STATE OF SOUTH DAKOTA COUNTY OF MINNEHAHA IN CIRCUIT COURT SECOND JUDICIAL CIRCUIT CHARLES RUSSELL RHINES, Plaintiff, v. SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, MIKE LEIDHOLT, SECRETARY, SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, DARIN YOUNG IN HIS CAPACITY AS WARDEN OF THE SOUTH DAKOTA STATE PENITENTIARY, and JASON R. RAVNSBORG IN HIS CAPACITY AS THE ATTORNEY GENERAL FOR THE STATE OF SOUTH DAKOTA, Defendants. CIV. 19- THIS IS A CAPITAL CASE EXECUTION SET FOR BETWEEN NOVEMBER 3, 2019 AND NOVEMBER 9, 2019 COMPLAINT COMES NOW PLAINTIFF, and for his Complaint against Defendants, states and alleges . as- follows: INTRODUCTION 1. This is a Complaint seeking injunctive and declaratory relief directing Defendants South Dakota Department-of Corrections Mike Leidholt, Secretary of the DOC, Darin Young, in his capacity as warden of the South Dakota State Penitentiary, and Jason R. Ravnsborg, in his capacity as the Attorney General for the State of South Dakota (collectively, ??Defendants?) to execute Plaintiff Charles Russell Rhines (?Rhines?) in accordance with South Dakota Codi?ed Law, to wit, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 49CIV19-002940 is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL 23A-27A-32. (1984). 2. Rhines is a prisoner sentenced to death by the State of South Dakota on January 29, 1993. 3. Rhines?s execution week is November 3, 2019 through November 9, 2019. 4. SDCL provides in pertinent part that ?Any person convicted of a capital offense or sentenced to death prior to July 1, 2007 may choose to be executed in the manner provided in 23 or in the manner provided by South Dakota law at the time of the person?s conviction or sentence. The person shall choose by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen.? SDCL 1. 5. At the time that Rhines was convicted and sentenced, South Dakota law provided, in pertinent part, that: ?The punishment of death shall be in?icted by the intravenous administration of a lethal quantity of an ultra?shortuacting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL (1984). I I 6. 'In enacting SDCL 1, the State of South Dakota created a statutory right that entitles Rhines to be executed in the manner provided by South Dakota law at the time of Rhines?s conviction or sentence if he chooses that manner. The State, in enacting SDCL also created life and liberty interests . entitling Rhines to the same. Rhines?s life and liberty interest is protected by the Due Process Clause Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 of the Fourteenth Amendment of the United States Constitution and the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. 8. In a Kite-Request Slip dated October 1, 2019, addressed to Defendant Young, Rhines chose to be executed in the manner that was in effect at the time that he was sentenced to death. 9. In an amended Kite-Request Slip dated October 4, 2019, addressed to Defendant Young, Rhines chose to be executed in the manner that was in effect at the time that he was sentenced to death, to wit, ?[t]he Two Drug Protocol of a Lethal Dose of An Ultra-Short Acting Barbiturate and a Chemical Paralytic.? 10. On October 15, 2019, attorneys for Rhines, emailed and mailed a letter to Defendants Young and Ravnsborg, and Paul Swedlund, Assistant Attorney General in the Of?ce of the Defendant Attorney General, requesting, among other things, con?rmation that Rhines?s request to be executed by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with alchemical paralytic agent would be honored. 11. In a letter dated October 17, 2019, Assistant Attorney General Swedlund advised counsel that he had received ?Mr. Rhines? request for execution pursuant to the combination of drugs provided by statute at the time of his execution.? Mr. Swedlund noted that will follow the law.? Mr. Swedlund further informed counsel that he ultra-short-acting barbiturate the state intends to use is pentobarbital.? 12. Upon information and belief, pentobarbital is not an ultra-short-acting barbiturate. 13. Numerous courts have held that pentobarbital is not an ultra-short- acting barbiturate. See, Smith 12. Montana, N0. BDV-2008-303, 2015 WL 5827252 (Mont. Dist. Ct. Lewis and Clark County Oct. 6, 2015) (unpublished) (attached hereto as Exhibit A) (?This Court rules that pentobarbital is not-an ultra-fast?acting barbiturate. The State of Montana will either need to select a Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota barbiturate that is ultra-fast acting to accomplish the execution of Plaintiffs or it will need to modify its statute?) 14. Medical journals provide that pentobarbital is not an ultra-short-acting barbiturate. 15. Defendants? decision to used pentobarbital, contrary to South Dakota law, deprives Rhines of his statutory right to be executed in the manner of his choice. It also deprives Rhines of his life and liberty interests in being executed in the manner of his choice without due process of law guaranteed under the Due Process Clause of the Fourteenth Amendment of the United States Constitution and the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. 16. Rhines?s execution week is a mere two weeks away. Thus, Rhines brings this action for injunctive and declaratory relief to enforce his right under South Dakota law to be executed by the manner he chose, intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent, and not by pentobarbital which is neither an ultra-short-acting barbiturate nor a chemical paralytic agent. PARTIES 17. Plaintiff Rhines is a United States citizen and a resident of the State of South Dakota. He is currently a condemned inmate in the custody of Defendants and under the supervision of the DOC in Sioux Falls, South Dakota. 18. Defendant South Dakota Department of Corrections is an agency of the State of South Dakota. The DOC is responsible for all prisons in the State of South Dakota, fOr the custody and treatment of death-sentenced inmates, and for the execution of such inmates. 19. Defendant Mike Leidholt is the Secretary of the DOC and is sued in his of?cial capacity. 20. Defendant Darin Young is the Warden of the South Dakota State Penitentiary and is sued in his of?cial capacity. Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 21. Defendant Jason R. Ravnsborg is the Attorney General for the State of South Dakota and is Sued in his official capacity. JURISDICTION AND VENUE 22. This Court has jurisdiction to adjudicate this action under the South Dakota Uniform Declaratory Judgments Act, SDCL 21-24-1 et seq. 23. Venue in this Court is proper under SDCL which provides that an action against a public of?cer shall be brought in the county where the cause, or some part thereof, arose. The injury to Plaintiff because of Defendants? illegal actions has occurred and will occur in the County of Minnehaha and, as such, venue is proper in this Court. FACTS 24. Rhines was sentenced. to death on January 29, 1993. 25. On June 25, 2019, Judge Robert Mandel granted a warrant of execution, which sets forth that Rhines shall be executed between November 3 and November 9, 2019. 26. SDCL provides that: Any person convicted of a capital offense or sentenced to death prior to July 1, 2007 may choose to be executed in the manner provided in 23 or in the manner provided by South Dakota law at the time of the person ?s conviction or sentence. The person shall choose by indicating in Writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen. Ifthe person fails or refuses to choose in the time provided under this section, then the person shall be executed as provided in SDCL (emphasis added). 27. At the time that Rhines was convicted and sentenced, in 1993, South Dakota law provided, in pertinent part, that, ?The punishment of death shall be in?icted by the intravenOus administration of a lethal quantity of an ultra?short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 5 . Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 28. In 2007, the South Dakota Legislature amended the law as follows: SOUTH DAKOTA 2007 SESSION LAWS 2007 REGULAR SESSION OF THE BEND LEGISLATURE Additions are indicated by Text; deletions by Text . Changes in tables are made but not highlighted. Ch. 15] (HB 1175) West?s No. 10! CAPITAL PUNISH FOR. AN ACT ENTITLED, An Act to provide for the substances used in the execution of a sentence of death and to allow the choice of the substances used in an execution under certain circumstances. BE IT ENACT ED BY THE LEGISLATURE OF THE SOUTH DAKOTA: Section I. That 23A-27A-32 be amended to read as follows: - so at The punishment of death shall be in?icted within the avails of some building at the state a -- a- .--, -- -- .- - .Thepunishmentot?death shallheinl'ticted .intravenous injection ofn sub-slants: or substances in a lethal quantit . The wanlen. subjazt to the approval of the secretary of corrections, shat! determine the substances and the quantity of substancesused for the punishment of death. An execution carried out by tethni intravenous injection shall be performed by a person selected-hy-the warden-end trained to administer the injection who is selected by the warden and approved by the secretary ot'oorrections. The person administering the intravenous injection need not be a physician. registered nurse. or liomsed practical nurse. or other medical professional licensed or registered under the laws or this or any edict state. Any in?iction of the punishment of death MW intravenous injection ofa substance or substances in the manner required by this section may not be construed to be the practice ot?medictneuudm . Any pharmacist or pharmaceutical supplier is authorised to dispense the drugs mhetanoe or substances used to in?ict the punishment or death to the warden without prescription. for carrying out the provisions of this section. notwithstanding any other provision of law. Section 2. That diapter 23-A-27A be amended by adding thereto a NEW SECTION to read as follows: Any person convicted of a capital offense or sentenced to death prior to the effective date or this Act may choose to be executed in the manner provided in this Act or in the manner provided by South Dakota law at the time of the person's conviction or sentence. The person shall choose by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen. If the person rails or refuses to choose in the time provided under this section. then the person shall be executed as provided in section 1 of this Act. Approved fie-thumpr 23. 2007. Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 29. In 2008, the South Dakota Legislature further amended the law as follows: SOUTH DAKOTA 2003 SESSION LAWS 2008 REGULAR SESSION OF THE B3RD LEGISLATURE Additions are indicated by Text: deletions by Tea-H . Changes in tables are made but not highlighted. Ch. 117 (SB 53) West's No. 244 CAPITAL FOR AN ACTENTITLED, An Act to revise certain provisions related to capital punishment. BE IT ENACTED BY THE OF THE STATE OF SOUTH DAKOTAThe punishment of death shall be in?icted within the walls of some building at the state penitentiary. The punishment of death shall be in?icted by the intravenous injection of a substance or substances in a lethal quantity. The warden, subject to the approval of the secretary of corrections. shall determine the substances and the quantity of substances used for the punishment of death. An execution carried out by intravenous injection shall be performed by apersnn persons trained to administer the injection who is are selected by the warden and approved by the secretary of corrections. The person persons administering the intravenous injection need not be physicians, registered nurse nurses, licensed practical nurse nurses, or other medical professionai professionals licensed or registered under the laws of this or any other state. Any in?iction of the punishment of death by intravenous injection of a substance or substances in the manner required by this section may not be construed to be the practice of medicine. Any pharmacist or pharmaceutical supplier is authorized to dispense to the warden the substance or substances used to in?ict the punishment of death to?t-he?waeden without prescription, for carrying out the provisions of this section, notwithstanding any other provision of law. 30. In a Kite-Request Slip dated October 1, 2019, addressed to Defendant Young, Rhines pursuant to SDCL 1, elected the method of execution that was in effect at the time that he was sentenced to death. (A true and correct copy of the October 1, 2019 Kite-Request Slip is attached hereto as Exhibit B.) 31. In an amended Kite-Request Slip dated October 4, 2019, addressed to Defendant Young, Rhinos elected the method of execution that was in effect at the time that he was sentenced to death, to wit, ?[t]he Two Drug Protocol of a Lethal Dose of An Ultra-Short Acting Barbiturate and 7 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 49CIV19-002940 a Chemical Paralytic.? (A true and correct copy of the October 4, 2019 Kite-Request Slip is attached hereto as Exhibit C.) I 32. As of October 15, 2019, Defendant Young had not responded to Rhines?s Kite- Request Slips. On October 15, 2019, attorneys for Rhines, emailed and mailed a letter to Defendant Young, Defendant Ravnsborg, and Paul Swedlund, Assistant Attorney General in the office of the Attorney General, requesting, among other things, confirmation that Rhines?s request to be executed by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent would be honored. (A true and correct copy of the October 15, 2019 letter is attached hereto as Exhibit D.) 33. Rhines?s attorneys also requested that the Defendants identify which ultra-short?acting barbiturates will be used to execute Mr. Rhines. (Id) 34. On October 17, 2019, Mr. Swedlund, from the of?ce of Defendant Young, emailed attorneys for Rhines a letter stating, am in receipt of your letter regarding Mr. Rhines' request for execution pursuant to the combination of drugs provided by statute at the time of his execution. The DOC will follow the law. The ultra~short-acting barbiturate the state intends to use is pentobarbital.? (A true and correct copy of the October 17, 2019 letter is attached hereto as Exhibit E.) 35. Upon information and belief, ultra-short-acting barbiturates include sodium methohexital and sodium thiopental. 36. Upon information and belief, pentobarbital is not an ultra-short-acting barbiturate. Nor is it a chemical paralytic agent. 37. Defendants intend to execute Mr. Rhines, in contravention of his statutory right to elect the method of his execution, with pentobarbital, a drug that is not an ultra-short-acting barbiturate. Pentobarbital is not a chemical paralytic agent either. Filed: 101222019 3:36 PM CST Minnehaha County, South Dakota 490IV19-002940 First Cause of Action?Violation of the Right to Choose the Manner of Execution Provided by Law at the Time of Sentence (Against All Defendants) 38. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 39. In enacting SDCL 1, the State of South Dakota created and codi?ed a state statutory right that entitles Rhinos to be executed in the manner provided by South Dakota law at the time of the Rhines?s conviction or sentence. Defendants have a. corresponding duty to ensure Rhinos can exercise this right. 40. The manner of execution provided by South Dakota law at the time of Rhines?s conviction and sentence was, in relevant part, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL 23A-27A-32 (1984). 41. SL 1984, ch 181 created a right to an execution ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL 23A- (1984). 42. Rhines has a right to execution ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? Id. I 43. Rhines?s right to be executed in the manner set forth in SL 1984, ch 181 is codi?ed and protected by SDCL Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 44. Rhines has exercised his right to choose the manner set forth in SL 1984, ch 181. Rhines has done so in accordance with the provisions of SDCL 1. 45. Defendants cannot deprive Rhines of his right to be executed in the manner of his choice. Defendants have a duty to ensure Rhines can exercise his right. I 46. Defendants assert pentobarbital is an ultra-short-acting barbiturate. (Exh. E.) 47. Upon information and belief, pentobarbital is neither an ultra-short-acting barbiturate nor a chemical paralytic agent. I 48. Upon information and belief, ultra-short?acting barbiturates include sodium methohexital and sodium thiopental. 49. By refusing to guarantee that Rhines will be executed in the manner set forth in SL 1984, ch 181, Defendants are depriving Rhines of his state statutory right created and protected by SDCL and SL 1984, ch. 181, codi?ed at SDCL (1984). Second Cause of Action? Deprivation of Due Process (Against All Defendants) 50. Rhines incorporates by reference each and every allegation contained inthe foregoing paragraphs as if specifically alleged herein. 51. In enacting SDCL 23A-27A-32.1, the State of South Dakota created life and liberty interests that entitle Rhines to be executed in the manner provided by South Dakota law-at the time of the Rhines?s conviction or. sentence. 52. The manner of execution provided by South Dakota law at the time of Rhines?s conviction and sentence was, in relevant part, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is-pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 10 Filed: 10/22/2019 3:36 PM CST Minnehaha' County, South Dakota 490lV19-002940 53. SL 1984, ch 181 creates protected life and liberty interests in execution ?by the intravenous administration of a lethal quantity of an ultra-short? acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 54. Rhines has life and liberty interests in execution ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 55. Rhines?s life and liberty interests in being executed in the manner set forth in SL 19 84, ch 181 are protected by the Due Process Clause of the Fourteenth Amendment of the United States Constitution. 56. Rhines?s life and liberty interests in being executed in the matter set forth in SL 1984, ch 181 are protected by the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. I 57. By stating their intention to execute Rhines using pentobarbital, which is neither an ultra-short-acting barbiturate nor a chemical paralytic agent, Defendants are deliberately and intentionally depriving Rhines of his life and liberty interests to be executed in the manner of his choice without due process of law. Third Cause of Action Iniunctive Relief Against All Defendants) 58. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 59. Defendants? decision to use pentobarbital to execute Rhines deprives Rhines of his statutory right to be executed using an ultra-short-acting barbiturate. It also deliberately and 11 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19?002940 intentionally deprives Rhines of his life and liberty interests in being executed using an ultra-short- acting barbiturate without due process of law guaranteed under the United States and South Dakota Constitutions. 60. Rhines has a substantial likelihood of success on the merits of his claims. 61. Rhines will suffer severe and irreparable injury if Defendants are not enjoined from executing Rhines with pentobarbital, in violation of his rights. 62. The interests of justice will be served by the Court ordering that: Defendants are prohibited from executing Rhines with Pentobarbital, and; Defendants are required to execute Rhines ?by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate?, to Wit, sodium methohexital or sodium thiopental. Fourth Cause of Action Declaratory Judgment [Against All Defendants! 63. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 64. The Uniform Declaratory Judgment Act, 21-24-1, provides that the ?Courts of record within their respective jurisdictions shall have power to declare rights, status, and other legal relations whether or not further relief is or could be claimed. No action or proceeding shall be open to objection on the ground that a declaratory judgment or decree is prayed for. The declaration may be either affirmative or negative in form and e??ect', and such declaration shall have the force and effect of a ?nal judgment or decree.? 65. A valid case or controversy exists between the parties because Defendants intend to execute Rhines in violation of Rhines?s statutory and constitutional rights. 66. Rhines seeks a declaration that pentobarbital is not an ultra-short-acting barbiturate. 12 Filed: 1012212019 3:36 PM CST Minnehaha County, South Dakota 67. Rhines seeks a declaration that Defendants are enjoined from executing Rhines with pentobarbital. 68. Rhines seeks a declaration that: Defendants are prohibited from executing Rhines with Pentobarbital, and; Defendants are required to execute Rhines ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate?, to wit, sodium methohexital or sodium thiopental. 69. Rhines has suffered and will su?er an injury in fact based upon Defendants? deprivation of his statutory and due process rights. 70. There is a causal connection between Rhines?s injury and Defendants? conduct. 71. Rhines?s injury will be redressed by a judgment declaring that: pentobarbital is neither an ultra~short~acting barbiturate nor a chemical paralytic agent; Defendants are enjoined from executing Rhines with pentobarbital, and Defendants are required to execute Rhines only ?by. the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate?, to wit, sodium methohexital or sodium thiopental. PRAYER FOR RELIEF WHEREFORE, Plaintiff prays for judgment against Defendants as follows: A. A judgment declaring that: pentobarbital is not an ultra-short-acting barbiturate; (2) Defendants are enjOined from executing Rhines with pentobarbital, and (3) Defendants are required to execute Rhines only ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate?, to wit, sodium methohexital or sodium thiopental. B. A preliminary and permanent injunction ordering that: (1) Rhines?s execution is stayed pending adjudication of this action; (2) pentobarbital is not an ultra-short?acting barbiturate; (3) Defendants are enjoined from executing Rhines with pentobarbital, and (4) Defendants are required to execute Rhines only ?by the intravenous administration of a 13 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 49CIV19-002940 lethal quantity of an ultra-short-acting barbiturate?, to wit, sodium methohexital or sodium thiopental. C. For other and further relief as the court deems proper. Dated this 22? day of October, 2019. BALLARD SPAHR LLP By: Daniel R. Fritz Daniel R. Fritz (2390) Timothy R. Rahn (4871) 101 South Reid Street, Suite 302 Sioux Falls, SD 57103 Telephone: (605) 978-5200 Email: fritzd@ballardspahr.eom rahnt@ballardspahr.com 14 Filed: 10l22/2019 3:36 PM CST Minnehaha County, South Dakota Smith v. State of Montana. Dept. of Corrections, 2015 WL 5827252 (2015) 2015 WL 58 27252 (Mont.Dist.) (Trial Order) District Court of Montana. First Judicial District Court Lewis And Clark County Ronald Allen SMITH and William Gollehon, Plaintiffs, - V. STATE OF MONTANA, DEPARTMENT OF Director Mike Batista; Warden Leroy Kirkegard; and John Does 1-20, Defendants. No. October 6, 2015. Findings of Fact, Conclusions of Law and Order Ronald P. Waterman. Jim Taylor. Gregory A. Jackson. Michael Donahoe. Timothy C. Ford C. Mark FowlerfParnela P. Collins/Jonathan M. Krauss, Robert Stutz. Jeffrey M. Sherlock. Judge. INTRODUCTION *1 Before proceeding, it important to clarify the nature of this case. This Court has not been asked and will not make a determination as to whether lethal injection of the Plaintiffs constitutes cruel and unusual punishment. This case is not about the constitutionality or appropriateness of the death penalty in Montana. This case is not about whether the use of pentobarbital in a lethal injection setting is cruel and unusual or if pentobarbital in the doses contemplated by the State of Montana would produce a painless death. Further, this case is not about the availability of pentobarbitai or any other drug. _This case is only about whether the drug selected by the Department of Corrections to effectuate the Plaintiffs? lethal injections, pentobarbital, meets the legislatively required classi?cation of being an ?ultra-fast acting barbiturate." This Court rules that pentobarbital is not an ultra-fast-acting barbiturate. The State of Montana will either need to select a barbiturate that is ultra?fast acting to accomplish the execution of Plaintiffs or it will need to modify its statute as will be detailed below. From the testimony and evidence presented, the Court enters the following: FINDINGS OF FACT Trial in this matter was held on September 2 and 3, 2015. Representing Plaintiffs were Ronald P. Waterman, James Park Taylor, and Gregory A. Jackson. Representing the State of Montana were C. Mark Fowler, Pamela P. Collins, Jonathan M. Krausc, and Robert Stutz. The Court received numerous exhibits and heard from two witnesses, Dr. Mark Heath and Dr. R. Lee Evans. WESTLAW 2019 Thomson Reuters. No claim ic original US Government Works. 1 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota I490IV19-002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 5327252 (21115) Jurisdiction and venue are proper in this Court. Plaintiff Ronald Allen Smith, an inmate at Montana State Prison, has been sentenced to death for the killing of two young men in 1982. Plaintiff William J. Gollehon, an inmate at Montana State Prison, has been sentenced to death for the killing of another inmate at Montana State Prison in 1990. The Montana Supreme Court has upheld the death sentences of both Plaintiffs. State v. Smith, 280 Mont. 158, 931 P.2d 1272 (1996); State v. Goflehon, 262 Mont. 1, 864 P.2d 249 (1993). Session law 1983 Montana Laws chapter 411 enacted lethal injection as an option for the execution of prisoners sentenced to death. That provision introduced the phrase ?ultm?fast-acting barbiturate? into-Montana Code Annotated 46-19- 103. As of March 19, 1997, lethal injection became the sole method of execution of a sentence of death. Montana Code Annotated 46?19-1036) provides: punishment of death must be inflicted by administration of a continuous, intravenous injection of a lethal quantity of an ultra-fast-acting barbiturate in combination with a chemical paralytic agent until a coroner or deputy coroner pronounces that the defendant is dea The current Execution Technical Manual (ETM) was adopted on January 16, 2013. (See PL's Ex. 1.) The two-drug protocol is referenced on pages 41, and 50 through 53 of the current ETM. There it is indicated that sodium pentothal and pancuronium bromide will be used in the execution. At page 51, it is indicated that these drugs may be substituted by another drug based on availability. It is speci?cally provided that pentobarbital with a dosage of 5 guns may be substituted for sodium pentothal. Further, rocuronitun bromide with a dosage of 1,000 may be substituted for pancuroniurn bromide. *2 The State of Montana is the only state that speci?es that the death penalty be accomplished by an ?ultra-fast?acting barbiturate." The other states employing the death penalty either specifya particular drug to be used or merely state that execution is to take place by means of lethal injection. The only issues remaining in this case are vvhat the Montana legislature meant by using the words ?ultra-fast-acting barbinn?ate? in Montana Code Annotated 46-19-103, and whether pentobarbital is an ultra-fast-acting barbiturate within the meaning of Montana Code Annotated 46~l9-103. Pentebarbital and thiopental are included in the class of drugs known as barbiturates. At trial, the ?rst witness was Dr. Mark Heath. His curriculum vitae was received as Plaintiffs Exhibit 8. Dr. Heath is a practicing anesthesiologist in New York at the Columbia Medical Center and also teaches medicine at the Columbia School of Medicine. Del-loath is a Board Certi?ed Anesthesiologist and has written extensively on lethal injection. He has testi? ed before various courts and legislatures, and has written articles and book chapters about lethal injection. Dr. Heath has also extensively studied various types of lethal injection, by reviewing witnesses descriptions, execution logs, publications, and electroencephalogram results of people who have been executed by means of lethal injection. All of Dr. Heath?s opinions, which will be cited below, were given with a reasonable degree of medical certainty. The bottom line for Dr. Heath is that pentobarbital the drug selected by the Montana Department of Corrections is not an ultra-fast-acting barbiturate. Barbiturates were ?rst created in the 19303 and, as a class, share a certain common core ring of molecules. In general, barbiturates are weak acids that are absorbed and rapidly distributed to all tissues of the human body. Barbiturate's are known by their WESTLAW Cc) 2019 Thomson Reuters. No claim to original US. Government Works. Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 Smith v. State of Montana, Dept. of Corrections, 2815 WL 5827252 {2015) lipid solubility. Barbiturates possessing more lipid solubility distribute more rapidly to the human brain. The basic core ring of barbiturate molecules has been modi?ed over the years, and these modi?cations affect how certain barbiturates operate. Experts speak of ?vcin-to-brain time," which is the amount of time it takes a barbiturate injected into the blood stream to transit to the human brain. In addition, there is a ?blood?brain barrier.? This is a grouping of cells and capillaries around the human brain that prevent toxins from entering the brain. Certain modi?cations to the basic barbiturate structure have allowed a rapid transfer through the blood-brain barrier. According to Dr. Heath, it is often important to have a very quick transition from consciousness to unconsciousness, quickly penetrating the blood-brain barrier, which allows physicians to lake control of a patient's breathing to prevent negative consequences from occurring as a patient enters unconsciousness. According to Dr. Heath, this is the purpose of the development of ultra-fast?acting barbiturates. Barbiturates are traditionally classi?ed as long-acting (phenobarbital), medium-acting (such as pentobarbital), short-acting (secobarbital), and ultra-short-aeting (thiopental). (See Test. Dr; Mark Heath; PL's Ex. 4, Margaret Wood, Alistair Wood, DRUGS AND ANESTHESIA PHARMACOLOGY FOR ANESTHESIOLOGISTS (2d. ed.,Williams Wilkins); see also PL's Ex. 5, Ronald D. Miller, ANESTHESIA, 6th ed. (2005). According to Dr. Heath and ANESTHESIA, the ultra-short-acting drugs are thiopental, methohexital, and thiamylal. By using terms such as short-acting or ultra-short-actiug, the classi?cation system refers to the duration of action or how long the barbiturate exercises its control over the human body. *3 As noted by Dr. Heath, there is another classi?cation of barbiturates which refers to the onset of action of the barbiturate or how soon the maximum effect is felt by the body. According to Dr. Heath, there is a correspondence between the two systems, and the terms ultra?fast and ultra-short refer to the same type of barbiturates, as do the terms fast and short, and as do the terms slow and long. Putting this in a tabular form, we ?nd the following: 1. Ultrafast acting Ultrashort acting I thiopental, thiamylal, methohexital 22" Fast acting I Short acting seoobarbital, pentobarbital Intermediate acting Intermediate acting pentobarbital? 4. Slow acting Long acting phenobarbital (*Some systems combine #2 and #3 into one group of intermediate acting drugs) fF'L?s Rebuttal Expert Disclosure, at 4 (June 25, 2013).) According to Dr. Heath, pentobarbital is either classi?ed ?fast,? ?short,? or ?intermediate." Pentobarbital is not used as an anesthetic, according to Dr. Heath, because its effects last too long. Rather, pentobarbital is commonly used in pill form as a treatment for epilepsy and is also used to induce comes in already unconscious patients. Pentobarbital in the doses suggested in Montana's ETM would undoubtedly cause the death of the inmate. Dr. Heath has used, in a clinical setting, both pentobarbital and thiopental. Dr. Heath has never heard, prior to this case, any reference to pentobarbital being classi?ed as being ultra-fast acting. According to Dr. Heath, the operation of thiopental and pentobarbital is noticeably different. Dr. Heath testi?ed that an administration of thiopental causes a ?lights out" effect, where a patient is unable to complete the thought that was in their mind upon the administration of the drug. A patient receiving thiopental would take one or two breaths before the drug exerted its control over the patient. Heath also opined that an individual given pentobarbital would breathe longer, would have various body movements, and would slur words before the pentobarbital took effect. Heath testi?ed that a patient given pentobarbital would physically be able to appreciate the accrual of sleepiness or unconsciousness, while a patient given thiopental would not. WESTLAW (is) 2019 Thomson Reuters. No claim to original S. Governr'nent Works. Filed: 10I22l2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 5827252 (2015] Of signi?cant import to the Court is the manufacturer?s insert provided for pentobarbital. (See PL's Ex. 7, manufacturer?s insert for Nembutal Sodium Solution (the manufacturer's name for pentobarbital).) At page one, the insert states Sodium is a short?acting barbiturate.? This comports with the classi?cation stated by Dr. Heath. Plaintiffs Exhibit 11 contains a compilation of a search engine results completed by Dr. Heath. His research shows that there were 28,600 results produced for a description of thiopental as an ultra-short-acting barbiturate. An additional 42 results were returned for the search phrase of thiopental being an ultra-fast-acting barbiturate. 0n the other hand, the search engine reported one ?nding for pentobarbital being an ultra-short-acting barbiturate, and a single ?nding of pentobarbital being an ultra-fast? acting barbiturate. (PL's Ex. 11, at 3.) The State produced the testimony of Dr. R. Lee Evans, a doctor of pharmacy and Dean of Pharmacy at Auburn University. In Dr. Evans? original declaration ?led in March 2015 and received into evidence as Plaintiffs Exhibit 9, he is "not aware of the origin of the term ?ultra-fast acting.? (PL's Ex. 9, at 6, 1] 14.) According to Dr. Evans, pentobarbital could be considered short acting, and thiopental, ultra-short acting. Dr. Evans opined that there is no meaningful difference between pentobarbital and thiopental in the time it takes to render a person comatose. (Id, at 7, 1] 15.) However, Dr. Evans noted that onset of action for pentobarbital is under a minute, while for thiopental, the onset of action could be ten to forty seconds. (Id) *4 Until the trial of this action. Dr. Evans had not testi?ed that pentobarbital was an ulna-fast-acting barbiturate. lie did so testify at trial. However, the Court struck that conclusion because it did not comport with his prior discovery responses or declarations ?led with the Court. (See PL's Exs. 9, 10.) At the trial of this matter, Dr. Evans indicated that the onset of pentobarbital was under one minute. However, on December 10, 2012, Dr. Evans indicated ?[thiopental is an onset of about - a half to one minute, duration of a little less than 30 minutes. Pentobarbital is onset three to four minutes with a duration that is somewhat longer. That?s the primary difference.? (PL's Ex. 14, Pardo v. Palmer, Case No. (MD. Fl. Dec. 10, 2012), Test. Roswell Lee Evans, Jr., at This testimony stands in stark contrast to what Dr. Evans stated at the trial this matter. Dr. Evans pointed out that there is no question that pentobarbital is fast acting. For example, Plaintiffs Exhibit? the package insert for pentobarbital indicates that ?the onset of action ranges from almost (PL's Ex. 7, at 2.) See also Defendant's Exhibit L, a TOXNET reference which indicates that the onset of thiopental and pentobarbital is "almost immediate. (Def.?s Ex. L, at 16.) TOXNET is a collection of databases operated by the National Library of Medicine. See also Defendant's Exhibit N, a Drugscom reference which indicates that the onset of pentobarbital is immediate. (Def. '3 Ex. N, at 1.) Thus, there is no question that pentobarbital is fast acting. The question remains as to whether it is ultra-fast acting. Dr. Evans did cite to references that indicate that if the onset of action of a drug is less than a minute, it can be considered ultra- fast acting. (See. cg, PL's Ex. Q, TOXNET reference, at 12; PL's Ex. R, Micromcdic reference, at 4 (?ultra-fast acting has an onset of one minute or less.).) The Court notes that at page 1 of Exhibit R, pentobarbital is listed as being ?short acting," not ultra-short acting. These references to pentobarbital being ultra-fast acting are consistent with Dr. Heath?s ?nding some sources refer to pentobarbital as being ultra-fast acting. However, that must be compared with the greater weight of authority that indicates that pentobarbital is not in the class of drugs considered to be ultra-fast acting. . Dr. Evans did indicate that, in his opinion, pentobarbital and thiopental are almost identical. Both, in his current opinion, reach maximum e??ect in less than one minute's time. However, Dr. Evans did acknowledge that thiopental is a little quicker to get to the brain because pentobarbital is not as lipid soluble. in making its decision, this Court has had to weigh the evidence presented by Dr. Evans versus Dr. Heath. Supporting Dr. Heath's testimony are standard pharmacology for anae sthesiologists textbooks Exs. 4, 5) and Dr. Heath?s own consistent testimony. Also Supporting Dr. Heath's position is the signi?cant research that classi?es thiopental as being ultra-short acting WESTLAW 2019 Thomson Reuters-No claim to original US. Government Works. 4 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490IV19-002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 582?252 (2015) (ultra-fast acting) and not so classifying pentobarbital, except for a few scattered references. (See Ex. Also of utmost import is the manufacturer's insert for pentobarbital Ex. 7), which classi?es pentobarbital as a short-actin barbiturate. Also crucial in this weighing the Court has undertaken is the fact that in the Panic v. Palmer case, in testimony given not three years ago, Dr. Evans testi?ed that pentobarbital's onset of action is three to fotu minutes as opposed to the less than one minute referred to in his testimony in this case. This is not to in any way insinuate that Dr. Evans is not a credible witness. However, it is a factor when weighing the evidence which shows by a relatively overwhelming nature that, while pentobarbital may operate in a fast nature, it is not ultra-fast as is required to comply with Montana?s execution protocol. Thus, through this weighing process, this Court concludes that pentobarbital is not an ultra-fast-acting barbiturate. *5 From the foregoing Findings of Fact, the Court enters the following: CONCLUSIONS OF LAW 1 Jurisdiction and venue are proper in this Court. 2. By using the limiting term ?ultra" in the phrase "ultra-fast?acting barbiturate" in Montana Code Annotated the legislature limited the State of Montana to using only drugs in the fastest category of barbiturates, namely thiopental, methohexital, and thiamylal. Under the express terms of the statute, the State of Montana is not allowed to use the ?fastest acting barbiturate available,? or a ?relatively fast-acting barbiturate,? only an ?ultra-fast?acting barbiturate," meaning drugs from the fastest class of barbiturates. 3. Had the legislature intended to give the State of Montana latitude in what drugs to use, it could have used much more general language in the statute authorizing execution, as many other states have now done. Pentobarbltal cannot properly be classi?ed as since there is another class of drugs that is faster. Whether those drugs are currently available is not an issue the Court can resolve for the State. The State's remedy is to ask the Legislature to modify the statute to allow the use of pentobarbital or other slower acting drugs. 4. The State of Montana has modi?ed the execution protocol several times during this litigation and has had many opportunities to return to the legislature to modify the language which limits the State of Montana to ??iltra-fast-acting barbiturates,? but has chosen not to. 5. Courts may not legislate through judicial interpretation of statutes. Albinger v. Harris, 2002 MT 118,11 38, 310 Mont 274, 8 P.3d 711 (It is not the province of this court or any other court to assume to legislate by judicial interpretation, and to create in favor of any individual or any class of people an exception to the limitation set by the legislature). A court cannot second- guess and substitute its judgment for that of the legislature or insert what has been omitted. 1* State Bar ofMont. v. Krt?vec, 193 Mont. 477, 481, 632 P.2d 707, 710 (1981). Indeed, Montana law regarding statutory? interpretation begins with Montana Code Annotated 1-2-101, which states: [i]n the construction of a statute, the of?ce of the judge is simply to ascertain and declare what is in terms or in substance contained therein, not to insert what has been omitted or to omit what has been inserted.? In Montana Code Annotated 46- 1 9- 103, the legislature mandates use of an ?ultra-fast-acting barbiturate," and the Department of Corrections plan to use a drug which is, without dispute, not classi?ed as an ultra-fast-acting barbinirate. Given these facts, the Court must ?nd an impermissible inconsistency between the legislative mandate and the Department of Corrections exercise of that mandate. Scrupulous adherence to statutory mandates is especially important here given the gravity of the death penalty. Accord i? 31:: re Ohio Execution Protocol Litigation, 840 F. Supp. 2d 1044 (SD. Ohio 2012). From the foregoing Findings of Fact and Conclusions of Law, the Court enters the following: ?23 2019 Thomson Reuters, No ctaim to original US. Government Works. 5 Filed: 10/22/2019 3:36 PM CST Minnehaha Co'unty, South Dakota 49CIV19-002940 Smith v. State of Montana. Deptof Corrections, 2015 WL 5821952 [2015) ORDER *6 The State of Montana is hereby ENJOINED from using the drug pcntobarbital in its lethal injection protocol unless and until the statute authorizing lethal injection is modi?ed in conformance with this decision. DATED this 6 day of October 2015. <> JEFFREY M. SHERLOCK District Count Judge pcs: Ronald F. Waterman Jim Taylor Gregory A. Jackson Michael Donahoe Timothy C. Fox/C. Mark FowlerfPamcla P. Colitis/Jonathan M. Klauss, Robert Stutz End of Document ?33 2019 Thomson Reuters. No claim to original 3. Government Works. WESTLAW 2019 Thomson Reuters. No claim to original US. Government Works, Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 . SOUTH DAKOTA PENITENTIARY KITE - REQUEST SLIP October 2019 __20 Inmate RHINES Charles No. 15036 Call No A 3 55 Works? I Pending Desires? Audience With mun: YOUNG: Warden: South Dakota State Penitentiary Give Reason -- Private Business Not Suf?cient As per South Dakota 1 I am here__by notifying you that I h9// elected the method of execution which we feet/Ale time I was sentenced to death: To: W1 away/29 1993 COUNTYOFMNNEEIAHA On October 1, 2019, Charles R. Rhinea personally appeared before me, whose Identity I proved on the basis of Incarcer- ation, to be the signer of the above document, and he acknow? ledged that he signed it. w-r- w: ?ed?223?. we OFFICER Filed: 1012212019 3:36 PM CST Minnehaha County, South Dakota . 49CIV19-002940 . -. I i-g-gu'?led: Minne'haha County, south pakqta; SECOND ITTERATION, SQPERCEDES ALL OTHERS NOT SO soum DAKOTA PENITENTIARY KITE - REQUEST SLIP October 4, 2019 20 Inmate RHINES, Charles, R. No. 15035 Works Pending DesiresanAudiencewith DARIN YOUNG: Warden: South Dakota State penitentiary Give Reason Private Business Not Suf?cient As per South Dakota Codified Law I am hereby notify- you that I have selected t/hz/?ethod of execution which was in eff- ect at the tinWI waswced to death on January 29, 1993. To Hit: The of a Lethal Dose of An Ultra?short Act? ing W?ay?? a Chemical paralytic agent. .. STATE DAKOTA COUNTY OF mum On October 4, 2019, Charles R. Rhinos personally appeared before me, whose Identity I proved on the babsis of Inrarr?prnrinn' be the signer of the above document, and he acknowledged that he .signed it. z/ A rate My Comnission Expires: 7" 17" 1?19: TAVI nn \znn-u- .I I Ir\l U01 .: NOTARY PUBLIC . 65%: p-?emeeg?gmmh? My bummission ExpiresliLILZe 2.7 '1 1626-000 - 3 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 49CIV19-002940 GreenbergTraurig Caroline .1. Heller Tel 212.801.2165 Fax 212.805.9483 hellerc@gtlaw.com October 15, 2019 VIA EMAIL AND clarin.vounu@state.5d.us Darin Young 1600 North Drive PO Box 5911 Sioux Falls, South Dakota S7117 Paul Swedlund, Esq. Assistant Attorney General 1302 East Highway 14, Suite 1 Pierre, South Dakota 57501 Re: Charles Rhines, SDDOC #15036 Dear Warden Young and Mr. Swedlund: We represent Charles Russell Rhines. As you know, on June 25, 2019, Judge Robert Mandel issued a warrant of execution for Mr. Rhines for between November 3 and November 9, 2019. Pursuant to S.D.C.L. 23A-27A-32.1, on a Kite-Request Slip dated October 1, 2019 and an amended Kite-Request Slip dated October 4, 2019, Mr. Rhines elected to be executed pursuant to the manner provided by South Dakota law at the time of his sentence; to wit, ?by the intravenous administration of a lethal quantity of an ultra-short acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. We write to request that you con?rm Mr. Rhines's request will be honored, and that he will be executed by the intravenous administration of an ultra-short-acting barbiturate. We also request that you identify which one of the three ultra-short-acting barbiturates will be used to execute Mr. Rhines: sodium methohexital; sodium thiamylal, or; sodium thiopental. Further, with respect to the ultra-short-acting barbiturate that is identi?ed for use in Mr. Rhines?s execution, we request that you provide the following information: (1) whether it was manufactured or compounded; (2) if manufactured, the identity of the country, or the State in the United States, from whence it was imported/obtained; (3) if compounded, the date on which any compounding was performed and whether it was performed by a licensed pharmaceutical company or pharmacist; (4) any testing conducted to ensure such drug?s or drugs? (including the API) potency, purity, and integrity, including the tests conducted, the date(s) of same, and the results; (5) whether GREENBERG TRAURIG. LLP I ATTORNEYS AT LAW I MetLife Building I 200 Park Avenue I New York, NY 10166 I Tel 212 3019200 I Fax 212.801.6400 Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 4901V19-002940 Warden Young Mr. Swedlund October 15, 2019 Page 2 - such testing was performed by a licensed pharmaceutical company, pharmacy, or pharmacist, and whether such pharmaceutical company, pharmacy, or pharmacist has been subject to disciplinary action or cited for violations of state or federal laws or regulations by either state or federal entities; (6) the ?beyond use? or ?expiration? date of such drug (including the API), and when and how such date(s) was/were established; (7) the date on which any API was ordered and received and how it was stored during transport and since it has been in possession, and; (8) how the drug has been stored since the time of compounding or importation. - We also request that you con?rm a licensed physician will be present at Mr. Rhines?s execution to pronounce death. Please provide this information no later than October 18, 2019 to my email address, hellerc?lgtlawcom. I look forward to your timely response. Sincerely, Is/ Caroline J. Heller Caroline J. Heller Greenberg Traurig, LLP 200 Park Ave. - New York, New York 10166 Telephone (212) 801-2165 Facsimile (212) 805?9488 hellere@gtlaw.com cc: Jason Ravnsborg, Esq. (via email and US. Mail) Charles Rhines (via US. Mail) Greenherg Traurig, LLP 1 Attorneys at Law Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490IV19-002940 STATE GF SOUTH DAKOTA OFFICE OF ATTORNEY GENERAL 1302 East Highway 14. Suite ?1 Pierre, South Dakota 57501~8501 JASON R. RAVNSBURG Phone (605) 773?3215 CHARLES D. ATTORNEY GENERAL Fax (605) 7734105 CHIEF ATTORNEY GENERAL TTY (605) ?(moses Win October 17,2019 VIA EMAIL AND USPS Caroline Heller GreenbergTraurig, LLP MctLife Building 200 Park Avenue, New York NY 10166 Illegllerc {out launcom Dear Ms. Heller: i am in receipt of your letter regarding Mr. Rhines? request for execution pursuant to the combination of drugs provided by statute at the time of his execution, The DOC will follow the law. ?Hie ultra-short acting barbiturate the state intends to use is pentobarhital. Recent case authorities have quite emphatically and unequivocally stated that ?[n]either the 14th or Amendrnents afford [inmates] the broad right ?to know where, how and by whom the lethal injection drugs will be manuihcmred," as well as ?the quali?cations of the person or persons who will manufacture the drugs, and who will place the catheters.? Weilont V. Georgia Deparnnen! of Corrections, 754 F.3d 1269. 1267 (l Cir. 2014). Consistent with this authority, with regard to your questions related Speci?cally to the pentobarbital: (1) The DOC will not disclose whether the drug is ?manufactured? or ?compounded.? The DOC will advise you that the barbiturate is produced for and used by medical practitioners in the United States. Obviously, drugs used in the United States must be produced in an FDA-approved facility according to accepted (EMF. (2) The DOC will not disclose the country or state of origin of the drug. (3) No drug has yet been compounded and, consistent with past practice, will not be compounded until 24 hours prior to the execution, Per DOC practice, compounding is performed by quali?ed persons, as demonstrated by past. testing and the ef?cacy of the drugs in the Robert, Moeller and Berget executions. - (4) The DOC will not disclose testing until after the execution. (5) Per DOC practice, all testing is performed by?a quali?ed independent lab. Filed: 10/22/2019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 (6) The DOC will not disclose any ?beyond use? or ?expiration" date of the drugs it intends to use as this could identify the source. The DOC will advise you that no drug it intends to use is beyond the ?beyond use? or ?expiration date" set by the manufacturer. (7) The DOC will not disclose the date any of its drugs were ordered or received. (8) All drugs have at all times been stored in accordance with manufacturer instructions while in the control. Finally, I can con?rm for you that a licensed physician will be present at Mt. Rhinos? execution. You Paul S. Swedlund Assistant Attorney General PSS/rar Filed: 10/2212019 3:36 PM CST Minnehaha County, South Dakota 490lV19-002940 STATE OF SOUTH DAKOTA IN CIRCUIT COURT COUNTY OF MINNEHAHA SECOND JUDICIAL CIRCUIT CHARLES RUSSELL RHINES, CIV. 19- Plaintiff, THIS IS A CAPITAL CASE EXECUTION SET FOR SOUTH DAKOTA DEPARTMENT OF BETWEEN NOVEMBER 3' CORRECTIONS, MIKE LEIDHOLT, 2019 AND NOVEMBER 9? 2019 SECRETARY, SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, DARIN YOUNG IN HIS CAPACITY AS WARDEN OF THE SOUTH DAKOTA STATE PENITENTIARY, and JASON R. RAVNSBORG IN HIS CAPACITY AS THE ATTORNEY GENERAL FOR THE STATE OF SOUTH DAKOTA, - Defendants . APPLICATION FOR A PRELIMINARY INJUNCTION. TEMPORARY RESTRAINING ORDER AND STAY OF EXECUTION I Plaintiff Charles Russell Rhines (?Rhines?), by his counsel of record, hereby submits this Application for a Preliminary Injunction, Temporary Restraining Order, and Stay of Execution pursuant SDCL 15-6-65(a) and 15-6-65(b) for the following relief: (1) a preliminary injunction with a temporary restraining for such duration as necessary to conclude a hearing on a preliminary injunction order as prayed for in Rhines?s Complaint, and; (2) a stay of Rhines?s execution week, currently schedule for November 3, 2019-November 9, 2019. In support of this Application, Rhines refers the Court to his Complaint, the Affidavit of Daniel R. Fritz, sworn to October 22, 2019 and the exhibits annexed thereto, the Affidavit of Craig Stevens, sworn to October 22,- 2019 and the exhibits annexed thereto, and the Memorandum of Law in Support of an Application Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19?002940 for a Preliminary injunction, Temporary Restraining Order and Stay of Execution, all submitted herewith. Because Defendants will not unduly suffer any damages as a result of this Application, Plaintiff requests the Court waive any written undertaking. If the Court determines an undertaking is necessary, Plainti?c is also prepared to provide a written undertaking to the Court pursuant to SDCL in the sum the Court determines to be appropriate. Dated this 22?? day of October, 2019. BALLARD SPAHR LLP By: Daniel R. Fritz Daniel R. Fritz (2390) Timothy R. Rahn (4871) 101 South Reid Street, Suite 302 Sioux Falls, SD 57103 Telephone: (605) 978-5200 Email: fritzd@ballardspahr.com rahnt@ballardsp ahr.com Filed: 1012212019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 STATE OF SOUTH DAKOTA IN CIRCUIT COURT COUNTY OF MINNEHAHA SECOND JUDICIAL CIRCUIT CHARLES RUSSELL RHINES, Plaintiff, THIS IS A CAPITAL CASE EXECUTION SET FOR BETWEEN NOVEMBER 3, 2019 AND NOVEMBER 9, 2019 SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, MIKE LEIDHOLT, SECRETARY, SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, DARIN YOUNG IN HIS CAPACITY AS WARDEN OF THE SOUTH DAKOTA STATE PENITENTIARY, and JASON R. RAVNSBORG IN HIS CAPACITY AS THE ATTORNEY GENERAL FOR THE STATE OF SOUTH DAKOTA, Defendants . MEMORANDUM OF LAW IN SUPPORT OF APPLICATION FOR A PRELIMINARY INJUNCTION. TEMPORARY RESTRAINING ORDER AND STAY OF EXECUTION Plaintiff Charles Russell Rhines (?Rhines?) is a prisoner sentenced to death by the State of South Dakota, with an execution warrant setting his execution week as between November 3, 2019 and November 9, 2019. Rhines was sentenced to death on January 29, 1993. Thus, pursuant to Section South Dakota Codified Laws, Rhines is entitled to elect to be executed in the manner set forth in South Dakota law at the time of his conviction or sentence. In 1993, South Dakota law provided that the punishment of death ?shall be in?icted by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent. . SL 1984, ch 181, codified at SDCL 23A-27A-32 (1984). In a Kite-Request Slip dated October 1, 2019, addressed to Defendant Darin Young, Warden of the South Dakota State Penitentiary (?Young?), Rhines chose to be executed in the Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota manner that was in effect at the time that he was sentenced to death. In an amended Kite?Request Slip dated October 4, 2019, addressed to Defendant Young, Rhines reiterated his choice to be executed in the manner that was in effect at the time that he was sentenced to death, to wit, ?[t]he Two Drug Protocol of a Lethal Dose of An Ultra-Short Acting Barbiturate and a Chemical Paralytic.? On October 15, 2019, attorneys for Rhines, emailed and mailed a letter to Defendants Young and Jason R. Ravnsborg in his capacity as the Attorney General for the State of South Dakota, and Paul Swedlund, Assistant Attorney General, requesting, among other things, con?rmation that Rhines?s request to be executed by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent would be honored. In a letter dated October 17, 2019, Assistant Attomey General Swedlund advised counsel that he had received ?Mr. Rhines? request for execution pursuant to the combination of drugs provided by statute at the time of his execution.? Mr. Swedlund noted that will follow the law.? Mr. Swedlund further informed counsel that ?[t]he ultra-short-acting barbiturate the state intends to use is pentobarbita Pentobarbital is not an ultra-short-acting barbiturate, nor is it a chemical paralytic agent. Defenda'nts? decision to use pentobarbital, contrary to South Dakota law, deprives Rhines of his statutory rights and of his life and liberty interests to be executed in the manner of his choice without due process of law guaranteed under the United States Constitution and the South Dakota Constitution. Thus, Rhines ?led an action for injunctive and declaratory relief to enforce his right under South Dakota law to be executed by the manner he chose. Rhines?s execution week is a mere two weeks away. Thus, Rhines now makes this application for a preliminary injunction prohibiting Defendants from executing him with Filed: 10/22/2019 4:54 PM CST Min-nehaha County, South Dakota 490lV19?002940 pentobarbital and ordering that Defendants shall execute Rhines only with an ultra-short-acting barbiturate in combination with a chemical paralytic agent. Rhines also seeks a stay of execution and temporary restraining order, pending disposition of the application for a preliminary injunction, enjoining Defendants from executing Rhines with pentobarbital. 1n the alternative, Rhines requests an expedited hearing on Rhines?s application for a preliminary injunction so that the Court may rule on the application in advance of the execution week beginning November 3, 2019. STATEMENT OF FACTS A. Rhines Asserts His Statutory Right to Be Executed By An Ultra?Short?Acting Barbiturate in Combination with a Chemical Paralytic Agent Rhines was sentenced to death on January 29, 1993. (Compl. 2, 24.)1 On June 25, 2019, Judge Robert Mandel granted a warrant of execution, which sets forth that Rhines shall be executed between November 3 and November 9, 2019. (Id. 1] 25.) Section South Dakota Codi?ed Laws provides that: Any person convicted of a capital offense or sentenced to death prior to July 1, 2007 may choose to be executed in the manner provided in 23 or in the manner provided by South Dakota law at the time of the person ?s conviction or sentence. The person shall choose by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen. Ifthe person fails or refuses to choose in the time provided under this section, then the person shall be executed as provided in SDCL (emphasis added). At the time that Rhines. was convicted and sentenced, in 1993, South Dakota law provided, in pertinent part, that ?[t]he punishment of death shall be in?icted by the intravenous administration of a lethal quantity of an ultra?short?acting acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced 1 The Complaint is attached to the Af?davit of Daniel R. Fritz, Esq. sworn to October 22, 2019, as Exhibit 1. 3 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota dead by a licensed physician according to accepted standards of medical practice. SL 1984, ch 181, codi?ed at SDCL 23A-27A-32 (1984). In 2007, the South Dakota Legislature amended the law as follows: SOUTH DAKOTA 2007 LAWS 200? REGULAR SESSION OF THE SEND LEGISLATURE Additions are indicated by Text; deletions by Tear . Changes in tables are made hut not highlighted. Ch. 151 (HP. 11?de West's Ho. 1m CAPITAL FOR AN ACT ENTITLED. An Act to provide for the substances used In the execution ota sentence of death and to allow the choice of the used in an execution under oertain circumstances. BE IT ENACTED B?it" THE LEGISLATURE OF THE STATE 0F SOUTH DAKOTA: Section 1. That lid-223.42 he mended to read as follows; ?an: 5D ST 3e:- The punishment. of death shall he in?i ted within the walls of some building at the state .The punishment of deadt shalihein?inted ot? a so tame or subs a lethal Quantity. The at en. auhject to the approval of the secretary of entreetinna, shall determine the and the quantity ofsuhstanees used for the ptmishrnent ofdeatit. An execution carried out by lathe} intravenous injection shall he perfonned hit a person seieeted-hy-tiw warden-and trained to administer the hijeotion who is selected hy the warden and approved by the secretary of oorreetions. The person administering the intravenous hijeotion need not he a physioimn registered nurse{ or licensed practical nurse+ or other medical professional lioensed or registered under the laws or this oral-nilI other state. Any in?iction ot?the punishment ofdeath hy intravenous injection of a substance or substaam in the nits-inter required hy this sention may not be construed to he the praetiee ol?ntedinine-and-eny . Any pharmacist or pharmaeeutieal nipplier is authorised to dispense the drugs substances or substantiates used to 'm?io'l the punishment of death to the warden without prescription. for carrying out the mansions of this seetion1 anir other provision oflaw. Bastion 2. That chapter he amended by adding thereto a NEW SECTIDN to read as follows: Any person convicted ot?a onpitnl offense or smtenoed to death prior to the eil?eetise date of this not niaj,l choose to he executed In the manner provided in this not or in the ntnimer provided by South Dakota law at the time of the person's conviction or sentence. The person shall choose by indicating in setting to the warden not less than seven days prior to the scheduled week of execution the manner oi?exeoution chasm. 1f the person fails or refuses to choose in the time provided under this section, then the person shall he executed as provided in section 1 of this net. i Approved February 23. 200?. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 In 2008, the South Dakota Legislature amended the law as follows: SOUTH DAKOTA 2008 SESSION LAWS 2008 REGULAR SESSION OF THE SBRD LEGISLATURE Additions are indicated by Text; deletions by Text . Changes in tables are made but not highlighted- Ch. 117 (SB 53) West's No- 244 CAPITAL PUNISHMENT JUDGES WARRANT FOR AN ACT ENTITLED, An Act to revise certain provisions related to capital punishment. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: ?31 SD ST ?2 The punishment of death shall be in?icted within the walls of some building at the state penitentiary. The punishment of death shall be in?icted by the intravenous injection of a substance or substances in a lethal quantity. The warden, subject to the approval of the secretary of corrections, shall determine the substances and the quantity of substances used for the punishment of death. An execution carried out by intravenous injection shall be performed by a-persen persons trained to administer the injection who is are selected by the warden and approved by the secretary of corrections. The person persons administering the intravenous injection need not be aphysieian physicians, registered nurse nurses, licensed practical nurse nurses, or oth er medical pret?essirmai professionals licensed "or registered under the laws ofthis or any other state. Any infliction of the punishment of death by intraizenous injection of a substance or substances in the manner required by this section may not be construed to be the practice of medicine. Any pharmacist or phannaceutical supplier is authorized to dispense to the warden the substance or subsranees used to in?ict the punishment of death te?thewden without prescription, for carrying out the provisions of this section, notwithstanding any other provision of law. Ultra-short-acting acting barbiturates include sodium methohexital and sodium thiopental. (Compl. ii 35; Affidavit of Craig Stevens, Ph. D. sworn to October 22, 2019 [?Stevens Aff.?] 1i 7.) In a Kite-Request Slip dated October 1, 2019, addressed to Defendant Young, Rhines, pursuant to SDCL l, elected the method of execution that was in effect at the time that he was sentenced to death. (Compl. 11 30, Exh. to Compl.) In an amended Kite-Request Slip dated October 4, 2019, addressed to Defendant Young, Rhines speci?ed his election of the method of execution in effect at the time that he was sentenced to death, to wit, ?[t]he Two Drug Protocol of Filed: 10/22l2019 4:54 PM CST Minnehaha County, South Dakota 490lV19?002940 a Lethal Dose of An Ultra-short-acting Acting Barbiturate and a Chemical Paralytic.? (Compl. 'll 31, Exh. to Compl.) As of October 15, 2019, Defendant Young had not responded to either the October 1 or the October 4 Kite-Request Slips. (Compl. 32.) On October 15, 2019, attorneys for Rhines emailed and mailed a letter to Defendant Young, Defendant Ravnsborg, and Swedlund, requesting, among other things, confirmation that Rhines?s statutory right to be execdted by the intravenous administration of a lethal quantity of an ultra- short-acting acting barbiturate in combination with a chemical paralytic agent would be honored. (Compl. 32, Exh. to Compl.) On October 17, 2019, Assistant Attorney General Swedlund advised counsel for Rhines ultra-short acting barbiturate the state intends to use is pentobarbita (Compl. 1t 34, to Compl.) B. Pentobarbital is Not An Ultra-Short?Acting Barbiturate Pentobarbital is neither an ultra-short-acting barbiturate nor a chemical paralytic. (Stevens 7, 8, ll.) Barbiturates are a drug group that derive from barbituric acid. (Id. 11 5.) Barbiturates depress the central nervous system and have been used as sedatives and hypnotics for over a century, (Id) Barbiturates are divided into the following classes: ultra-short?acting, short- acting, intermediate-acting, and long-acting. (Id, ll see Fritz Aff. Exh. 2 The classi?cations refer to the time of onset and duration of the drug effects. (Stevens ll 6.) These classi?cations are widely accepted in the ?eld of pharmacology. (163.) Ultra-short?acting barbiturates include sodium methohexital and sodium thiopental. (Id. 1l see Fritz Aft. Exh. 2 p.2, Exh. 3 p. 13.) Pentobarbital is neither an ultra-short-acting barbiturate nor a chemical paralytic, but rather is classi?ed as a short-acting barbiturate. (Stevens 8, ll.) Notably, the manufacturer?s package insert provided for Nembutal Sodium Solution, which is the manufacturer?s name for pentobarbital, states Sodium is a short?acting Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 barbiturate.? (Fritz Exh. 4.) Pentobarbital is not an ultra-short-acting barbiturate and has never been classi?ed as such. (Stevens Aff. 1i 8.) Thiopental, the most frequently used ultra-short?acting barbiturate, is used for surgery of short duration. (Id. 1i 9.) The onset of anesthesia is usually within 10 to 30 seconds, because thiopental is so lipid soluble that it rapidly enters the brain. (Id) Conversely, pentobarbital?s effects take longer to begin onset and last longer than the effects of ultra-short-acting barbiturates. (Id. ?t 8.) In pharmacology, chemical paralytic agents are synonymous with neuromus cular blockers. (Id. 1] 10.) Paralytics by themselves do not typically lessen a patient?s awareness of pain. (Id) Rather, they inhibit muscle action and thus prevent movement. (Id) They are typically used during surgical procedures in combination with analgesics or anesthetics. (Id) Common chemical paralytic agents include pancuronium bromide and vecuronium. (Id) Pentobarbital is'not a chemical paralytic and has never been classi?ed as such. (Id. 11 11.) Rhines has a right to be executed in the manner he has chosen: with an ultra-short?acting barbiturate, not merely a short? or short?to-mtermradiate?acting barbiturate. C. Rhines Has the Right to Be Executed in the Manner He Has Chosen Rhines?s execution week is now less than two weeks away, yet Defendants have stated their intention, only after inquiries from Rhines?s counsel, to execute Rhines with pentobarbital, in violation of his statutory rights, without due process of law, and in violation of his constitutional rights. Accordingly, on October 22, 2019, Rhines filed his Complaint. (See Compl.) Rhines alleges four causes of action. The First Cause of Action, Violation of the Right to Choose the Manner of Execution Provided by Law at the Time of Sentence, alleges that, in enacting SDCL 23A-27A-32. 1, the State of South Dakota created a state statutory right that entitles Rhines to be Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota executed in the manner provided by South Dakota law at the time of the Rhines?s conViction or sentence. (Compl. 39-44.) Defendants have a corresponding duty to ensure Rhines can exercise this right. (Id. 45.) The manner of execution provided by South Dakota law at the time of Rhines?s conviction and sentence was, in relevant part, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181, codified at SDCL 23A- 27A-32 (1984.) Rhines has exercised his right to choose the manner set forth in SL 1984, ch 181. (Compl. 1t 44.) Rhines has done so in accordance with the provisions of SDCL Defendants cannot deprive Rhines of his right to be executed in the manner of his choice. (Id. 11 45.) Defendants have a duty to ensure Rhines can exercise his right. (Id. 1t 45.) In stating their intention to execute Rhines with pentobarbital, which is neither an ultra-short-acting barbiturate nor a chemical paralytic agent, defendants deprive Rhines of his statutory rights. (Id. Till 47-49.) The Second Cause of Action, Deprivation of Due Process, alleges that in enacting SDCL 1, the State of South Dakota created life and liberty interests that entitle Rhines to be executed in the manner provided by South Dakota law at the time of the Rhines?s conviction or sentence, to wit, by the intravenous administration'of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent. (Compl. 51-54.) Rhines?s life and liberty interests in being executed in this manner are protected by the Due Process Clause of the Fourteenth Amendment of the United States Constitution and the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. (Id. 55-56.) By refusing to guarantee that Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota .4QCIV19-002940 Rhines will be executed in the manner he has chosen, Defendants are depriving Rhines of his constitutionally protected life and liberty interests without due process of law. (Id. 1] 57.) The Third Cause of Action, Injunctive Relief, and the Fourth Cause of Action, Declaratory Judgment, seek injunctiVe and declaratory relief: (1) Staying Rhines?s execution pending adjudication of this action; (2) declaring that pentobarbital is neither an ultra-short-acting barbiturate nor a chemical paralytic agent; (3) enjoining Defendants from executing Rhines with pentobarbital', and (4) ordering that Defendants shall execute Rhines only with an ultra-short- acting barbiturate, to wit, sodium methohexital or sodium thiopental, in combination with a chemical paralytic agent. (Id. 58-71.) ARGUMENT ?The recognized purpose of a temporary restraining order is to suspend proceedings until the court can determine whether an injunction should issue.? Golden v. Oahe Enterprises, Inc. 90 SD. 263, 279, 240 102, 111 (SD. 1976). ?Whether apreliminary injunction should issue involves consideration of (1) the threat of irreparable harm to the movant; (2) the state of the balance between this harm and the injury that grantng the injunction will in?ict on other parties [sic] litigant; (3) the probability that movant will succeed on the merits; and (4) the public interest.? Dataphase Systems, Inc. v. Systems, Inc, 640 F.2d 109, 113 (8th Cir. 1981) (en banc); see also Gross v. ConnecticutMut. Life Ins. Co., 361 259 (SD. 1985); OZson v. Cass, 349 435 (SD. 1984). No single factor is determinative in deciding whether to issue a temporary restraining order, and the likelihood that the movant will prevail on the merits must be examined in the context of the relative injuries to the parties and the public. See Dataphase Systems, Inc., 640 F.2d at 113. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 Similarly, stay [of an execution] is an equitable remedy, and ?[e]quity must take into consideration the State's strong interest in proceeding with its judgment and attempt[s] at manipulation.? Nelson v. Campbell, 541 U.S. 637, 649 (2004) (quoting Gomez 12. United States Dist. Courtfor Northern Dist. of Cal., 503 U.S. 653, 654 (1992) (per curiam)). ?Thus, before granting a stay, a district court must consider not only the likelihood of success on the merits and the relative harms to the parties, but also the extent to which the inmate has delayed unnecessarily in bringing the claim.? Id, 541 U.S. at 649-50. ?Given the State?s signi?cant interest in enforcing its criminal there is a strong equitable presumption against the grant of a stay where a claim could have been brought at such a time as to allow consideration of the merits without requiring entry of a stay.? Id. (internal citations omitted). As set forth below, the Court should issue a temporary restraining order and a-stay of execution pending a disposition on the application for a preliminary injunction because there is a threat of irreparable harm to Rhines, there is a likelihood that Rhines will succeed on the merits of his case, the harm to the State is minimal, and the balance of equities weighs in favor of the relief sought. POINT I: Rhinos Will Be Irreparably Harmed if the State is Permitted to Proceed with Rhines?s Execution Contrarvto South Dakota Law ??Death is a punishment different from all other sanctions in kind rather than degree.? Bucklew v. Precythe, 139 S. Ct. 1112, 1146, 203 L. Ed. 2d 521 (2019) (quoting Woodson v. North Carolina, 428 U.S. 280, 303?304 (1976)). ?For that reason, the equities in a death penalty case will almost always favor the prisoner so long as he or she can show a reasonable probability of success on the merits.? Id. (citing Nken v. Holder, 556 U.S. 418, 434 (2009) (noting that success on the merits and irreparable injury ?are the most critical? factors)); cf. Glossip v. Gross, 135 S. Ct. 2726, 2737 (2015) (observing, in a preliminary- injunction posture, that ?[t]he parties agree that this 10 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 case turns on Iwhether petitioners are able to establish a likelihood of success on the merits? and analyzing the case accordingly); accord, I'd, at 2792 (SOTOMAYOR, 1., dissenting). Rhines faces execution in two weeks, a punishment that once done cannot be undone. A stay of the execution, and atemporary restraining order enjoining Defendants from proceeding with the execution using pentobarbital, is required to guarantee that Rhines is not deprived of his right to be executed in the manner provided for in South Dakota law and to guarantee Rhines due process of law. Indeed, stay of the execution and a temporaiy restraining order are required to make Rhines?s statutory and due process rights. meaningful. See Bartaglz'a v. Stephens, 824 F.3d 470, 475 (5th Cir. 2016) (granting stay of execution and ?nding it was warranted to make indigent capital I defendant?s right to federally-funded substitute counsel meaningful). POINT II: Rhines is Likely to Succeed on the Merits of His Complaint A. Rhines is Likely to Succeed on the Merits of his First Cause of Action Rhines is likely to succeed on the merits of his cause of action alleging a violation of state statutory law. The plain language of the statutes at issue is clear. In enacting SDCL 23A-27A- 32.1, the State of South Dakota created a right that entitles Rhines to be executed in the manner provided by South Dakota law at the time of the Rhines?s conviction or sentence. See SDCL 23A-27A-32J. The South Dakota Legislature enacted this provision in February of 2007 and made no changes to it when the Legislature amended portions of 23A-27A-32 in 2008. At the time that Rhines was convicted and sentenced, in 1993, South Dakota law provided, in pertinent part, and unequivocally, that ?[t]he punishment of death shall be in?icted by the intravenous administration of a lethal quantity of an ultra?short-acting barbiturate in combination with a chemical paralytic agent. and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1 1 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 1984, ch 181, codi?ed at SDCL (1984) (emphasis added). The statute allows no discretion in the manner of execution, but rather gives specific directives as to the manner of execution. Accordingly, SDCL and SL 1984, ch 181 create a protected right to an execution ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. Pursuant to the SDCL Rhines shall be executed in this manner if he ?choose[s] by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen.? SDCL Rhines did chose to be executed in this manner??more than 4 weeks prior to his week of execution?in a written Kite-Request Slip dated October 1, 2019, addressed to Defendant Young, and in amended written Kite-Request Slip dated October 4, 2019, addressed to Defendant Young. (Compl. 1111 30, 31, Exhibits B, to the Compl.) Based upon the foregoing, Rhines has demonstrated that he has a right to be executed in the manner he has chosen arising from South Dakota Codi?ed Law. Defendants cannot deprive Rhines of his right to be executed in the manner of his choice. Defendants have a duty to ensure Rhines can exercise his right. Defendants, however, have taken the position that pentobarbital is an ultra-short?acting barbiturate. (Compl 11 34, Exh. to the Compl.) Defendants? assertion is erroneous. Pentobarbital is not an ultra-short-acting barbiturate. -(Compl 1] 36', Stevens Aff1111 7, 8.) Ultra-short-acting barbiturates include sodium methohexital and sodium thiopental. (Compl11 35', Stevens Aff11 7.) The statute?s plain language requires that the Defendants use one of these two ultra-short?acting barbiturates for the execution. By refusing to guarantee that Rhines will be executed in the manner set forth in SL 1984, ch 181, Defendants 12 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490IV19-002940 are depriving Rhines of his state statutory right codi?ed and protected by SDCL and SL 1984, ch 181. This case is analogous to Smith v. State ofMontana, Department of brrections, No. BDV- 2008-303, 2015 WL 5827252 (Mont. Dist. Oct. 6, 2015) (Exh. A to the Compl.). In Smith, the Court addressed a similar Montana law that provided ?[t]he punishment of death must be in?icted by administration of a continuous, intravenous injection of a lethal quantity of an ultra-fast-acting barbiturate in combination with a chemical paralytic agent until a coroner or deputy coroner pronounces that the defendant is dead.? Id. at 1. However, the State of Montana intended to execute Smith using pentobarbital, which, Smith argued, is not an ultra-short?acting barbiturate. Id. After a trial, the court concluded, among other things, that pentobarbital is not an ultra-fast? acting barbiturate and enjoined the State of Montana from executing Smith using pentobarbital. Id. at The Montana statute at issue in Smith and SL 1984, ch 181 are nearly verbatim. The evidence presented by Rhines demonstrates, as was demonstrated in Smith, that pentobarbital is not an ultra?short?acting barbiturate. Thus, just as Smith succeeded on the merits of his claims, Rhines is likely to succeed on the merits of his as well. B. Rhines is Likely to Succeed on the Merits of his Second Cause of Action Rhines is likely to succeed on the merits of his cause of action alleging deprivation of due process. ?Procedural due process constrains government decisions ?which deprive individuals of ?liberty? or ?property? interests within the meaning of the Due Process Clause of the Fifth or Fourteenth Amendment.??Kr0upa v. Nielsen, 731 F.3d 813, 818 (8th Cir. 2013) (quoting Mathews v. Eldridge, 424 U.S. 319, 332 (1976)). ??To establish a procedural due process violation, a plaintiff must demonstrate that he has a protected property or liberty interest at stake and that he 13 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 was deprived of that interest without due process of law.? Osloond v. Farrier, 659 20, 24 (SD. 2003) (quoting Hopkins v. Saunders, 199 F.3d 968, 975 (8th Cir. 1999) (citation omitted?. ?[S]tate law may create a ?liberty interest? protected by the Fourteenth for example, a state statute gives ?specific directives to the decision maker that if the [statute?s] substantive predicates are present, a particular outcome must follow,? a ?liberty interest? protected by the Fourteenth Amendment is created.? Bagley v. Rogerson, 5 F.3d 325, 328 (8th Cir. 1993) (quoting Kentucky Department of Corrections v. Thompson, 490 U.S. 454, 463 (1989)); see Hicks v. Oklahoma, 447 U. S. 343, 346 (1980) (Oklahoma statute providing jury could impose a sentence of no fewer than 10 years in prison created a liberty interest protected by the 14th Amendment in defendant having the jury apply that sentence). To constitute a due process violation, the individual must have been deprived of this right by a state actor. See Osloond v. Farrier, 659 20, 24 (SD. 2003); DeShaney v. Winnebago County Dept ofSoc. Serva, 489 U.S. 189, 195, (1989). Here, in enacting SDCL l, the State of South Dakota created life and liberty interests that entitle Rhines to be executed in the manner provided by South Dakota law at the time of the Rhines?s conviction or sentence. See SDCL 23 The South Dakota Legislature enacted this provision in February of 2007 and made no changes to it when the Legislature amended portions of 23A-27A-32 in 2008. At the time that Rhines was convicted and sentenced, in 1993, South Dakota law provided, in pertinent part, and unequivocally, that ?[t]he punishment of death shall be in?icted by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 14 Filed: 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 1984, ch. 181 (emphasis added). The statute allows no discretion inthe manner of execution, but rather gives speci?c directives as to the manner of execution. See Bagtey, 5 F.3d at 328. Accordingly, SDCL 23A-27A-32.1 and SL 1984, ch. 1 81 create protected life and liberty interests in execution ?fby the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch.181. As set forth in Point 1, supra, South Dakota Codi?ed Law mandates that Rhines shall be executed in this manner if he chooses it more than seven days before his execution week, which he did. (Compl. 1111 30, 31, Exhibits B, to the Compl.) Based upon the foregoing, Rhines has demonstrated that he has protected life and liberty interests in being executed in the manner he has chosen arising from South Dakota Codi?ed Law. See OsZoond, 659 at 24. Defendants, State actors, cannot deprive Rhines of his life and liberty interests without due process of law to which-he is entitled under the due process clauses of the Fourteenth Amendment of the United States Constitution and Article Six, Section 2 of the South Dakota Constitution. See US. Const. amend. XIV, SD. Const. art. XI, 2. Pentobarbital is neither an ultra?short-acting barbiturate nor a chemical paralytic. (Compl 11 36', Stevens Aff. 1111 7, 8, 11.) Ultra-short-acting barbiturates include sodium methohexital and sodium thiopental. (Compl11 35;. Stevens 11 7.) By stating that Rhines will be executed using pentobarbital, which is not an ultra?short?acting barbiturate, Defendants are deliberately and intentionally depriving Rhines of his constitutionally protected life and liberty interests without due process of law. Based upon the foregoing, Rhines is likely to succeed on the merits of his Second Cause of Action. 15 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 POINT The Balance of Harms and Public Interest Favors Granting the Relief Sought Bv Rhines, Who Has Not Delayed in Brining His Action As set forth above, Rhines will suffer irreparable injury without a stay and temporary restraining order pending disposition of his application for a preliminary injunction. Conversely, the harm to Defendants is a minimal incremental delay andthe administrative inconvenience of seeking another execution warrant. Thus, the balance of harms weighs in favor of granting the stay and temporary restraining order. Further, Rhines has timely ?led his action and this application. South Dakota law provides that he may elect to be executed in-the manner provided by South Dakota law at the time of his sentence and that he shall choose by indicating in writing to Defendant Young not less than seven days prior to the scheduled week of execution the manner of execution chosen. SDCL 23A- 27A?32.l. Rhines exercised his right to elect the manner of execution by submitting a Kite- Request Slip to Warden Young on October 1, 2019, 32 days prior to Rhines?s scheduled week of execution, and then by submitting an amended Kite-Request Slip on October 4, 2019, 29 days prior to Rhines?s scheduled week of execution. (Compl. 30, 31, Exhs. B, to the Compl.) The Warden did not respond to either of Rhines?s Kit?Request Slips. (Compl. 32.) On October 15, 2019, 18 days before Rhines?s scheduled week of execution, his attorneys wrote a letter to Defendant Young, Defendant Ravnsborg, and Swedlund, requesting confirmation that Defendants would comply with Rhines?s rights. (Compl. 11 32, Exh. to the Compl.) On October 17, 2019, more than two weeks a?er Rhines-submitted his ?rst Kite-Request Slip, Defendants responded by letter to counsel for Mr. Rhines. (Compl. ii 34, Exh. to the Compl.) Defendants conceded that Mr. Rhines had the statutory right to elect the execution procedure available at the time of his sentence and conviction: administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent. (Id) Defendants claim that they will follow the law, 16 Filed: 10/2212019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 and abide by Mr. Rhines? choice. (Id) Defendants informed Mr. Rhines, however, that they intend to execute. him using pentobarbital. (fat) Pentobarbital is neither an ultra?short?acting barbiturate nor a chemical paralytic agent. (Compl 36', Stevens Aff. 8, 11.) Rhines ?led his action and this application as soon as practicable after learning from Defendants that they intend to execute him in a manner that contradicts the law. Further, a stay, temporary restraining order, and injunction are in the public interest. There is a ?public interest in preventing unconstitutional executions.? Kindler v. Horn, 642 F.3d 398, 406 (3d Cir. 2011). Indeed, there can be no negative impact on the public from an injunction mandating compliance with laws designed to serve the public and guaranteeing compliance with South Dakota law is serving the public interest. CONCLUSION For all the reasons set forth above, Rhines respectfully requests that the Court set this matter for a hearing on the preliminary injunction, grant a stay of execution, and issue a temporary restraining order ordering that: (1) pentobarbital is neither an ultra?short-acting barbiturate nor a chemical paralytic agent; (2) Defendants are enjoined from executing Rhines with pentobarbital, and (3) Defendants shall execute Rhines only with an ultra-short-acting barbiturate (such as sodium methohexital or sodium thiopental) in combination with a chemical paralytic agent. In the alternative, Rhines requests an expedited hearing on Rhines?s application for a preliminary injunction so that the Court may rule on the application in advance of the execution week beginning November 3, 2019. 17 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 Dated this 22nd day of October, 2019. BALLARD SP AHR LLP By: Daniel R. Fritz Daniel R. Fritz (2390) Timothy R. Rahn (4871) 101 South Reid Street, Suite 302 Sioux Falls, SD 57103 Telephone: (605) 978-5200 Email: fritzd@ba11ardspahr.com rahnt@ballardsp ahr.eom 18 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 AFFIDAVIT OF CRAIG W. STEVENS, I, Craig W. Stevens, do hereby af?rm and attest under penalty of perjury: 1. I am a full-time faculty member in the department of Pharmacology and Physiology at the College of Osteopathic Medicine, 3 unit of Oklahoma State University, Center for Health Sciences campus in Tulsa, Oklahoma. After receiving my in Pharmacology from the Mayo Clinic, in Rochester, Minnesota, I completed a 2-year postdoctoral fellowship at the University of Minnesota Medical School in Minneapolis, Minnesota, and secured a position as an Assistant Professor of Pharmacology with my present employer in 1990. advanced through the academic ranks to Associate Professor of Pharmacology in 1993, and Professor of Pharmacology in 2000. 2. Besides my regular duties of teaching medical students, pursuing research and scholarly activities, and sewing on college committees, i work part-time as a litigation consultant/expert witness on cases involving pharmacological issues. I have consulted in both civil and criminai cases, working with both the prosecution or plaintiff and the defendant. With regard to the pharmacological issues of lethal injection, have worked as a consultant with the state as well as with attorneys representing condemned inmates. 3. have been retained by counsel for Charles Rhines. Counsel have asked me to provide the Court with information regarding the classification and function of various pharmacological drugs. 4. I have reviewed the following materials in preparing this Af?davit: the South Dakota statute ?Place and manner of execution Qualifications to perform Exemptions,? 1993 SD. Codi?ed Laws Letter from Paul Swedlund, Assistant Attorney General, to Caroline Heller, dated October 17, 2019; Research Issues 26, Guide to Drug Abuse Research Terminology; Harwood Nuss? Clinical Practice of Emergency Medicine, Sixth Edition, October 2014 Update; Nembutal Sodium Solution lpentobarbital sodium injection} label; Poisoning and Drug Overdose, Edition, Chapter 28 Barbiturates, Timothy E. Albe rtson, and Pentobarbital, Thomas E. Kearney; Pharmacology of Intravenous Sedative/Anesthetic Medications Used in Oral Surgery, Joseph A. Giovannattl Jr.; Pharmocakinetics of Methohexltal and Thiopental in Surgical Patients, Robert J. Hudson, et al.; Brevital Sodium Methohexital Sodium for Injection Label; Use of Ultrashort-Acting Hypnotic Agents in Emergency Departments, Western Journal of Medicine, 1996, Michael S. Schneider and Wendy C. Coates; The Relative Potencies of Methohexitone and Thiopentone, Journal of Anesthesia, Volume 22, 1967, ET. Thomas. 5. Barbiturates are a drug group that derive from barbituric acid. Barbiturates depress the central nervous system and have been used as sedatives and hypnotics for over a century. 6. Barbiturates are divided into the following classes: ultra-short-acting, short-acting, intermediate-acting, and long-acting. The classi?cations refer to the time of onset and duration of the drug effects. These classifications are widely accepted in the ?eld of pharmacology. Filed: 10I22l2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 7. I am aware of two ultra-short-acting barbiturates: sodium thiopental and methohexital. Short-acting barbiturates include pentobarbital and secoberbital. intermediate-acting barbiturates include amobarbital and butabarbital. Long-acting barbiturates include phenobarbital and mephobarbital. 8. As Indicated above, pentobarbital is not an ultra-short?acting barbiturate and has never been classi?ed as such. Its effects take longer to begin onset and last longer than the effects of ultra-short-acting barbiturates. 9. Thiopental, the most frequently used ultra-short-acting barbiturate, is used for surgery of short duration. The on set of anesthesia is usually within 10 to 30 seconds, because thiopental is so lipid soluble that it rapidly enters the brain. 10. In pharmacology, chemical paralytic agents are synonymous with neuromuscular blockers. Paralytics by themselves do not typically lessen a patient?s awareness of pain. Rather, they inhibit muscle action and thus prevent movement. They are typically used during surgical procedures in combination with analgesics or anesthetics. Common chemical paralytic agents include pancuronium bromide and vecuronium. 11. Pentobarbital is not a chemical paralytic and has never been classi?ed as such. 12. Attached hereto is my curriculum vitae. I hereby certify that the facts set forth above are true and correct to the best of my personal knowledge, information, and belief, subject to the penalty of perjury. C?r'aig W?evens, Date STATE OF OKLAHOMA SS COUNTY or TULSA Subscribed and sworn to before me this 22 day of October, 2019. mile :3 RY p063; ?15. 65:3 2333? NOTARY PUBLIC 23$ [if-35?? '94 0e My Commission Expires a! if? Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 Craig W. Stevens, Professor of Pharmac ology Department of Pharmac ology Physiology OSU?Center for Health Sciences, College of Osteopathic Medicine 1111 W. 17th Street Tulsa, OK 74107-1898 PROFESSIO NAL APPOINTMENTS 2000?present 2012-2018 2007-2009 1993-2000 1990-1993 1989-1990 1984-1986 MARCH, 2019 CURRICULUM VITAE Ph. 918.561. 8234 email: cw. stevens@okstate.edu Professor of Pharmacology, OSU?College of Osteopathic Tulsa, OK Chair, Coalition Against Prescription and Substance Abuse of Tulsa (CAPSAT) Chair, Dept. of Pharmacology/Physiology, OSU-CHS, Tulsa, OK Associate Professor of Pharmacology, Dept. of Pharmac elegy/Physiology, Tulsa, OK Assistant Professor of Pharmacology, Dept. of Pharmac elegy/Physiology, Tulsa, OK Development Manager, Minnesota Academy of Science, St. Paul, MN . President (founding), Mayo Graduate Students Association, Mayo Grad. Scthed., Rochester MN EDUCATION AND TRAINING 2005 1988-1990 1984-1988 1981-1984 1978-1981 1974-1978 MoleCular Biology and PCR Course, Smith College/New England Biolabs, Northampton, Massachusetts Postdoctoral Research Fellow, Dept. of Cell Biology and Neuroanatomy, Univ. of Minnesota, Minneapolis, MN. Supervisor: Dr. Virginia Seybold Mayo Graduate School of Medicine, Rochester, MN, in Pharmacology. Thesis: Behavioral and Biochemical Characteristics of Opioid Tolerance in Rat Spinal Cord Supervisor: Dr. onyL. Yaksh University of Illinois, Chicago, MS. in Biological Sciences. Thesis:Endogenoiis Opioid?ystems in Amphibians. Supervisor: Dr. Paul D. Pezalla American Peace Corps in Nepal; Science/Math Instructor, Katmandu, Augustana College, Rock 13., BA. in Biology, cum laude EXIRAMURAL FUNDING 2010-2014 2007L2011 2004-2007 2002?2004 2001?2003 1999-2001 1998-1999 1995-1997 1994?1996 1992-1998 1992-1995 1991-1992 1988-1990 1987-1988 1985-1986 1985-1986 ?Novel Opioid/1 ction at all?Like Receptors?, Oklahoma Center for the Advancement of Science and Technology (OCAST) OW. Stevens, $126,090 (direct costs) ?i'i'anctional Evolution of OpioidReceptons?, NIH NIDA AREA Grant, R15DA12448, CW. Stevens (PI), $150,000 (direct costs) (no?cost extension for 201 1) ?Fanctional Evolution ofOpioidReceptors?, NIH NIDA AREA Grant, R15DA12448, OW. Stevens (PI), $100,000 (direct costs) ?Sequence and Pharmacology of Novel Opioid eceptors Oklahoma Center for the Advancement of Science and Technology (OCAST) CW. Stevens, $68,264 (direct costs) ?Fanct?ional Evolution of OpioidReceptors?, NIH NIDA AREA (Academic Research Enhancement Award) Grant, R15DA12448, CW. Stevens (PI), $100,000 (direct costs) ?Ti'tinctional Evolution of OpioidReceptors?, NIH NIDA AREA (Academic Research Enhancement Award) Grant, R15DA12448, OW. Stevens (PI), $69,605 (directcosts) ?Testing and Comparison of A nalgesicA gents?, American College of Laboratory Animal Medicine (ACLAM), OW. Stevens $11,555 (direct costs) ?Graduate StudentResearch?, Gardner Spring, Co., Tulsa, OK ($4,000) NRSA postdoctoral grant for Dr. Stan Willenbring, OW. Stevens (sponsor). ?Studies of OpioidAnalgesia in Amphibians", First Award (DA07326), CW. Stevens, Principal Investigator (PI), $418,000. (direct osts) (no -cost extension for 1998) ?Spinal Sites ofEndogenous Opioid Action inAmphibians", Research Grant, Whitehall Foundation, CW. Stevens, PI, $70, 785. ?Nociceptive Processing in theAmphibian Spinal Cord?, Grants-ln-Aid, Whitehall Foundation, C. W. Stevens, Pl, $10,375. NIDA Neuroscience Training Grant, Postdoctoral position, Dept. of Cell Biology and Neuroanatomy, University of Minnesota Medical School, Minneapolis, MN ?Issues related to tolerance development and tissue toxicology of chronically administered 4- anilinopiperidines?, TL. Yaksh (PI) and CW. Stevens JanssenPharm., $46,000. "E?ects of capsaicinoid agents on peptide levels and behavioral function?, T.L. Yaksh (PI) and CW. Stevens Procter and Gamble Co., $25,000. ?E?ects of drugs on the shock titration threshold in the primate", T..L. Yaksh (PI) and CW. Stevens (Co- $10,000, Sterling Winthrop Pharmaceuticals. 1 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 TEACHING EXPERIENCE 1990-2014 2009-2013 1997-2009 1991-2009 2000-2004 1998-2001 1989-1990 1989-1990 1984-1987 1984-1987 1981-1983 Lecturer, Medical Phannocology I-II, (Course-Coordinator 1997-2007) OSU-CI-IS, COM, Tulsa, OK Instructor, Receptors? (graduate course, alternate years) OSU-CH8, COM, Tulsa, OK Instructor, Neurophamocology (graduate course, alternate years) OSU-CH8, COM Tulsa, OK Facilitator, Mediootlrg?ormotion Systems Course, COM, Tulsa, OK Visiting Professor, NeuroscienceLab Course, of MN Medical School, Minneapolis, MN Adjunct Professor ofPharmac ology, University of Tulsa Nursing School, Tulsa, OK Lecturer, PhormacologyforNurse Anesthetists, University of Minnesota, IVIinneapolis, MN Lecturer, Neurophomocology Course, Dept. of Neurology, Univ. of MN, Minneapolis, MN Community Education, Juggling Instructor, Rochester, MN IBM-PC Instructor, MicrocomputerEducotion Cntr. Mayo Clinic, Rochester, MN Teaching Assistant; Dept. of Biological Sciences, University of IL at Chic ago, IL ACADEMIC 2011 2010-2012 2004 2003 2002-2003 2002-2003 2001-2002 1994-2001 1996?2001 Member, Honorary Degree Committee, Stillwater Secretory Group 6 of the Graduate College, OSU-Stillwater Member, Research and Creative Activities Task Fore e, OSU-System, appt. by OSU President Schmidly Member, Search Committee for VP Health Affairs OSU-COM - President: Faculty Senate Member, Board of Directors for Academic Health Center, joint affiliation of TRMC and Vice?P resident Faculty Senate FoundingMember Choir (20008001), Biomedical Sciences Graduate Committee Chair, Hazardous Materials and Equipment 199498, 2000-16 Member, Chair (2001?2004; 2006?2007;2010?2013) OSU-CH8 Promotion and Tenure Committee 1996-1998, 2009 Senator, Faculty Senate 1991-2000, 2006 Member, (Chair, 2006) Research Committee 1991-92, 2002?04 Member, (Chair, 2002?2004) Academic Appeals Board 1991?1992 1990-1999 Member, Learning Resources Committee Chair (1990-1993), Member (1994-1999), Animal Use Committee (IACUC) PROFESSIONAL SOCIETY NIEMBERSHIPS International Narc otics Research Conference (INRC, member of Executive Committee) American Society for Pharmacology and Experimental Therapeutics (ASPET) Society for Neuroscience (SFN), Americ an Association for the Advancement of Science Committee on Problems of Drug Dependenc (CPDD) H0 NORS AND AWARDS 2006 Regents Research Award, Inaugural awardee for OSU-Center for Health Sciences 1992 Young Investigator Travel Award, American Pain Society, San Diego, CA 1992 NIDA Travel Award, International Narcotics Res. Comm. (INRC), Keystone, CO 1991 Young Investigator Travel Award, American Pain Society, New Orleans, LA 1991 Young Scientist Travel Award, ASPET Annual Meeting, San Diego, CA 1990 Fulbright Scholarship for Research Teaching in India (declined to accept faculty position) 1990 CPDD Travel Award, CPDD Annual Meeting, Keystone, CO 1989 NIDA Travel Award, CPDD Annual Meeting, Keystone, CO 1987 Upjohn Travel Award, ASPET Annual Meeting, Honolulu, HA 1987 NIDA Training Grant, Gordon Research Conference, ?Mode ofA ction of Opiates?, CA 1983 UIC Research Assistantship, University of Illinois, Chicago, IL 1983 NIH Training Grant, "Neural Systems Behavior", MBL Summer course, Woods Hole, MA 1982 UIC Research Board Travel Grant, ?Strategies for stud? mg the role of peptides in neuronolfunction", Society for Neuroscience Short Course, Minneapolis, MN GRADUATE TRAINING Ac TIVITIES 1997-2000 1998-2005 2001-2005 2002-2004 2002-2004 2001?2007 Chair/Major Advisor to Leslie C. Newman student, completed 8/2000 with university?wide honors). Member, Advisory Committee for John Paulson student, completed 8/2005) Chair, Advisory Committee for Eva Garringer student, completed 5/2005) Member, Advisory Committee for Randy Benton (MS. student; completed 5/2004) Member, Advisory Committee for Raju N. Kach'am (MS. student at OSU-CVHS, Stillwater; completed 5/2004) Chair/Major Advisor to Kristin Martin (MS. student; completed 5/2007) 2 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota GRADUATE TRAINING (CONT.) 2003-2008 Chair/Major Adviser to Christopher M. Brasel student, completed 5/2008) 2004-2008 Chair/Major Adviser to Shekher Mohan student, completed 12/2008) 2005-2008 Chair/Major Adviser to Julie Duffey (MS. student, completed MS degree 5/2008) 2007-2009 Member, Advisory Committee for Danielle (M S. student, completed MS. 7/2009) 2006-2011 Member, Advisory Committee for Neda student, awarded May, 2011) 2007-2011 Member, Advisory Committee for Arunkumar Thangaraju student, awarded Dec., 2011) 2008-2011 Chair/Major Adviser to ShruthiAravind (MS. student, S. awarded May 2011) 2010-2013 Chair/Major Adviser to Larry Johnston S. student) 2009-2013 Chair/Major Adviser to John Knox student) 2011-2015 Chair/Major Adviser to Summer Dodson degree awarded Summer, 2015) 2011- Member, Advisory Committee for Leandra Figueroa student) GRANT STUDY SECTIONS Reviewer ferNJH grants, Special Emphasis Pain Study Sections (1998-pres ent) Grant consultant forthe Univ of Michigan, Centers of Res earch Excellence project (2003) Grant Reviewer for National Science Foundation (1996-2002) Grant Reviewer for the Veterans Administration (1995? present) Chair (1999), Member (1997) Biological Sciences Pane], Texas State Granting Program-Advanced Research Proposals Grant Reviewer (2008) for Neuros cience and Mental Health Grants, The Wellcome Trust EDITORIAL ADVISORY ER FORTHE FOLLOWING scramnuc JOURNALS Peer?Reviewer fer'J. Pharmacol. Exp. Then, BrainResearch, Life Sciences, Neuroscience Letters, Em: J. Pharmacology, J. Neuroscience, Pain, American Journal of Physiology, Journal of Pain, LaboratoiyAnimals Editorial Advisory Board, Pharmacology Online (Italy), Editor: Anna Capasse. Editorial Advisory Board, Computational Biology and Chemistry: Advances and Applications, Editor: Bruno Villeutreix Advisory Board Member, Tobacco-Free Zone, Tulsa, OK Consultant, Reuters News Service, Insight Service COMPUTER CONSULTING SigmaPlet for Windows, ,B-tester, Jandel Scientific, CA, 1992-1999. Reference Manager for Windows, B?tester, Research Information Systems, Inc., CA, 1993-1999. Institute for Scientific Information (181), focus group meeting, San Francisc 0, CA, April, 1998. Knew ledge Acquisition Consultant for Ingenuitycem (2001). B-tester for PET Online Review and Submission website (2001). SCIENCEINITIATIVES Science Fair Judge at School (Carver and Elliot) and Regional (Tulsa County) Level 1990~2010. Institutional Representative or the Tulsa Biologic a1 and Clinical Research Alliance (TBCRA), 1998-2001 Science Enrichment for University of Tulsa- Gifted School, 199S-present, also at Trinity Episcopalian Day School. Faculty Participant in High SchoolAmbassador Program at OSU-CI-IS, 1994?2000 Workshop participant in "Speaking out for Science", sponsored by March 28, 2009. Member, Oklahomans for Excellence in ScienceEducatien. VIS ITING TIRES EARC CO NS IDE CO LLABO RATIO 1994 Laboratory of Tony L. Yaksh, P11.D., Vice Chair for Research, Dept. of Anesthesiology,UCSD, La Jolla, CA. Project entailed characterization of met-enkephalin extended sequences inRana pipiens and presentationto research group. 1996 Laboratory of George Wilcox, Profess er of Pharmacology, University of MinnesotaM edical School, Minneapolis, MN. Training of intrathecal catheterizationto research group and general lab QC. 1999 Laboratory of Howard Gutstein, ., Director of Res earch, Dept. of Anesthesiology, Anderson Cancer Center, Heust on, X. Training of intrathecal catheterization and analgesic modeling techniques toresearch group. 2000 Research consultant for Ligand Phanrlaceuticals, San Diego,'CA. 2000 Laboratory of Dr. Sandra Reerig, Professor ofPharmacology/Associate Dean for Research, LSU Medical Center, Shreveport, LA. Training of intrathecal catheterization and analgesic modeling techniques to research group. 2000 Laboratory of Dr. James Zadjna, Professor of Pharmacology/ Director of Neurosciences Program, Tulane University School of Medicine, New Orleans, LA. Training of intrathecal catheterization to research group. 2001 Visiting Professor, Neuroscience Lab Course, Dr. George Wilcox, co-director, University of Minnesota Neuroscience Program. Amphibian model for testing analgesics used in a live laboratory course (also subsequent years). 2001 Laboratory of Ken MeCarson, Associate Professor of Pharmacology, University of Kansas Medical Center, Kansas Cit y, KS. Training and collaboration on vanilloid-like receptor function in Rana pl'pienS?. 2002 Laboratory of Paul Prather, Associate Professor of Pharmacology. University of Arkansas for Medical Sciences, Little Rock, AR. Collaboration on transfection of frog opioid receptors in cell lines. 2002 Visiting Professor, Dept. of Neuroscience, University of MinnesotaMedical School, March 1 2-1 4, 2002. 2003 Visiting Professor, Dept. of Neuroscience, University of innesota Medical School, April 8 to 10, 2003. 2003 Visiting Professor, Dept. of edicinal Chemistry,University of Mississippi, Oxford. M1, May 7-9,2003. 2004 Visiting Professor, Dept. of Neuroscience, University of inneseta Medical School, April 12-15, 2004. 2005 ?siting Professor, Dept. of Neuroscience, University of MinnesotaMedical School, April 11 ?13, 2005. 3 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 INVITED TALKSISEMINARSIKEYNO TE PRESENTATIO 12. 13. 14. 15. 16. 18. 19. 20. 21. 22. 23. 24. 25. 26. 28. 29. 30. 31. 32. 33. 34. "Opio id aniinocice ption in amphibians?, Satellite Symposium: Behavioral Biology of Nociception: Comparative, Developmental, and Sexual Aspect, Society for Neuros cience,New Orleans, LA, Nov ember, 198?. ?An amphibian model for the assessment of opioid action AnnualMeeting of the College on Problems in Drug Dependence (CPDD), Richmond, VA, June, 1989. ?Alternatives to the use of manmrals for pain research OSU College of Veterinary Sciences, AnnualRes earch Symposium, Stillvvater OK, May 1991. ?An amphibian model for pain research?, Northeastern State University, Science and Technology Seminar Series, Tahlequah OK, October, 1991. ?An amphibian model for pain research Children's Medical Center, Chapman Research Institute Seminar Series, Tulsa OK, November, 1991. ?An amphibian model for pain research Oklahoma State University, Dept. of Zoology Seminar Series, Stillwater OK, January, 1992. ?Alternatives to the use of mamals for opioid researc OSU College of Veterinary Sciences, Annual Res earch Symposium, Stillwater OK, May 1992 . ?An amphibian pain model for opioid research",University of TulsaBiology Department Colloquium, Tulsa, OK, September 1992. ?An amphibian pain model for opioid research ?,Univ ers ity of Oklahoma Health Sciences Center, Dept. of Anatomy, Oklahoma City, OK, October, 1992. "Studies ofopioid tolerance in an amphibian pain model 1st Annual Young Investigators Symposium, College onProblems in Drug Dependence (CPDD), Toronto, June, 1993. ?Pelative analgesic potency ofmu and kappa opio ids in amphibians: a unique assayfor kappa opioid action? College on Problems of Drug Dependence (CPDD), Palm Beach, FL, 1994. "An amphibian pain model for op ioid research?,UCSD, Anesthesiology Res earchLab Group, April, 1994. ?An amphibian modelfor pain research?, Pharmacology Dept, LSU Med Center, New Orleans, 9/27/94. ?Alternativesto the use of manmrals for pain research spons oredworkshop,New Orleans, September 29-30, 1994. ?Hlternativesto the use ofmammalsfor pain research: an amphibianmodel SCAWICCAC Conference, Toronto, Canada, September 28, 1995. ?An amphibian model for studies of opioid action University of Minnes otaMedical School, Dept. of Pharmacology Seminar Series, Minneapolis, MN, January 19, 1996. - ?An alternative model for testing of op ioid analgesics and pain research using amphibians?, 2nd World Congres on Alternatives and Animal Use in the Life Sciences, Utrecht, Netherlands, October 21, 1996. ?Prom Pond to Pain: An Amphibian Model for Opio id Analgesia Anatomy/Physiology Seminar Series, University of Oklahoma Health Sciences Center, Oklahoma City, OK, May 20, 199?. . ?From Pond to Pain: An AmphibianModel for Op io idAnal gesia invited Symposium speaker, AnnualMeeting of the Midwest Pain Interest Group (PIG), Medical College of Wiscons in, Milwaukee, WI, June 6, 199?. ?Studiesofselective mu opioid antagonism after spinal administration ofbeta-FNA in amphibians?, invited Symposium speaker, College on Drug Dependence (CPDD) Annual Meeting, Nashville, TN, lune 16, 199?. ?The unireceptor hypothesis of opio id antinociception in amphibians: implicationsforthe evolution of opioid receptors invited Symposium speaker, International Narcotics Research Conference GNRC), Munich, Germany, July 20-25, 1998. ?An Amphibian Whole-Animal Alternative for the Study ofPain invited participant for symposium, All Creatures Weird and Wonderful: Revolutionary Approaches to Medical Dis covery, Anaheim, CA, Jan, 23, 1999. ?Perspectives on Opioid Tolerance from Basic Research Anders on? Univ ersity of Texas Medical Center, Dept. of Anesthesiology and Critical Care, Houston, TX, November 18, 1999. ?An AlternativeModelforPain andAnalgesiaResearch UsingAmphibians?, invited Symposium speaker, Scientists Center for Animal Welfare (SCAW), Spring Meeting, Baltimore, MD, May 19, 2000. ?From Pond to Pain: Investigatin gMechanismsofOp ioid Analgesia Using Amphibians?,OSU, Zoology, Stillwater, OK, 9/22t00. ?InvestigatingMechanisms of Op ioid Analgesia inAmphib ians?, LSU-Medical Center, Dept. of Pharmacology, Shreveport, LA, December 5, 2000. ?An Amphib ianModel for the Study of OpioidAnalgesics?, University of Kansas Medical Center, Dept. of Pharmacology, Toxicology and Therapeutics, Kansas City, KS, September 11, 2001 (re?scheduled andpresented on December 11, 2001). ?An AmphibianModel for Analgesia Testing?, Univ. of Oklahoma Dental School, StudentResearch Society AnnualBanquet, Myriad Convention Center, Oklahoma City, OK, April 12, 2002. ?Mechanisms of Opioid Analgesia inAmphibians?, Dept. of Neuros cience, Univ. of MN, Minneapolis, MN, April 16, 2002. ?An AmphibianModeljbr Investigation ofOpio id Analgesia and Pain processing at the Cross -Species Approach to Pain and Analgesia conference, spons or: Mayday Fund, Airlie Conference Center, Warenton,VA, Sept. 19, 2002. ?An Amphib ianModel for OpioidResearch Dept. of Pharmacology and Toxicology, University of Arkansas for Medical Sciences, Little Rock, AR, October 16, 2002. ?Opioid research using amphibians and the evolution ofop io id receptors?, Dept. of Medicinal Chemistry, University of Mississippi, Oxford. Ml, May 8, 2003. ?Opio id research using amphibians and the evolution ofopioid receptors invited Symposium speaker, British Society for Experimental Biology, Edinburgh, Scotland, April 2, 2004. ?Opioid research using amphibians and the evolution ofopioid receptors?, invited Symposium speaker, European Opioid Conference, Budapest, Hungary, April 8, 2004. 4 . Filed: 1012212019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 INVITED TALKSIS TE PRESENTATIO NS (C 0 NT.) 35. 36. 37. 33. 39. 40. 41. 42. 43. 44. 45. 46. ?Opioid research using amphibians: a unique perspective on the evolution of vertebrate opioid receptors Seminar for the Center for Pain Research, University of Minnesota, Minneapolis, W, April 15, 2004. ?AnEvolutionaryApproach to Understanding Vertebrate OpioidRceptors?, Veterinary Biomedical Sciences Seminar Series, OSU- College of Veterinary Medicine, Stillwater, OK, January 27, 2005. ?Opioid research using amphibians:An EvolutionaryApproach to Understanding Vertebrate Op io idRece ptors Seminar for the Department of Neuros cience, University of MinnesotaMedical School, April 12, 2005. ?Opioid analgesia research in behavioral assay to cloning opio id receptor genes?, Keynote speaker, Annual meeting of the Association of Reptile and Amphibian Veterinarians, Baltimore, MD, April 23-26, 2006. ?Insights on theMolecularEvolution of Vertebrate OpioidReceptors: From Frog to an ",Phys iology Seminar Series, University of Oklahoma Health Sciences Center, Oklahoma City, OK, January 25, 2007. ?Evolution of opioid receptors: hy the mu opioid receptor would make Darwin proud AnnualMeeting, Charleston, SC, USA, July 15, 2008. "Evolution of 0p ioidReceptors: Why the Mu Opio id Receptor Would Make DarwinP roud Veterinary Biomedical Sciences Seminar Series, OSU-Center for Veterinary Medical Sciences, OSU-Stillwater, Stillwater, OK, March 5, 2009. ?Evolution of OpioidReceptors?, Meeting, Tulsa, OK, March 30, 2009. ?MolecularEvolution ofVertebrate OpioidReceptors", Invited speaker, Genetics Group, St. Francis Hospital, March 15, 2012. ?MolecularEvolution ofOpio id Receptors", Seminar Speaker, Human Anatomy and Physiology Society (HAPS) Annual Meeting, University of Tulsa, May 28, 2012. ?Ethical Issues of an Amphibian PainModel 1a ouffrance animale: de la science au droit (Animal suffering: the science and the law) World Organization for Animal Health (DIE) Paris, France, October 18-19, 2012. ?PharnracologicalExculpation orMitigation:E?ects ofDrugs on Brain and Behavior? Oklahoma Criminal Defens Institute, Hard Rock Casino, Tulsa, OK, June 23, 2016. SCIENTIFIC PRESS wawNH Stevens C. W. "No Pain Some Gain: A New Model forNeuropathic Pain", lournal of NIH Research, May, 1990, p. 33-35. Stevens (1W. unding for oungl nvesti gators?, Letters to the Editor, Science, Vol. 255, p. 142, 1992. Stevens CW. Responseto "Letters from the Editor?, Lab Animal, Vol. 25, p. 42, 1996. Stevens CW: Response to ProtocolReview Column, Lab Animal, Vol. 26, 23-24, October, 1997. Stevens CW. "Evolution andFaith: EmpathyIsMisplaced", Letters to the Editor, Science, Vol. 320, p. 745, 9 May 2008. MEDIA ARTIC CONFERENCES 28 ?Northern grass frog helps Tulsan gig research grants", Tulsa World Newspaper, August21, 1992. "Research Grants?, op?ed page, Tulsa World Newspaper, September 7, 1992 (Animal rights response). ?Get Priorities Strai ght", op-ed page, Tulsa World Newspaper, September 20, 1992. (support of research) ?AnimalResearch Needed", op-ed page, Tulsa World Newspaper, September 20, 1992. (support) ?Who Suffers? Children or the Frogs??, op-ed page, Tulsa World Newspaper, September 27, 1992. (support) ?The rogman?, Tulsa People Magazine, March, 1994. (profile) ?Success by Six? Interview on brain activity in children, KGRH, Tulsa 6pm Evening News, August 10, 1996 ?State?s Share of Funds Short, Researchers Say?, interviewed (mis)quoted, The Daily Oklahoman, January 11, 1999. ?State ?sResearch FundMalnourishe interviewed (mis)quoted, Tulsa World, Jan. 15, 1999, A10 ?All Creatures Weird and Wonde?ul: Revolutionaij/Approaches toMedical Discovery Press Conference, American Association for the Advanc ement of Sciences Anaheim, CA, Jan 23, 1999. . ?ResearchReport?, radio interview for Radio Netherlands, Jan 23, 1999. nimals Hold Key to Cures: Medical Science Plumbs Secrets of Scorpions, Fish, Frogs? SF Examiner, Jan. 25, 1999. ?What will ease the pain? Ask afrog?, ScienceNews, Vol. 155, p. 91, February 6, 1999. ?Painful Choices?, New Scientist Online ConferenceReports, Feb. 6, 1999. ?Notebook: Frog Simplicity'?, The Scientist, V01. 13 (4), p. 32, February 15, 1999. ?Suffer the little amphibians?, The London Times- Higher Education Supplement, Issue 1379, pp. 22-23, April 9, 1999. ?Heat, Some Medicines Don ?tMix?, Tulsa World Newspaper, August 4, 1999. grant allows pain medicine study?, The Daily Oklahoman, p. 3-B, August 27, 2001 esearch frogs may lead to medical leaps and bounds?, The Tulsa World, Sept. 5, 2001. . researchers to stuehr pain relief The Tulsa World, p. Aug. 22, 2002. . ?OfFrogs and Pain 4 Weird LabRecognized?, Tulsa Business Journal, Vol 12 p. 10, Sept 6-12, 2002. ?Oklahoma Innovations Radio Show?, invited guestto talk about OSU-CBS and OCAST-funded research, 3/4/03. . ?Oklahoma Scientists and the Human Genome?, article about Dr. Stevens? lab, Oklahoma Magazine, Oct. 2003. ProfessorReceives Grant?, The Daily O?Collegian, OSU Newspaper, September 8, 2004. . ?The Other 0. C. (Oigzcontin) The Tulsa World Newspaper, Feb, 17, 2005, 13-1 (cont. D-6). CW is the ?voice of reason?. ?Do Boiling Lobsters eel Pain?? interviewed for ABC news specialseries on pain, May 10, 2005. http://abcnews. go.com Tough times add to panic, anxiety disorders?, Tulsa World Newspaper interview, D-3, April 2, 2009. ake pains to excercise?, Tulsa World Newspaper interview, D-3, July 18, 2009. 5 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota MEDIA CONFERENCES (CONTJ 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. medical students say juggling is great for the brain Dr. Stevens? Med School juggling club and video interview by Rick Wells from Newson6.com, August 25, 2010 (video at: Jugglers: Fox 23 Daybreak Show?, Kristin Talent interview and juggling by Dr. Stevens, Feb. 11, 2011 (video at: http://c ate. 0 om/video/playlist/0/220 83 85 ?wpid=9601) ?Juggle Heads: Keeping both sides of brain active is key to a healthy mind Tulsa World article by Kim Brown featuring interview and photos of Dr. Stevens and the Med School Chapter of the T?Town Juggling Club. Jan. 27, 2011. ?TnnovationsRadio Show?, interview with Dr. Stevens about his research on opioids.Oklahoma City, OK. April 6, 2011. ?Letters to the Editor: Research Supported?, The Tulsa World Newspaper, Aug. 28, 2011. ?Turning to Frogs A id in Horse Races?, The New York Times Newspaper Front Page, June 20, 2012. ?Secrets still shroud Clayton Lockett?s execution The Tulsa World Newspaper, May 11, 2014. ?Questions inconsistencies aboutClayton Lockett execution remain unanswered?, The Tulsa World, August 31, 2014. ?Federal nursing home comparison website receives updates?, The Tulsa World Newspaper, February 21, 2015. ?Scientists in Tulsa conducting ground-breaking research to eliminate addiction?, KOCO News at 6, Feb. 6, 2016. PRIMARY PUBLICATIONS l. 2. 3. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. Stevens CW. and Pezalla, P.D., Aspinal site mediates opiate analgesia in frogs. Life Sci. 33: 2097?2013, 1983. Stevens C. W. and Pezalla, P.D., Naloxone bloc ks the analgesic action of levorphanol but not dextrorphan in the leopard frog. Brain Research 301: 171-174, 1984. Pezalla, PD, and Stevens CW. Behavioral effects of morphine, levorphanol, dextrorphan, and naloxone in Rana pi pi ens. Pharm. Biochem. Behavior 21: 213?217, 1984. Yaksh, T.L., and Stevens, C.W., Simple catheter preparation permitting bolus intrathecal administration during chronic intrathecal infusion. Pharmacology, Biochemistry and Behavior, 25: 483-485, 1986. Stevens CW. and Yaksh, T.L., Spinal action of dermorphin an extremely potent opioid peptide from frog skin, Brain Research, 385: 300?304, 1986. Stevens C. W. and Yaksh, T.L., Dynorphin A and related peptides administered intrathec ally in the rat: A search for putative kappa opiate receptor activity. J. Pharmacol. Exp. Ther., 238: 833?838, 1986. Stevens, C.W. Pezalla, P.D., and Yaksh, T.L., Spinal antinociceptive action of three representative opioids in frogs. Brain Research, 402: 201-203, 1987. Stevens CW. Weinger, MB. and Yaksh, T.L., lntrathecaldynorphins suppress hindlimb electromyographic activity in rats. Eur. J. Pharmacol., 138: 299?302, 1987. Stevens CW. and Yaksh, T.L., Chronic antagonist infusion does not increase morphine antinociception in rat spinal cord. Brain Research, 425: 388-390, 1987. Stevens CW. Monasky MS. and Yaksh, T.L., Spinal infusion of opiate and alpha-2 agonists in ratszTolerance and cross- tolerance studies, J. Pharmacol Exp. Ther. 244: 63-70, 1988. Schick, RR, Stevens, C.W., Yaksh, TL. and Go, V.L.W., Chronic intraventricular administration of CCK octapeptide suppresses feeding in rats. Brain Research, 448 1294-298, 1988. Stevens, C.W., and Yaksh, T.L., Potency of infused spinal antinocic eptive agents is inversely related to magnitude of tolerance after continuous infusion. J. Pharmacol. Exp. Ther. 250: 1-8, 1989. Sosnow ski, M., Stevens CW. and Yaksh, T.L., Assessment of the role of adenosine receptors mediating the purine . antinociceptive, motor, and autonomic function in rat spinal cord. 1. Pharmac 01. Exp. Ther. 250: 915-922, 1989. Stevens, C.W., and Yaksh, T.L., Time course characteristics of tolerance development to continuously infused antinociceptive agents in rat spinal cord. J. Pharmacol. Exp. Ther. 251: 216-233, 1989. Stevens, C.W., and Yaksh, T.L., Magnitude of opioid dependence after continuous intrathec a1 infusion of mu and delta opioids in the rat. Eur. J. Pharmacol. 166: 467-472, 1989. Moron, M.A., Stevens CW. and Yaksh, T.L., Diltiazem enhances and flunarizine inhibits nimodipine's antiseizure effects. Eur. J. Pharmacol. 163: 299-307, 1989. Stevens C. W. and Pezalla, P.D., Endogenous opioid system down-regulation during hibernation in amphibians. Brain Research, 494: 227-231, 1989. Yanez, A, Sabbe, MB, Stevens, C.W., and Yaksh, T.L., Interaction of midazolam and morphine in the rat spinal cord. Neuropharmacology 29: 359?364, 1990. Moron, M.A., Stevens CW. and Yaksh, T.L., The antiseizure activity of dihydropyridine calcium channel antagonists in the conscious rat. J. Pharmacol. Exp. Ther. 252: 1150?1155, 1990. Monasky, M., Zinsmeister, A. Stevens CW. and Yaksh, T.L., The interaction of intrathecal morphine and on antinociception in the rat. J. Pharmacol. Exp. Ther. 254: 383-392, 1990. Stevens CW. Lacey, CB, Miller, KE, Elde, RR, and Seybold, VS, Biochemical characterization and regional quantification of mu, delta, and kappa opioid binding sites in rat spinal cord. Brain Research 550: 77-85, 1991. Stevens C. W. Kajander, KC, Bennett, G. ., and Seybold, VS, Bilateral and differential changes in spinal mu, delta and kappa opioid binding in rats with a painful, unilateral neuropathy. Pain 46: 315-326, 1991. . Stevens CW. and Yaksh, T.L., Studies of morphine and DADLE cross-tolerance after continuous intrathecal infusion in the rat. Anesthesiology 76: 596-603, 1992. 6 Filed: 1012212019 4:54 PM CST Minnehaha County, South Dakota PRIMARY PUBLICATIONS (Co NT.) 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 45. 46. 47. 48. 49. 50. 51. Stevens, CW. and Kirkendall, K, Time course and magnitude of tolerance to the analgesic effects of systemic morphine in amphibians, Life Sciences 52: 1993. Stevens, C. W., Alan J. Klopp, and J. Anthony Fac ello, Analgesic potency of mu and kappa opioids after systemic administration in amphibians. J. Pharmacol Ep. Ther. 269: 1086-1093, 1994. Brenner, GM, Deason, L. L, Klopp, A.J., and Stevens CW Analgesic potency of alpha?adrenergic agents after systemic administration in amphibians J. Pharmacol. Exp. Ther. 270: 540-545, 1994. Stevens C.W., Sangha S. and Ogg, B., Analgesia produced by immobilization stress and anenkephalinase?inhibitor in amphibians. Pharm. Biochem. Behav. 50: 675-680, 1995. Stevens CW. and Seybold, VS, Changes of opioid binding density in the rat spinal cord following unilateral dorsal rhizotomy, Brain Research 687: 53-62, 1995. Willenbring, B. and Stevens CW. Thermal, mechanical, and chemical peripheral sensation in amphibians: opioid and adrenergic effects. Life Sciences 58: 125-133, 1996. Stevens, CW. Relative analgesic potency of ma, delta, and kappa opioids after spinal administration in amphibians. J. Pharmacol. Exp. Ther. 276: 440-448, 1996. Stevens CW. and Brenner, G. 1V1, Spinal administration of adrenergic agents produces analgesia in amphibians, Eur. J. Pharmacol, 316: 205?210, 1996. Stevens CW. and Rothe, KS, Supraspinal administration of opioids with selectivity for 11-, 8- and lc-opioid receptors 3 produces analgesia in amphibians, European Journal of Pharmacology, 331: 15-21, 1997. Willenbring, B. and Stevens C.W., Spinal ma, delta, and kappa opioids alter chemical, mechanical and thermal sensitivities in amphibians Life Sciences 61: 2167-2176, 1997. Stevens, C.W., and Newman, L.C., Spinal administration of selective opioid antagonists in amphibians: evidence for an opioid unireceptor. Life Scienc es-Pharmacology Letters 641PL125-130, 1999 Newman, L. C., Wallace DR. and Stevens, C.W., Characterization of [3H]-diprenorphine binding in Rana pipiens: observations of filter binding enhanced by naltrexone. J. Pharmacol. Toxicol. Meth. 41: 43?48, 1999. - Newman, L. C., Wallace DR. and Stevens C.W., Selective opioid agonist and antagonists displacement of [3H]-naloxone binding in amphibian brain, European Journal of Pharmacology, 397: 255-262, 2000. Newman, L. (3., Wallace DR. and Stevens, C.W., Selective opioid agonist and antagonists competition for [3H]-naloxone binding in amphibian spinal cord, Brain Research, 884: 184-191, 2000. Stevens, C.W., Maclver, D. N., Newman, L.C., Testing and comparison of non-opioid analgesics in amphibians, Cont. Topics in Lab. Animal Sciences 40: 47-51, 2001. Newman, L. C., Sands, S.S., WallaceD.R and Stevens OW. Characterization of selective K, and 5 opioid radioligand #3 binding in amphibian brain. ournal of Pharmacology and Experimental Therapeutics 3013644370, 2002. Mohan, S. and Stevens, C.W., Systemic and spinal administration of the ma opioid, remifentanil, produces antinociception in amphibians, European Journal of Pharmacology, 534: 89?94, 2006. Stevens C. W. Toth G., Borsodi A, Benyhe S, Xendorphin B1, a novel opioid-like peptide determined from a Xena-pas laevis brain library, produces opioid antinociception after spinal administration in amphibians. Brain Res Bulletin, 71 :628- 632, 2007. Stevens CW. Brasel, CM and Mohan, SK, Cloning and bioinformatics of amphibian ma, delta, kappa, and nociceptin opioid receptors expressed in brain tissue: evidence for opioid receptor divergence in mammals. NeuroscienceLetters, 419: 189-194, 2007 Davis, R. L., Buck, D.J ., Saffarian, N. and Stevens CW. The opioid antagonist, B-funaltrexamine, inhibits chemokine expressionin human astroglial cells. Journal of Neuroirnmuunology 186: 141 ?149, 2007. Davis, R. L., Buck, DJ, Saffarian, N., Mohan, SK, Desilva, U., Fernando, SC, Stevens, C.W., B-funaltrexamine inhibits inducible nitric?oxide expression in human astroglial cells. J. Neuroirnmune Pharm. 3: 150-153, 2008. Brasel, CM, Sawyer, G.W. and Stevens, C. W., Apharmac ologic a1 comparison of the cloned frog and human mu opioid receptors reveals differences in affinity and function. Eur Pharmac01599:36-43, 2008. Stevens CW. Martin, KK. and Stahlheber, B.W., Nocic eptin produces antinocic eption after spinal administration in amphibians. Pharm Biochem Behav 91:436-440, 2009. - Mohan S.K., Davis R.L., Des ilva U. and Stevens C.W., Dual regulation of mu opioid receptors in neuroblastoma cells by morphine and interleukin-Meta: Evidence for opioid-immune crosstalk. Neuroimmunology 227126-34, 2010. Stevens CW. Aravind S., Das S, and Davis R. L., Pharmacological characterization of LPS and opioid interactions at the toll- like receptor 4. Br Pharmacol. 168:1421-1429, 2013. Davis R.L., Das 8., Buck, DJ ., and Stevens C.W., B-funaltrexamine inhibits chemokine(CXCL10) expression in normal human astrocytes. Neurochem. Int. 62:478?485, 2013. Stevens CW. New pathways for an old molecule: the role of the ATPase pump in peripheral neuropathy. Neurol Sci. 3403-4, 2014. Davis, RL., Das, 8., Curtis, .T., Stevens, opioid antagonist, B-funaltrexamine, inhibits NF-KB signaling and chemokine expression in human astrocytes and in mice. Eur Pharmac 01762:193 -201, 2015. 7 Filed: 10122/2019 4:54 PM CST Minnehaha County, South Dakota PRIMARY PUBLICATIONS (Co NT.) 52. Vardy E, Sassano ME, Rennekamp AI, Kroeze WK, Mosier PD, Westkaemper RB, Stevens CW, Katritch V, Stevens RC, Peterson RT, Roth BL. Single amino acid variation underlies spec ies-specific sensitivity to amphibian skin?derived opioid-like peptides. Chem Biol. 22:764-75, 2015. 53. Davis RL, Stevens CW Thomas Curtis J. The opioid antagonist, B-funaltrexarnine, inhibits lipopolysaccharide-induc ed neuroin?ammation and reduces sickness behavior in mice. Physiol Behav. 173 :52-60, 2017. BOOKS, BOOKCHAPTERS, REVIEWS CONFERENCE PROCEEDINGS . 17'. 18. 19. 20. 21. 22. 23. 24. Yaksh, T.L., Durant, P., Onofrio, B. and Stevens, C.W., The effect of spinally administered agents on pain transmission in man and animals. In: Spinal Opioids and the Relief of Pain, lM. Besson and I. Lazorthes (Eds), INSERM127: 317-332, 1984. Yaksh, T.L., Durant, PAC, Gaumann, D.M., Stevens CW. and Mjanger, E, The use of receptor-selective agents as analgesics in the spinal cord: Trends and possibilities. J. Pain Manag. 2: 129-138, 1987. . Stevens CW. and Yaksh, T.L., Opioid and adrenergic spinal receptor systems and pain control, In: Problems of Drug Dependence I 987, Harris, L.S. NIDA Research Monograph, 81: 343-352, 1988. Yaksh, T.L, Durant, P. AC, Monasky, M.S., Stevens CW. and Schick, RR, Spinal pharmacology of agents which alter pain transmission and muscle tone. In: Local?Spinal Therapy of Spasiicity, H. Muller, I. Zierski, R.D. Penn, (Eds), Springer-Verlag, Berlin, pp. 19?36, 1988 Yaksh, T.L., Stevens, C.W., Gaumann, D.M., and Mjanger, E., Receptors in the dorsal horn and intrathec a1 drug administration. In: Neurological applications of implanted drag pumps, Ann. ad. Science 531: 90-107, 1988. Yaksh, T.L. and Stevens, C.W., Properties of the modulation by rec eptor?selective agents of spinal nociceptive processing. In: Proceedings ofthe 5th World Congress of Pain, R. Dubner, G.F. Gebhart, MR. Bond (Eds), Elsevier Science Publishers, Amsterdam, pp. 417?435, 1988. Yaksh, T.L., Mjanger, E., and Stevens, C.W., Pharmacology of the analgesic effects of opioid and non-opioid receptor selective agents in the spinal cord. I. Anest. Reanirn. pp. 221-242, 1988. Stevens, C.W., Opioid antinociception in amphibians, Brain Research Bulletin, 21: 959-962, 1988. Stevens, C. W. and Yaksh, T.L., Opioid dependence after continuous intrathecal infusion of ma and delta opioids in the rat. In: Problems ofDrag Depend. ?88, Harris, L.S., NIDA Res. Mongr. 95 :544-545, 1989. Stevens, C.W., Kajander, KC, Bennett, G.I., and Seybold, V. 8., Differential regulation of opioid binding sites in an experimental model of chronic pain. In: Proceedings of the 6th World Congress of Pain, MR. Bond, IE. Charlton, C.I. Woolf (Eds), Elsevier Science Publishers, Amsterdam, 283u289, 1991. Stevens, C.W., Intraspinal opioids in frogs: a new behavioral model for the assessment of opioid action. In: Problems of Drag Dependence 1990, Harris, L.S., NIDAResearch Monograph 105: 561?562, 1991. Stevens, C.W., Alternatives to the use of mammals for pain research. Life Sciences 50: 901-912, 1992. Adams, I.U., Izenwasser, S., Kramer, T.H., Stevens C.W., Tiseo, Pi, and Unterwald, Tolerance and sensitization to opioids and cocaine. In: Problems of Drag Dependence 1993, Harris, L. 8., NIDA Research Monograph 140: 69-73, 1994. Stevens CW. Environmental factors influenc ing pain physiology in amphibians. In: 38th Annual Conference of theAssociation of Physiologists and Phannacologists oflndia, Mallick, B. N. and Singh, R. (Eds), Narosa Publishing House, New Delhi, pps. 54-61, 1994. Perspectives on opioid tolerance ?om basic res earch: behavioralstudies after spinal administration in Cancer Surveys: Pal liaiiveM edicine Volume 21, Banks, G.W. (Ed),Cold Spring Harbour Laboratory Pres 3, London, pps. 25-47, 1994. Stevens CW. Relative analgesic potency of mu and kappa opioids in amphibians; a unique assay for kappa opioid action? In: Problems of Drag Dependence 994, Harris, L.S., NIDA Res earch Monograph 152: 446, 1995. Stevens C.W., An amphibian model for pain research, Lab Animal: 24: 32-36, 1995. Stevens CW. An amphibian model for the asses sment of opioid analgesia: systemic and spinal studies. Free. International Narcotics Research Conference, Analgesia 1: 766-769, 1995. Retire-Skinner, KS. and Stevens, C.W., Distribution of opioid-expressing neurons in the frog: an in situ hybridization study.Proc. International Narcotics Research Conference, Analgesia 1: 683-686, 1995. Stevens, QW. andPaul, DJ. Opioid analgesia after spinal administration in amphibians: binding andbehavioral studies,In: Problems ofDmg Dependence 1995,Harris, L.S., NIDA Res earch Mon, 162: 222, 1996. Stevens CW. An altemative model for testing opioid analgesics and pain research us ing amphibians, In: van Zutphen, L.F.M., and Balls, M. (eds)Animal Alternatives, Welfare and Ethics, Elsevier Science Publishers, Amsterdam, pp. 247-251, 199? Stevens??, andWillenbring, 8., Pain sensation andanalgesiain amphibians and reptiles, In: The Biology,Husbandry andHealth Care ofRepiiles andAmphibians Vols. LILIH. Ackerrnan, L. T.F.H. Publications, Neptune City, New Jersey, pp. 309-324, 199?. Stevenscw A whole-animal, alternative model for pain research. Animal Welfare Information Center (AWIC) Newsletter, Volume 8: 3-5, 1998. Stevens CW ., An amphibian model for investigation of opioid analgesia and pain-processing. In: Proceedings of the Mayday Conference: A Cross-Species Approachto Pain and Analgesia - 2002, Ludders I .W., et al. (Eds). International Veterinary Information Service, Ithaca NY 2002; P05121202. 8 Filed: 1012212019 4:54 PM CST Minnehaha County, South Dakota 490lV19?002940 BOOKS, BOOK CHAPTERS, REVIEWS CONFERENCE PROCEEDINGS (CONT) 25. 26. 2'7. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 39. 40. 41. 42. 43. Stevens C.W., Opioid research in amphibians: a unique perspective on mechanisms of opioid analgesia and the evolution of opioid receptors.ReviewsinAnalgesia 7: 69?82, 2003. Stevens C.W., Opioid research in amphibians: an altemative pain model yielding insights on the evolution of opioid receptors. Brain Res BrainRes Rev. 46:204-15, 2004. Stexens,C.W., Molecular evolution of vertebrate opioid receptor proteins: a preview. In: RecentDevelopments in Pain Research, 2005,pps. 13?29, Ed. Capasso,A., Research Signpost,Kera1a, India, 2005. Brenner, GM. and Stevens C.W., Pharmacology, 2/e. Pharmacology textbook for medical and health professional students, Saunders/Es evier, PhiladelphiafLondon, March, 2006. Stevens, CW, Opioid analgesia research in amphibians: from behavioral as say to cloning opioid receptor genesProceedings ofthe Annual Conference of the Association ofReptilianandAmphibian Veterinarians 13: 9?15, 2006. Stevens C.W., Non?Mammalian Models forthe Study of Pain, in Sourcebook ojModeis for BiomedicalResearch, Ed. Conn, M, Humana Press,Tovvata, NJ, USA, pp. 341 -352, 2008. Stevens C.W., The evolution ofvertebrate opioid receptors, Frontiers in Bioscience, 14: 1242?1269, 2009. Brenner, GM. and Stevens CW. Phannacology?ie. Pharmacology textbook for medical and health professionalstudents, SaundersiEls evier, Philadelphia/London, February, 2009. Stevens CW. Alternative Models for Pain Research: A Translational, Non-Mammalian Model with anEthical Advantage,in Translational Neuroscience anditsAdvancementof/inimal Research Ethics, pp. 3-27, Eds. Wamick, I .E. andKalueff, AM, Nova Science Publishers,New York, NY, USA, 2010. I Stevens CW. Analgesiain Amphibians: Preclinical Studies and Clinical Applications, Veterinary Clinics of North America: Exotic Animal Practice, 14:33-44, 2011. Stevens CW. (Editor) Methods for the Discovery and Characterization ofG vol. 60, Humana Press, Spring er Science+Bus iness Media, LLC, New York, NY, 2011. Stevens CW. Deciphering the molecular evolution of vertebrate protein?coupled receptors. In Stevens, CW. (Ed) Methodsfor the Discovery and Characterization ofG vol. 60, Humana Press, Spring er Science+Business Media, LLC, New York, NY, 2011. Brenner, GM. and Stevens CW. Phameacology?m edition. Pharmacology textbook for medical and health professionalstudents, Saunders/E15 evier, PhiladelphiatLondon, 2013. Stem-ms, C. W. (Editor) Protein-CoupledReceptor Genetics: Research and Methods in the Post-Genomic Era, Springer Science+Bus iness Media, LLC, New York, NY, 2014. Stevens CW. Protein-Coupled Receptor GeneticsrRes earch and Methods inthe Pos t-Genomic Era. In Stevens,C.W. (Ed) Prote in-ConpledReceptor Genetics: Research andMethods in the Post?Genomic Era, Spring er, New York, NY, 2014. Vardy, 13., Roth, BL, The functional evolution of opioid family protein?coupled receptors. In Stevens, CW. (Ed) Research andMethods in the Post-GenomicEra, Springer, New York, NY, 2014. mm Bio informatics and evolution of vertebrate no ciceptin and opioid receptors. In Litvvack, G. (Ed) Vitamins and Hormones Volume 97, Burlington: Academic Press, 2015. Brenner, GM. and Stevens,C.W., Brenner andStevens?PharrnacoZog, 5th editionPhannacology textbook for medical andhealth . professional students, Saunders [Els evier, Philadelphia/London, 2018. Steyens= CW The Discovery of a Spinal Portal for Pain and Analges ia. In: Farquhar-Smith et al. (Eds) Landmark Papers in Pain, Oxford University Press,Oxford, UK, 2018. Stevens CW. Foreword, In: SoysaNS, Basics in Pharmacology, S. Godage and Brothers, Colombo, Sri Lanka, 2018. 44. Stevens, CW .. The Drug Expert: A Practical Guide to the Impact of Drug Use in Legal Proceedings. Academic Pres s/Els evier, Philadelphia/London, 2019 (in preparation). CO NFERENC ABS IS 1. 2. 3. and Pezalla, P.D., Antinociceptiveactivity of intraspinal morphine and naloxone attenuation in Rana pipiens, Chicago Chapter Soc. Neuroscience, 1983. Stexens, andPezalla, P.D., Dextrorphan analgesia inRana pipiens,Committee onNeuroscience, University of Illinois, 1984. - Pezalla, P.D., Stevens, CW, and Dicig, M., Opioid and non-opioid pain in an amphibian, Chicago Chapter Society for Neuroscience (SFN), 1984. Stevens CW. and Yaksh, T.L., Is intrathecal dynorphinA a kappa ligandin rats? Society for Neuroscience (SFN) Dallas, Texas, Oct. 20-25, 1985. Stevens CW. and Yaksh, T.L., Studies of opiate tolerance in spinal catheterized rats, Society for Neuroscience (SFN) Washington, DC, Nov. 9-14, 1986. and Yaksh, T.L., Time courseof tolerance development in rat spinal cord, American Society of Pharmacology and Experimental Therapeutics Honolulu, HA, 198?. Stevens CW. and Yaksh, T.L., Time courseof tolerance development to antinociceptive agents inrat spinal cord, Society for Neuroscience (SFN), New Orleans, Louisiana, Nov. 16-21, 198?. . Moron, M.A., Yaksh, T.L., and Stevens, ., Further studies on the anticonvulsant activity of nimodipine. Workshop: Pre-clinical Studies with Nimodipine. Miles Pharmaceutical, 1988. Moron, M.A., Yaksh, TL, and Stevens CW. The anti?epileptic activity of eight calcium channel antagonists: mechanism of action. American Society of Pharmacology and Experimental Therapeutics (A SPET) 1988. 9 Filed: 10122/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 Co NFERENCE ABSTRACTS (C ONT.) 10. Moron, M.A., Yaksh, TL, and Stevens CW. Diltiazem enhances and flunarizine suppresses nimodipine's anti-epileptic actions: a 1.. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. re?ection of allos teric binding interactions at the dihydropyridine binding site?, Society for Neuroscience (SEN) Toronto, Canada, Nov. 13?18, 1988. Sabbe,M., Yanez?Gonzalez, A., Stevens C.W., and Yaksh, T.L., Society for Neuroscience (SEN) Toronto, Canada, Nov. 13-18, 1988. Sosnowski, M., Stevens, and Yaksh, T.L., Effects of intrathecal adenos inereceptoragonists on the nociceptive, motor, and bladder function in the rat, Society forNeuroscience (SFN) Toronto, Canada, Nov. 13?18, 1988. Stevens C.W., and Yaksh, T.L., Infusion potency is inversely related to the magnitude of spinal antinociceptive tolerance, Society for Neuroscience (SFN) Toronto,Canada, Nov. 13?18, 1988. Stevens C.W., and Yaksh, T.L., Opioid dependence after continuous intrathecal infusion of mu and delta opioids in the rat. College on Problems of Drug Dependence (CPDD) 1989, Keystone, CO, USA, June19-22, 1989. Stevem?? Kajander, K.C., Bennett, GI, and Seybold, VS, Analysis of mu, delta, and kappa opioidbinding sites in the spinal cord ofrats in a model of neuropathic pain. Society for Neuroscience (SFN) Phoenix, Arizona, Oct. 29?Nov. 3, 1989. Stevens C.W., Kajander, K.C., Bennett, G.J., and Seybold, V.S., Differential regulation of opioid binding sites in the spinal cord of rats in an experimental model of chronic pain. Intemational Association for the Study of Pain (IASP) 1990. Stevens, CW, and Seybold, VS, Distribution of mu, delta, and kappa opioid receptors in rat spinal cord after unilateral dorsal rhizotomy. Society for Neuroscience (SFN) St. Louis, Missouri, Oct. 28-Nov. 2, 1990. Steyens,Q,W., Spinal analgesia in frogs: studies with highly?selective opioid agents.American Society of Pharmacology and Experimental Therapeutics (ASPET), Atlanta, GA, USA, April 21 -25, 1991. Kirkendall, K. and Stevens, C.W., Studies of morphine tolerance in amphibians, Oklahoma Academy of Science AnnualMeeting, Durant, OK, 1991. Stevens, Spinal analgesia in frogs: studies with highly-s elective opioid agents. Society for Neuros cience (SEN) New Orleans Louisiana, Nov. 10-15, 1991. Stevens C.W., Relative potency of systemic opioids and morphine tolerance in an amphibian pain model. Joint meeting of InternationalNarcotics Res. Comm. (INRC) and College on Problems of Drug Dependence (CPDD), Keystone, CO, 1992. Stevens CW, and Klopp, A.J., Opioid analgesia after systemic administration of eight opioid agents in amphibians, Society for Neuroscience (SEN) Anaheim, California, Oct. 25-30, 1992. Mitchell, M.A., Stevens, andKlopp, A.J., Sedative~induced analgesia in a non-mammalian vertebrate pain mode], American Osteopathic As sociation Meeting, San Diego, CA, 1992. Stevens C.W., Brenner, G.M., Deas on, LL, andKlopp, A.J., Studies of opioid and alpha ?2 analgesia and morphine tolerance in amphibians. Inaugural Symposium of the Oklahoma Center for Neuroscience, Oklahoma City, OK, 1992. mm, Studies of morphine tolerance in an amphibian pain model. College on Problems of Drug Dependence (CPDD), Toronto, Canada, 1993. Stevens C.W., Opioid analgesia administration of eight opioid agents in amphibians, 7th World Congress, InternationalAssociation for the Study of Pain (IASP), Paris, France, 1993. Deas on, L.L., Brenner, GM., and Stevens CW. Alphaz-analgesia after systemic administration of adrenergic agents in amphibians, Society for Neuroscience (SFN) Washington,DC, Nov. 7-12, 1993. Stevens?? ., Deas on, LL, and Brenner, G.M., Analgesic action of intraspinal adrenergic agents in amphibians, Society for Neuroscience (SFN) Washington,DC, Nov. 7-12, 1993. Stevens CW. Brenner, G.M., Analgesic action of opioid and adrenergic agents in amphibians. American Society of Pharmacology and Experimental Therapeutics (ASPET), 1994. Stevens, ., Relative analgesic potency of mu and kappa opioids in amphibians: a unique assay for kappa opioid action?, College on Problems of Drug Dependence (CPDD), Palm Beach, FL, 1994. Stevens C.W., Studies of dynorphin and kappa opioid agents after spinal administration in amphibians, Society for Neuros cience (SFN) Miami Beach, Florida, Nov. 13-18, 1994. RotheQSkirmer, K. S. and Stevens, C.W., Dynorphin expression in amphibian brain and spinal cord: in situ hybridization studies, Society for Neuroscience (SEN) Miami Beach, Florida, Nov. 13?18, 1994. Stevens, Analgesic action of spinal rm, delta, and kappa opioids in amphibians. American Society of Pharmacology and Experimental Therapeutics (A SPET), Atlanta, GA, USA, 1995 Stevens CW. andPaul, D.J. Opioid analgesia after spinal administration in amphibians: binding andbehavioral studies,Colleg on Problems of Drug Dependence (CPDD), Seotts dale, AZ, 1995. Stevens CW. An amphibian model for the ass essment of opioid analgesia: systemic and spinal studies.lnternationalNarcotics Research Committee (JNRC) St. Andrews, Scotland, UK, July 8?13, 1995. Rothe-Skinner, KS. and Stevens, CW ., Distribution of opioid?expressing neurons in the frog: an in situ hybridization study IntemationalNarcotics Research Committee St. Andrews, Scotland, UK, July 8-13, 1995. Willenbring, BS. and Stevens CW. Somatic hypersensitivity following peripheral nerve injury in frogs: a novel model for studying neuropathic pain, American Pain Society (APS) San Diego, California, Nov. 8-11, 1995. Willenbr'ing, BS. and Stevens, cw, Effects of morphine or nerve injury onmechanical and chemical responsethresholds in frogs, Society for Neuroscience (SFN) San Diego, California, Nov. 11-16, 1995. Stevens CW. and Brenner, Studies of opioid and alphaz analges ia after spinal administration in amphibians Society for Neuroscience (SFN) San Diego, California, Nov. 11-16, 1995. Rothe-Skinner, KS. and Stevens CW. Analgesia produced by intracerebroventricular injection of morphine in amphibians, College on Problems of Drug Dependence (CPDD), San Juan, Puerto Rico, 1996. 10 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota CO NFERENC ABS TRAC TS (C ONT.) 41. 42. 43. 44. 45. 46. 4756. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. 67. 68. 69. 70. 71. 72. 73. 74. Stevens C.W., Deas on, L., and Rothe -Skinner, K.S., Analgesia after icv injection of mu, delta, and kappa opioids in amphibians. InternationalNarcotics Research Conference (INRC), Long Beach, CA, July, 1996. Stevens, C, 3131,, An alternative model for the testing of opioids and pain research using amphibians. 2nd World Congress on Animal Alternativ es and Use in the Life Sciences, Utrecht, Netherlands, October, 1996. Stevens CW. and Deason, L.L., Seasonal variation in analgesic thresholds to morphine and melatonin analgesia in amphibians, Society for Neuroscience (SFN) Washington, DC, Nov. 16-21, 1996. Willenbring, S. and Stevens C.W Spinal opioid pharmacology inthe ?og. chemical, thermal and mechanical sensitivities, Society for Neuroscience (SFN) Washington, DC, Nov. 16-21, 1996. Steyens, CW, and Newman, L.C., Studies of selective mu opioid antagonism a?er spinal administration of amphibians, College on Problems of Drug Dependence (CPDD) Nashville, TN, June, 12-18, 1997. Hamamoto, D.T .,Wi11enbring, S., Stevens, C.W., and Kajander, K.C., Changes in tissue pH and responses of cutaneous receptors to acetic acid app licationin the frog. Society for Neuroscience (SFN) New Orleans, Louisiana, Oct. 25-3 0, 1997. Willenbring, S. and Stevens, Gly cinergic mechanisms in amphibian peripheral sensitivity. Society for Neuroscience (SFN) New Orleans, Louisiana, Oct. 25-30, 1997. Steyens, CE, and Newman, L.C., Selective opioid antagonists and spinal opioid analgesia in amphibians. Society for Neuroscience (SFN) New Orleans, LA, October 27-Nov. 1, 1997. Stevens CW. and Newman, L.C., The unireceptor hypothesis of op ioid antinociception in amphibians. American Society of Pharmacology and Experimental Therapeutics (ASPET), San Francisco, April, 1998. Newman, L.C., and DR Wallace, The unirecept or hypothesis of opioid antinociceptionin amphibians: Implications for the functional evolution of opioid receptors. International Narcotics Research Conference (INRC) Germany, July 1998. Stevens CW. and Newman, L.C., Evolution of opioid receptors: the unireceptor hypothesis of opioid antinociception in amphibians, International Union of?PharrnacoIogy (IUPHAR) Munich, Germany, July, 1998. .. Stevens CW. and Newman, L.C., The unireceptor othesis of opioid antinociception in amphibians, Society for Neuroscience (SFN) Los Angeles, CA, November 7-12, 1998. Newman, L.C., and Wallace D.R., Binding and behavioral studies of the opioid unirecep tor in amphibians, International Narcotics Research Conference (INRC) Saratoga Springs, NY, July 10-15, 1999. Stevens, CW. and Newman, L.C., The unireceptor hypothesis of opioid antinociception in amphibians: behavioral studies, Society for Neuroscience (SFN) Miami Beach, FL, October 23 -28, 1999. Newman, L.C., Wallabe, .R., and Stevens, C.W., The unirecep tor othesis of opioid antinocicep tion in amphibians: binding studies, Society for Neuroscience (SFN) Miami Beach, FL, October 23-28, 1999. Stevens, C.W., Maciver D., and Newman, L.C., Testing and comparison of non-opioid analgesics in amphibians, American College of Laboratory Animal edicine (ACLAM) Fort Myers, FL, ay 21-24, 2000. Stevens, C.W., Newman, L.C., Wallace, D.R., From pain: From pondtopain: Amphibian opioid unireceptors and speculations on the divergence of mammalian mu, kappa, and delta opioid receptor types, Committee on Problems of Drug Dep endence (CPDD) San Juan, Puerto Rico, June 17?22, 2000. Stevens, C.W., Newman, L.C., and Wallace, D.R., Mu, kappa, and delta opioid radioligand binding in amphibian brain, International Narcotics Research Conference (INRC) Seattle, WA, July 15-20, 2000. Stevens, C.W., Newman, L.C., and Wallace, D.R., Amphibian opioid receptors: characterization of mu, kappa, and delta opioid ligand binding, Society for Neuroscience New Orleans, LA, November 4-9, 2000. Stevens, C.W., Newman, L.C., and Wallace, D.R., Opioid receptors in amphibian brain: radioljgand binding studies, American Society of Pharmacology and Experimental Therapeutics (ASPET) Orlando, FL, March 30-Ap1il4, 2001. Sands, S. 3., Wallace, D.R., and Stevens, C.W., Chronic opioid agonist regulation of a novel opioid receptor in amphibians, lntemational Narcotics Research Conference (INRC) Helsinld, Finland, July 14-20, 2001. Sands, S.S., Wallace, D.R., and Stevens C.W., Chronic morphine regulation of opioid receptors in amphibian brain, Society for Neuroscience (SFN) San Diego, CA, November 10-15, 2001 Stevens CW. and CM. Brasel, Cloning of an arm opioid-like receptor in an amphibian, Rana pipiens, Committee on Problems of Drug Dependence (CPDD) Quebec City, Canada, June 8-13, 2002. Sands, S. S. and Steyens, CAM, Characterization of opioid receptortyp es in amphibian spinal cord, International Narcotics Research Conference (INRC) Pacific Grove, CA, July 9-14, 2002. Stevens CW. and CM . Brasel, Sequence and homology of a mu opioid-like receptorin an amphibian, International Narcotics Research Conference (INRC) Paci?c Grove, CA, July 9?14, 2002. Martin, K. K. and W, Nociceptin analgesia after spinal administration in amphibians, Society for Neuroscience (SFN) Orlando, FL, November 2-7, 2002. Stevens, CW, and CM. Brasel, Cloning and homology of a mu opioid-like receptor ?om amphibian brain tissue, Society for Neuroscience (SEN) Orlando, FL, November 2-7, 2002. Stevens CW. and C.M.Brase1, Evolution of opioidreceptors: insights from the cloning of opioid-like receptors in amphibians, American Society of Pharmacology and Experimental Therapeutics (ASPET), San Diego, CA, April 11-15, 2003. CM . Brasel and Cloning and homology of an ORLl/nociceptin-like receptor ?om amphibian brain and spinal cord, International Narcotics Research Conference (INRC) Perpignan, France, July 6-11, 2003. and CM . Brasel, Cloning of opioid-like receptors in amphibians: insights on the evolution of opioid receptors, International Narcotics Research Conference (INRC) Perpignan, France, July 6-11, 2003. artin, K.K. and Stevens C.W., Nociceptin analgesia after spinal administration in amphibians, Society for Neuroscience (SFN) New Orleans, LA, November 8-12, 2003. CM. Brasel and Cloning and homology of an ORLI/nociceptin?like receptor from amphibian brain and spinal cord, Society for Neuroscience (SFN) New Orleans, LA, November 8?12, 2003. Stevens, CW. and CM. Brasel, Cloning of opioid-like receptors in amphibians: insights on the evolution of opioid receptors, Society for - Neuroscience (SFN) New Orleans, LA, November 8?12, 2003. - Stevens C.W. Opioid research in amphibians; an alternative pain model yielding insights on the evolution of opioid receptors, British Society for Experimental Biology (SEB) Edinburgh, Scotland, April2-5, 2004. 11 Filed: 1012212019 4:54 PM CST Minnehaha County, South Dakota 490lV19?002940 CONFERENCE ABSTRACTS (0 our.) 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. 89. 90. 91. 92. 93. 94. 95. 96. 97. 98. 99. 100. 101. 102. 103. 104. 105. 106. 107. 108. 109. 110. Stevens CW. Opioid research in amphibians: behavioral and molecular studies on the evolution of opioid receptors, Europ ean Opioid Conference (EOC) Visegrad, Hungary, April 6-9, 2004. CM. Brasel, K.K. artin, and Stevens CW. An amphibian ORLI receptor sugests pattern of vertebrate opioid receptor evolution, International Narcotics Research Conference (INRC), Kyoto, Japan, July 1823,2004. Stevens, CW. and CM, Brasel, Molecular evolution of vertebrate opioid receptors: the amphibian contribution, International Narcotics Research Conference (INRC), Kyoto, lapan,July 18-23, 2004. CM. Brasel and Stevens CW. Phylogenetic analysis vertebrate opioid receptors, Society for Neuroscience (SFN) San Diego, CA, Oct. 23-27, 200 4. Stevens CW. Opioid receptors in vertebrates: evolution of ligand type-selectivity, American Society of Phannacology and Experimental Therapeutics (ASPET) San Diego, CA, April 1-6, 2005. Stevms, CW. and T. B. Summers, From one to four: gene duplications and the evolution of mu, delta, and kappa e-selectivity of vert ebrate opioid receptors, International Narcotics Research Conference (IN RC) Annapolis, MD, July 10-15, 2005. Mohan, SK. and Stevens, C.W., Studies of remifentanil in amphibians. Society for Neuroscience (SFN) Washington DC,Novernber 12?16, 2005. Brasel, CM . and Stevens CW. Opioid receptors in vertebrates: evolution of ligand e-selectivity. Society for Neuroscience (SFN) Washington DC, November 12?16, 2005. Davis, R.L., Buck, D.J., Saffarian, N., and Stevens, CW, The opioid antagonist, [l-funaltreiarnine, inhibits chemokine expression in human astroglial cells. International Narcotics Research Conference (INRC) St. Paul, MN, July 9-14, 2006. . Brasel, CM. and Stevens, Comparison of OR op ioid receptors from amphibians and humans, Society for Neuroscience (SFN) Atlanta, GA, November 12?16, 2006. Davis, R.L., Buck, Saffarian, N., and Stevens C.W., Inhibition of chemokine expressionin human astroglial cells by the opioidreceptor antagonist B-FNA, Society for Neuroscience (SFN) Atlanta, GA, November 12?16, 2006. - Mohan, SK, Davis, R. L. and ?evens, Human mu opioidreceptor-l expression in cells after IL-lbeta treatment, Society for Neuroimmune Pharmacology Salt Lake City,UT, April 1 1?14, 2007. Savvy er, G.W., Stevens, C.W., and Brasel, CM, Pharmacological comparison of human and ?og mu opioid receptors. Committee on Problems of Drug Dependence (CPDD) Quebec City, Canada, June 16-21, 2007. Sawyer, G.W., Stevens, CW, and Brasel, CM, Pharmacological comparison of human and frog OR. International Narcotics Research Conference (INRC) Berlin, Germany, July 8-13, 2007. Mohan, SK. and ?eyens, CW, Opioid receptors in the chick, Callus galius. Society for Neuroscience (SFN) San Diego, CA, November 3-7, 2007. Brasel, CM ., Sawyer,G.W., and Stevens, C.W., Pharmacological comparison of human and frog mu opioid receptors: differences in receptor internalization. Society for Neuroscience (SFN) San Diego, CA, November 3-7, 2007. Stevens CW. Brasel, CM ., and GW. Savvy er, Characterization of receptor internalization and inhibition of 0AM in cell lines expressing amphibian or human mu opioid receptors. American Society of Pharmacology and Experimental Therapeutics (ASPET) San Diego, CA, U.S.A., April 5-9, 2008. Mohan, SK, Fernando, S.C., DeSilva, U., Davis, R.L. and Steyens, Q, E, Signaling pathwaysinvolved in IL-lB-induced regulation of hM OR expression in neurons, International Congress of Neuroimmunology, 2008 Stevens, C.W., C. M. Brasel, and G.W. Savvy er, Comparison of amphibian and human mu opioid receptors: differences in receptor internaliz ation and inhibition of CAMP in stable cell lines. Committee on Problems of Drug Dependence (CPDD) San Juan, Puerto Rico June 14-19, 2008. Evolution of opioid receptors: why the mu opioid receptor would make Darwin proud. International Narcotics Research Conference (INRC) Charleston, SC, USA, July 13-18, 2008. ohan, S.K., Fernando, S.C., DeSilva, U., Davis, R.L. and Stgens, Molecular signals responsible for IL-lbeta effects on hM OR. expression in SK-N-SH cells: potential targets for opioid tolerance treatment? Society for Neuroscience (SFN) Washington DC, USA, November 15-19, 2008. Stevens, C.W., Evolution of opioid receptors: Why the ma opioid receptor would make Darwin proud. Society for Neuroscience (SFN) Washington DC, USA, November 15-19, 2008. Davis, R.L., Buck, D.R., Saffarian, N.,Mohan, S.K., Fernando, S.C., DeSilva, U. and B-Funaltrexamine inhibits in?ammatory signaling in human astrogiial cells. Society for Neuroscience, (SFN) Washington DC, USA, November 15-19, 2008. Davis, R.L., Buck, D.R., Sa?'arian, N.,Mohan, S.K., Fernando, S.C., DeSilva, U. and CW. Stevens, B-Funaltrexamine inhibits in?ammatory signaling in human astroglial cells. Glial Biology in edicine, 2008 Stevens, C.W., Evolution of opioid receptors. American Association for the Advancement of Science-Sothvvestern Regional eeting OK,March28-31, 2009. Davis, R.L., Buck, DR, Saffarian, N., and Steyens, Novel anti-in?ammatory actions of the opioid receptor antagonist, beta- funaltrexamine. International Society for NeuroVirology, 2009. Stevens, C.W., Evolution of vertebrate opioid receptors: evidence from cloning and bioinformatics. Experimental Biology -American Society for Pharmacology and Experimental Therapeutics (ASPET), New Orleans, LA, USA, April 18-22, 2009. Stevens, C.W., The special case of the mu opioid receptor and the evolution of the opioid receptor family. Committee on Problems of Drug Dependence (CPDD), Reno, NV, USA. June 20-25, 2009. Brasel, CM ., Sawyer, G.W., and Pharmacological comparison of the cloned frog and human mu opioid receptors reveals differences in opioid af?nity and function, International Narcotics Research Conference (INRC) Portland, OR, USA, July 12-17, 20 09. Davis, R.L., Buck, D.J., D.J., Saffarian, N., and Stevens CW. B?Funaltrexamine, an opioid receptor antagonist, inhibits CCL2 and CXCLIO expression in astroglial, Society for Neuroscience (SEN), Chicago, IL, October 16-21, 2009. Davis, R.L., Buck, D.J.,Aravind S., Saffarian N., and Stevens C.W., Anti-in?ammatory actions of the opioid receptor antagonist, B-?rnaltrexamine: . implications in neuroin?ammation. Society on Pharmacology (SNIP), anhattan Beach, CA, April 13?17, 2010. Steygs, C, W, Aravind, S., and BL. Davis, The selective mu opioid antagonist B-funaltrexamine (B-PNA) reduces toll-like receptor-4 signaling. Experimental Biology-American Society for Pharmacology and Experimental Therapeutics (ASPET) Anaheim, April 23-28, 2010. Grewe, E., Buck, D.J ., Aravind, S., Stevens CW. and R.L. Davis, Anti-in?ammatory actions of the opioid receptor antagonist, B-?rnaltrexamine: role of LR-4 and International osium on NeuroVrrology, Milan, Italy, October 10, 2010. Davis, R.L., Buck, D.J.,Aravind, S., and Stevens opioid receptor antagonist, B-funaltrexamine, inhibits in?arrunatory signaling. Society for Neuroscience (SFN), San Diego, CA, November 12-17, 2010. Stevens, Aravind, S., and RI. Davis, Opioid agonists and antagonists alter toll-like receptor-4 (TLR4) signaling Society for Neuroscience (SFN), San Diego, CA, November 12-17, 2010. Stevens CW. Novel opioid effects on toll-like receptors,Annual OCAST Health Research Conference, Oklahoma City, OK, April 6, 2011. 12 Filed: 10122l2019 4:54 PM CST Minnehaha County, South Dakota CONFERENCE ABS (C ONT.) 111. Stevens CW. Novel opioid effects ontoll-like receptors,Annual OCAST Health Research Conference, Oklahoma City,OK,Ap1ii 4, 2012. 112. Dodson, S., Castoro, K, Das, S., Davis, R.L., and Stevens C.W., Characterization of non-classical opioid activity at toll-like Receptor 4, International Narcotics Research Conference (INRC), July 15-20, 2012, Kansas City, MO, USA. 113. Vardy, E., Stevgrs, CW, and Roth, B.L., Evolutionary differences of opioid receptors are re?ected in their pharmacological pro?les, International Narcotics Research Conference (INRC), July 15-20, 2012, Kansas City, 114. Figueroa?Hall, L.K., Das, 8., Buck, DJ ., Stevens (1W, Davis, R.L., B-Funaltrexamine inhibits and TLR4-signaling pathways inhuman giial cells. Society for Neuroscience, New Orleans, LA, USA, Oct 13-17, 2012. 115. Stevens C.W., Novel opioid effects on toll-like receptors, Annual OCAST Health Research Conference, Oklahoma City, OK, March 1 3, 2013. 116. Dodson, 8., Das S., Davis, R.L., and Stevgrs, CW, The in?uence of methadone on toll-like receptor 4 and human mu opioid receptor expression. Experimental Biology-American Society for Pharmacology and Experimental Therapeutics (ASPET) Boston MA, USA, April 20?24, 2013. 11?. Stevens C.W., Castoro, R.J., and Davis, R.L., Opioid-immune crosstalk: role of microRNA regulation following opioid and cytokine treatment in normal human astrocytes. Experimental Biology-American Society for Pharmacology and Experimental Therapeutics (ASPET) April 20-24, 2013. 118. Figueroa-Hall, L.K., Das, 8., Buck, D.J., Stevens C.W., Davis, R.L., Investigating TLR4-signaling mechanisms in CHM E-S human microglial cells and the effects of B-?maltremmine treatment. American Association of Immunologists, Honolulu, May 3-7, 2013. 13 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 4SCIV19-002940 STATE OF SOUTH DAKOTA IN CIRCUIT COURT COUNTY OF SECOND JUDICIAL CIRCUIT CHARLES RUSSELL RHINES, CW. 19- Plaintiff, THIS IS A CAPITAL CASE EXECUTION SET FOR BETWEEN NOVEMBER 3, SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, MIKE LEIDHOLT, SECRETARY, SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, DARIN YOUNG IN HIS CAPACITY AS WARDEN OF THE SOUTH DAKOTA STATE PENITENTIARY, and JASON R. RAVNSBORG IN HIS CAPACITY AS THE ATTORNEY GENERAL FOR THE STATE OF SOUTH DAKOTA, 2019 AND NOVEMBER 9, 2.019 Defendants. AFFIDAVIT OF DANIEL R. STATE OF SOUTH DAKOTA COUNTY OF MINNEHAHA 335 Daniel R. Fritz, being ?rst duly sworn on oath, states and alleges as follows: 1. I am an attorney for Plaintiff Charles Russell Rhine-s in the above-captioned case, and I have knowledge of the matters herein. 2. Attached hereto to as Exhibit 1 is a true and correct copy of a Complaint, with exhibits, ?led by Charles Russell Rhines (?Rhines?) seeking injunctive and declaratory relief directing Defendants South Dakota Department of Corrections Mike Leidholt, Secretary of the DOC, Darin Young, in his capacity as warden of the South Dakota State Penitentiary, and Jason R. Ravnsborg, in his capacity as the Attorney General for the State of South Dakota Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota (collectively, ?Defcndants?) to execute Rhines in accordance with South Dakota Codi?ed Law, to wit, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical praCtice.? SL 1984, ch 181, codi?ed at SDCL (1984). 3. Attached hereto as Exhibit 2 is a true and correct copy of Harwood Nuss? Clinical Practice of Emergency Medicine, 6th Ed. CH3 which can be found at on Westlaw CH307. 4. Attached hereto as Exhibit 3 is a true and correCt copy of selected pages from Guide to Drug Abuse Research Terminology, Nelson, Jack National Institute on Drug Abuse, (1982). 5. Attached hereto as Exhibit 4 is a true and correct copy of the manufacturer?s package insert provided for Nembutal Sodium Solution, which can be located at -501- 20. Dated this 22"" day of October, 2019. sameness Subscribed and sworn to before me this 22"d day of October, 2019 ?g (SEAL) Ejn?ubg ?South bakota oComer Expires?m JUDY L. DECKER Notary Public: SEAL South Dakota Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 STATE OF SOUTH DAKOTA COUNTY OF MINNEHAHA IN CIRCUIT COURT SECOND JUDICIAL CIRCUIT CHARLES RUSSELL RHINES, Plaintiff, V. SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, MIKE LEIDHOLT, SECRETARY, SOUTH DAKOTA DEPARTMENT OF CORRECTIONS, DARIN YOUNG IN HIS CAPACITY AS WARDEN OF THE SOUTH DAKOTA STATE PENITENTIARY, and JASON R. RAVNSBORG IN HIS CAPACITY AS THE ATTORNEY GENERAL FOR THE STATE OF SOUTH DAKOTA, Defendants. CIV. 19- THIS IS A CAPITAL CASE EXECUTION SET FOR BETWEEN NOVENIBER 3, 2019 AND NOVEMBER 9, 2019 COMPLAINT COMES NOW PLAINTIFF, and for his Complaint against Defendants, states and alleges as follows: INTRODUCTION 1. This is a Complaint seeking injunctive and declaratory relief directing Defendants South Dakota Department of Corrections Mike Leidholt, Secretary of the DOC, Darin Young, in his capacity as warden of the South Dakota State Penitentiary, and Jason R. Ravnsborg, in his capacity as the Attorney General for the State of South Dakota (collectively, ?Defendants?) to execute Plaintiff Charles Russell Rhines (?Rhines?) in accordance with South Dakota Codi?ed Law, to wit, ?by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 496lV19-002940 is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL (1984). 2. Rhines is a prisoner sentenced to death by the State of South Dakota on January 29, 1993. . 3. Rhines?s execution week is November 3, 2019 through November 9, 2019. 4. SDCL provides in pertinent part that ?Any person convicted of a capital offense or sentenced to death prior to July 1, 2007 may choose to be executed in the manner provided in 23 A-27A-32 or in the manner provided by South Dakota law at the time of the person?s conviction or sentence. The person shall choose by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen.? SDCL 23A- 5. At the time that Rhines was convicted and sentenced, South Dakota law provided, in pertinent part, that: ?The punishment of death shall be in?icted by the intravenous administration of a lethal quantity of an ultra?short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL 23A- (1984). 6. In enacting SDCL 23A-27A-32. l, the State of South Dakota created a statutory right that entitles Rhines to be executed in the manner provided by South Dakota law at the time of Rhines?s conviction or sentence if he chooses that manner. i 7. The State, in enacting SDCL also created life and liberty interests entitling Rhines to the same. Rhines?s life and liberty interest is protected by the Due Process Clause Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota of the Fourteenth Amendment of the United States Constitution and the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. 8. In a Kite-Request Slip dated October 1, 2019, addressed to Defendant Young, Rhines chose to be executed in the manner that was in effect at the time that he was sentenced to death. 9. In an amended Kite-Request Slip dated October 4, 2019, addressed to Defendant Young, Rhinos chose to be executed in the manner that was in effect at the time that he was sentenced to death, to wit, ?[t]he Two Drug Protocol of a Lethal Dose of An Ultra-Short Acting Barbiturate and a Chemical Paralytic.? 10. On October 15, 2019, attorneys for Rhines, emailed and mailed a letter to Defendants Young and Ravnsborg, and Paul Swedlund, Assistant Attorney General in the Office of the Defendant Attorney General, requesting, among other things, con?rmation that Rhines?s request to be executed by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent would be honored. 11. In a letter dated October 17, 2019, Assistant Attorney General Swedlund advised counsel that he had received ?Mr. Rhines? request for execution pursuant to the combination of drugs provided by statute at the time of his execution.? Mr. Swedlund noted that will follow the law.? Mr. Swedlund further informed counsel that ?[t]he ultra-short-acting barbiturate the state intends to use is pentobarbital.? 12. Upon information and belief, pentobarbital is not an ultra-short-acting barbiturate. 13. Numerous courts have held that pentobarbital is not an ultra-short-acting barbiturate. See, 9.3., Smith 12. Montana, No. 2015 WL 5827252 (Mont. Dist. Ct. Lewis and Clark County Oct. 6, 2015) (unpublished) (attached hereto as Exhibit A) (?This Court rules that pentobarbital is not an ultra-fast-acting barbiturate. The State of Montana will either need to select a Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota - 490lV19-002940 barbiturate that is ultra-fast acting to accomplish the execution of Plaintiffs or it will need to modify its statute?) 14. Medical journals provide that pentobarbital is not an ultra-short-acting barbiturate. 15. Defendants? decision to used pentobarbital, contrary to South Dakota law, deprives Rhines of his statutory right to be executed in the manner of his choice. It also deprives Rhines of his life and liberty interests in being executed in the manner of his choice without due process of law guaranteed under the Due Process Clause of the Fourteenth Amendment of the United States Constitution and the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. 16. Rhines?s execution week is a mere two weeks away. Thus, Rhines brings this action for injunctive and declaratory relief to enforce his right under South Dakota law to be executed by the manner he chose, intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent, and not by pentobarbital which is neither an ultra-short-acting barbiturate nor a chemical paralytic agent. PARTIE 17. Plaintiff Rhines is a United States citizen and a resident of the State of South Dakota. He is currently a condemned inmate in the custody of Defendants and under the supervision of the DOC in Sioux Falls, South Dakota. 18. Defendant South Dakota Department of Corrections is an agency of the State of South Dakota. The DOC is responsible for all prisons in the State of South Dakota, for the custody and treatment of death-sentenced inmates, and for the execution of such imnates. 19. Defendant Mike Leidholt is the Secretary of the DOC and is sued in his of?cial capacity. 20. Defendant Darin Young is the Warden of the South Dakota State Penitentiary and is sued in his of?cial capacity. Filed: 10(2212019 4:54 PM CST Minnehaha County, South Dakota 21. Defendant Jason R. Ravnsborg is the Attorney General for the State of South Dakota and is sued in his official capacity. JURISDICTION AND VENUE 22. This Court has jurisdiction to adjudicate this action under the South Dakota Uniform Declaratory Judgments Act, SDCL 21-24-1 et seq. 23. Venue in this Court is proper under SDCL which provides that an action against a public of?cer shall be brought in the county where the cause, or some part thereof, arose. The injury to Plaintiff because of Defendants? illegal actions has occurred and will occur in the County of Minnehaha and, as such, venue is proper in this Court. I FACTS 24. Rhines was sentenced to death on January 29, 1993. 25. On June 25, 2019, Judge Robert Mandel granted a warrant of execution, which sets . fonh that Rhines shall be executed between November 3 and November 9, 2019. 26. SDCL provides that: Any person convicted of a capital offense or sentenced to death prior to July 1, 2007 may choose to be executed in the manner provided in 23 or in the manner provided by South Dakota law at the time of the person ?s conviction or sentence. The person shall choose by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen. Ifthe person fails or refuses to choose in the time provided under this section, then the person shall be executed as provided in . SDCL (emphasis added). 27. At the time that Rhines was convicted and sentenced, in 1993, South Dakota law provided, in pertinent part, that, ?The punishment of death shall be in?icted by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 5 . Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 28. In 2007, the South Dakota Legislature amended the law as follows: SOUTH DAKOTA 2007 SESSION LAWS 2007 REGULAR SESSION OF THE BEND LEGISLATURE Additions are indicated by Text; deletions by diet . Changes in tables are made but not highlighted. Ch. 15! 1175] West?s No. lOl CAPITAL FOR AN ACT ENTITLED. An Act to provide for the substances used in the execution of a sentence of death and to allow the choice of the substances used in an execution under certain circumstances. BE IT ENACTED BY THE LEGISLATURE OF THE STATE-30F SOUTH DAKOTA: Section I. That 23A-27A-32 be amended to read as follows: or: so at camera?32 The punishment of death shall be in?icted within the walls of some building at the state imidhi .. v' 2 mcpn?imnl ?rm?lsmu Rim a -. t: . tr. intravenous injection ofn substance or substances or a lethal quantit . The warden. subject to the approval of the annular}! of corrections. shall determine the substances and the quantity of substances used for the punishment ot?denth. An execution carried out by ietind intravenous htjection shall be by a personaeiccheel-brtbe sentiment} trained to administer the injection who is selected by the warden and approved by the secretary of corrections. The person administering the intravenous injection need not he a physician. registered nurse. or licensed practical nurse. or other medical professional licensed or registered under the laws or this or any other state. Any in?iction of the punishment ofdenth by intravenous injection of a substance or substances in the manner required by this section may not be construed to be the practice of medidne-undm . Any phannaciat or pharmaceutical supplier isnulhoriacd to dispense the drugs Imbalance or substances used to in?ict the punislunent ordealh to the warden without prescription. for carrying out the provisions of this section. notwithstanding any other provision of law. Section 2. That chapter ILA-27A be amended by adding thereto a NEW SECTION to read as follows: Any person convicted of a capital offense or sentenced to death prior to the effective date of this Act may choose to he executed in the manner provided in this Act or in the manner provided by South Dakota law at the time of the person's conviction or sentence. The person shall choose by indicating in writing to the warden not less than seven days prior to the scheduled week of execution the manner of execution chosen. If the person fails or refuses to choose in the time provided under this section. then the person shall be executed as provided in section 1 of this Act. . in: Approval Fehntary 23. 2007. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 496lV19-002940 29. In 2008, the South Dakota Legislature further amended the law as follows: SOUTH DAKOTA 2008 SESSION LAWS 2008 REGULAR SESSION OF THE 8312]] LEGISLATURE Additions are indicated by Text; deletions by irate! . Changes in tables are made but not highlighted. Ch. 117 (so 53) West's No. 244 CAPITAL TS FOR AN ACT ENTITLED. An Act to reVise certain provisions related to capital punishment. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: so at ran?279.42 s> The punishment of death shall be in?icted within the walls of some building at the state penitentiary. The punishment of death shall be in?icted by the intravenous injection of a substance or substances in a lethal quantity. The warden. subject to the approval of the secretary of corrections. shall determine the substances and the quantity of substances used for the punishment of death. Au execution carried out by intravenous injection shall be performed by n?person persons trained to administer the injection who is are selected by the warden and approved by the secretary of corrections. The person persons administering the intravenous injection need not be ephysieian physicians, registered nurse nurses, licensed practical nurse nurses. or other medical professionai professionals licensed or registered under the laws of this or any other state. Any in?iction of the punishment of death by intravenous injection of a substance or substances in the manner required by this section may not be construed to be the practice of medicine. Any pharmacist or pharmaceutical supplier is authorized to dispense to the warden the substance or substances used to in?ict the punishment of death reside?warden without prescription, for carrying out the provisions of this section, nonvithstanding any other provision of law. -- 30. In a Kite-Request Slip dated October 1, 2019, addressed to Defendant Young, Rhinos pursuant to SDCL 23A-27A-32J, elected the method of execution that was in effect at the time that he was sentenced to death. (A true and correct copy of the October 1, 2019 Kite-Request Slip is attached hereto as Exhibit B.) 31. In an amended Kite-Request Slip dated October 4, 2019, addressed to Defendant Young, Rhines elected the method of execution that was in effect at the time that he was sentenced to death, to wit, ?[t]he Two Drug Protocol of a Lethal Dose of An Ultra-Short Acting Barbiturate and ?7 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940- a Chemical Paralytic.? (A true and correct copy of the October 4, 2019 Kite-Request Slip is attached hereto as Exhibit C.) 32. As of October 15, 2019, Defendant Young had not responded to Rhines?s Kite- Request Slips. On October 15, 2019, attorneys for Rhines, emailed and mailed a letter to Defendant Young, Defendant Ravnsborg, and Paul Swedlund, Assistant Attorney General in the office of the Attorney General, requesting, among other things, con?rmation that Rhines?s request to be executed by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent would be honored. (A true and correct copy of the October 15, 2019 letter is attached hereto as Exhibit D.) 33. . Rhines?s attorneys also requested that the Defendants identify which ultra-short-acting barbiturates will be used to execute Mr. Rhines. (Id) 34. On October 17, 2019, Mr. Swedlund, from the of?ce of Defendant Young, emailed attorneys for Rhines a letter stating, am in receipt of your letter regarding Mr. Rhines' request for execution pursuant to the combination of drugs provided by statute at the time of his execution. The DOC will follow the law. The ultra-short-acting barbiturate the state intends to use is pentobarbital.? (A true and correct copy of the October 17, 2019 letter is attached hereto as Exhibit E.) 35. Upon information and belief, ultra-short-acting barbiturates include sodium methohexital and sodium thiopental. 36. Upon information and belief, pentobarbital is not an ultra-short?acting barbiturate. Nor is it a chemical paralytic agent. 37. Defendants intend to execute Mr. Rhines, in contravention of his statutory right to elect the method of his execution, with pentobarbital, a drug that is not an ultra-short-acting barbiturate. Pentobarbital is not a chemical paralytic agent either. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 First Cause of Action?Violation of the Right to Choose the Manner of Execution Provided by Law at the Time of Sentence (Against All Defendants) 38. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 39. In enacting SDCL 23A-27A-32. 1, the State of South Dakota created and codi?ed a state statutory right that entitles Rhines to be executed in the manner provided by South Dakota law at the time of the Rhines ?s conviction or sentence. Defendants have a corresponding duty to ensure Rhines can exercise this right. 40. The manner of execution provided by South Dakota law at the time of Rhines?s conviction and sentence was, in relevant part, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician accordingto accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL 23A-27A-32 (1984). 41. SL 1984, ch 181 created a right to an execution ?by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch. 181, codi?ed at SDCL 23A- (1984). 42. Rhines has a right to execution ?by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? Id. 43. Rhines?s right to be executed in the manner set forth in SL 1984, ch 181 is codi?ed and protected by SDCL Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 44. Rhines has exercised his right to choose the manner set forth in SL 1984, ch 181. Rhines has done so in accordance with the provisions of SDCL 23A-27A-32. 1. 45. Defendants cannot deprive Rhines of his right to be executed in the manner of his choice. Defendants have a duty to ensure Rhines can exercise his right. 46. Defendants assert pentobarbital is an ultra-short-acting barbiturate. (Exh. E.) 47. Upon information and belief, pentobarbital is neither an ultra?short?acting barbiturate nor a chemical paralytic agent. 48. Upon information and belief, ultra-short-acting barbiturates include sodium methohexital and sodium thiopental. 49. By refusing to guarantee that Rhines will be executed in the manner set forth in SL 1984, ch 181, Defendants are depriving Rhines of his state statutory right created and protected by I SDCL and SL 1984, ch. 181, codified at SDCL (1984). Second Cause of Action? Deprivation of Due Process (Against All Defendants) 50. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 51. In enacting SDCL the State of South Dakota created life and liberty interests that entitle Rhines to be executed in the manner provided by South Dakota law at the time of the Rhines?s conviction or sentence; I 52. The manner of execution provided by South Dakota law at the time of Rhines?s conviction and sentence was, in relevant part, ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 10 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 53. SLI 1984, ch 181 creates protected life and liberty interests in execution ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 54. Rhines has life and liberty interests in execution ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. 55. Rhines ?s life and liberty interests in being executed in the manner set forth in SL 1984, ch 181 are protected by the Due Process Clause of the Fourteenth Amendment of the United States Constitution. 56. Rhines?s life and liberty interests in being executed in the matter set forth in SL 1984, ch 181 are protected by the Due Process Clause of Article Six, Section 2 of the South Dakota Constitution. 5?7. By stating their intention to execute Rhines using pentobarbital, which is neither an ultra-short-acting barbiturate nor a chemical paralytic agent, Defendants are deliberately and intentionally depriving Rhines of his life and liberty interests to be executed in the manner of his choice without due process of law. Third Cause of Action Iniunctive Relief (Against All Defendan?) 58. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 59. Defendants? decision to use pentobarbital to execute Rhines deprives Rhines of his statutory right to be executed using an ultra-short?acting barbiturate. It also deliberately and 11 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota intentionally deprives Rhines of his life and liberty interests in being executed using an ultra-short- acting barbiturate without due process of law guaranteed under the United States and South Dakota Constitutions. 60. Rhines has a substantial likelihood of success on the merits of his claims. 61. Rhines will suffer severe and irreparable injury if Defendants are not enjoined from executing Rhines with pentobarbital, in violation of his rights. 62. The interests of justice will be served by the Court ordering that: Defendants are prohibited from executing Rhines with Pentobarbital, and; Defendants are required to execute \Rhines ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate?, to wit, sodium methohexital or sodium thiopental. Fourth Cause of Action Declaratorv Judgment (Against All Defendants) 63. Rhines incorporates by reference each and every allegation contained in the foregoing paragraphs as if speci?cally alleged herein. 64. The Uniform Declaratory Judgment Act, 21-24-1, provides that the ?Courts of record within their respective jurisdictions shall have power to declare rights, status, and other legal relations whether or not further relief is or could be claimed. No action or proceeding shall be open to objection on the ground that a declaratory judgment or decree is prayed for. The declaration I may be either af?rmative or negative in form and effect; and such declaration shall have the force and effect of a ?nal judgment or decree.? .- 65. A valid case or controversy exists between the parties because Defendants intend to execute Rhines in violation of Rhines?s statutory and constitutional rights. 66. Rhines seeks a declaration that pentobarbital is not an ultra-short-acting barbiturate. 12 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 67. Rhines seeks a declaration that Defendants are enjoined from executing Rhines with pentobarbital. 68. Rhines seeks a declaration that: Defendants are prohibited from executing Rhines with Pentobarbital, and; Defendants are required to execute Rhines ?by the intravenous administration of a lethal quantity of an ultra-short-acting barbiturate?, to wit, sodium methohexital or sodium thiopental. 69. Rhines has suffered and will suffer an injury in fact based upon Defendants? deprivation of his statutory and due process rights. ?70. There is a causal connection between Rhines?s injury and Defendants? conduct. 71. Rhines?s injury will be redressed by a judgment declaring that: pentobarbital is neither an ultra-short-acting barbiturate nor a chemical paralytic agent; Defendants are enjoined from executing Rhines with pentobarbital, and Defendants are required to execute Rhines only ?by the intravenous administration of a lethal quantity of an ultra-short?acting barbiturate?, to wit, sodium methohexital Or sodium thiopental. PRAYER FOR RELIEF -WHEREFORE, Plaintiff prays for judgment against Defendants as follows: A. A judgment declaring that: pentobarbital is not an ultra-short-acting barbiturate; (2) Defendants are enjoined from executing Rhines with pentobarbital, and (3) Defendants are required to execute Rhines only ?by the intravenous administration of a lethal quantity of an ultra-short? acting barbiturate?, to wit, sodium methohexital or sodium thiopental. B. A preliminary and permanent injunction ordering that: (1) Rhines?s execution is stayed pending adjudication of this action; (2) pentobarbital is not an ultra-short?acting barbiturate; (3) Defendants are enjoined from executing Rhines with pentobarbital, and (4) Defendants are required to execute Rhines only ?by the intravenous administration of a 13 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota lethal quantity of an ultra-short-aeting barbiturate?, to wit, sodium methohexital or sodium thiopental. C. For other and further relief as the court deems proper. Dated this 22rld day of October, 2019. BALLARD SPAHR LLP By: ls/ Daniel R. Fritz Daniel R. Fritz (2390) Timothy R. Rahn (4871) 101 South Reid Street, Suite 302 Sioux Falls, SD 57103 Telephone: (605) 978-5200 Email: fritzd@ballardspahr.eom rahnt@ba11ardspahr.eom 14 Filed: 10l2212019 4:54 PM CST Minnehaha County, South Dakota 490lV19?002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 5827252 (2015) 2015 WL 5827252 (Mont.Dist.) (Trial Order) District Court of Montana. First Judicial District Court Lewis And Clark County Ronald Allen SMITH and William Gollehon, Plaintiffs, v. STATE OF MONTANA, DEPARTMENT OF Director Mike Batista; Warden Leroy Kirkegard; and John Does 1?20, Defendants. No. October 6, 2015. Findings of Fact, Conclusions of Law and Order Ronald F. Waterman. Jim Taylor. Gregory A. Jackson. Michael Donahoe. Timothy C. Fox} C. Mark Fowlen?Pamela P. Coll-i-nsr?Jonathan M. Krauss, Robert Stutz. Jeffrey M. Sherlock, Judge. INTRODUCTION *1 Before proceeding, it important to clarify the nature of this case. This Court has not been asked. and will not make a determination as to whether lethal injection of the Plaintiffs constitutes cruel and unusual punishment. This case is not about the constitutionality or appropriateness of the death penalty in Montana. This case is not about whether the use of pentobarbital in a lethal injection setting is cruel and unusual or if pcntobarbital in the doses contemplated by the State of Montana would produce a painless death. Further, this case is not about the availability of pentobarbital or any other drug. This case is only about whether the drug selected by the Department of Corrections to effectuate the Plaintiffs' lethal injections, pcntobarbital, meets the legislatively required classi?cation of being an ?ultra-fast acting barbiturate.? This Court rules that pentobarbital is not an ultra-fast?acting barbiturate. The State of Montana will either need to select a barbiturate that is ultra?fast acting to accomplish the execution of Plaintiffs or it will need to modify its statute as will be detailed below. From the testimony and evidence presented, the Court enters the following: FINDINGS OF FACT Trial in this matter was held on September 2 and 3, 2015. Representing Plainti?'s were Ronald F. Waterman, James Park Taylor, and Gregory A. Jackson. Representing the State of Montana were C. Mark Fowler, Pamela P. Collins, Jonathan M. Krause, and Robert Stutz. The Court received numerous exhibits and. heard from two witnesses, Dr. Mark Heath and Dr. R. Lee Evans. WESTLAW ?2019 Thomson Reuters. No claim to original US. Government Works. 1 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490IV19-002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 5327252 (2015) Jurisdiction and venue are proper in this Court. Plaintiff Ronald Allen Smith, an inmate at Montana State Prison, has been sentenced to death for the killing of two young men in 1982. Plaintiff William J. Gollehon, an inmate at Montana State Prison, has been sentenced. to death for the killing of another inmate at Montana State Prison in 1990. The Montana SupremeCourt has upheld the death sentences of both Plaintiffs. State. v. Smith, 280 Mont. 158, 931 P.2d 1272 (.1996); State v. Gable-hon, 262 Mont. l, 864 P.2d. 249 (1993). Session law 1983 Montana Laws chapter 411 enacted lethal injection as an option for the execution of prisoners sentenced to death. That provision introduced the phrase ?ultra-fast?actin barbiturate" into Montana Code Annotated 46?19-103. As of March 19, 1997, lethal injection became the sole method of execution of a sentence of death. Montana Code Annotated 46?19?1036) provides: ?[t]he punishment of death must be in?icted by administration of a continuous, intravenous injection of a lethal quantity of an ultra-fast-acting barbiturate in combination with a chemical paralytic agent until a coroner or deputy coroner pronounces that the defendant is dead.? The current Execution Technical Manual (ETM) was adopted on January 16, 2013. (See PL's Ex. 1.) The two-drug protocol is referenced on pages 41, and 50 through 53 of the current There it is indicated that sodium pentothal and pancuronium bromide will be used in the execution. At page 51, it is indicated that these drugs may be substituted by another drug based on availability. It is speci?cally provided that pentobarbital with a dosage of 5 gins may be substituted for sodium pentothal. Further, roeurom'um bromide with a dosage of 1,000 may be substituted for pancuronium bromide. *2 The State of Montana is the only state that speci?es that the death penalty be accomplished by an ?ultra-fast?acting barbiturate.? The other states employing the death penalty either specify a particular drug to be used or merely state that execution is to take place by means oflethal injection. The only issues remaining in this case are what the Montana legislature meant by using the words ?ultra- fast-acting barbiturate" in Montana Code Annotated 46-19-103, and whether 'pentobarbital is an ultra?fast-acting barbiturate within the meaning of Montana Code Annotated 46-19-103. Pentobarbital and thiopental are included in the class of drugs known as barbiturates. At trial, the ?rst witness was Dr. Mark Heath. His curriculum vitae was received as Plaintiffs Exhibit 8. Dr. Heath is a practicing anesthesiologist in New York at the Columbia Medical Center and also teaches medicine at the Columbia School of Medicine. Dr. Heath is a Board Certi?ed Anesthesiologist and has written extensively on lethal injection. He has testified before various courts and legislatures, and has written articles and book chapters about lethal injection. Dr. Heath has also extensively studied various types of lethal injection, by reviewing witnesses descriptions, execution logs, publications, and electroencephalogram results of people who have been executed by means of lethal injection. All of Dr. Heath's opinions, which will be cited. below, were given with a reasonable degree of medical certainty. The bottom line for Dr. Heath is thatpentobarbital the drug selected by the Montana Department of Corrections is not an ultra-fast-acting barbiturate. Barbiturates were ?rst created in the 1930s and, as a class, share a certain common core ring ofmolec ules. In general, barbiturates are weak acids that are absorbed and rapidly distributed to all tissues of the human body. Barbiturates are known by their WESTLAW 2019 Thomson Reuters. No claim to original U.S. Government Works. 2 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota Smith v. State of Montana, Dept. of Corrections, 2015 WL 5827252 (2015) lipid solubility. Barbiturates possessing more lipid solubility distribute more rapidly to the human brain. The basic core ring of barbiturate molecules has been modi?ed. over the years, and those modi?cations affect how certain barbiturates operate. Experts speak of time," which is the amount of time it takes a barbiturate injected into the blood stream to transit to the human brain. In addition, there is a ?blood~brain barrier.? This is a grouping of cells and capillaries around the human brain that prevent toxins from entering the brain. Certain modi?cations to the basic barbiturate structure have allowed- a rapid. transfer through the blood?brain barrier. According to Dr. Heath, it is o?cn important to have a very quick transition from consciousness to unconsciousness, quickly penetrating the blood-brain barrier, which allows physicians to lake control ot?a patient?s breathing to prevent negative consequences from occurring as a patient enters unconsciousness. According to Dr. Heath, this is the purpose of the development of ultra-fast?acting barbiturates. Barbiturates are traditionally classi?ed as long-acting (phenobarbital), medium-acting (such as pentobarbital), short-acting (secobarbital), and ultra-short-acting (thiopental). (See Test. Dr. Mark Heath; PL's Ex. 4, Margaret Wood, Alistair H. Wood, DRUGS AND ANESTHESTA PHARMACOLOGY FOR ANESTHESTOLOGISTS (2d. Wilkins); see also Ex. 5, Ronald D. Miller, ANESTHESIA, 6th ed. (2005). According to Dr. Heath and ANESTHESIA, the ultra-short?acting drugs are thiopental, methohexital, and thiamylal. By using terms such as short?acting or ultra-short-aeting, the classi?cation system refers to the duration of action or how long the barbiturate exercises its control over the human body. *3 As noted by Dr. Heath, there is another classi?cation of barbiturates which refers to the onset of action of the barbiturate or how soon the maximum effect is felt by the body. According to Dr. Heath, there is a correspondence between the two systems, and the terms ultra-fast and ultra?short refer to the same type of barbiturates, as do the terms fast and short, and as do the terms slow and long. Putting this in a tabular form, we ?nd the following: . Ultrafast acting Ultrashort acting thiopental, thia'mylal, methohexital Fast acting Short acting seeobarbital, pentobarbital Intermediate acting Intermediate acting pentobarbital* 4. Slow acting Long acting phenobarbital (*Some systems combine #2 and #3 into one group of intermediate acting drugs) (PL's Rebuttal Expert Disclosure, at 4 (June 25, 2013).) According to Dr. Heath, pentobarbital is either classi?ed ?fast,? ?short," or ?intermediate.? Pentobarbital is not used as an anesthetic, according to Dr. Heath, because its effects last too long. Rather, pentobarbital is commonly used in pill form as a treatment for epilepsy and is also used to induce comes in already unconscious patients. Pcntobarbital in the doses suggested in Montana?s ETM would cause the death of the inmate. Dr. Heath has used, in a clinical setting, both pentobarbital and thiopental. Dr. Heath has never heard, prior to this case, any reference to pentobarbital being classi?ed as being ultra-fast acting. According to Dr. Heath, the operation ofthiopental and pentobarbital is noticeably different. Dr. Heath testi?ed that an administration of thiopental causes a ?lights out? effect, where a patient is unable to complete the thought that was in their mind upon the administration of the drug. A patient receiving thiopental would. take one or two breaths before the drug exerted its control over the patient. Heath also opined that an individual given pe'ntobarbital would breathe longer, would have various body movements, and would slur words before the pentobarbital took effect. Heath testi?ed that a patient given pentobarbital would physically be able to appreciate the accrual of sleepiness or tmconsciousness, while a patient given thiopental would not. WESTLAW ?2019 Thomson Reuters. No claim to original US. Government Works. 3 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 5827252 (2015) Of signi?cant import to the Court is the manufacturer?s insert provided for pentobarbital. (See PL's Ex. 7, manufacturer's insert for Nembutal Sodium Solution (the manufacturer?s name for pentobarbital).) At page one, the insert states Sodium is a short-acting barbiturate.? This comports with the classi?cation stated by Dr. Heath. Plaintiffs Exhibit '11 contains a compilation ofa search engine results completed by Dr. Heath. His research shows that there were 28,600 results produced for a description of thiopental as an ultra-short-aeting barbiturate. An additional 42 results were returned for the search phrase of thiopental being an ultra-fast?acting barbiturate. 0n the other hand, the search engine reported one ?nding for pentobarbital being an ultra-short-acting barbiturate, and a single ?nding of pcntobarbital being an ultra-fast- acting barbiturate. Ex. ll, at 3.) I The State produced the testimony of Dr. R. Lee Evans, a doctor of pharmacy and Dean of Pharmacy at Auburn University. [11 Dr. Evans? original declaration filed in March 2015 and received. into evidence as Plaintiffs Exhibit 9, he is ?not aware of the origin of the term ?ultra-fast acting.? Ex. 9, at 6,1! 14.) According to Dr. Evans, pentobarbital could be considered short acting, and thiopental, ultra-short acting. Dr. Evans opined that there is no meaningful difference between pentobarbital and thiopental in the time it takes to render a person comatose. (id, at 7, 1 15.) However, Dr. Evans noted that onset of action for pentobarbital is under a minute, while for thiopental, the onset of action could be ten to forty seconds. (Id) *4 Until the trial of this action. Dr. Evans had not testified that pcntobarbital was an ultra-fast-acting barbiturate. lie did so testify at trial. However, the Court struck that conclusion because it did not comport with his prior discovery responses or declarations filed with the Court. (See. Exs. 9, 10.) At the trial of this matter, Dr. Evans indicated that the onset of pentobarbital was under one minute. However, on December 10, 2012, Dr. Evans indicated ?[thiopental is an onset of about a half to one minute, duration of a little less than 30 minutes. Pentobarbital is onset three to four minutes with a duration that is somewhat longer. That?s the primary difference." Ex. 14, Pam?o v. Palmer, Case No. 3: 12-cv-1328-J?3213T (MD. F1. Dec. 10, 2012), Test. Roswell Lee Evans, Jr., at This testimony stands in stark contrast to what Dr. Evans stated at the trial this matter. Dr. Evans pointed out that there is no question that pentobarbital is fast acting. For example, Plaintiffs Exhibit 7 the package insert for pcntobarbital indicates that ?the onset of. action ranges from almost (PL's Ex. 7, at 2.) See also Defendant's Exhibit L, a TOXNET reference which indicates that the onset of thiopental and 'pentobarb'ital is ?almost immediate. (Deffs Ex. L, at 16.) TOXNET is a collection of databases operated by the National Library ofMedicine. See also Defendant's Exhibit N, a reference which indicates that the onset of pentobarbital is immediate. (Def?s Ex. N, at 1.) Thus, there is no question that pentobarbital is fast acting. The question remains as to whether it is ultra-fast acting. Dr. Evans did cite to references that indicate that if the onset of action of a drug is less than a minute, it can be considered ultra- fast acting. (See. Ex. Q, TOXNET reference, at l2; PL's Ex. R, Micromedic reference, at 4 (?ultra?fast acting has an onset of one minute or less.).) The Court notes that at page 1 of Exhibit R, pentobarbital is listed as being ?short acting," not ultra-short acting. These references to pentobarbital being ultra-fast acting are consistent with Dr. Heath's ?nding some sources refer to pentobarbital as being ultra-fast acting. However, that must be compared with the greater weight of authority that indicates that pentobarbital is not in the class of drugs considered to be ultra-fast acting. Dr. Evans did indicate that, in his opinion, pentobarbital and thiopental are almost identical. Both, in his current opinion, reach maximum effect in less than one minute?s time. However, Dr. Evans did acknowledge that thiopental is a little quicker to get to the brain because pentobarbital is not as lipid soluble. In making its decision, this Court has had to weigh the evidence presented by Dr. Evans versus Dr. Heath. Supporting Dr. Heath?s testimony are standard. pharmacology for anaesrhesiologists text books (PL's Exs. 4, 5) and Dr. Heath's own consistent testimony. Also supporting Dr. Heath's position is the signi?cant research that classi?es thiopental as being ultra?short acting WESTLAW 2019 Thomson Reuters. No claim to original U.S. Government Works. 4 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota Smith v. State of Montana, Dept. of Corrections, 2015 WL 5827252 (2015) (ultra-fast acting) and not so classifying pentobarbital, except for a few scattered references. (See PL's Ex. 11.) Also ofutinost import is the manufacturer?s insert for pentobarbital Ex. 7), which classi?es pcntobarbital as a short-acting barbiturate. Also crucial in this weighing the Court has undertaken is the fact that in the Pardo v. Painter case, in testimony given not three years ago, Dr. Evans testi?ed that pentobarbital's onset of action is three to four-minutes as opposed to the less than one minute referred to in his testimony in this case. This is not to in any way insinuate that Dr. Evans is not a credible Witness. However, it is a factor when weighing the evidence which shows by a relatively overwhelming nature that, while pentobarbital may operate in a fast nature, it is not ultra-fast as is required. to comply with Montana?s execution protocol. Thus, through this weighing process, this Court concludes that pentobarbital is not an ultra-fast-acting barbiturate. *5 From the foregoing Findings of Fact, the Court enters the following: CONCLUSIONS OF LAW Jurisdiction and venue are proper in this Court. 2. By using the limiting term ?ultra? in the phrase ?ultra-fast-acting barbiturate? in Montana Code Annotated 46-19-1036), the legislature limited the State of Montana to using only drugs in the fastest category of barbiturates, namely thiopental, 'methohexital, and thiamylal. Under the express terms of the statute, the State of Montana is not allowed to use the ?fastest acting barbiturate available,? or a ?relatively fast-acting barbiturate,? only an ?ultra-tast-acting barbiturate,? meaning drugs from the fastest class of barbiturates. 3. Had the legislature intended to give the State of Montana latitude in what drugs to use, it could have used much more general language in the statute authorizing execution, as many other states have now done. Pentobarbital cannot properly be classified as since there is another class of drugs that is faster. Whether these drugs are currently available is not an issue the Court can resolve for the State. The State?s remedy is to ask the Legislature to modify the statute to allow the use of pcntobarbital or other slower acting drugs. 4. The State of Montana has modified the execution protocol several times during this litigation and has had many opportunities to return to the legislature to modify the language which limits the State of Montana to ?ultra-tast-aeting barbiturates,? but has chosen not to. 5. Courts may not legislate through judicial interpretation ot'statutes. Albmger v. Harris, 2002 MT 1 18,1l 38, 310 Mont 274, 8 P.3d 711 (It is not the province of this court or any other court to assume to legislate by judicial interpretation, and to create in favor of any individual or any class ofpeople an exception to the limitation set by the legislature.) A court cannot second- guess and Substitute its judgment for that of the legislature or insert what has been omitted. State Bar ofMont. v. Krivee, 193 Mont. 477, 481, 632 P.2d 707, 710 {1981). indeed, Montana law regarding statutory' interpretation begins with Montana Code Annotated 1-2-101, which states: [i]n the construction ot?a statute, the of?ce of the judge is simply to ascertain and declare what is in terms or in substance contained therein, not to insert what has been omitted or to omit what has been inserted.? In Montana Code Annotated 46-1941 03, the legislature mandates use of an ?ultra-fast- acting barbiturate,? and the Department of Corrections plan to use a drug which is, without dispute, not classified as an ultra?fast-acting barbiturate. Given these facts, the Court must find an impermissible inconsistency between the legislative mandate and the Department of Corrections? exercise of that mandate. Scrupulous adherence to statutory mandates is especially important here given the gravity of the death penalty. Accord In re. Ohio Execution Protocol Litigation, 840 F. Supp. 2d 1044 (SD. Ohio 2012). From the foregoing Findings ot?Fact and Conclusions ot?Law, the Court enters the following: WESTLAW 2019 Thomson Reuters. No claim to original U.S. Government Works. 5 Filed: 10122I2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 Smith v. State of Montana, Dept. of Corrections, 2015 WL 5827252 (2015) ORDER *6 The State of Montana is hereby ENJOFNED from using the drug pe'ntobarbital in its lethal injection protocol unless and until the statute authorizing lethal injection is modi?ed in conformance with this decision. DATED this 6 day of October 2015. <> JEFFREY M, SHERLOCK District Court Judge pcs: Ronald P. Waterman Jim Taylor Gregory A. Jackson Michael Donahoe Timothy C. Fox-?C. Mark Fowler-?Pamela P. Coll-insi?Jonathan M. Krauss, Robert Stutz End ofDocumcnt E12019 Thomson Reuters. No claim to original US. Government Works. WESTLAW ?2019 Thomson Reuters. No claim to original US. Government Works. 6 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 . SOUTH DAKOTA PENITENTIARY KITE - REQUEST SLIP October 2019 #20_ Inmate RHINES, Charles #No, 15036 Pendigg Cell No 3" 55 Works_ DasiresanAudiencewlth DARIN YOUNG: Warden: South Bah?ota . . State Penitentiary Give Reason - Private Business Not Sufficient As per South Dakota Codifip?fLaw 1, I am hereby notifying you that I the method of execution l?f' he time I was sentenced to death: (mm OFMIEMEAHA On October 1. 2019, Charles R. Rhinos personally appeared Incarcer? before me, whose Identity I proved on the basis 0 ation, to be the signer of the above document, and he acknow? ledged that he signed it. A - . mu?: - ii?mehwvamowaa ?awwu?r @w ?at OFHCEH v- Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota . - . . Filed: MOST Minn?haha County, south pakpta': SECOND ITTERATION, ALL OTHERS NOT SO SOUTH DAKOTA PENITENTIARY KITE - REQUEST SLIP October 4, 2019 20 Inmate RHINESI. Charles . No. 15035 Cell No?" 3?55 Works Pending State penitentiary Give Reason - Private Business Not Suf?cient As per South Dakota Codified Law I am hereby notify-? you that I have selected ge/?ethod of execution which was in eff- eat at the tiny/I wee/641cm to death on January 29, 1993. To Hit: The. Tng/r/y?col of. a Lethal Dose of An Ultra?short Act? ing W?ay?e? a Chemical paralytic agent. 3 STATE OF SOUTH DAKOTA COUNTY OF MINNEHAHA On October 4, 2019, Charles R. Rhines personally appeared before me, whose Identit)? I proved on the babsis of Inrarrprarinn' n. be the signer of. the above document, and he acknowledged that he .signed it. . A Jr: My Cemn?ssion Expires: 7" TAVI nn \Inn-r I In! NOTARY PUBLIC - 1620-000 - 8 ?mm: My Commission Expires 'Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19?002940 GreenbergTrau rig Caroline .1. Heller Fax 212.803.9438 hellerc@gtlaw.omn October 15, 2019 VIA EMAIL AND USPS. Darin Young 1600 North Drive PO Box 5911 Sioux Falls, South Dakota 57117 Paul Swedlund, Esq. Assistant Attorney General 1302 East Highway 14, Suite 1 Pierre, South Dakota 5750]. Re: Charles #15036 Dear Warden Young and Mr. Swedlund: We represent Charles Russell Rhines. As you know, on June 25, 2019, Judge Robert Mandel issued a warrant of execution for Mr. Rhines for between November 3 and November 9, 2019. Pursuant to S.D.C.L. 23A-27A-32J, on a Kite-Request Slip dated October 1, 2019 and an amended Kite-Request Slip dated October 4, 2019, Mr. Rhines elected to be executed pursuant to the manner provided by South Dakota law at the time of his sentence; to wit, ?by the intravenous administration of a lethal quantity of an ultra-short acting barbiturate in combination with a chemical paralytic agent and continuing the application thereof until the convict is pronounced dead by a licensed physician according to accepted standards of medical practice.? SL 1984, ch 181. We Write to request that you con?rm Mr. Rhines?s request will be honored, and that he will be executed by the intravenous administration of an ultra-short-acting barbiturate. We also request that you identify which one of the three ultra-short-acting barbiturates will be used to execute Mr. Rhines: sodium methohexital; sodium thiamylal, or; sodium thiopental. Further, with respect to the ultra?'short?acting barbiturate that is identi?ed for use in Mr. Rhines?s execution, we request that you provide the following information: (1) whether it was manufactured or compounded; (2) if manufactured, the identity of the country, or the State in the United States, from whence it was imported/obtained; (3) if compounded, the date on which any compounding was performed and whether it was performed by a licensed pharmaceutical company or pharmacist; (4) any testing. conducted to ensure such drug?s or drugs? (including the API) potency, purity, and integrity, including the tests conducted, the date(s) of same, and the results; (5) whether GREENBERG TRAURIG. LLP I ATTORNEYS AT LAW I MetLife Building I 200 Park Avenue I New York. NY 10166 i Tel 212 801.9200 I Fax 212.801.6400 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota Warden Young Mr. Swedlund October 15, 2019 Page 2 such testing was performed by a licensed pharmaceutical company, pharmacy, or pharmacist, and whether such pharmaceutical company, pharmacy, or pharmacist has been subject to disciplinary action or cited for violations of state or federal laws or regulations by either state or federal entities; (6) the ?beyond use? or ?expiration" date of such drug (including the API), and when and how such date(s) was/were established; (7) the date on which any was ordered and received and how it was stored during transport and since it has been in possession, and; (8) how the drug has been stored since the time of compounding or importation. We also request that you con?rm a licensed physician will be present at Mr. Rhines?s execution to pronounce death. Please provide this information no later than October 18, 2019 to my email address, 1 look forward to your timely response. Sincerely, Caroline J. Heller Caroline J. Heller Greenberg Traurig, LLP 200 Park Ave. New York, New York 10166 Telephone (212) 801-2165 Facsimile (212) 805?9488 hellerc@gtlaw.com cc: Jason Ravnsborg, Esq. (via email and US. Mail) Charles Rhines (via U. S. Mail) 'I?r'aurig, LLP Attorneys at Law Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 STATE or SOUTH DAKOTA OFFICE OF ATTORNEY GENERAL 1302 East Highway 14, Suite 1 Pierre. South Dakota 57501~8501 JASON R. RAVNSBORG Phone (605) 773-3215 CHARLES D. ATTORNEY GENERAL Fax (605) 773-4106 CHIEF DEPUTY ATTORNEY GENERAL TTY (605) 773-6585 October 17, 2019 VIA EMAIL AND USPS Caroline Heller GreenbergTraurig, LLP MetLife Building 200 Park Avenue, New York NY 10166 hellercfcilgtlaweom Dear Ms. Heller: I am in receipt of your letter regarding Mr. Rhines? request for execution pursuant to the combination of drugs provided by statute at the time of his execution. The DOC will follow the law. The ultra-short acting barbiturate the state intends to use is pentobarbital. Recent case authorities have quite emphatically and unequivocally stated that ?[n]either the 14m or 1St Amendments afford [inmates] the broad right ?to know where, how and by whom the lethal injection drugs will be manufactured,? as well as ?the quali?cations of the person or persons who will manufacture the drugs, and who will place the catheters.? Wellons v. Georgia Department of Corrections, 754 F.3d 1260, 1267 (11?11 Cir. 2014). Consistent with this authority, with regard to your questions related speci?cally to the pentobarbital: (1) The DOC will not disclose whether the drug is ?manufactured? or ?compounded.? The DOC will advise you that the barbiturate is produced for and used by medical practitioners in the United States. Obviously, drugs used in the United States must be produced in an FDA-approved facility according to accepted GMP. (2) The DOC will not disclose the country or state of origin of the drug. (3) No drug has yet been compounded and, consistent with past practice, will not be compounded until 24 hours prior to the execution. Per DOC practice, compoundng is performed by quali?ed persons, as demonstrated by past testing and the efficacy of the drugs in the Robert, Moeller and Berget executions. (4) The DOC will not disclose testing until after the execution. (5) Per DOC practice, all testing is performed by a quali?ed independent lab. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 (6) The DOC will not disclose any ?beyond use? or ?expiration? date of the drugs it intends to use as this could identify the source. The DOC will advise you that no drug it intends to use is beyond the ?beyond use" or ?expiration date? set by the manufacturer. (7) The DOC will not disclose the date any of its drugs were ordered or received. (8) All drugs have at all times been stored in accordance with manufacturer instructions while in the control. Finally, I can con?rm for you that a licensed physician will be present at Mr. Rhines? execution. Y0 Paul S. Swedlund Assistant Attorney General PSS/rar Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940 CH307, Hanivood Nuss' Clinical Pract. of Emergency Medicine, Harwood Nuss' Clinical Pract. of Emergency Medicine, 6th Ed. CH307 Harwood Nuss' Clinical Practice of Emergency Medicine, Sixth Edition October 2014 Update Editor-in-Chief Allan B. Wolfson, MD Associate Editors Robert L. Cloutier, MD Gregory W. Hendey, MD Louis J. Ling, MD Carlo L. Rosen, MD Jeffrey Schaider, MD SECTION Toxicology PART 4. Anticonvulsants and Sedative-Hypnotics . Chapter 307 Barbiturates Samuel J. Stellp?ug Carson Hands '2 lmagei within document in PDF format. Introduction Barbiturates are central nervous system (CNS) depressants used as anxiolytics and hypnotics, for the induction of anesthesia, and as anticonvulsants. They act by enhancing y?aminobutyric acid (GABA) inhibition in excitable tissues mainly in the CNS, but also to a lesser extent in skeletal muscle, smooth muscle, and heart. Barbiturates bind to the GABAA receptor complex, - augment the chloride current and also increase the duration of channel opening, hyperpolarizing the cells and thereby inhibiting depolarization. This enhances the activity of GABA, potentially acting synergistically with other GABA?active agents. That being said, especially in high doses, barbiturates can stimulate GABAA receptors directly even in the absence of GABA. In addition, phenobarbital also decreases the paroxysmal firing of nerve cells by an unknown mechanism along with GABA stimulation. Barbiturates are divided into four distinct categories based on their duration of action: (1) ultrashort?acting, (2) short-acting, (3) intermediate-acting, and (4) long-acting barbiturates (Table 307.1). TABLE 307.1 Barbiturate Kinetic Data Drug Usual Adult Onset (hr) Peak (hr) Duration (hr) Half?Life (hr) Percentage Volume of Dose (mg) Protein Binding Distribution (Likg) [Htrashort?Ac?ng Thiop enta] 50?75 <0.1 <0.1 <0.5 3*11 72?86 1.4?6. 7 WESTLAW 2019 Thomson Reuters. No claim to original US. Government Works. 1 Filed: 10/22l2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 LWWEMERG 6TH CH307, Harwood Nuss? Clinical Pract. of Emergency Medicine, Methohexital 50?120 <02 <02 <05 1?4 83 1?2. 6 Sh art-Acting Pentobarb ital 50?200 0.25 0.5?2 >3?4 15?50 45-70 0.5?1 Secobarb ital 100?200 0.25 1?6 >3?4 19?34 45-70 1.5?1.9 Intermediate-Acting Amobarbital 55~2oo <1 2 >4?6 10?40 59 0.91.4 Aprob arbital 40?160 <1 12 >4?6 14?34 20 Butabarb ital 100?200 <1 0.5?1.5 bit?6 66?140 26 Butalbilal 100?200 2 61 Long-Acting Mephobarbital 50?100 0.5?2 ?36?12 10?70 40450 2.6 Phenobarbital 100?320 <01 0.5?2 >642 530-120 20?50 0.5?0.9 Primidone 3.3?12 2040 0.4?1 The ultrashort-acting barbiturates (thiopental, methohexitol) are highly lipophilic, rapidly entering the CNS, and thus their primary use is anesthesia induction. Overdose of this group of barbiturates is typically iatrogenic as these agents are available only as intravenous formulations. Short-acting barbiturates (pentobarbital, secobarbital) were extensively prescribed in the 1960s and 1970s as sedative? hypnotics. In the late 1970s, nearly 70% of all suicides by drug ingestion involved barbiturates (1). Their use markedly declined over the subsequent decades with the introduction of newer and safer sedative?hypnotics and anticonvulsants. Short?acting barbiturates have a lower therapeutic margin than the benzodiazepines, more frequent development of tolerance, and a greater potential for abuse. Moreover, drug?drug interactions are numerous, with more than 150 drugs and herbal interactions. Interm ediate-acting barbiturates (am obarbital, aprobarbital, butabarbital, butalbital) are most commonly found in combination analgesic medications (Fiorinal, Fioricet, etc.) containing butalbital to treat tension?vascular headaches. Amobarbital and butabarbital have been replaced by benzodiazepines, and the use of sodium am obarbital as ?truth serum? has allegedly long been abandoned. Long-acting barbiturates (phenobarbital and primidone) are still used to treat epilepsy. They have lower lipid solubility than short?acting barbiturates, causing them to accumulate more slowly in tissue and to have peak effects that are delayed for several hours. Onset of usually occurs within 1 to 2 hours, and the peak effect may occur more than 10 hours after ingestion (2). Pharmacokinetic data are summarized in Table 307.1. Barbiturates are well absorbed from the intestinal tract, except for mephobarbital, which is about 50% absorbed. The onset of action varies from 10 to 50 minutes depending on the agent and formulation. Food in the stomach decreases the rate of absorption but not the total amount absorbed. In overdose, the onset and peak of may be delayed. Ultrashort?acting barbiturates are administered intravenously, with initial effect seen within 1 minute and duration of effect of 10 to 30 minutes. Short-acting barbiturates are almost entirely metabolized in the liver to inactive metabolites that are excreted in the urine as glucuronides. However, liver metabolism of barbital, phenobarbital, primidone, and is limited because of lower lipiduwater partition coefficients; so urinary excretion accounts for 95%, 25% to 35%, 15% to 42%, and 95% of the elimination of these agents, respectively. Phenobarbital undergoes enterohepatic recirculation, which contributes to its long half -]jfe. Barbiturates induce cytochrome P450 isozymes, including CYP2C9, CYP2019, CYP2C8, and CYP3A4, thus enhancing elimination of other drugs metabolized by these enzymes. Although phenobarbital is a strong inducer of cytochrome P450, it does not induce its own metabolism and appears to have a longer half-life with chronic use (2). Barbiturates also induce 6- aminolevulinic acid (ALA) leading to increase production of a precursor of porphobilinogen. This may precipitate attacks of acute intermittent and variegata in susceptible individuals; thus although uncommon, is a contraindication to barbiturate use. WESTLAW 2019 Thomson Reuters. No claim to original US. Government Works. 2 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 CH307, Harwood Nuss' Clinical Pract. of Emergency Medicine, Clinical Presentation Significant ingestions are now rare but still life-threatening and typically present with depressed level of consciousness ranging from lethargy to deep coma. Patients may also have respiratory depression, which is responsible for most deaths. With the short and interm ediate-acting barbiturates, usually begin within 1 hour of ingestion, and peak effects are seen within 4 to 6 hours. Patients with chronic lung disease and sleep apnea are more susceptible to severe respiratory depression, even at therapeutic doses. Other clinical findings in overdose include hypothermia, sluggish pupillary light re?ex, nystagmus, and diminished bowel sounds. Bullous skin lesions, occasionally referred to as ?coma blisters,? may appear on shoulders, hands, buttocks, and knees, where the body weight has caused pressure ischemia to the skin. About 40% of patients with severe toxicity also develop aspiration pneumonia (3). Cardiovascular collapse may manifest with bradycardia or tachycardia, hypotension, and shock. Drug-induced venous dilatation with consequent pooling of blood and reduction in effective vascular volume can lead to shock. Prolonged coma increases the risk for hypothermia, venous thromboembolism, rhabdomyolysis, and acute tubular necrosis secondary to shock. The acid?base abnormality, especially in a severe overdose, is likely to be a mixed respiratory and metabolic acidosis from hypoventilation and lactate. Coingested ethanol, benzodiazepines, and barbiturates have synergistic effects, and there is increased risk even when lesser amounts are ingested. Withdrawal occur when the drug is discontinued after chronic use of barbiturates leads to tolerance. Tolerance can develop with prolonged use and abuse, leading to a progressive increase in doses needed to achieve the desired effect. The withdrawal state is similar to ethanol withdrawal. Laboratory abnormalities include hypoglycemia, electrolyte disturbances, and alterations in acid?base and fluid balance. The creatine phosphokinase (CPK) may be elevated if the patient has been comatose and immobile for a prolonged period. A chest radiograph may show aspiration pneumonia or pulmonary edema. The electrocardiogram (ECG) is usually normal but in severe toxicity may show bradycardia or tachycardia. The electroencephalogram (EEG) shows diffuse slowing during barbiturate- induced coma. The amount of drug required to produce toxic can vary significantly depending on patient tolerance (4). The therapeutic doses for common barbiturates are given in Table 307.1. For nonaddicted patients, the toxic dose for short-acting barbiturates is about 3 to 6 (S to 8 mg/kg in pediatrics) and for phenobarbital is about 6 to 9 (8 mg/kg in pediatrics). Patients with physical dependence on barbiturates may tolerate higher doses. Geriatric patients may be much more sensitive to drug effects and can present with significant findings at lower doses. This may be attributed to decreased enzyme activity in the elderly and the higher likelihood of drug interactions and com orbidities in this population (5). Differential Diagnosis Other sedative?hypnotic agents, opiates, or alcohol intoxication should be included in the differential. Similar presentations may be encountered with y-hydroxybutyrate, clonidine, skeletal muscle relaxants, and imidazoline decongestants oxymetazoline). An overdose of medications such as cyclic antidepressants, trazodone, phenothiazines, and also cause sedation and respiratory depression Carbon monoxide poisoning, head trauma, CNS infections, sepsis, hypoglycemia, electrolyte abnormalities, and hypothermia may present similarly to barbiturate overdose and must be considered. ED Evaluation The initial history is not always obtainable or reliable but, when possible, one should attempt to identify the drug ingested, the approximate amount ingested, the time of ingestion, and the reason for the ingestion accidental or intentional). The physical examination should focus on the vital signs, including rectal temperature and oxygen saturation, and the degree of CNS depression. Other findings on examination may point to unsuspected trauma or other conditions in the differential. Absence of bowel sounds suggests ileus; suprapubic percussion or bedside ultrasound may detect a distended bladder. WESTLAW 2019 Thomson Reuters. No claim to original US. Government Works. 3 Filed: 10f22l2019 4:54 PM CST Minnehaha County, South Dakota Hamood Nuss' Clinical Pract. of Emergency Medicine, After initial stabilization, physical examination, bedside fingerstick glucose and basic metabolic panel (electrolytes, blood urea nitrogen, creatinine) should be ordered. Testing is generally not helpful in the diagnosis but can detect other condition and may help general supportive care. These include breath or blood alcohol concentration, and an acetaminophen concentration should be considered, as with most ingestions, and especially since it is contained in some preparations of barbiturate combination products. A salicylate concentration, and an ECG are reasonable, however will not be diagnostic of barbiturate ingestion. A complete blood count is almost always quite unhelpful. A total CPK concentration is reasonable, especially if there is concern for prolonged patient down time. With signs of acid?base imbalance blood gas analysis (venous if patient is well perfused, arterial if the patient has hemodynamic compromise) can help in the analysis. Chest radiography may reveal normal findings, however pulmonary edema and signs of aspiration are common. As with other causes of altered mental status, head computed tomography and lumbar puncture for testing is sometimes necessary to rule out causes other than ingestion. In the case of prolonged ED stay time, EEG can be obtained in the nonresponsive patient, but should not be used to rule out barbiturate overdose, as the EEG can reflect brain death in this setting. Barbiturate-specific testing does not impact decision making in the emergency department (ED). Clinical signs of barbiturate overdose should dictate management rather than relying on serum or urine concentrations. Rapid urine immunoassay testing (?drug screen?) for qualitative presence of barbiturates is relatively reliable for exposure (more reliable than other drug classes tested by urine irnmunoassays), but is not particularly helpful because the exposure could have been hours or days prior to arrival and may not have anything to do with the clinical presentation. There can be an argument for never ordering rapid urine immunoassay screens in the workup of overdoses. Blood concentrations are not available at many facilities, and plasma concentrations may not accurately concentrations, as tissue solubility changes with fluctuation in pH. However, quantitative testing can be done with more adv anced'techniques on serum and urine with chromatography combined with mass spectrometry, and this should be considered in cases where child abuse, elder abuse, and drug-facilitated sexual assault are concerns. This may also prove beneficial in cases of clinical brain death without another reasonable cause. Key Testing There are no specific tests for typical cases. - Qualitative barbiturates levels may be helpful to document in cases of child abuse, elder abuse, date rape, and falsely presumed brain death. I ED Managem ent The treatment of barbiturate toxicity is primarily supportive. Patients with depressed respirations and altered mental status require airway management and intubation to support breathing and protect the airway. Blood pressure should be supported initially with intravenous administering 10 to 20 mL/kg boluses barring preventive comorbidities, and with close monitoring of response. The core temperature should be checked and rewarming instituted if needed. Management decisions should be based on the patients clinical condition rather than on blood drug levels. For serious phenobarbital overdose, multidose activated charcoal (MDAC) leads to more rapid recovery and a significant reduction in elimination half-life (6, 7). The usual dose is 1 g/kg, followed in 2 to 4 hours by 0.5 g/kg in aqueous solution and alternating for 24 hours. Sorbitol-based charcoal has fallen out of av or and aqueous-based charcoal should be used. Barbiturates are weak acids, and theoretically increasing the urine pH increases the fraction of ionized drug in the urine and thus decreases the amount of nonionized drug available for passive tubular reabsorption. This is most well established for phenobarbital and not well for other barbiturates; urine alkalinization can increase the renal clearance of phenobarbital up to 10-fold and can shorten the half?life by one-half to two-thirds (8). The best evidence for urinary alkalinization even in the context of phenobarbital is inferior to MDAC. There are no data to support the use of urine alkalinization for overdose with WESTLAW 2019 Thomson Reuters. No claim to original US. Government Works. 4 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota CH307, Harwood Nuss' Clinical Pract. of Emergency Medicine, short? and interrn ediate-acting barbiturates (8). Urine alkalinization is contraindicated in patients with renal insufficiency and cerebral or pulmonary edema. Hem odialysis ay be used in life-threatening barbiturate overdose (9). Early notification of the nephrology service can expedite initiation of treatment. Both charcoal hemoperfusion and high-flux hem odialysis enhance the elimination of all barbiturates. High-efficiency hem odialysis with a high blood ?ow rate may be superior to hemoperfusion which is also difficult to accomplish and has more inherent complications than dialysis (10). As these procedures have some risk, their use should be reserved for patients with pulmonary edema, cerebral edema, or shock unresponsive to supportive measures. Critical Interventions 0 Provide appropriate airway management with supplemental oxygen. Treat hypotension with intravenous ?uids, and vasopressors if necessary. Adm inister MDAC, especially for phenobarbital poisoning. Consider early hem odialysis for severe overdoses, especially phenobarbital ingestions. Disposition Nephrology consultation should be obtained when hem odialysis is being considered. Awake patients who have ingested short?acting barbiturates and whose are mild and are not progressing may be observed for 4 to 6 hours and then evaluated for admission or discharged. For patients who have ingested long-acting barbiturates, the observation period should be based on both barbiturate levels and clinical If quantitative serum concentrations are available (as with phenobarbital), serial concentrations can be obtained and the patient observed until concentrations peak and are de creasing, although this should likely be done during inpatient stays rather than in the ED. Patients with abnormal vital signs or significant CNS depression should be admitted to an intensive care unit. Patients who require intensive care or extracorporeal elimination may need to be transferred if necessary. Advanced life -support measures to stabilize the patient and activated charcoal giv en prior to transfer. Suicide evaluation is indicated for all suspected suicide attempts when the patient is alert enough to be mterviewed. Common Pitfalls . Failure to check for hypoglycemia as a cause of altered mental status. Failure to protect the airvvay in a somnolent patient. Failure to repeat MDAC and failure to check bowel sounds. 0 Failure to consider barbiturate withdrawal in patient with seizures. References l. Goldfrank L, Osborn H. The barbiturate overdose. Hosp Physician. 1977;9z30?34. 2. Viswanathaen CT, Booker HE, Welling PG. Pharmacokinetics of phenobarbital following single and repeated doses. Clin Phammcol. WESTLAW 2019 Thomson Reuters. No claim to original US. Government Works. 5 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota CHSOT, Harweod Nuss' Clinical Pract. of Emergency Medicine, 3. Hardman JG, Limbird LE, eds. Goodman and Gilman's: The Phamacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill', 2001. 4. McCarron M, Schulze B, Walberg C, et a1. Short-acting barbiturate overdosage. JAMA. 5. Greenblatt DJ, Allen MD, Hannatz IS, et al. Overdosage with pentobarbital and secobarbital: Assessment of factors related to outcome. Clin Phamiacol. 6. Boldy DA, Vale IA, Prescott LF. Treatment of phenobarbitone poisoning with repeated oral administration of activated charcoal. Med. 7. Frenia ML, Schauben JL, Wears RL, et al. Multiple-dose activated charcoal compared to urinary alkalinization for the enhancement of phenobarbital elimination. Toxicol Clin Toxicol. 8. Proudfoot AT, Krenzelok EP, Vale A. Position paper on urine alkalinization. Toxicol Clin Toxicol. 9. Palm er BF. Effectiveness of hemodialysis in the extracorporeal therapy of phenobarbital overdose. Am Kidney Dis. 20003 6(3) 640?643. 10. Quan Winter ME. Extracorporeal removal of phenobarbital by highuflux hemodialysis. Appl Ther Res. Wolters Kluwer Health/Lippinc ott, Williams, and Wilkins. CH307 End of Document 2019 Thomson Reuters. No claim to original U.S. Government Works. WESTLAW ?2019 Thomson Reuters. No claim to original US. Government Works. 6 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 If you have issues viewing or accessing this file contact us at U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administration National Ins?tute on Drug Abuse Filed: 10122l2019 4:54 PM CST Minnehaha County, South Dakota RESEARCH ISSUES SERIES . Drugs and Em pioyment . Drugs and Sex . Drugs and Attitude Change . Drugs and Famiineer influence . Drugs and Pregnancy Drugs and Death . Drugs and Addict Lifestyles . A Cocaine Bibliography?Nonannotated . Drug Themes in Science Fiction . Drug Themes in Fiction . Predicting Adolescent Drug Abuse . Drug Abuse instrument Handbook . Data Analysis Strategies and Designs for Substance Abuse Research 14. Drugs and Personality 15. Cocaine?Summaries of Research 16. The Lifestyles of Nine American Cocaine Users?Summary 17. Drugs and Crime 18. Drug Users and the Criminal Justice System 19. Drugs and 20. Drug Users and Driving Behaviors 21. Drugs and Minorities 22. Research issues Update. 1978. 23. International Drug Use 24. Perspectives on the History of Substance Use 25. Use and Abuse of Amphetamine and its Substitutes 26. Guide to Drug Abuse Research Terminology" Guide to the Drug Research Literature '28. Assessing Marijuana Consequences: Selected Questionnaire Items 29. Drugs and the Family omm?pumoww?n Cover illustration by Sumishta Brahmin, copyright 1978. Used by permission of the artist. Further reproduction is prohibited without permission of the artist. .Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota .490lV19-002940. issues Guide to Drug Abuse Research Terminology Edited by Jack E. Nelson 89255 LLB. Department of Justice Helen Waiiens?tein Pearson National institute of Justice This document has been reproduced exactly as received from the Mollie Sayers person or organizaiion originating it. Points of View or opinions mated in this document are those of the authors and do not represent the official position or policies of me National institute of Justice. Thomas J. Permission to reproduce this copyrighie? maierial has been re 19 . 19 110 Domain/U. . Department 1932 We?hmm- to the National Criminal Justice Reference Service Further reproduction outside of the systern requires permis- sion of the copyright-owner. US. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service . Alcohol, Drug Abuse and Mental Health Administration National institute on Drug Abuse . 5600 Fishers Lane Rockviile. 2085? Filed: 10/22/2019 4:54' PM CST Minnehaha County. South Dakota 4SCIV19-002949- .. The U.S. Government does not endorse or favor any speci?c commercial product or commodity. Trade or- proprietary names appearing in this publication are used only because they are con- sidered esSentlal in the context of the studies reported herein. Materiai contained in this volume except for copyrighted material is in the public domain, and may be used and reprinted without obtaining permission from the institute or the author. Cite- tion as to source is appreciated. Permission has been obtained from the copyright holders to reproduce certain quoted material. Further reproduction of these quotations is prohibited without specific permission of the copyright holder. Permission to quote has been obtained for the following copyrighted material:_ (Chaplin 12, 13, 11+,15, 23, 29, 31, 36, 37-38, 50, 51, 52, 61, Eli, 71, 71:, 77, 79, 80, 81, 89, 91%. From Dictionary of New Revised Edition by James P. Chaplin. Copyright 1975 by James P. Chaplin. Rep?nted by permission of Dell Publishing (30., inc. [Encycioraedia of Socioio 5, 23, 26, 27, 33, 1111, 116, 52, 53, 65, 83, 813, 97, 99. Worn EncycIOpedia oFSocmlogy, New E. Updated. Guilford, Conn.: Doshkin Pubiishing GroUp, 1981. copyright 1981 by DPC Reference Publishing, inc. Reprinted with permission. [Fairchild 26, 30, 51, 52, 71}, 90, 99. From Fairchiid, H.P., ed. Dictionar of Socioiog_y and Related Totowa, N.J.: Littiefield, Adams, 19?6 (orig. puE. 1911115. REpi-inted? With permission from Philosophical Library Publishers, copyright holders. [Lingeman 15-46, 21, H3, 119, ?It, 72, 83, an, 36, 99, 100. From Lingeman. R. Drugs From A to Z: A Dictionary. New York: McGraw?Hili, 1969. Copyright 1969. Reprinted with permission i?rom McCraw?Hili Book Company. [Zadrozny 1959]"pp. 26, 115', 46, 80, 82, 86, 99. From Zadrozny, J. Dictidnary of Social Science. Washington, D.C.: Public Affairs Press, 1959. Reprinted With permission. THE EDITORS: Jack E. Nelson, Helen Wailenstein Peafeon, and acme payers, of Metrotea, Inc? Washington, pwtioipated in developmg tine pnbi'ieatiion for. the National Institute on Drug Abuse under Contmoi: No. fi'homas J. Deviation of Research, NIQA, served as co?editor in development of the mammals, and are NEDA of?cer. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 CONTENTS PREFACE USE OF GUIDE DRUG ABUSE RESEARCH TERMINOLOGY REFERENCES APPENDIXES Appendix A: Drug massi?cation Appendix Bzi Drug Slang Terms Appendix C: Trade Names Appendix D: Acronyms NQJRE I FEB 10 1933 .- Filed: 10122l2019 4:54 PM CST Minnehaha County, South-Dakota 490lV19-002940 101 115 116 121 127 129 PREFACE The first volume of the Research Issues Series was published in November 1974. Since that time, 29 volumes have been published in this series by the Division of Reaearch, National institute on Drug Abuse. The primary objective of the Research Issues Series is to provide both lay and professional read- ers comprehensive, yet succinct, information on topics of central interest to the drug abuse ?eld. The approach frequently used has been to provide abstracts of the relevant literature on a par- ticular topic. in other cases materials have been deveIOped and written especially for the series. This volume falls in the latter category and addresses the need for a reference guide to the ter? minology of the drug abuse field. it is based upon a draft compiled by Gregory Austin of the Southern California Research institute and reviewed by an editorial board of drug experts whose names and affiliations are listed below. The board members have not reviewed this extensively revised final edition, and the editors, while gratefully acknowledging the seminal contribution of' the board members, take major responsibility for any imprecision or errors that may' occur. Richard J. Bonnie, J.D. Howard B. Kaplan, University of Virginia Department of School of Law Baylor College of Medicine Charlottesville, Virginia Houston, Texas Marcelline Burns Dan J. Lettieri, Southern California Research Institute Sciences Branch Los Angeles, California Division of Research National lnstitute on Drug Abuse Sidney Cohen, Rockviile, Maryland institute University of Californiar?Los Angeles Mary Macari Documentation Associates, inc. Peter Fehrenbach Los Angeles, California Graduate Student Department of Stanton Peele, University of Missouri Department of Health Education Columbia, Missouri Teachers College at Columbia University New York City George J. Huba, Department of Patricia B. Sutker, University of Californian-Les Angeles Chief, Service Veterans Administration Medical Center Bruce Johnson, Phi). New Orleans, Louisiana Research Scientist New York State Division of Substance Abuse Services New York City Filed: 10/2i2l2019 4:54 PM CST Minnehaha County, South Dakota INTRODUCTION ?The drug abuse field consists of an amalgam of medical, social, and disciplines. This, in turn, reflects upon its terminology, which ranges from colorful along to advanced blo? medical nomenclature. The breadth of drug abuse terms is thus vast- and varied?-from lie-letter slang to chemicals and from conceptualizations based on street-wise hip to those taken from advanced molecular biomedicine. For example, a sociologist in the drug- field may be found observing a street dude who is taking care of business bags of China White so he can cop some real good snow: an epidemiologist may be concerned about the balloon effect likely to occur with implementation of a supply reduction strategy; a doctor may prescribe nepenthes, soporifics, or ergogenics to help patients cape; and a biochemist may 'be interested in studying 'the dose?response relationship of cholinergic agents on the parasympathetic nervous system. A vast array of drug users, dealers, clinicians, researchers, teachers, theorists, politicians, and others related to the drug abuse field have produced a large lexicon of terms that vary from the simple, but often clever, to the ultraoomplex. Many drug terms are ambiguous, especially slang, and, their meanings may vary over time ie.g., blues, black beauties, white stuff, kif, narcotic}. Other terms may be deadly concise but are often confusing to lay readers and professionals alike endorphinfenkephalin, agonistlantag? onist, analgesicianesthetic, congenerfiigand}. There frequently are slang and scientific terms for the same concept to insufflatelto blow, to injectlto shoot up, diacetyimorphine hydro? chloridefhorse, smack, or funk]. Some terms have exotic sounding names sinsemilla, khat, etonitazene), and others though widely used are grossly imprecise high, addiction, toler- ance, drug abuse, treatment). Explosive discoveries in the field are producing new and rapidly evolving terms, many of which are not currently defined in dictionaries or other standard reference works. These terms'are defined only in the research literature where they are being discussed and debated. Examples of this typelinclude the constantly expanding list of newly identified endogenous agonists, the newer urinalysis screening techniques, and the newer approaches to treatment. This Guide" to DruLAbuse Research Terminology attempts to bring a major segment of the myriad assortment of terms found in the drug abuse field under one cover and to present in glossary form definitions of many of the drug abuse terms that have to date been described only in the research literature. it has been designed and written to serve as a convenient guide for those requiring brief, nontechnical explanations of drug abuse terms. it can, hOWever, also be used as a sourcebooit for those interested in exploring drug ?abuse concepts in further depth through the numerous reference citations included and the cross-references to Research issues Series. in selecting terms for inclusion, a careful analysis of the field's terminology was undertaken. A primary source was the abstracts and the indexes of the MBA Research issues Series. Now covering over 1,000 documents and 25 volumes, the series deals with almost every aspect of human drug research. In the final selection process, four principal criteria were used: the frequency with which a term appeared In the literature, the importance of the term to the field, the extent to which a term might be unfamiliar to individuals outside certain disciplines, and (ii) the extent to which confusion or ambiguity surrounded a term's definition or usage. The definitions provided. are intended to reflect preferred or common use at present. They were developed either from the professional drug research literature, particularly that covered by the Research Issues Series, or from specialized dictionaries in the field and in related disciplines. Whenever possible, definitions were drawn directly from the research literature. in these instances, since it was not possible to cite all the materials pertaining to a particular term, topic, or concept, at least one source is cited for the interested reader. Filed: 10/2212019 4:54 PM CST Minnehaha CountyL80uth Dakota 490lV19-002940 - Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 490lV19-002940 2 USE OF THE GUIDE The guide consists of the main body of definitions and appendixes containing a general drug classification scheme, a comprehensive collection of slang terms for selected drugs, and a list of the acronyms and abbreviations frequently encountered in the drug abuse field and described in the main body of this volume. Terms are listed in alphabetical order. Drugs are defined under their generic names. Brand names [as listed in the 1981 Physician's Desk Reference] are presented in the body of the drug definitions. Users starting out with brand names only are referred to appendix A, where both brand and generic names for all of the drugs contained in this volume apiwear. Drug definitions also indicate the drug?s classification and common. slang names. A complete clas- sification scheme for the drugs contained in this guide is presented in appendix A. Only the most common and currently used drug slang terms are included in the body of the definition. if the drug is one of those for which a comprehensive list of slang terms is presented in appen- dix B, the reader is referred there. The inclusion of nondrug slang terms in this volume was done sparingly for the reasons that there are numerous. well-done drug slang dictionaries currently in existence. and (2) the primary emphasis of the guide is on research?literature?based terminology. Only those slang terms are included that are frequently encountered in the literature andlor are conceptually important in understanding drug abuse issues rush, booting, chipping]. Readers inter- ested in defining drug slang terms are referred to the bibliography in appendix 8. Terms that appear in the body of de?nitions with all letters capitalized are defined elsewhere in the guide. Terms appearing in the guide that may be useful to the reader of a particular defi- nition are noted at the end by "See.? . . or ?See also. . . Research Issues Series Volume Guide to the Drug Research Literature. is a cumulative index to the first 26 volumes in the series. if the term being defined is indexed in Research issues Series Volume 27, the term or related term. the page number, and the number of literature ref- erence entries to be found there are listed in parentheses at the end of the definition. Terms in the guide that are listed in volume 27 are indicated at the end of individual entries in the following manner: entries] This entry, for example, refers to Research issues Series No. 27:page 300?43 entries listed. A reference may also be included for a term that is different from but related to the term being defined. For example: term: anesthetics reference: [anesthetic uses, entries] The format components for the definitions are explained and demonstrated graphically in figure 1 on the following page. Tenn being de?ned, listed in word-byword alphabetical order. All caps indicates this ?3:115: Related terms that may word is de?ned else- The leest'potent of the amphetamines. be useful to the reader where in the guide, manufactured as Benzedrine. that are defined else? in 1927 it was ?rst used In 1932 as an where in the guide. inheler decongestent and In the treatment -- eff During World War II it troernphetamine pennies. henz. 13,, e; 199-?136entrles; Benzedrlne R18 27: 202" 12 entries} - ?mgr @5333 W. Classification of drug according to the H, scheme shown in appendix A. . Fre uentl used slen Terms indexed R13 pangs. 9 summary volume 21~- ?amphetamines? appears on page 199 and has 136 references; "Benze- drtne," a related com pound, appears on page 202 and has 12 references. FIGURE 1m~Definition components Filed:l101_2212019 4:54 PM CST Minnehaha CountyISouthDakote the chemical components of a substance. See also urine testing for drugs. ataractics [ate raxics) See tranquilizers. ataxia Gross muscular incoordination as in alcohol intoxication. at?risk populations Subgroups within the population whose members have been identified as being par- ticularly susceptible to becoming drug mlsusers. These subgroups are usually targeted by organized drug misuse preven? tion efforts and often include groups such as adolescents, the elderly, and middle? aged housewives. autonomic nervous system .See nervous system. automatiom, drug The consumption of drugs without con? scious awareness of the amount being taken. This state occurs with heavy users of central nerVous system DEPRESSANTS and it has been suggested. that it accounts for some deaths from BARBITURAT: over- dosage. According to this theory, the drug creates a confused state and the user does not recall taking the dose; while in this condition the individual takes another capsule; this process often continues until a lethal overdose has been ingested. Mal? colm (1971:1511 considers this theory entirely speculative and unproven: "If a person takes an overdose of barbiturates he intends either to die or to indicate to certain signi?cant people that his environ- ment must change. if his intention is the latter and he dies, it is accidental, but this accident is not due to automatism." aversion therapy In BEHAVIOR MODIFICATION, the reduc? tion of a behavior through a conditioning procedure in which the behavior is associ? ated with real or imagined noxious stimuli [for example, an electric shock). which would be avoided if possible [Chaplin 1975}. A treatment that suppresses unde? sirable behavior by associating a painful or unpleasant reaction with the behavior (A Glossary 1975}. Aversion therapy is frequently used in smoking ces? sation programs. bad trip See panic reaction. bag Slang. A quantity of leafy or powdered illicit drug marijuana, heroin] that comes in a paper or glassine envelope or plastic bag. Local convention and prevail- ing illicit drug prices determine the quan? tities of drugs sold by the "bag." The terms "nickel" and ?dime" bags have long been used as standard street retail units for the packaging of small quantities of drugs, but they have been made nearly extinct by inflation over the years. balloon effect Refers to the phenomenon of drug users substituting the use of one type of drug for another when authorities clamp down on their original drug of choice; like a balloon, when drug use is squeezed in one direction it often expands in another, often with adverse results. For example, heroin use increased in Southern California after Operation intercept's blockade of Mexican marijuana [Bryant et al. 1973]. loam Slang. Street name for PHENMETRAZINE HYDROCHLORIDE [Preludin]. barbital One of the long?acting BARBITURATES. Manufactured in 1883, barbital was one of the ?rst barbiturates used in medicine. Manufactured as Veronal. Classification: sedatiVe/ hypnotics . barbiturates The largest and most common group of the sedativeihypnotlcs. in small doses they are effective in sedation and in relieving tension and anxiety, and. like TRANQUILIZERS, they do not cause much drowsiness .. in larger doses they are used as hypnotics [sleep inducers]. Certain barbiturates are used for epilepsy and intravenous anesthesia. When large dos- ages are not followed by sleep, signs of mental confusion, euphoria, and even stim? ulation may occur, similar to that produced Filed: 19/22/2019 4:54 PM CST Minnehaha County, South Dakota 13 by ALCOHOL, another sedativei'hypnotic. Hence barbiturates are often used recrea- tionaiiy by people seeking similar effects to those produced by alcohol, often cam- bining the two. As alcohol potentlates [see barbiturate effects, this practice is extremely hazardous. Bar? biturates are also used in combination with, or as a substitute for other depressants. such as heroin, and are often taken alter? nately with AMPHETAMINES, as they tend to enhance the euphoric effects of ampheta? mines while calming the overwrought nerv- ous states they produce. in large dosages they can ease severe poisoning, deep comes, respiratory and kidney failure, and death. Thus barbiturates play a lead- ing role in fatal poisonings and suicides in the United States. TISM has been identi?ed as a potential cause of deaths due to excessive barbitur? ate Use. Since first used in 1903, over 2,500 bar? biturates have been produced, but only 50 commercial brands are now available and only 12 are widely used. in 1970, barbiturates and barbiturate substitutes accounted for 28.6 percent of all prescripm tions for drugs in America [National Commission on Marihuana and Drug Abuse 1973:43}. Although still con? sidered indispensible in medicine, their medical applications have declined primarily due to the availability of other drugs with similar effects such as the antianxiety tranquilizers and other nonbarbiturate sedative-hypnotics. The barbiturates are usually divided into three categories according to the rate of speed with which they are eliminated from the body: long-acting [6-24 hours)?- iLuminal), [Veronal]; (2.) short-to-intermedlate-acting {3-6 SODIUM [Nembutall, SECOBARBITAL SODIUM [Seconali.-Tuinai (a secobarbitai sodium! combination), and BARBITAL SODIUM [Butisoi Sodium or Buticaps]; and ultra-short?acting (under 3 SODIUM [Pantothai]. The most widely abused and dangerous are the short-to-intermediate? acting barbiturates. Primarily prescribed to treat sleep disturbances, they are the ones most likely to be used to produce intoxication, to be found on the illicit market, and to be used in suicide attempts. in Great Britain, the suf?x u-~ai" is replaced by barbitone instead of barbltal. Classification: seda? Slang names: rainbows, blue devils, reds, yellows, yellow jackets, F__iled:_ 1012212019 4:54 PM CST Minnehaha County, South Dakota blues, blue heavens (based on the unique colors of their pharmaceutical capsules]; barbs, dormers. down, goofballs, sleeping pills. See also appendix B. 27:202-? 48 entries: pentobarbital, RIS 27:222-wl entry phenobarbital, RI 5 27 :223-?2 entries; secoba rbital RI 27 entries] beer An alcoholic beverage obtained by the FER- MENTATION of barley mall; or other grains, often "hopped" (flavored with hops or other aromatic hitters). Most beers con- tain 3 to 6 percent alcohol by volume {compared to 25 to 50 percent for distilled spirits and 8 to ill percent for wine). Prior to the 13th century, beer was dis- tinguished from ale by being hopped; with the industrialization of brewing in the 13th century, all malt liquor gradually became hopped and beer and ale'are now generally synonymous. in the early 19th century, beer was regarded as a foreign urban drink in the United States [Keller and McCormick 1958). Classification: sedativeihypnotics. behavior disorder A broad term that describes a behavior abnormality believed not to be associated with specific organic causes or in general, the term is used for abnormal? ities that affect general and social adjust- ment, Such as drug use, antisocial behavior. and crime. behavior modi?cation The changing of human behavior through conditioning or other learning techniques; often used as a synonym for BEHAVIOR THERAPY. One of the major concepts employed by THERAPEUTIC COMMUNITIES. See also aversion therapy. behavior therapy The systematic application 'of learning prin? ciples and teChniques to the treatment of behavior disorders that focuses on attack- ing the rather than tracing the history of the problem as in traditional forms of (Chaplin 1975-]. BEHAVIOR MODIFICATLON is often utilized as a synonym, although the American Psy~ chological Association views behavior ther- apy as one method of behavior modification, along with aversion therapy (Kinkade 1971i]. behavioral pharmacology The branch of pharmacology that deals with the effects of drugs on behavior. particularly operant behavior processes. See dose?response relationship. benzene A toxic, volatile hydrocarbon derived Nembutal? Sodium Solution (pentobarbital sodium injection, USP) Egoniy Vials DO NOT USE IF MATERIAL HAS PRECIPITATEO DESCRIPTION The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (See "Drug Abuse and Dependence" section). The sodium salts of amobarbital, pentobarbital, phenobarbital, and secobarbital are available as sterile parenteral solutions. Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. . Sodium Solution (pentobarbital sodium injection) is a sterile solution for Intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a 'vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume. The pH is adjusted to approximately 9.5 with hydrochloric acid andior sodium hydroxide. NEMBUTAL Sodium is a shortacting barbiturate, chemically designated as sodium barbiturate. The structural formula for pentobarbital sodium is: on. I smut-unmet: [ll-lI 0 The sodium salt occurs as a white, bitter powder which is treely soluble in water and alcohol but practically insoluble in benzene and ether. CLINICAL PHARMACOLOGY Barbiturates are capable of producing all levels of CNS mood alteration from excitation to mild sedation, to hypnosis. and deep coma. Overdosage can produce death. In high enough therapeutic doses, barbiturates induce anesthesia. Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, and hypnosis. Barbiturate?induced sleep differs from physiological sleep. Sleep laboratory studies have demonstrated that barbiturates reduce the amount of time spent in the rapid movement (REM) phase of sleep or dreaming stage. Also, Stages and IV sleep are decreased. Following abrupt cessation of barbiturates used regularly, patients may experience markedly increased dreaming, nightmares, andior insomnia. Therefore, withdrawal of a single therapeutic dose over 5 or 6 days has been recommended to lessen the REM rebound and disturbed sleep which contribute to drug withdrawal (for example, decreasethe dose from 3 to 2 doses a day for 1 week). In studies, secobarbital sodium and pentobarbital sodium have been found to lose most of their effectiveness for both inducing and maintaining sleep by the end of 2 weeks of continued drug administration at fixed doses. The short?-, intermediate, and, to a lesser degree, long?acting barbiturates have been widely prescribed for treating insomnia. Although the clinical literature abounds with claims that the short-acting barbiturates are superior for producing sleep while the intermediate?acting compounds are more effective in maintaining sleep, controlled studies have failed to demonstrate these differential effects. Therefore, as sleep medications, the barbiturates are of limited value beyond short-term use. Barbiturates have little analgesic action at subanesthetic doses. Rather, in subanesthetic doses these drugs may increase the reaction to painful stimuli. All barbiturates exhibit anticonvulsant activity in anesthetic doses. However. of the drugs in this class, only phenobarbital, mephobarbital, and metharbital have been clinically demonstrated to be effective as oral anticonvulsants in doses. Barbiturates are respiratory depressants. The degree of respiratory depression is dependent upon dose. With hypnotic doses, respiratory depression produced by barbiturates ls similar to that which occurs during physiologic sleep with slight decrease in blood pressure and heart rate. Studies in laboratory animals have shown that barbiturates cause reduction in the tone and contractility of the uterus, ureters, and urinary bladder. However, concentrations of the drugs required to produce this effect in humans are not reached with sedative- hypnotic doses. Barbiturates do not impair normal hepatic function, but have been shown to induce liver microsomal enzymes, thus increasing andior altering the metabolism of barbiturates and other drugs. (See ?Precautions?Drug interactions" section). Pita rma cokinetics: Barbiturates are absorbed in varying degrees following oral, rectal, or parenteral administration. The salts are more rapidly absorbed than are the acids. The onset of action for oral or rectal administration varies from 20 to 60 minutes. For Hit administration, the onset of action is faster. Following IV administration, the onset of action ranges from almost immediately tor pentobarbital sodium to 5 mlnutesfor phenobarbital sodium. Maximal CNS depression may not occur until 15 minutes or more after IV administration for phenobarbital sodium. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota Duration of action, which is related to the rate at which the barbiturates are redistributed throughout the body, varies among persons and inthe'same'person from time to time. No studies have demonstrated that the different routes of administration are equivalent with respect to bioavailability. Barbiturates are weak acids that are absorbed and rapidly distributed to all tissues and fluids with high concentrations in the brain, liver, and kidneys. Lipid solubility of the barbiturates is the dominant factor in their distribution within the body. The more lipid soluble the barbiturate, the more rapidly it penetrates all tissues of the body. Barbiturates are bound to plasma and tissue proteins to a varying degree with the degree of binding increasing directly as a function of lipid solubility. Phenobarbital has the lowest lipid solubility, lowest plasma binding, lowest brain protein binding, the longest delay in onset of activity, and the longest duration of action. At the opposite extreme is secobarbital which has the highest lipid solubility, plasma protein binding, brain protein binding, the shortest delay in onset of activity, and the shortest duration of action. Butabarbital is classified as an intermediate barbiturate. The plasma half?life for pentobarbital in adults is 15 to 50 hours and appears to be dose dependent Barbiturates are metabolized primarily by the hepatic microsomal enzyme system, and the metabolic products are excreted in the urine, and less commonly, in the feces. Approximately 25 to 50 percent of a dose of aprobarbital or phenobarbital is eliminated unchanged in the urine, whereas the amount of other barbiturates excreted unchanged in the urine is negligible. The excretion of unmetabolized barbiturate is one feature that distinguishes the long-acting category from those belonging to other categories which are almost entirely metabolized. The inactive metabolites of the barbiturates are excreted as conjugates of glucuronic acid. IN DICATIO NS AND USAGE Parenteral: a. Sedatives. b. Hypnotics, for the she rt-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See "Clinical Pharmacology? section.) c. Preanesthetics. d. Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to or local anesthetics. CONTRAINDICATIONS Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent WARNINGS l. Habit forming: Barbiturates may be habit forming. Tolerance, and physical dependence may occur with continued use. (See "Drug Abuse and Dependence? and "Pirarmacokinetics" sections.) Patients who have dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive dosage over long periods of time. (See "Drug Abuse and Dependence" section.) 2. ll/ administration: Too rapid administration may cause respiratory depression, apnea, Iaryngospasm, or vasodilation with fall in blood pressure. 3. Acute or chronic pain: Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established. 4. Use in pregnancy: Barbiturates can cause fetal damage when administered to a pregnant woman. Retrospective, case-controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Following oral or parenteral administration, barbiturates readily cross the placental barrier and are distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain. Fetal blood levels approach maternal blood levels following parenteral administration. Withdrawal occur" in infants born to mothers who receive barbiturates throughout the last trimester of pregnancy. (See ?Drug Abuse and Dependence" section.) if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. . synergistic effects: The concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects. . Pediatric neurotoxicity' Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block receptors andior potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is not clear. However, based on the available data, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation throughthe first several months of life, but may extend out to approximately three years of age in humans (see ?Precautions-Pregnancy and Pediatric Use" and ?Animal Pharmacology andto'r Toxicology"). 490lV19-002940 CH Some published studies in children suggest that similar deficits may occur after repealed or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations. and it is not clear if the observed effects are due to the anestheticisedation drug administration or other factors such as the surgery or underlying illness. Anesthetic and sedation drugs are a necessary part of the care of children and pregnant women needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks. PRECAUTIONS General: Barbiturates may be habit forming. Tolerance and and physical dependence may occur with continuing use. (See "Drug Abuse and Dependence" section.) Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. Elderly or debilitated patients may react to barbiturates with marked excitement, depressron, and confusion. In some persons, barbiturates repeatedly produce excitement rather than depression. In patients with hepatic damage. barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma. - Parenteral solutions of barbiturates are highly alkaline. Therefore, extreme care should be taken to avoid perivascular extravasation or intra-arterial iniection. Extravascular injection may cause local tissue damage with subsequent necrosis; consequences of intra~arterial injection may vary from transient pain to gangrene of the limb. Any complaint of pain in the limb warrants stopping the injection. information for the patient: Practitioners should give the following information and instructions to patients receiving barbiturates. 1. ta The use of barbiturates carries with it an associated risk of andior physical dependence. The patient should be warned against increasing the dose of the drug without consulting a physician. . Barbiturates may impair mental and/or physical abilities required forthe performance of potentially hazardous tasks driving, operating machinery, etc.). . Alcohol should not be consumed while taking barbiturates. Concurrent use of the barbiturates with other CNS depressants leg, alcohol, narcotics, tranquilizers, and antihistamines) may result in additional CNS depressant effects. . Effect of anesthetic and sedation drugs on early brain development Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs. Because some animal data suggestthat the window of vulnerability includes the 3rd trimester of pregnancy, discuss with pregnant women the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs. (See ?WarningsPediairic Neurotoxicity?.) boratory tests: Prolonged therapy with barbiturates should be accompanied by periodic laboratory evaluation of organ systems, including hematopcietic, renal, and hepatic systems. (See "Precautions-Generai' and ?Adverse Reactions? sections.) Drug interactions: lvlost reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However. the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies. 1. 01 Anticoaguiants: Phenobarbital towers the plasma levels of dicumarol (name previously used: and causes a decrease in anticoagulant activity as measured by the prothrombin time. Barbiturates can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants warfarin, acenocoumarot, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. . Corticosteroids: Barbiturates appear to enhance the metabolism of exogenous corticosteroids probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. .Gn?seofuivin: Phenobarbital appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofutvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs. . Phenobarbital has been shown to shorten the halt~life of for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If phenobarbital and are administered concurrently, the clinical response to should be monitored closely. . Piienytoin, sodium valproate, valproic acid: The effect of barbiturates on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota while others report no effect. Because the effect of barbiturates on the metabolism of phenytoin is not predictable, phenytoin and barbiturate blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease barbiturate metabolism; therefore, barbiturate blood levels should be monitored and appropriate dosage adjustments made as indicated. . Centrai nervous system depressants: The concomitant use of other central nervous system depressants, including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects. . Monoamine oxidase inhibitors MAOI prolong the effects of barbiturates probably because metabolism of the barbiturate is inhibited. . Estradioi, estrone, progesterone and other steroidai hormones: Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (eg, phenobarbital) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking phenobarbital. Carcinogenesis: 1. Animal data. Phenobarbital sodium is carcinogenic in mice and rats after lifetime administration. In mice, it produced benign and malignant liver cell tumors. In rats, benign liver cell tumors were observed very late in life. . Human data. In a 29?year epidemiological study of 9,136 patients who were treated on an anticonvulsant protocol that included phenobarbital, results indicated a higher than normal incidence of hepatic carcinoma. Previously, some of these patients were treated with thorotrast, a drug that is known to produce hepatic carcinc mas. Thus, this study did not provide sufficient evidence that phenobarbital sodium is carcinogenic in umans. Data from one retrospective study of 235 children in which the types of barbiturates are not identified suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumor. (Gold, E., et at, "Increased Risk of Brain Tumors in Children Exposed to Barbiturates," Journal of National Cancer Institute, 61 :1031?1034. 1978). Pregnancy 1. Teratogenic effects. Pregnancy Category D#See "Warnings?Use in Pregnancy? section. 2. Nonteratogenic effects. Reports ofinfants sufferingfrom long?term barbiturate exposure in utero included the acute withdrawal of seizures and hyperirritability from birth to a delayed onset of up to tel days. (See ?Drug Abuse and Dependence" section.) .Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors andior potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain ofthe when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. In a published study, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isofiurane or propofoi for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits (see ?Warnings? Pediatric Neurotoxicity?, Precautions-Pediatric Use?, and "Animal Pharmacology andi or Toxicology?). tabor and delivery.- Hypnotic doses of these barbiturates do not appear to significantly impair uterine activity during labor. Full anesthetic doses of barbiturates decrease the force and frequency of uterine contractions. Administration of sedative?hypnotic barbiturates to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of barbiturates. If barbiturates are used during labor and delivery, resuscitation equipment should be available. Data are currently not available to evaluate the effect of these barbiturates when forceps delivery or other intervention is necessary. Also, data are not available to determine the effect of these barbiturates on the later growth, development, and functional maturation of the child. Nursing mothers: Caution should be exercised when a barbiturate is administered to a nursing women since small amounts of barbiturates are excreted in the milk. Pediatric use; No adequate well-controlled studies have been conducted in pediatric patients; however, safety and effectiveness of pentobarbital in pediatric patients is supported by numerous studies and case reports cited in the literature. Pediatric dosing information for Nembutal is described in the DOSAGE AND ADMINISTRATION section. Published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as Pentobarbital Sodium Injection USP, (Nembutal) that either block NMDA receptors or potentiate the activity of GABA during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species. the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans. 49CIV19-002940 in primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. Data irom isoflurane?treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates. and young children who require procedures with the potential risks suggested by the nonclinical data. (See ?Warnings-Pediatric Neurotoxicity?, "Precautions?Pregnancy?. and ?Animal Pharmacology andtor Toxicology") Geriatric use: Clinical studies of Nembutal have not included sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. reflecting the greater frequency of decreased hepatic, renal or cardiac function. and of concomitant disease or other drug therapy. Elderly patients may react to barbiturates with marked excitement. depression. and confusion. In some persons, barbiturates repeatedly produce excitement rather than depression. Dosage should be reduced in the elderly because these patients may be more sensitive to barbiturates. ADVERSE REACTIONS The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients. Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients. More than in 100 patients. The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 1 00 is: Nervous System: Somnolence. Less than in 100 patients. Adverse reactions estimated to occur at a rate of less than 1 In 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are: Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality. Respiratory system: Hypoventilatlon. apnea. Cardiovascular system: Bradycardia, hypotension, syncope. Digestive system: Nausea. vomiting, constipation. Other reported reactions: Headache, iniection site reactions. hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever. liver damage, megaloblastic anemia following chronic pheno barbitai use. To report SUSPECTED ADVERSE REACTIONS, contact Oak Pharmaceuticals, Inc. at or FDA at or DRUG ABUSE AND DEPENDENCE Pentobarbital sodium injection is subject to control by the Federal Controlled Substances Act under DEA schedule It. Barbiturates may be habit forming. Tolerance, dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. Daily administration in excess of 400 milligrams (mg) of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree of physical dependence. A dosage of from 600 to 800 mg taken for at least 35 days is sufficient to produce withdrawal seizures." The average daily dose for the barbiturate addict is usually about 1.5 grams. As tolerance to barbiturates develops. the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxicating dosage and fatal dosage becomes smaller. of acute intoxication with barbiturates include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic Intoxication include confusion, poor judgment. irritability, insomnia, and somatic complaints. of barbiturate dependence are similar to those of chronic alcoholiSm. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested. The of barbiturate withdrawal can be severe and may cause death. Minor withdrawal may appear 8 to 12 hours after the last dose of a barbiturate. These usually appear in the following order: anxiety, muscle twitching. tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal gradually declines over a period of approximately 15 days. Individuals susceptible to barbiturate abuse and dependence include alcoholics and opiate abusers, as well as other sedative-hypnotic and amphetamine abusers. - Drug dependence to barbiturates arises from repeated administration of a barbiturate or agent with barbiturate?like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence to barbiturates include: a strong desire or need to continue taking the drug; a tendency to increase the dose; a dependence on the effects of the drug related to subjective and individual appreciation of those-effects; and a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self?limited abstinence when the drug Is withdrawn. Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. in all cases withdrawal takes an extended period of time. One method involves substituting a 30 mg dose of phenobarbital for each too to 200 mg dose of barbiturate that the patient has been taking. The total daily amount of phenobarbital is then administered in 3 to 4 divided doses. not to exceed 600 mg daily. Should signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of phenobarbital may be administered IM in addition to the oral dose. After stabilization on phenobarbital, the total daily dose is decreased by 30 mg a day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patients regular dosage level and decreasing the daily dosage by 10 percent if tolerated by the patient. Infants physically dependent on barbiturates may be given phenobarbital 3 to 10 After withdrawal (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved. the dosage of phenobarbital should be gradually decreased and completely withdrawn over a 2?week period. The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and with various neurological disorders. Acute overdosage with barbiturates is manifested by CNS and respiratory depression which may progress to Shayne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may show paralytic dilation), oligurla, tachycardia. hypotension, lowered body temperature, and coma. Typical shock (apnea, circulatory collapse, respiratory arrest, and death) may occur. In extreme overdose, all electrical activity in the brain may cease, in which case a ?flat" EEG normally equated with clinical death cannot be accepted. This effect is fully reversible unless hypoxic damage occurs. Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to Involve trauma. Complications such as pneumonia, pulmonary edema. cardiac congestive heart failure, and renal failure may occur. Uremia may increase CNS sensitivity to barbiturates. Differential diagnosis should include hypoglycemia, head trauma, cerebrovascular accidents, convulsive states, and diabetic coma. Blood levels from acute overdosage for some barbiturates are listed in Table 1. Table 1. Concentration of Barbiturate in the Blood Versus Degree of CNS Depression Blood barbiturate level in (jigimL) Onsett a Barbiturate duration 1 2 3 4 5 Pentobarbital Fastishort Secobarbitat Fastishort Amobarbital lntermediatei intermediate Butabarbital Intermediate100 intermediate Phenobarbital Slowrlong 510 200 *Categorles of degree of depression in nontoierant persons: 1. Under the influence and appreciably impaired for purposes of driving a motor vehicle or performing tasks requiring alertness and unimpaired judgment and reaction time. 2. Sedated, therapeutic range, calm, relaxed, and easily aroused. 3. Comatose, difficult to arouse, significant depression of respiration. 4. Compatible with death in aged or-iII persons or in presence of obstructed airway, other toxic agents, or exposure to cold. 5. Usual lethal level, the upper end of the range includes those who received some supportive treatment. Treatment of overdosage is mainly supportive and consists of the following: 1. Maintenance of an adequate airway, with assisted respiration and oxygen administration as necessary. - 2. Monitoring of vital signs and fluid balance. 3. Fluid therapy and other standard treatment for shock, if needed. 4. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates, especially phenobarbital, also aprobarbital and mephobarbital (which is metabolized to phenobarbital). 5. Although not recommended as a routine procedure, hemodialysis may be used in severe barbiturate intoxications or if the patient is anuric or in shock. 6. Patient should be rolled from side to side every 30 minutes. Y. Antibiotics should be given if pneumonia is suspected. 8. Appropriate nursing care to prevent hypostatic pneumonia, decubiti, aspiration, and other complications of patients with altered states of consciousness. DOSAGE AND ADMINISTRATION Dosages of barbiturates must be individualized with iull knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical. intramuscularAdministration: injection of the sodium salts of barbiturates should be made deeply into a large-muscle, and a volume of 5 mL should not be exceeded at any one site because of possible tissue irritation. After injection of a hypnotic dose, the patient's vital signs should be monitored. The usual adult dosage of NEMBUTAL Sodium Solution single livl injection; the recommended pediatric dosage ranges from 2 to 6 as a single livi injection notto exceed 100 mg. intravenousAdministration: NElvl BUTAL Sodium Solution should not be admixed with any other medication or solution. IV injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia. or status epilepticus). or because the patient resists (as in delirium), or because prompt action is imperative. Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded, and equipment for resuscitation and artificial ventilation be available. The rate of iv injection should not exceed 50 mgimin for pentobarbital sodium. There is no average intravenous dose of NEMBUTAL Sodium Solution (pentobarbital sodium injection) that can be relied on to produce similar effects in different patients. The possibility of overdose and respiratory depression is remote when the drug is injected slowly in fractional doses. A commonly used initial dose for the 70 kg adult is 100 mg. Proportional reduction in dosage should be made for pediatric or debilitated patients. At least one minute is necessary to determine the full effect oiintravenous pentobarbital. If necessary, additional small increments of the drug may be given up to a total of from 200 to 500 mg for normal adults. Anticonvuisant use: In convulsive states, dosage of NEMBUTAL Sodium Solution should be kept to a minimum to avoid compounding the depression which may follow convulsions. The injection must be made slowly with due regard to the time required for the drug to penetrate the blood?brain barrier. Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease. inspection: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. whenever solution containers permit. Solutions for injection showing evidence of precipitation should not be used. HOW SUPPLIED NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 per vial (NDC 76478-50120); and 50?mL multiple-dose vial, 2.5 per vial (NDO Each mL contains: Pentobarbital Sodium, derivative of barbituric acid 50 mg Propylene glycol 40% via Alcohol 10% Waterfor Injection qs (pH adjusted to approximately 9.5 with hydrochloric acid andior sodium hydroxide.) Vial stoppers are latex tree. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at however, brief excursions are permitted bebneen 15?-30?0 See USP controlled room temperature. ANIMAL PHARMACOLOGY AN DIOR TOXICOLOGY Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend outto approximately 3 years of age in humans. in primates, exposure to 3 hours of exposure to an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and ollgodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data (see "Warnings-Pediatric Neurotoxicity' and "Precautions?Pregnancy and Pediatric Use"). OAKORN Distributed by: Akorn, Inc. Lake Forest, lL 60045 Manufactured for: Oak Pharmaceuticals. Inc. Trademark of Oak Pharmaceuticals, Inc. OPN MOON Rev. 12116 P1028 Fiev. 02118 Filed: 10/22/2019 4:54 PM CST Minnehaha County, South Dakota 49CIV19-002940