US Pharm. 2008;33(11):40-42.

As of September 1, 2008, there are 37 states in the United States that permit the use of the death penalty for individuals who have committed the most heinous of crimes. The other 13 states (Alaska, Hawaii, Iowa, Maine, Massachusetts, Michigan, Minnesota, New Jersey, North Dakota, Rhode Island, Vermont, West Virginia, Wisconsin), and the District of Columbia do not permit the use of capital punishment.1 However, the Nebraska Supreme Court ruled in February 2008 that inducing the death of a condemned prisoner by use of the electric chair violates that state's own constitution.2 New York State's highest court concluded that the procedures used to impose a death penalty on a convicted criminal are also unconstitutional.3 Of the states that do permit use of the death penalty, 35 of them employ the use of lethal injection.4 Questions have been raised by death row inmates as to whether the protocol used to administer the lethal dose of drugs is constitutional.

On September 25, 2007, the U.S. Supreme Court granted a motion to hear an appeal in the case of Ralph Baze and Thomas C. Bowling, Petitioners, v. John D. Rees, Commissioner, Kentucky Department of Corrections, et al.5 This case offers the nation's highest court the opportunity to examine issues related to the use of legally marketed pharmaceuticals for carrying out lawful, court-ordered executions by lethal injection. The case centers on arguments related to the constitutionality of this method of execution under the third provision in the Eighth Amendment to the U.S. Constitution--"Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted."6

The parties to the case have pointed out that the Supreme Court frequently receives such requests for review, with over half the death row inmates facing an imminent execution in the last two years filing suits challenging the chemicals used. This case presents a record containing undisputed evidence that any and all of the current lethal injection chemicals (i.e., sodium thiopental, pancuronium bromide, potassium chloride) could be replaced with other chemicals that would pose less risk of pain while causing death than the chemical combination currently in use. The Kentucky statute in question provides that "every death sentence shall be executed by continuous intravenous injection of a substance or combination of substances sufficient to cause death."7

The last case before the Supreme Court presenting an opportunity to rule on an Eighth Amendment issue involving a method of execution was on March 17, 1879, in Wilkerson v. Utah, when it upheld the use of a firing squad.8 The most recent ruling was on May 19, 1890, in the case of In re Kemmler, when the Court upheld the use of the electric chair against a due process challenge.9 Lethal injection was first adopted in Oklahoma in 1977, with the understanding that it would be more humane than other execution methods (e.g., electric chair, gas chamber, firing squad, hanging).10

In 1985, the Supreme Court addressed a case involving use of legally marketed medications for lawful executions.11 A group of inmates facing execution by lethal injection petitioned the FDA to prevent the use of FDA-approved drug products to carry out lethal injection executions. The FDA refused, and the inmates filed suit in U.S. District Court seeking an order under the Administrative Procedures Act that the agency be required to do so. The federal trial court granted summary judgment for the FDA. The inmates appealed, and the U.S. Court of Appeals ruled that the refusal by the FDA was both subject to review by the courts and an abuse of discretion, one of the tried-and-true bases for challenging an action or failure to act by an administrative agency. Having lost at the appellate court level, the FDA requested that the Supreme Court hear the case, which it did, ruling in favor of the agency. The Court concluded that the FDA's failure to act on the petition was not subject to review by the courts.

Facts of the Case
The 2007 appeal was filed by two Kentuckians who were convicted of homicide and received death sentences for committing double murders.12 Ralph Baze was convicted of the shooting murders of a sheriff and a deputy sheriff in Powell County, Kentucky, in 1992. Bowling was convicted of the shooting murders of a couple and the wounding of their two-year-old son in 1990, as the victims sat inside their car in a parking lot in Lexington, Kentucky.

Both Bowling and Baze have completely exhausted all legitimate state and federal means for challenging their convictions and the propriety of the death sentences. Both have also refused to select a method of execution as provided by state statute. The statutory option allows an inmate to choose electrocution or to submit to the default approach of lethal injection as punishment.13

Procedural History
Baze and Bowling filed challenges to the three-drug protocol in Kentucky state court in 2004, seeking a declaratory judgment under Ky Rev Stat §418.040 that the lethal injection protocol violated or threatened to violate their right to be free from cruel and unusual punishment.14 On April 18, 2005, the trial judge began a bench trial to determine the sole issue regarding the propriety of the lethal injection protocol and issued his decision on July 8, 2005, but the Circuit Court of Franklin County denied that request. The inmates appealed to the Kentucky Supreme Court, which issued a ruling rejecting their challenge on April 19, 2007.

The Medications Used
The protocol for lethal injection execution begins with the availability of a therapeutic dose of diazepam, if it is requested for the relief of anxiety and associated nervousness and tension.15 Certified phlebotomists and emergency medical technicians (EMTs) are allowed up to an hour to insert the appropriate needles into the arm, hand, leg, or foot of the inmate. Three grams of sodium thiopental, a fast-acting barbiturate and general anesthetic, are injected. The line is then flushed with 25 cc of a saline solution to prevent adverse chemical interaction between the medications. Fifty milligrams of pancuronium bromide are administered next to induce paralysis. The purpose is to suspend muscular movement, stopping respiration. The line is again flushed with 25 cc of a saline solution to prevent any adverse chemical reaction between the drugs. Finally, 240 mg of potassium chloride are injected. This disrupts the heartbeat, resulting in cardiac arrest. An ECG verifies the cessation of heart activity. A physician and a coroner then verify the fact and cause of death.

Legal Issues
Three legal issues are presented for consideration by the Supreme Court: 1) Does the Eighth Amendment to the U.S. Constitution prohibit means for carrying out a method of execution that create an unnecessary risk of pain and suffering as opposed to only a substantial risk of the wanton infliction of pain? 2) Do the means for carrying out an execution cause an unnecessary risk of pain and suffering in violation of the Eighth Amendment upon a showing that readily available alternatives that pose less risk of pain and suffering could be used? and 3) Does the continued use of the three medications, individually or together, violate the cruel and unusual punishment clause of the Eighth Amendment because lethal injections can be carried out by using other chemicals that pose less risk of pain and suffering?

It should be borne in mind that the appellants are not challenging their convictions, death sentences, or the general proposition that lethal injection is a constitutionally valid method of execution. The focus of this appeal is exclusively on the specific medication protocol used in Kentucky and other states. "Even an execution method such as lethal injection that is humane in theory," the brief contends, "can be carried out by means of flawed or haphazard procedures that create a foreseeable danger of inflicting severe pain in actual practice." Kentucky's system, they add, is "highly vulnerable to multiple errors, any one of which will result in the infliction of agonizing pain."16

The defense lawyers do not suggest that there has to be a high level of predictability that pain would result from those procedures. Instead, they advance a standard of "unnecessary risk" involving a three-step approach: 1) assess the severity of the pain risked; 2) weigh the likelihood that pain would occur; and 3) determine the extent to which an alternative means would be feasible, either by changing a present process or switching to an alternative. This is their legal definition: "An execution procedure creates unnecessary risk where, taken as a whole, it presents a significant risk of causing severe pain that could be avoided through the use of a reasonably available alternative or safeguard."17

The Commonwealth's brief denounces the proposed standard, saying it focuses on "the mere risk of future pain and suffering."18 The "unnecessary risk" approach, the state asserts, "places the states under a continuing obligation to adopt the ‘lowest risk' alternative that is ‘reasonably available,' even if the risk being avoided is insignificant." Kentucky adds, "any method of lethal injection that does not minimize the risk of pain and suffering would apparently be deemed unconstitutional." The only workable standard, it contends, is one keyed to whether a method or manner of execution creates "substantial risk" of pain and suffering. Historically, it says, the focus has been on whether pain is actually inflicted by a given method of execution. It thus implies that use of a "substantial risk" approach would be more humane.

Cruel and Unusual?
The inmates advance a number of objections to the execution protocol that in their view make its implementation cruel and unusual:

1. The effects of the three-drug formula used in Kentucky were undisputed at trial.

2. "It is undisputed that the administration of pancuronium bromide and potassium chloride, either separately or in combination, would result in a terrifying, excruciating death if injected into a conscious person…Consequently, inducing general anesthesia is ‘critical'…to ensuring humane execution…If the intended dose of thiopental is not injected successfully, or does not bring about general anesthesia, the inmate will experience both the terror and agony of conscious suffocation and the excruciating pain caused by the potassium, but will appear peaceful and unconscious to observers."19

3. "Drug preparation involves getting medication from six separate kits of 0.5 grams of powder, each of which must be individually mixed with solution…The combination of several thiopental kits and accompanying calculations are difficult tasks for those who do not prepare drugs in their day-to-day, and can lead to an insufficient dose." The thiopental packaging states "that the only people who should mix or administer the sodium thiopental are those ‘trained and experienced in the administration of intravenous anesthetics'…The EMTs and phlebotomists responsible for mixing the thiopental in Kentucky have not been trained" in this area.20

4. "IV problems" are an issue because the Kentucky Department of Corrections' "execution protocol does not specify the rate at which the chemicals are to be injected, or how to determine that rate."21

5. IV infiltration may occur if the catheter is not inserted completely into or goes through the vein. "If undetected, infiltration can result in the delivery of insufficient thiopental to induce general anesthesia, but sufficient pancuronium and potassium chloride to paralyze and cause pain."22 Kentucky's protocol requires the insertion of two catheters, with the warden, who likely has no expertise in IV insertion, selecting which ones will actually be used.23

6. The facilities used to carry out the protocol are inadequate.

7. Under Kentucky law (Ky Rev Stat §311A:170), EMTs are permitted to function only under the direct supervision of a doctor. Phlebotomists have no licensure requirements in Kentucky.24

8. There is no provision for the inmate to be monitored during the procedure.25

Pharmacy Issues and Analysis
Is this an opportunity for pharmacists to apply their knowledge and insights about medication alternatives to meet a stated objective? Is this akin to a pharmacist's recommending a better medication for palliative care? The primary objection to the method adopted and the combination of agents used appears to be that the initial administration of the sodium thiopental does not eliminate the negative sensations associated with the intended actions of the subsequent two medications.

A number of provisions in the American Pharmacists Association (APhA) Code of Ethics for Pharmacists have potential application in situations similar to this.26 The code is designed to provide guidance for practitioners rather than specifically prescribe or proscribe their decisions and actions.27,28 Certainly, there will be pharmacists who have strong objections to members of their profession participating in this process, just as there are some physicians who share that view. "Physicians and other health care providers should not be involved in capital punishment, even in an advisory capacity. A profession dedicated to healing the sick has no place in the process of execution."29

Perhaps an additional point for pharmacists to consider is whether the mere act of providing the medications to be used does not raise a similar level of objection, as would the more active participation inherent in recommending the medications to be used. In at least one state (North Carolina), the board of pharmacy has become embroiled in this issue by initially ruling that physicians were prohibited from participating in executions. This was challenged by the North Carolina Department of Corrections, leading to a court ruling that state statutes prevailed over the board's ruling.30

Does this approach to carrying out executions represent a lawful application of legally available medications or an unconstitutional invasion of an individual's rights? Will the Court want to get into the quagmire of what medications should be used and how best to administer them safely and effectively to achieve the intended outcome? We will find out when the Supreme Court issues its decision later this year.

Adapted from a presentation at the American Society for Pharmacy Law 33rd/APhA 155th Annual Meeting; March 15-17, 2008; San Diego, CA.

1. The death penalty in the U.S. (1976-2008). The Clark County Prosecuting Attorney. Accessed October 5, 2008.
2. Reed L. Nebraska Supreme Court says electrocution unconstitutional. Omaha World-Herald. February 8, 2008. Accessed October 5, 2008.
3. New York's death penalty law declared unconstitutional: People v. Stephen LaValle. Death Penalty Information Center. July 8, 2004. Accessed October 7, 2008.
4. Lethal injection. Accessed October 7, 2008.
5. 217 SW3d 207 (Ky 2006), cert granted, 76 USLW 3154 (U.S. September 25, 2007)(No. 07-5439).
6. 99 U.S. 130 (1878).
7. Ky Rev Stat §431.220(a)(1).
8. See note 6, supra.
9. 136 U.S. 436 (1890).
10. Methods of execution. The Clark County Prosecuting Attorney. Accessed October 15, 2008.
11. Heckler v. Chaney, et al., 470 U.S. 821 (1985).
12. See note 5, supra.
13. Ky Rev Stat §431.220.
14. See note 5, supra.
15. Brief for the Respondent, Baze and Bowling v. Rees, 217 SW3d 207 (Ky 2006), cert granted, 76 USLW 3154 (U.S. September 25, 2007)(No. 07-5439).
16. See note 13, supra.
17. Brief for the Petitioner, Baze and Bowling v. Rees, 217 SW3d 207 (Ky 2006), cert granted, 76 USLW 3154 (U.S. September 25, 2007)(No. 07-5439).
18. See note 15, supra.
19. See note 17, p. 12.
20. See note 17, p. 12-13.
21. See note 17, p. 14.
22. Id.
23. See note 17, p. 15.
24. See note 17, p. 17.
25. See note 17, p. 19.
26. APhA. Code of ethics for pharmacists. Accessed October 7, 2008.
27. Fink JL III. Updating the code of ethics. Am Pharm. 1994;NS34:80.
28. Fink JL III. Ethics and a code of ethics in pharmacy practice: special additional introduction. In: White BD. Drugs, Ethics, and Quality of Life: Cases and Materials on Ethical, Legal, and Public Policy Dilemmas in Medicine and Pharmacy Practice. Binghamton, NY: The Haworth Press; 2007:7-12.
29. Curfman GD, Morrissey S, Drazen JM. Physicians and execution. N Eng J Med. 2008;358:403-404.
30. Barksdale T. Doctors lose in execution ruling. News & Observer. September 22, 2007. Accessed October 7, 2008.

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