Embryonic stem cell research and the theory of medical self-defense.

• Author: Hicks, Kristin M.

1. INTRODUCTION. II. THE ARGUMENT FOR MEDICAL SELF-DEFENSE IN THE STEM CELL CONTEXT A. The Theory of Medical Self-Defense B. Application of Medical Self-Defense to Stem Cell Treatments and Stem Cell Research 1. The Imminence Requirement 2. Injury to the Embryo 3. Protection for Stem Cell Research III. THE FUNDAMENTAL RIGHTS ANALYSIS A. Weaknesses of the Medical Self-Defense Theory B. The Medical Self-Defense Right May Be Unique to Abortion C. Framing the Right of Access to Stem Cell Therapies as Medical Self-Defense IV. CONCLUSION I. INTRODUCTION

   Human embryonic stem cell research has been heralded as a miraculous discovery that will one day help cure some of humanity's most devastating illnesses, such as Huntington's disease and Parkinson's disease. (1) Though still in its early stages, (2) stem cell research holds the potential to help scientists understand the mechanisms of cell development and to provide effective models for developing new drugs and testing them for safety and efficacy. (3) Furthermore, because stem cells can develop into many different types of cells, further research may enable the generation of organs and tissue for transplantation. (4)

   Despite the promise of stem cell research, it has nevertheless been the subject of considerable controversy since the technology was first developed. Much of this controversy has centered on the moral status of human embryos. Currently, researchers create stem cell lines by extracting cells from a pre-implantation embryo approximately five days after fertilization. (5) This process destroys the embryo. (6) Some people believe an embryo has the moral status of a person and consequently view stem cell research as killing human beings. (7) As a result of strongly held views on both sides of this debate, supporters and opponents of stem cell research in Congress have reached an impasse; although President Bush has announced that federal funds may only be used for research on a limited number of stem cell lines, (8) currently no federal law supports or bans embryonic stem cell research. (9)

   State legislatures have filled the void left by the lack of federal regulation concerning stem cell research. The resulting state laws vary widely. Some states authorize or fund stem cell research, (10) while others ban research on embryonic stem cells from some or all sources, including existing stem cell lines, aborted or miscarried embryos, embryos created for in-vitro fertilization, and cloned embryos. (11) Many of the restrictions focus on therapeutic cloning, (12) one of the most promising methods of creating stem cell lines for research. (13) The restrictions appear to be motivated in part by an apparent fear that engaging in this process will lead scientists down a slippery slope towards reproductive cloning. (14) Currently, at least five states prohibit therapeutic cloning. (15) Furthermore, the Food and Drug Administration ("FDA") has claimed authority to regulate cloning as an investigational new drug ("IND"). (16) Research sponsors are required to submit an IND application to FDA that describes the proposed cloning research, and FDA has stated that it will not approve any human cloning IND applications until an IND appropriately addresses the safety concerns related to the use of cloning technology. (17)

   Recent attacks on regulations limiting access to experimental drugs have cast doubt on the legitimacy of stem cell research restrictions. Notably, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation ("Abigail Alliance") recently brought suit against FDA, claiming that agency regulations denying access to drugs that had successfully completed Phase I clinical trials violated the constitutional rights of terminally ill patients. (18) Abigail Alliance argued that for patients who have life-threatening conditions and no other treatment options, restrictions on pre-approval drugs amount to a death sentence, which violates the Fifth Amendment protection against deprivation of life without due process. (19) This type of claim rests upon a line of cases that the Court has characterized as "interpret[ing] the Fifth and Fourteenth Amendments' guarantee of 'due process of law' to include a substantive component, which forbids the government from any infringement upon certain 'fundamental' liberty interests, no matter what process is provided, unless the infringement is narrowly tailored to serve a compelling state interest." (20)

   Somewhat surprisingly, (21) a three-judge panel of the D.C. Circuit agreed with Abigail Alliance and held that terminally ill patients, acting on a doctor's advice, had a fundamental right "to obtain potentially life-saving medication when no alternative treatment approved by the government is available." (22) The D.C. Circuit later vacated the decision, however, and granted FDA's motion for a rehearing en banc. (23) The en banc panel held that there was no constitutional right of access to experimental drugs for the terminally ill, (24) and the Supreme Court recently denied certiorari. (25)

   In addition to Abigail Alliance, several commentators have argued that there may be a substantive due process right to pursue medical treatment. Notably, Professor Eugene Volokh proposed a constitutional right to protect one's life using medical procedures, a right he termed "medical self-defense." (26) Drawing upon the medical self-defense theory and applying it in the stem cell context, some commentators have suggested that the right of access to stem cell treatments may also be protected as a fundamental right. (27)

   A fundamental right of access to stem cell therapies would have important implications for state laws restricting stem cell research. Upon finding that a law implicates a fundamental right, courts must analyze government regulations interfering with that right under "strict scrutiny"--a rigorous standard famously characterized as "'strict' in theory and fatal in fact." (28) To survive strict scrutiny, laws must be "both necessary and narrowly tailored to serve a compelling governmental interest." (29) While analysis of the governmental interests in regulating stem cell research is beyond the scope of this Note, it is possible that state bans on stem cell research would fail such a stringent test. (30)

   This Note analyzes the threshold question of whether terminally ill patients have a fundamental right of access to stem cell treatments. Because Professor Volokh's theory of medical self-defense is the most relevant concept to this issue, and the one that has attracted the most attention in the legal community, (31) this Note focuses on whether a right of access to stem cell treatments can be defended under his theory of medical self-defense. It also examines how such a right might be extended to protect the ability to conduct stem cell research. Part II provides background on Professor Volokh's theory of medical self-defense and explains how it would theoretically apply in the stem cell research context. Part III goes on to conclude that the theory of medical self-defense does not create a fundamental right of access to stem cell treatments for three reasons: First, Part III.A argues that the general theory of medical self-defense is not supported by the Supreme Court's substantive due process jurisprudence, including the abortion case law. Second, Part III.B contends that application of the medical self-defense theory is even weaker in contexts, such as stem cell therapy, that do not implicate family and intimate association interests. Third, Part III.C argues that the current Supreme Court would be unlikely to frame the right of access to stem cell treatments as an abstract right to engage in medical self-defense. Finally, Part IV briefly summarizes and concludes.

2. THE ARGUMENT FOR MEDICAL SELF-DEFENSE IN THE STEM CELL CONTEXT

   1. The Theory of Medical Self-Defense

      Self-defense has long been recognized as a valid justification for the violation of criminal laws. (32) It allows would-be victims to use lethal force against an attacker, and it is not limited to defense against attackers that are morally culpable, or even human. (33) Many commentators have argued that self-defense is constitutionally protected as a fundamental right because it is an extension of the "right to life" recognized by the Due Process Clauses of the Fifth and Fourteenth Amendments. (34) The Supreme Court has never directly addressed the issue, though some commentators have hypothesized that the near-universal acceptance of the self-defense doctrine obviates the need for this type of judicial review. (35) In addition, some state courts have held that the right to self-defense is protected under state constitutions. (36)

      Drawing upon the traditional right of self-defense to defend oneself against an attacker, Professor Volokh posits that the logical extension of that right would be the ability to use medical means to defend oneself against lethal medical threats such as cancer or organ failure. (37) Volokh finds his primary support for the medical self-defense right in the abortion context. Noting that the Supreme Court has continuously held that abortion regulations must contain an exception for the life or health of the mother, (38) Volokh argues that this requirement is grounded in a theory of medical self-defense. (39) He characterizes the exception as "a right to defend oneself using medical care, even when this requires destroying the source of the threat," (40) and reasons that such a right to defend oneself using medical procedures cannot be limited to abortion; it should instead extend to other types of medical self-help. (41) In short, he concludes that medical self-defense shares a "moral core" with traditional self-defense: "people should be free to defend themselves against that which is threatening their lives." (42)

   2. Application of Medical Self-Defense to Stem Cell Treatments and Stem Cell Research

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