Case: 14-12663 Date Filed: 06/17/2014 Page: 1 of 46 IN THE UNITED STATES COURT OF APPEAL FOR THE ELEVENTH CIRCUIT _________________ NO. 14-12663 CAPITAL CASE EXECUTION SCHEDULED TODAY, JUNE 17, 2014, 7:00 P.M. _________________ MARCUS A. WELLONS Appellant/Plaintiff, versus BRIAN OWENS, Commissioner, Georgia Department of Corrections, et. al. Appellee/Defendants. __________________________________________________ EMERGENCY BRIEF OF APPELLANT ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA, ATLANTA DIVISION __________________________________________________ Gerald W. King Jr. (Ga. Bar No. 140981) Jeffrey Lyn Ertel (Ga. Bar No. 249966) Federal Defender Program, Inc. 101 Marietta Street, Suite 1500 Atlanta, GA 30303 (404) 688-7530 Mary Elizabeth Wells (Ga. Bar No. 747852) Law Office of M.E. Wells 623 Grant Street, SE Atlanta, GA 30313 (404) 408-2180 COUNSEL FOR MR. WELLONS Case: 14-12663 Date Filed: 06/17/2014 Page: 2 of 46 CERTIFICATE OF INTERESTED PERSONS Pursuant to Fed.R.App.P. 26.1 of this Court, counsel hereby certify that the following have an interest in the outcome of this case: (a) Hon. Timothy Batten, United States District Court Judge for the Northern District of Georgia; (b) Beth Attaway Burton, counsel for appellee; (c) Bruce Chatman, Warden, Georgia Diagnostic Prison, appellee (d) Jeffrey Ertel, counsel for appellant; (e) Sabrina Graham, counsel for appellee; (f) Hon. Willis J. Hunt, United States District Court Judge, for the Northern District of Georgia; (g) Gerald King, counsel for appellant; (h) Brian Owens, Commissioner, Department of Corrections, Appellee; (i) Hon. Mary Staley, Judge of the Superior Court, Cobb County, trial judge; (j) Unknown Employees and Agents, Georgia Department of Corrections; (k) Mitchell Watkins, counsel for appellee; C-1 Case: 14-12663 Date Filed: 06/17/2014 Page: 3 of 46 CERTIFICATE OF INTERESTED PERSONS (l) Dana Weinberger, counsel for appellee; (m) Marcus Wellons, appellant; and (n) Mary Elizabeth Wells, counsel for appellant. C-2 Case: 14-12663 Date Filed: 06/17/2014 Page: 4 of 46 JURISDICTION This is an appeal from the district court’s order granting the Defendants’ Motion to Dismiss Plaintiff’s 42 U.S.C. § 1983 action and Motion for Temporary Restraining Order and Stay of Execution. This Court has jurisdiction under 28 U.S.C. § 1291. This Court reviews the district court’s grant of a motion to dismiss de novo. Powell v. Thomas, 643 F.3d 1300 (11th Cir. 2011). STATEMENT OF THE ISSUES Appellees have told Plaintiff Marcus Wellons that they will execute him by lethal injection at 7:00 p.m. today. They will tell him little more. Instead, Appellees rely upon Georgia’s new lethal injection secrecy act to shield critical aspects of their execution procedures from scrutiny by Mr. Wellons, the public, and the courts. Appellees refuse to disclose the provenance – and true nature – of the substance with which they will inject Mr. Wellons to end his life. Nor will they confirm the qualifications of the personnel whom they have delegated to carry out his execution, including those who will place the catheters into his veins. In his underlying complaint, Mr. Wellons challenges neither the conviction underlying his sentence of death nor that sentence itself. Nor does he allege that lethal injection as a form of execution is per se unconstitutional. But Appellees’ refusal to disclose these critical aspects of their lethal injection procedures deprives him and the 1 Case: 14-12663 Date Filed: 06/17/2014 Page: 5 of 46 courts of the information necessary to determine whether those procedures present a “substantial risk of significant harm” in violation of his Eighth Amendment rights – a risk recently underscored by Oklahoma’s secretive and botched execution of Clayton Lockett. It also deprives Mr. Wellons of his First Amendment right of access to governmental proceedings. Accordingly, as Appellees’ conduct cannot be sanctioned by the Constitution, Mr. Wellons respectfully appeals the district court’s denial of declaratory and injunctive relief. STATEMENT OF THE CASE Mr. Wellons was convicted of malice murder and rape and sentenced to death in the Superior Court of Cobb County in 1993. The Supreme Court of Georgia affirmed Mr. Wellons’s convictions and sentences, Wellons v. State, 463 S.E.2d 868 (1995), and the Supreme Court of the United States denied Mr. Wellons’s certiorari petition, Wellons v. Georgia, 519 U.S. 830 (1996). Mr. Wellons sought state habeas corpus relief, which was denied. Mr. Wellons filed a petition for writ of habeas corpus in the District Court for the Northern District of Georgia which was denied. This Court affirmed the denial of relief on June 25, 2010. Wellons v. Hall, 554 F.3d 923 (11th Cir. 2006). The Supreme Court granted Mr. Wellons’s petition for writ of certiorari and remanded Mr. Wellons’s 2 Case: 14-12663 Date Filed: 06/17/2014 Page: 6 of 46 case for further consideration. Wellons v. Hall, 558 U.S. 220 (2010).1 After this Court remanded Mr. Wellons’s case to the district court for “further proceedings consistent with the Supreme Court’s opinion,” Wellons v. Hall, 603 F. 3d 1326 (11 Cir. 2010), that court entered its order and judgment denying habeas corpus relief on August 5, 2011. This Court affirmed the district court’s denial of Mr. Wellons’s habeas petition on September 19, 2012 (D153-Appendix A). The Supreme Court denied his petition for a writ of certiorari on October 7, 2013. Wellons v. Humphrey, 134 S.Ct. 177 (2013). Pursuant to an order entered by the Superior Court of Cobb County on May 28, 2014, Defendant GDC has scheduled Mr. Wellons for execution on June 17, 2014. On June 12, 2014, Mr. Wellons filed a complaint pursuant to 42 U.S.C. § 1983 in the United States District Court for the Northern District of Georgia seeking declaratory and injunctive relief. Mr. Wellons concurrently a motion for a temporary restraining order and stay of execution. That Court denied that motion and granted Appellants’ 1 The Court found no procedural bar for Mr. Wellons’s claims of judge, juror, and bailiff misconduct, which centered upon “unreported ex parte contacts between the jury and the judge, that jurors and a bailiff had planned a reunion, and that ‘either during or immediately following the penalty phase, some jury members gave the trial judge chocolate shaped as male genitalia and the bailiff chocolate shaped as female breasts . . . . ’” Wellons, 558 U.S. 220 (“From beginning to end, judicial proceedings conducted for the purpose of deciding whether a defendant shall be put to death must be conducted with dignity and respect”). 3 Case: 14-12663 Date Filed: 06/17/2014 Page: 7 of 46 motion to dismiss. This emergency appeal follows. Summary of Factual Allegations Only Appellees know exactly how they plan to execute Mr. Wellons on Tuesday night. In refusing to disclose information about the provenance of their lethal injection drugs, Appellees rely upon O.C.G.A. § 42-5-36, a measure adopted by the Georgia Legislature in March of 2013 that classifies all “identifying information” about a “person or entity who participates in or administers the execution of a death sentence . . . [or] that manufactures, supplies, compounds, or prescribes the drugs, medical supplies, or medical equipment” used in an execution as a “confidential state secret” not subject to disclosure through Georgia’s Open Records Act or “judicial process.” O.C.G.A. § 42-5-36 (d); see also Rhonda Cook and Bill Rankin, Lethal injection secrecy bill wins approval, ATLANTA JOURNAL-CONSTITUTION (March 26, 2013).2 “Identifying information” includes “professional qualifications.” Accordingly, Appellees have asserted that this statute excuses them from disclosing any information concerning the origins of their lethal injection drugs or, for that matter, the qualifications of those personnel whom they designate to administer the execution. This lethal injection secrecy act was adopted following a series of embarrassing 2 Available at: http://www.ajc.com/news/news/state-regional-govt-politics/ lethal-injection-secrecy-bill-wins-approval/nW4tK/ (Last visited June 10, 2014). 4 Case: 14-12663 Date Filed: 06/17/2014 Page: 8 of 46 and potentially-illegal missteps by the Appellees as they attempted to obtain drugs for use in lethal injections in spite of widespread shortages. In their seemingly-desperate quest to continue executions unabated, Appellees have run afoul of the Drug Enforcement Administration by illegally importing sodium thiopental. They have also repeatedly and abruptly altered their lethal injection procedures in spite of a series of botched executions, once changing their protocol on the very eve of an execution. Rather than be chastened by these experiences, however, Appellees have evidently decided that the solution to their problems with lethal injection is to shield their procedures from scrutiny and prevent further discovery of their errors or improprieties by the public or the courts. Indeed, the only information Appellees have divulged concerning the substances that they intend to use in Mr. Wellons’s execution is a copy of the lethal injection procedures that they adopted on July 17, 2012. See Letter from Wilson to Munro of 05/27/2014 (attached as “Ex.1”) at 000005-000017. These procedures outline a onedrug lethal injection protocol featuring “Pentobarbital.” Id. As Appellees have not had any FDA-approved Pentobarbital in their possession since March of 20133, Mr. Wellons suspects that Appellees will use a substance that purports to be pentobarbital, but that has been manufactured from unknown ingredients and in unknown circumstances by a 3 Discussed infra at 11-15. 5 Case: 14-12663 Date Filed: 06/17/2014 Page: 9 of 46 compounding pharmacy.4 The considerable risks presented by compounded pentobarbital are discussed infra at *19-25.5 Further, the statute shields not only the source of the execution drugs, but the qualifications of the personnel whom Appellees have charged with administering the lethal injection drugs. This is not an abstract concern. As is discussed infra at 25-32, the consequences of error in the placement of the intravenous lines during an execution include suffering that cannot be sanctioned by the Eighth Amendment, as illustrated by Florida’s botched execution of Angel Diaz and Oklahoma’s botched execution of 4 Counsel for Appellees has indicated to Mr. Wellons’s counsel that they have obtained Pentobarbital for his execution. 5 As Mr. Wellons noted in his complaint below, Georgia’s lethal injection statute does not limit the drugs that the Appellees can use when carrying out executions beyond requiring that they use “a substance or substances sufficient to cause death . . . .” O.C.G.A. § 17-10-38(a), and the Supreme Court of Georgia has empowered Appellees to change their protocol at will and at any time with no supervision from any other entity or meaningful notice to the prisoner or the public. Hill v. Owens, 292 Ga. 380 (2013)(as “[t]he particular issue of lethal injection procedures is heavily litigated and closely scrutinized by state and federal courts throughout the nation, including this Court. . . . judicial review and oversight of the Department of Corrections’ procedures is preferable to APA administrative proceedings”). Mr. Wellons accordingly raised the concern that if Appellees opted to change their protocol at the last minute – as they attempted to do on the eve of a scheduled execution in July of 2012 – even the little information that Mr. Wellons he had would become obsolete before June 17. In the proceeding below, counsel for Appellees represented as an officer of the court that Appellees will execute Mr. Wellons pursuant to their protocol they provided to him. It is telling, however, that only a lawsuit could compel that commitment. 6 Case: 14-12663 Date Filed: 06/17/2014 Page: 10 of 46 Clayton Lockett. The Lethal Injection Secrecy Act Will Conceal Future Misconduct by Appellees Any assessment of either the legitimacy of the statute or Appellees’ motivations in passing it must account for Georgia’s checkered history with lethal injection. In the last several years, there have been widespread shortages of the drugs favored by Georgia and other states for use in executions. Appellees’ conduct in the face of these shortages suggests that their primary goal is to carry out executions as rapidly as possible, with little regard for the safety and efficacy of these drugs or, indeed, the laws that regulate them. Beginning in 2010, Georgia was faced with an acute nationwide shortage of sodium thiopental, the first of the three drugs that it administered to prisoners during lethal injections under its then-protocol. See, e.g., Carol Williams, Maker of Anesthetic Used in Executions is Discontinuing Drug, LOS ANGELES TIMES, January 22, 2011.6 When the FDA placed an administrative hold upon a shipment of imported sodium thiopental that Georgia and several other states had ordered through a U.S. pharmacy, Appellees opted to circumvent federal law governing the importation of controlled substances by directly purchasing a supply of mislabeled sodium thiopental for use in 6 Available at: http://articles.latimes.com/2011/jan/22/local/la-me-executiondrug-20110122 (Last visited June 10, 2014). 7 Case: 14-12663 Date Filed: 06/17/2014 Page: 11 of 46 lethal injections from Dream Pharma, Inc., a fly-by-night pharmaceutical wholesaler/distributor which operated out of a storefront driving school in London, England. Appellees chose this course despite the fact that they were not registered with the Drug Enforcement Agency (DEA) as an importer of non-narcotic controlled substances and did not provide a declaration of importation to the DEA.7 On March 16, 2011, after the Attorney General was notified of Georgia’s illegal importation, the DEA seized Georgia’s entire supply of thiopental. Bill Rankin et al., DEA seizes Georgia’s supply of lethal injection drug, ATLANTA JOURNAL-CONSTITUTION (March 16, 2011).8 Unfortunately, this thiopental of questionable provenance had already been used in the executions of Brandon Rhode and Emanuel Hammond, both of whom appeared to remain conscious throughout their executions.9 7 Nor did Georgia possess a DEA license to possess, dispense, or distribute a Schedule III non-narcotic controlled substance such as thiopental. 8 Available at: http://www.ajc.com/news/news/local/dea-seizes-georgiassupply-of-lethal-injection-dru/nQrdf/ (Last visited June 10, 2014). 9 On September 27, 2010, Georgia used its illegally-imported thiopental in its execution of Brandon Rhode. Mr. Rhode’s eyes remained open throughout his execution, which strongly suggested that he was conscious after the administration of thiopental. On January 25, 2011, Georgia executed Emanuel Hammond with the same batch of thiopental; Mr. Hammond opened his eyes and grimaced after the injection of the thiopental, suggesting that he was inadequately sedated. Liliana Segura, the Executioner’s Dilemma, the Nation (May 12, 2011), available at: http://www.thenation.com/article/160648/executioners-dilemma# (Last visited June 10, 2014). 8 Case: 14-12663 Date Filed: 06/17/2014 Page: 12 of 46 Following the seizure, Appellees altered its three-drug lethal injection protocol to replace thiopental with pentobarbital, a barbiturate and controlled substance. Appellees made this substitution despite the fact that the sole manufacturer of FDA-approved pentobarbital, Lundbeck Inc., warned them that the drug was not safe for use in judicial lethal injections, as it had not been tested for the induction of anesthetic comas in humans. Sten Stovall, Lundbeck“Horrified” at Drug Execution Use, WALL STREET JOURNAL (June 8, 2011).10 Appellees ignored this caution and, on June 23, 2011, executed Roy Blankenship pursuant to their new protocol. An AP reporter who witnessed the execution offered the following account of Mr. Blankenship’s reaction: As the injection began, [Blankenship] jerked his head toward his left arm and made a startled face while blinking rapidly. He soon lurched to his right arm, lunging with his mouth agape twice. He then held his head up, and his chin smacked as he mouthed words that were inaudible to observers . . . . His eyes never closed. Greg Bluestein, Ga. Executes inmate convicted of Savannah slaying, THE ATLANTA JOURNAL-CONSTITUTION (June 23, 2011). As another eyewitness said of the execution, “Blankenship was apparently much more aware of his surroundings at a time when he shouldn’t have been.” Eddie Ledbetter, Making a date with death, STATESBORO HERALD (June 25, 2011). 10 Available at: http://online.wsj.com/article/ SB10001424052702304259304576373020954841208.html (Last visited June 10, 2014). 9 Case: 14-12663 Date Filed: 06/17/2014 Page: 13 of 46 Lundbeck announced on July 1, 2011, that it was establishing a new distribution system to “deny orders from prisons located in states currently active in carrying out death sentences” and prohibiting the redistribution of pentobarbital without its authorization. Jeanne Whalen and Nathan Koppel, Lundbeck Seeks to Curb Use of Drug in Executions, WALL STREET JOURNAL (July 1, 2011).11 Undaunted, Appellees used the same protocol in short order to carry out the executions of Andrew DeYoung on July 21, 2011, and Troy Davis on September 21, 2011. Appellees hastily adopted a new, one-drug lethal injection protocol at approximately noon on July 17, 2012 – the day before the scheduled execution of Warren Hill. Rhonda Cook and Bill Rankin, State changes lethal injection protocol, reschedules execution, ATLANTA JOURNAL-CONSTITUTION (July 17, 2012).12 While Appellees offered no explanation for this eleventh-hour change, later reports revealed that Georgia’s supply of pancuronium bromide – the second drug administered pursuant to its now-abandoned three-drug protocol – had expired on July 1, 2012, some two 11 Available at: http://online.wsj.com/article/ SB10001424052702304584004576419092675627536.html (Last visited June 10, 2014). 12 Mr. Hill’s execution was ultimately stayed by the Supreme Court of Georgia. The last-minute protocol adopted by Appellees for his execution is the same one that they have indicated they will use to execute Mr. Wellons. See Ex. 1 at 000005-000017. 10 Case: 14-12663 Date Filed: 06/17/2014 Page: 14 of 46 weeks before Mr. Hill’s scheduled execution. Rhonda Cook, Expired drugs led to cancellation of execution by lethal injection, ATLANTA JOURNAL-CONSTITUTION (Aug. 2, 2012).13 Following litigation over whether state law prohibited Georgia from changing its protocol without complying with the notice-and-comment procedures of its Administrative Procedures Act14, Appellees promptly scheduled two executions: Warren Hill for February 19, 2013, and Andrew Cook on February 21, 2013. It is worth noting that Appellees’ decision to schedule Mr. Hill and Mr. Cook’s executions within days of each other appears to have been based upon its mistaken belief that its supply of pentobarbital expired on March 1, 2013; it actually expired on March 31. Ed Pilkington, Georgia rushes through executions before lethal injection drugs expire, THE GUARDIAN (February 21, 2013)(“Georgia confirmed to the Guardian that its entire supply of pentobarbital expires on 1 March”).15 While Mr. Hill’s execution was stayed, Mr. Cook was executed pursuant to the novel protocol. Shortly thereafter, in March of 2013, the Georgia Legislature adopted the lethal 13 Available at: http://www.ajc.com/news/news/local/expired-drugs-led-tocancellation-of-execution-by-/nQXhn/ (Last visited June 10, 2014). 14 See discussion supra at 8-9 and n. 6. 15 Available at: http://www.guardian.co.uk/world/2013/feb/21/georgiaexecutions-lethal-injection-drug-pentobarbital (Last visited June 10, 2014). 11 Case: 14-12663 Date Filed: 06/17/2014 Page: 15 of 46 injection secrecy act. O.C.G.A. § 42-5-36 (d); see also Rhonda Cook and Bill Rankin, Lethal injection secrecy bill wins approval, ATLANTA JOURNAL-CONSTITUTION (March 26, 2013).16 As contemporaneous media accounts noted, the legislation had two purposes: The legislation should make it easier for Georgia to obtain lethal-injection drugs as companies worldwide, in the face of strong criticism from opponents of capital punishment, have either stopped making lethal injection drugs or forbidden such drugs from being used for executions . . . . [and] is also expected to make it more difficult for lawyers representing death-row inmates to challenge the state’s lethal-injection process. Ibid (emphasis added). Indeed, these same reports suggest that Georgia first erected its lethal-injection-secrecy legislation in order to shield itself and the compounding pharmacies with which it might work from the “legal and public relations problems with a local pharmacist making up a batch of lethal injection drug on a case-by-case basis.” Rhonda Cook, Compounding pharmacies may be source of lethal injection drugs, ATLANTA JOURNAL CONSTITUTION (April 27, 2013)(emphasis added).17 Interviews with the legislation’s sponsor confirmed this motivation: The state would be pressed [to obtain drugs] if . . . executions [were] 16 Available at: http://www.ajc.com/news/news/state-regional-govt-politics/ lethal-injection-secrecy-bill-wins-approval/nW4tK/ (Last visited June 10, 2014). 17 Available at: http://www.myajc.com/news/news/state-regional/ compounding-pharmacies-may-be-source-of-lethal-inj/nXXxT/ (Last visited June 10, 2014). 12 Case: 14-12663 Date Filed: 06/17/2014 Page: 16 of 46 scheduled in the near future. That’s why it’s important for the state to shield the identities of doctors, pharmacists or drug providers that could be involved with procuring lethal injection drugs, said State Rep. Kevin Tanner, R-Dawsonville. He sponsored the legislation to keep those identities secret, expecting the state will have to turn to a pharmacist. Id. The act took effect on July 1, 2013. Two days later, on July 3, the Superior Court of Lee County, Georgia, issued an execution warrant for Mr. Hill, and Appellees set his execution for July 15. Rhonda Cook, Execution date set for Warren Hill, ATLANTA JOURNAL CONSTITUTION (July 3, 2013).18 On July 10, the Georgia Department of Corrections responded to an Open Records Act request made on behalf of Mr. Hill with redacted documents that failed to disclose the identities of the manufacturer, individuals or entities in the chain of supply, prescriber, compounding pharmacy, or pharmacist responsible for making the drugs available to the Department of Corrections for Mr. Hill’s execution. See Letter from Wilson to Painter of 07/10/2013 (attached as “Ex. 2”). The Department of Corrections expressly relied on O.C.G.A. § 42-5-36 as the justification for redacting this information. Id. at 000001-000005. The documents nonetheless revealed that beginning on July 2, Defendant GDC had quickly entered into agreements with an unknown compounding pharmacy and an 18 Available at http://www.ajc.com/news/news/state-regional/executiondate-set-for-warren-hill/nYc4m/ (Last visited June 10, 2014). 13 Case: 14-12663 Date Filed: 06/17/2014 Page: 17 of 46 unknown prescriber of drugs in order to procure pentobarbital for the execution of Mr. Hill, which was then scheduled for July 15, 2013. Ex. 2 at 000005-000039. Under the terms of Appellees’ proposed Professional Services Agreement with this prescriber – which, if signed, would be effective through June 30, 2014 – Appellees agreed to pay him or her a sum of $5,000 per annum in exchange for writing the prescriptions they require to obtain their lethal injection drugs. Ex. 2 at 000025-000026. They also offered to provide the prescriber with a litigation reserve fund of $50,000 and add the prescriber to the Georgia Department of Administrative Services’ General Liability Policy, insuring him or her for “acts of medical negligence and omissions” in the amount of $1,000,000 per person and $3,000,000 per occurrence. Id.19 19 In their correspondence with the prescriber, Appellees attempt to reassure him or her of the legality of the arrangement by citing and attaching Section 1710-38 of the Georgia Code, which reads: Notwithstanding any other provision of law, prescription, preparation, compounding, dispensing, or administration of a lethal injection authorized by a sentence of death by a court of competent jurisdiction shall not constitute the practice of medicine or any other profession relating to health care which is subject by law to regulation, licensure, or certification. O.C.G.A. § 17-10-38(c)(emphasis added); see Ex. 2 at 000022-000032. Tellingly, Appellees also reassure the prescriber that his or her arrangement with Appellees will never be discovered, citing O.C.G.A. § 42-5-36 for the proposition that “the identifying information about any person or entity assisting in this process is a confidential state secret.” Ex. 2 at 000022. 14 Case: 14-12663 Date Filed: 06/17/2014 Page: 18 of 46 Mr. Hill subsequently filed a declaratory judgment action in the Superior Court of Fulton County that, pursuant to O.C.G.A. § 9-4-1 et seq., challenged the Constitutionality of O.C.G.A. § 42-5-36(d). The Superior Court granted Mr. Hill’s concurrently-filed request for an injunction to maintain the status quo until such time as the court could rule upon the merits of his Complaint for declaratory judgment, which the Supreme Court of Georgia overturned on interlocutory review on May 19, 2014. Owens v. Hill, No. S14A0092, --- S.E.2d ----, 2014 WL 2025129 (Ga. May 19, 2014). Mr. Wellons’s execution warrant followed nine days later. As noted supra, Appellees have subsequently refused to disclose any documents – even redacted ones – concerning the sources of their lethal injection drugs. Ex. 1 at 000002-000004. The Risks of Compounded Pentobarbital The simple truth about any drug is that unless you know how it was made – where, and from what, and by whom – you cannot know what it is. A drug approved by the Food and Drug Administration provides those assurances. However, “[t]he true contents of pharmacy-compounded pentobarbital injection, or any pharmacy-compounded drug, prepared from a non-sterile API are unknown.” Declaration of Dr. Larry Sasich (“Sasich Decl.”)(attached as “Ex. 3”) at 9.20 Accordingly, Appellees’ decision to use compounded 20 Mr. Wellons has attached the Declaration of Dr. Larry Sasich, a pharmacist and consultant specializing in drug safety and efficacy. The parties agreed to stipulate that the declarations of Dr. Sasich and Dr. Katz, 15 Case: 14-12663 Date Filed: 06/17/2014 Page: 19 of 46 pentobarbital from an undisclosed source poses a substantial threat of undue pain and suffering to Mr. Wellons. The compounding pharmacy industry operates in a “grey market” that is not subject to the FDA’s drug-approval process or manufacturing standards. Sasich Decl. at 4. To receive FDA approval, injectable drugs must be sterile and meet other stringent requirements for quality, purity, and stability. Sasich Decl. at 5. These requirements are not luxuries. They exist because “[c]ountless members of the public have suffered and experienced pain before science-based federal regulations were implemented to protect the public from what had become the obvious hazards of injectable drugs contaminated with fungi, bacteria, and other contaminates.” Id. at 6. Indeed, pharmacists began compounding drugs not because they considered FDAapproval unimportant, but because the needs of some patients could not be met by FDAapproved products due to medical reasons. Id. at 2 (“For example, a two-year-old transplant patient may require a medication that is only available in an FDA-approved tablet form. In such a case, tablets may be reformulated into an oral liquid for administration.”) This practice knowingly compromised federal standards, but only because it was necessary in order to meet critical medical needs. Id. Drug compounding has now grown, however, into an industry that manufactures what purport to be copies of FDA-approved products, but that are produced through manufacturing 16 Case: 14-12663 Date Filed: 06/17/2014 Page: 20 of 46 processes that are not federally regulated. Id. Because compounding pharmacies are not subject to FDA’s drug approval process, rigorous checks, and regulatory procedures, even a compounding pharmacy operating in good faith can make critical mistakes that it lacks the capacity to detect until the damage has been done. Id. For example, compounding pharmacies generally are unable to test chemicals to confirm their identity, potency, and purity, and to detect contamination. Id. at 4-5. Accordingly, while a pharmacist might accurately measure or weigh individual ingredients, he or she would have no way of discovering in a pharmacy setting if the ingredients themselves were adulterated or counterfeit. Id. at 5. A pharmacist unable to confirm the identity of a chemical would miss contaminants – a risk present at any stage of the chemical’s manufacture – that would cause pain immediately upon intravenous administration. Id. This is not an abstract problem. Compounding pharmacies frequently purchase bulk Active Pharmaceutical Ingredients (or “API’s”) and have become an entry point for counterfeit product whose manufacturer, impurity profile, age, storage history, manufacturing environment, and synthesis cannot be determined. Id. at 4. Many come from plants in India or China that are not registered with the FDA and that in some instances manufacture pesticides on the same equipment as they make API’s. Id. A product made from such an ingredient will always be lacking, regardless of the 17 Case: 14-12663 Date Filed: 06/17/2014 Page: 21 of 46 pharmacist’s skill, and the pharmacist would be unable to detect its dangers. Other, subtler risks that would not evade FDA inspection can plague even wellmeaning compounding pharmacies. Cross-contamination can occur when the air supply for the room in which one drug is being compounded is not scrupulously segregated from the air supply in the room in which another, allergy-causing agent is being produced. Id. at 6. The consequence of cross-contamination can be immediate anaphylaxis. Id. Similarly, the acidity (or “pH”) of any injectable drug “must be carefully adjusted to ensure that the recipient of the drug does not suffer an immediate painful sensation at the time of injection. Both a compromised API and improper compounding procedures can cause the pH of an injectable drug to be unacceptable.” Id. Contamination with endotoxins can elicit an inflammatory reaction that causes shock. Id. Particulate matter contaminating sterile injectable drugs can become lodged in small blood vessels to agonizing effect. Id. Accordingly, “there are parameters beyond [a compounding pharmacy’s] professional control that build risk and uncertainty into all compounded products.” Id. at 5. This, above all else, is why FDA approval and oversight is necessary, and why Appellees’ decision to employ these drugs behind a veil of secrecy cannot be tolerated. State Board of Pharmacy Inspections Are Not Equivalent to FDA Approval While some compounding pharmacies are subject to inspection by state pharmacy 18 Case: 14-12663 Date Filed: 06/17/2014 Page: 22 of 46 boards, the level of scrutiny applied is insufficient to address the concerns detailed above. An illustration of this can be found in a recent FDA Warning Letter issued to Grandpa’s Compounding Pharmacy, Inc., in Placerville, California, on May 2, 2014, following a four-day inspection in October of 2013. Id. at 7-8 and App. B. The FDA found serious deficiencies in the pharmacy’s production of sterile drug products, including: that the “cleanroom” where these products were being manipulated had air supply ductwork that was held together with duct tape and contained an in-wall air conditioner that could introduce outside air with unacceptable microbial and particulate levels; that operators were manipulating these “sterile” drugs with their wrists and forearms exposed; and that the pharmacy used tap water to clean the containers and closures intended for injectable drug products. Id. These deficiencies risk the contamination of compounded sterile products and could pose a substantial risk of immediate harm and pain when injected. Id. In light of these dangers, it is unsurprising that states using compounded drugs in executions have seen botched executions. When Oklahoma executed Michael Lee Wilson with compounded pentobarbital in January 2014, he cried out, “I feel my whole body burning!” Charlotte Alter, Oklahoma Convict Who Felt “Body Burning” Executed 19 Case: 14-12663 Date Filed: 06/17/2014 Page: 23 of 46 With Controversial Drug, TIME MAGAZINE (January 10, 2014).21 Mr. Wilson’s reaction is consistent with exposure to contaminants introduced by the unsafe compounding of Pentobarbital. Sasich Decl. at 6-7 (“the injection used in Mr. Wilson's execution likely contained cross-contaminates that he was allergic to, bacteria and endotoxins . . . . [and] could have had an altered pH due to contaminates or inadequate procedures used in the preparation of the drug.”) Similarly, Jose Luis Villegas complained of a burning sensation when Texas executed him with compounded pentobarbital in April of 2014.22 Further, when Eric Robert was executed with compounded pentobarbital in South Dakota in October 2013, he gasped and snorted heavily, turned a blue-purplish hue, and took more than twenty minutes to die.23 These events were “consistent with the administration of a compounded drug that was contaminated or sub-potent.” Sasich Available at: http://nation.time.com/2014/01/10/oklahoma-convict-whofelt-body-burning-executed-with-controversial-drug/ (Last visited June 9, 2014) 21 22 Vivian Kuo and Ralph Ellis, U.S. Supreme Court grants stay of ‘excruciating execution, CNN (May 21, 2014)(discussing Villegas execution), available at http://www.cnn.com/2014/05/20/justice/missouri-videotapedexecution-russell-bucklew-duplicate-2/index.html (Last visited June 10, 2014) Jill Johnson, Witnesses Describe Events Inside Chamber, KBLT NEWS, available at: http://www.kdlt.com/index.php?option=com_content&task= view&id=21169&Itemid=72 (Last visited June 10, 2014); see also Steve Young, Execution: South Dakota Delivers Eric Robert His Death Wish, ARGUSLEADER.COM (Oct. 16, 2012), available at: http://www.argusleader.com/article/20121016/NEWS/ 310160016/Execution-South-Dakota-delivers-Eric-Robert-his-death-wish (Last visited June 10, 2014). 23 20 Case: 14-12663 Date Filed: 06/17/2014 Page: 24 of 46 Decl. at 7. Subsequent analysis of the State’s pentobarbital supply indicated that it was, in fact, contaminated with fungi.24 It is important to note that the risks detailed above are only those generally raised by the use of drugs compounded in a pharmacy without FDA approval and regulation. Given the lack of scrutiny of compounding pharmacies in general, the specific pharmacy used by Appellees could present different and even graver risks. Appellees’ refusal to disclose information about their pharmacy, however, will ensure that those risks do not come to light. This Court cannot countenance the dangers that this secrecy presents. The Risks of Botched Intravenous Lines On April 29, 2014, the State of Oklahoma attempted to execute Clayton Lockett by lethal injection. Instead, his execution was halted when he “began to writhe and gasp after he had already been declared unconscious and called out ‘oh, man,’ according to witnesses.” Erik Eckholm, One Execution Botched, Oklahoma Delays the Next, N.Y. TIMES (April 30, 2014).25 One media witness offered a minute-by-minute account of Mr. See South Dakota Covers Up Source of ‘DIY’ Death Penalty Drugs Ahead Of Execution, REPRIEVE (Oct. 30, 2012).Available at: http://www.reprieve.org.uk/press /2012_10_30_South_Dakota_execution_drugs/ (Last visited June 10, 2014). 24 25 (available at: http://www.nytimes.com/2014/04/30/us/oklahomaexecutions.html (Last visited June 10, 2014); see also Erik Eckholm and John Schwartz, Timeline Describes Frantic Scene at Oklahoma Execution, N.Y. TIMES (May 1, 2014). 21 Case: 14-12663 Date Filed: 06/17/2014 Page: 25 of 46 Lockett’s agony. 6:33 p.m. The doctor checks Lockett a second time after a full minute without movement. “Mr. Lockett is unconscious,” [Warden] Trammell states. It seems like it took longer than expected for this to occur . . . . 6:36 p.m. Lockett kicks his right leg and his head rolls to the side. He mumbles something we can’t understand. 6:37 p.m. The inmate’s body starts writhing and bucking and it looks like he’s trying to get up. Both arms are strapped down and several straps secure his body to the gurney. He utters another unintelligible statement . . . . 6:38 p.m. Lockett is grimacing, grunting and lifting his head and shoulders entirely up from the gurney. He begins rolling his head from side to side. He again mumbles something we can’t understand, except for the word “man.” He lifts his head and shoulders off the gurney several times, as if he’s trying to sit up. He appears to be in pain. 6:39 p.m. The physician walks around to Lockett’s right arm, lifts up the sheet and says something to Trammell. “We’re going to lower the blinds temporarily,” she says. The blinds are lowered and we can’t see what is happening. Ziva Branstetter, Eyewitness account: A minute-by-minute look at what happened during Clayton Lockett’s execution, TULSA WORLD, May 1, 2014.26 Mr. Lockett continued to writhe in agony for thirty minutes. Id. The Oklahoma Department of Corrections later announced that Mr. Lockett had died in the execution chamber of a heart attack at 7:06 p.m. Id. 26 Available at: http://www.tulsaworld.com/news/state/eyewitnessaccount-a-minute-by-minute-look-at-what-happened/article_f7764efc-d036-11e3af7e-0017a43b2370.html (Last visited June 10, 2014) 22 Case: 14-12663 Date Filed: 06/17/2014 Page: 26 of 46 It seems indisputable that Mr. Lockett’s execution violated his Eighth Amendment rights. Erik Eckholm & Motoko Rich, Oklahoma Faces Sharp Scrutiny Over Botched Execution, N.Y. TIMES, (April 30, 2014)(“As [Mr. Lockett] began to buck and moan in apparent agony, corrections officials pulled the blinds on witnesses.”)27 While the explanation for why Mr. Lockett’s execution went so horribly awry is not settled, an independent autopsy of Clayton Lockett has confirmed that Oklahoma’s execution personnel punctured Mr. Lockett’s femoral vein, which resulted in the lethal injection drugs entering his subcutaneous tissue. Erik Eckholm, Defense Reports Puncture Led to Botched Execution, NEW YORK TIMES (June 13, 2014)28 ; see also Oklahoma, Investigating Failure, Extends Delay of Execution To November, N.Y. TIMES, May 8, 2014.29 Indeed, Oklahoma has disclosed that it took fifty-one minutes to insert an 27 Available at: http://www.nytimes.com/2014/05/01/us/oklahoma-facessharp-scrutiny-over-botched-execution.html?hp. The White House joined those condemning the execution, stating that the Lockett execution fell short of the country’s standard that “even when the death penalty is justified, it must be carried out humanely,” and pledged to examine executions by lethal injections. 28 Available at: http://mobile.nytimes.com/2014/06/14/us/defense-exam-of-body-finds-puncturedvein-led-to-botched-execution.html?hpw&rref=us&_r=0&referrer= (Last visited: June 16, 2014). 29 Available at: http://www.nytimes.com/2014/05/09/us/oklahoma-attorneygeneral-agrees-to-6-month-delay-of-execution.html?src=rechp (Last visited June 10, 2014)) The Attorney General of Oklahoma has consented to a six-month stay of executions while an investigation into Mr. Lockett’s execution is conducted. 23 Case: 14-12663 Date Filed: 06/17/2014 Page: 27 of 46 peripheral intravenous line, with the execution team ultimately inserting it through his groin – “a more difficult procedure because the intended vein is not visible.” Id. This raises the question of whether the placement of the intravenous line into Mr. Lockett’s groin was done by a person who lacked the necessary qualifications to do it properly. The investigation into this possibility, however, will be restricted by Oklahoma’s secrecy statute, which – as with Georgia’s – states that the sources of the drugs used and the identities and qualifications of the participants in an execution are “confidential and shall not be subject to discovery in any civil or criminal proceedings.” Cary Aspinwall and Ziva Branstetter, Secrets still shroud Clayton Lockett's execution, Failed IV line was started by a medical professional whose credentials are a secret under state law, TULSA WORLD (May 12, 2014).30 Oklahoma’s botched execution of Mr. Lockett highlights the risks of Appellees’ refusal to disclose the qualifications of the personnel who will prepare Mr. Wellons for his execution. Pentobarbital is a barbiturate. Declaration of Dr. Eric Katz (“Katz Decl.”)(attached as Ex. 4) at ¶3. When manufactured in accordance with FDA regulations, Pentobarbital typically has a pH of 9.5, which qualifies it as a strong 30 Available at: http://m.tulsaworld.com/news/state/secrets-still-shroudclayton-lockett-s-execution/article_5513ea6b-1f24-519e-934066c42b109502.html?mode=jqm)(Last visited June 10, 2014). 24 Case: 14-12663 Date Filed: 06/17/2014 Page: 28 of 46 alkaline, or “basic,” chemical. Katz Decl. at ¶6.31 It is, by nature, extremely caustic. Id. Accordingly, if Pentobarbital were injected under the skin and not into a vein, it would cause severe and agonizing chemical burns. Id. Intravenous access is obtained “by using a needle to introduce a catheter into either a peripheral vein, typically in the arm or hand, or a central vein, typically in the neck, chest or groin.” Katz Decl. at ¶7. “Training and regular experience is required in order to place either type of line.” Id. at ¶8. The medical standard of care for placement of a peripheral line would require “a professional technician or nurse with demonstrated competency with the procedure,” as the peripheral line is placed “in a very small distal vein.” Id.. Trained and experienced personnel are also needed in order to anticipate and address difficulties with venous access. Id. As placing a central line is a more complicated task, the standard of care would require “a doctor or specialized nurse who has completed specialized training and demonstrated competence for that procedure.” Id. at ¶9 (placement of central line requires larger needle; must bore through skin and subcutaneous tissue to reach central vein). Further, best practices call for ultrasound guidance in the placement of the line, as 31 As noted supra at 22, one risk associated with compounding pharmacies is errors in pH. Further, an increase of one number on the pH scale reflects a tenfold increase in the causticity of the drug. Katz Decl. at ¶¶5, 6. Accordingly, small deviations in pH can dramatically affect the causticity of the drug. 25 Case: 14-12663 Date Filed: 06/17/2014 Page: 29 of 46 it “can assist in predicting both the patient's anatomy and any potential complications.” Id. at ¶9. Far riskier is an attempt to place a central line “by feeling certain physical landmarks - a process called ‘blind placement’ . . . .” Id. An error in placing either kind of intravenous access “would cause the chemical solution being introduced to the patient to escape into his or her subcutaneous tissue” – which, in the case of Pentobarbital, would cause “excruciating” pain and would “diminish [its] efficacy . . . as it would be absorbed much more slowly.” Id. at ¶10. Further, the improper placement of a central line “can have terrible consequences, including extraordinary pain, damage to vascular and other tissues, embolisms, and death.” Id. at ¶9. Florida's botched execution of Angel Diaz in 2006 further illustrates the gruesome consequences of the improper placement of an intravenous line by inexperienced or unqualified personnel. In Mr. Diaz’s case, the misplaced line allowed the caustic lethal injection drugs to leak into the soft tissue of his arms. The drugs accordingly failed to render him unconscious while causing chemical burns so severe that a great deal of the skin on his arms sloughed away, mutilating him. Mr. Diaz likely suffocated to death before the execution drugs could end his life. Ben Crair, Photos 26 Case: 14-12663 Date Filed: 06/17/2014 Page: 30 of 46 from a Botched Lethal Injection, THE NEW REPUBLIC (May 29, 2014).32 Another consequence of unqualified execution team personnel is illustrated by the case of Romell Broom, whom Ohio attempted to execute in 2009. After Mr. Broom was brought to the execution chamber, the personnel on Ohio’s execution team – none of whom were qualified to insert an intravenous line – stabbed him with needles for an hour in an attempt to find a vein. The team ultimately brought in a prison doctor to assist, but after another ninety minutes of futile attempts and a total of eighteen needle sticks – which left Mr. Broom in agony – the governor halted his execution. In the five years since, Ohio has been unable to schedule Mr. Broom’s execution because of litigation over whether a state can try again to execute a prisoner who survives the first attempt, and whether the initial, failed attempt constitutes cruel and unusual punishment – an appeal that will soon go the Ohio Supreme Court. Stephanie Mencimer, Is it legal to try executing someone twice?, MOTHER JONES (June 6, 2014).33 A similar situation could readily occur in Georgia, which might delay executions indefinitely. Any one of these incidents should compel Appellees to provide, at the very least, 32 (available at: http://www.newrepublic.com/article/117898/lethalinjection-photos-angel-diazs-botched-execution-florida (Last visited: June 10, 2014). Mr. Wellons cautions the Court that the photos of the damage done to Mr. Diaz by the improperly-injected drugs are quite graphic. 33 Available at: http://www.motherjones.com/politics/2014/06/ romell-broom-ohio-execution (Last visited June 10, 2014). 27 Case: 14-12663 Date Filed: 06/17/2014 Page: 31 of 46 the qualifications of those members of the execution team responsible for inserting the catheters into Mr. Wellons’s body. Their refusal to do so cannot be reconciled with the Constitution. Defendants’ Refusal to Disclose this Information Violates Mr. Wellons’s Rights. A. The Eighth Amendment Entitles Mr. Wellons to the Information Necessary to Determine if Georgia’s Method of Execution is Cruel and Unusual The Eighth Amendment’s prohibition against cruel and unusual punishment forbids methods of execution that present “a substantial risk of significant harm.” U.S. Const. amend VIII; Baze v. Rees, 553 U.S. 35, 50-52 (2008) (plurality opinion); see also in re Kemmler, 136 U.S. 436, 447 (1890) (“Punishments are cruel when they involve torture or a lingering death”). Implicit in that protection is a right to due process as to information about the method and means by which the State proposes to mete out that punishment. Appellees’ refusal to disclose the true nature of the drugs they will use to end Mr. Wellons’s life and the qualifications of those who will carry out the execution seeks to nullify those protections and, accordingly, Mr. Wellons’s rights. The Supreme Court has not hesitated to recognize a due process right to the information necessary to determine whether an Eighth Amendment violation exists. In Ford v. Wainwright, 477 U.S. 399, 417-18 (1986), the Supreme Court held that the 28 Case: 14-12663 Date Filed: 06/17/2014 Page: 32 of 46 Eighth Amendment’s prohibition against the execution of the insane entitled Mr. Ford to adequate procedures for determining his sanity. Noting that “[t]he fundamental requisite of due process of law is the opportunity to be heard,” the Court faulted the Florida procedure for “its failure to include the prisoner in the truth-seeking process” in favor of an assessment conducted entirely by the executive branch. Ford, 477 U.S. at 413.34 The Court wrote: [C]onsistent with the heightened concern for fairness and accuracy that has characterized our review of the process requisite to the taking of a human life, we believe that any procedure that precludes the prisoner or his counsel from presenting material relevant to his [Eighth Amendment claim] or bars consideration of that material by the factfinder is necessarily inadequate. The minimum assurance that the life-and-death guess will be a truly informed guess requires respect for the basic ingredient of due process, namely, an opportunity to be allowed to substantiate a claim before it is rejected. Id. at 414 (1986)(internal quotations omitted). Accordingly, the Court wrote: [T]he lodestar of any effort to devise a procedure must be the overriding dual imperative of providing redress for those with substantial claims and of encouraging accuracy in the factfinding determination. The stakes are high, and the “evidence” will always be imprecise. It is all the more important that the adversary presentation of relevant information be as unrestricted as possible. Ford, 477 U.S. at 417. 34 Florida’s practice did not permit any material relevant to the ultimate decision to be submitted on behalf of the prisoner facing execution. Id. 29 Case: 14-12663 Date Filed: 06/17/2014 Page: 33 of 46 Similarly, in Morgan v. Illinois, the Supreme Court held that a criminal defendant’s Sixth Amendment right to an impartial jury and “the requirement of impartiality embodied in the Due Process Clause of the Fourteenth Amendment” in tandem entitled the defendant to information about whether potential jurors would automatically vote for a death sentence in every capital case, and required that the trial court afford him adequate process to conduct voir dire and make challenges for cause. Morgan v. Illinois, 504 U.S. 719, 728-29 (1992)(“the Sixth and Fourteenth Amendments . . . ensure the impartiality of any jury that will undertake capital sentencing”). As the Court noted, “[w]ere voir dire not available to lay bare the foundation of petitioner’s challenge for cause against those prospective jurors who would always impose death following conviction, his right not to be tried by such jurors would be rendered as nugatory.” Id. at 733 (emphasis added). Further, in Brady v. Maryland, 373 U.S. 83, 86 (1963), the Supreme Court held that due process requires the government to disclose evidence which “would tend to exculpate [the defendant] or reduce the penalty.” The underlying principles of Brady, which recognize that the government cannot withhold information bearing upon the rights of a person whom they wish to deprive of life or liberty, apply with equal force here. Finally, a bedrock principle of our rule of law is that “where there is a legal right, there is also a legal remedy by suit or action at law, whenever that right is invaded.” See Marbury v. Madison, 5 U.S. 137, 163 (1803); see also General Oil Co. v. Crain, 209 U.S. 30 Case: 14-12663 Date Filed: 06/17/2014 Page: 34 of 46 211, 221-30 (1908) (holding that a state court must provide a remedy for a constitutional violation). Appellees, in denying Mr. Wellons the information necessary to establish an Eighth Amendment violation are depriving him of the remedy while claiming not to implicate his rights. That cannot stand. Mr. Wellons seeks information from Appellees that he and this Court require to protect his Eighth Amendment rights. He seeks to know where, how, and by whom the lethal injection drugs will be manufactured. He seeks to know the qualifications of the person or persons who will manufacture the drugs, and who will place catheters in his veins. This is not a fishing expedition. The origins and, accordingly, true nature of these drugs will affect, if not determine, whether he will suffer during his execution. The same can be said of the training and experience of the person who will place catheters in his veins, and whether it is adequate to protect against the agonizing consequences of a misplaced line. The Constitution cannot permit Appellees to withhold that information from him. B. The Fifth and Fourteenth Amendments Entitle Mr. Wellons to the Information Necessary to Determine if Georgia’s Method of Execution is Cruel and Unusual Georgia cannot execute Mr.Wellons without first affording him due process of law. See U.S. Const. amend. V (1791) (“No person shall … be deprived of life, liberty, or property, without due process of law…”); U.S. Const. amend XIV (1868) (“nor shall any 31 Case: 14-12663 Date Filed: 06/17/2014 Page: 35 of 46 State deprive any person of life, liberty, or property, without due process of law”); see also Adams v. United States ex rel. McCan, 317 U.S. 269, 276 (1942)(“procedural devices rooted in experience were written into the Bill of Rights not as abstract rubrics in an elegant code but in order to assure fairness and justice before any person could be deprived of ‘life, liberty, or property.’”) “Due process, unlike some legal rules, is not a technical conception with a fixed content unrelated to time, place and circumstances.” Mathews v. Eldridge, 424 U.S. 319, 334 (1976), quoting Cafeteria Workers v. McElroy, 367 U.S. 886, 895 (1961). Rather, “due process is flexible and calls for such procedural protections as the particular situation demands.” Id., quoting Morrissey v. Brewer, 408 U.S. 471, 481 (1972). It is clear, however, that due process entitles a person whose constitutional rights might be affected by state actions to, at minimum, both notice of those actions and an opportunity to be heard “at a meaningful time and in a meaningful manner.” Fuentes v. Shevin, 407 U.S. 67, 80 (1972)(emphasis added)(“Parties whose rights are to be affected are entitled to be heard; and in order that they may enjoy that right they must first be notified.”) This refusal also denies Mr. Wellons his constitutional right of access to the courts, which, per the Supreme Court, must be “adequate, effective, and meaningful.” Bounds v. Smith, 430 U.S. 817, 822-23 (1977); see also Wolff v. McDonnell, 418 U.S. 539, 579 (1974)(“right of access to the courts . . . is founded in the Due Process Clause.”) This right of access to courts, thus, advances the due process notion that the aggrieved have “a 32 Case: 14-12663 Date Filed: 06/17/2014 Page: 36 of 46 reasonably adequate opportunity to present claimed violations of fundamental constitutional rights to the courts.” Lewis v. Casey, 518 U.S. 343, 351 (1996) (quoting Bounds, 430 U.S. at 825); see also Murray v. Giarratano, 492 U.S. 1, 11, n. 6 (1989)(plurality opinion)(access to courts a due process right). C. Appellees’ Refusal to Provide Plaintiff with Information That Would Enable Him to Determine How the State Intends to Execute Him Denies Him His First Amendment Right of Access to Governmental Proceedings. The Supreme Court of the United States has long held that the First Amendment guarantees a qualified right of access to governmental proceedings. Press–Enter. Co. v. Superior Court, 478 U.S. 1, 8–14 (1986)(preliminary hearings); Press–Enter. Co. v. Superior Court, 464 U.S. 501, 510–11 (1984)( voir dire ); Globe Newspaper Co. v. Superior Court, 457 U.S. 596, 603–11 (1982)(testimony of child victim of sex offense); Richmond Newspapers, Inc. v. Virginia, 448 U.S. 555, 579, 100 S.Ct. 2814, 65 L.Ed.2d 973 (1980)(criminal trials). This right of access is founded upon “the common understanding that a major purpose of the First Amendment was to protect the free discussion of governmental affairs.” Globe Newspaper, 457 U.S. at 604 (emphasis added)(internal citations omitted); quoting Mills v. Alabama, 384 U.S. 214, 218 (1966). “By offering such protection, the First Amendment serves to ensure that the individual citizen can effectively participate in and contribute to 33 Case: 14-12663 Date Filed: 06/17/2014 Page: 37 of 46 our republican system of self-government.” Globe Newspaper Co. v. Superior Court for Norfolk County, 457 U.S. 596, 604 (1982), citing Thornhill v. Alabama, 310 U.S. 88, 95 (1940). Accordingly, while the right of access is not enumerated in the First Amendment, it is “nonetheless necessary to the enjoyment of other First Amendment rights,” and is accordingly implicit to the amendment. Id. at 604. As the Supreme Court has held, the First Amendment’s “expressly guaranteed freedoms share a common core purpose of assuring freedom of communication on matters relating to the functioning of government.” Richmond Newspapers, Inc. v. Virginia, 448 U.S. at 575 (plurality opinion). The Supreme Court has further held that the right to access extends to the information about prison conditions and operations. In Pell v. Procunier, 417 U.S. 817 (1974), the Court recognized that “the conditions in this Nation's prisons are a matter that is both newsworthy and of great public importance.” Id. at 831 n. 7.35 Accordingly, both the press and the public must be “accorded substantial access to the federal prisons in order to observe and report 35 While affirming a prison regulation prohibiting face-to-face interviews between the press and individual inmates, the Court premised that holding upon its conclusion that “this regulation is not part of an attempt by the State to conceal the conditions in its prisons or to frustrate the press’ investigation and reporting of those conditions,” and upon its satisfaction that “both the press and general public are accorded full opportunities to observe prison conditions.” Id. at 830. Pell also confirms that a prisoner “retains those First Amendment rights that are not inconsistent with his status as a prisoner or with the legitimate penological objectives of the corrections system.” Pell, 417 U.S. at 822. 34 Case: 14-12663 Date Filed: 06/17/2014 Page: 38 of 46 the conditions they find there.” Saxbe v. Washington Post Co., 417 U.S. 843, 847 (1974). Per the Supreme Court, when determining whether the public has a First Amendment right of access to a particular governmental proceedings, reviewing courts must inquire into two “complimentary considerations”: (1) “whether the place and process have historically been open to the press and general public” and (2) “whether public access plays a significant positive role in the functioning of the particular process in question.” Press–Enterprise Co. v. Superior Court, 478 U.S. 1, 8–9 (1986). It is indisputable that executions have historically been open public events. See, e.g., California First Amendment Coalition v. Woodford, 299 F.3d 868, 875 (9th Cir. 2002)(summarizing history of public executions in U.S.). Even after executions shifted from the public square to the prison, every state provides public witness to executions. Id. Indeed, Georgia’s current Reception and Holding Procedures for death-sentenced prisoners allow the presence of five media witnesses, and the condemned’s counsel, a member of the clergy, and a reasonable number of relatives and friends. See Ex. 1 at 22-24; O.C.G.A. § 17-10-41. Further, Georgia’s lethal injection procedures provide that a designated representative of the media can witness the preparation of the prisoner for the execution, including the placement of the intravenous accesses. See Ex. 1 at 10. Further, the means of execution has been open to the public until the adoption of the lethal injection secrecy act. Prior to the effective date of that legislation, Appellees would, 35 Case: 14-12663 Date Filed: 06/17/2014 Page: 39 of 46 in response to Open Records Act requests, routinely provide prisoners and members of the press and public with detailed information about the drugs used in lethal injections, typically photocopying the labels for the drugs – which identified their name, lot number, place of manufacture, and chemical properties – along with invoices for the ordering of the drugs. See Letter from Whetzel to Yellin of 10/15/2012 (attached as Ex. 5). Further, the public and the press certainly had ready access to information about earlier methods of execution, as those methods – including hanging, the gas chamber, and electricity – were decidedly less opaque than lethal injection. Indeed, “[t]he public could not only view the prisoner's death, they could see the precise cause and its effects.” Schad v. Brewer, No. CV-13-2001, 2013 WL 5551668 (D. Ariz. Oct. 7, 2013)(finding state’s refusal to disclose source of drugs violative of First Amendment). Further, public access to information about lethal injection drugs plays a significant positive role in the functioning of capital punishment. “An informed public debate is critical in determining whether execution by lethal injection comports with ‘the evolving standards of decency which mark the progress of a maturing society.’ “ California First Amendment Coalition, 299 F.3d at 876 (quoting Trop v. Dulles, 356 U.S. 86, 101, 78 S.Ct. 590, 2 L.Ed.2d 630 (1958)). “To determine whether lethal injection executions are fairly and humanely administered, or whether they ever can be, citizens must have reliable information about the ‘initial procedures,’ which are invasive, possibly painful and may give rise to 36 Case: 14-12663 Date Filed: 06/17/2014 Page: 40 of 46 serious complications.” Id. That principle applies with no less force to the lethal injection drugs themselves and the qualifications of those who administer them. Once established, the right of access can be overcome “only by an overriding interest based on findings that closure is essential to preserve higher values and is narrowly tailored to serve that interest.” Id. at 9-10 (quoting Press-Enterprise Co. v. Superior Court, 464 U.S. 501, 510 (1984)). Mr. Wellons respectfully submits that Appellees cannot approach that standard. D. The District Court’s Error Is Illustrated by Justice Benham’s Dissent The district court dismissed the above claims because it “presumes that the state acted in good faith in selecting the company that produced the pentobarbital and in appointing the team slated to carry out Plaintiff s execution.” Order at 9(emphasis added). As demonstrated by Georgia’s checkered history, this is an insufficient safeguard for Mr. Wellons’s constitutional rights. It is one thing to presume that “state government officials . . . carry out their duties in a good-faith manner and in compliance with the federal laws,” Order (Doc. No. 10) at 8, citing Alaska Dep't of Envtl. Conservation v. E.P.A., 540 U.S. 461, 507, (2004); Alden v. Maine, 527 US. 706, 755 (1999). We nonetheless have laws and procedures that exist so that we are not left to trust in presumption alone to protect our rights. Those protections include Open Records Acts and judicial proceedings such as § 37 Case: 14-12663 Date Filed: 06/17/2014 Page: 41 of 46 1983 proceedings and habeas. Appellants, however, seek to use their secrecy statute to remove themselves from the purview of all such scrutiny as they carry out the gravest duty with which we entrust them. As Justice Benham noted for himself and Justice Hunstein in dissenting from the Supreme Court of Georgia’s decision upholding the lethal injection secrecy act: I write because I fear this State is on a path that, at the very least, denies Hill and other death row inmates their rights to due process and, at the very worst, leads to the macabre results that occurred in Oklahoma. There must be certainty in the administration of the death penalty. At this time, there is a dearth of certainty namely because of the scarcity of lethal injection drugs. Georgia's confidential inmate state secret statute does nothing to achieve a high level of certainty. Rather, the law has the effect of creating the very secret star chamber-like proceedings in which this State has promised its citizens it would not engage. See State v. Brown, 293 Ga. 493(1), 748 S.E.2d 376 (2013). As this Court stated in Atlanta Journal v. Long, 258 Ga. 410(1), 369 S.E.2d 755 (1988), “[J]ustice faces its gravest threat when courts dispense it secretly. Our system abhors star chamber proceedings with good reason.” The fact that some drug providers may be subject to harassment and/or public ridicule and the fact that authorities may find it more difficult to obtain drugs for use in executions are insufficient reasons to forgo constitutional processes in favor of secrecy, especially when the state is carrying out the ultimate punishment. Owens v. Hill, --- S.E.2d ----, 2014 WL 2025129 at *11 (Benham and Hunstein, JJ., dissenting). The district court ultimately concluded that, given its presumption of good faith by Appellants, that Mr. Wellons’s argument is “simply an extension of the speculation that the Court found unpersuasive in Landrigan.” Order at 9. As Justice Benham noted, however, 38 Case: 14-12663 Date Filed: 06/17/2014 Page: 42 of 46 any “speculation” as to the implications of Appellees’ lethal injection procedures for MR. Wellons’s Eighth Amendment rights “arises solely from the State’s unwillingness, in light of the secrecy statute, to disclose information that would allow him to make more specific claims.” Hill, 2014 WL 2025129 at *11. Indeed, Justice Benham recognizes Appellants’ assurances to the district court for what they truly are. [I]n this case the State has only made baseline assurances that the compounding pharmacy it used was able to produce a high quality execution drug. These assurances amount to little more than hollow invocations of “trust us.” While the State produced a redacted laboratory report from an independent laboratory that it claimed had tested Hill’s execution drug, Hill, without knowing even the name of the laboratory, was left again with little more than the State’s invocation of “trust us.” Hill, 2014 WL 2025129 at *11 (Benham and Hunstein, JJ., dissenting)(emphases added). This Court should not accept such meager assurances. CONCLUSION The Eighth Amendment protects Mr. Wellons from cruel and unusual punishment. That is uncontroversial. But it is a hollow right unless it can be enforced prospectively. Few would contest that Clayton Lockett’s Eighth Amendment rights were violated by Oklahoma’s botched execution, but there is certainly no redress available to him now. If Mr. Wellons can be deprived of the information necessary to determine whether Appellees’ method of execution presents “a substantial risk of significant harm,” Baze, then his Eighth Amendment rights have been nullified. The same is true of his First Amendment rights, if 39 Case: 14-12663 Date Filed: 06/17/2014 Page: 43 of 46 Appellees are allowed to conceal from him – and the public, and this Court – how they will carry out the gravest duty entrusted to them. But the harm from Appellees’ conduct is not limited to Mr. Wellons. “No better instrument has been devised for arriving at truth than to give a person in jeopardy of serious loss notice of the case against him and opportunity to meet it.’” McGrath, 341 U.S. at 170 (Frankfurter, J., concurring). The heart of the matter is that democracy implies respect for the elementary rights of men, however suspect or unworthy; a democratic government must therefore practice fairness; and fairness can rarely be obtained by secret, one-sided determination of facts decisive of rights. Joint Anti-Fascist Refugee Committee v. McGrath, 341 U.S. 123, 170-72 (1951) (Frankfurter, J., concurring). Accordingly, Appellees’ actions to shield these critical aspects of how they intend to carry out judicial executions harms not only Mr. Wellons. It deprives the Appellees themselves of the feedback that could help them avoid a botched execution – an opportunity that those who executed Clayton Lockett would no doubt welcome, in retrospect. M o r e critically, it attempts to prevent this Court from fulfilling its central mandate: to protect the Constitution. Further, it places the courts in the position of deciding issues about which Appellees have intentionally kept them uninformed. See Cleveland Bd. of Educ. v. 40 Case: 14-12663 Date Filed: 06/17/2014 Page: 44 of 46 Loudermill, 470 U.S. 532, 541 (1985) (holding that the process required by due process is a constitutional question that must be determined by the judiciary). The district court noted Appellees’ “strong interest in executing its condemned prisoners in a manner that does not violate their rights. Botched executions lead to embarrassment, investigations, bad press, and, perhaps worst of all for the individuals involved, the knowledge that they caused an individual needless pain and suffering.” Id. Appellants have already experienced embarrassment, investigations, and bad press because of their mismanagement of lethal injection. The executions of Brandon Rhode, Emanuel Hammond, and Roy Blankenship should at least have given them pause. Instead, they have moved not to examine how they carry out their duties, but by hiding it from Mr. Wellons, the public and the courts. In doing so, they act against the interest of all, including themselves. They must not be allowed to do so. Accordingly, Mr. Wellons respectfully requests that this Court enter a stay of execution or a temporary restraining order to allow full briefing and argument and that the decision of the lower court be reversed. 41 Case: 14-12663 Date Filed: 06/17/2014 Page: 45 of 46 This, the 17th day of June, 2014. Respectfully submitted, /s/ Gerald W. King, Jr. Gerald W. King, Jr. (Ga. Bar No. 140981) Jeffrey Lyn Ertel (Ga. Bar No. 249966) FEDERAL DEFENDER PROGRAM, INC. 101 Marietta Street, Suite 1500 Atlanta, Georgia 30303 404-688-7530 (fax) 404-688-0768 Gerald_King@fd.org Jeff_Ertel@fd.org Mary Elizabeth Wells (Ga. Bar No. 747852) LAW OFFICE OF M.E. WELLS 623 Grant Street SE Atlanta, Georgia 30312 (404) 408-2180 COUNSEL FOR MR. WELLONS 42 Case: 14-12663 Date Filed: 06/17/2014 Page: 46 of 46 CERTIFICATE OF SERVICE This is to certify that the forgoing has been served upon counsel for Respondent by by Electronic Case Filing: Sabrina Graham Georgia Department of Law RM 306 40 CAPITOL SQ SW ATLANTA, GA 30334-1300 Beth Attaway Burton Georgia Department of Law 40 CAPITOL SQ SW ATLANTA, GA 30334-1300 Mitchell Philip Watkins Georgia Department of Law 40 CAPITOL SQ SW ATLANTA, GA 30334-1300 Dated, this the 17th day of June 2014. /s/ Gerald W. King, Jr. Gerald W. King, Jr. (Ga. Bar No. 140981) 43 Case: 14-12663 Date Filed: 06/17/2014 Page: 1 of 29 Exhibit 1 Case: 14-12663 Date Filed: 06/17/2014 Page: 2 of 29 GEORGIA DEPARTMENT OF CORRECTIONS Office of Legal Services Nathan Deal 13.0. BOX 1529 Governor? Georgia 3 Brian Owens Telephone (478) 992-5240 . Facsimile (478) 992-5241 Robert E. Jones General Counsel ?May 27, 2014 INVOICE Federal Defender Program, Inc. Attn: Douglas Munro Suite 1500 Centennial Tower 101 Marietta Street, Nw Atlanta, GA 30303 OR: Open Records Request _24_ copies .10 2.40 Search and Retrieve I $0.00 (.2 hrs?x_ $12.00/per 111', first quarter hour no charge) Shipping/Handling $0.00 Total Due: $2.40 *Please make checks payable to: Georgia Department of Corrections. You can mail payment to our office at the address at the top, and put? to the attention of Jamie 0?Steen. 000001 Case: 14-12663 Date Filed: 06/17/2014 Page: 3 of 29 GEORGIA DEPARTMENT OF CORRECTIONS Of?ce of Legal Services P.0. Box 1529 Nathan Deal . 31029 Gem? Telephone (478) 992-5240 Brian Owens Facsirni1e(478) 992-5241 -Robert E. Jones General Counse? May 27, 2014 Via Mat?! Federal Defender Program, Inc. Attn: Douglas Munro Suite 1500 Centennial Tower 101 Marietta Street, NW Atlanta, GA 30303 Re: Open Records Act Request Dear Mr. Munro: The purpose of this correspondence is to respond to your Georgia Open Records Act request received by the Department on May 23, 2014. Your requests are listed below followed by the Department?s response. 1. Request: The expiration dates and lot numbers of any and all drugs currently in the possession of the Georgia Department of Corrections that the GDC intends to use, has used in the past, or has considered for use in executions. Response: The Department does not have any lethal injection drugs in our possession. 2. Request: All inventory logs of the drugs discussed in item 1 of this list from January 1, 2014 to the present. Response: The Department does not have any inventory logs on ?le for the period of January 1, 2014 to the present. 3. Request: All activity by the GDC (or its agents/representatives) ?oin January 1, 2014 to the present to purchase or otherwise acquire any drugs that the GDC intends to use, has used in the past, or has considered for use in_executions. ?Activity? includes, but is not limited to, purchase orders or transfers front another agency, state, _or entity. Response: Pursuant to O.C.G.A. ?the identifying infonnation of any person or entity who participates in or administers the execution of a death sentence and the identifying information of any person or entity that manufactures, supplies, compounds, or prescribes the drugs, medical supplies, or medical equipmentutilized in the execution of a death sentence shall be Therefore, records related to the acquisition and" purchase of lethal injection drugs are not subject to disclosure under the Open Records Act. 4. Request: Any correspondence or other communications from January 1, 2014, to the present between the (or its agents/representatives) and any manufacturers, distributors, or compounding pharmacies concerning the acquisition of any drugs that GDC intends to use, has used in the past, or has considered for use in executions. 000002 Case: 14-12663 Date Filed: 06/17/2014 Page: 4 of 29 Response:.Pursuant to 0.C.G.A. ?the identifying information of any person or entity who participates in or administers the execution of a death sentence and the identifying information of any person or entity that manufactures, supplies, compounds, or prescribes the drugs, medical supplies, or medical equipment utilized in the execution of a death sentence shall be Therefore, records related to the acquisition and purchase of lethal injection drugs are not subject todisclosure under the Open Records Act. O.C.G.A. 5. Request: Any documents ?om January 1, 2013, to the present regarding execution- protocols, regulations, guidelines, checklists-, or other documents that provide instruction or direction in carrying out of an execution, including correspondence between the GDC (or its and any party concerning protocols used in other states or jurisdictions. Response: The Department is providing the current Lethal Injection'Protocol (13 pages), the procedures for Delivery,'Processing, and Con?nement of UDS Inmates (3 pages), and the procedures for Holding and Preparation of UDS Inmates for Execution (8 pages). The_ Department does not have any correspondence with any other party concerning protocols used in other states or jurisdictions.- 6. Request: Any correspondence or other communications or contracts or other agreements from January 2013, to the present between the GDC (or its agents/representatives) and any doctor or other medical professional concerning obtaining from that professional?- including retaining or compensating that professional for the provision of??the prescription necessary to order a pharmacy or other entity to compound drugs for use in lethal injection. Response: "Pursuant to 0.C.G.A. ?the identifying information of any person or entity who participates in or administers the execution of a death sentence and the identifying information of any person or entity that manufactures, supplies, compounds, or prescribes the drugs, medical supplies, or medical equipment utilized in the execution of a death sentence shall be con?dential. . Therefore, the records you requested are not subject to disclosure under the Open Records Act. O.C.G.A. 7. Request: Any correspondence or other communications from January 1, 2014, to the present between the GDC (or its agents/representatives) and any other state or federal agency concerning attempts by either the GDC or that state or entity to acquire drugs for use in lethal injections. Response: The Department does not have any records responsive to this request. In accordance with O.C.G.A. an agency may impose a reasonable charge for the search, retrieval, redaction," and copying of records. The charge for search, retrieval, or redaction shall not exceed the prorated salary of the lowest paid full-tirne employee who, in the reasonable discretion of the custodian of records, has the necessary skill and training to perform the request; however, no charge shall be made for the first quarter hour. Your request took less a quarter hour to retrieve, and therefore, there is no charge for retrieving the records. Additionally, pursuant to 0.C.G.A. an agency may charge a fee for copying of records, not to exceed 10 cent(s) per page. The Department charges $.10/page for copying. The records you have requested are 24 pages in length and will be charged at $.10/page, totaling $2.40. The total costs of the records you requested -is $2.40. Please see the attached invoice and make your payment accordingly. 000003 Case: 14-12663 Date Filed: 06/17/2014 Page: 5 of 29 . Ifyou have any questions or concerns, please do not hesitate to contact this of?ce at the number 3? listed above or by email at wilsob06@dcor. state. Sincerely, GEORGIA DEPARTMENT OF CORRECTIONS ?z2Q_ Bryan S. Wilson Assistant Counsel 000004 If Case: 14-12663 Date Filed: 06/17/2014 Page: 6 of 29 GEORGIA DEPARTMENT OF CORRECTIONS GEORGIA DIAGNOSTIC AND CLASSIFICATION PRISON LETHAL INJECTION PROCEDURES July 17, 2012 000005 Case: 14-12663 Date Filed: 06/17/2014 Page: 7 of 29 GEORGIA DIAGNOSTIC AND CLASSIFICATION PRISON LETHAL PROCEDURES TABLE OF CONTENTS I. Pre-execution Procedures A. Designation and Noti?cation of Staff B. Restrictions 11. Day of Execution Within Three (3) Hours of the Execution Within Two (2) Hours of the Execution Within One (1) Hour of the Execution Preparation of the Condemned Execution Process Post Execution Interment of Condemned Critical Incident Debrie?ng TABLE OF APPENDICES Appendix I Appendix 11 TITLE IV Team 2- Instructions Controlled Chemical Handling Procedures for Execution by Lethal Injection with Attachments PAGE 8-11 000006 Case: 14-12663 Date Filed: 06/17/2014 Page: 8 of 29 LETHAL INJECTION PROCEDURES I. PROCEDURES A. Designation and Noti?cation of Staff The individuals listed below shall be present at each execution. At least twelve (12) hours prior to the execution, the Warden or the Warden?s designee will notify the following individuals of the time and date of execution and place to report for assignment. These individuals will then acknowledge receipt of the Warden?s' noti?cation. The Warden has the authority to waive the twelve (12) hour requirement on an emergency basis. 1. 9. Warden or Deputy Warden who shall ensure that the court ordered execution is carried out. Two (2) Assistants or more as directed by the Warden. Two (2) Physicians - to determine when death supervenes. One (1) Physician - to provide medical assistance during the execution process (may be one of the Physicians identi?ed in I.A.3 above)?. IV Team to consist of two (2) or more trained personnel, including at least one (1) Nurse, to provide intravenous access. Six (6) Correctional O?icers to serve as a Special Escort Team who apply restraints to the condemned during the execution process. Injection Team to consist of three (3) trained staff members to inject solutions into the intravenous during the execution process. One (1) Chaplain to administer to the spiritual needs of the condemned and to I provide a prayer on the condemned?s behalf upon request. Security personnel as appropriate. B. Restrictions: No photographic, audio, video, recording, or computerized equipment will be permitted in the Execution Chamber or Execution Witness Room except as 1 _Page 000007 Case: 14-12663 Date Filed: 06/17/2014 Page: 9 of 29 - speci?cally authorized by the Warden. Only pencils, note pads, or other writing materials issued and controlled by designated GDC staff will be permitted. II. DAY OF EXECUTION A. Within Three (3) Hours of Execution Within three (3) hours of the scheduled execution, the following tasks shall be performed: 1. 2. A communications check will be performed. Telephone and private lines between the Command Center (CPI), . Execution Chamber (CP2), and the Front Gate (CP3) will be checked. The Execution Chamber and Execution Witness Room will be inspected as directed by the Warden. A radio check between the Command Center, Execution Chamber, and Front Gate will be initiated. I B. Within Two (2) Hours of Execution Within two (2) hours of the scheduled execution, the followingytasks shall be perfonned: Chemicals will be delivered to the H-5 Chemical Room by the Deputy Warden of Security or Correctional Major. The IV Team will perform a check of all necessary equipment and instruments. Communications Check - The same procedure will be followed as at three (3) hours prior to the execution as speci?ed in Paragraph ILA. The Execution Chamber and Execution Witness Room will be inspected as directed by Warden. The condemned will be prepared in accordance with prior responsibilities previously designated by Warden. The condemned may visit with clergy." 2 Page 000008 Case: 14-12663 Date Filed: 06/17/2014 Page: 10 of 29 7-. An opportunity for the condemned to make a last statement will be provided. Any such statement will be recorded by designated" staff. A showerand clean clothing will be provided to the condemned. A designated staff member shall con?rm the" presence of witnesses required by to attend the execution. Any ?nal instructions will be issued by the Warden. 10. A designated sta?? member shall con?im the presence of the witnesses designated and approved by the Commissioner. Instructions will be issued to the witnesses to assure an understanding of their conduct in the Execution Witness Room and while being escorted to and from the Execution Witness Room. All witnesses are to have previously acknowledged, in writing, -their understanding and agreement to abide by the rules, regulations, and procedures of the GDC. (2. Within One (1) Hour of Execution Within one (1) hour of the scheduled execution, the following tasks shall be performed: 1. The IV Team will perform a check of all necessary equipment and instruments. - The designated sta?' members will prepare lethal injection syringes. Medical staff will perform a test on the heart monitor. . The condemned will be offered a mild sedative by a Physician. Special Escort Team members will ensure that all straps are in place and" functional on the execution gurney. Communications Check: The same communications check procedures speci?ed in Paragraph ILA. above will be repeated In addition, the telephone lines between the Command Center (CPI), the Execution Chamber (CP2), and the Front Gate (CP3) are to remain open beginning thirty (30) minutes prior to the scheduled execution. The Execution Chamber and Execution Witness Room will be inspected as directed by the Warden. 3 Page 000009 Case: 14-12663 8. Date Filed: 06/17/2014 Page: 11 of 29 Attendees and those required by 1 7-1 0-41 to attend executions will be issued additional instructions, and will be escorted to the Execution Chamber or Execution Witness Room as appropriate. Any witnesses for the condemned inmate, any media representatives, and? the State?s witnesses" will be processed, instructed, and transported separately.- Upon arrival at the Execution Witness Room, witnesses and media representatives will be con?rmed. The media representative designated to observe the preparation of the condemned will be identi?ed and con?rmed. The presence of witnesses requested by the condemned and those approved by the Commissioner, including media representatives, will be con?rmed. B. Preparation of the Condemned 1. The condemned inmate will be escorted to the lethal injection gumey by rnember(s) of the Special Escort Team approximately twenty (20) minutes prior to the time of the execution The Special Escort Team will securely control the movements of the condemned from the holding cell to the execution chamber. The Special Escort Team ?will secure the condemned to the gnmey by attaching restraints to the arms, legs, and body of the condemned. The IV Team will provide two (2) intravenous accesses into the condemned. If the veins are such that intravenous access cannot be provided, a Physician will provide access by central venous cannulation or other medically approved alternative. Heart monitor leads will be applied to the condemned by a Nurse from the IV Team. Witnesses will be escorted to tl1e"Execution Witness Room. The Warderrwill introduce himselfto witnesses and issue ?nal instructions regarding the execution. The Warden will ask the condemned if he has anything to add to the ?nal statement. Any additional statement will be limited to two (2.) minutes. The statement will he recorded by designated sta??. A prayerwill be offered if requested by the condemned. The prayer will be limited to two (2) minutes. The condemned will be read the Execution Order of the Court. 4 Page 000010 Case: 14-12663 9. 10. Date Filed: 06/17/2014 Page: 12 of 29 Execution o?icials will take their places. The Attorney General, or the Attorney General?s designee, shall advise the Conzuznissioner as to whether or not to proceed. The Commissioner then instructs the Warden as to whether or not to proceed. E. Execution Procws Upon the Order of the Warden, the execution process will proceed as follows: 1. A staff member designated by the Warden will monitor the time when the injection process begins. The ?rst member of the Injection Team will inject-one (1) syringe containing 2.5 grams of Pentobarbital (labeled The second member of the Injection Team will inject an additional syringe containing 2.5 grams of Pentobarbital (labeled The third member of the Injection Team will inject one (1) syringe containing 60 cubic centimeters of Saline (labeled ensuring a steady, even ?ow of the chemical. Throughout the lethal injection process, an IV Ntuse will monitor the progress of the injection in the Execution Chamber to ensure proper delivery of chemicals and to monitor for any signs of consciousness. If the IV Nurse in the execution chamber observes a problem with intravenous ?ow, the Nurse will inform the attending Physician, who will inform the Warden as to whether or not using an alternative intravenous access is appropriate. The Warden will give the appropriate instructions to the Injection Team. If, after a suf?oient time for death to have occurred, the condemned individual exhibits visible signs of life, the Warden shall instruct the_ Injection Team to administer an additional 5 grams of Pentobarbital followed by 60 cubic centimeters of Saline as outlined in Subsection 2 of Section above. Upon completion of the injection of the ?nal syringe, the designated Physician will advise the Warden when the heart monitor indicates that the condemned inmate is deceased. The Wardenand the two Physicianswill then enter the Execution Chamber to determine if death has occurred. If the condemned shows residual signs of life within a reasonable period after all injections have been completed, steps 1 through 5 above will be repeated upon the order of the Warden. The Warden will then announce the fact of death to the witnesses. The 000011 Case: 14-12663 Date Filed: 06/17/2014 Page: 13 of 29 Execution Chamber curtains will then be closed. F. Post Execution 1. The witnesses and media representatives will be escorted from the Execution Witness Room. Media representatives will be immediately escorted from the prison to the press area. 2. The IV lines will be detached by the IV Team, the straps will be removed by . the Special Escort Team, and the body will be removed from the gumey. The body will be placed in a body bag and placed on a stretcher. provided by the State Crime Lab. The body will then be taken by van to the State Crime Lab for a postmortem examination. 3. Press release: The Public Information Officer for the Department of Corrections will advise news media that the Order of the Court has been . carried out. G. Interment of Condemned. 1. The Warden or designee and attending physicians will prepare a certi?cate of execution and certify the fact of execution. The certi?cate will be forwarded to the Clerk of Superior Court of the county in which the sentence was pronounced. A copy shall be forwarded to the Commissioner. 2. The last statement of the condemned will be forwarded to the Central Of?ce, as appropriate. 3. Interment: The body may be released to the relatives at their expense or should the nearest relative of the condemned so desire, the body will be carried to the former home of the person so executed, if in the State of _Georgia. The expense of such transportation to the former home shall be paid by the Ordinary, County Commissioners, or person(s) having the charge of county funds in which the person was convicted. (O.C.G.A. 17-10-43). 4. If the relatives do not claim the body of the executed person, interment will be in" accordance with Board of Corrections Rule 125-2-4.20. II. Critical Incident Debrie?ng Staff participants will be seen by the Critical Team within seventy?two (72)'hours of each execution or as soon as possible. 6 P'age 000012 1. Case: 14-12663 Date Filed: 06/17/2014 Page: 14 of 29 APPENDIX I IV TEAM - INSTRUCTIONS SET PROCEDURE: The Warden or designee will have two (2) intravenous infusion devices placed in the veins of the condemned and a Saline solution available for an infusion medium. Those persons engaged in this activity will be referred to as the IV Team. 2. An IV administration set will be into the outlet of the bag of Normal Saline IV solution. Two (2) IV bags will be set up in this manner. 3. The IV tubing shall be cleared of air and made ready for use. 4. The standard procedure for providing IV access will be used. 5. The IV tubing for both set-ups will be connected to the receiving port of the IV access; one for the vein, the other for the secondary vein. 6, At this point, the administration sets shall be running at a slow rate of ?ow (KVO), and ready for the insertion of syringes containing the lethal agents. The Warden or his dcsignee shall maintain observation of both set-ups to ensure that the rate of ?ow is uninterrupted. NO ACTION shall be taken until the prearranged signal to start the injection of lethal agents is given by the Warden or designee. 7 a 000013 Case: 14-12663 Date Filed: 06/17/2014 Page: 15 of 29 APPENDIX II - CONTROLLED CHEMICAL HANDLING PROCEDURES FOR EXECUTION BY LETHAL INJECTION The following procedures will be utilized to obtain controlled chemicals,?transport the chemicals to the Execution Chamber at the Georgia Diagnostic and Classi?cation Prison (GDCP), dispose of andfor return unused chemicals to the GDCP Pharmacy. - A. The certi?cate issued by the Drug Enforcement Agency (DEA), Unitedstates Deparnnent of Justice will be posted in the medical room of the GDCP Execution Chamber. A copy of the certi?cate will be? kept on ?le at the GDCP Pharmacy. B. All controlled materials, blank ?Controlled Chemical Disposition Record? forms, and a lockable transport case will be kept in the GDCP Pharmacy. C. The designated key ring, located in the Tunnel Entrance Restricted Key Box, will be utilized to gain access to the chemical storage containers, transport case and the temporary chemical storage containers located in the Execution Chamber. Access to this key ring and the receipt andfor transportation of chemicals is restricted to: Deputy Warden for Security, Correctional Major, and designated Pharmacist. In an emergency, the Warden of GDCP may designate another of?cial this dutyscheduled execution, one of the authorized staff members will draw the proper keys, proceed to the pharmacy and procure the appropriate amount of chemicals. E. The appropriate amount of chemicals to be issued is as follows: Pentobarbital - a total of 15 grams of the chemical. F. During the procedures outlined in step the ?Controlled Chemical Disposition Record? will be initiated at this time. The Pharmacy will keep a temporary copy upon issuance. The original will be kept with the chemicals in the transport case. The appropriate sections will be completed as needed. G. Chemicals will be delivered to the Execution Chamber and locked in the chemical storage container. H. Within one hour of the scheduled execution, the chemicals will be drawn into syringes to be used by the Injection Team by a trained staff member supervised by a nurse. 1. Chemicals will be drawn up as follows: 1. ?Pentobarbital - 2.5grams Syringe #1 . 8 Page 000014 Case: 14-12663 Date Filed: 06/17/2014 Page: 16 of 29 2. Pentobarbital 2.5 grams Syringe 2. 3. Saline Solution 60 cubic centimeters each - Syringe 3. I. A secondary set of Syringe Numbers 1, 2 and 3 will be prepared in the nianner outlined above in section I if an additional dosage of Pentobarbital is needed. The secondary set of Pentobarbital will not be drawn into Syringe Numbers 1 and 2 prior to the execution, but will be immediately available, together with the appropriate syringes, if an additional dosage of Pentobarbital is needed. K. The remaining chemicals, along with appropriate syringes will be_ locked in the transport case and placed in the mechanical room ?in the event they are needed. L. At the conclusion of the execution, the amount of each chemical injected into the condemned inmate is to be recorded on the Controlled Chemical Disposition Record form, along with the date, time, inmate name and number. M. Any chemical loaded into a syringe that is not used will be destroyed by disposing of the chemicals in an appropriate manner. This must be witnessed and the section completed and signed on the Controlled Chemical Disposition form. N. Any unused chemicals will be returned to the pharmacy via the transport case and the remainder of the Controlled Chemical Disposition Record form will be completed. 0. The original Controlled Chemical Disposition Record form will be retained by the Pharmacy. A copy willbe sent to the Warderfs office for inclusion into the Execution ?le. P. An inventory will be kept by the Pharmacy of each chemical used and returned. The Controlled Chemical Disposition form and the inventory logs will be kept in a red binder attached to the chemical storage container. Q. The attachments 1 through 2 will be completed and submitted as required. Attachments: (1) Controlled Chemical Disposition Fonn (2) Inventory Log for Pentobarbital 9 Page' 000015 Case: 14-12663 Date Filed: 06/17/2014 DISPOSITION RECORD . (LETHAL INJECTION) GEORGIA DEPARTIVIENT OF CORRECTIONS GDCP D-ISPENSED BY GDCP PHARMACY Name of Chemical Amount PENTQBARBITAL Date Issued Lot 15 Page: 17 of 29 APPENDIX II I of Vials ISSUED BY: (SIGN AND PRINT NAME) RECEIVED BY: (SIGN AND PRINT NAME) DEFPILOCATION CHENIICALS ADMINISTERED BY INJECTION TEAM DATE TINIE 1-NNIATE ER CALS QTY PENTOBARBIIAL DESTROYED CHEMICALS DESTROYED QTY OF SYRINGES DATE DESTROYED DEPTILO CATION PENTOBARBITAL DESIEOYED BY: (SIC-NAND NAME) wrmEssED BY: (SIGNAND PRINTNAMB) RBI TO GDCP EMACY DATE RE CHENIICAL RE QTY RETURNED OF VIALS PENTOBARBITAL I RECEIVED BY: DEF-NLOCATIQN 10 Page 000016 Case: 14-12663 Date Filed: 06/17/2014 Page: 18 of 29 :58 .nmzmE.mm EOE numzmman EOE HEM mac: . uwumzmmu I MUQU I HO SUMOEU GOA WMOHZEE .EoE?mo QHHAOMHZOU Case: 14-12663 Date Filed: 06/17/2014 Page: 19 of 29 GEORGIA DEPARTMENT OF CORRECTIONS Office of Legal Services Nathai1?Deal P.0. BOX 1529 Gc0rgi.a Brian Owens Telephone (478) 992-5240 Facsimile (478) 992-5241 Robert E. Jones General Counsel May 27, 2014 INVOICE TO: Federal Defender Program, Inc. Attn: Douglas Munro Suite 1500 Centennial Tower 101 Marietta Street, NW Atlanta, GA 30303 FOR: Open Records Request copies .10 2.40 Search and Retrieve $0.00 (.2 1: $12.00[per hr, ?rst quarter hour no charge) . Shipping/Handling $0.00 Total Due: $2.40 *Please make checks payable to: Georgia Department of Corrections. You can mail payment to our of?ce at the address at the top, and put to the attention of Jamie 0?Steen. 000018 Date Filed: 06/17/2014 Case: 14-12663 Page: 20 of 29 UNDER DEATH SENTENCE RECEPTION AND HOLDING PROCEDURES APRIL 2011 000019 Governor To: From: Subject: Case: 14-12663 Date Filed: 06/17/2014 Page: 21 of 29 GEORGIA DEPARTMENT or CORRECTIONS comassromax as OFFICE 300 PATROL ROAD FLOOR, GIBSONHALL . :24 30129 Geoyg-tam Brian Owens Commissioner April 12, 2011 Warden Carl Humphrey Georgia Diagnostic and Classi?cation Prison -Commissioner Brian Owens Holding and Preparation of UDS Inmates for Execution The following procedures will be utilized for the holding and preparation of UDS inmates for execution. HOLDING AND PREPARATION FOR EXECUTION PREPARATION FOR EXECUTION AND TIME OF EXECUTION The order of the court will specify a time span for the execution. A speci?c date and time, the designated time span will be established and. announced by the Commissioner to the appropriate.personnel on a need to know basis. The date and time for execution should be ?nalized seven (7) days in advance. NOTIFICATION Upon receipt, the Warden or his_ designee shall read to the condemned inmate the Order of Execution issued by the court of conviction. The condemned will sign the? Order acknowledging noti?cation of the Order and the signature of the condemned will be witnessed by the staff member and same will provide the condemned with a copy of ?d1e?Order. Ifthe condemned refuses to acknowledge receipt of the Order of Execution, the Warden or designee shall read the Order of the Court and acknowledge receipt for the condemned, in writing, which shall be witnessed by a sta?? member other than the Warden and attached to the Order. DEATH WATCH After the Order of Execution is read to the condemned inmate, the condemned shall be given a medical examination and searched for contraband. Following the medical examination and search, the condemned will be moved ?to a cell designated by the'Warden. Once the condemned is moved to the cell designated by the Warden, the condemned inn1ate_?s personal property will not be returned tothe condemned, with the exception of legal materials, religious materials or personal items expressly permitted, in writing, by the Warden". The Warden may provide the condemned with any additional State issued property as the Warden deems appropriate. A list of all property speci?cally approved by the Warden shall be kept with the activity log, and initialed by the Warden. 000020 Case: 14-12663 Date Filed: 06/17/2014 Page: 22 of 29 A minimum of two (2) of?cers shall be assigned to observe the condenmed at all times during Death Watch. If the condemned is a female, security will be maintained by female security personnel. Duties shall be established by the Deputy Warden of Security and the Warden No other correctional staff, or civilian personnel, exceptmedical personnel, shall be allowed in the Death Watch area without approval of the Warden or designee. No inmates are allowed in the Death Watch area. (1) - Observation Security of the Execution Chamber and the Execution Witness Room is the responsibility of the Warden. Security brie?ngs shall be held as appropriate". The o?-icer in charge on each shift shall supervise the use of all items retained by me condemned and shall maintain a log of all activities of the condemned to include, but not limited to, the times of feeding, showering and all other occurrences. All meals for the condemned during the Death Watch shall be prepared/procured and delivered by the Food Service Director, or designee. The activity log sheet - shall re?ect all names of persons delivering meals, menu items served the condemned and whether they were consumed or returned, to include date and time. A communication check, by telephone/radio, shall be made every thirty (30) minutes, on a continuous basis, during this period by the Death -?Watch Officer to the institutio_n?s control center. This communication check shall be logged. (2) Medical Sick call will be in accordance with institution Rules and Regulations prior to the Death Watch period. During the Death Watch, sick call will be in the Death Watch area. ?Request for medical attention by the condemned, in addition to sick call, will be provided in the Death Watch area unless determined inappropriate by the Medical Authority. A medical determination to examine or treat the condemned in other than the Death Watch area should be coordinated with the Warden as soon as possible. PERSONAL PROPERTY OF THE CONDEMNED (1) The conden1ned?s personal property will be packed by institutional staff and secured in the Property Room. (2.) The inventory process and sealing of personal property shall be perfonned by an institutional officer and another staff person as designated by the Warden. (3) The condemned shall sign a completed inventory sheet, which shall be witnessed by the officer and? me other staff member. 000021 Case: 14-12663 Date Filed: 06/17/2014 Page: 23 of 29 (4) (1) (2) (3) (4) The condemned shall indicate, in on the completed inventory sheet the recipient of all personal property. E.. STATE ISSUED ITEMS The condemned shall be ?n-nished with the following state-issued items while under Death Watch: - 1 Mattress 1 Pillow - 1 Pillowcase 2 Blankets (as necessary) - 2'Sheets - 2 Towels - 1 Bar of Soap - 1 Shirt - 1 Jacket (provided as needed) - 1 Pair of Pants - 1 Pair of Boxer Shorts - 1 Pair of Socks 1 Pair of Shower Shoes -, 1 Religious Material - 1 Toothbrush and Tube of Toothpaste (provided as needed) - 1 Use of Electric Razor (Cordless) The Warden may provide the condemned with any additional State issued property, as the Warden deems appropriate. A list of all property speci?cally approved by the Warden shall be kept with the activity log and initialed by the Warden. The condemned may be provided the following upon request: - -1 Television Set to be Located Outside the Cell - 1 Radio to be Located Outside the Cell - Playing Cards - Stationery - Newspapers and Magazines (as approved by the Warden) - Personal Items Approved by the Warden or Designee (limited to essential needs) Any variation ?'on1 theabove list shall be approved by the Warden or designee, in writing, and attached to the activity log. The condemned will not be provided with the following: - Razors or Blades (other than cordless electric) Belts - T-Shirts 000022 Case: 14-12663 Date Filed: 06/17/2014 Page: 24 of 29 FUNERAL ARRANGEMENTS At the beginning of the Death Watch, if not previously done, the condemned may specify, in writing, his or her request for funeral arrangements. This information shall be conveyed if necessary to the inmate-?s family, or others as appropriate, by the Warden or his designee at least twelve (12) hours prior to the scheduled execution. WITNESSES WHO MAY BE PRESENT (1) (2) (3) Witnesses to the execution beyond those specifically prescribed by law or elsewhere this procedure must be approved by the Commissioner prior to the day of the scheduled execution. Restrictions: (1) No photographic, audio, recording, or computerized equipment will be permitted in the execution chamber or witness room except as speci?cally authorized by the Warden. All pencils, note pads, etc. will be issued and controlled by designated GDC staff. (2) Space limitations may limit the number of witnesses to be present in the execution witness room. Witnesses will be selected as outlined below: Five (5) witnesses selected by the condemned. These witnesses may not consist of inmate or victim family members unless approved by the Commissioner of the Georgia Department of Corrections. Five (5) witnesses representing the news media organizations.? Media representatives - shall be determined as follows: The Georgia Bureau Chief of the Associated Press Wire Services may designate one news reporter to be its media representative. The Georgia Press Association, through its Executive Director, may designate two pool newspaper reporters to be its media representatives, including one pool . reporter ?'om a newspaper published within the county in which the condemned was convicted. The Georgia Association of Broadcasters, through its President, may designate two pool news reporters to be its representatives for the electronic media, including one television or radio reporter from the county in which the condemned was convicted. The names of the news reporters representing the above mentioned classes or news media and designated "alternates, shall be communicated telephonically to the Commissioner of the Department of Corrections at least twenty-four (24) hours prior to an execution. 000023 Case: 14-12663 (4) (6) Date Filed: 06/17/2014 Page: 25 of 29 All approved media witnesses will be certi?ed in writing by- the Commissioner to the Warden of the Georgia Diagnostic and Classi?cation Prison. In the event that more than one execution is carried out in a single day, the same ?media representatives shall be the witnesses for those executions. The newspaper and broadcast representatives from the county of conviction will change if the offenders to be executed are from di??erent?counties. Upon entering the Georgia Diagnostic and Classi?cation Prison, each media representative must present suf?cient evidence to establish his/hervidentity to the Warden or designee that he/she is entitled access to the press conference interview. This shall include a current photo I.D. Pencils, pens, notebooks, etc., will not be allowed; these items will be provided by Department of Correctioris staff. Facility policy prohibits witnesses Wearing or bringing jewelry or other personal items into the facility. Not less than ?ve (5) witnesses approved in writing by the Commissioner of the Department of Corrections. (3) (0) The Commissioner of the Department of Corrections may approve ?ve (5) or more witnesses to be present in the witness room. These witnesses may include of?cials with the Executive, Judicial or Legislative Branch of Government, or private citizens. The Commissioner?s Office shall maintain a tentative list of witnesses and keep the list updated. The Commissioner may approve one or more witnesses representing the victim(s). Requests of this nature will be received by the Commissioner no later than twelve (12) business hours prior to the day of the scheduled execution. All approved witnesses will be certi?ed in writing by the Commissioner to the Warden of the Georgia Diagnostic and Classi?cation Prison prior to the time of the scheduled execution, if possible. Prior to the time of the execution, the Warden shall con?rm participation. Witnesses: Request of the Condemned Ifthe condemned person so desires, the following may be present at such execution: hisfher counsel, relatives, clergyman and friends, (OCGA 17-10-41), pursuant to approval as outlined in 12.1.1. The condemned may update the names of those he/she desires to be present at the execution with the, Commissioner?s approval. These names shall be recorded in writing, (1) witnessed and maintained by the Warden or designee. Not later than twelve (12) hours prior to time of execution these witnesses requested by the condemned shall be contacted by the Warden or designee in the most expeditious and appropriate method of communication to con?rm the request and advise them of the time .and date of the execution, assembly, orientation and escort procedures to the execution witness room. 000024 Case: 14-12663 Date Filed: 06/17/2014 Page: 26 of 29 Witnesses - Other (1) (2) (3) Those witnesses to the execution required by law shall be under thesupervision of the Warden of the institution or designee and shall appear at the institution at a time and place as directedlby the Warden. Those witnesses requested by the condemned shall appear at the institution no later than two (2) hours prior to the execution for orientation and escort to the execution witness room (refer to Paragraph 12.2). Those witnesses to the execution who are approved by the Commissioner of the Georgia Department of Corrections shall appear at the institution no later than two (2) hours prior to the execution for orientation and escort to the execution witness room. MEDIA INFORMATION AND -PUBLIC INFORMATION OFFICE (1) (2) (3) News media representatives shall- not be allowed to visit any inmate at the institution ?during the Deathwatch. Brie?ngs for news media representatives shall be conducted as appropriate during the Death Watch and immediately after the execution by the Public Information Officer or designee at a time and place designated by the Warden of the institution. Broadcast reporters will be allowed to broadcast live ?'om a pre-designated area on the grounds of the institution during the hours designated by the Warden on the day of the execution. A delay in the execution may require that these hours be adjusted accordingly. VISITATION The condemned shall be allowed contact visits the day prior to and the day of the execution with I family, ?iends, private clergy and his legal representatives as approved by the Warden. Except as otherwise noted below, nonnal visitation policies will apply. (1) . (2) (3) Ifpossible, all visitors should be processed into the institution at one time and placed in the room provided. A maximum of ?ve (5) visitors at a time shallbe allowed in the institution at one time. The condemned may eat an institutional meal while in the visiting room with his visitors. Visitors may purchase an institutional meal which may be consumed in the visitation area in the presence of the condemned." Attorney(s) shall be allowed to visit the condemned upon approval of the Warden or - designee. VICTIIVPS FAMILYIRELATIVES A sta?? member will be designated to care for any of the victim?s family who remain within the institution during the execution. A room shall be designated for this purpose. 000025 Case: 14-12663 Date Filed: 06/17/2014 Page: 27 of 29 TELEPHONE Telephone access shall be provided to the condemned, with the following limitations: (1) Telephone calls shall be in accordance to institutional rules and regulationsprior to Death Watch. (2) At least one (1) ?fteen (15) minute call per day during Death Watch, unless otherwise approved by the Warden; a phone will be provided to the condemned, unless otherwise restricted by the Warden. (3) All telephone calls shall be made collect, unless the Warden makes exceptions. (4) All telephone calls are to be made between the hours of 8:00 am. and 6:00 p.m. unless otherwise approved by the Warden. (5) Incoming calls for the condemned will be referred to the Warden or designee for screening and approval. Such calls will be denied unless the purpose involves family and/or legal matters requiring the condemned?s involvement. 000026 Case: 14-12663 Date Filed: 06/17/2014 Page: 28 of 29 GEORGIA DEPARTMENT OF CORRECTIONS OFFICE - 300 PATROL ROAD FLOOR, GIBSONHALL s? FORSYITH, GA 3 0129 Geo-lrg-la: Brian Owens Governor Commissioner April 12, 2011 To:- Warden Carl Humphrey Georgia Diagnostic and Classi?cation Prison From: Commissioner Brian Owens Subject: Delivery, Processing and Con?nement of UDS Inmates The following procedures will be utilized for the deliver, processing and con?nement of UDS inmates once sentenced by the court. I. RECEPTION on DEATH SENTENCE (ups) CASES A. THE SENTENCE (1) Upon a verdict or judgement of death made by a jury or a judge, it is the responsibility of the Clerk of Court, in which said sentence is pronounced, to forward a certi?ed copy of said sentence to the Warden of the Georgia Diagnostic and Classi?cation Prison not less than ten (10) days prior to the ?rst day of the seven (7) day execution period as ?xed by the court (OCGA 17~10-3 3). (2) Where the date for execution has passed for any reason, appeal, habeas corpus," State Board of Pardons and Paroles, etc., the judge of the Superior Court of the county where the case was tried shall have the power and authority to ?x a seven (7) day period for the execution of the original sentence. Such order shall ?x the seven (7) day period not less that ten nor more than twenty (20) days ?om the_date.of such order. Such order shall ?be sent immediately to the Warden of the ?Georgia Diagnostic and Classi?cation Prison (OCGA 17-10-40). (3) Upon noti?cation, the Warden of the Georgia Diagnostic and Classi?cation Prison will I immediately notify the Commissioner and forward a copy of the sentence (Execution Order) or other orders. - (4) Upon noti?cation as described in 1.3, the Commissioner will forward a copy of the execution order to the Governor (Attention: Legal Counsel, Governor's Office) andthe Chairman of the'State Board of Pardons and Paroles. 000027 Case: 14-12663 Date Filed: 06/17/2014 Page: 29 of 29 B. Delivery of the Condemned Person (1) In all cases in which the defendant is sentenced to be executed, it shall be the duty of the trial judge inpassing sentence, to direct that the defendant be delivered to the Commissioner of the Georgia Department of Corrections for execution at such state prison as may be designated by said Commissioner, (OCGA 17- 1 0-3 8). (2) It shallube the duty of the sheriff of the county in which such convicted person is so sentenced to convey such convicted person to said state prison not more than twenty (20) nor less than two (2) days prior to the time ?xed in the sentence for execution of the condemned person unlessotherwise directed by the State Board of Pardons and Paroles, or unless a stay of execution has been caused by appeal, granting of a new trial, _or other order of a court of competent jurisdiction, and the expense for transporting of said person to the state prison for the purpose of execution shall be paid by the Ordinary of the County wherein the conviction was had, or the Board of County Commissioners, the County Commissioner, or other person or persons having charge of the county funds, out of any funds on hand in the treasury of such County, (OCGA 17-10-.3 3). (3) The Commissioner will issue assignment orders to the Sheriff of the County of conviction and forward copies of the Order and sentencing documents to the state prison. Delivery of the condemned person by the Sheriff will be arranged and coordinated by the Commissioner between the Sheriff of the County concernedand the Warden of the prison. Persons under death sentence incarcerated? at institutions. other than the institution designated by the Commissioner as the execution site will be transferred to the execution site approximately two (2) days prior to the scheduled execution date. Details of such transfer will be coordinated by the Commissioner. C. ADMISSION PROCESSING Upon arrival of the condemned person at the Georgia Diagnostic and Classi?cation Prison or Arrendale State Prison, he/she will be processed through regular inmate admission procedures, to include security search, medical examination, ?ngerprint, photograph, personal history information, etc., to include a complete diagnostic evaluation, a copy of which will be provided to the Commissioner of the Department of Corrections, and the State Board of Pardons and Paroles. D. CONFINEMENT i The condemned person will be con?ned in a cell designated by the Warden. Appropriate safeguards and security measures will be maintained as directed by the Warden; Pending the invoking of the Death Watch, the condemned person will be maintained in accordance with Departmental Rules and Regulations, special regulations for persons under death sentence, and speci?c court order. Persons delivered to the execution site less than thirty?six (36) hours prior to the time of execution, (refer to Paragraph 2.2), will be processed immediately and assigned to the Death Watch Cell. A I 000028 Case: 14-12663 Date Filed: 06/17/2014 Page: 1 of 40 Exhibit 2 Case: 14-12663 Date Filed: 06/17/2014 Page: 2 of 40 GEORGIA DEPARTNIENT OF CORRECTIONS Office of Legal Services P.0. BOX 1529 Nathan Deal Georgia 31029 Gm? Telephone (473) 992-5240 Brian Owens Facsimile (473) 992-5241 Cvmwow Robert E. Jones General Carma? July 10, 2.013 Georgia Resource Center Attn: Robyn Painter 303 Elizabeth Street, N.E. Atlanta, GA 30307 . ainter areso Re: Open Records Act Request Dear Ms. Painter: The purpose of this correspondence is to respond to your Georgia Open Records Act request received by the Department on July 5, 2013. 1. Request: The quantity of any and all pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, hydromorphone, or any other drug for use in lethal injections currently in the possession of the Georgia Department of Corrections (GDC), or which the GDC expects to obtain possession of on or before July 15, 2013. Response: The Department currently does not have any pentobarbital, sodium thiopenthal, phenobarbital, propofol, rnidazolam, hydromorphone, or any other drug for use in lethal injections in its possession. The Department is providing email correspondence (wiattachments) relating to the Department?s attempts to obtain drugs for carrying out executions (35 pages). The Department will not produce information which if disclosed could compromise security against criminal orterroristic acts pursuant to 0.C.G.A. 50-18- Additionally, the Department will not disclose certain identifying information pursuant to 0.C.G.A. Therefore, certain portions of the records have been redacted. Certain documents have not been provided as they are protected by the attorney-client privilege and attorney-work product doctrine. 0.C.G.A. 5 0-1 2. Request: Any and all documents and records regarding the expiration dates of any and all pcntob arbital sodium thiopenthal, phenobarbital, propofol, midazolam, hydromorphonc, or any other drug for use in lethal injections currently in the possession of the GDC, or which the GDC expects to obtain possession of on or before July 15, 2013. Response: The Department currently does not have any pentobarbital, sodium phenobarbital, propofol, midazolam, or any other drug for use in lethal injections in its possession and cannot provide the information requested for any lethal injection drug we have not yet obtained. Therefore, the Department does not have any 000001 Case: 14-12663 Date Filed: 06/17/2014 Page: 3 of 40 record responsive to this request. . Request: Copies of the controlled chemical inventory lo g, other storage records, invoices, purchase agreements, communications about, or records of delivery, of any pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolarn, hydromorphone, or any other drug for use in lethal injections curren?y in the possession of the GDC or which the GDC expects to obtain possession of on or before? July 15, 2013; ?om July 1, 2012, through the present. Response: The Department previously provided Mr. Brian Georgia Resource Center, the Controlled Chemical Inventory Log (1 page) and the DEA Form 222 (1 page) on June 28, 2013. No changes have occurred to these documents since June 28, 2013. If you wish to receive a copy of the Controlled Chemical Inventory Log (1 page) and the DEA Form 222 (1 page), please let me know. Additionally, the docurnents provided in #1 are responsive to this request. Request: Copies of any and all labels of each unit or box of pentobarbital, sodium . thiopenthal, phenobarbital, propofol, midazolam, hydromorphone, or any other drug for use in lethal injections currently in the possession of the GDC, or which the GDC expects to obtain possession of on or before July 15, 2013; from July 1, 2012, through the present. Response: Same as . Request: The name and address of the manufacturer and supplier of each unit or box of pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, hydromorphone, or any other drug for use in lethal injections currently in the possession of GDC, or which the GDC expects to obtain possession of on or before July 15, 2013; from July 1, 2012, through the present. Response: The Department does not have any pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, hydromorphone, or any other drug for use in lethal injections in its possession; therefore, the Department does not have any records responsive to this request. I With regards to the name and address of a manufacturer or supplier of any drug that could be obtained by the GDC for use in lethal injections on or before July 15, 2013, disclosure of this information is not required. Pursuant to O.C.G.A. 42-5-3 ?the identifying information of any person or entity who participates in or administers the execution of a death sentence and the identifying information of any person or entity that manufactures, supplies, compounds, or prescribes the drugs, medical supplies, or medical equipment utilized in the execution of a death sentence shall be con?dential and shall not be subject to" disclosure under Article 4 of Chapter 18 of Title 50 or under judicial process. Such information shall be classi?ed as a con?dential state secret.? . Request: Any and all documents, including purchase orders, invoices, and emails as well as any other records relating to the purchase, attempted purchase, and potential future purchase of pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, hydromorphone, or any other drug for use in lethal injections currently in the possession of GDC, or which the GDC expects to obtain possession of on or before July 15, 2013; from July 1, 2012, through the present Case: 14-12663 Date Filed: 06/17/2014 Page: 4 of 40 Response: Same as 7. Request: Copies of any communications between GDC and any party, including foreign manufacturer, compounding pharmacy, supplier, wholesaler, or distributor and! or any other state?s department of corrections or equivalent of?ce, regarding pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, hydromorphone, or any other drug for use in lethal injections currently in the possession or which the GDC expects to obtain possession of on or before July 15, 2013; from July 1, 2012, through the present. Response: Same as 8. Request: Copy of the full lethal injection protocol currently used by the GDC. Response: A copy of the current GDC lethal injection protocol (13 pages) was provided to Mr. Brian Krammer on June 28, 2013, and no changes have occurred since this information was provided. Ifyou wish to receive a copy of the GDC lethal inj eotion protocol, please let me how. - 9. Request: The full lethal injection protocol used by the GDC at the time of Andrew Coolc?s execution in February 2013. Response: This information can be found in the lethal injection protocol that is responsive to 10. Request: The dosage of any and all drugs, including but not limited to pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, and hydromorphone, required by the GDC for a single execution. Response: This information can be found in the lethal inj ection protocol that is responsive to 11. Request: The procedures to be implemented by the GDC should the protocol dosage of drugs ?'om item #10 proye insufficient for inducing unconsciousness or death at the time of administration during an execution. Response: This information can be found in the lethal injection protocol that is responsive to 12. Request: The procedure implemented by the GDC for detemiining consciousness and death after administration of lethal injection drugs including, but not limited to pentobarbital, sodium thiopenthal, phenobarbital, propofol, midazolam, and during an execution. Response: This information can be found inthe lethal injection protocol that is responsive to 13. Requut: A list of any potential chemical substitutions used by the GDC should the lethal injection drugs speci?ed in #10 be unavailable at the time of an execution. Response: The Department does not have any records responsive to this request. 000003 Case: 14-12663 Date Filed: 06/17/2014 Page: 5 of 40 14. Request: The positions and roles of each person involved in the execution process in Georgia, from the time a warrant for execution is issued to the time at which death is declared. Response: This information can be found in the lethal injection protocol that is responsive to 15. Request: A list of any and all medical personnel, including but not limited to physicians, nurses, and emergency technicians, involved in the execution process in Georgia. Response: This information is not subject to disclosure. Pursuant to 0.C.G.A. 42-5- ?the identifying information of any person or entity who participates in or administers the execution of a death sentence and the identiiying information of any person or entity that manufactures, supplies, compounds, or prescribes the drugs, medical supplies, or medical equipment utilized in the execution of a death sentence shall be con?dential and shall not be subject to disclosure under Article 4 of Chapter 18 of Title 50 or under judicial process. Such information shall be classi?ed as a con?dential state secre 16. Request: The protocol used by the GDC for housing and treating an inmate under a warrant of execution. Response: The Department previously provided the GDC Directive (3-pages) that is responsive to this request to Mr. Brian Georgia Resource Center, on June 28, 2013, and no changes have occurred since this information was provided. Ifyou wish to receive a copy of the GDC Directive, please let me" how. 17. Request: The protocol used by the GDC for monitoring the physical and mental health of an inmate in the days and hours immediately preceding his execution. Response: The Department previously provided the GDC Directive (8-pages) that is responsive to this request to Mr. Brian Krammer, Georgia Resource Center, on June 28, 2013, and no changes have occurred since this information was provided. Ifyou wish to receive a copy of the GDC Directive, please let me know. The responsive records provided to you are attached electronically and therefore, the Department is not charging a fee for the records. If you have any questions or concerns, please do not hesitate to contact this o?ice at the number listed above or by email at wilsob06@dcor.state.ga.us. Sincerely, GEORGIA DEPARTMENT OF CORRECTIONS Bryan S. Wilson Assistant Counsel 000004 Case: 14-12663 Date Filed: 06/17/2014 Page: 6 of 40 essage From: To:' D-ats:= 7! 012013 9:09:16 AM Subject: massage . Gleam call me as soon as you have a moment. Thank yum!? Georgia Department of Gomac?ons 000005 Case: 14-12663 Date Filed: 06/17/2014 Page: 7 of 40 From: To: .- Date: PM Subject: . I Please find attached the statutes we discussed. Call me If you have any questions or concerns. Best regards, 4% Cell Gee la Department of corrections - 000006 Case: 14-12663 Date Filed: 06/17/2014 Page: 8 of 40 D?3B.rtf age I Page 1 cries. 5 17-10-33 a . . LexIsNexIs? 1 of1 DOCUMENT .. -OFFICIAL cone or oaoneraaimorxrco 3? . - ., All rights reserved. 2 Annotations Current Through March 29, 2013 it . TITLE 17. IRIMINAL PROCEDURE I0. AND 2. DEATH PENALTY GO TO GEORGIA STATUTES ARCHIVE DIRECTORY (2013) 17-10-38. Death mntenoes generally ofa capital o?ense endbavehsdimposed uponthemasentenoeofdeeth shall suffer such lethal injection. Lethal irdec?onis the continuous intravenous injection ofasubstance or su?iciontto causedeathintothe body ofthoporsonsentencedto deathuntll suchpersonisdesd. (b)Inalioeses inwhicli?ie defendantissentertcedto death, itshallhe the duty oftisebialjudge inpassingsentenoe to direotthatthe defendantbe for exeoutionoftbe deatheontence atastate correctional institution department. Notwithstanding any other provision of law, prescription. preparation. dispensing, or administration ofe lethal injection aulhorizedby a. sentence ofdeathbya court of competentjurlsdiction shall not constitute the practice ofmotilcine or any other profession relating to health care which is subject by law to regulation, llcensure, or certi?cation. No state agency, department, or o?oisl may, through regulation or otherwise, require or compel a physician to participate in the execution of a death sentence. "To participate inthe execution of a death sentence? means any of the ?allovving actions: selecting injection sites; starting an intravenous line or lines as a. port for st lethal injection device; prescribing, preparing, administering. or supervising injection drug or their doses or types; inspecting, testing, or maintaining lethal injection devices; or consulting with or supervising lethalinjection personnel. HISTORY: (311. L. 1914. p. 195, 1; Code 1933, 27-2512; GI.L. 1937-38, Ex. Seen, 330. 1; Ga. L. 1985, p. 283,? 1; 2000, p. 947, 5 3. NOTES: NOTES. -Ga. L. 2000. p. 947. 5 1. not codi?ed by the General Assembly. provides that: ?It is the intention of the General Assembly to provide for execution by lethal injection persons sentenced to death otter conviction crimes committed onor afterMay1, 2000. Itis the ?trther intention ofthe General Assembly that persons sentenced to death for crimes committed prior to the o?hotive date of this Act he executed by lethal injection if the Supreme CourtoftheUnited3taiea ConstitutionoftheUnited States Supreme Court of Georgia declares that electrocution violates the Constitution of the United States or the Constitution of Georgia." Ge. L. 2000, p. 947. 6, not codi?ed bythe General Assembly, provides that: "Section 3 of1i1isActshell apply to persons stunned to death for crimes committed on or afterMay l, 2000. Code Section as it existed prior to 000007 Case: 14-12663 Date Filed: 06/17/2014 Page: 9 of 40 9 Faeeil n? Page 2 - O.C.G.A. 17-10-38 . rumndiumbysooaona 1.2000. exeeptthetSeetion3 ofthisrltetshall allpereoris seotencedto deethfor ifthe Supreme Court'oftl:reUnited Stein: orif . the Supreme Court cf?eorgla declares that electrocution violaiesthe Conltihrtion of the United States or the LAW REVIEWS. -For article, "The Right nctto Kill," see 6.2 .EmoryL.J. (2012). JUDICIAL DECISIONS FOR CHAILLENGB OF GA. L. 1937-38, EX. 330, 5 1 POST GROUNDS, see Benton State, 187 Ga. 149, 199.513. 749 (I939). AILEGATION THAT SECTION VIOLATB8 SEPARATION OF POWERS PROVISION. -Allegaiion thezthia section was Iancunr?tn?onnl, null. and void became ?ue statute supposedlyviolnted Ge. Count. 187?. Art. I. See. I, Pm. Go. Corn-?1983, Art. I. See. H. Para. prenenterlnc quea?onforjudleial rleterminationsincethe statute failedeopoirrt out and onnl provision. William: 9. Stars, 187 Go. 415, I (I939). - GA. 1.. 1937-38, EX. P. 330, 5 1 NOT UNCONSIITUHONAL ?Thia section was notnneonstitutionel an yioletive ofcin. Const.1li'l'7. See. 1, Peru. I (see Go. Com-t. 1983, Art. H13 Sec. Para. mm the Wi?ianuv. State. 1870:. 415. 3.112.! 27 (1939). VARIANCE TITLE-AND MATTER OF LEGISLATION. -68. L. 1924, p. 195 did nctooniein matter nntexpressed inits caption, invioln?on ofGa. Const.1B77. All 111. 3% V11. P311 V111 (509 99- 1933: An?. HI, Sec. 7, Porn. HI). Store, 154 Go. 204, 17385.5. 305, nppeeldlamissed, 275 US. 575, 435'. Ct?. LN, 72 1. Ed. 435 (1927; MANNERIN WHICH CB3 EXECUTED IS FOR. IJBGISLATIVE ENACTEEBNT. --T315113 being no provision inthe Constitution conferring upon sherif?r ofecuntlea thiflcwer to ofthe court: in capital cases, the manner of execution ofruohsentence: in for legislative enactment Dunaway v. Gare. 154 Go. 219, I38 213 (192 OF -A: electrocution inflicts purposeleu violence and needles: mutilation. in violation of the prescription of cruel and ununnl pnnishrnents of Ga. Caner. I983, Art. I. See. Porn. JFV, ?xture executions of dea?uentencea are to be carried out by lethal iniec?on only. Bowman Skrte. 274 Go. 327, 554 137 (2001). RELAIIONSI-DP T0 9-3-33. -In 342 US. C. 59 I983 case in which 9. death mwiemaie challenged Georgia?: three-drug lethal injection method. the oomplaintwu xnninnely; the complaint was governed bythe two-year statute oflimliaticns found in ?9-3-33, and the claim accrued In 2001 when the General Assembly adopted lethal injection as Georgia?: method of execution ofdeaih sentences as found in 1 7-10-38. Alderman v. Donald No. 08-12550. 2008 LES App. ?9072 (1 1th Cir. Sept. 3, 2003) (Unpublished). ii. Erpasifo v. State. 273 Go. 133, 533 .5225 55 (2000); Hal owem-. 2.92 Ga. 330." 7.13 55 (2013). omzrous or ATTORNEY GENERAL DE BIGNATION BY on PLACE or EXECUTION. I-Commissioner of (now commissioner ofcorreetiens) is authorized to designate any state correctional institution as the place for carrying out an execution. 1980 01.1. Atty Gen. No. 80-121. STATE CORRECIIONAI. DEFINED. --State correctional irrstituticn in any faellity used to 000008 Case: 14-12663 Date Filed: 06/17/2014 Page: 10 of 40 em Fags 3! criminal o?bndars. 19:0 No. 20-121. RESEARCH REFERENCES AM. JUR. 219. Jur. 24 747, 743, 759. -24 C.I.S., caimgnal Lnw. 5 ALE. -?Subs:nn?vc challenges to propriety ofcxacution by hajcc?on in min cupital pmceedings, 21 ALREIFI I. Title Not: Ar?clo Nata 000009 Case: 14-12663 Date Filed: 06/17/2014 Page: 11 of 40 age Page 1 0.C.G.A. E26-4-114.1 Lexis Nexi 5? 1 OFFICIAL CODE OF GEORGIA ANNOTATED Copyright 2013 by The State ofcieorgia All riglats reserved. Crnrent Ilrroughthe 2013 Regular Session we Annotations 2013 FOOD, DRUGS, AND COSMETICS CHAPTER4. PHARMACISTS AND PHARMACIES 6. GO TO GEORGIA STATUTES ARCHIVE 0.0.0.4. 264-114.! (2013) 26-4-114.1. Appli?on to board for nornesirient pharmacy permits; requirements Any person, pharmacy, or facility located outside this state may apply/to the board for anonresidont dangerous drugs andcontrolledsubstances, slrailestabliahanapplication sndrequlresuch investigatlonofapplicants sndto ensure that the purposes ofthis Code section are met. Such application shall include: (1) Proofofavalid, unexpired license, permit, or registrationtc operate a pharmacy in compliance withtire laws and rules ofeach state in which the applicant receives and dispenses prescription drug orders, including but not iirnitcd to orders for prescription drug, dangerous drugs, and controlled substances; (2) Addresses, names. ofsll principal corporate c?icers and the pharmacist in charge of to residents oftlris state; and (3) A statement ofwhether the applicantls in compliance with all lawiirl directions and requests for information from theregulatory or licensing agencies ofeach state in vrhichthe applicant is licensed as well as all requests for section. beard anapplicatlonfee andthe biennialrenewslfee for apennitundertiris Code a. The board may only deny an application for a nonresident pharmacy permit for failure to comply with rules of the board or aoyrequirements of this Code section or for good cause reiatedto substantial evidence cfmisfessance or by the applicant. Applicants granted a permit under this Code section shall provide pharmacy care in a safety, andwelfare oftheresidentsoftiris stato.A pharmacy, fac?ity. or entity licensed under Title 33 shall not be required to hold a. nonresident pharmacy permitfortheenibrcernent Ofth? nonresident pharmacy permits, w?llforanyperscn. pharmacy, or tlistisiocatedolrlsidethis stateandthatdoes notpossessa nonresident pharmacy permit to ship, mail, or deliver prescription drug orders or-to advertise its services inthis state, or for any personwho is aresident of this state to advertise the services ofsuoh person, pharmacy, or the knowledge that the advertisement will or is likely to induce residenta_oftb.is state to use such person, phmacy, or 000010 Case: 14-12663 Date Filed: 06/17/2014 Page: 12 of 40 26-4-114.1.rtf . P5802 O.C.G.A. 5 26-4-1l4.1_ - . The board govcmingthehoiderofanomesident Code section. Suchrules andregnlations shellmhiimaliyincludethe foliowingreqnirements phermeoistincharge residenis ofthis inhis or herstatooflocation; (2) thehoard days ofsny change ofapermit orphazmaeistincharge ofdilpensingdrugltoresidents (3) A thepenniiholdcfa stateof registration in addition to proof ofthe license, pennit. or registration fromthe permit holder's new state ofregistration and the United States Drug Enforcement Administration rogistreiion for such new location; calendar daysto all communications iiomthe bcardconcerning state; (5) thebesrdofeech locetionatwhichihepermitholder srereedily relrlevable ii-omihe ?business records ofihe permit holder; end (6) A pennit holdm shall maintain atoll-?ee telephone operational during the pemtholdea-?s regular house perweekfor amininunn of?tl hours perweekthatshailhe used to provide and facilitate patient counseling. number shall be capable of receiving inbound calls ?orn patients to the permitholderandshellhe disclosed suspend, compiywithruiu of the board or with any requirement of this Code section or for ccnductwhich causes serious bodily erpsyehologicai injurytn aresident cfthis state, provided that thehoerdhes referred the matter involvingihe conduct in the regulatory or state perrnitholderis sgencyfails to initiate eninvestigsiionintn thematterwithin 180 days orfaila, inthebosrd'sjudgment,to render sn?ieicnt resolution. (3) (Disc aprerequisite or sterile or cornpounding for practitioners to use in patient care inthe practitioner's o?ce shall submit a. copy of the mostrecentendeurrent inspection reportresulting?omsninspection agency of the jurisdiction inwhioh it is located that indicates compliance with the requirements of this chapter, including compliance withUS1?-NF standards for performing sterile and compounding. The inspection suhsectionshallnotbe required ifthe componndingwithinthefacilityis done pursuantte a prescription. Such inspoctionreport shall be deemed current the purpose of this subsection if the inspection was conducted: (A) No more than six months prior to the date cfeubmission of an application for registration with the board; or (B) No more than two years prior to the date ofsubmiesicn of an application for renewal ofa registration with the board. (2) Ifthe nonresident phennacy sterile or has not been inspected by the regulatory or licensing agency of the jurisdiction-in which it is located within the thnefrsmes required in parlarlph (1) of. this subsection, the hoard may: . (A) Accept an inspection report or other documentation from another entity that is to the board; or locatedto ceuacaninspectiontobe Anomesident pharmacy shall be responsible for paying my inspection fee incurred pursuant to this paragraph. HISTORY: Code 1981, 26-4-114.1, enactedby Ge. L. 2013, p. 127, 811313 209. 000011 Case: 14-12663 Date Filed: 06/17/2014 Page: 13 of 40 NOTES: EFFECTIVE DATE. -This Code sw?an became n?tbctive July 1. 2013. CODE COMMISSION to Code Section 28-9-5, in 2013, "with" was near the and 03? ?an ?rs! sanmnoe - - 'I'it1c Note Chapt.-.rNota 000012 Date Filed: 06/17/2014 Case: 14-12663 Page: 14 of 40 5596.111 Page 1 O.C.G.A. ?42-5-36 . . . . LexIsNexIs? CODE OF GEORGIA ANNOTATED Copyright 2013 byThe State o:l?Gecrgia All rights Current Throughthe 2013 Regular Session Annotations Current 29. 2013 mm 42. ranar. cnsirrsn s. CORRECIIONAL JNSTITUHONS or srxra AND counnzes Annexe 2. weapons, AND OTHERPERSONZNEL Go To Grzoacra srartrras ARCHIVE nmacromr 0.C.G.A. 42-5-35 (2013) 42-5-36. Con?dentiality by inmates; penalties for breach; classi?ed nature investigation reports; of certain identifying information; custodians of records Ot?ciala and employees ofthn department shall respect the con?dential nature of information supplied by inmates who cooperate abuses andwrongdoing inthe pena1system.Anyo??.icial oremployeewho breaks such a and thereby auhjech a cooperating inmate to phyaicaijecpardy or harassment shall be subject to suspension or go. Cb) Investigation reports and intelligence data prepared by the Internal Investigations Unit ofthe department shall be classi?ed as con?dential state secrets and under law, unless declassi?ed inwriting bythe commissioner. All instimtlonal inmate ?les anricentral c?ice inmate ?les of the deperlmentshall he classi?ed as con?dential state secrets and privileged Irndorlaw. unless declassi?ed inwritingby the commissioner; provided, however. these records shall be subject to suhpo?na by a court of cfthis state. (1) As used in this subsection, the term "identifying information" means any records or that revesil a name, residential or business address, residential or business telephone number, day and month ofbirth, social security number, or professional quali?cations. (2) The entity who participatesinozr administers the execution ofa death sentence andthe identifying information ofanyperson or supplies, compounds, or prescribes mcdicslsuppiies, con?dmtialand 18 ct"I?it1e S?orunderjudicial process. Suehiniionnation The commissioner shall designate members ofthe department to he the oi?cisl custodians of the records oftbe department. The custodians may certify copies or compilations, including extracts ?lcmof, of the records ofthe department. Suhjecttothoprovisions ofthis Code section, inresponse to asubpoenaor uponthe request ofany appropriate government orjudicisl o?icial, the department may provide a duly auliieniicated copy ofsny record of other document. This sutlnenticated copy may consist of a photocopy or computer printout ofthe requested document certi?ed bythe commissioner orhiaorherdulyanthoriped representative. HISTORY: 1968, p. 1399, 1983, p. 680, 1; Ga. L. 1984, p. 22, 42: Ga. L. 1984, p. 1361, 1; Ga. - L. 1935. p. 149, 5 52; 1985, p. 283,? 1; Ga. L. 1997, p. 851, 1; (is. L. 2013. 13.1056, IAIHB 122. 000013 Case: 14-12663 Date Filed: 06/17/2014 Page: 15 of 40 on?den?Iiw of nformat1gn.rtf THE 1997 AMENDMENT, e?boiivu April 21, 1997. added subsection THE 2013 o?bo?vo July 1, 2013, sddod suhsao?on and redeaignated fonnor subsection as presont subsection CROSS REFERENCES. --Priv?ogod communications Jr? 24-5-.501 at seq. Inspection ofpublic records gonersliy, 50-18-70 at seq. LAWREVIEWS. --For nx?ols oommon?ngun the 1997 amendment ofthis suction, see 14 Ga. Sr. 0.1. Rev. 230 (1993. inPr?snsH'v. Stars, 274 Ga. 245, 551 .52.-123 723 (2001). omuons or me ATTORNEY GENERAL DECLASSIFICAIION BY --Pursuant to this section, investigation reports and Imelligcnoo data prepared by I11: Inturnsl Investigations Unit of tho ofo?isndar am as oon?don?sl sisto sacral: and priviloged undo: law oxocpt ss declassi?ed in writing by tho oommissionor of oifondor tchabiIita1ion(oormctIons). 1985 01:. Att'y Gan. No. 85-4. Title Noto ChaptorNoto Ar?olo Note 000014 Case: 14-12663 Date Filed: 06/17/2014 Page: 16 of 40 559213 ?95, JUN 3, 2013 From- To Date. subject: Re: Statutes 1 Executed NDA attached. Thank you for your assistance. !e artrnent of Corrections Plse ?nd attached an NBA. Let me know If you have any questions or concerns. Thank you. -?-Original To: Sent: Wed, JI.il 3, 2013 11:3 am Subject: FW: Applicable Statutes Please instigate a cen?dentlallty wim?: Message? From:?? Iltc. dcor.stat . Sent: Tuesday, July 02, 2013 2:03 PM To: Subject: Applicable Statutes 1 Please find attached the statutes we dlcpussed. Call me If you have any questlons or ccncems. Best regards, 000015 Case: 14-12663 Date Filed: 06/17/2014 Page: 17 of 40 ?Gangs !epartmant df Corrections ?$23 000016 Case: 14-12663 Date Filed: 06/17/2014 Page: 18 of 40 CD NOND CLOSURE MB This Con?dentiality and Nondisclosure Agreement this is made and entered into as of IuIy_3__, 2013, by and between ?01?P?flti?n Ind I 90'' . - On? NIL Recipient the Georgia Department of Corrections; WHEREAS, in connection with such Recipient's relationship with the Company, the Company will need to provide certain Con?dential Information (as de?ned below) to Recipient in order for_Reoipient to per?orm certain aspects of Recipient?: employment with Georgia Department of Corrections (the WHEREAS, Company will disclose the Con?dential Information to Recipient for such Purpose only, and the patties believe that this Agreement is necessaryto adequately protect the Con?dential Information; and . without such protections, the Company would be unable to provide such Con?dential Information to Recipient. NOW, THEREFORE, in consideration of Company?: disclosure of the Con?dential Information and the other agreements, covenants and conditions set forth herein, Company and Recipient hereby agree as follows: . . 1. Cog?dentigl Inibrmg?og. As used herein, shallmean all information, data or produom, whether disclosed by Company to Recipient at any time orally, in writing, or in electronic format, and whether or not marked as "oon:l:'1dentiai? or "pr0pl'ie131'y.? in my way related to the business a?fairs of Company that is not generally available to other employees of the Company (excluding any Company employee who is also a Company stockholder), including without limitation any records, drafts, and ?nancial or other information or data of or relating to Company or any information related to a potential transaction involving the Com and its stockholders. The term "Con?dential Information" shall not include information that (1) is or becomes public knowledge through no act or omission of Recipient; or (ii) is received by, or otherwise made available to, Recipient from a third party who does not owe a duty of con?dentiality to Company in connection with the Con?dential Information disclosed. - - 2. ?op?isclosure of Con?dpn? Recipient acknowledges and agrees that the Con?dential Information is of great value to Company and that the restrictions and agreements contained in this Agreement are reasonably necessary to protect the Con?dential Information and the goodwill of Company. Accordingly, Recipient shall not, directly? or indirectly, disclose to any other person or entity the Con?dential Information or the fact that discussions between Company and Recipient are taking place regarding such Con?dential Information, or use the Con?dential Information for any purpose other than the Purpose. If Recipient is required to disclose Con?dential Information pursuant to any applicable law or judicial-or governmental order, she may do so to the extent so required notl?ing Company thereof and ?lrnishing to Company any associated subpoena, demand, or similar 000017 Case: 14-12663 Date Filed: 06/17/2014 Page: 19 of 40 documents and a summary of the circumstances related thereto. Recipient shall, at Company's election, return to Company or destroy any Con?dential Information immediately stint at request by Company. 3. the Con?dential Infonnation, there may not be adequhte remedy at -law for any breach of Recipient?: obligmons under this Agreement and, therefore, that upon any such breach or any threat thereof, Company shall be entitled to appropriate equitable reliefln addition to whatever remedies it might have at law, including, without limitation, attorneys? fees, in connection with any breach or enforcement of Recipient?: obligations hereunder or the unauthorized use or release of any such Con?dential Information. Recipient shall notify Company in writing immediately upon the occurrence of any such unauthorized release or other breach of which she is aware. Further, Company reserves the right to take any employment action that it deems appropriate upon any breach of this Agreement by Recipient. 4. . The rights and obligations of the parties under this Agreeptent shall inure to the bene?t of and be binding upon their permitted successors and assigns. The parties agree that this Agreement shall be governed and construed in accordance- with the laws of the State of Sections 1, 2, 3 and 4 hereof shall survive any termination of this Agreement. mecment shall be binding upon and inure to the bene?t cfhoth parties and their respective successors and assigns, including any third party with which or into which Company may be merged or which may succeed to Company's assets or business; provided, however, that Recipient may not assign any of her rights or delegate any of her duties under this Agreement. This Agreement contains the entire understanding of the parties hereto with regard to the subject matter contained herein, and supersedes all prior agreements, understandings or intents between the parties hereto. ?Ibis Agreement may be amended, modi?ed or supplemented only by a writing signed by the parties hereto. No Waiver or any breach of this Agreement shall be held to constitute twelve: of any other or subsequent breach. This Agreement may be executed in one or more counterparts, each of which shall be considered an original instrument, but all of which shall be considered one and the same agreement. IN WTINESS WI-IERBOF, the undersigned have executed this Agreement as of the day and year first above written. RECIPIENT: COMIPANY: 00'50'18'? Case: 14-12663 Date Filed: 06/17/2014 Page: 20 of 40 -L asked me to contact you. He wiil be out of the this week and be serving as your terniow contact person. However, ifyou need or wish to speak with him he can be reached on his cell From? To: I Date: 7idI2013 10:48:49 AM Subject: Georgia Department of Gonections Order a at i need confirmation from you on a couple of items: 1. The drug does NOT need to be refrigerated, correct? 2. if we get a prescription to you the drug will be in our hands my 3. What will the cost be for 15 grams of the drug? Once we have the cost. a check will be ovamighted to you immediate . if have any questions or concerns. please do not hesitate to contact me. My direct line to rid my cell ani-rs so much! - Best regards, a a entof corrections .. dcor.state.ga.us "The Department of Corrections creates a safer Georgia by effectively managing offenders and providing opportunities for positive change." This e-mail. and any attachments. contains information that is, or may be, covered by the electronic communications privacy laws. and is also con?dential and proprietary in nature. ifyou are not the intended recipient. please be advised that you are legaily prohibited from retaining, using. copying. distributing, or otherwise disclosing this Information in any manner. Instead. please reply to the sender that you have received this communication in error. and then immediately delete it. Thank you in advance for your timely cooperation. cc: 000019 Case: 14-12663 Date Filed: 06/17/2014 Page: 21 of 40 From: To: @clcor.state.ge.us> Date: YIQIZO13 :34 PM Subject: RE: Georgia Department of Corrections Order Today's date lnm?te Name, DOB and Address Inmate SSN Drug Name: PENTOBARBFFAL SODIUM BDMGIML INJ SOL QTY: 6 5DML SYRINGES (2.5GM EA) . SIG: ADMINISTER AS ORDERED-PER DEATH WARRANT Dr's Printed Name and signature Dr's DEA - Professionally, -?--Original Mess From: ellto dcor.state.ga. us] Sent: Monday, July 08. 2013 9:Subject: Georgia Department of Corrections Order P?sked me to contact you. He will be out of the office this week and I will be sewing as your porery contact person. However. l_fyou need or wish to speak with him he can be reached on his sell I need con?nnatlon from you on a couple of items: 1. The drug does NOT need to be refrigerated, correct? 2. lfwe get a prescription to you on grnorning, the drug will be in our hands orig? 3. the cost betor 15 grams ofthe drug? 0 Once we have the cost. a check will be to you immediately. if ou have any questions or concerns, please do not hesitate to contact me. My direct line is nd my cell l*Thenks so much] Best regards, 000020 Georgia De of Corrections . aLo29 Case: 14-12663 Date Filed: 06/17/2014 Page: 22 of 40 1 --1-K dcor.stato.ga.us "The Department of Corrections creates a safer Georgiaby effectively managing offenders and providing opportunities for positive change.? This e-mall, and any attachments, contains infonnation that is, or may be. covered by the electronic communications privacy laws. and is also con?dential and propiietary in nature. if you are not the intended recipient, please be advised that you are legally prohibited from retaining. using, copying. distributing. or otherwise disclosing this information in any manner. instead. please reply to the sender that you have received this communication in error, and then immediately delete it. Thank you in advance for your timely cooperalion. 00: 2?dcor.s1ata.ga.us> 000021 Case: 14-12663 Date Filed: 06/17/2014 Page: 23 of 40 From: -To: . Date: Wed, Jul 3, 2013 2:24 PM . Subject: Profassionalservices.D7.D3.?l3 revisions or corrections. We have also attached for your review three Geogla statutes addressing this Issue. provides: a) Notwithstanding any other provision of law, prescription. preparation. compounding, dispensing. or administration of a lethal injection authorized by a sentence of death by a court of competent Jurisdiction shall not constitute the practice of medicine or any other profession relating to health care which is subject by law to regulation. iicensure. or certification. Additionally, 0.C.G.A. 17-10-42.1 provides that any participation by a medical professional in this process cannot serve as a basis for challenge or suspension of any medical professiona ?s license. Finally. 0.G.G.A. 42-5-33 was amended this year to provide that the identifying information about any person or entity assisting in this process is a confidential state secret. if you have any questions whatsoever about this matter. please let me know. Best regards. cell Geo De 'rtment of Corrections i 000022 Case: 14-12663 Date Filed: 06/17/2014 Page: 24 of 40 Name Size Modi?ed . 590 1!2lB0 1,479 1/2180 12:00 AM wordIthemaJtl1ame1.xml 6.992 12:00 AM wordldocumentoqnl 23.415 112100 - word?oomotesxml 1,472 1I2I80 wordIsettings.xm!- 3,483 15,713 112180 17,615 1l2I80 12:00 AM wordffontTable.xml 1,467 112130 12:00 AM wordInumber ng.xml 8,973 415 12:00 AM docPnopsIapp.xml 1.019 12:00 AM docPro'pslcure.xrn 002 1I2I80 12:00 AM 1.047 112180 12:00 AM 000023 Case: 14-12663 Date Filed: 06/17/2014 Page: 25 of 40 Comment 000024 Case: 14-12663 Date Filed: 06/17/2014 Page: 26 of 40 PROFESSIONAL SERVICES AGREEMENT THIS AGREEMENT is entered into the 1st day of July, 2013, by and between the Georgia Department of Corrections, an _.agency of the State of Georgia (hereinafter referred to as the ?Department?), an "(the ??Contractor??), duly authorized by law to perform services in tate of Georgia. NOW, THEREFORE, in consideration of the mutual promises and? agreements hereinafter set forth, the parties hereby agree as follows: 1. Scope of Services. At the Department?s request, the Contractor agrees to provide professional services to the Department. Contractor agrees to maintain all appropriate licenses and registrations necessary to provide services to the Department. 2.. Term of Agrgement. This Agreement shall be effective as of July 1, 2013 and shall continue in force and effect until 11:59 p.m. on June 30, 2014 unless such period is extended by mutual agreement of the parties in writing. 3. Termination. Either party may terminate this Agreement by providing written notice to the other party, thirty days in advance of the termination of this agreement. 4. Compensation. The Department agrees to pay Contractor an annual fee of Five Thousand Dollars ($5,000) for the full and faithful performance of services provided during the term of this Agreement. . 5. Litigation Reserve Fund. The Department will fund a reserve ?md for the purpose of paying for Contractor?s attorney fees and expenses necessary to defend any litigation or other legal proceeding, related to the services provided by Contractor to the Department during the duration of this Agreement. The reserve ?md will be ?mded at Fifty Thousand Dollars The Contractor will be responsible for payment of attorney fees and expenses necessary to defend any litigation or other legal proceeding and will request reimbursement ?orn the Department. Contractor will provide the Department with a summary of all fees and expenses to support Contractor?s reimbursement requests. Upon request, Contractor shall make available the original, detailed invoices for Department?s review and inspection. Department agrees to reimburse Contractor within thirty (30) days of a reimbursement request if all fees and expenses are con?rmed to have been incurred in defending any litigation or other legal proceeding that is brought against Contractor and that is related to the services provided by Contractor to the Department. 000025 Case: 14-12663 Date Filed: 06/17/2014 Page: 27 of 40 6. Con?dentiality. Pursuant to 0.C.G.A. the Department shall maintain the con?dentiality and anonymity of Contractor and any of Con11'actor?s staff, principles, employees, representatives, contractors, and agents to the extent permitted by Georgia law. The Department further pledges to have the Georgia Attorney General?s Office raise all proper defenses against third parties seeking information or documents that would breach the con?dentiality ahd anonymity of Contradtor or Contractor?s staff, principles, employees, representatives, contractors, and agents. 7. Insurance. The Department agrees to add Contractor as additional insureds up to the limits of the General Liability Policy issued by the Georgia Department of Administrative Services, including but not limited to acts of medical negligence and omissions per person and $3,000,000.00 per occurrence). 8. Entire Agreement. ?This Agreement constitutes the entire agreement and understanding between the parties hereto and replaces, cancels and supersedes any prior agreements and understandings relating to the subject matter hereof; and all prior representations, agreements, and undertakings between the parties hereto with respect to the subject matter hereof are merged herein. 9. Assignment. Neither party may assign its respective rights and obligations arising out of this Agreement without the prior consent in writing of the other party. IN WITNESS HEREOF, the parties have caused the authorized representatives of each to execute this Agreement on the day and year first above written. GEORGIA DEPARTMENT OF CONTRACTOR: CORRECTIONS: By: By: NW Title: 000026 Case: 14-12663 Date Filed: 06/17/2014 Pageam: man O.C.G.A. 5 17-10-33 1of1D OFFICIAL CODE OF GEORGIA ANNOTATED Copyright 2013 by The State of?eorgis All rights reserved. Current 'I'hreugh?the 2013 Regular Session Annotations Ccn'ent'IhroughMerd-1 29, 2013 17. CRIMINAL PROCEDURE CHAPTER 10. AND ARTICLE 2. DEATH PENALTY GO TO GEORGIA STATUTES ARCHIVE DIRECTORY 0.C.G.A. 5' I 7-10-38 (2013) 5 17-10-38. Death sentences generally all persons who havebeen convicted of: capital and have had imposed upon them a sentence of death shall suffer such punishment by lethal injection. Lethal injection is the continuous intravenous injection of a substance or substances sumcientto cause death into the body ofthe person sentenced to deathuntii such person is dead. sentence- to directthatthe defendanthe deliveredto thenepartmentofcorrections forexecutlonofthe deathsentence atastate (0) Notwithstanding any other provision aflaw. prescription, preparation. compounding. dispensing. or administration ofa lethal injection authorized by a sentence of death by a court of ccmpetentjurisdictlon shall not Iicensure, or certi?cation. No state agency, department. or o?cial may, through regniationor otherwise, require or compel aphysiclantc meansenyofthe thllowing actions: selecting injection sites; startinganintravenous line orlines as apertfor alethal injection device; lnspeedngtea?ng, or maintaining lethal injection devices; or consulting with or supervising lethal injection personnel. Ga. L. 1924, p. 195, 1; Code 1933, Ga. 1.. 1937-38, Ex. Sosa, p. 330, 1; Ga. 1985, p. 283, 1; Ga. L. 2000, p. 947, 5 3. NOTES: NOTES. L. 2000, p. 947. 5 1, not codi?ed by the General Assembly, provides that: ?It is the intention ofthe General Assembly to provide for executicnby lethal injection for persons sentenced to death after conviction ofcapitai crimes committed on or after May 1, 2000. It is the ?nther Intention ofthe that persona sentencedto deethforcrimea committedpriortothe effective date ofthis Aotbe executed by lethal tnjectionif the Supreme CourtoftheUnitcd States declares that the Constitution ofthe United or ifthe Supreme Court of?eorgia declares that electrocution violates the Constitution of the United States or the Constitution of Georgia.? Ge?. L. 2000, p. 947, 6, not codi?ed bythe General Assembly, provides that: "Section 3 of this Actshall persons death tier crimes committed on or a:0;erMay 1, 2000. Code Section I7-I0-38 as itexisled prlorto 000027 constitute the practice cfmedtcine or any other profession relating to health care which is subject by law to regulation, -- Case: 14-12663 Date Filed: 06/17/2014 PagePage 2 0.C.G.A. 17-10-38 - itsamendmentb}-Section3 Constit:otionoftheUniied States orif -- Constitu?on ofGoorgia.." JUDICIAL DECISIONS FOR CHAHEJGB OF GA. L. 1937-38. EX. SE88, P. 330. 1 ON EX POST GROUNDS, see Benton v. State, 187 Go. I49. I99 S.1i'. 749 (I939). THAT SBCHON VIOLATBS SEPARATION OF POWERS PROVISION. -Allcgation that this section was unconstitutional, null, and void because the statute supposedly violated Go. Genet. 1877, Art. I. See. I, Pare. X3011 (see Ga. Court. 1983, Art. 1; Sec. Para. 1.13, proscntedno question forjudioial determination ainm the statute failed to point out wherein the Act was rcpumant to and in conflict with that constiiu?onal provision. Williams v. Store. 18? Ga. 413 I (I935). GA. 1937-38, EX. 38., P. 330, 5 1 NOT --This acotionwas nohmconstitutional as violative oi:'Ga. Conat.187'i.Art. 111, See. I, Para. I (see Go. Consr. 1983. Art. 111'. Sec. V, effectthatno law shall be amended or repealed by more reference to its title or section mnnber. Williams Store, 187 Go. 415. I 27 (I939). VARIANCE narwaan sunanor MATPER or LEGISLATION. ?Ga. L. 1924, p. 195 did not contain matter notoxpresacdinits caption, inviolation ofGs. Coast. 1377, Art. Sec. vm (sec Get. Court. 19.93. Art. HI. See. p: Para. my. zaromuv. sum, :54 Go. 204, 1333.3. 206. aopeat dismissed, 27: us. 57:: 43.: Cl. 114. 72 L. Ed. 435 (1927). MANNER IN WHICH CAPITAL EJEECUIBD IS FOR IEGISLAIIVE -Theme being no provision inthe Constitution conferring upon sheri? of counties the powerto execute sentences ofthe courts in capital cases, the manner ofcxecution of such sentences is for legislative enactment. Dtotawoy v. Gore. 154 Go. 2J9, 138 SE. 213 (I927). OF --As electrocution in?icts purpoacless violence and needless mutilation, in violation of the prescription oforucl and unusual punishments of Go. Const. 1.983. Art. 1; Sec. 1, Para. XV, future executions ofdeath sentences are to be curled out by lethal injection only. Dawson v. State, 2.74 Ga. 327, 554 S.E'.2d.i37 (2001). RELATIONSHIP TO 9-3-33. --In 1142 1983 case inwhich a dcaihrow inmatae challenged Georgia?: three-drug lethal injection method. the complaint was untimely; the complaint was governed by the two-year statute oflimitaiioms found in ?9-3-33, and the inmate's claim accrued in20 Jl whenthc General Assembly adopted lethal injection as Georgia?: method of execution of death sentences as fomad in 0. 1 7-40-38. Donald. No. 08-12550, .2003 US. App. LEHS 19072 (11th Cir. Sept. 3, 2008) (Unpublished). inEs-posito Stars, 273 Ga. 133, 533 55 (2000): Hill Owens, 2.02 Ga. 380, 738 56 (2013). OPINIONS OF THE ATIORNEY GENERA1. BY COMMISSIONER OF PLACE OF EIECUTION. ?Commissioner of offender rehabilitation (now commissioner ofcozrections) is authorized to designate any state correctional institution as the place for carrying out an execution?. 1980 Op. Atty Gen. No. 80-121. STATE CORRECTIONAL DEFINED. -State correctional institu?on is any facility used to plmish ?Ila L. 000028 Case: 14-12663 Date Filed: 06/17/2014 Page: 30 of 40 a?ndurs. 1930 Op. Atfy Gen. No. 30-121. RESEARCH REFERENCES AM. JUR. 2D. --21 Am. Jar. 24?. Crime! Law, 2747, 748, 750. mam lumlu?la n: up 3 ALR. -?-Substun?va proprintyofuxecu?onbylothal Iqiac?oninmeoapital proceedings. 21 1- 'I'i?eNoto 000029 Case: 14-12663 Date Filed: 06/17/2014 Page: 31 of 40 Mdcm? a?on.? vi Page 1 D.C.G.A.. 9 42-5-36 lofl DOCUMENT OFFICIAL CODE OF GEORGIA ANNOTATED Copyrighi20l3 byThe sum of?eorgia All rights reserved. us Current Through the 2m Regular Session --I Ctnrent'I1:roughMarch 29, 2013 TITLE 42. PENAL INSTITUTIONS CHAPTER 5. CORRECTIONAL 0NS OF STATE AND OOUNIIBS 2. WARDENS, AND OTHER. PERSONNEL so To GEORGIA er.-rrurns ARCHIVE DIRECTORY O.C.G.A. 42-5-36 (2013) 42-5-36. Con?dentiality ofinfonnation supplied by inmates; penalties for breach; classi?ed nature of department investigation reports; con?dentiality of certain idonti?ring information; custodians ofrecords Of?cials and employees of the department shall respect the con?dential nature ofinfonna?on supplied byinmetes who cooperateinremcdying abuses con?dence and thereby subjects acooperating inmate to or harassment shall be subject to suspension or discharge. Investigation reports and intelligence data prepared by the Internal Investigations Unit of the department shall be classi?ed as con?dentialatata secrets andprivilegedunder law, unless declassi?ed commissioner. All institutional inmate ?les and central o?ce inmate ?les oftbn department shall be classi?ed as con?dential state secrets and In-lvileged under law, unless declassi?ed in writing bytire commissioner; provided, however. these records shall be subject to subpoena by a court ofcompetenijurisdiclicn of this state. ginfom1atlon"moans reveals a name. residential or business address, residential or business telephone number, dny and mouth of birth, social security number, or professional quali?cations. (1)'I'he iden?fyingiufounation entitywho partlcipatesinorsdministers the exectriionofadcath sentence and the identifying information ofsny person or entity tbatmauufaotures, supplies, compounds, or prescribes shallbocon?denrlal and shall not be subject to disclosure under Article 4 of Chapter II of Title 50 or underjudiclal process. Such infonna?on . (.5) The commissioner shall designate members of?re deparlmentto be the o?ioial custodians oftho records oftbe department. ?Ilse custodians may cer?fy copies or compilations, including thereof; oftbo records ofthe department. Subject to the provisions ofthis Code section, in response to a subpoena or upon the request of any appropriate government or judicial o?cinl. the department may provide a duly atnben?cated copy of any record or other authenticated phntocopyor computer printout ofthe requested document certi?ed by the commissioner: or his or her duly authorized representative. HISTORY: Ga. L. 1968, p. 1399, 5; Ga. L. 1983, p. 680, 1; 1984. p. 22, 42; Ge. L. 1984, p. 1361, 1; Ga. L. 1985, p. 149, 42; Ga. L. 1985, p. 283, 1; Ga. L. 1997, p. 851, 1; Ga. L. 2013, p. 1056, INBB 122. 000030 epdmomo m.hmwmo?p?Hom0? Case: 14-12663 Date Filed: 06/17/2014 Page: 32 of 40 -- proton: o?oc?vo -3 gunurally, at aoq. LAW REVIEWS. --For article on the 1997 amendment of this noc?on, son 14 Ga. 51 111.. Rev. 230 (19.97). JUDICIAL DECISIONS CITED i1:L.PrwIeIIv. Stall. 274? Ga. 246. 551 723 (2001). OPINIONS OF THE ATTORNEY GENERAL DBCLASSIFICAITON BY COMMISSIONER. ?Pursuant to this section. invoa?gs?on reports and 6811 praparod by the Iniaornnl Investigations Unit of tho Depaxhnont ofO?'ondor Rohnhilita?on (Corrootio:ns) are classi?ed as con?tientlal state secrets and privileged Imdor law axon-pt as declassi?ed in writing by tho commissioner of Off?nd?r rohnbiJitation(oorroo1ions). 1985 Op. Atfy Gen. No. 85-4. Titlo Not: ChapharNota Artiolo Noto 000031 Date Filed: 06/17/2014 Page: 33 of 40 Case: 14-12663 m?m?mmb?f :Lexis Nexis OFFICIAL CODE OF GEORGIA Copyrightzolz by?I'he State ofGem-gin All right rmrvad. Cuuant the 2012 Regular Session Annotations Current 'I?hroughNovember 9, 2012 CRIMENALPROCEDURE CHAPTER 10. SEJIBNCE AND ARTICLE 2. DEATH GENERALLY GO TO GEORGIA ARCHIVE DIRECTORY 0.C.G.AL (2012) 17-10-42. 1. Participation ofmedical professional: in axacu?onl Partioipn?oniu anyoxocu?on ofany convicted person carried out mdimhia article shall notbo?lo subject ofany licensure suspension, or revocation for any physician or medical prohsaional lioansed in the Stat: of Georgia. HISTORY: Code 1981, 55? enacted by Ga. L. 2006, p. 274, JJHB 5'1. NOTES: -Ga. L. 2006, p. 274. MIR not codi?ed by tho Genera1Asaembly, provides that: "This Act shall bncome uffcc?ve on July 1, 2006, and shall apply to acewtions carried out on or a?nr July 1, 2006." TitIoNota Chapter Note Artiole?ota 000032 Case: 14-12663 Date Filed: 06/17/2014 Page: 34 of 40 From: To: . Date: 718f2D13 . subject: Execution Order . - cu-haveran about the attached please do not hesitate to contact me. My direct line is nd my col is will not be in the office this week, but may be reached I1 Wis tospeakw m. 'eseIetn1e you woul prefer. Acidltionaily. feel free to contact us if have any uos or concerns about the professional services contract that was forwarded to you last week. Best regards. I Geo la Department-of car?ecuans "The Department of Corrections creates a safer Georgia by efrectiyely managing offenders and providing opportunities for positive change." This e-mail. and any attachments, contains information that is, or may he, covered by the electronic communications privacy laws, and is also con?dential and proprietary In nature. if you are not the Intended recipient. please be-advised that you are legaily prohibited from retaining, using, copying, distributing, or otherwise disclosing this information in any manner. instead, please reply to the sender that you have received this communication in error, and then immediately delete it. Thank you in advance for your timely cooperation. 000033 Case: 14-12663 Date Filed: 06/17/2014 Page: 35 of 40 aypc Ilnn.nmpr PAGE: aziea a7iaa!2a1a 15:54 2234335545 ELPERIDR azunr on aupmn-an coon: or an comm: - --. ACEIDN IID Oil? manna IE3 Ema, naiondmc. I-I-ril?-I-$ anon? 1-h. court hm-nag santonuad. woman Inn 11111: 0'2! on tho 17? day of September: 1991. to be 335' th' napnxumqnh or correction: at inch penal institution as may be - by said? yepartmant, in with tho law oi ?tho stats at Georgia, and: ?rho: data fan?: the axooution or said I-oa H111: Fund by reason aupnraodonu incidont to appellate Eaviaw; Ian :a cameraman, ?enema. mu: anaunamn by puauant to 5 that within a time puriod camnancinq at n?on. on the 13? dny of July, 2013_ gnid ending seven days later at. noon on the 20? day or the Detendantr Lu shall be executed by tbs?: Dopartmont oi cornaotionn at auoh_pana1. institution and on auoh a data and _t:imo within the aforamanhionad time pnriod as may ha designated by said Dapartmont in ncoordanoo with tho lawn oi ?Eh! state u:E Georgia. u-ma/znu mm 15:na_ ND nasal lion000034 Case: 14-12663 Date Filed: 06/17/2014 Page: 36 of 40 a'ms3!2a1a 15:34 2254335349 ELPERIIJR cuurr ma aazaa It is PDEEHR ORDERED that the Clark of Superior Court county, Georgia -- the ccurt_and shall ciuan of tha ohiginnl sentence to be anrvad immadiatnly to cxacntiun Attarney General of Gaorgin, the Bouthwautern ?udicinl Circuit Diltrict attarnny, the of thc,Gaurg1n of Corrections, the warden at the Gcorgia Diagnostic and attorney and Classification Prison, of rscord. .. This day an 42 . snonam u. PEAELER, JUDGE, aurmaxon COURT 1 souwawnammnn JUDICIAL cxacum LEE couunr wmamamuw . - wmaeas MY HAND saw. :35 usage Ln county. margin - E1 9&9 . . um:/201: 15:11:" mt/000035 Case: 14-12663 Date Filed: 06/17/2014 Page: 37 of 40 *1 Page From: .. To: Date: 71812013 1:42: Subject: Georgia Department of corrections . -- wanted to relay some instructions he gave regarding the prescription. Along with the patient name. he also needs their birthday and social security number. I will be happy to forward this information along to you when you are preparing to wnte the prescription. justwinted to grii you a neads up. If you have any questions, please do not hesitate to contact me. Best regards, ent of corrections on 31029 Phon Fax: "The Department of Corrections creates a safer Georgia by effectively managing offenders and providing opportunities for positive change." This e-mail. and any attachments, contains lnfonnatlon that is. or may be, covered by the electronic oommunioatlons privacy laws. and is also con?den?aiand proprietary in nature. If you are not the intended recipient, please be advised that you are legally prohibited from retaining. using. copying. distributing, or otherwise disclosing this information in any manner. Instead. please reply to the sender that you have received this communication In error. and then immediately delete It. Thank you In advance for your timely cooperation. CC: 000036 Case: 14-12663 Date Filed: 06/17/2014 Page: 38 of 40 .l I lEI5=lEl From: To: Date: 7! D13 3: Subject: information for GDC Prescription -..--. . .. . -. . 0prescription Please let me know if you need any clari?cation or additional lnforrnation. Juiy 8. 2613 Nan1e:Warren Leo Hill. Jr. DOB: 0612811 960 SSN: 253-17-B486. Address: 2975 Hwy 36 W. Jackson, GA 30233 Drug Name: PENTOBARBITAL SODIUM EUMGIML INJ SOL QTY: 6 SDML SYRINGES (2.5GM EA) SIG: ADMINISTER AS ORDERED PER EXECUTION ORDER Dre Printed Name and nature Dr's DEA Reng_nj_?. Georgia Department of corrections Phone; . te.ga.us "The Department of Corrections creates a safer Georgia by effectively managing offenders and providing opportunities for positive change.? This e-mall, and any attachments, contains information that is, or may be, covered by the electronic communications privacy laws, and is also con?dential and proprietary In nature. If you are not the Intended recipient, please be advised thatyou are legally prohibited from retaining. using, copying. distributing, or otherwise disclosing this lnfonnation in any manner. Instead, please reply to the sender that you have received this communication in error. and then immediately delete it. Thank you in advance for your timely cooperation. cc: 000037 Case: 14-12663 Date Filed: 06/17/2014 Page: 39 of 40 U?Ull I7a?!gaI2a1a 15:34 mm? PAS was "1 :n ma: aurnazan noun: or court Imam: orr:namJ:man swam: or nuunnmn, 'cn:u:umL acumen no :3 . I1-Isl! manna um um, .13., nnscudnnt. 2 '4 '1.-ha court hnvinq nntencnd in:-nan ma 31:111. in: 1 an the 11?? day of Beptambar} 1951., tn be executed by the napaztmant or correction: at such pans]. institution as my bu lag na:I.d- gnpartmunt, in accordance with than law! 9-5 ?tha'at:at- or aeorqilr and: The data tha ?nxauution or and Lea Hill. Jr? incident to nppollata huvinq passed by raamon n? nupnru-.d.aa.a :':aviam IT :3 nun anaunan by th1a,cuurt. ?g pursuant to 5 17-?1q-40, that within 3 time pariod - na?unncing at n?on an tha 13?? day or July, 2013' and ending maven days la.-Izar at noon 6n the 20?? ciay at the Defendant, gwarz.-an Lao be oxnuutad. by that: Dapaa.-lzmant en?! correction: at institution and on such a data and time withip the nfuramantionad time period am my bu designated by said in accardauua with the law: at the: skate of Georgia. own:/201: min max nu ma] lion000038 Case: 14-12663 Date Filed: 06/17/2014 Page: 40 of 40 execution ordenpdf mu 5 15:54 2234355?! PHE BSIB3 is ma.-mama that the: Clark. or the c-I Ifui Georgia.? ahnlil. record i:h1a- on .. execution of -Lhn cfriginal to auwad dmadiatnly to . this attorney General of Gnargia, thu Bouthwutern smdiuinl circuit Din-Erich nttaxnay, tha cumtinianar or the margin - can Departmant or coxraatiann, 1.11:: n:E tho Gaoargil? and cluni?iantion and nth-nt1nn'h'I Of an This? 3'aunsn, auennzon couam souwnwnammau cxacuzw - ngg. GEORGIA. LEE COUNTY frhbihtu mrliy Ind Isatrunlnd nurrabtoupyn?lil in Ihls of?o?. - :wam::?:aa MY HAND aauusosnga 20 ggf? I--a . two:/201: mm um ms) moo000039 Case: 14-12663 Date Filed: 06/17/2014 Page: 1 of 26 Exhibit 3 Case: 14-12663 Date Filed: 06/17/2014 Page: 2 of 26 DECLARATION or LARRY D. SASICH, PHARMZD, MPH, FASHP My name is_ Larry D. Sasich. I am a consultant pharmacist with experience in pharmacy practice, academia, public interest research, drug regulation, -and drug safety. My "interest and continued involvement with pharmacy compounding dates. from the passage of the Food and Drug Administration Modernization Act (FDAMA) of 1997. .My background, experience and quali?cations, in part, include: 9 Serving as Chairperson- of the Department of Pharmacy Practice at the LECOM School of Pharmacy in Erie, 0 Serving as a consultant to Public Citizen Health Research Group, Washington, D.C. Serving as a Consumer Representative on the Science Board of Food and Drug Administration's, an advisory to the FDA Commissioner. S_e_1_'ving as a consultant to the Saudi Food and Drug Authority, Riyadh, Saudi Arabia. I have a;'Masters' in Public Health, with an emphasis in biostatistics and from The George. Washington University, and a Doctorate of _Pharmacy degree ?otn University of the Paci?c. I completed my residency in nuclear pharmacy at the University oflslew Mexico. I have also been elected a Fellow in the American Society of Health-Systern Pharmacists (F ASHP). I have authored publications and/or presented analysis on drug safety issues. A complete list of my publications and presentations are list'e.d in my Curricu1urnVitae, which is appended to this Declaration as Exhibit A. The Federal. Defender Program, Inc., Atlanta, Georgia has retained me to provide my opinions on the quality, safety, and risks of pharmacy compounded drugs with particular attention to the preparation of injectable drugs made ?om non-sterile Active Pharmaceutical Ingredients (APIS) that may be used in executions in Georgia. I previously provided -a declaration to the lawyers representing Georgia death row inmate Warren Hill, in which I provided an overview of the problems in the compounding industry. That declaration was written on short notice, and in the face of the Georgia law that almost all aspects of the execution process and lethal injection drugs a secret. As such, it necessarily lacked specjiftcity. I still do not know the name or location of the compounding "pharmacy that will prepare drugs _for use in Georgia executions.-. Nor have I _s_ee?n testing results for the compounded. drugs that will be used. Without this complete information, a full and complete report is not possible. For the reasons detailed below, there is a foreseeable risk that the compounded drugs used in lethal injections in Georgia be sub-standard in a manner that will cause 1 Case: 14-12663 Date Filed: 06/17/2014 Page: 3 of 26 severe? pain uponor shortly after injection. These include the risk that the compounded drug will be sub-_potent, expired?, unintended additives, or will contain ?a substantial level of particulates. Any testing performed on the drugs in the possession of Department of Corrections both because of its limited nature and because of the laboratories doing thetesting is unlikely to address the potentially severe problems that are identi?ed in thi_s declaration. Pharmacy Compounding Overview Pharmacy ?compounding is a traditional practice -of the profession of pharmacy. Thereare two types of cornpounding'? traditional and non?traditional. Traditional compounding does not involve the creation of drugs from scratch. Rather, it uses active and inactive ingredients to ?meet the speci?c, individual needs of a patient whose needs cannot be met with an FDA-approved product for niiedical reasons. Traditional compounding -requires a. legal prescription ?for an individual patient. For example, a two- ye_ar?old transplant patient may require a medication that is only available in an FDA- approved tablet form. In such. a. case, tablets may be reformulated into an oral liquid for Traditionally compounded products are not FDA approved, but the FDA generally exercises -its enforcement discretion to "allow provision of these products. to meet the speci?c needs? of patients. Non?traditional pharmacy compounding involves the use of raw ingredients called Active Pharmaceutical Ingredients (APIS) to manufacture a copy or substitute for an DA?ap_proved drug. These products are not made for a specific patient with a speci?c medical need, but for general distribution. on-traditional. compounding resembles drug more than it d.oes.'.th'e practice of -pharmacy. Unlike pharmaceutical manufacturers, however, compounding pharmacies are not subject. to the drug approval process and ri.gorou_s checks and regulatory procedures required under federal Good lvlanufacturing. Practice (GMP) guidelines. Pharmacies practicing non-traditional compounding are not required, under federal law, to demonstrate that their products are pure, ?potent, safe, or effective, nor are they required to compliance with federal manufacturing guidelines or ove_rs'ight. Products made by non?traditional compounding are primarily regulated by state pharmacy laws. .Non-traditional compounded drugs, such as the pentobarbital used in executions, are not DA-approved for any purpose. This means that the FDA has not veri?ed their safety or effectiveness or the -quality of their manufacture. They do not meet federal requ.ire1ne11ts for purity, potency, efficacy and safety. Existing outside of the FDA regulatory ?amework that ensures these qualities in manufactured pharmaceutical drugs, compounding pharmacies make large quantities of unregulated, unpredictable and potentially unsafe drugs. The Web site lists numerous examples of serious public health risks associated with the use of pharmacy compounded products at: See the section on Compounding: Inspections, Recalls, and other Actions. Case: 14-12663 Date Filed: 06/17/2014 Page: 4 of_ 26 of animals, the American Veterinary Medical" Association I - actively discourages the use- of compounded except in cases of veterinary medical necessity. This professional -policy was undersdiired. after the death of '21 polo -ponies from _poiso._n_i.ng by -compounded -drugs. The American Veterinary Medical Association advises that because one cannot assure the quality of bulk APIS, they must not be. compounded for? use irranirnals. See Katie Thomas, Polo Ponies were given Incorrect .Medication,_ NEW YORK TIMES, April. 23, 2009, available here: Katie Thomas, Deaths of Polol-Iorses Highlight Practices of Disputed Pharmacies, NEW YORK TIMES, April 30, 2009, available ?here: no-lohtnal. The Compounding Process Drug manufacturing is highly? technical, ?requiring strict adherence to -current GMP and a rigorous and -continuous process of FDA inspection, regulation, supervision -and oversight. The manufacture of sterile drugs intended for intravenous administration, such as pentobarbital, is acknowledged by pharmaceutical manufacturers and the FDA alike to be one of the most.? difficult of all pharmaceutical processes to execute. The preparation of sterile drugs is unavoidably complex, often involving many steps and manipulations. Each step poses an opportunity for error, including unintended introduction of potentially dangerous cross contaminants?, and the. possibility of a problematic osmolality or imbalanced pl-I. Unlike manufacturers, compounding pharmacies do not have to adhere to the rigorous FDA approval. procedures for manufacturing sterile drugs. Instead, the less rigorous United States Pharmacopoeia (USP) <79'7> chapter standards may be applied to AS a result, product contamination in compounded.-drugs is far higher than that in manufactured drugs. In some states, state law and Boards of Pharmacy do not even require compliance with this lesser USP standard. Questionable Ingredients Used In. Compounded Drugs The iililolity of the APIS, or raw bulk products, used in "compounding is far more suspect than those used in -manufactured drugs. A hearing before the U.S. House Energy and Commerce Committee cited compounding pharmacies as a primary route of -entry for count"erfeit'bt'1ll< drugs: ?Lured by high prices and potential pro?ts in the United States, counterfeit bulks can get into our prescription drugs in several ways: (1) as imported ingredients to US. manufacturers; (2) as irnported ingredients to pharmaceutical compounders; and (3) as source ingredients for Internet pharmacies marketing to- the The. .counte1'feiters use sophisticated methods such as. preparing "false labeling, containers, seals and certi?cates of analysis, or using a manufacturing process that differs from the ?led manufacturing process.? See Prepared Statement -of Honorable Fred Upton before the House Commerce Committee Subcommittee on Case: 14-12663 Date Filed: 06/17/2014 Page: 5 of 26 Otiersi-ght and Investigations Counterfeit Bulk Drugs, June 8, 2000, available here: veil F[on'ner FDA Associate Commissioner Dennis Baker testified that ?[counterfeit bulk" drugs] pose a real or potential health hazard because their? manufacturer is often unknown. . The impurity pro?le is unknown, and the age, the storage, the manufacturing environment,. or the of the product cannot be determined,? cre_a_ting- a situation where ?no amount of ?nished product testing can -build quality into the product.? Id., Statement of Dennis Baker, available at: aslf It is ?very? -dif?cnlt, if not imp'os_s_ib1e, to trace the raw API -chemicals used in -co1np.ou'tiding back to the original manufacturer for information on quality, packaging, storage, shipment conditions, and chains of custody - all necessary to. ascertain the identity, purity, potency, and ef?cacy of a medication. Much of the bulk API used in .non-traditional compounding is not produced in FDA-registered ?and. inspected. facilities. This is not an idle concern. Plants in China have been found to pesticides using the same equipment used to make? APIS bound for human ingestion as part of -a compounded product. See "Statement of Dennis Baker, supra. By contrast, APIS used. in manufactured (F DA?r'egulated) pharmaceuticals must come from a manufacturer that holds a Drug Master File (a con?dential, detailed document submitted. by API manufacturers to the FDA containing the chemistry, _manufacturing _and controls of a drug component) for the chemical, and must be manufactured in an FDA-registered plant. Ethical chernical :manufacturers who adhere to- professional Responsible Care principles -are more likely to ?sell directly to FDA-approved manufacturers of ?nished products -and are unlikely? to sell chemicals that may be used in grey market drug production. unethical chemical 1nanufactu_rer's and those that are not regulated by the FDA are more likely to release large quantities of bulk chemicals into .the grey market-, increasing the likelihood. that substandard chemicals will serve as the starting ?materials for both traditional and non?traditional compounding. In this unregulated market, a chemical labeled to represent a certain active ingredient? may contain another, quite -different ingredient. Practitioners, regulators, and experts have identi?ed this problem as to chemicals. distributed in large quantities to ?pharmacies throughout the nation for use in compounding. There can be no guarantees that APIs purchased from the grey market -are safe for use, are not c'o'ntaminate'd, or even contain the ingredient listed on the product"lab'e1. Furthermore, because chemicals may not have been manufactured in an DA-registered facility ?under current GMP standards, there can be no assurance as to the quality variation from or container-to?container. .If poor quality ingredients are used, even the best compounding practices will not build quality and suitability into the ?nal product. The compounded drug may be 4 Case: 14-12663 Date Page:6of 26 contaminated, super-?potent or sub-potent, non-sterile, or at risk of an unusually short shelf life.- A pharmacist may have con?dence in ?her ability to accurately measure or Weigh and -extend this con?dence as a quality measure for the ?nished compound. _But if the pharmacist is. starting with an adulterated or counterfeit -that would go unrecognized in a pharmacy setting (as opposed to a manufacturing facility with the capacity to test the quality of ingredients and overseen by federal regulators), accurate measurement of chemicals cannot remedy an already adulterated or otherwise unsafe product with respect to identity, purity, potency, or harmful contamination. Despite a pharn1'acist's best e?'oits, there are parameters beyond her professional control that build risk and uncertainty into all compounded products. TESTING. THE API AND THE FINAL PRODUCT Compounded pentobarbital injection is made from the API, pentobarbital sodium, which is then mixed; with other ingredients. Testing of both the API and each step in the production .of the ?nal compounded product is important, but an educated understanding of the test results and their ?potential inadequacies is crucial. The quality and adequacy of the an'a.lytic'al lab or labs conducting the testing is also vital. Testing only provides a very provisional indication of an APPS suitability for compounding. given the unknowns about the integrity, storage, and custody in the timeframe ?om testing to pharmacy compounding and use. Compounding pharmacists generally do not have the ability to test chemicals for identity, potency, purity -and contamination. Many contract laboratories that conduct testing are in business to perform such tests for compounding pharmacies and their suppliers. Geor-gia?s execution protocol does not include provisions for testing the API or -the ?nished, compounded dosage form of the pentobarbital to be used in executions. The ability of the Georgia. Department of Corrections.? source of pentobarbital to engage a reliable and competent. laboratory to conduct testing to con?rm the identity of the chemical, or to identify -the presence of harmful contaminants that pose an immediate safety threat if administered intravenously, is vital to avoiding the serious? hazards inherent in the use of compounded drugs for executions. -Substantial Risk of Harm From Pharmacy Compounded Drugs Injectable drugs ?regulated by the FDA must be sterile and meet other stringent requirements for quality, purity, and? stability. Compounded inj ectable drugs made from a non?st'e'rile API outside of an FDA-regulated facility carry a substantial risk of causing immediate harm and pain to the recipients of such drugs. This risk is real, not hypothetical or speculative, and is based on objective evidence from the real world that has been observed over the last century in this country. Case: 14-12663 Date Filed: 06/17/2014 Page: 7 of 26 Conntl'_e'ss rnembers. of the public have suffered and experienced pain before science ?based federal regulations were implemented to protect the public from what had become the obvious hazards of inj ectable drugs contaminated with fungi,_ bacteria, and other contaminates. A recent exarnple of the consequences of injectable drugs not meeting. strict FDA sitandards is the 2012'fu1'1gal meningitis epidemic caused by the New England Compounding Center that resulted in more than 700 cases of meningitis and over 60 deaths, all of which were preventable. The risks associated with the preparation of 'si1ppo_se_dly sterile i1'1jecti_ons made from non?sterile APIs produced outside federally regulated production facilities were clearly known. In addition to lack of sterility there are additional risks of immediate harm and pain from loosely? regulated ='p'har'macy compounded drugs; These known risks include -cross contamination of lethal injection drug with a drug to which the condemned ?prisoner may be highly allergic. This o'ccu:rs when the air supply (atmosphere) of the room in which the lethal -injection drug is being prepared compounded is not scrupulously segregated from the air supply in the room in which an is being -procliteed. In a severe allergic reaction the throat can swell making breathing extzremely di?icult or impossible. The addityfalkalinity (pH) of? any injectable drug must be care?tlly adjusted to ensure. that the recipient of the drug does not suffer an immediate painful sensation at the time of injection-. Both -a compromised API and improper compounding procedures can cause the pH of an injectable drug to be unacceptable. Endotoxins are potential contaminates of injectable drugs. These substances elicit an in?ammatory reaction and can result in shock. Particulate matter contaminating sterile injectable drugs can become ?lodged in small blood vessels?. Depending on the size of these particles the response could be immediate. or delayed. Problems With Pharmacy Compounded Pentobarhital Used in Executions On January 10,. 2014 Oklahoma prisoner Michael Lee Wilson was executed under a three drug" protocol that used pentobarbital sodium injection produced by an unknown compounding pharmacy. Time Magazine reported that within 20 seconds of receiving the injection Mr. Wilson cried that -he felt his ?whole body burning.? It ismy opinion that Mr. 'Wilson"?s reaction is consistent with a contaminated pentobarhital sodium injection. Because of common problems with safety procedures of and testing laboratories, and the lack of adequate oversight by federal and state authorities, the injection used in Wilsonfs execution likely contained cross-contaminates -that he was allergic to, bacteria and endotoxins. The injection could have had an altered pH due to contaminates or inadequate procedures used in the Case: 14-12663 Date Filed: 06/17/2014 Page: 8 of 26 _prep:a.ration of'tlie- Additionally", because of this lack of oversight described above, no one knows for sure what was injected into Mr. Wilson. The South Dakota-execution .ofEric Robert on October 15, 2012 used pharmacy- compounded pentobarbital. According to reports, Mr. Robert appeared to clear his throat, gasped heavily and snored. Over a ten-minute period his skin turned a blue-gpurplish hue. During the course. of his execution, he opened his eyes and they remained open until his "death. It took 20 minutes for the state to declare Mr. Robert dead. Mr. Robert?s heart continued to? beat ten minutes after he stopped breathing. It is my opinion that the events observed? during Mr. Robert?s execution are "consistent with the administration of a compounded drug that was contaminated or sub- potent. FDA Compared to State Board of Pharmacy Inspections In the absence of rout_ine_FDA regulation and oversight, compounding pharmacies are able to produce injectable drugs under conditions that create a substantial risk that the drugs will be sub.-standard in a manner that will cause severe pain upon or shortly after injection. A recent FDA Warning Letter issued to a compounding pharmacy in California is instructive. -On May .2, 2014, the FDA issued a Warning Letter to Grandpa?s Compounding Pharmacy, Inc., in Placervil-le, CA. The letter summarized ?ndings made by the FDA fol_lovving a site inspection that applied Go.od Manufacturing Practice (GMP) guidelines. FD-A i'nspector_s- were on site at Grandpa?s Compounding Pharmacy for a period of 4 days in September 2013. The initial ?ndings of the inspection were documented on an FDA Form 483 that was left at the pharmacy byregulation. This form is required to be placed in the public -domain and is now available of the Web site. Subsequently, the FDA issued a detailed "Warning Letter to Grandpa?s Compounding Pharmacy documenting a number of serious -problems in the preparation. compounded sterile products. The. FDA found serious de?ciencies in producing sterile drug products and ?aws in the -design? of aseptic processing areas, which could lead to contamination of products, potentially putting patients at risk. For example, it was observed that the air supply ductwork for the cleanroom was held together, in part, with duct tape. The also observed that_ the cleanroom contained an in?-Wall air conditioner bringing outside air into the room where aseptic manipulations are occurring. These items are di?icult to clean and could allow air to enter the cleanroorn that has unacceptable microbial and particulate levels. Furthermore, according to the FDA, operators were observed with exposed wrist and forearm skin. engaging in. aseptic manipulations. In addition, it was observed that this pharmacy used tap water to clean and depyrogenate containers and -closures; these. are not suitable to depyrogenate the containers and -closures intended for injectable -drug products. The FDA stated that products produced in Grandpa?s Compounding Pharmacy may be produced in an environment that poses a signi?cant contamination risk. 7 Case: 14-12663 Date Filed: 06/17/2014 Page: 9 of 26 The include, for example: 1 . Failure to establish an adequate air supply ?ltered through high-efficiency particulate air ?lters under positive pressure in the aseptic processing areas (21 CFR 21 2. Failure to establish and follow appropriate written procedures that are designed to prevent contamination ofdrug products purporting to be sterile, and that include "validation of all. aseptic and sterilization processes (21 CFR Failure to ensure that rnanufacturing personnel Wear clothing appropriate to protect drug pro"du'ct from contamination (21. CFR 21 1 .2 4. Failure to establish an adequate system for monitoring environmental conditions in -aseptic processing areas (21 CFR 21 5. This pharmacy did -not have for each batch of drug product purporting to be sterile andfor pyriogen-free, a_pprop_riate'1ab'oratory determination of satisfactory conformance to ?nal speci?cations for the drug product (21 CFR 21 The FDA -inspection found signi?cant de?ciencies in air quality at Grandpa?s Cornpoundi-ng Pharmacy. These de?ciencies. could allow for the contamination of compounded: sterile products that could pose a substantial risk of immediate harm and pain-to condemned prisoners. Due to? ?inadequate oversight of compounding pharmacy by state and federal regulatory authorities, Grandpa?s Compounding Pharmacy may be the rule rather than the exception. Failure to Properly Test Pharmacy Compounded Drugs Adding to the problems of the known risks of pharmacy compounded injectable drugs made from non-sterile bulk API is the testing of these drugs by contract testing -laboratories. Poorly regulated, if regulated -at all, contract testing laboratories are supposed to test conlpounded drugs for safety and effectiveness. Too often, however, these labs are thernselves substandard, and many-are established to serve the ?nancial interests ofithe pharmacies for which they are doing the testing. Five laboratories that test compounded drugs have had enforcement actions taken against them by the FDA. Adequate regulatory oversight is absent from the pharmacy industry. Contract testing laboratories used by compounding pharmacies cannot rule out that compounded products are contaminated with bacteria andfor fungi, cross contaminates that could cause severe allergic particulate matter that may lodge in small blood vessels, endotoxins that may elicit pharmacological effects, incorrectly adjusted acidity and other unknown contaminates. A product that passes testing is assumed to have met 8 Case: 14-12663 Date Filed: 06/17/2014 Page: 10 of 26 but the results obtained ?om contract testing laboratories used-j-by compounding pharmacies are reliahrig and should not be used to make reliable decisions about the safety, e?cacy, and qualityijf pharrnacy?cornpou.nded drugs. Conclusion The true contents of ?pharmacy compounded pentobarbital injection, or any gplrarznacyacornpounded -drug, prepared from a non-sterile API are unknown. The use of injections made ?om non-sterile API presents an immediate "risk ?of Suffering and" pain tothe -recipient of such :a drug. I swear -under pain-and penalty of perjury that the foregoing is true and accurate to the best of my knowledge. Dated this, the day of June, 2014. Ugo. ML 1201 North Shore Blvd. #802, Burlington?, Ontario, 1Z5 CANADA Phone: 705 -491 -0609 Email: Case: 14-12663 Date Filed: 06/17/2014 Page: 11 of 26 CURRICULUM VITAE Larry D. Sasich, Pharm.D., M.P.H., FASHP 1201 North Shore #802 Burlington, L7S 125, Ontario Canada Cell Phone: 705-491-0609 E?Mail: EDUCATION 1995 to 1997 1974 to 1975 1966 to 1970 RESIDENCY 1986 to 1987 PROFESSIONAL LICENSES 1970 to Present Master of Public Health - Epidemiology The George Washington University School of Public Health and Health Services Washington, D.C. Doctor of Pharmacy University of the Pacific College of Pharmacy Stockton, California Bachelor of Science Pharmacy Idaho State University College of Pharmacy Pocatello, Idaho Nuclear Pharmacy University of New Mexico College of Pharmacy Albuquerque, New Mexico California RPH 27094 Case: 14-12663 PROFESSIONAL EXPERIENCE April 2013 to date July 2007 to April 2013 November 2009 to 2012 2007 to 2009 2006 to 2007 2005 to 2006 2006 to 2008 Date Filed: 06/17/2014 Page: 12 of 26 Consultant, Drug Policy, Drug Safety and Efficacy Burlington, ON Canada Consultant, Saudi Food and Drug Authority 3292 Northern Ring Rd. Al Nafal District Riyadh, Saudi Arabia Consultant, Public Citizen_?s Health Research Group 1600 20th Street, NW Washington, D.C. 20009 Chairman, Department of Pharmacy Practice LECOM School of Pharmacy 1858 Grandview Blvd. Erie, PA 16505 Acting Chairman, Department of Pharmacy Practice LECOM School of Pharmacy 1858 Grandview Blvd. Erie, PA 16505 Assistant Professor, Department of Pharmacy Practice LECOM School of Pharmacy 1858 Grandview Blvd. Erie, PA 16505 Consultant Centre for Science and the Public interest Canada Suite 4550, CTTC Bldg. 1125 Colonel By Drive Ottawa, Ontario K1 8 5R1 Canada Case: 14-12663 Date Filed: 06/17/2014 Page: 13 of 26 PROFESSIONAL EXPERIENCE Consultant 2005 to 2007 Public Citizen?s Health Research Group 1600 20th Street, NW Washington, D.C. 20009 Consultant 2005 to 2006 Canadian Agency for Drugs and Technologies in Health 600-865 Carling Avenue Ottawa, Ontario K1 5S8 Canada 1995 to 2005 Research Analyst Public Citizen?s Health Research Group 1600 20th Street NW Washington, D.C. 20009 1991 to 1995 Drug Information Pharmacist King Faisal Specialist Hospital and Research Centre Riyadh 11211, Saudi Arabia 1993 to 1996 Adjunct Clinical Faculty Welch School of Pharmacy University of Wales Cardiff, Wales 1992 to 1995 Clinical Instructor College of Pharmacy King Saud University Riyadh, Saudi Arabia Graduate and Undergraduate Teaching 1988 to 1990 Clinical Pharmacist St. Helens Hospital and Health Center St. Helens, OR Emanuel Hospital and Health Center Portland, OR 1985 to 1988 Associate Professor of Clinical Pharmacy Idaho State University College of Pharmacy Pocatello, Idaho Promoted and Tenured July 1, 1984 Case: 14-12663 Date Filed: 06/17/2014 Page: 14 of 26 PROFESSIONAL EXPERIENCE 1983 to 1984 Assistant Professor of Clinical Pharmacy College of Pharmacy Idaho State University Pocatello, Idaho Acting Associate Dean for Student Affairs 1982 to 1983 Assistant Professor of Clinical Pharmacy College of Pharmacy Idaho State University Pocatello, Idaho Director of Professional Practice 1979 to 1982 Assistant Professor of Clinical Pharmacy College of Pharmacy Idaho State University Pocatello, Idaho Director, Idaho Drug Information Service and Regional Poison Control Center 1976 to 1979 Assistant Director of Pharmacy Services USA MEDDAC Berlin, West Germany 1975 to 1976 Staff Pharmacist USA MEDDAC Wuerzburg, West Germany 1970 to 1974 Pharmacist Baneth's Pharmacy Menlo Park, CA HONORARY SOCIETIES 1982 Rho Chi 1982 Sigma Xi Case: 14-12663 Date Filed: 06/17/2014 Page: 15 of 26 AWARDS 2000 Distinguished Person of the Year - Pharmacists Planning Services 1995 Fellow American Society of Health-System Pharmacists 1986 Ciba-Geigy Leadership Award 1983 Outstanding Service Idaho Board of Pharmacy 1982 Phi Delta Chi Faculty Achievement Award APPOINTMENTS 2009 FDA Science Board Sub Committee on the Center for Food Safety and Applied Nutrition (CFSAN) 2008 FDA Science Board Sub Committee on the review of the National Center for Toxicological Research 2007 Grant Reviewer U.K. Economic and Social Research Council Large Grant proposal: Governance of Pharmaceuticals and Health 2007 Consumer representative, Science Board to the Food and Drug Administration advisory committee to the FDA Commissioner 2007 Pharmacists Association Pharmacy Compounding Task Force 2006 Food and Drug Administration Pediatric Advisory Committee November 16, 2006 substitute consumer representative 2006 Reviewer PLOS Medicine 2000 . Reviewer for the Western Journal of Medicine 2000 Reviewer for the Journal of the American Medical Association 1996 Department of Health and Human Services Steering Committee for the Collaborative Development of a Long- Range Action Plan for the Provision of Useful Prescription Drug Information 1996 Department of Health and Human Services, Food and Drug Administration, Consumer Consortium Case: 14-12663 Date Filed: 06/17/2014 Page: 16 of 26 APPOINTMENTS 1995 Reviewer for the Saudi Pharmaceutical Journal 1993 Reviewer for the Annals of Saudi Medicine 1986 Reviewer for Annals of Pharmacotherapy 1987 Idaho Delegate to Western Regional Conference on Clinical Pharmacy Practice 1985 Idaho Health Systems Ethics Conference Task Force 1984 American Pharmaceutical Association Committee to prepare accreditation standards for a community pharmacy residency 1982 Assistant Editor 1981 USP Dispensing Information Contributors Panel PUBLICATIONS Sasich LD, Abi-Jaoude E. Making use of the Food and Drug Administration Briefing Documents to reconsider the safety profile of sertindole. British Journal of 2014 (under review). Sasich LD, Abi-Jaoude E. Drug approval packages and briefing documents are already freely available. BMJ 2013;347:f4861. Sasich LD. Rapid Response: Tamiflu: 14 flu seasons and still questions. BMJ 2013. At Accessed January 28, 2013. Sasich LD, Sukkari SR. The US Withdrawal of the Breast Cancer Indication for Avastin (Bevacizumab). Saudi Pharmaceutical Journal 2012; 20: 381-385. Sukkari SR, Humaidan AS, Sasich LD. The content of Arabic language consumer medication information leaflets for three drugs: a pilot study. Saudi Pharmaceutical Journal 2012 Sukkari SR, Sasich LD, Humaidan AS, Burikan ON. An Analysis of Metformin Treatment for Adolescent Obesity at 48 Rather Than 24 Weeks after Treatment Cessation. Archives of Pediatrics Adolescent Medicine 2010; Cook GE, Sukkari SR, Sasich LD. An Additional Source of Bias in Antidepressant and Other Trials. Pharmacotherapy 18e. Cook GE, Sukkari SR, Sasich LD. Lost in Transmission FDA Drug Information That Never Reaches Clinicians. New England Journal of Medicine Case: 14-12663 Date Filed: 06/17/2014 Page: 17 of 26 PUBLICATIONS Cook GE, Sasich LD, Sukkari SR. DIONYSOS study comparing dronedarone with amiodarone. BMJ 2010;340:0285. Sasich LD, Sukkari SR, Barasain MA. An Academic Perspective on the Educational Significance. American Journal of Pharmaceutical Education 2009; 73: article 139. Tuttle DA, Sasich LD, Sukkari SR. Improving Access to FDA Reviews and Documents. Journal of the American Medical Association 2009; 302: 2204. Sasich LD, Sukkari SR, Cook GE, Tuttle DA. The Importance of FDA Approval Packages and Briefing Documents in Pharmacy Education. American Journal of Pharmaceutical Education 2009; 73:126-127. Sasich LD, Barasain MA, Al Kudsi MA. Three country comparison of selected safety information in the prescribing information for rosiglitazone (Avandia). Saudi Pharmaceutical Journal 2009 17: 195-198. Sukkari SR, Sasich LD. Look in the Looking Glass Not Through It. American Journal of Pharmaceutical Education 2009; 73:56-58. B_rown S, Olson P, Sasich LD. My First Drug Information Question Should My Wife and Baby be Subjects in an Uncontrolled Clinical Trial? Journal of the American Pharmacists Association 2008; 48:444-445. Sukkari SR, Sasich LD, Tuttle DA, Abu-Baker A, Howell H. Development and Evaluation of a Required Patient Safety Course. American Journal of Pharmaceutical Education 2008; 73(3) Kronmal R, Sasich LD. The FDA Should Not Have Approved Kuvan. PKU News 2008; 20: 2-11 and 12 [invited editorial]. Sasich LD. Book Review: Evaluating Clinical Research All that Glitters is not Gold. American Journal of Pharmaceutical Education. 2008; 72(2). Sasich LD, Barasain MA, Al Kudsi MA. The CV Risks of Etoricoxib (Arcoxia). Annals of Saudi Medicine 2008; 28:141-142. Vitry A, Lexchin Sasich LD, Dupin-Spriet T, Reed T, Bertele V, Garattini S, Toop L, Hurley E. Provision of information regulatory authorities? websites. Internal Medicine Journal 2008 (doi:10.11 Sasich LD, Sukkari SR. Unknown risks of pharmacy compounded drugs. Journal of the American Osteopathic Association 2008; 108:86 [letter]. Case: 14-12663 Date Filed: 06/17/2014 Page: 18 of 26 PUBLICATIONS Miller J, Olmer J, Sasich LD. Importance and methods for accessing FDA approval packages and briefing documents. Annals of Pharmacotherapy 2007; 41 :2071?2072. Sasich LD. Remembering Jere Goyan. American Journal of Health-System Pharmacists 2007; 64:1142 [letter]. Sasich LD. Patients may not be receiving Medication Guides. Scribe international Society of Pharmacoepidemiology 2006; 9:8. Sasich LD. Don't forget to give out MedGuides. Drug Topics April 3, 2006. Sukkari SR, Sasich LD. Patient Information Leaflets. Canadian Medical Association Journal 2004; 171 :10 [letter]. Sasich LD. Viewpoint - Useful drug information: 20 years and still waiting. Drug Topics 2003; 147:17. Sukkari SR, Sasich LD. Cisapride and patient information leaflets. Canadian Medical Association Journal 2001 164:1276-1278. Wolfe S, Lurie P, Sasich LD, Barbehenn E. Information on thiazolidinediones. Lancet 2000; 356:254-258 [letter]. Lurie P, Sasich LD. Safety of FDA-approved drugs. Journal of the American Medical Association 1999; 282:2297 [letter]. Sasich LD. Useful prescription drug information. American Journal of Health-System Pharmacists 1999; Sasich LD, Sukkari SR. International Drug Information Notes: Update on cisapride (Prepulsid). Saudi Pharmaceutical Journal 1998; 6:270-272. Wolfe SM, Sasich LD, Barbehenn E. Safety of sildenafil citrate. The Lancet 1998;352: 1393 [letter]. Sasich LD, Sukkari SR. International Drug Information Notes: Old German drugs. Saudi Pharmaceutical Journal 1998; 6: 1 60-1 63. Bradley L, Sasich, LD, Wolfe SM. The Information Content of Patient Medication Information Leaflets Distributed by Pharmacists: Examination of Five Fluoroquinolone Antibiotics. Journal of the American Pharmaceutical Association 1998; 38:278- 279[abstract]. Sasich LD. Book Review: Moore TJ. Prescription for Disaster New York: Simon Schuster; 1998. American Journal of Health-System Pharmacists 1998; 55:511. Sasich LD, Sukkari SR. International Drug Information Notes: Recent drug withdrawals and proposed withdrawals in the US and UK. Saudi Pharmaceutical Journal6:92-98; 1998. Case: 14-12663 Date Filed: 06/17/2014 Page: 19 of 26 PUBLICATIONS Sasich LD, Wolfe SM, Pearson C, Swankin DA, Levin DA, Levin AA, Beard J. The National Council on Patient Information and Education. Journal of the American Medical Association 278: 1 491 -1492; Sasich LD, Sukkari SR. Bromocriptine: reply to Sandoz. Saudi Pharmaceutical Journal 5:197?199; 1997[letter]. Sasich LD, Sukkari SR. International Drug Information Notes: Fluoroquinolone associated tendinopathy, tendinitis and tendon rupture. Saudi Pharmaceutical Journal 5:130-134; 1997. Sasich LD, Wolfe SM. Deficiencies in patient information leaflets concerning gastrointestinal complications of nonsteroidal anti-inflammatory drugs. Journal of General Internal Medicine 12:79; 1997[abstract]. Sasich LD, Sukkari SR. International Drug Information Notes: Probucol: lack of efficacy and market withdrawal. Saudi Pharmaceutical Journal 997. Sasich LD. Book Review: Power and Dependence. Saudi Pharmaceutical Journal4:212? 213; 1996. Sasich LD, Sukkari SR. International Drug Information Notes: The lack of safety and efficacy of tramadol (Ultram, Zydol). Saudi Pharmaceutical Journal4:207-209; 1996. Sasich LD, Sukkari SR. International Drug Information Notes: Bromocriptine (Parlodel) and postpartum breast engorgement. Saudi Pharmaceutical Journal4:204-207; 1996. Sukkari SR, Sasich LD, Nicholls PJ. Therapeutic class redundancy as a measure of formulary system effectiveness. Saudi Pharmaceutical Journal4:190-195; 1996. Sasich LD, Sukkari SR. International Drug Information Notes: The risk of calcium channel blockers. Saudi Pharmaceutical Journal 4:1 19-122; 1996. Sukkari SR, Sasich LD, Nicholls PJ. Promoting therapeutic information to the medical staff: the evidence based formulary. Saudi Pharmaceutical Journal 996. Sasich LD, Sukkari SR, N_uess e SJ. Post-graduate pharmacy education relevant to developing countries. WHO Eastern Mediterranean Region Drugs Digest 10:48-50; 1995-. Sukkari SR, Sasich LD, Nicholls PJ. The formulary as a source of comparative efficacy drug information in developing countries. Proceedings of the European Symposium on Pharmacoeconomics, Gent, Belgium, 18-20 May 1994. Sasich LD, Sukkari SR. The drug evaluation process at King Faisal Specialist Hospital. Saudi Pharmaceutical Journal 2: 1 89-1 97; 1994. Nuessle SJ, Sasich LD. Criteria for use of interferon alpha-2a or interferon alpha-2b for selected indications in adults. American Journal of Hospital Pharmacy 51:1030-1033; 1994. Case: 14-12663 Date Filed: 06/17/2014 Page: 20 of 26 PUBLICATIONS Sasich LD: Book Review The Use of Essential Drugs: Model List of Essential Drug (Seventh List) Fifth Report of the WHO Expert Committee. Annals of Pharmacotherapy 27:1145; 1993. Sasich LD: Blood Transfusion-Associated Bacterial Sepsis In: Conner CS, Rumack BH, eds. Information System. Denver, CO: Micromedex, Inc., 1992. Julnes T, Sasich LD. Oregon's health rationing act and the policy process. New England Journal of Human Services 9:20-26; 1991. Sasich LD. Pneumococcal revaccination after splenectomy. Drug Intelligence and Clinical Pharmacy 22:722-723; 1 988. Sasich LD. Bleomycin - therapy of malignant pleural effusions In: Conner CS. Rumack BH, eds. DRUGDEX Information System. Denver, CO: Micromedex, Inc. 1987. Dodson RA, Sasich LD. Calcium channel blockers: their actions and indications. Pharmacy Times 50:4; 1984. Huff MR, Williams L, Crothers RW, Driver PS, Endo RK, Manske TA, Sasich LD. Preventing burnout: an alternative approach. Hospital Pharmacy19; 1983. Sasich D. Proposal for a community pharmacy practice residency program. American Pharmacy 1983; 23:25-28. Driver PS, Endo RE, Levin A, Hall DH, Sasich LD. Anaphy actic? ike reactions to zomepirac. Drug Intelligence and Clinical Pharmacy 152384; 1981. Sasich L, Morriss HA. A computerized on-line key word indexing system for drug information retrieval. Hospital Pharmacy16:136; 1981. Sasich L. Drug literature filing systems for the practicing pharmacist. The Idaho Pharmacist 17:16; 1980. Hansten PD, Sasich LD, Biggs RL, Cohen SM. Computerization and drug interaction data for a community pharmacy. Journal of Clinical Computing. 3:270; 1975. BOOKS AND CHAPTERS Furberg BD, Furberg CD, Sasich LD. Knowing Your Medications. 2010. Sukkari SR, Sasich LD. Drug induced blood disorders. In: Applied Therapeutics: the Clinical Use of Drugs. Young, LY, Koda-Kimble, eds. Baltimore: Lippincott, Williams Wilkins, 2008. Wolfe SM, Sasich LD, Hope R-E. Worst Pills, Best Pills. New York: Pocket Books, 2005. Sasich LD, Sukkari SR. Drug induced blood disorders. In: Applied Therapeutics: the Clinical Use of Drugs. Young, LY, Koda-Kimble, eds. Baltimore: Lippincott, Williams Wilkins, 2004. Case: 14-12663 Date Filed: 06/17/2014 Page: 21 of 26 BOOKS AND CHAPTERS Wolfe SM, Sasich LD, Ardati AK. Worst Best Pills Companion. Washington DC: Public Citizen, 2002. Sasich LD, Sukkari SR. Drug induced blood disorders. In: Applied Therapeutics: the Clinical Use of Drugs 6th ed. Young, LY, Koda-Kimble, eds. Baltimore: Lippincott, Williams Wilkins, 2001. Wolfe SM, Sasich LD, Hope Worst Pills, Best Pills. New York: Pocket Books, 1999. References available on request '11 Case: 14-12663 Date Filed: 06/17/2014 Page: 22 of 26 Home Inspections, Compliance, Enforcement, and Criminal Investigations Grandpa?s Compounding Pharmacy, Inc. 512114 at? Public Health Service Department of Health and Human Services Food and Drug Administration San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94501-7070 Telephone (510) 337-6700 Warning Letter WL: 423162 CERTIFIED MAIL RETURN RECEIPT REQUESTED May 2, 2014 Daniel B. Wills General Business Manager Grandpa's Compounding Pharmacy, Inc. 7563 Green Valley Road Placerville, CA 95667-3917 Dear Mr. Wills: Between September 3, 2013 and September 10, 2013, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Grandpa's Compounding Pharmacy, lnc., 7563 Green Valley Road, Placerville, CA 95667-3917. During the inspection, FDA's investigators were accompanied by California State Board of Pharmacy (BOP) inspectors. At that time, the investigators noted that you were not PT 0? W?ie I 1 e? ra d.eS_i_ . . . . . . wrist and forearm skin engaging in aseptic manipulations. In addition, we observed that your firm uses tap water and a to clean and depyrogenate containers and closures; these are not suitable to depyrogenate the containers and closures intended for injectable drug products. Therefore, your products may be produced in an environment that poses a significant contamination risk. These observations and others were noted on a Form FDA 483, issued on September 10, 2013. We acknowledge receipt of your firm?s response to the Form FDA 483 dated September 20, 2013, in which your firm stated it would cease all sterile compounding. Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA). A. compounded Drugs Under the FDCA Case: 14-12663 Date Filed: 06/17/2014 Page: 23 of 26 At the time FDA inspected your facility, there were conflicting judicial decisions regarding the applicability of section 503A of the FDCA [21 U.S.C. 353a], which exempts compounded drugs from several key statutory requirements if certain conditions are met.? Nevertheless, receipt of valid prescriptions for individua ly~ identified patients prior to distribution of compounded drugs was relevant for both section 503A of the FDCA Pharmacy Com (CPG 2002 which was . .. tag. 6 on which amended FDCA section 503A by eliminating the advertising restrictions that h_a_cl_ iutdtieiatiltdecistioii In addition, we remind you that there are a number of other conditions that must be satisfied to qualify for the exemptions in section 503A of the B. Violations of the FDCA The drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are misbranded drugs in violation of section 502(f)(1) [21 U.S.C. 352(f)(1)] of the FDCA. In addition, your sterile drug products are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. As 3" Sterile YOU manufast Ofthe H. . . 9 DA investigators observed significant CGMP violationsat your facility, causing such drug product(s) to be adulterated within the meaning of section 501 of the FDCA [21 U.S.C. Fe Because the drug products for which you have not obtained valid prescriptions for individually-identified patients are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layperson can use these drug products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FDCA [21 U.S.C. and they are not exempt from the requirements of section 502(f)(1) of the FDCA (see, 21 201.115). it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being misbranded. Adulteration Charges Additionally, FDA investigators noted that your sterile drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501 of the FDCA [21 U.S.C. Examples of these conditions include an air supply system that is composed of, in part, a held together, in part, with duct tape; an in-wall air conditioner; operators performing aseptic manipulations with exposed wrist and forearm skin; and the use of tap water and a to clean and depyrogenate containers and closures intended for injectable drug products. FDA investigators also noted CGMP violations at your facility, causing the drug products for which you have not obtained valid prescriptions for individually-identified patients to be adulte_rated und_er section 501(a)(2)(B) of the FDCA [21 U.S.C. 351 Case: 14-12663 Date Filed: 06/17/2014 Page: 24 of 26 Your firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFB Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR Your firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product (21 CFR It is a prohibited act under section 301 of the FDCA [21 U.S.C. 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being adulterated. C. Corrective Actions We are aware that the California State BOP issued a Notice of Violation and Embargo Notice to your firm on September 6, 2013. Additionally, on September 10, 2013, the California St_ate BOPj_ssued another Embargo Notice to recall all sterile drug products due to a lack of viable sterility and testing, ordered your firm to immediately cease and desist the compounding of injectable sterile dr ducts (effective until October 31, 2013), and cancelled your firm?s sterile compounding license. in a letter to the BOP dated September 16, 2013 (and referenced in your response to the Form FDA 483 dated September 20, 2013), you agreed to voluntarily relinquish your State of California Sterile Compounding License (LSC 99109) to the BOP. In your September 20, 2013 response to the Form FDA 483, you stated that you had decided at that time to no longer continue sterile compounding. in addition, you stated that your lawyer was ?looking over the observations and may have a further response, but he is currently on vacation.? No other responses from your firm have been received by FDA since that time. In your letter to the California State BOP dated September 16, 2013, you stated you would continue to compound products that do not require you to have the licensed sterile compounding permit, as well as all other operations as a retail pharmacy. FDA strongly recommends that if you decide to resume production of sterile drugs, your management immediately undertake a comprehensive assessment of your manufacturing operations, including facility design, procedures, personnel, processes, materials, and systems. in particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation. I . Before resuming such operations. you should fully implement corrective actions that meet the minimum requirements of 21 CFR Part 211 in order to provide assurance that the drug product(s) produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity. in addition, if you resume sterile compounding, you should also correct the violations of FDCA section 502(f)(1) noted above. D. Conclusion The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. Case: 14-12663 Date Filed: 06/17/2014 Page: 25 of 26 If you decide to resume sterile drug operations, you should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within fifteen working days of receipt of this letter, please notify this office in writing if you have taken specific steps to correct violations, or you may inform us that you do not intend to resume production of sterile drugs. If you intend to resume production of sterile drugs in the future, please include ._an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. if you do not believe that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office prior to resuming production of any sterile drugs in the future. Your written reply should be addressed to: Lawton Lum Director, Compliance Branch U.S. Food and Drug Administration 1431 Harbor Bay Parkway Alameda, CA 94502 If you have questions regarding any issues in this letter, please contact Mr. Russell Campbell, Compliance Officer, at 510-337-6861. Sincerely, Kathleen M. Lewis, J.D. District Director cc: Virginia Herold, Executive Officer California State Board of Pharmacy 1625 Market Street Sacramento, CA 95834 Compare Western States Med. Ctr. v. Shalala, 238 F.3d 1090 (9th Cir. 2001) with Medical Ctr. Pharm. v. Mukasey, 536 F.3d 383 (5th Cir. 2008). The CPG set forth a non-exhaustive list of factors that FDA considered in determining whether to take enforcement action when the scope and nature of a pharmacy's activities raised concerns. This CPG has been withdrawn in light of new legislation. See below. See 21 U.S.C. 353a(a) (granting compounded drugs statutory exemptions it, among other things, ?the drug product is compounded for an identified individual patient based on the . . . receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription orderthat a compounded product is necessaryfor the identified patient . . . CPG at 2 recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs upon receipt of a valid prescription for an individually-identified patient from a licensed practitioner. This traditional activity is not the subject of this Drug Quality and Security Act, Public Law 113-54, 127 Stat. 587 (Nov. 27, 2013). Case: 14-12663 Date Filed: 06/17/2014 Page: 26 of 26 [5]The CQA contains a number of other provisions, including new exemptions and requirements for compounders seeking to operate as outsourcing facilities. A discussion of the CQA and the agency's plans to implement the new law may be found at For example, section 503A also addresses anticipatory compounding, which includes compounding (not distribution) before receipt of a valid prescription orderfor an individual patient. We are not addressing anticipatory compounding here. Page Last Updated: 05/19/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Case: 14-12663 Date Filed: 06/17/2014 Page: 1 of 16 Exhibit 4 r? .r :22 sat-~ OF EM ERG ENCY MIEZDICZN Office {602} 344-5413 Fax (cm) 344-1423 J. MD Chair Eric D. Kata. Mi) Vice Chair C. Ml?) Vice-Chair for Adlninismttiou Frunk DO Vice Chnii for Rcscaizcli Michael Eplei. DO Residency Program Director Jason Knight. Ml) Mcrlicai Director MMC Adult Eancrgency Depanmenl John Sarko. MD Medical Student Director Bruce T. Hotwclod. MD Associatc Director of Trenton Scwices Medical Director Dan 14 Quart. MD Medical Toxicology Consultation Service A. Seligson, MD Quality Ditcctor Ben Bobtow, MD Resuscitation Science Director Teresa Wu, MD Ultrasound Director Simulnlion Dircctor Thomas Holly, MI) Patricio Bayless. MD Paul A. [30 Brad Bullet, MD David Licii. Ml) Kara MD Thomas Boslwick. MD Michele Adaix~Rus5o Residency (602) 3-tot-5808 Marie Aags;e2 of 7 GEORGIA DEiPAR'r1vn?jNr or CORRECTIONS it A ?Office of Legal Services" Georgia 31029 . . . Gowrnor . Telephone (478) 992-5240 2 . Brian Qwens; Facsimile (473) 992-5241 ccomresfvner Robert . GeneraI_C0zmsef oagberis, 2012 Via Facsimile {El Mas: Stephanie Yellin 1 Federal Defender Program, Inc. 1500 Centennial Tower I Dear Ms. 'Ye1lin: - 101 Marietta Street Atlanta," Georgia 30303 Re: Open Records Request I . Lethal Injection - -.The purpose ofthis correspondence is to respond to your Georgia Open Records Act . request received by the Department on October 10, 2012. Enclosed you will ?nd two with several documents responsive to your requests. The ?rst CD contains documents that were - previously provided to you in response to your May 2012 request." This second CD contains documents that were used in making the determination to switch protocols and are responsive to request number 6. Please note that certain information has been redacted because disclosure of the redacted information would compromise security and safety of the Department, 0.C.G.A. Below is the Department?s response to each of yourrequests: - - 1. Paper" copies of this information have been enclosed for your review. - 2. GDCP is currently gathering responsive documents. Once they have been _receiv_ed_by_ this of?ce, they will be forwarded to you. Currently, the Department has 17 vials of pentobarbital that will expire March 2013 and 44 vials of potassium chloride that wil-1 expire on February 1,2013. - . . - Documents on CD 1 are responsive to this request. Documents on CD 1 are responsive to this request. Documents on CD 1 and 2 are responsive to this request. Documents on CD 2 are responsive to this request. Please do not hesitate to contact me if you have any questions or concerns. Sincerely, GEORGIA DEPARTMENT OF CORREC ONS I any Whetzel Assistant Counsel - 1529 - .0 I I . W: _.m:nlulnu . .. . . . . . . . . . HGT . . .. . mnaun?aunau .. . E032 . . .. . . . . . . - uu?unqcia . . . . . . . Em . . .. .. . o: .4 -. muom m?a . . WHOM mmz.Lxm. mnumomm ?m . . umonomm pm: uwn..: . . . V. am. mm - . m?am man . .h - mHum.mmmomumm . a . ?mm? .. . Urd. nur msa?ua E: 53 sum E: anon E5 Bncun?u mm ma?a?au . . 2 E?ea 3 ?3.08 . 9.: 5.31 _w:_Eno ?Pr u_F_mE . 28:32.6 sauna: 3. .53 a an .3: asst wean . mm . . . Vania E_u_a.5om BE :5 ca n.5uG_umM. huE 31 xuo?apau inBan?! 5? 20? uni nus.-n .83 Sun ua?u? ?oz .. .0 .m .95 uubcao .5. audxuh . . =3 muiputu .331 u.Hu.sann._u bi 33:2 33: ova: Havoc Huuoo Saz . . . mama . . . . - . . . zx.. . . . mu HBOt.!r1II .. . .. .. .. .. . .. . .- . .. if ..mmnm ..nqwom . .mm-mwa m. u.;.ww..Azom HE wzom gum mmaumamz om . ..: ;s.muHmmHHZD mmomw . dm?umpxunz. . . zmom . . . . . . . Aw .zomMuma . . mm mam pnmm.Mom .o.m mm Aw yzowmudd. mm mam Mom..o?m . . . - zomHmm.uHawozm4Hm aw. zomamm aw zomamm mmm:?n F0 . vmmanma :2 mmsowmnu .02 .02 due . aH.mo .mou moHo>zH EH .mAqHmHozm . n5.Hm HHOUHMMS mama . .. . . .1 4:41 aas w.nm.\.mm.m no . mega I . . - . mmw. m?44 we .Em: Emm?mmom am $53 . Emma. xam On. . nutmeg. .3 0.5 62. 5.E_Eum .592. nae:-u an mun . .?.EnuE dd: gb?uz?e Bbiu?ui 3. 3.2.3 inc .5 E_.w.n ion to cur: no En?unn? mun? Bu. Hanna. .35 333332 .5 2 uses 5.: E. Ed !u=?uE uuta .3 .u__uEu 53.5 may ?5 mam mumuuoocm u?.n.a o.Em =oun_._mwm.E. . um: 53 unm um: menu. ._mm:unm_u Fix a sun due: in .53 n. Hanan mm xdn_E._.uaa. mu. ?223 32 .5. 30 .ou_ES . 12 Hanna zm cam uusaa 0 men? 32 .0 .m .55 . 35F.m_uoU an ?a fa wa?w. .. m?xuwm nl. Tl \.nuu .m . .. . r. aa?ral . .m?mm . mam - .. .0. ..-55.11.. . . . zamgazsti mm 1 I I um. .m?mw . .. w..n.n .muHmm dz _.oz ?mm . mmnommw . . mmoo muwo>zH AHZHEHMO dzomm .2. Nb m. .. mf. nohmgom tn .5 .1..- wk .mnmmom mm u..%.hr1lunu .. . .zomMu?H mm _2.mm.Nom ..O-.H. zomnmm UHBWOZUANHQ Aw nuxrmama . . .. . . . . . . . . "..W.F ONU . Juh?a? . rn mw.H II I .. .-HIE yum Hom.-o.m . zw . npam mama . zomhmm anl1rn