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Article Excerpt
This Article exposes how recent attempts at lethal injection reform have involved unethical and illegal research on prisoners. States are varying the doses and types of drugs used, developing methods designed for non-medical professionals to administer medical procedures, and gathering data or making provisions for the gathering of data to learn from executions gone wrong. When individual prisoners are executed under these conditions, states are conducting research on them. Conducting research or experimentation on prisoners in the process of reform is problematic because it violates state laws and ethical principles.
The Supreme Court has recently taken up the challenge of elucidating the standard for determining the constitutionality of lethal injection. The Court's fractured decision suggests that states may need to conduct lethal injection reform to develop procedures substantially similar to those used in Kentucky. It follows that the Court's decision may lead states to contravene state laws or ethical precepts regarding research with prisoners. Thus, this Article provides important limitations on the kinds of reform that may be permissible and outlines the open questions that must be addressed before it can be determined whether the risks and uncertainties involved in lethal injection can be remedied.
INTRODUCTION
The Supreme Court recently issued a fractured decision in the case of Baze v. Rees allowing Kentucky's lethal injection procedures to stand and articulating standards for applying the Eighth Amendment's prohibition on cruel and unusual punishment to execution by lethal injection. (1) Execution by lethal injection had previously come to a halt in eleven states as a result of dramatic evidence of its potential to cause excruciating pain and prolongation of death. (2) These problems led some courts to conclude that, as currently practiced, the lethal injection system is broken and runs a substantial risk of involving cruel and unusual punishment. (3) States have applied varying standards for evaluating lethal injection, such as "wanton infliction of pain," "excessive pain," "unnecessary pain," "substantial risk," "unnecessary risk," and "substantial risk of wanton and unnecessary pain." (4) These standards reflected considerable confusion in the courts about how to evaluate lethal injection. In attempts to resolve the uncertainty and concern about the risk of pain inherent in existing lethal injection protocols, many states began to reform their current lethal injection procedures.
The Supreme Court decision in Baze may resolve some of the controversy in the short-term. A majority of justices agreed that the petitioners did not carry their burden to show that Kentucky's lethal injection protocol is unconstitutional, and further signaled that states that refuse to change their methods when there are feasible alternatives presented to them may be in violation of the constitution. (5) Yet, the long-term picture is much more unclear. The justices are in considerable disagreement about the correct standard for evaluating lethal injection procedures. (6)
In all of the extensive litigation and debate over lethal injection, one important issue has been entirely neglected. This Article will argue that in their attempts to reform lethal injection, states have experimented with different procedures and revised their lethal injection protocols, thereby conducting research on prisoners. The process of revision and reform therefore comes into conflict with regulations or policies governing research on prisoners, with which states must comply. (7) Thus, attempts to develop appropriate lethal injection protocols in a manner that constitutes experimentation on prisoners have required the use of prisoners as research subjects in a manner that violates state laws and ethical precepts. The Supreme Court's ruling in Baze may exacerbate this problem by prompting states to reform their procedures. Future attempts at reform may be similarly problematic and, indeed, without substantive changes in state law and regulations, this conflict may ultimately be irresolvable.
The potential scope of this problem is vast. Several states are conducting impermissible research on prisoners, and the number of prisoners involved, although decreasing each year, is troubling. In 2006, fifty-two people were put to death by lethal injection; sixty people were put to death the previous year. (8) In all, 897 inmates have been put to death using lethal injection since the reinstatement of the death penalty in 1976. (9)
In Part I of this Article, I will first provide some background on how lethal injection protocols were developed, how they are currently implemented, and what problems have arisen. In Part II, I will provide a definition of research and apply that definition to lethal injection reform, as well as clarify two areas of conceptual confusion with a discussion of quality control and what counts as a medical procedure. In Part III, I will analyze how the laws governing research with prisoners apply to California and Florida, two of the states which have undertaken extensive reform efforts, and Kentucky, the state involved in the litigation currently before the Supreme Court (while briefly noting how these arguments would apply to other states). In Part IV, I will address the ethical problems in the conduct of execution research on prisoners, and in Part V, I will respond to a potential objection to the ethical arguments raised herein. I will conclude with a discussion of how these arguments pertain to the Supreme Court litigation, future attempts to reform lethal injection, and laws governing research with prisoners more broadly.
I. LETHAL INJECTION PROTOCOLS
A. Historical Background
In 1977, Oklahoma pioneered the first lethal injection protocol. (10) The protocol was developed by two state legislators, State Senator Bill Dawson and House Representative Bill Wiseman. (11) These two politicians approached medical societies for help in devising lethal injection protocols, but their requests for assistance were denied. (12) Wiseman and Dawson then contacted Dr. A. Jay Chapman, Oklahoma's Chief Medical Examiner, whose initial response was to demur because his expertise was in "dead bodies but not [] in getting them that way." (13) Nevertheless, Wiseman and Dawson persuaded Dr. Chapman to give his assistance, and he devised a process that would involve an intravenous saline drip, into which a lethal chemical would be introduced. (14) The lethal chemicals he proposed were an ultra-short-acting barbiturate and a chemical paralytic. (15) Chapman further suggested that the procedure use sodium thiopental as the barbiturate and chloral hydrate as the chemical paralytic. (16) However, the protocol was designed to be vague and not specify the specific chemicals that would be used. At the time, it was not clear when lethal injection would be implemented, or what drugs would be available at the time it was put into practice. (17)
Dr. Stanley Deutsch developed a similar protocol that may also have served as a basis for subsequent lethal injection methods. (18) Dr. Deutsch was initially approached by Dawson to devise a method of lethal injection that was relatively inexpensive and more humane than the alternative which, at the time, was electrocution. (19) Dr. Deutsch suggested the use of two drugs: an ultra-short-acting barbiturate followed by a drug that would create "a long duration of paralysis." (20)
Legislation implementing a lethal injection protocol based on Chapman's recommendations passed the Oklahoma Senate on March 2, 1977 and the Oklahoma House of Representatives on April 20, 1977. (21) However, it is unclear whether Dr. Deutsch's input influenced Oklahoma's protocol, because Chapman provided the senators with information after the initial passage of the statute. (22) At the time, officials with the Oklahoma Department of Corrections (ODOC) were not certain what drugs would be used in implementing the statute; they assumed that new and better drugs might be available when the statute was put into practice. (23) In fact, the drugs that were used by the ODOC varied over time. In May 1978, the execution procedures used in Oklahoma specified the following: "The execution shall be by means of a continuous, intravenous administration of a lethal quantity of sodium thiopental combined with either tubo-curarine or succinyl-choline chloride or potassium chloride which is an ultrashort-acting barbiturate combination with a chemical paralytic agent." (24) In 1981, Chapman assisted the ODOC once more in creating a lethal injection protocol by adding a third drug to what has become known as the lethal injection "cocktail"--potassium chloride. (25) By 2004, the ODOC used sodium thiopental and vecuronium bromide, followed by potassium chloride. (26)
B. Current Lethal Injection Protocols
Lethal injection protocols vary somewhat amongst the states. Although some states do not specify a particular combination of drugs in their lethal injection statutes, in practice, all states administer injections of a sequence of three drugs modeled after Oklahoma's three-drug protocol. (27) The first drug is a dose of sodium thiopental that would not necessarily be lethal in the time allotted for execution, but that is intended to induce an anesthetic state. (28) The second chemical is pancuronium bromide, a neuromuscular blocking agent. (29) Pancuronium bromide only serves to paralyze the inmate. (30) The final chemical administered is potassium chloride, which is the agent that typically causes death by inducing cardiac arrest. (31) All states also use a saline solution in between the administration of each chemical to prevent the sodium thiopental and the neuromuscular blocking agent from mixing and forming a precipitate that could occlude the IV line. (32)
Many inmate-specific issues may complicate the administration of anesthesia in the context of an execution, including the fact that a person anticipating an execution might be fearful or anxious in a manner that would impede the effect of the anesthesia, or the likelihood that inmates with histories of chronic substance abuse may have a high tolerance for sedatives and may require larger than normal doses for any anesthetic effect. (33) Notably, the method by which anesthesia is used in lethal injection is much less careful and less likely to be effective than the use of anesthesia in clinical practice. The use of anesthesia in lethal injection in the United States was not developed with prior testing in clinical trials. (34) In clinical practice, the use of anesthesia is carefully regulated, has been tested in clinical trials, and is administered by practitioners who undergo years of specialized training. (35)
Importantly, if the anesthesia is ineffectively delivered or wears off so that the inmate regains awareness, the use of the paralytic agent raises serious concerns because it prevents the inmate from indicating that he is aware or reacting to the pain with physical movements. If an inmate is not sufficiently anesthetized after the administration of the first drug, "the inmate may suffer excruciating suffocation caused by a paralyzing dose of pancuronium bromide and the heart attack induced by the potassium chloride," but because the inmate would be unable to move, he would be unable to communicate the experience of suffering to execution witnesses. (36)
An examination of lethal injection protocols conducted through the use of questionnaires in 2001, and repeated in 2005, determined that the criteria set out in most lethal injection protocols failed to specify necessary information, which "heightened the likelihood that a lethal injection would be botched." (37) Additionally, the details that were provided often included errors. (38) In 2005, the study's author found that there is no national consensus for conducting lethal injection, and that the responsibility of working out the details of lethal injection protocols is often left to untrained department of corrections personnel. (39)
C. Recent Problems with Executions by Lethal Injection
Problems with the administration of lethal injection have also been demonstrated on numerous occasions. Since 1985, at least thirty lethal injections have been prolonged because executioners had difficulty finding suitable veins in which to inject the cocktail of drugs. (40) In 1998, Texas conducted the longest execution on record--the execution lasted for two hours, in part because of the difficulty prison officials experienced in trying to insert intravenous lines into the inmate's veins. (41)
Several inmates have shown signs of experiencing significant pain after administration of lethal injection. (42) In May 2006, the State of Ohio ran into several difficulties during the execution of Joseph Clark. (43) According to reports made by members of the execution team, they initially took several minutes to find a vein in which to inject the drugs. (44) The vein then collapsed, and Mr. Clark had to push himself up and inform the execution team that the procedure was not working. (45) An autopsy revealed that Mr. Clark had nineteen needle puncture marks and signs of paravenous injection of drugs. (46) Misplacing the drugs in this manner would minimize the effectiveness of the anesthesia and make it much more likely that Mr. Clark was aware of the severe pain associated with awareness of the heart-stopping action of the final drug in the sequence. A medical examiner in Michigan who reviewed Mr. Clark's execution called the persons inserting IV catheters "incompetent." (47) All told, Mr. Clark's execution lasted for ninety minutes. (48)
Later that year, Angel Diaz's execution in Florida lasted a full thirty-four minutes before the declaration of death. (49) Mr. Diaz continued to move, squint, grimace, and attempt to speak after the first injection was thought to have been administered. (50) An autopsy revealed that the medical personnel inserting the IVs into Mr. Diaz failed to place the IVs inside his veins. (51) The tip of each IV pierced the veins and was placed in the soft tissue of his arms. (52) As a result, the chemicals were injected directly into the tissue of Mr. Diaz's arms, and he sustained internal chemical blisters of approximately one foot in length. (53) The failure on the part of the execution team to deliver the execution drugs to Mr. Diaz's venous system effectively, and instead into his arm tissue, prevented any of the drugs, including the anesthetic drug, from taking effect as intended. (54) Exacerbating the already devastating problem of misplacement of the IVs, the execution team failed to administer the drugs in the correct order. The likely result is that Mr. Diaz felt the excruciating effects of potassium chloride, which causes death by cardiac arrest, before the anesthesia could take effect to block the pain. (55)
In hearings in a recent California lethal injection case, the court noted that, based on the heart rates recorded in an execution log, there was a high likelihood in the California execution of Robert Lee Massie on March 27, 2001, that Massie may have been awake when injected with potassium chloride. (56) If this is true, it would indicate that Massie experienced tremendous suffering before his death. (57) The court was forced to look at indicators such as Massie's heart rate to determine whether he was aware of the pain because of the administration of the second drug in the sequence, which causes paralysis. After the administration of a paralytic agent, an inmate like Massie would be unable to communicate or even squirm in a manner that would demonstrate any pain he was experiencing to the observers.
II. HOW LETHAL INJECTION REFORM CONSTITUTES RESEARCH ON PRISONERS
A. Definition of Research
Research "refers to a class of activities designed to develop or contribute to generalizable knowledge." (58) Typically, research involves an activity that tests an intervention or procedure for some purpose, such as ascertaining whether the intervention is safe and effective. In order to demonstrate that the intervention achieves the intended purpose, researchers measure the effects of the intervention or procedure when it is used on people who serve as test subjects. Researchers gather evidence, or data, about how this intervention works in the test subjects, and then seek to use the data to prove that the intervention will achieve the intended purpose if used more generally in the population. Thus, research subjects are exposed to an intervention when there is uncertainty about whether the intervention will achieve its intended purpose, in order to obtain some degree of certainty so the intervention can be used in the future for the benefit of others.
By contrast, medical practice involves "a class of activities designed solely to enhance the well-being of an individual patient or client." (59) The critical distinction here is that standard medical practice typically requires a reasonable expectation of success and is aimed at improving the health of one particular patient, whereas research is aimed at developing knowledge that can be used to benefit society. In other words, the distinction between medical practice and research is not solely based on the uncertainty of the outcome. Although medical practice may involve some uncertainty because of individual variation in physiology or behavior, (60) uncertainty about some important scientific question is what drives the conduct of research. To develop knowledge about a scientific or medical question that can be generalized to many others, however, individual subjects involved in research take on some risk of being harmed. This risk of harm borne by research subjects is what raises the most salient ethical issues in research: the potential for exploitation of human subjects "[b]y placing some people at risk of harm for the good of others." (61) The primary reason that research is subject to stringent ethical requirements is "to minimize the possibility of exploitation by ensuring that research subjects are not merely used but are treated with respect while they contribute to the social good." (62)
B. Overview of Argument
Attempts to reform the practice of lethal injection have involved substantial ill-conceived medical research. State Departments of Corrections have tried to develop procedures for performing lethal injection in a manner that does not constitute cruel and unusual punishment under the Eighth Amendment of the U.S. Constitution. States have modified the drugs used in lethal injection cocktails, the dosages of those drugs, the procedures for people untrained in medicine to administer injections and anesthesia, and the procedures for people who are not medical professionals to determine an inmate's anesthetic depth. These revisions typically require large amounts of data-gathering both during and after an execution. As states develop lethal injection procedures through modifications and adjustments, test those procedures in an attempt to find a constitutionally sound procedure that can be generalized to future inmates, gather data on the tests of these procedures, and then disseminate the results of their investigations to courts and to the public, they are conducting medical research on prisoners.
In order to explain how states are conducting research on prisoners, it will be necessary to examine specific reform efforts. The next section will examine the extensive and fairy public attempts to reform lethal injection conducted by states such as California and Florida. Another important example is the state of Kentucky, because the Supreme Court has examined the procedures used in Kentucky in order to answer the questions presented in Baze. Before proceeding with the application of these arguments to specific state reform efforts, however, it is important to distinguish possible sources of confusion. For the sake of conceptual clarity, the next segment examines possible classifications of lethal injection reform other than medical research. The most common sources of confusion are whether lethal injection reform should be thought of as quality control and not research and whether lethal injection is a medical procedure that should be held to medical standards.
C. Some Clarifications
1. Is Lethal Injection Reform Research or Quality Control?
Proponents of lethal injection may argue that lethal injection should be thought of as punishment, and not research. This distinction, however, ignores the fact that the arguments above relate to the process of reform of lethal injection, and not to the practice of lethal injection. Arguably, the administration of lethal injection prior to the attempts to reform the procedure would not be considered research. It is the attempts at reform that involve changing dosages and gathering data that lead to the conclusion that departments of corrections are conducting research on prisoners.
Departments of corrections may argue that the attempts at reform are merely quality control designed to improve their procedures; therefore, they would argue that lethal injection reform is not research. Quality control or innovation is described as an activity that "aims to improve health care quality and outcomes through local innovations and adaptation in the processes and systems of care." (63) If these activities are being undertaken at local levels and are designed to improve different systems, based on their different contexts, then some argue that they should not be treated research. Research is typically defined as "a systematic investigation ... designed to develop or contribute to generalizable knowledge." (64)
This distinction is far from clear, however. Even those who argue for distinctions between quality improvement and research are unable to avoid the conclusion that the two overlap. (65) Both research and quality control involve attempts to determine better ways of determining whether an intervention works. Some research is undertaken at local levels and designed to improve a particular system, such as single-site research that is conducted in only one hospital or clinic. More importantly, both research and quality control activities attempt to find answers beyond what works for an individual patient. Therefore, whether an activity is called research or quality control, it will likely involve exposing individuals to procedures and gathering data in order to develop knowledge beyond that needed for the individual participant undergoing the intervention. By exposing an individual to additional risk beyond what is necessary for that individual's situation, research and quality control activities pose the possibility of exploitation of individuals for the benefit of others.
Furthermore, it is possible to conduct research on procedures for quality control. Even if departments of corrections are trying to improve their procedures, when they make modifications in drug dosages, develop new procedures, collect evidence on how well these procedures work, and try to prove they have come up with a constitutional system, they may be doing...
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