOR
E"MA!L: GCLEMENTS@CPCPL.ORG
April 16, 2012
Louisiana Department of Corrections
P.O. Box 94304
By Fax: 225-342-3095
And 1 st Class Mail
Baton Rouge, Louisiana 70804-9304
Attn: Department of Corrections Secretary James M. LeBlanc
Re: Request for Public Records re:
Drugs Used by the Department of Corrections in Executing a Sentence of Death
by Lethal Injection
Dear Mr. LeBlanc:
Pursuant to the Louisiana Public Records Act, La.R.S. 44:1, et seq., I hereby request a copy of
the following material:
Any and all documentary material possessed by the Louisiana
Department of Correction (DOC), including at the Louisiana State
Penitentiary at Angola, relating the DOC's possession of or ability to
obtain sodium thiopental or any other chemical anesthetic for use in
lethal injection executions in Louisiana. This includes but is not
limited to:
o The current, total quantity of sodium thiopental in the
possession of or readily obtainable by the DOC;
o The date(s) of expiration of the sodium thiopental in the
possession of or readily obtainable by the DOC. If there are
distinct quantities of sodium thiopental with different
expiration dates, please indicate such.
o The names and countries of origin of the manufacturer(s) and
distributer( s) of the sodium thiopental currently possessed by
or readily obtainable by the DOC and all communications
between the DOC and said manufacturer(s) and distributer(s).
This includes but is not limited to any pending, fulfilled,
refused, or partially fulfilled requests or orders by the DOC for
quantities of sodium thiopental.
o The current, total quantity of any other anesthetic chemical
besides the sodium pentothal in the possession of or readily
obtainable by the DOC;
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8a
Page 2 of3
April 16,2012
Letter re: PRA Request Drugs for Use in Louisiana Executions by Lethal Injection
o The date( s) of expiration of any other anesthetic chemical
besides the sodium thiopental in the possession of or readily
obtainable by the DOC. If there are distinct quantities of
sodium thiopental with different expiration dates, please
indicate such.
o The names and countries of origin of the manufacturer(s) and
distributer( s) of any other anesthetic chemical besides the
sodium thiopental currently possessed by or readily obtainable
by the DOC and all communications between the DOC and
said manufacturer( s) and distributer( s). This includes but is not
limited to any pending, fulfilled, refused, or partially fulfilled
requests or orders by the DOC for quantities of any other
anesthetic chemical besides sodium thiopental.
Any and all documents pertaining to, memorializing, referencing, or
containing communications to or from any manufacturer of any drug
used in the execution of iumates by the DOC regarding the
manufacturer's authorization, non-authorization, or other opinion
about the use of said drug in executions performed by the DOC. This
includes, but is not limited to any communications between the DOC
and any agent of Hospira, Morris and Dickson Company, LLC, Dream
Pharma, Ltd.
For the purposes of this public records request, the terms "documentary materials" and
"documents" are intended to include, without limitation, any and all written, typed, printed,
recorded, graphic computer-generated, or other matter of any kind from which information can
be derived, whether produced, reproduced, or stored on paper, cards, tapes, films, electronic
facsimiles, computer storage devices or any other medium. They include, without limitation,
letters, memoranda (including internal memoranda), calendars, schedules, books, indices, notes,
printed forms, publications press releases, notices, minutes, sununaries or abstracts, reports, files,
transcripts, computer tapes, printout, drawings, photographs, recordings (including both
videotapes and audiotapes), telegrams, and telex messages, as well as any reproductions thereof
that differ in any way from any other reproduction, such as copies containing marginal notations.
I hereby request this material pursuant to Louisiana's Public Records Statute, which recognizes
the "custodian" to mean the public official or head of any public body having custody or control
of a public record, or a representative specifically authorized by him to respond to requests to
inspect any such public records. See La. R.S. 44:1. Further, as the Supreme Court stated in
Lemmon v. Connick 590 So.2d 574 (La. 1991):
La.R.S. 44:3, listing the exceptions to the general rule that records held by
public bodies are public, exempts from disclosure "[r]ecords pertaining to
pending criminal litigation or any criminal litigation which can be
reasonably anticipated, until such litigation has been fmally adjudicated or
otherwise settled." (West 1982). Post-conviction relief is not "criminal
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9a
Page 3 of3
April 16, 2012
Letter re: PRA Request Drugs for Use in Louisiana Executions by Lethal Injection
litigation" within the meaning of this section of the Public Records Act.
The reasons for this conclusion were well stated by the court of appeal in
Harrison v. Norris, 569 So.2d 585 (La.App. 2d Cir.1990).
If any records or documents pertaining to this request are withheld for any reason, please make
an inventory and complete copy of the records withheld, and provide me with a copy of the
inventory and the specific reason for non-disclosure of each item, and preserve a complete copy
to enable subsequent judicial review.
I will remit copying costs upon receipt of an invoice. If you have any questions regarding this
request, please contact me at (504) 212-2110.
Thank you for your assistance.
Sincerely,
Gary Clements
Director, CPCPL
Suite 1700
1340 Poydras Street
New Orleans, LA 70112
504.212.2111 DIRECT PHONE
504.212.2130 FAX
gclements@cpcpl.org
Case 3:l2-cv-00796-JJB-SCR Document 24-2 02/06/l3 Page 3l of 35
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10a
APPENDIX D

11a
E. Wade Shows
Ma-ry Catherin< Cili
Johne W,J,h
luny L Mclnnis
Jdf'''YKCody
Jacqueline B. Wtlson
Austin P. Ganey
Gary Clements
SHOWS, CALI & WALSH, LLP
628 St. Louis Street (70802)
Post Office Drawer 4425
Baton Rouge, LA 70821
Telephone: (225) 346-1461
Fax: (225) 346-1467
July 19, 2012
Capita! Post-Conviction Project of Louisiana
1340 Poydras Street, Suite 1700
New Orleans, Louisiana 70112
RE: Response to April 17, 2012 Requestfor Public Records
Dear Mr, Clements:
Mal'}' Ann M. Vi'hite
Lindsay L Panraleo
Gnie L Jones
Caroline T Bon.d
Grant J. Guillot
Megan R. Stafford
Please accept this letter as a response to your public records requests to the Louisiana Department
of Corrections dated April 17, 2012, entitled "Request for Public Records reo Drugs Used by the
Department of Corrections in Execnting a Sentence of Death by Lethal illjection."
First, your request is very broad and at some points unclear, but DOC has attempted to locate and
disclose what inforruation it appears you seek without over-burdening the agency and interfering with its
lawful operations. Vandenweghe v. Parish of Jefferson, 11-52 (La. App. 4 Cir. 5/24/11), 70 So.2d 51,
writ denied, 2011-1333 (La. 9/30/11), 73 So.3d 289; Elliot v. District Attorney of Baton Rouge, 94-1804
(La. App. 1 Cir. 9/14/95), 664 So.2d 122, writ denied, 95-2509 (La. 12/15/95); and Alliance for
Affordable Energy v. Frick, 96-1763 (La. App. 4 Cir. 5/28/97),695 So.2d 1126. Furthermore, a public
agency is not required to create a public record that is not already in existence in response to a request for
specific information. Williams Law Finn v. Board of Supervisors of Louisiana State University, 03-0079
(La.App. 1 Cir. 4/2/04), 878 So.2d 557,563; and Nungesser v. Brown, 95-3005 (La. 2fl6/96), 667 So.2d
1036, 1037. Additionally, much of the information you have requested encompasses privileged
information not subject to disclosure, including the attorney-client privilege, the deliberative process
privilege, and the work product rule.
1. Current, total quantity Of sodium thiopental in the possession of or readily obtoinable by
the DOC;
First, releasing the current total quantity of a drug used for lethal injection executions to the
public creates a potential security risk, therefore, making such information uonpublic. La. R.S.
44:3(AX3). Releasing this type ofiuformation jeopardizes not only the safety of DOC employees and
offenders housed by DOC, but also the eutire lethal injection process, as it could subject future executions
to manipulation or obstruction by interfering with the supply of lethal injection drugs. Notwithstanding
the foregOing, DOC has no public records responsive to this request.
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12a
Gary Clements
July 19, 2012
Page 2
2. The dates(s} of expiration of the sodium thiopental in the possession of or readily
obtainahle by the DOC.
DOC has no public records responsive to this request.
3. The names and countries of origin of the manufacturers(s) and distributer(s) of the sodium
thiopental currendy possessed by or readily obtainable by the DOC and all
communications between the DOC and said manufacturer(s) and distributer(s).
First, releasing the names and countries of origin of the manufacturers and distributers of a drug
used for lethal injection executions to the pnblic creates a potential security risk, therefore, making such
information nonpublic. La. R.S. 44:3(A)(3). Releasing this type of information to the pnblic through a
pnblic records request subjects future executions to manipulation or obstruction by interfering with the
supply oflethal injection drugs. Notwithstanding the foregoing, DOC has no public records responsive to
this request.
4. The current, total qumrtity of any other chemical anesthetic or barbiturate in the
possession of, or readily obtainable by the DOC, including, but not limited to Pentobarbital
(Nembutal);
First, releasing the current total quautity of a drug used for lethal injection executious to the
public creates a potential security risk, therefore, making such information nonpublic. La. R.S.
44:3(A)(3). Releasiug this type of information jeopardizes the safety of not only DOC employees and
offenders housed by DOC, but also the entire lethal injection process, as it subjects future executions to
manipulation or obstruction by interfering with the supply of the lethal injection drugs. Notwithstanding
the foregoing, DOC has no public records responsive to this request.
5. The date(s) of expiration of any other chemical anesthetic or barbiturate in the possession f
or reudily obtainable by the DOC, including, but not limited to Pentabarbital (Nembutal);
DOC has no public records responsive to this request.
6. The names and countries of origin of the manufacturer(s} ami distributer(s} of any other
chemical anesthetic or barbiturate currently possessed by or reudily obtainable by the DOC
and all communications between the DOC and said manufacturer(s) and distributer(s).
First, releasing the names and countries of origin of the manufacturers and distributers of a drug
used for lethal injection executions to the public creates a poteutial security risk, therefore, making such
information nonpublic. La. R.S. 44:3(A)(3). Releasing this type of information to the pnblic through a
public records request subjects futore executions to manipulation or obstrUction by interfering with the
lethal injection drugs. Notwithstanding the foregoing, DOC has no public records responsive to this
request
Case 3:l2-cv-00796-JJB-SCR Document 24-2 02/06/l3 Page 34 of 35
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13a
Gary Clements
July 19,2012
Page 3
7. Photos or xerographic copies of the labels of the thiopental, anesthetic drugs, andlor
barbiturates that the DOC has.
DOC has no public records responsive to this request.
8. Any correspondence from or to the DOC or any of its representative agencies, including,
but not limited to Louisiana State Penitentiary at Angola, from or to the departments of
corrections in any other state, or any of their representative agencies, regarding the
acquisition of, by any of the aforementioned party, any of the chemical agents or
barbiturates referenced anywhere in this request;
DOC has no public records responsive to this request.
9. A precise description of the method and date of acquisition of each type of chemical
anesthetic drug andlor barbiturate for use in lethal injection executions in Louisiana by
the DOC since Oerober 28, 2010, the date on which DOC Counsel William L Kline write to
CPCPL attorney Kristin TraicofJ the following note: "Pursuant to our telephone
conference today, this will confirm !hut the Louisiana Department of Public Safety and
Corrections currently has no sodium thiopental in stock. OllT pharmacy vendor, Morris
and Dickson Company, LLG, has ativised that the drug is currently unavailable. At the
present time, we are unaware of a thneline for obtaining the drug or when the
manufacturer may produce additional quantities. "
This is not a public records request. It seeks to have the Department create documents not
presently in existence.
10. Any and all documents pertaining to, memorializing, referencing, or containing
communications to or from any manufacturer of any drug used in the execation of inamtes
by the DOC regarding the manufacturer's authorization, non-authorization, or other
opinion about the use of the said drug in executions performed by the DOC. This includes,
but is not limited to any communications between tlte DOC and any. agent of Hospira,
Morris and Dickson Company, LLG, Dream Pltarma, Ltd.
DOC has no public records responsive to this request.
Sincerely,
SHOWS, CALI & WALSH, LLP
ce: Department of Corrections
Case 3:l2-cv-00796-JJB-SCR Document 24-2 02/06/l3 Page 35 of 35
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14a
APPENDIX E
15a
16a
17a
18a
19a
20a
21a
APPENDIX F
22a
Writer's Contact Information:
JACQUELINE B. WILSON
ibw@scbllp.com
Gary Clements
SHOWS. CALI & WALSH, LLP
628 St. Louis Street (70802)
Post Office Drawer 4425
Baton Rouge, LA 70821
January 7, 2013
Capital Post-Conviction Project of Louisiana
1340 Poydras Street, Suite 1700
New Orleans, Louisiana 70112
Telephone: (225) 346-1461
Fax: (225) 346-1467
RE: Response to December 18, 2012 Requestfor Public Records Directed to Department of
Corrections
Dear Mr. Clements:
Please accept this letter as a response to your public records requests to the Louisiana Departtnent
of Corrections dated December 18, 2012, entitled "Request for Public Records re: Department of
Corrections Protocol in Execution (sic) a Sentence of Death by Lethal Injection." My office has been
asked to respond to your public records request.
First, your request is very broad and at some points unclear, but DOC has attempted to locate and
disclose what information it appears you seek without over-burdening the agency and interfering with its
lawful operations. Vandenweghe v. Parish of Jefferson, 11-52 (La. App. 4 Cir. 5/24/11), 70 So.2d 51,
writ denied. 2011-1333 (La. 9/30111), 73 So.3d 289; Elliot v. District Attorney of Baton Rouge, 94-1804
(La. App. 1 Cir. 9/14/95), 664 So.2d 122, writ denied, 95-2509 (La. 12/15/95); and Alliance for
Affordable Energy v. Frick. 96-1763 (La. App. 4 Cir. 5/28/97), 695 So.2d 1126. Furthermore, a public
agency is not required to create a public record that is not already in existence in response to a request for
specific information. Williams Law Firm v. Board of Supervisors of Louisiana State University, 03-0079
(La.App. 1 Cir. 4/2/04), 878 So.2d 557, 563; and Nungesser v. Brown, 95-3005 (La. 2/16/96), 667 So.2d
1036, 1037. Additionally, much of the information you have requested encompasses privileged
information not subject to disclosure, protected by the attorney-client privilege, the deliberative process
privilege, and the work product rule.
Furthermore, because you seek documents as old as twenty years, many of tire documents fall
outside of the Department's record retention policy. Subject to the foregoing, please find below the
Departtnent's response to your public records request.
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23a
Gary Clements
January 7, 2013
Page 2
1. Any and all records from DOC relating to the procedures and protocols for the
administration of lethal injection, in effect before July 2012, including, but not limited to,
all DOC regulations promulgated or revised pursuant to the enactment of lethal injection
as the exclusive manner of execution in La. R.S. 15:569, however named, describing all
details of the administration of the lethal injection protocol;
These records contain internal security information pertaining to imnates at a state correctional
facility. The Department's regulations that you seek are directly related to the internal security of the
inmates at the Louisiana State Penitentiary and nonpublic by virtue of La. R.S. 44:3(A)(3). Since the
records sought are internal management tools that explain how Department persOimel are to implement
statutory rules and laws regarding lethal injections, their disclosure could create a heightened security
risk, the prevention of which significantly outweighs the right of the public to be informed on such
matters.
2. Any and all DOC records relating to the administration of lethal injection which describe
any revision in the process from September 15, 1991, to the present, including but not
limited to any changes in factors used by DOC to take into consideration the weight, age,
physical condition of the inmate in administering the dosage of chemicals, and the relation
between the timing of the lethal injection and time and quantity offood last ingested by the
inmate;
Again, these records contain internal security infonnation and, if disclosed, could create a
heightened security risk to the Department, Louisiana State Penitentiary, the employees thereof, and the
imnates located at the Penitentiary. La. R.S. 44:3(A)(3). Since the information you seek is internal
management tools that explain how Department personnel are to implement statutory rules and laws
regarding lethal injections, their disclosure could create a heightened security risk. To the extent that you
seek reasons for changes or modifications, that information is also shielded from disclosure by La. R.S.
44:3(A)(3), as well as the attorney-client and deliberative process privileges.
3. Any and all records reflecting the current inventory of supplies relating to lethal injection,
and each inventory of supplies carried out in advance of all executions between September
15,1991, and the present;
Records containing the inventory of supplies relating to lethal injection are directly related to the
internal security of the Department and releasing such records creates a potential security risk, making
such information nonpublic. La. R.S. 44:3(A)(3). Releasing tbis information would subject future
execution to manipulation or obstruction by interfering with the supply oflethal injection drugs.
Case 3:l2-cv-00796-JJB-SCR Document 24-6 02/06/l3 Page 2 of 6
USCA5 374
Case 3:l2-cv-00796-JJB-SCR Document 52-l 03/25/l3 Page 374 of 429
24a
Gary Clements
January 7, 2013
Page 3
4. All records reflecting the country and company of origin for each drugs currently in
possession of the DOC for the purpose of carrying out an execution by lethal injection,
including but not limited to, all order forms and receipts, all records of communication
with DOC employees regarding the procurement of any drugs possessed by DOC for use in
an execution by legal injection, any communications with or about potential or actual
suppliers of any drugs by DOC for use in an execution by lethal injection, and the dates on
which such drugs were obtained by DOC;
Releasing the names of the country and company of origin of lethal injection drugs creates a
potential security risk, making such information nonpublic. La. R.S. 44:3(A)(3). Releasing this type of
information jeopardizes the safety of not only DOC employees and offenders housed by DOC, but also
the entire lethal injection process, as it subjects future executions to manipulation or obstruction by
interfering with the supply of the lethal injection drugs.
5. All records relating to the purchase, maintenance, repair, or existence of equipment used
for medical monitoring during lethal injection, including any repair history and purchase
history, including but not limited to an EKG machine and a pulse oximeter;
Records pertaining to the purchase, maintenance, or repair of equipment for medical monitoring
during executions is highly sensitive information, the disclosure of which could create a heightened
security risk. La. R.S. 44:3(A)(3). This disclosure of this information to the public potentially allows
manipulation or interference with the equipment andlor manufacturer used in the lethal injection process.
6. All records containing version of Department Regulation C-03-001 in existence at any
point between September 15,1991 and the present;
These records contain internal security information pertaining to inmates at a state correctional
facility. The Department's regulations that you seek are directly related to the internal security of the
inmates at the Louisiana State Penitentiary and nonpublic by virtue of La. R.S. 44:3(A)(3). Since the
records sought are internal management tools that explain how Department personnel are to implement
statutory rules and laws regarding lethal injections, their disclosure could create a heightened security
risk, the prevention of which significantly outweighs the right of the public to be informed on such
matters.
7. Any and all records pertaining to the execution by lethal injection of every prisoner
executed on or after September 15, 1991, which were produced by the officials and
witnesses delineated in R.S. 17:570 namely, by the following persons: a. the warden of the
Louisiana State Penitentiary at Angola, and all persons selected by him pursuant to R.S.
15:570(A)(I); b. the coroner of the parish of West Feliciana or his deputy, pursuant to R.S.
15:570(A)(2); the physician summoned by the warden of the Louisiana Penitentiary at
Angola, pursuant to R.S. 15:570(A)(3); and the person selected by the warden of the
Louisiana Penitentiary at Angola to administer the lethal injection, pursuant to R.S.
15:570(A)(4).
Case 3:l2-cv-00796-JJB-SCR Document 24-6 02/06/l3 Page 3 of 6
USCA5 375
Case 3:l2-cv-00796-JJB-SCR Document 52-l 03/25/l3 Page 375 of 429
25a
Gary Clements
January 7, 2013
Page 4
Any reports or records generated by either the coroner of West Feliciana or his deputy, or the
physician summoned by the warden pursuant to La. R.S. 15:570(A)(3) are exempt from disclosure by La.
R.S.44:7. Furthermore, the identity of the person selected to administer lethal injections pursuant to La.
R.S. 15:570(A)(4) is nonpublic. La. R.S. 15:570(F). Subject to the foregoing, attached are all records
responsive to this request.
8. Any and all records produced by DOC personnel regarding the actual preparation for and
execution by lethal injection of every prisoner executed on or after September 15, 1991,
including but not limited to:
a. All documents describing the protocol for lethal injection that itemizes the amounts
and concentrations of all chemical substances utilized during execution by lethal
injection;
Again, these records contain internal security information pertammg to inmates at a state
correctional facility. The Department's regulations that you seek are directly related to the internal
security of the inmates at the Louisiana State Penitentiary and nonpublic by virtue of La. R.S. 44:3(A)(3).
Since the records sought are internal management tools that explain how Department personnel are to
implement statutory rules and laws regarding lethal injections, their disclosure could create a heightened
security risk, the prevention of which significantly outweighs the right of the public to be informed on
such matters.
b. All internal communication, reports, telexes, emails, or faxes, or other reporting device
that details the procedure for Angola and/or DOC's planned administration of these
drugs in future executions, including, but not limited to, the timing of each step of the
process, the anonymous description of each person involved in the administration of
the lethal injection, (names may be redactedfor privacy) and a description of the extent
of medical training if any, of each of these persons.
Because you seek records of the planned administration of lethal injection drugs in future
executions, the disclosure of these records would create a heightened security risk, placing DOC
employees, inmates and the lethal injection process at risk. Because these records are directly related to
the internal security of the Department personnel, offenders, and participants in the lethal injection
process, it is shielded from disclosure. La. R.S. 44:3(A)(3). Furthermore, the person selected to
administer the lethal injection is exempt from disclosure by law, including any information which could
lead to the identification of such person. La. R.S. 15:570. For this reason, the information you seek is
also nonpublic.
c. All documents regarding the administration of lethal chemicals and other requested
information in this regulation that are separate and distinct from the cursory
description of the names of the three chemical agents listed separated in DOC
Regulation No. C-03-001, 11 C;
The Department is unable to respond to this request, as it is unclear what information you seek.
Case 3:l2-cv-00796-JJB-SCR Document 24-6 02/06/l3 Page 4 of 6
USCA5 376
Case 3:l2-cv-00796-JJB-SCR Document 52-l 03/25/l3 Page 376 of 429
26a
Gary Clements
January 7, 2013
Page 5
d. Any other notes (printed, typed or handwritten), reports, statements, photographs,
supplemental reports, initial reports, memoranda, scientific reports, tapes of
statements, interviews notes, interview summaries, narratives, affidavits, files, audio
and video records, drawings, sketches, physical evidence, inventory logs, chronologies,
summaries, witness statements, witness interviews, and witness affidavits, which are
responsive to the foregoing request;
This request is too vague and overbroad for the Department to respond.
e. All death certificates issuedfor each prisoner executed on or after September 15,1991;
You do not fall within one of the classes of persons qualified to receive a copy of a death
certificate pursuant to La. R.S. 40:41(C). As such, this information is nonpublic. La. R.S. 44:4.1 (B)(24).
f Each proces verbal and/or press release for every prisoner executed on or after
September 15,1991;
Attached are all public records responsive to tbis request.
g. All correspondence with and signed agreements from prospective witnesses to each
execution for every prisoner executed on or after September 15, 1991;
Attached are all public records responsive to this request.
h. All Unusual Occurrence Reports generated in connection with every execution carried
out on or after September 15,1991;
Attached are all public records responsive to tbis request.
i. All death warrants issued for every prisoner executed on or after September 15, 1991;
Attached are all public records responsive to this request.
j. All internal memoranda! letters/ emails/ communications among prison employees,
including wardens, medical staff, and civilian staff, involved in an upcoming
communication concerning the carrying out of the execution
The Department does not know what infonnation you seek.
k. All sign-in sheets for all witnesses to each execution carried out on or after September
15,1991;
The Department has been unable to locate tbese records. Should this change, I will supplement
my response to tbis public records request.
Case 3:l2-cv-00796-JJB-SCR Document 24-6 02/06/l3 Page 5 of 6
USCA5 377
Case 3:l2-cv-00796-JJB-SCR Document 52-l 03/25/l3 Page 377 of 429
27a
Gary Clements
January 7, 2013
Page 6
/, All records of overtime hours worked by DOC employees in connection with each
execution carried out on or after September 15,1991;
Any such records cannot be disclosed, as the identities of these employees and any information
which could identifY them are specifically designated to remain "strictly confidential." La, R.S.
15:570(F).
m. All mental health assessments, interviews, evaluations, etc carried out for inmates in
advance of every execution carried out on or after September 15,1991;
These records are exempt from disclosure pursuant to La. R.S. 44:7.
n. All medical summaries for each execution carried out on or after September 15, 1991;
These records are exempt from disclosure pursuant to La. R.S. 44:7.
Sincerely,
cc: Department of Corrections
Case 3:l2-cv-00796-JJB-SCR Document 24-6 02/06/l3 Page 6 of 6
USCA5 378
Case 3:l2-cv-00796-JJB-SCR Document 52-l 03/25/l3 Page 378 of 429
28a
APPENDIX G
29a

"##$#%&'()*+,-$ ./ (

To: Waiuen Cain
Fiom: Chiis Sepulvauo
Bate:
Re: Lethal Injection


"#$% $% & '()*(%" +,' &-.$/$%"'&"$0( '(.(-$(% 1&'234 %"(2 ,/(

Beai Waiuen Cain,
I am an inmate cuiiently sentenceu to ueath at Angola. I biing this complaint against
the Bepaitment of Public Safety anu Coiiections, Secietaiy }ames LeBlanc, Waiuen Buil
Cain, anu all paiticipants in the execution piocess at Angola Louisiana State Penitentiaiy,
many of whose iuentities aie not known to me.
When my sentence is caiiieu out, the State anu its agents, by statute, will execute me
by use of lethal injection. The piecise piocess that the state will use to caiiy out the lethal
injection has been maue seciet anu iemains unuiscloseu, unpublisheu, anu peihaps even
un-piomulgateu by the state anu the Bepaitment of Public Safety anu Coiiections.
If theie is a new piotocol in place, I have not seen it anu woiiy that it has not been
appioveu oi uesigneu with the help of a ceitifieu meuical piofessional anu that it uoes not
incluue auequate safeguaius to piotect my constitutional iights against toituie, pain, anu
suffeiing.
Baseu on an outuateu piotocol useu by the state, I have ieason to believe that the
membeis of the execution team have not been piopeily tiaineu in executions, that theie is
insufficient meuical supeivision ovei the pioceuuies, anu that the pioceuuies themselves
uon't incluue auequate safeguaius to piotect me fiom ciuel anu unusual punishment. I
woiiy that those who might be selecteu to caiiy out the execution lack the qualifications,
tiaining, anu competence to uo so in a constitutional mannei.
I woiiy that I will be toituieu to ueath. I am woiiieu that I will expeiience
substantial pain anu suffeiing, incluuing conscious paialysis, suffocation, oi conscious
caiuiac aiiest. I woiiy that if the uiugs aie not auministeieu piopeily, my execution will
become toituious.
I also have ieason to believe that, if the olu piotocol is still in place, the state intenus
to caiiy out the execution using expiieu uiugs since the uiugs in the olu piotocol aie no
longei available.
I am also conceineu that the piotocol has not been anu will not be consistently
auheieu to.
I also believe that the current protocol should be subject to public review or at least some
oversight in order to ensure that there is due process of law and to help ensure that the
procedures contain adequate safeguards. I am concerned that the protocol is arbitrary and
capricious. I believe that the proper administrative law procedures were not adhered to and that
the power to make the lethal injection protocol has been unlawfully delegated to the Department
of Corrections or not delegated at all.
These conceins amount to violations of seveial clauses of the 0niteu States'
Constitution, incluuing, among otheis, the equal piotection clause of the fouiteenth
30a

"##$#%&'()*+,-( ./ (

amenument, the ciuel anu unusual punishment clauses of the eighth amenument, anu the
uue piocess clause of the fifth anu fouiteenth amenuments, anu also amount to violations
of the analogous piovisions of the Louisiana Constitution.

!"#$"%&% ()* !"+,"(
- *"%."/&($++0 *"#$"%& &1" ()++)2,34 *"+,"(5

1. A copy of all past anu cuiient piotocols, guiuelines, iules anu pioceuuies ielateu
to executions by lethal injection anu any othei mateiials whatsoevei about the
cuiient lethal injection pioceuuies. This iequest incluues any uiafts of these
uocuments as well.
2. All uocumentation ielating to the execution of ueialu Boiuelon in }anuaiy of
2uu9.
S. Infoimation about the type, quantity, manufactuiei, anu souice of all uiugs to be
useu in the lethal injection piocess, as well as any uocumentation of FBA
appioval foi the uiugs, whethei they aie appioveu foi human oi veteiinaiian
use, anu the expiiation uates of all uiugs.
4. Bocumentation of the qualifications anu tiaining foi all membeis of the
execution team
S. A ueclaiatoiy juugment that the cuiient plan foi lethal injection in Louisiana is
unconstitutional anu injunction pieventing the State of Louisiana fiom caiiying
out my sentence.
6. Expeuite ieview of this iequest, as the State is set to execute me on Febiuaiy 1S,
2u1S.
7. I also iequest any othei equitable ielief that might be appiopiiate.


Submitteu by:


______________________________
Chiis Sepulvauo


Piepaieu by:

Kathy Kelly, Bai No. XXXXXXX
Capital Post-Conviction Pioject of Louisiana, 1S4u Poyuias Stieet, Ste. 17uu
New 0ileans, La
7u112
(Su4)212-211u

31a
APPENDIX H
32a
LOUISIANA DEPARTMENT OF PUBLIC SAFETY AND CORRECTIONS
CORRECTIONS SERVICES
OFFENDERS RELIEF REQUEST FORM
CASE NUMBER: LSP-2013 -0010
TO: CHRISTOPHER SEPULVADO 186756 DR B TIER
x
Offender's Name and Number Living Quarters
12/18/2012
Date of Incident
ACCEPTED: This request comes to you from the Wardens Office. A response will be
issued within 40 days of this date.
REJECTED: Your request has been rejected for the following reason(s):
YOUR REQUEST FOR AN ARP IS BEING REJECTED AT THIS TIME
BECAUSE AS OF THIS DATE NOTHING HAS PERSONALLY HAPPENED TO YOU.
01114/2013 Trish Foster
Date Warden's Signature or Designee
Case 3:l2-cv-00796-JJB-SCR Document 24-5 02/06/l3 Page l of l
USCA5 372
Case 3:l2-cv-00796-JJB-SCR Document 52-l 03/25/l3 Page 372 of 429
33a
APPENDIX I
34a
35a
APPENDIX J
36a
37a
APPENDIX K
38a
kaLhy,

ln response Lo your leLLer, please be advlsed LhaL uCC ls ln Lhe process of lmplemenLlng Lhe leLhal ln[ecLlon proLocol, lncludlng procurlng Lhe
penLobarblLal. We are ln Lhe process of preparlng formal responses Lo dlscovery ln accordance wlLh M! 8ledllnger's order. We wlll provlde you wlLh
a copy of same [usL as soon as lL ls ready.

lease provlde us wlLh a courLesy copy of any wrlL or oLher courL flllngs you may flle wlLh respecL Lo Lhe upcomlng execuLlon.

1hanks,

Jeffrey K. Cody
Shows, Cali & Walsh, LLP
Attorneys at Law
628 St. Louis Street (70802)
P.O. Drawer 4425
Baton Rouge, LA 70821
Phone: 225-346-1461
Fax: 225-346-1467
jeffreyc@scwllp.com (lease noLe my emall address has changed.)
cONlluN1lAll1 NO1lc. 1bls commoolcotloo ooJ ooy ottocbmeots tbeteto, coostltote oo "electtoolc commoolcotloo" wltblo tbe meooloq of tbe lecttoolc
commoolcotloos ltlvocy Act, 18 u.5.c.A. 2510, ooJ Jlsclosote of tbese cooteots ls llmlteJ to tbe teclpleot(s) loteoJeJ by tbe seoJet of tbls messoqes. uoless exptessly
stoteJ otbetwlse, tbls messoqe ooJ ooy Jocomeots occompooyloq tbls moll ttoosmlssloo ote cooflJeotlol ooJ moy be sobject to tbe ottotoey clleot ptlvlleqe ot JeemeJ
wotk ptoJoct Jocomeots. 1be 5eoJet's expectotloo of ptlvocy teqotJloq tbe cooteot of tbls e-moll messoqe ooJ ooy Jocomeots occompooyloq tbls ttoosmlssloo ls exttemely
blqb. 1bls messoqe ls loteoJeJ solely fot tbe oJJtessee(s). lf tbe teoJet of tbls messoqe ls oot tbe loteoJeJ teclpleot, yoo ote beteby ootlfleJ tbot yoo bove tecelveJ tbls lo
ettot ooJ ooy tevlew, Jlssemlootloo, ot copyloq ls sttlctly ptoblblteJ. lf yoo ote oot oo oJJtessee, ooy Jlsclosote ot copyloq of tbe cooteots of tbls e-moll, ot ooy octloo tokeo
ot oot tokeo lo tellooce oo lt, ls sttlctly ooootbotlzeJ ooJ moy be oolowfol. lf yoo ote oot oo oJJtessee, pleose Jesttoy tbe messoqe ooJ lofotm tbe seoJet lmmeJlotely ot
tbe oombet, oJJtess ot moll oJJtess obove. 1bls e-moll ttoosmlssloo ooJ ooy occompooyloq motetlol moy cootolo embeJJeJ metoJoto. Aoy locloJeJ metoJoto ls
cooflJeotlol ot ptlvlleqeJ lofotmotloo ooJ ls oot loteoJeJ to be vleweJ by o ooo-clleot teclpleot.



From: Kathy Kelly [mailto:KKelly@cpcpl.org]
Sent: Thursday, January 16, 2014 1:51 PM
To: James Hilburn; Shanna Hugle
Cc: Jeffrey Cody; Gary Clements; Mercedes Montagnes (MMontagnes@thejusticecenter.org); Cecelia Trenticosta (CTrenticosta@thejusticecenter.org);
Michael D. Rubenstein
Subject: 'RE: SEPULVADO: Plaintiff's Discovery

l'm sorry l [usL senL Lhe wrong aLLachmenL Lhls ls Lhe correcL leLLer.

From: Kathy Kelly
Sent: Thursday, January 16, 2014 1:48 PM
To: 'James Hilburn'; Shanna Hugle
Cc: Jeffrey Cody; Gary Clements; Mercedes Montagnes (MMontagnes@thejusticecenter.org); Cecelia Trenticosta (CTrenticosta@thejusticecenter.org);
Michael D. Rubenstein
Subject: RE: SEPULVADO: Plaintiff's Discovery
Importance: High

uear Mr. Pllburn and Mr. Cody, lease see aLLached leLLer and please respond ln wrlLlng as soon as posslble.

Slncerely
kaLhy kelly, uepuLy ulrecLor
Cary ClemenLs, ulrecLor
CaplLal osL-ConvlcLlon ro[ecL of Loulslana
From: Jeffrey Cody <jeffreyc@scwllp.com>
Subject: RE: SEPULVADO: Plaintiff's Discovery
Date: January 16, 2014 4:16:54 PM EST
To: 'Kathy Kelly' <KKelly@cpcpl.org>, James Hilburn <jamesh@SCWLLP.COM>, Shanna Hugle <SHugle@cpcpl.org>
Cc: Gary Clements <GClements@cpcpl.org>, Mercedes Montagnes <MMontagnes@thejusticecenter.org>, Cecelia Trenticosta
<CTrenticosta@thejusticecenter.org>, "Michael D. Rubenstein" <mdrubenstein@liskow.com>, Jackie Wilson <jbw@SCWLLP.COM>

39a
APPENDIX L
40a
41a
42a
APPENDIX M
43a
From: James Hilburn [mailto:jamesh@SCWLLP.COM]
Sent: Wednesday, January 22, 2014 12:29 PM
To: Kathy Kelly
Cc: Jeffrey Cody
Subject: RE: SEPULVADO: Plaintiff's Discovery

Kathy,

This is in response to your emailed letter dated January 21, 2014, wherein you
requested information about revisions to the execution protocol.

We are in the process of preparing responses to the compelled interrogatories
and requests for production of documents. We expect to have the responses, with
accompanying documents, delivered to your office on or before Friday, January 24
th
.
We are not aware of any changes to the current execution protocol.


JAMES L. HILBURN
Associate Attorney
Shows, Cali & Walsh, LLP
628 St. Louis Street
Baton Rouge, LA 70802
Telephone: 225.346.1461
Facsimile: 225.346.1467

CONFIDENTIALITY NOTICE: This communication and any attachments thereto, constitute an "electronic communication"
within the meaning of the Electronic Communications Privacy Act, 18 U.S.C.A. 2510, and disclosure of these contents is limited to
the recipient(s) intended by the sender of this messages. Unless expressly stated otherwise, this message and any documents
accompanying this Email transmission are confidential and may be subject to the attorney client privilege or deemed work
product documents. The Sender's expectation of privacy regarding the content of this e-mail message and any documents
accompanying this transmission is extremely high. This message is intended solely for the addressee(s). If the reader of this
message is not the intended recipient, you are hereby notified that you have received this in error and any review, dissemination,
or copying is strictly prohibited. If you are not an addressee, any disclosure or copying of the contents of this e-mail, or any action
taken or not taken in reliance on it, is strictly unauthorized and may be unlawful. If you are not an addressee, please destroy the
message and inform the sender immediately at the number, address or Email address above. This e-mail transmission and any
accompanying material may contain embedded metadata. Any included metadata is confidential or privileged information and
is not intended to be viewed by a non-client recipient.


44a
APPENDIX N
45a
46a
APPENDIX O
47a
48a
49a
50a
51a
52a
53a
54a
55a
56a
APPENDIX P
57a
TN THE UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF MISSOURI
CENTRAL DIVISION
DAVID S. ZINK et aI. , )
)
)
)
)
)
)
)
)
)
Plaintiffs,
v.
No.2: 12-CV-4209-NKL
GEORGE A. LOMBARDI et aI.,
Defendants.
AFFIDAVIT OF LARRY D. SASICH
I. My name is Larry D. Sasich, PharmD, MPH, FASHP. I am over the
age of twenty-one and competent to testify to the truth of the matters contained
herein. The factual statements I make in thi s affidavit are true and correct to the
best of my knowledge and experience. The opinions I express in this statement
are made to a reasonable degree of scientific certainty.
2. I am a Consultant specializing in drug safety and efficacy issues. My
experience and qualifications, in part, include:
a. Consultant to the Saudi Food and Drug Authority, Riyadh, Saudi
Arabia.
b. Chairperson of the Department of Pharmacy Practice at the
LECOM School of Pharmacy in Erie, Pennsylvania.
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l of 36
58a
c. Consultant to Public Citi zen Health Research Group, Washington,
D.C., and
d. Consumer Representative on the Science Board of Food and Drug
Administration's Science, an advisory committee to the FDA
Commissioner.
3. [have a Masters in Public Health, with an emphasis in biostatistics
and epidemiology from the George Washington University, and a Doctorate of
Pharmacy from University of the Pacific. [have completed a residency in
nuclear pharmacy at the University of New Mexico. I have also been elected a
Fellow in the American Society of Health-System Pharmacists (F ASHP). 1 have
also authored publications and/or presented analysis on drug safety issues. A
complete list of my publications and presentations are listed in my Curriculum
Vitae, which is appended to this statement.
4. Counsel representing David Zink et aI. , a group of Mi ssouri death-
sentenced prisoners, have asked me to provide opinions on the use and practice of
compounding pharmacy in the United States. [n particular, I have been asked to
comment on the intention of the Missouri Department ofCorrecliolls to employ a
compounding pharmacist to compound drugs - in this case pentobarbital -
intended for use in lethal injection. Counsel for the prisoners have asked me to
2
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 2 of 36
59a
review the processes involved in compounding and assess whether there IS a
substanti al risk of serious harm in using compounded drugs for thi s purpose.
l. Pharmacy Compounding Review
5. Pharmacy compounding is a traditional practice of the profession of
pharmacy. Traditional compounding does not involve the creation of drugs from
scratch. It uses acti ve and inacti ve ingredients to meet the indi vi dual needs of a
patient that cannot be met with an FDA-approved product for medical reasons,
according to a legal prescription for an individual patient. For instance, a two-
year-old transplant patient may require a medication that is only avai lable in an
FDA-approved tablet form. In such a case, a tabl et's ingredients may be
reformul ated into an oral liquid for administration. This medication would be
considered to be life-sustaining, and the expected benefits would li kely be judged
by the patient's learned intermediary (a licensed healthcare professional who
holds prescri ptive authori ty) to outweigh ri sks associated with the use of a non-
FDA approved, non-GMP (Good Manufacturing Pract ices) produced product.
With traditional pharmacy compounding, then, the FDA generally exercIses
enforcement discretion, as opposed to the non-traditional practice, which is
regulated if at all only by the states. Such benefit-risk regulatory decisions are
only very rarely made on a population level: during the 2009 Influenza
3
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 3 of 36
60a
Pandemic, the FDA made explicit provisions for the compounding of a pediatric
version of an anti viral medication that did not exist in a dose or dosage form
suitable for chi ldren according to a validated compounding formula.
6. The FDA may use its resources to enforce provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA) with respect to compounding in order to
ensure that the following restrictions apply:
a. the existence of indi vidual medical necessity that cannot be met
with FDA-approved products as determined by a licensed
prescriber acting as the learned intermediary, and
b. a tacit understanding that FDA-approval, federal Good
Manufacturing Practice, and federal inspection and oversight
constitute a basic standard of care for pharmaceuticals in the
United States, with a tolerance for circumvention of those
standards only under the rarest circumstances of medical necessity.
7. Over the past several decades, marketing experts have leveraged the
traditional, medically-driven, therapeuti cally essential role of compounding-
where federal standards are compromi sed for critical medical need- to legitimize
a substandard drug industry, supported and driven by chemical distributors and
other entities, who provide training and supply active and inactive ingredients,
4
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 4 of 36
61a
compounding equipment, recipes, and marketing tool s for growing compounding
businesses. This industry operates in a "grey market," where non-federally
regulated drug manufacturing, marketing, and promotion throughout the United
States is strategically legitimi zed through consistent messaging around the
hi storical role of drug compounding.
8. Non-traditional compounding pharmacy practice resembles drug
manufacturing more than it does the practice of pharmacy. Non-traditional
compounding involves the use of raw ingredients to manufacture a copy or
substitute for an FDA-approved drug, not for a specific patient with a specific
medical need, but for general di stribution. In contrast to drug manufacturers, non-
traditional compounding pharmacies avoid the costs of drug development and
testing to prove their products are pure, potent, safe, and effective. They al so
avoid the substantial costs associated with maintaining compliance with federal
manufacturing oversight. At the same time, they charge equivalent or even hi gher
prices for their products, often using the tenn "custom_ized" to suggest a designer-
quality and impart a perceived added value to the product.
9. Unlike manufacturers, compounding pharmacies are generally not
subject to the drug approval process and rigorous checks and regul atory
procedures required under federal GMPs.
It is questionable whether
5
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 5 of 36
62a
compounding pharmacists would even be able to define risks associated wjth
compounding untested and unapproved new drugs when they lack the expertise
that federal manufacturing oversight provides.
10. Serious compli cations are foreseeable when a drug IS not
manufactured by an approved manufacturer. For example, a compounding
pharmacist may mistakenly conclude that drugs made accordi ng to the
enforceable sterile compounding standards issued by the United States
Pharmacopeia (USP) Chapter 797 have a hi gh degree of sterility assurance,
compared to the federal standard for sterili ty. In fact, experts have concluded the
opposite: that drugs compounded in accordance with USP Chapter 797 have a
low standard of sterility assurance compared to the federal standard. A product's
sterility is very basic ri sk information, yet compounding phannacies do not
generally assess it, much less convey it to prescribers or patients.
I 1. Similarl y, a pharmaci st may have confidence in her ability to
accurately measure or weigh indi vidual ingredients and extend this confidence as
a quality measure for the finished compound. But if the pharmacist is starting
with an adulterated or counterfeit chemical that would go unrecognized in a
pharmacy setting <as opposed to a manufacturing facility with the capacity to test
the quality of ingredients and overseen by federal regulators), accurate
6
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 6 of 36
63a
measurement of chemicals cannot remedy an already adulterated or otherwise
unsafe product with respect to identity, purity, potency, or harmful
contamination. Despite a pharmacist's best efforts, there are parameters beyond
her professional control that build risk and uncertainty into all compounded
products.
12. Compounded drugs do not meet federal requirements for purity,
potency, efficacy and safety. Existing outside of the FDA regulatory framework
which ensures the quality, safety and efficacy of manufactured pharmaceutical
drugs, compounding pharmacies represent an emerging, substandard drug
industry responsible for making large quantities of unregulated, unpredictable
and potentially unsafe drugs.
13. Former FDA Commissioner David Kessler, M.D., warned that
exempting pharmacy compounding from the FFDC would create a shadow
industry of unapproved drug manufacturing, which would create a risk to the
public through the manufacture of ineffective or unsafe products. Pharmacists
are drug experts, not manufacturing experts. Pharmacists who compound drugs
may not understand the complex system of drug regulations that provide
necessary public health protections.
7
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 7 of 36
64a
14. Compounded drugs are not FDA-approved for any purpose. This
means that the FDA has not verified their safety or effectiveness or the quality of
their manufacture. Counterfeit or substandard ingredients, andlor poor pract ice
on the part of drug compounders, often results in drugs which are contaminated,
sub-potent or super-potent, or which do not have the strength, quality or purity
represented on thei r labeling or required for the safe and effective treatment of
patients. The potential harm associated with the use of such contaminated or sub-
potent drugs is extremely high. Consumers who use compounded drugs do so at
their own risk.
15. Missouri has announced that it will obtain the pentobarbital specified
as the lethal agent in its execution protocol from a compounding pharmacy. The
Department of Corrections would have a compounding pharmacist perform a
non-traditi onal form of compounding, by manufacturing what is essentiall y a
copy of an FDA-approved pentobarbital drug product, not pursuant to the
determination of a licensed physician ("a learned intermediary") that an FDA-
approved product cannot be used for medical reasons, but instead for the use in
executing prisoners. Because neither the pharmacist nor the prescribing physician
is fulfilling the professional rol e as the prisoners' learned intermedi ary, this non-
medically-directed compounding is tantamount to drug counterfeiting. The
8
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 8 of 36
65a
resulting dosage form is experimental and unpredictabl e in both composition and
with respect to intended and unintended adverse effects.
Il.l!!gredients Used In Compounding Pharmacy
16. The quali ty of raw bulk product, or Active Pharmaceutical Ingredients
("APTs"), used in compounding is suspect. A 2000 hearing before the House
Energy and Commerce Committee cited compounding pharmacies as a primary
route of entry for counterfeit bulk drugs: "Lured by high prices and potential
profits in the United States, counterfeit bulks can get into our prescription drugs
in several ways: (I) as imported ingredients to U.S. manufacturers; (2) as
imported ingredients to pharmaceutical compounders; and (3) as source
ingredients for Internet pharmacies marketing to the U.S. The counterfeiters use
sophisticated methods such as preparing false labeling, containers, seals and
certificates of analysis, or using a manufacturing process that differs from the
filed manufacturing process." Former FDA Commissioner Jane Henney testified
that "[counterfeit bulk drugs] pose a real or potential health hazard because their
manufacturer is often unknown" and that the Himpurity profile is unknown, and
the age, the storage, the manufacturing envirorunent, or the synthesis of the
product cannot be determined" creating a situation where "no amount of fmished
product testi ng can build quality into the product."
9
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 9 of 36
66a
17. Compounding phannaci sts generall y do not have the abi lity to test
chemicals for identity, potency, purity and contamination. Because of Missouri' s
secrecy laws as invoked by the Department of Corrections, the phannacy
preparing the pentobarbital sodium injection and the source of the pentobarbital
sodium API are unknown at this time. It is unlikel y that the pharmacy supplying
pentobarbital to the Department of Corrections is capable of conducting testing to
confinn the identity of the chemical, or to identify the presence of harmful
contaminants that pose an immediate safety threat if admini stered intravenously.
It is similarly unlikely that the compounding pharmacy intends to have either Ca)
the inactive chemical ingredients, or Cb) the fini shed and compounded dosage
form of the drug, tested using methods of analysis that meet the standard of care
the law demands under nonnal circumstances. Missouri's execution protocol
does not include any such provisions.
18. The ability to trace the raw API chemicals used in compounding back
to the original manufacturers for information on quality, packaging, storage,
shipment conditions, and chains of custody that are necessary to ascertain the
identity, purity, potency, and efficacy of a medication is incredibly difficult even
without the layer of secrecy added by the Missouri Department of Corrections.
10
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l0 of 36
67a
19. The active ingredients used in the compounding pharmacy may come
from the grey market, having been produced in non-FDA-registered, non-FDA
inspected facilities. Ambiguous or false marketing statements are frequently
used to mislead physicians into authori zing prescriptions for non-FDA-approved
medications. The prescribing physician may believe that if ingredients are FDA-
approved, they must be safe to use in compounding. But such a belief would rest
on a false assumption. In fact, the FDA inspects chemical plants but does not
approve chemical ingredients: it approves products in their fini shed dosage
forms, with packaging and labeling to support safe use. Chemicals used in
compounding are hi ghly suspect, and there is no practical way to verify their
quality, constitution or uniformity in limited pharmacy settings.
20. The ingredi ents often come from plants in China or India, which may
or may not be registered with or have records of inspection by the US FDA. [n
thi s case, there is no evidence that the pentobarbital sodium selected for use in
the non-traditional compounding of what is essentially a copy of an FDA-
approved drug has been produced in an FDA-registered and inspected facility.
Plants in China have been identified in which pesticides are manufactured using
the same equipment as is used to make APls bound for human ingestion as part
of a compounded-pharmacy product. By contrast, for an active ingredient to
II
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page ll of 36
68a
qualify for use in a finished dosage form, it must be manufactured in a US FDA-
approved plant by a manufacturer which holds a Drug Master File for the
chemical. (In any event, the Missouri Department of Corrections has concealed
the identity of the chemical manufacturer and subsequent
distributors/repackagers.) If one were to assume that pharmacists were able to
verify the registration status of repackagers from which they purchase chemicals,
it remains practically impossible for pharmacists to independently verify the
registration status of the actual chemical manufacturer, due to complexities and
vulnerabilities in global supply chains.
21. Ethical chemical manufacturers who adhere to professional
Responsible Care principles are unlikely to sell chemicals that may be used in
grey market drug production operations (non-traditional pharmacy compounding
or "manufacturing under the guise of pharmacy compounding"). Instead, they
are more likely to sell directly to FDA-approved manufacturers of finished
products. Accordingly, non-FDA registered chemical manufacturers are more
likely to release large quantities of bulk chemicals into the grey market,
increasi ng the likelihood that substandard chemicals will serve as the start ing
materials for both traditional and non-traditional compounding.
12
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l2 of 36
69a
22. In this unregulated market, a chemical labeled to represent a certain
active ingredient may actually contain another, quite different ingredient.
Practitioners, regulators, and experts have identified this problem as to chemicals
di stributed in large quantities to pharmacies throughout the nation for use in
compounding.
23. There can be no guarantees that APls purchased from the grey market
are safe for use, are not contaminated, or even contain the ingredient listed on the
product label. Furthermore, because chemicals may not have been manufactured
in an FDA-registered facility under current Good Manufacturing Practice
standards (GMP) standards, there can be no assurance as to the quality variation
trom lot to lot or container to container.
24. Testing for one lot of a chemical does not prove that a subsequent lot
would have the same characteristics as the lot that was tested, and testing would
provide only very provisional indication of its suitability for compounding given
the unknown disposition of the chemical in the timeframe from testing to
pharmacy compounding and use.
25. In order to represent to the Court or otherwise that a substance will
have the effect it is supposed to have, one must use ingredients manufactured by
FDA-registered and inspected manufacturers in order to ensure the quality of the
13
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l3 of 36
70a
final product. If poor quality ingredients are used, even the best compounding
practices will not build quali ty and suitability into the final product. The
compounded drug may be contaminated, super-potent or sub-potent, making it
dangerous in that it poses a foreseeable risk of pain and suffering to the "patient"
to whom it was administered.
26. Even for the treatment of animals, the American Veterinary Medical
Association actively di scourages the use of compounded drugs except in cases of
veterinary medical necessity. This professional policy was recently underscored
after the death of 21 polo ponies from poisoning by compounded drugs. The
American Veterinary Medical Association advises that because one cannot assure
the quality of bulk active ingredients, bulk active ingredients must not be
compounded for use in animals. The ri sk of contamination is extremely high,
and veterinary associations draw an ethical line to avoid the ri sks of
admini stering contaminated drugs to animals.
27. The Missouri Department of Corrections has not disclosed any
evidence that the API in thi s case was manufactured in an FDA-registered
facility. There is also no evidence that the API meets U.S. Pharmacopeia
standards required for the finished dosage form: there is no way of knowing the
current quality of the API in the bottle, after manufacture and initial testing (if
14
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l4 of 36
71a
performed), and after supply-chain, repackaging and pharmacy handling. The
Department has not di sclosed preliminary evidence and additional verification of
production in a facility that is registered and inspected by FDA in any
compounding process. Administering such an ingredient introduces an
unacceptable risk of harm and is ill-advised.
28. Pentobarbital injection compounded from unverified ingredients poses
a substantial risk of harm from the ingredients alone: the use of untested,
inadequately tested and/or non-validated formulas and compounding methods,
environmental controls and contai ner packaging, coupled with lack of
instructions for safe use introduces very high burdens of uncertainty and risk of
harm. These risks of harm include sub- or super- potency, contami nation with
dangerous allergens or substances that may cause immediate anaphylactic
reactions, contamination with bacteria or fungus with immediate excruciating
effects before the condemned person is unconscious (assuming it works even to
that extent), and even the administration of an entirely incorrect chemical or
active ingredient.
29. [n the wake of the fungal meningi tis outbreak of fa ll 2012 due to
contaminated injectable steroids manufactured by a Massachusetts compounding
pharmacy, the FDA has increased its scrutiny of compounding pharmacies and
15
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l5 of 36
72a
found widespread safety ri sks for 30 out of 31 pharmacies inspected. FDA
Commi ssioner Margaret Hamburg, in a related "Sixty Minutes" interview in
April 2013 stated: " ... what I think emerged in the meningitis outbreak was that
many patients and their health care providers didn't realize that they in fact were
using a compounded product." The interviewer then asked "As Commissioner of
the FDA then you can't tell us sitting here now that every drug being used in the
United States is safe and effective?" Hamburg replied, "No. I really cannot". If
the Commissioner of the U.S. FDA cannot verity that drugs produced in
compounding pharmaci es are safe and effective for therapeutic use, doctor(s) and
compounding pharmacist(s) involved in the prescribing and manufacture of drugs
used for non-therapeuti c procedures such as lethal injections should have even
less confidence in their purity and potency, and subsequentl y their intended and
unintended effects.
30. To use drugs from compounding pharmacies in the execution by lethal
injection of a prisoner presents a substantial ri sk that the drugs will not work
effectively for the announced purpose. Compounded pentobarbital may give rise
to a completely unantici pated response including an allergic or anaphylactic
reaction to an unidentifi ed adulterant arising from intrinsic contamination of the
ingredients or extrinsic contamination during the compounding procedure, or a
16
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l6 of 36
73a
-------------------- -
pulmonary embolism arising from unanticipated drug incompatibilities, or partial
or complete lack of effect due to ingredient tampering or controlled drug
diversion after analytical testing--circumstances that would be expected to
prolong the execution and multiply the pain and suffering beyond the objective of
causing the condemned person's death. Highly unpredictable, rapidly evolving,
and potentially painful and agonizing reactions may ensue should the
pentobarbital be contaminated by endotoxins or exotoxins. Similarly, should
solid particulate matter of any kind contaminate the solution or precipitate out of
solution during intravenous injection, there is a substantial risk of pain and
suffering upon injection of the solution.
31. With a compounding-pharmacy product used instead of an FDA-
compliant product, there is a substantial likelihood that the pH (acidity) of the
sol ution inj ected will be incorrect. When the pH of the solution is incorrect,
Plaintiffs will experience a burning sensation on injection analogous to the effect
of injecting an unanethetized condemned person with potassium chloride.
32. The use of non-sterile and potentially contaminated active ingredients
creates a serious risk of harm, including primary risks of infection and toxic
blood reactions from bacterial, fungal and endotoxin contamination. It is
foreseeable that the presence of adulterants or growing organisms will accelerate
17
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l7 of 36
74a
chemical degradation, and that larger than expected moisture content will result
in inaccurate weighing. If they occur, such initial compounding conditions will
logically result in products that are sub-potent and will fail to attain the results
expected of the substances with which health-care providers, regulators, and
academics have practical experience and theoretical knowledge.
33. As noted, failure of the dosage form to attain or maintain the
necessary pH will increase the likelihood of a burning sensation on injection. An
analogous effect to be anticipated is the formation of precipitates, or solid
particles of drug and other substances, with the foreseeable result of a painful
pulmonary embolism in the most serious of cases. Bacteria and fungus are living
organisms that grow and reproduce-their present and metabolic capacity in a
solution may alter important qual ity attributes of the solution, including final pH,
with the potential to create instability and/or incompatibility with human blood.
In thi s case, compounding a copy of a non-human formulation- untested in
humans and with a higher concentration compared with the FDA-approved
human formulation- presents a substantial risk that the injection of the
Department of Corrections' compounded drug will, for a variety of reasons,
cause unnecessary and lingering pain and suffering.
18
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l8 of 36
75a
34. There is also a substantial risk that the Department will administer a
sub-potent dose of pentobarbital, resulting in less than effective depression of the
central nervous system. The pentobarbital solution wi ll be made of a proportion
of water and active ingredient. There does not appear to be any mechanism
within Missouri 's execution protocol to adjust measurements to account for the
hygroscopic (water absorbing) nature of the chemical. In all circumstances, non-
adjustment for the hygroscopic nature of a chemical will result in a concentration
lower than the intended concentration. The difference will depend on the actual
water content of the API. If unaccounted for, this known reduction in potency
owing to water content adds to other known threats regarding the purity and
potency of the drug as it exists at the time of compounding, its potential for
degradation after initial testing, its potential for intentional or unintentional
adulteration, its potential for mislabeling, all of which, added together, increase
the risk of formulating a sub-potent dosage fonn. [fpentobarbital is administered
in a non-l ethal dose, the prisoners will foreseeably experience symptoms of acute
but not lethal intoxication including nausea and vomiting, symptoms of life-
threatening but not fatal respiratory depression and corollary organ damage
(including brain damage), and paradoxical central nervous system excitation.
19
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page l9 of 36
76a
35. There is also a substantial risk that compounding error could result in
a super- or sub- potent injection. Foreseeable consequences of the administration
of a super-potent drug include suffocation and gasping for breath, before the loss
of consciousness.
III. The Compounding Process
36. Drug manufacture is highly technical, requlflng strict adherence to
current Good Manufacturing Practice (GMP) and a ri gorous and continuous
process of FDA inspection, regulation, supervi sion and oversight.
37. The manufacture of steri le drugs intended for intravenous
administration, such as pentobarbital, IS acknowledged by pharmaceutical
manufacturers and the FDA alike to be one of the most difficult of all
pharmaceutical processes to execute. The preparation of steril e drugs is
unavoidably complex, often involving many steps and manipulations. Each step
poses an opportunity for error, including unintended introduction of adulterants,
bacteria or fungus.
38. Unlike manufacturers, compounding pharmacies do not have to
adhere to the rigorous FDA-approved procedures for manufacturing sterile drugs.
Instead, the less rigorous United States Pharmacopoeia (USP) 797 chapter
standards are applied to compounders. As a result, the potential for product
20
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 20 of 36
77a
contamination In compounded drugs is far higher than that in manufactured
drugs. In some states, compliance with even this lesser standard is not required
by Boards of Pharmacy.
IV. Testing
39. Several studies, including a survey conducted by FDA in 2001, have
reported a high prevalence of quality problems with various phanmacy-
compounded drugs, including sub-potency, super-potency, and contamination.
A survey of compounded drug products was conducted by the FDA in 2006 to
explore these issues further. The results showed that thirty-three percent of the
compounded drugs fai led analytical testing using rigorously defensi ble testing
methodology.
40. Further testing by the Missouri Board ofPhanmacy, which is the only
state agency which regularly tests compounded drugs, revealed that compounded
drugs fail tests for potency and purity on average around twenty-five per cent of
the time, an unacceptable failure rate consistent with rates observed by FDA.
This is an extremely high failure rate, further supported by recent FDA inspection
observations related to absent or limited sampling and testing of compounded
drug products that would serve to identify substandard products prior to
distribution.
21
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 2l of 36
78a
V. Compounded Pentobarbital In Executions
41. Compounded drugs have been shown to be unreliable in purity,
potency, safety and effectiveness, and have contributed to significant morbidity
and mortality threatening public health and safety throughout the United States.
This should be expected due to the abject lack of regulation and oversight of the
compounding pharmacy sub-industry. The FDA states categorically that,
because of their very nature, the safety and effectiveness of compounded drugs
cannot be established. Drugs that are manufactured in developed and even
developing countries wi th federal oversight of drug manufacturing are likely to
be of a better quality and uniformity than compounded drugs produced without
federal oversight in the United States. Here, we have none of the assurances
afforded by US FDA or EU oversight, and in this case, the manufacturer of the
API (and middlemen) are undisclosed due to the Missouri Department of
Corrections' secrecy concerning the compounding phannacy from which it
intends to purchase pentobarbital.
42. Compounded drugs exist outside of the FDA regulatory framework
and their quality, safety and effectiveness cannot be assured. In fact, they have a
much higher probability of being substandard (sub- or super- potent,
contaminated or of poor quality). In the context of executions by lethal injection,
22
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 22 of 36
79a
introducing a further element of unpredictability by using compounded drugs is a
wanton invitation to pain and suffering over and above the statutory objective of
the death of the condemned person.
43. Physician experts in the branches of pharmacology known as
phannacokinetics and pharmacodynamics are qualified to render opinions on the
effect of drugs including pentobarbital sodi um in li ving organisms including
humans in research and clinical settings. Pharmacokinetics involves the study of
the absorption, distribution, metabolism, and excretion of drugs in animals and
humans. Pharmacodynam ics is the study of the pharmacological effects of a drug
on the body. This type of study involves FDA approved drugs or the use of
highly purified research chemicals in laboratory animals.
44. What is in question here, with Missouri 's proposed execution method,
is the quality and safety of pharmacy compounded pentobarbital sodi um inj ect ion
produced from a bulk drug substance or active phannaceutical ingredient from an
unknown source and of unknown composition prepared under unregulated
conditions not meeting FDA Good Manufacturing Practice (GMPs) guidelines,
rather than the pharmacological effect of FDA approved pentobarbital sodium in
human subjects.
23
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 23 of 36
80a
45. [have reviewed the report of Dr. Mark Dershwitz, dated October 20,
2013. He opines that pentobarbital "will result in the rapid and painless death of
the inmate to whom it is administered." That opinion does not address the
compounded pentobarbital at issue here, for which the final composition is
unknown, as opposed to the use of FDA-approved pentobarbital and the
assurances of safety, effectiveness, and purity that accompany it.
46. Starting with poor quality and/or contaminated pentobarbital sodium
API combined with potential errors in compounding and lack of adherence to
OMP guideline and steri lity standards, is likely to result in substandard,
contaminated or super- or sub-potent pentobarbital. There is a substantial ri sk
that if such drugs were used in an execution by lethal injection, they would not
work in a predictable manner, and could cause serious pain upon injection,
considerable mental anguish and anxiety, and thereby put the prisoners at
substantial risk of serious, unnecessary and substantial harm and mental angui sh.
Further, affiant saith naught.
. r'-
Dated thiS';> - day of November, 2013.
24
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 24 of 36
81a
Sworn to and subscribed before me
this 1-11Iay of_ November, 2013.
c. John 'E)'lAgostino
& Associates
BaClister & Solicitor
255C FisnefStreet, North Bay, ON P1 B 2CB
LSUC No. 33213Q
25
Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 25 of 36
82a
1
CURRICULUM VITAE

Larry D. Sasich, Pharm.D., M.P.H., FASHP
839 Main Street West #3
North Bay, P1B 2V8, Ontario
Canada
Cell Phone: 705-491-0609
E-Mail: larry.sasich@gmail.com




EDUCATION
1995 to 1997 Master of Public Health - Epidemiology
The George Washington University School of
Public Health and Health Services
Washington, D.C.
1974 to 1975 Doctor of Pharmacy
University of the Pacific
College of Pharmacy
Stockton, California
1966 to 1970 Bachelor of Science Pharmacy
daho State University
College of Pharmacy
Pocatello, daho

RESIDENCY
1986 to 1987 Nuclear Pharmacy
University of New Mexico
College of Pharmacy
Albuquerque, New Mexico

PROFESSIONAL LICENSES
1970 to Present California RPH 27094





Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 26 of 36
83a
2
PROFESSIONAL EXPERIENCE

April 2013 to date

Consultant, Drug Policy, Drug Safety and
Efficacy
North Bay, ON Canada

July 2007 to April 2013
Consultant,
Saudi Food and Drug Authority
3292 Northern Ring Rd. Al Nafal District
Riyadh, Saudi Arabia

November 2009 to 2012
Consultant,
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, D.C. 20009

2007 to 2009

Chairman,
Department of Pharmacy Practice
LECOM School of Pharmacy
1858 Grandview Blvd.
Erie, PA 16505

2006 to 2007
Acting Chairman,
Department of Pharmacy Practice
LECOM School of Pharmacy
1858 Grandview Blvd.
Erie, PA 16505

2005 to 2006
Assistant Professor,
Department of Pharmacy Practice
LECOM School of Pharmacy
1858 Grandview Blvd.
Erie, PA 16505

2006 to 2008
Consultant
Centre for Science and the Public nterest
Canada
Suite 4550, CTTC Bldg.
1125 Colonel By Drive
Ottawa, Ontario K1S 5R1
Canada

Exhibit 3
Case 2:l2-cv-04209-NKL Document l57-3 Filed ll/l8/l3 Page 27 of 36
84a
3
PROFESSIONAL EXPERIENCE

2005 to 2007
Consultant
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, D.C. 20009

2005 to 2006
Consultant
Canadian Agency for Drugs and Technologies
in Health
600-865 Carling Avenue
Ottawa, Ontario K1S 5S8
Canada
1995 to 2005 Research Analyst
Public Citizen's Health Research Group
1600 20th Street NW
Washington, D.C. 20009
1991 to 1995 Drug nformation Pharmacist
King Faisal Specialist Hospital and
Research Centre
Riyadh 11211, Saudi Arabia
1993 to 1996 Adjunct Clinical Faculty
Welch School of Pharmacy
University of Wales
Cardiff, Wales
1992 to 1995 Clinical nstructor
College of Pharmacy
King Saud University
Riyadh, Saudi Arabia
Graduate and Undergraduate Teaching
1988 to 1990 Clinical Pharmacist
St. Helens Hospital and Health Center
St. Helens, OR

Emanuel Hospital and Health Center
Portland, OR
1985 to 1988 Associate Professor of Clinical Pharmacy
daho State University
College of Pharmacy
Pocatello, daho

Promoted and Tenured July 1, 1984
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PROFESSIONAL EXPERIENCE

1983 to 1984 Assistant Professor of Clinical Pharmacy
College of Pharmacy
daho State University
Pocatello, daho

Acting Associate Dean for Student Affairs
1982 to 1983 Assistant Professor of Clinical Pharmacy
College of Pharmacy
daho State University
Pocatello, daho

Director of Professional Practice
1979 to 1982 Assistant Professor of Clinical Pharmacy
College of Pharmacy
daho State University
Pocatello, daho

Director, daho Drug nformation Service and
Regional Poison Control Center
1976 to 1979 Assistant Director of Pharmacy Services
USA MEDDAC
Berlin, West Germany
1975 to 1976 Staff Pharmacist
USA MEDDAC
Wuerzburg, West Germany
1970 to 1974 Pharmacist
Baneth's Pharmacy
Menlo Park, CA


HONORARY SOCIETIES
1982 Rho Chi
1982 Sigma Xi




Exhibit 3
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AWARDS
2000 Distinguished Person of the Year
Pharmacists Planning Services
1995 Fellow American Society of Health-System
Pharmacists
1986 Ciba-Geigy Leadership Award
1983 Outstanding Service daho Board of
Pharmacy
1982 Phi Delta Chi Faculty Achievement Award

APPOINTMENTS
2009
FDA Science Board Sub Committee on the Center for Food
Safety and Applied Nutrition (CFSAN)

2008
FDA Science Board Sub Committee on the review of the
National Center for Toxicological Research

2007
Grant Reviewer
U.K. Economic and Social Research Council
Large Grant proposal: Governance of Pharmaceuticals and
Health
2007 Consumer representative, Science Board to the Food and
Drug Administration advisory committee to the FDA
Commissioner
2007 Pennsylvania Pharmacists Association Pharmacy
Compounding Task Force
2006 Food and Drug Administration Pediatric Advisory Committee
November 16, 2006 substitute consumer representative
2006 Reviewer PLoS Medicine
2000 Reviewer for the Western Journal of Medicine
2000 Reviewer for the Journal of the American Medical
Association
1996 Department of Health and Human Services Steering
Committee for the Collaborative Development of a Long-
Range Action Plan for the Provision of Useful Prescription
Drug nformation
1996 Department of Health and Human Services, Food and Drug
Administration, Consumer Consortium
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APPOINTMENTS
1995 Reviewer for the Saudi Pharmaceutical Journal
1993 Reviewer for the Annals of Saudi Medicine
1986 Reviewer for Annals of Pharmacotherapy
1987 daho Delegate to Western Regional Conference on Clinical
Pharmacy Practice
1985 daho Health Systems Ethics Conference Task Force
1984 American Pharmaceutical Association Committee to prepare
accreditation standards for a community pharmacy residency
1982 Assistant Editor DRUGDEX
1981 USP Dispensing nformation Contributors Panel

PUBLICATIONS

Sasich LD. Rapid Response: Tamiflu: 14 flu seasons and still questions. BMJ 2013. At
http://www.bmj.com/content/346/bmj.f547?tab=responses. Accessed January 28, 2013.

Sasich LD, Sukkari SR. The US FDA's Withdrawal of the Breast Cancer ndication for
Avastin (Bevacizumab). Saudi Pharmaceutical Journal 2012; 20: 381-385.

Sukkari SR, Humaidan AS, Sasich LD. The content of Arabic language consumer
medication information leaflets for three drugs: a pilot study. Saudi Pharmaceutical
Journal 2012

Sukkari SR, Sasich LD, Humaidan AS, Burikan ON. An Analysis of Metformin Treatment
for Adolescent Obesity at 48 Rather Than 24 Weeks after Treatment Cessation. Archives
of Pediatrics & Adolescent Medicine 2010; 164(7):678.

Cook GE, Sukkari SR, Sasich LD. An Additional Source of Bias in Antidepressant and
Other Trials. Pharmacotherapy 2010;30:117e-118e.

Cook GE, Sukkari SR, Sasich LD. Lost in Transmission FDA Drug nformation That
Never Reaches Clinicians. New England Journal of Medicine 2010;362(6):561-563.

Cook GE, Sasich LD, Sukkari SR. DONYSOS study comparing dronedarone with
amiodarone. BMJ 2010;340:c285.

Sasich LD, Sukkari SR, Barasain MA. An Academic Perspective on the APPEs'
Educational Significance. American Journal of Pharmaceutical Education 2009; 73: article
139.
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PUBLICATIONS

Tuttle DA, Sasich LD, Sukkari SR. mproving Access to FDA Reviews and Documents.
Journal of the American Medical Association 2009; 302: 2204.

Sasich LD, Sukkari SR, Cook GE, Tuttle DA. The mportance of FDA Approval
Packages and Briefing Documents in Pharmacy Education. American Journal of
Pharmaceutical Education 2009; 73:126-127.

Sasich LD, Barasain MA, Al Kudsi MA. Three country comparison of selected safety
information in the prescribing information for rosiglitazone (Avandia). Saudi
Pharmaceutical Journal 2009; 17: 195-198.

Sukkari SR, Sasich LD. Look in the Looking Glass Not Through t. American Journal of
Pharmaceutical Education 2009; 73:56-58.
Brown S, Olson P, Sasich LD. My First Drug nformation Question Should My Wife and
Baby be Subjects in an Uncontrolled Clinical Trial? Journal of the American Pharmacists
Association 2008; 48:444-445.

Sukkari SR, Sasich LD, Tuttle DA, Abu-Baker A, Howell H. Development and Evaluation
of a Required Patient Safety Course. American Journal of Pharmaceutical Education
2008; 73(3)

Kronmal R, Sasich LD. The FDA Should Not Have Approved Kuvan. PKU News 2008; 20:
2-11 and 12 [invited editorial].

Sasich LD. Book Review: Evaluating Clinical Research All that Glitters is not Gold.
American Journal of Pharmaceutical Education. 2008; 72(2).

Sasich LD, Barasain MA, Al Kudsi MA. The CV Risks of Etoricoxib (Arcoxia). Annals of
Saudi Medicine 2008; 28:141-142.

Vitry A, Lexchin J Sasich LD, , Dupin-Spriet T, Reed T, Bertele V, Garattini S, Toop L,
Hurley E. Provision of information regulatory authorities' websites. Internal Medicine
Journal 2008 (doi:10.1111/j.445-5994.01588.x).

Sasich LD, Sukkari SR. Unknown risks of pharmacy compounded drugs. Journal of the
American Osteopathic Association 2008; 108:86 [letter].

Miller J, Olmer J, Sasich LD. mportance and methods for accessing FDA approval
packages and briefing documents. Annals of Pharmacotherapy 2007; 41:2071-2072.
Sasich LD. Remembering Jere Goyan. American Journal of Health-System Pharmacists
2007; 64:1142 [letter].
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PUBLICATIONS
Sasich LD. Patients may not be receiving Medication Guides. Scribe International
Society of Pharmacoepidemiology 2006; 9:8.
Sasich LD. Don't forget to give out MedGuides. Drug Topics April 3, 2006.
Sukkari SR, Sasich LD. Patient nformation Leaflets. Canadian Medical Association
Journal 2004; 171:10 [letter].
Sasich LD. Viewpoint - Useful drug information: 20 years and still waiting. Drug Topics
2003; 147:17.
Sukkari SR, Sasich LD. Cisapride and patient information leaflets. Canadian Medical
Association Journal 2001; 164:1276-1278.
Wolfe S, Lurie P, Sasich LD, Barbehenn E. nformation on thiazolidinediones. Lancet
2000; 356:254-258 [letter].
Lurie P, Sasich LD. Safety of FDA-approved drugs. Journal of the American Medical
Association 1999; 282:2297 [letter].
Sasich LD. Useful prescription drug information. American Journal of Health-System
Pharmacists 1999; 56:477-478[letter].
Sasich LD, Sukkari SR. nternational Drug nformation Notes: Update on cisapride
(Prepulsid). Saudi Pharmaceutical Journal 1998; 6:270-272.
Wolfe SM, Sasich LD, Barbehenn E. Safety of sildenafil citrate. The Lancet 1998;352:
1393 [letter].
Sasich LD, Sukkari SR. nternational Drug nformation Notes: Old German drugs. Saudi
Pharmaceutical Journal 1998; 6:160-163.
Bradley L, Sasich, LD, Wolfe SM. The nformation Content of Patient Medication
nformation Leaflets Distributed by Pharmacists: Examination of Five Fluoroquinolone
Antibiotics. Journal of the American Pharmaceutical Association 1998; 38:278-
279[abstract].
Sasich LD. Book Review: Moore TJ. Prescription for Disaster New York: Simon &
Schuster; 1998. American Journal of Health-System Pharmacists 1998; 55:511.
Sasich LD, Sukkari SR. nternational Drug nformation Notes: Recent drug withdrawals
and proposed withdrawals in the US and UK. Saudi Pharmaceutical Journal 6:92-98;
1998.
Sasich LD, Wolfe SM, Pearson C, Swankin DA, Levin DA, Levin AA, Beard J. The
National Council on Patient nformation and Education. Journal of the American Medical
Association 278:1491-1492; 1997[letter].
Sasich LD, Sukkari SR. Bromocriptine: reply to Sandoz. Saudi Pharmaceutical Journal
5:197-199; 1997[letter].
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PUBLICATIONS
Sasich LD, Sukkari SR. nternational Drug nformation Notes: Fluoroquinolone
associated tendinopathy, tendinitis and tendon rupture. Saudi Pharmaceutical Journal
5:130-134; 1997.
Sasich LD, Wolfe SM. Deficiencies in patient information leaflets concerning
gastrointestinal complications of nonsteroidal anti-inflammatory drugs. Journal of General
Internal Medicine 12:79; 1997[abstract].
Sasich LD, Sukkari SR. nternational Drug nformation Notes: Probucol: lack of efficacy
and market withdrawal. Saudi Pharmaceutical Journal 5:72-73;1997.
Sasich LD. Book Review: Power and Dependence. Saudi Pharmaceutical Journal 4:212-
213; 1996.
Sasich LD, Sukkari SR. nternational Drug nformation Notes: The lack of safety and
efficacy of tramadol (Ultram, Zydol). Saudi Pharmaceutical Journal 4:207-209; 1996.
Sasich LD, Sukkari SR. nternational Drug nformation Notes: Bromocriptine (Parlodel)
and postpartum breast engorgement. Saudi Pharmaceutical Journal 4:204-207; 1996.
Sukkari SR, Sasich LD, Nicholls PJ. Therapeutic class redundancy as a measure of
formulary system effectiveness. Saudi Pharmaceutical Journal 4:190-195; 1996.
Sasich LD, Sukkari SR. nternational Drug nformation Notes: The risk of calcium channel
blockers. Saudi Pharmaceutical Journal 4:119-122; 1996.
Sukkari SR, Sasich LD, Nicholls PJ. Promoting therapeutic information to the medical
staff: the evidence based formulary. Saudi Pharmaceutical Journal 4:48-55;1996.
Sasich LD, Sukkari SR, Nuessle SJ. Post-graduate pharmacy education relevant to
developing countries. WHO Eastern Mediterranean Region Drugs Digest 10:48-50; 1995.
Sukkari SR, Sasich LD, Nicholls PJ. The formulary as a source of comparative efficacy
drug information in developing countries. Proceedings of the European Symposium on
Pharmacoeconomics, Gent, Belgium, 18-20 May 1994.
Sasich LD, Sukkari SR. The drug evaluation process at King Faisal Specialist Hospital.
Saudi Pharmaceutical Journal 2:189-197; 1994.
Nuessle SJ, Sasich LD. Criteria for use of interferon alpha-2a or interferon alpha-2b for
selected indications in adults. American Journal of Hospital Pharmacy 51:1030-1033;
1994.
Sasich LD: Book Review - The Use of Essential Drugs: Model List of Essential Drug
(Seventh List) Fifth Report of the WHO Expert Committee. Annals of Pharmacotherapy
27:1145; 1993.
Sasich LD: Blood Transfusion-Associated Bacterial Sepsis n: Conner CS, Rumack BH,
eds. DRUGDEX nformation System. Denver, CO: Micromedex, nc., 1992.
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PUBLICATIONS
Julnes T, Sasich LD. Oregon's health rationing act and the policy process. New England
Journal of Human Services 9:20-26; 1991.
Sasich LD. Pneumococcal revaccination after splenectomy. Drug Intelligence and Clinical
Pharmacy 22:722-723; 1988.
Sasich LD. Bleomycin - therapy of malignant pleural effusions n: Conner CS. Rumack
BH, eds. DRUGDEX nformation System. Denver, CO: Micromedex, nc. 1987.
Dodson RA, Sasich LD. Calcium channel blockers: their actions and indications.
Pharmacy Times 50:4; 1984.
Huff MR, Williams L, Crothers RW, Driver PS, Endo RK, Manske TA, Sasich LD.
Preventing burnout: an alternative approach. Hospital Pharmacy 19; 1983.
Sasich L D. Proposal for a community pharmacy practice residency program. American
Pharmacy 1983; 23:25-28.
Driver PS, Endo RE, Levin A, Hall DH, Sasich LD. Anaphylactic-like reactions to
zomepirac. Drug Intelligence and Clinical Pharmacy 15:384; 1981.
Sasich L, Morriss HA. A computerized on-line key word indexing system for drug
information retrieval. Hospital Pharmacy 16:136; 1981.
Sasich L. Drug literature filing systems for the practicing pharmacist. The Idaho
Pharmacist 17:16; 1980.
Hansten PD, Sasich LD, Biggs RL, Cohen SM. Computerization and drug interaction data
for a community pharmacy. Journal of Clinical Computing. 3:270; 1975.


BOOKS AND CHAPTERS
Furberg BD, Furberg CD, Sasich LD. Knowing Your Medications. 2010.
Sukkari SR, Sasich LD. Drug induced blood disorders. n: Applied Therapeutics: the
Clinical Use of Drugs. Young, LY, Koda-Kimble, M eds. Baltimore: Lippincott, Williams &
Wilkins, 2008.
Wolfe SM, Sasich LD, Hope R-E. Worst Pills, Best Pills. New York: Pocket Books, 2005.
Sasich LD, Sukkari SR. Drug induced blood disorders. n: Applied Therapeutics: the
Clinical Use of Drugs. Young, LY, Koda-Kimble, M eds. Baltimore: Lippincott, Williams &
Wilkins, 2004.
Wolfe SM, Sasich LD, Ardati AK. Worst Pills, Best Pills Companion. Washington DC:
Public Citizen, 2002.
Sasich LD, Sukkari SR. Drug induced blood disorders. n: Applied Therapeutics: the
Clinical Use of Drugs 6th ed. Young, LY, Koda-Kimble, M eds. Baltimore: Lippincott,
Exhibit 3
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BOOKS AND CHAPTERS
Williams & Wilkins, 2001.
Wolfe SM, Sasich LD, Hope R-E. Worst Pills, Best Pills. New York: Pocket Books, 1999.


References available on request
Exhibit 3
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