A death by any other name: the federal government's inconsistent treatment of drugs used in lethal injections and physician-assisted suicide.

• Author: Miller, Colin

1. INTRODUCTION II. HECKLER V. CHANEY AND THE FDA's RELUCTANCE TO ACT III. WASHINGTON V. GLUCKSBERG AND OREGON'S DEATH WITH DIGNITY ACT IV. THE EMERGENCE OF LETHAL INJECTION AS THE SOLE METHOD OF EXECUTION A. Lethal Injection's Rise to Exclusivity B. Lethal Injection's Effect on All Prisoners C. Botched Executions V. THE PRACTICE OF MEDICINE EXCEPTION A. Medical Association Views B. The Hippocratic Oath C. Physicians Play a More Active Role in Causing Death in Lethal Injection than in PAS D. Lethal Injection Does Not Fit the Standard Model of the Practice of Medicine VI. DULY AUTHORIZED STATE PRACTICE VII. CONCLUSION I. INTRODCUTION

   In 1985, in Heckler v. Chaney, the Supreme Court rejected a challenge by death row inmates to the Food and Drug Administration's (FDA) failure to initiate enforcement actions against drugs used in capital punishment. Rehnquist's majority opinion cursorily held that agency decisions not to institute such proceedings are unreviewable, and the Court has persistently upheld this principle in Chaney's progeny. As important as this principle may be, even more important is why the FDA chose not to review the safety and efficacy of drugs used in capital punishment.

   First, the FDA argued that lethal injection was a distinctly minority practice affecting few prisoners and that scant empirical evidence existed that the drugs used in the procedure were dangerous. Second, it claimed that lethal injection constitutes the practice of medicine, and the FDA has a policy of non-interference with physician's professional treatment decisions. Finally, the FDA asserted that it has a policy of not initiating enforcement actions against state laws that are duly authorized and further legitimate state interests.

   In 1997, the Supreme Court gave such authorization to states to experiment with physician-assisted suicide (PAS). Although the Court found no fight to PAS, it explicitly delegated to states the power to legalize and regulate its practice. Based on this decision, Oregon enacted its Death with Dignity Act (DWDA) that same year, legalizing PAS for terminally ill patients. Later, Attorney General John Ashcroft--usually a federalist--challenged the DWDA under the federal Controlled Substance Act. A primary contention of his challenge was that PAS is subject to federal regulation because it does not constitute the practice of medicine.

   Concurrently, lethal injection has become the primary, almost the sole, method of execution in this country. Despite frequently clandestine execution procedures, many observers have filed reports of "botched" executions based on improper dosages and combinations of drugs. Doctors who treat other prisoners frequently participate directly in these executions, and non-medical personnel often improperly inject the drugs, causing painful and prolonged deaths.

   While the FDA is under no legal obligation to regulate the drugs used in executions, these recent developments certainly create a moral imperative requiring review. This paper will argue that the federal government cannot consistently refrain from regulating lethal injection drugs while arguing for prosecution of those prescribing drugs to be used by patients in assisted suicide.

   Part II will look at the opinions in Chaney and the factors behind the FDA's decision not to regulate the drugs used in executions. Part III will look at Oregon's Death with Dignity Act and its authorization by the Supreme Court. Parts IV-VI will analyze how the justifications given by the FDA in the early 1980s, for not regulating the drugs used in executions, are no longer valid in 2003. Part IV will discuss how lethal injection now constitutes a serious public health issue. In the early 1980s, only two hundred prisoners were subject to lethal injection, and scant evidence existed of its dangerousness. Now, after two decades of botched executions and the ascendance of lethal injection as the near exclusive method of execution, it is evident that the process has caused serious damages.

   Part V will look at the inconsistency in the federal government's classification of lethal injection as a legitimate medical practice that the FDA will not regulate and in its claim that PAS is an illegal state practice subject to federal nullification. It will argue that lethal injection is 1) more disfavored by medical groups, 2) less consistent with the Hippocratic Oath, 3) a more active form of killing for the physician, and 4) less consistent with the standard medical treatment model than PAS. Finally, Part VI will discuss how capital punishment is less of a duly authorized state practice than PAS. Specifically, capital punishment has been circumscribed severely by the Supreme Court based on doubts as to its constitutionality. Meanwhile, states have been given broad authority to implement PAS statutes. While there has been less time for challenges to PAS statutes, the key point is that the patients who desire PAS would never challenge such statutes as cruel and unusual.

2. HECKLER V. CHANEY AND THE FDA'S RELUCTANCE TO ACT

   In 1981, eight death row inmates in Texas and Oklahoma "filed suit in the District Court seeking to compel the FDA to fulfill its statutory obligation to investigate and to regulate the unapproved use of approved drugs in human execution systems." (2) The district court granted summary judgment to the FDA because courts presumptively cannot review agency decisions not to institute investigations. (3) Because the FDA provided reasons for its failure to act, it "had not completely abdicated its statutory responsibilities," and no basis for judicial review existed. (4)

   The Court of Appeals reversed, arguing that judicial review of agency decisions not to act is proper only when no "law to apply" to agency nonenforcement exists. (5) The Court found the requisite "law to apply" in a policy statement by the FDA: "Where the unapproved use of an approved new drug becomes widespread or endangers the public health, the Food and Drug Administration is obligated to investigate it thoroughly and to take whatever action is warranted to protect the public." (6)

   Having established the prerequisite for judicial review, the Court then found that the FDA's decision was arbitrary and capricious for two principal reasons. First, the FDA regulates drugs used in animal euthanasia and on prisoners in clinical investigations. (7) This review precludes the argument that the FDA should not spend its resources regulating drugs inducing death and drugs used solely on prison populations. Second, the Court challenged the FDA Commissioner's assertion that state laws advancing legitimate interests "cannot, as a matter of law, pose ... a danger to the public." (8) Instead, "uncontroverted evidence ... shows that drugs used in lethal injections pose a substantial threat of torturous pain to persons being executed." (9)

   Judge Scalia's dissent, in addition to arguing that judicial review was improper, held that the FDA's decision to forgo regulating lethal injection drugs was not in clear error. (10) He argued that no serious public health issue existed because only two hundred prisoners were on death row in states providing for lethal injection. (11) Scalia also challenged the inhumanity of lethal injections, claiming that the process is "the most 'humane' way of putting hopelessly crippled or diseased animals out of their misery." (12) He asserted that the report revealing the dangers of lethal injection was outdated, based on "medical knowledge and technique thirty years ago...." (13) Scalia then charged the majority with misconstruing the dichotomy. He held that the comparison should not be made between unregulated and regulated lethal injection drugs but between unregulated lethal injection drugs and other forms of execution such as electrocution and the gas chamber. (14) In this calculus, the use of even unregulated lethal injection drugs is, "in all likelihood substitution of a lesser pain, since that is the principal purpose of the lethal injection statutes." (15)

   Scalia's final argument was that the FDA Commissioner had not said that a practice must be consistent with public health "only by virtue of the fact that" it is authorized by state law. (16) Instead, he construed the Commissioner's assertion as holding that the specific nature of lethal injection laws makes them immune from judicial review. (17) Read one way, this argument could mean that the FDA legitimately found that the drugs used in lethal injections were safe and effective. In his Petition for Writ of Certiorari to the Supreme Court, however, the Solicitor General seemed to construe this argument as focused on the state interest in punishing offenders rather than on the safety and efficacy of lethal injection procedures. After citing Scalia's above language, the Petition defended the FDA's inaction because "[e]nacting laws to prevent and punish crime is among the most important powers of the states...." (18) Inherent in this argument was the belief that "[t]he FDA's decision ... was based upon a proper consideration for the principles of federalism." (19)

   In Heckler v. Chaney, the Supreme Court reversed the Court of Appeals, concluding that agency decisions against instituting proceedings are not subject to judicial review and not reaching the merits of the arbitrary and capricious argument. (20) Specifically, the Court found that the FDA's policy statement (21) was both vague and not a properly adopted agency rule. (22) The Court also held that the enforcement provisions of the Federal Food, Drug, and Cosmetic Act did not abrogate the presumption that agency decisions are immune from judicial review. (23) Courts have universally adhered to Chaney's precedent in failing to review agency decisions not to act, especially in the lethal injection context. For instance, a year after Chaney, the Fifth Circuit Court of Appeals rejected Randy Woolls's argument that Congress' failure to provide...