Determining Death: Settled or Unsettled?

Alexander M. Capron

Four decades ago, law and medicine were locked in a struggle over death. Under the common law standard, death occurred upon “a total stoppage of the circulation of the blood, and a cessation of the animal and vital functions consequent thereon, such as respiration, pulsation, etc.”1 Yet many physicians regarded the traditional vital signs as uninformative in unconscious hospitalized patients receiving support from drugs and devices such as vasopressors, mechanical ventilators, and cardiac pacemakers. They looked instead to the conclusions of an ad hoc Harvard Medical School committee which in 1968 had offered a poorly named but quickly acclaimed “definition of irreversible coma”2 under which death could be declared in artificially supported patients based on certain clinical and laboratory findings despite continued respiration and heartbeat.3 The resulting legal-medical conflict left physicians uncertain whether they could remove ventilators and other interventions from these patients; in the era before Quinlan4 and

1 BLACK’S LAW DICTIONARY4th Edition 488 (1968). 2 Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death, A Definition of Irreversible Coma, 205 J.A.M.A. 337 (1968)[hereinafter Irreversible Coma]. In addition to ten physicians, the committee included an historian, a lawyer and a theologian, all members of the Harvard University faculty. Both “brain death,” which was part of the committee’s name, and “irreversible coma,: which was the way it described its conclusions were problematic, the former because it mistakenly suggests that organs die (organisms die; organs cease functioning), the latter because it misleadingly suggests that dead persons are comatose (coma is a state of being alive albeit unconscious). The latter problem eventually disappeared, in that physicians ceased using the term “irreversible coma” to describe death, but the former problem persist, in that “brain dead” remains the common short-hand to describe a bodies determined to be dead based on a determination that they have suffered a permanent loss of all brain functions. 3 Briefly, the clinical criteria for diagnosing death were “unreceptivity and unresponsivity” to “externally applied stimuli and inner need, an absence of spontaneous muscular movements or spontaneous respiration, and no elicitable reflexes; the principal confirmatory test was the electroencephalogram (EEG), with an isoelectric reading being “of great confirmatory value” in diagnosing death. Id at 337-38. 4 70 N.J. 10 (1976).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 1 Cruzan,5 it was widely believed in medical circles that it was illegal and perhaps unethical to withdraw such support if doing so would cause a patient’s death.6

More dramatically, the transplantation of hearts from “dead” bodies into recipients where they would start beating again challenged the conventional understanding of death and raised the specter of liability. That became a reality when

Drs. Richard R. Lower, David M. Hume, David H. Sewell, and H. M. Lee, surgeons at the Medical College of Virginia who had performed the world’s seventeenth human heart transplant on May 25, 1968, in Richmond, were sued for wrongful death by William E.

Tucker who claimed that they had not only lacked approval from the next of kin to remove his brother Bruce’s heart and kidneys but also acted before Bruce had died.7

Although the neurologist who had examined Bruce found him to be “dead from a neurological standpoint” before the respirator was turned off, the trial judge “rejected the invitation offered by the defendants to employ a medical concept of neurological death in establishing a rule of law.”8 Denying the defendants’ motions to suppress plaintiff’s

5 497 U.S. 261 (1990). 6 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, DECIDING TO FOREGO LIFE-SUSTAINING TREATMENT xx-yy (1982). In the absence of a modern standard for determining death in ventilator-dependent patients, physicians and families could find themselves at an impasse. For example, Dr. Ron Wright, deputy chief medical examiner for Dade County Florida (which didn’t adopt a statute until 1980), had to go to court to have medical interventions stopped for bodies declared dead based on neurological grounds. “Wright was able to get a judge to hold a special Sunday morning hearing at the hospital—with reporters and photographers in attendance—at which he successfully argued that the family was being forced to pay $2,000 a day to keep a dead body in the intensive care unit.” Colen, Medical Examiner’s Solution to Life and Death Problem, Jan. 28, 1978, WASHINGTON POST §A at 8, col. 1. 7 Tucker v. Lower, 1 Va. Cir. 124, 1972 Va. Cir. LEXIS 6 (No. 2381, Richmond, Va., L & Eq. Ct., May 23, 1972). Bruce Tucker had been brought to the hospital by ambulance on May 24th, having fallen at work and suffered a severe head injury. Following neurosurgery, he was placed on a respirator, but when he did not improve, a neurologist was called for an evaluation of his condition. The neurologist declared Bruce dead when he was found to have no signs of cortical activity, a flat EEG, and no ability to breathe spontaneously. The defendants contended that, before Bruce’s organs were removed, the chief of surgery had tried through the police to locate his family to obtain permission but no relative was found; permission to remove the organs for transplantation was instead obtained from the medical examiner’s office. 8 The trial court’s decision to treat death a something to be defined by the law rather than by medicine may have been reinforced by the variety of “types” of death described by the neurologist:

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 2 evidence and for summary judgment, the judge ruled that the jury could assess damages if it concluded “that the decedent’s life was terminated at a time earlier than it would ordinarily have ended had all reasonable medical efforts been continued to prolong his life.” This ruling was equivalent to directing a verdict for the plaintiff, since under the

Black’s Law Dictionary definition, which the judge quoted in haec verba, Bruce Tucker was alive when he was taken to the operating room to have his organs removed as it was uncontroverted that he still maintained “for the most part, normal body temperature, normal pulse, normal blood pressure and normal rate of respiration.”9 But, without further explanation, when he sent the case to the jury, the judge permitted all possible causes of death—not merely cessation of breathing or heartbeat but also injury to the brain—to be considered, and the jury returned a verdict for the defendants.10 Similar uncertainties bedeviled the criminal law at the time; for example, defendants in two cases in which their victims had become organ donors received conflicting rulings from

California trial judges on motions to dismiss homicide charges based on the deaths having been caused not by the defendant but instead by the physicians who removed the organs; on appeal, the cases were resolved, consistently, against the defendants.11

As heated as these disagreements and as pronounced as these uncertainties may have been, within a dozen years all were seemingly laid to rest. The argument that

In addition to theological death, the neurologist defined two other types of death. First, he defined clinical or neurological death as total cessation of function of the central nervous system or brain. He then defined biological death as the death of an organ or a part of the body or a cell. He described death as a continuing thing since tissue and organs live after the brain dies, but he stated that in his opinion the individual dies when the brain dies. Id. at 126. 9 Id. at 126-27. 10 The judge instructed the jury that, in determining the time of death, they could consider in addition to the traditional evidence as in the opinion of May 23, 1972, "the time of complete and irreversible loss of all function of the brain; and, whether or not the aforesaid [circulatory and respiratory] functions were spontaneous or were being maintained artificially or mechanically." Id. at 134 [Reporter’s Note]. 11 [citation]

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 3 crafting a “definition” of death was a task for medicine rather than law12 was resolved by establishing a role for both.13 The debate over whether the common law standard should be revised by courts or legislatures,14 led to the conclusion “that courts should update the standards for declaring death as the issue arises in litigation” but the formulation of new standards should not “have to await judicial decision” and should instead be undertaken by legislatures which are more open and accountable and more able to “investigate both public views and the full range of expert opinion.”15 And the question whether the legislation should articulate only a neurological standard or include the traditional circulatory and regulatory definition was resolved in favor of the latter view.16

In the decade following the adoption in 1970 by Kansas of the first statute

“defining” death, twenty-seven states placed laws on their books. By 1980, when the presidential bioethics commission assembled the sponsors of then extant legislative proposals—the American Bar Association (ABA), the American Medical Association

(AMA), and the National Conference of Commissioners on Uniform State Laws

(NCCUSL)—to develop a single statute, the major impediment to legislation in the remaining jurisdictions was the confusion caused by the slight differences in the wording

12 See, e.g., What and When is Death?, 204 J.A.M.A. 539 (1968)(editorial). 13 See Capron & Kass, A Statutory Definition of the Standards for Determining Human Death: An Appraisal and a Proposal, 121 U. PA. L. REV. 87, 102-03 (1972) which differentiates four levels at which death may be “defined”: (1) the basic, (2) general physiological standards,, and (3) operational criteria and (4) specific tests and procedures. Setting aside (1) as a philosophical matter that is inappropriate for a statute because it provides little guidance for action, and leaving (3) and (4) to the normal processes for reaching agreement within the medical profession, level (2) becomes the basis for statutory enactment. 14 See, e.g., Kennedy, The Kansas Statute on Death: An Appraisal, 285 NEW ENG. J. MED. 946 (1971) and Capron & Kass, A Statutory Definition of the Standards for Determining Human Death: An Appraisal and a Proposal, 121 U. PA. L. REV. 87 (1972)[hereinafter Capron & Kass]. 15 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, DEFINING DEATH: MEDICAL, LEGAL AND ETHICAL ISSUES IN THE DETERMINATION OF DEATH 50- 51 (1981)[hereinafter DEFINING DEATH]. 16 Capron & Kass, note 14 supra, at 113; DEFINING DEATH, note 15 supra, at 57-59.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 4 of those varied model laws.17 The four groups developed the Uniform Determination of

Death Act (UDDA), which was elaborated in the commission’s first report, Defining

Death: Medical, Legal and Ethical Issues in the Determination of Death. By the time that report was published in July 1981, two states had already adopted the UDDA,18 and today

30 more states and the District of Columbia have as well.19 The substantive provision of the UDDA reads:

An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards.20

Substantially similar provisions exist in the 14 further states that have either one of the earlier models laws or an idiosyncratic statute, while the four remaining states have sanctioned neurological determinations of death in judicial decisions and state regulations governing hospital practices.21 While the differences among the statutes (not only between the UDDA and others but in small modifications, such as statutory scope or purpose, added by legislators when adopting the law) might have been expected to lead to inconsistent results and while the importance of the subject might have been expected to lead to frequent, highly charged litigation (as has been true regarding the related area of

17 The proliferation of model acts and uniform acts, while indicating a legislative need, also may be confusing. All existing acts have the same principal goal - extension of the common law to include the new techniques for determination of death. With no essential disagreement on policy, the associations which have drafted statutes met to find common language. National Conference of Commissioners on Uniform State Laws, Prefatory Note, UNIFORM DETERMINATION OF DEATH ACT 1 (1981). 18 The UDDA was recommended to the States for enactment after it had been approved by the NCCUSL at its Annual Conference, July 26 - August 1, 1980. Thereafter, the model law was approved by the AMA on Oct. 19, 1980, by the ABA on Feb. 10, 1981, and by the President’s Commission on July 9, 1981. The NCCUSL published the UDDA, with its Prefatory Note, early in 1981, and Defining Death was published and widely distributed by the President’s Commission later that year. 19 [citation] 20 The text quoted is §1 of the UDDA, entitled “Determination of Death.” §2 is the standard language on uniformity of construction and application, and §3 states the short title by which the Act may be cited. 21 [citation]

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 5 withholding and withdrawing life-support from dying patients), neither has occurred in the ensuing decades. Not every decision may have been pellucid—judges are, for example, no more immune to the confusions sown by the term “brain death” than are physicians, journalists, or members of patients’ families22—but conversely none seriously misconstrued, much less questioned the validity of, the statute in question.

A similar consensus has prevailed on the medical side over the past 30 years. The

“accepted medical standards” that are to be employed in diagnosing death are not limited to those in the 1968 report of the ad hoc Harvard committee. Indeed, a group of 56 of the leading medical authorities, including neurologists, neurosurgeons, pathologists, anesthesiologists, intensivists, and physician-lawyers, prepared a set of medical guidelines for diagnosing death on either circulatory and respiratory or neurologic grounds that was published in conjunction with Defining Death23 and that formed the basis for policies implemented at hospitals across the country and abroad. As contemplated by the UDDA’s drafters, the criteria applied and the tests used to measure whether the criteria have been met have evolved with medical experience and scientific findings. In 1995, the American Academy of Neurology restated the consensus regarding neurological determinations,24 and six years later, the New England Journal of Medicine published a further refinement written by a leading neurologist.25

22 One Pennsylvania judge tied himself up declaring that "when the life-supporting measures were suspended, death ensued [although the person] was legally dead even before heroic life support procedures were discontinued." Commonwealth v. Kostra, 502 A.2d 1287, 1291 (Pa. Super Ct 1985). 23 Medical Consultants on the Diagnosis of Death to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Guidelines for the Determination of Death, Appendix F, DEFINING DEATH, note 15 supra. The Guidelines appeared in November at 246 J.A.M.A. 2184 (19810 and were subsequently reprinted in a large number of medical and nursing journals. 24 The Quality Standards Subcommittee of the American Academy of Neurology, Practice Parameters for Determining Brain Death in Adults (summary statement), 45 NEUROLOGY 1012 (1995). 25 Wijdicks, The Diagnosis of Brain Death, 344 NEW ENGL. J. MED. 1215 (2001).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 6 From the late 1960s (after the first human-to-human heart transplant in December

1967) through the 1980s, critical attention had been focused on the means used in determining death on neurological grounds, while the circulatory-respiratory standard, which continued to be the one actually employed in diagnosing the vast majority of deaths, received less attention. (For example, the Guidelines prepared by the President’s

Commission’s medical consultants devoted only about a fifth as much space to providing a clear and complete statement of the basis for determining death based on irreversible loss of circulatory and respiratory functions as they gave to explaining how death should be determined based on the irreversible cessation of neurological functions.26) In the past dozen or so years, however, an increased amount of critical attention has been given to the circulatory-respiratory standard—or, more precisely, its application to a particular group of people, namely, unconscious patients whose deaths are managed so as to allow them to become donors (at their request or that of their designated surrogate decisionmaker) in a way that will maximize the viability of their transplanted organs.27

When the hospital protocols for determining death in these “non-heart-beating cadavers”28 were first announced, questions were raised about whether death was being

26 Guidelines for the Determination of Death, note 19 supra. 27 See, e.g., University of Pittsburgh Medical Center Policy and Procedure Manual. Management of Terminally Ill Patients Who May Become Organ Donors after Death. 3 KENNEDY INST. ETHICS J. A1-A15 (1993). 28 This terminology, which may seem awkward, was used to distinguish these potential organ donors from persons diagnosed dead on neurological grounds whose hearts continue to beat as a result of medical interventions. Prior to the late 1960s, kidney donors other than living relatives (especially an identical twin of the recipient) were actually “non-heart-beating donors,” though that term wasn’t used. The advent of cardiac transplantation changed that because waiting for the heart to stop was regarded as too damaging to a heart that was going to be transplanted. The switch to determining death based on cessation of brain functions, while the heart continues to circulate blood oxygenated thanks to mechanical ventilation, ended reliance on non-heart-beating donors (of kidneys as well as hearts). The development of the new protocols for “non-heart-beating cadavers” relied upon a refinement of the old methods of determining death following cessation of circulation; it was driven by the need to increase the pool of donors with viable organs for transplantation, a change described—and basically endorsed—in two Institute of Medicine reports: Division of Health Care Services, NON-HEART-BEATING TRANSPLANTATION: MEDICAL AND

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 7 declared prematurely in these cases. 29 After careful scrutiny, however, leaders in medicine, law, and ethics came to the conclusion that the existing circulatory-respiratory standard could be accurately met by the criteria and tests used in these protocols, which were restyled as allowing Donation after Circulatory Determination of Death (DCDD).30

And yet, despite the breadth and durability of the consensus embodied in the

UDDA and the routine use of the statutory standards and related medical guidelines to determine death in such highly charged settings as the donation of hearts and kidneys for transplantation and the evaluation of patients in intensive care units (ICUs), questions and objections have been continuously raised by physicians, philosophers, lawyers, and others about the concepts underlying the prevailing statutes and the extent to which physicians are able to apply the statutory standards accurately and reliably. Indeed, the most severe critics find the existing law and practices to be so incoherent that they argue that the laws (such as the Uniform Anatomical Gift Act) be changed to remove the “dead donor rule” and allow organ donation by people who agree to have their organs removed

(under anesthesia, of course) prior to their death being declared.31 Thus, it would appear that “If one subject in health law and bioethics can be said to be at once well settled and persistently unresolved, it is how to determine that death has occurred.”32

ETHICAL ISSUES IN PROCUREMENT, National Academy Press (1997), and Committee on Non-Heart-Beating Transplantation II: The Scientific and Ethical Basis for Practice and Protocols, NON-HEART-BEATING TRANSPLANTATION: PRACTICE AND PROTOCOLS, National Academy Press (2000). 29 See, e.g., Fox, "An Ignoble Form of Cannibalism": Reflections on the Pittsburgh Protocol for Procuring Organs from Non-Heart-Beating Cadavers, 3 KENNEDY INST. ETHICS J. 231 (1993), and Lynn, Are the Patients Who Become Organ Donors under the Pittsburgh Protocol for "Non-Heart-Beating Donors" Really Dead? 3 KENNEDY INST. ETHICS J. 167 (1993).. 30 ORGAN DONATION: OPPORTUNITIES FOR ACTION, J.F. Childress & C.T. Liverman, eds., National Academies Press, (2006), the third Institute of Medicine report in this field. 31 See, e.g., Truog & Robinson, Role Of Brain Death and the Dead-Donor Rule in the Ethics of Organ Transplantation, 31 CRIT. CARE MED. 2391 (2003), Truog & Miller, The Dead Donor Rule and Organ Transplantation, 359 NEW ENGL. J. MED.674 (2008), and Miller & Truog, Rethinking the Ethics of Vital Organ Donations, 38 HASTINGS CENT. REPT. 38 (2008). 32 Capron, Brain Death: Well Settled yet Still Unresolved, , 344 NEW ENGL. J. MED. 1244 (2001).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 8 Why is that the case? To attempt to answer that question, this article begins by briefly reviewing the prevailing law and the objectives its developers sought to achieve

(Part I). It turns in Part II to two objections to the neurological determination of death, namely, that the commonly used medical criteria and tests do not in fact demonstrate the loss “of all functions of the entire brain, including the brain stem,” and that the explanation offered by the President’s Commission (and others) for looking to a loss of neurological functions as a standard for determining death is unpersuasive. Part III takes up the objections that have been raised to DCDD, especially that it fails to meet the statutory standard that the cessation of circulatory and respiratory functions must be

“irreversible” before death can be declared. Finally, some conclusions are drawn in Part

IV about the philosophical and policy tasks and the light they may shed on the persistence of the essential legal and medical consensus in the face of the doubts and questions raised over the past four decades.

I. The Shape and Purpose of the Law on Determining Death

The assignment facing the drafters of the UDDA is commonly described as

"defining death"33 but that depiction would be misleading if it were taken to involve trying to establish the “meaning” of death (and life). Instead, the task was the narrower and more practical one of setting standards to determine when death has occurred, particularly in patients whose circulatory and respiratory functions are artificially sustained. This new category of patients began to appear in the 1960s, particularly those who had suffered trauma to the head or had experienced a stroke or cardiac arrest. Such events can cause cerebral edema (an accumulation of fluid and swelling in the brain

33 Part of the Congressional mandate of the President’s Commission was studying “the ethical and legal implications of the matter of defining death, including the advisability of developing a uniform definition of death.” Pub. Law 95-622, 42 U.S.C. §1802 (1978).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 9 tissue), which in turn produces intracranial pressure that prevents blood from circulating to the brain. Brain cells can be damaged if deprived of oxygenated blood for even brief periods. Thus, edema and other pathophysiologic mechanisms can cause the brain to cease functioning even when the damage to other organs is less severe.34 Some of these patients will have only suffered harm to their higher brains; they will remain persistently unconscious but can eventually breathe without mechanical support. Others, however, will have suffered more extensive damage involving the centers in the brain, particularly the brain stem, that are responsible for breathing and bodily regulation. These patients do not respond to their environment and are profoundly unconscious. Indeed, an early study by French physicians Mollaret and Goulon described this phenomenon as le coma depassé (beyond coma), a term that is more descriptive than the Harvard committee’s

“irreversible coma.” Without artificial support, these persons would be regarded as dead, yet with that support they continue to manifest the traditional vital signs of heartbeat and respiration.

The need to address the status of such patients was, of course, catalyzed by the wave of highly publicized heart transplants that occurred in the United States in 1968, following the first human-to-human cardiac transplant in South Africa at the end of the previous year. How could a donor, whose heart was beating, be dead, while a recipient, whose own heart had been removed, was considered alive? This question focused attention on the techniques used to establish the absence of brain functioning and on whether they are as reliable a method of determining death as the older techniques?

34 The sad fact that efforts to support a desperately injured patient until he or she can resume normal functioning sometimes “have only partial success so that the result is an individual whose heart continues to beat but whose brain is irreversibly damaged," Irreversible Coma, note 2 supra, was recognized early on by the Harvard ad hoc committee.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 10 A. The Methodology of Determining Death on Neurological Grounds

The methods used to establish loss of brain function differ somewhat from country to country. While British neurologists measure the loss of functioning in the brain stem in patients with coma of known origin, physicians in the United States utilize clinical signs and confirmatory laboratory tests such as the EEG to measure the absence of any activity in the entire brain and tests, long favored by Continental experts, that focus on the preconditions for brain function, such as detecting the absence of intracranial blood circulation.35 All of the methods aim to establish the same condition, namely that the functioning of the brain (including the brain stem) has so fully and permanently ceased that in the absence of artificial support the patient's heart and lungs would not be functioning. In effect, by measuring whether a person's brain has ceased functioning, physicians create a new window through which to view the phenomenon of death when their own interventions obscure what could otherwise be seen through the window of cardiopulmonary function.

Before the neurological standard for determining death could be accepted, the reliability of observations made through the new window had to be carefully established through studies of comatose patients in whom cerebral unresponsivity and unreceptivity and the absence of brain stem reflexes were assessed clinically with great care, apnea occurred when the respirator was withdrawn, and laboratory tests established the absence of blood flow to the brain or a "flat" EEG.36 These studies either demonstrated that patients who met the criteria either soon arrived at cardiac standstill despite the continuation of artificial support or, when maintained on a respirator for a time after

35 [citations] 36 Because the issue involves brain functions, the observation of spinal reflexes is not inconsistent with a diagnosis of death

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 11 death was determined, were then found on autopsy to have experienced widespread brain necrosis.37 “The published criteria for determining cessation of brain functions have been uniformly successful in diagnosing death.”38

The criteria developed to diagnose death stress the importance of knowing the origin of the coma (whether through injury, anoxia, or otherwise) both to rule out reversible causes of non-responsivity (such a sedation, hypothermia, and neuromuscular blockade) and to determine how long the patient must be observed and subjected to which clinical or confirmatory tests. The standards promulgated by the Harvard committee in 1968 required repeat testing after 24 hours, but as the diagnostic procedures were further refined, different standards were established for various categories of patients, for some of whom 6 hours of observation suffices.

B. Legislating at the Levels of Uniform Standards

As previously noted, the “definition of death” provided by the UDDA and the other state laws is framed at the level of general physiologic standards rather than as the higher level of abstract concepts. Equally important, it stays at the level of standards rather than getting down to medical criteria or clinical tests. The result is a law that is sufficiently precise to set forth the public understanding of what constitutes death but not so specific that it is tied to the details of contemporary technology. It sets forth the general standards by which death is to be determined but leaves the medical community to establish and apply appropriate criteria and specific tests for determining that the

37 See, e.g., Jennett, Gleave & Wilson, Brain Death in Three Neurosurgical Units, 282 BRIT. MED. J. 533 (1981); U.S. Department of Health and Human Services, THE NINCDS COLLABORATIVE STUDY OF BRAIN DEATH, N.I.H. Pub. No. 81-2286 (1980); An Appraisal of the Criteria for Cerebral Death. A Summary Statement. A Collaborative Study, 237 J.A.M.A. 982 (1977); Black, Brain Death, 299 New Eng. J. Med. 338 & 393 (1978). 38 DEFINING DEATH, note 15 supra, at 27.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 12 standards have been met, recognizing that techniques may change in light of experience and further study.

The standards set by the UDDA are unvarying in two senses: they apply to all situations in which human death needs to be determined, and they are the same for all persons. An accepted standard for determining death is needed in making decisions about a wide range of issues: appropriate medical care, the timing of organ removal, homicide, life insurance benefits, probating a will and transferring property, taxes, and marital status, to name a few. In theory, varying policy objectives might dictate different standards in particular context, but just as the traditional heart-lung standard was employed across all situations, so too is the UDDA, a course that is preferable to any attempt to "define" death separately (and perhaps inconsistently) in a myriad of statutes.39

Using a single definition for all purposes does not preclude relying on other events besides death as a trigger for some decisions, it simply means that "death" means the same thing in all contexts, so that the same person is not "alive" for life insurance purposes but "dead" according to the criminal law. Most jurisdictions make provision, for example, for the distribution of property and the termination of marriage after a person has been absent without explanation for a period of years, even though a person

"presumed dead" under such a law would not be treated as a corpse were he or she to turn up alive.40

39 In adopting the UDDA or another statutory model, a number of states have used “purpose” language (e.g., “for all legal purposes,” “for all medical and legal purposes,” etc.); such introductory phrases add nothing and do not differentiate among legal purposes. A few states, however, have attached their statute on death to legislation on organ transplantation, which has the unfortunate effect of seeming to establish a different death for potential organ donors than for other people. See Goldsmith, Wanted! Dead and/or Alive: Choosing Among the Not-So-Uniform Statutory Definitions of Death, 61 U. MIAMI L. REV. 871 (2007). 40 Likewise, proposals to meet transplantation needs by allowing certain people (e.g., competent, terminally ill patients) to donate vital organs before they have died would not create a separate meaning of death.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 13 The second aspect of uniformity is that the standards for determining death apply equally to all people, without reference to their social status or wealth, the circumstances in which they are hospitalized, or their potential social utility as an organ donor. Only one jurisdiction, New Jersey, has departed from this objective; under a statute adopted in

1991, people whose religious beliefs would be violated by the use of brain-based criteria are allowed to have their deaths declared solely on the traditional circulatory-respiratory basis.41

C. Basing the Standards on the Loss of Functions

Both brain and respiratory-circulatory standards are framed in terms of loss of functions not failure of the organs that usually perform the functions. For example, a conscious person who requires mechanical assistance to breathe would not be regarded as dead even if his lungs were unable to operate so long as his respiratory function could be sustained artificially. By driving an activity (such as bringing oxygen into the body) that is no longer stimulated by signals from the brain, certain forms of intensive medical care in effect substitute for brain functions, though no full replacement has yet been created for all functions of the entire brain. Moreover, damage to the normothermic adult brain is usually irreversible after even a relatively brief (e.g., 10 min) period of anoxia. Further, what is important is the loss of the particular function, not a total absence of activity in all cells in the relevant organ, which in any case cannot be feasibly assessed with certainty, at least not before autolysis. Individual cells or groups of cells—even in neurologic tissue—may continue to function after death of the organism as a whole. A familiar example is that fingernails and hair continue to grow briefly after death. Some challenges to the brain-based "definitions" of death are based on findings that certain

41 [NJ statute]

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 14 biologic processes (such as the secretion of hormones) persist for a period in the brains of persons determined to be dead by currently accepted standards. The existence of cellular activity is not inconsistent with a diagnosis of death, however, provided that the vital function in question has ceased and cannot be replaced, and that the cellular activity itself is not a central function of an integrated organism.

D. The Bifurcated Standard

The drafters of the UDDA deliberately decided to recognize two standards for the occurrence of death, one based on cessation of brain functions and the other on cessation of blood flow and breathing. Employing a "bifurcated" standard departed from the approach taken by the NCCUSL in its previous proposal, the Uniform Brain Death Act, which in effect provided a new, neurological “definition” while saying nothing about the existing, common law standard. Yet the UDDA also differs from other earlier model statutes, such as the Capron-Kass proposal, that included both standards because the

UDDA simply states the two standards in parallel, with no attempt to explain how the alternatives are related. Bifurcation is based on the notion that either means of determining death can be used in appropriate circumstances to measure the same phenomenon, namely, death of the organism as an integrated whole. It can be argued that the bifurcated standard sows the potential for confusion because it can be misunderstood to establish two kinds of death, "heart-lung death" and "brain death." Yet this problem is probably inevitable because only a small percentage of patients are diagnosed as dead based on direct assessments of brain functions, so the two methods of determining death will continue to exist. To the extent that confusion exists, it seems more the result of imprecision—and underlying sloppy thinking—by physicians, journalists, and even

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 15 judges in communicating with the public and especially patients’ families than from the language of the statute which presents the two bases for determining death as equivalent but, it is true, fails to be explicit on this matter or to explain when one or the other might be used.

An alternative—stating the standard for determining death solely in neurological terms—has been advanced both to avoid the “two deaths” problem and as a better account of what constitutes death. For example, the Canadian Law Reform Commission proposed that the irreversible cessation of brain functions be the sole definition of death, but this standard could be met not only by showing directly that brain functions are absent, but also "by the prolonged absence of spontaneous cardiac and respiratory functions."42 A number of commentators would go further, on grounds of conceptual superiority. Neurologist James Bernat proposes that the definition actually be "the permanent cessation of the functioning of the organism as a whole," with cessation of brain functions playing the role of the "criterion for death," intermediate between the definition and the two distinct sets of tests ("cardiorespiratory" and "neurological") by which death would actually be diagnosed.43 While such approaches are attractive in underlining that human death is a single phenomenon, their conceptual clarity is dependent on general public comprehension of the brain's particularly important role in integrating the functioning of the whole organism and of the brain’s great vulnerability to injury, particularly through loss of blood flow, so that the uncorrected loss of breathing and heartbeat (which are observable and hence “accessible” phenomena both to lay people and to physicians using basic clinical methods) is significant either because it

42 Law Reform Commission of Canada, CRITERIA FOR THE DETERMINATION OF DEATH (Report No. 15), Minister of Supply and Service, Canada 7- 20 (1981). 43 Bernat, How Much of the Brain Must Die in Brain Death? 3 J. CLIN. ETHIC 21 (1992).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 16 shows that brain functions have been lost or because it foretells such loss. Yet, as a

President's Commission concluded in rejecting the Canadian approach, "most of the time people do not, and need not, go through this two-step process. Irreversible loss of circulation is recognized as death because—setting aside any mythical connotations of the heart—a person without blood flow simply cannot live."44 Continuing to recognize the traditional circulatory-respiratory grounds for declaring death has additional advantage of being an incremental rather than a radical change in the law.

II. Challenges to the Prevailing Neurological Standard

A. Loss of Whole-Brain or Higher Brain Functions?

The UDDA specifies that death occurs when "the entire brain, including the brain stem," ceases functioning. Some patients, such as those in a persistent vegetative state

(PVS), who usually never regain consciousness even when vigorously supported, do not meet this whole-brain standard even though they have lost all higher brain functions associated with consciousness and interaction. Many people would agree that certain features of consciousness (or at least the potential for consciousness) are essential to being a person as distinct from merely a human being. Should the law equate a loss of personhood with death? A related question rests on the ontological proposition that to be a particular individual means to have a personal identity, which depends on continuity of personal history as well as on self-awareness. If the loss of consciousness destroys such identity, does that mean the person has died, even if the body continues to live?

Society has thus far answered both versions of the question-which is essentially whether the loss of higher brain functions should allow death to be declared-in the negative. Some of the reasons for doing so are clinical, since it is more difficult (some

44 DEFINING DEATH, note 15 supra, at xx.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 17 would say impossible) to diagnose the permanent loss of higher brain functions with the same degree of certainty as the loss of whole-brain or circulatory-respiratory functions, though advances in diagnostic methods may eventually overcome this problem. More basically, the very concept of what functions pertain to the higher brain is highly contested. For example, the specific characteristics deemed by philosophers to be essential for personhood have varied widely from John Locke's focus on self-awareness to Immanuel Kant's requirement of a capacity for rational moral agency. Thus, one higher brain standard might encompass only those such as PVS patients who lack any capacity for self-knowledge, while another would include senile or severely retarded individuals who cannot synthesize experience or act on moral principles.

Furthermore, the difficulties in making accurate predictions that neocortical functions will not return following certain injuries pale in comparison to diagnosing that an irreversible "loss of personhood" or "loss of personal identity" has occurred. Simply put, neurologists have no way of directly correlating concepts such as "loss of personhood" with particular neurological structures whose condition could be measured.

If Charles Culver and Bernard Gert are correct that "death can be applied directly only to biological organisms and not to persons,"45 absence of consciousness and cognition could still be relevant in deciding, for example, whether—and if so, for how long—patients who lose (or never achieve) personhood or who have lost their personal identity should continue to receive life-prolonging treatment. Unlike the situation in

1968, when medicine first began formally to address the question of terminating treatment for artificially supported patients, most people would not now regard changes in the "definition" of death as a principal or particularly useful way to address the issue.

45 C. Culver & B. Gert, PHILOSOPHY IN MEDICINE, New York: Oxford Univ. Press (1982).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 18 Additional guidance has been developed by courts and legislatures as well as by professional bodies concerning the cessation of treatment in patients who are alive by brain or heart-lung criteria, but for whom further treatment is considered (by the patients or by others) to be pointless or degrading. In a word, "when to allow to die?" is a very distinct question, from an ethical as well as a policy viewpoint, from "when to declare dead?"

Most problematically, any move to treat some or all persons who lack consciousness and other higher brain functions as dead because they lack "personhood" or "personal identity" would lead either to burying spontaneously respiring bodies or to having first to take affirmative steps, such as those used in active euthanasia, to end their breathing, circulation, and the like. The statute proposed in 1976 by philosopher Robert

Veatch, which equates death with cessation of cerebral function, recognized that this would be unacceptable to most persons. Therefore, he included a "conscience clause" that allowed people, while still competent, or their next of kin to decline to have death determined on the higher brain standard.46 No jurisdiction has adopted a higher brain standard, nor does the "conscience clause" in the New Jersey statute encompass that standard.

The closest policy makers have come to allowing death to be determined on higher brain grounds arose in the context of several highly publicized attempts to transplant organs from anencephalic infants about twenty years ago. These babies are born without a neocortex and with the tops of their skulls open, exposing the underlying tissue. When, as is often the case, their brain stems function, they can breathe on their own and may even show basic reflexes, such as sucking. While they can survive for long

46 R. M. Veatch, DEATH, DYING, AND THE BIOLOGICAL REVOLUTION xx (1976).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 19 periods with vigorous support, in most cases they are provided only comfort care and expire within two weeks.

Beginning in 1987, Loma Linda Medical Center tried to obtain more organs, particularly hearts, from this source. The physicians placed anencephalic infants on respirators and waited until death could be diagnosed neurologically (a procedure that was controversial in itself because the reliability of such determinations in very young infants is questioned). In the end, no organs were transplanted because the infants either did not expire within the 2-week period specified in the protocol or, if the respirator were delayed, the intermittent episodes of anoxia that damaged their brain stems (and permitted death to occur) also caused deterioration in other organs that rendered these organs useless for transplantation. The Medical Center ended its program the following year.47

In several other instances, women who expected to give birth to a baby with anencephaly publicly sought authorization to allow harvesting of organs immediately after birth, so that their child's death could at least give another sick child the chance to live with a transplanted organ. But in the only case to produce an appellate decision, the

Florida Supreme Court in 1992 declined to create a special standard of death for anencephalic infants.48

In deciding not to expand the standards for death to include anencephalic infants, nor to amend the organ transplant acts to allow premortem harvesting from these infants, judges and legislators were clearly aware of two slippery slopes. First, as the pediatricians caring for the potential Loma Linda donors found, parents and physicians of

47 Shewmon, Capron, Peacock & Schulman, The Use of Anencephalic Infants as Organ Donors: A Critique. 261 J.A.M.A.1773 (1989). 48 In re T.A.C.P., 609 So.2d 588 (Fla. 1992).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 20 other infants with severe anomalies and limited life expectancy would also regard these children as comparable on relevant grounds to the anencephalic infants; hence, once death is not required for the donation of anencephalic infants’ organs, they could see no reason no to allow them to do likewise with an ever-expanding group of neonates or infants near death. Second, the change in the standard for determining death could not be limited to infants, since the salient criteria—absence of higher brain function and limited life expectancy—apply to many other persons as well, such as patients with severe brain injuries or advanced Alzheimer's disease. The decision to accept anencephaly as a basis for declaring death would thus imply acceptance of a higher brain standard for diagnosing any and all patients, with the attendant problems of regarding a spontaneously functioning body as "dead."

B. Changing Clinical Criteria

Some commentators have suggested that society should rethink neurological determinations of death because some bodies so determined to be dead exhibit functions

—such as hypothalamic-endocrine function and cerebral electrical activity—that indicate that not “all functions of the entire brain” are absent as required by the UDDA.49 Two sorts of response seem appropriate. On the one hand, if examinations of artificially supported bodies diagnosed dead based on neurological grounds reveals the persistence of functions that indicate the organism has not lost its integrative functioning, the proper response could be simply to expand the range of tests used in reaching neurologically based diagnoses of death to include appropriate assessments of these additional factors.

Since a number of organic activities persist in dead bodies, the real question is whether any particular finding—such as the secretion of a hormone—demonstrates the persistence

49 [citation]

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 21 of a function that is as physiologically integrative as the others whose absence is one of the accepted criteria for brain-based diagnoses. Certainly, if the same functions continue in persons who are declared dead under cardiopulmonary standards, then their presence does not show that the clinical criteria for the brain-based standards are inaccurate or incomplete, and neither a "redefinition" of the neurologic standard nor a change in criteria used to establish that a body fulfills that standard would be needed.

On the other hand, a more fundamental challenge to the neurological standard for death determination has been mounted by critics who argue that the persistence (even for a brief time and certainly in the rare longer-term cases) of the ability of artificially supported “brain dead” bodies to control their temperature, excrete waste, heal wounds, fight infections, and—most dramatically—gestate fetuses, contradicts the rationale offered thirty years ago by the President’s Commission and others that cessation of brain functions entails a loss of somatic integration of the body as a whole. The Commission recognized that the functioning of many organs—such as liver, kidneys, and skin—is vital to life, in the sense that if any ceases and is not restored or replaced the organism as a whole cannot survive. But the Commission described the functioning of the heart, lungs, and brain as having a special significance “because their interrelationship is very close and the irreversible cessation of any one very quickly stops the other two and consequently halts the integrated functioning of the organism as a whole.”50 In this view, the traditional vital signs of breathing and heartbeat are not important in and of themselves but because they confirm the continued functioning of “a triangle of interrelated systems with the brain at its apex.”51 Thus, the neurological criteria for

50 DEFINING DEATH, note 15 supra, at 33. 51 Id.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 22 determining death are merely measuring the breakdown of the interrelated systems at a different point in situations when it is not possible to assess the system by means of breathing and heartbeat. If, as an ontological matter, the existence of an intact triangle is essential for an organism to be alive, it follows that showing that any part has failed proves the organism can no longer be considered alive unless some means has been employed to provide the missing function, circulatory, respiratory or neurological. Yet to those who object to the integrative functioning model for determinations of death, the importance of that intact triangle is itself in doubt.

The critics contend that the evidence in at least some cases is that after physicians have determined that brain functions have ceased, it is possible to sustain organismic

“life” for a period of time by continuing the circulation of oxygenated blood (typically by supporting breathing with a mechanical ventilator; this either generates cardiac rhythm or cardiac function can be stimulated with drugs or electrical stimulation). One response would be to suggest that the ventilator, drugs, and other devices and stimuli are simply stepping in (albeit briefly or inadequately) to bridge the gap in the triangle caused by the cessation of brain functions. A further response would be that, assuming the tests for determining death neurologically included an apnea test (as they usually do), which demonstrates that a body does not attempt to breathe spontaneous when removed from the ventilator, even when oxygen levels fall and carbon dioxide levels rise to levels that usually stimulate breathing in living beings, then the cessation of spontaneous respiration is diagnostic because it shows that the brain, including the brain stem, has ceased functioning. “Other signs customarily employed by physicians in diagnosing death, such as unresponsiveness and absence of papillary light response, are also indicative of loss of

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 23 the functions of the whole brain.”52 What all these tests indicate, then, is that the brain is no longer playing its role as the complex organizer and regulator of bodily functions, a role that is essential for human life (as also for all complex animals). This is why artificial support, which is capable of maintaining patients in the persistent vegetative state for decades, can—even with the most exacting efforts—maintain “brain dead” bodies for only relatively brief periods. Nonetheless, the critics conclude that the fact that respiration and circulation can, with effort, be induced in bodies determined to be dead indicates that the neurological standard at best supports a prognostic judgment—that the person is about to die (perhaps very, very soon)—but not a diagnosis.

The President’s Council on Bioethics has recently replied to both arguments of the critics—that particular functions (such as the production of hormones) which suggest some degree of bodily integration can sometimes be detected in bodies labeled dead on neurological grounds, and that the “integrated functioning” model employed by the

President’s Commission is contradicted by cases in which important activities persist in artificially supported “dead bodies”—by reframing the explanation for the coherence of a brain-based standard for determining death. The Council concludes that the persistence of some functions is not inconsistent with a diagnosis of death, if death is understood to mean that a organism is no longer operating as a whole because it is unable to carry on it essential “work,” which depends on three fundamental capacities: “openness to the world” (receptivity to stimuli), “the ability to act upon the world to obtain selectively what it needs,” and the “basic felt need that drives the organism to act as it must.”53

Without going further, it is sufficient to note that a body which has suffered total brain

52 Id. at 34. 53 CONTROVERSIES IN THE DETERMINATION OF DEATH: A WHITE PAPER OF THE PRESIDENT’S COUNCIL ON BIOETHICS 61(2008).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 24 failure is neither receptive nor able to act; indeed, as demonstrated by the apnea tests that are a standard part of determining death on neurological grounds, such bodies do not spontaneously exercise the muscles necessary to obtain the oxygen that is essential to their survival.

III. The Controversies over the Circulatory-Respiratory Standard and DCDD

While objections to neurological determinations of death arose even as the UDDA and the predecessor model acts were first being formulated and adopted, objections to determining death on circulatory-respiratory grounds were not voiced until about 20 years ago when, as already mentioned, organ donation programs began to rely on protocols for controlled or uncontrolled DCDD.54 The growth of DCDD–also known as donation after cardiac death, donation after cardiocirculatory death, or non-heart-beating organ donation–has been spurred by the U.S. Department of Health and Human Services through support of programs such as the Organ Donation Breakthrough Collaborative, run by Health Resources and Services Administration (HRSA), and by The Joint Commission’s recent establishment of quality criteria for hospitals engaged in DCDD.55

As the first DCDD protocols were developed to expand the circumstances in which patients could become organ donors, they were initially met with questions about whether they were consistent with the dead donor rule.56 While these doubts have largely been

54 I will focus on controlled DCDD (i.e., when the dying process is managed in a hospital environment after a patient or surrogate has decided that life-sustaining therapy should be withdrawn and consent has been given for the removal of organs after the patietn’s death) which is the prevailing practice in the US, although trials of uncontrolled DCDD, similar to programs already used in some European countries (where emergency responders recover organs from people outside hospitals who cannot be resuscitated) are however planned or underway in several locations. See Childress, Organ Donations after Circulatory Determination of Death: Lessons and Unresolved Controversies, 36 J. LAW, MED. & ETHICS 766 (2008). 55 Steinbrook, Organ Donation after Cardiac Death, 357 NEW ENG. J. MED. 209 (2007). 56 See note 25 and accompanying text.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 25 resolved,57 recent efforts to extend the “boundaries” of DCDD by adding hearts to the list of organs that may be recovered, expanding the organ donor pool, or initiating medical interventions to protect organs in the donor before death is determined, have revived questions about whether the new protocols skirt relevant ethical or legal norms and other accepted principles of organ donation.11

What is it about DCDD protocols that raises concern? Suppose a ventilator-dependent patient (usually as a result of brain damage that interferes with normal respiratory drive and airway maintenance) has previously indicated that he or she does not wish to undergo prolonged treatment in an unconscious state if the prospects for recovering from the underlying illness and regaining consciousness are small or nil; alternatively, if the patient has not expressed his or her wishes, the patient’s next of kin or other surrogate decisionmaker may believe that further extending the patient’s life is not in the patient’s best interest. Once the decision has been reached to discontinue life support, the question of the patient becoming an organ donor can be addressed. Again, the patient may have previously expressed the wish to donate organs, such as by signing a UAGA “donor card,” or those acting for the patient may believe this would be a good outcome. When this is the case, the patient will be evaluated and if found to be a suitable organ donor, the DCDD protocol will be followed. At an appropriate time (after the next of kin have been able to engage in any last rites and otherwise bid the patient adieu), the patient will be taken to an operating room, given opioid and benzodiazepine medications that would be appropriate for palliative purposes in this setting irrespective of organ donor status, and the ventilatory and other support withdrawn

57 See notes 26 and 55.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 26 either by extubation or rapid weaning from the ventilator.58 The usual sequence of loss of vital functions leading to the death of the DCDD patient is respiratory arrest followed by cardiac arrest, though the reverse sequence can also occur.

Once asystole (absent heartbeat) occurs, the exact duration of mechanical asystole and apnea are carefully measured before death is declared. After two to five minutes without breathing and heartbeat (depending on the protocol in use at the hospital), the physicians will declare a patient dead, based upon the patient’s circulatory and respiratory functions having ceased permanently. Studies have shown that patients in this setting do not spontaneously recover circulation or breathing (“auto-resuscitate”) after 65 seconds of asystole,59 and it is inherent in DCDD no attempt will be made (through CPR or otherwise) to restore functioning of the heart and lungs because the patient or surrogate have chosen to allow death to occur by withholding further life-support in a manner that enables the donation of organs.

Nonetheless, the critics of DCDD raise three types of objections: first, that the permanent cessation of circulation and respiration which is produced in the absence of auto- resuscitation and CPR does not meet the statutory standard of the UDDA, second, that the evidence of permanence is insufficient, and third, that other steps taken with patients under

DCDD protocols are incompatible with physicians’ obligations to patients.

A. Permanence versus Irreversibility under the UDDA

The UDDA’s use of the term “irreversible cessation” of circulation and respiration to demarcate when death occurs has led many observers to assume that irreversibility sets an

58 Truog, Campbell, Curtis, et al., Recommendations for End-of-Life Care in the Intensive Care Unit: A Consensus Statement of the American College of Critical Care Medicine, 36 CRIT. CARE MED. 953 (2008). 59 DeVita, The Death Watch: Certifying Death using Cardiac Criteria, 11 PROG. TRANSPLANTATION 58 (2001); DeVita, Snyder, Arnold et al., Observations of Withdrawal of Life-Sustaining Treatment from Patient who Became Non-Heart-Beating Donors, 28 CRIT. CARE MED. 1709 (2000).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 27 unmistakable legal standard of death but understanding what the statute means requires more analysis than simply reading the plain words.

The UDDA does not contain a set of definitions and hence does not define the term

“irreversible.” Guidance in interpreting the term must therefore be found in the explanatory materials from its creators that accompanied its promulgation to and adoption by the states.

The NCCUSL’s “Prefatory Note” provides no help on this point, as it mainly addresses the relationship between the UDDA and its predecessor, Uniform Brain Death Act, and why medical advances have made a revision of the law necessary. In describing what the UDDA added to the earlier statute, the Note thrice uses the phrase “cessation of respiration and circulation,” twice with no modifier and once with “irreversible,” but it never elaborates on the meaning of the term.

Defining Death, which serves as the principal piece of legislative history for the use of

“irreversible” in the UDDA in the absence of reports or remarks in state legislatures addressing the term, does shed light on the term’s meaning. In Defining Death, “irreversible” is used interchangeably with “permanent,” because both words designate a condition that is stable and unchanging. The report’s reliance on the term “permanent” is hardly surprising, as that was the modifier used by the common law. Prior to the modern era of medical resuscitation of stopped hearts and lungs, the major concern of physicians and the general public alike when it came to determining death was not resurrection but diagnostic error, whether caused (in the pre-stethoscope era) by the limitations of the art or by the inadequacies of individual medical practitioners. Thus, the assurance that people wanted was permanence: if declared dead, they would remain dead and neither rise up during their own funeral or,

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 28 worse, awaken from a deep slumber inside a coffin that had already been placed in the ground.

Today, in the era of “code blue!” and cardiopulmonary resuscitation, a further complication is added to declaring that vital functions have permanently ceased. The difference between permanent and irreversible relates not to the certainty or duration of the cessation of relevant functions but rather to the implication in “irreversible” that an external actor or force is present that could attempt to restore the function but would be unable to do so. The temporal or ordinal relationship of the two concepts can be explained in two opposing ways. On the one hand, “irreversible” can be seen as the higher standard:

An “irreversible” cessation of function means that the function cannot be restored by any known technology. “Irreversible” is an absolute and univocal condition that implies impossibility (with currently available technology) and does not rely on intent or action. In contrast, a “permanent” cessation of function means that the function will not be restored because it will neither return spontaneously, nor will return as a result of medical intervention because resuscitation efforts will not be attempted. In this analysis, “permanent” is a contingent and equivocal condition that admits possibility and relies on intent and action to be realized.60

In this view, since all functions that are irreversibly lost are also permanently lost but not vice versa, a condition may be declared permanent only if an attempt has been made and failed to reverse it. On the other hand, “permanent” can be seen as the ultimate goal, with the question of irreversibility being a point along the way only in those cases where an attempt has been made to restore lost functions. In this view, when there is no known possibility of unaided resumption of the functions that have ceased and no intention to attempt to restore them artificially, then the question of irreversibility does not arise and the only question is the reliability of the conclusion that the cessation is permanent.

60 Bernat, Capron, Bleck et al., The circulatory-respiratory determination of death in organ donation, 38 CRIT. CARE MED. 963, 964-65 (2010) [hereinafter The circulatory-respiratory determination].

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 29 Rather than solely analyze “irreversible” terminologically, the meaning of the word in the UDDA can be examined contextually by asking how the term was elaborated in Defining

Death, beyond being used interchangeably with “permanent.” The Commissioners’ understanding of what it would mean to determine that an individual met the statutory standard of “irreversible cessation of circulatory and respiratory functions” was greatly informed by the medical evidence it heard (and included in relevant chapters in the report) and particularly by the discussion provided by the Commission’s medical consultants in their

Guidelines, which were published with the report. As two each of the two standards, the consultants provided specific guidance on the meaning of both “cessation” and “irreversible.”

Cessation “is recognized by an appropriate clinical examination” that discloses “at least the absence of responsiveness, heartbeat, and respiratory effort,” while irreversibility “is recognized by persistent cessation of functions during an appropriate period of observation and/or trial of therapy.”61 The consultants elaborated on the “appropriate period of observation” as follows:

In clinical situations where death is expected, where the course has been gradual,

and where irregular agonal respiration or heartbeat finally ceases, the period of

observation following the cessation may be only the few minutes required to

complete the examination. Similarly, if resuscitation is not undertaken and

ventricular fibrillation and standstill develop in a monitored patient, the required

period of observation thereafter may be as short as a few minutes. When a possible

death is unobserved, unexpected, or sudden, the examination may need to be more

detailed and repeated over a longer period, while appropriate resuscitative effort is

maintained as a test of cardiovascular responsiveness. Diagnosis in individuals

61 Guidelines, note xx supra, at yy.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 30 who are first observed with rigor mortis or putrefaction may require only the

observation period necessary to establish that fact.62

When CPR is not performed, the statutory requirement–which the medical consultants described as a “persistent cessation of functions”–is met by the relatively brief period of observation following asystole that is sufficient to determine that the loss of spontaneous heartbeat and respiration is permanent, meaning that it will not spontaneously reverse. When

CPR is performed, a longer period may be required before one concludes that the loss of circulation and respiration cannot be reversed. The period of observation before death can be declared is intended to assure that the patient’s circulatory and respiratory functions have ceased permanently. Thus, the medical standard that shows the irreversible cessation of circulation and respiration, and thus satisfies the UDDA, is their permanent cessation.

If one takes the opposite view, that irreversibility not permanence is the medical goal

(as well as the statutory mandate), one would focus on what is occurring to a DCDD patient’s body during the period of observed asystole.

Following a determination of permanent cessation of circulatory and respiratory functions (assuming normothermia and an absence of depressant medications that could reduce cerebral metabolism and lengthen the process), as the patient’s brain becomes completely destroyed by hypoxic-ischemic injury, the cessation will evolve from permanent to irreversible. The exact timing of this transition is unknown and usually moot because no attempt is made to resuscitate or further assess the patient.63

Physicians attending dying patients try to make the determination of death as soon as it is medically clear. The guidance on what tests and procedures to use to determine death on circulatory-respiratory grounds set forth by the Commission’s medical consultants in their

1981 report, which recognizes permanent cessation as the relevant standard in patients not undergoing a trial of resuscitation, are reflected in physicians’ customary practices for

62 Id. 63 The circulatory-respiratory determination, note 60 supra, at 965.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 31 determining death based on circulatory-respiratory tests. The use of these tests is customary, is sanctioned by social practice, and unquestionably represents “accepted medical standards.”

The manner in which permanent cessation of circulation and respiration is used to determine death in DCDD is completely consistent with physician’s use of this standard in all other contexts in which circulation and respiration are measured. Of course, it is essential that physicians apply circulatory-respiratory testing for death in a consistent way, irrespective of whether the patient is an organ donor candidate. Yet it is also appropriate that they exercise greater precision in determining the moment and totality of permanent cessation of circulation in the DCDD circumstance, because of its consequentiality. The advent of DCDD has simply highlighted the need for physicians to make death determination more uniformly and reliably.

A further concern is whether the act of organ donation interrupts or accelerates the donor’s rapid and inevitable transition from permanent to irreversible cessation. In fact, the removal of donor organs has no impact whatsoever on the process of progressive hypoxic- ischemic brain destruction that when completed is the hallmark of irreversibility.64 Once circulation ceases permanently, the same brain destruction occurs whether the organs remain present or have been removed. Although there is a clear difference in the context and consequentiality of death determination in DCDD when compared to other circumstances, there is no physiological difference in the inevitable sequence from permanence to irreversibility. Therefore, employing the criterion of permanence produces no difference in donor outcome from using irreversibility.65

B. Do Adequate Methods Exist to Ensure “Permanence”?

64 Menikoff, Doubts about Death: The Silence of the Institute of Medicine, 26 J. LAW MED. & ETHICS 157 (1998). 65 Bernat, Are Organ Donors after Cardiac Death Really Dead? 17 J. CLIN. ETHICS 122 (2006)..

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 32 The second point raised by critics of DCDD is that even if permanent cessation is a legitimate standard, the methods used in DCDD fail to meet appropriate criteria for application of the standard. The protocols all hinge on a period of asystole, so their proper use plainly requires both clarity about what is meant and care in applying the criteria. Since the determination of death is based on the cessation of circulation of blood, physicians look for an absence of pulse. The term “mechanical asystole” signifies the absence of arterial pulsations, whereas “electrical asystole” means that no electrical cardiac activity exists and

“electromechanical asystole” means the absence of both electrical and mechanical cardiac activity. For death determination, a consensus exists that mechanical asystole is sufficient even when coordinated electrical cardiac rhythm persists, because mechanical asystole means that circulation is absent.66 Although residual pulseless electrical cardiac activity may continue for many minutes despite complete mechanical asystole proved by blood flow measurements,67 it is inconsequential for death determinations because it generates no circulation. Thus, when tests demonstrate electrical asystole, that alone is sufficient to prove mechanical asystole because neither heartbeat nor circulation can occur during electrical asystole in the absence of external cardiac or circulatory support.

Physicians can assess asystole by several techniques. Traditionally, physicians have determined mechanical asystole by palpating arterial pulses or listening for heartbeat.

Although these techniques are sufficient in ordinary circulatory-respiratory death determinations, in the DCDD donor patient for whom the determination is more consequential, these usual means may be inadequate to distinguish a complete loss of

66 Bernat, D’Alessandro, Port, et al., Report of a National Conference on Donation after Cardiac Death, 6 AM. J. TRANSPLANTATION 281 (2006) [hereinafter National Conference]. 67 Wijdicks & Diringer, Electrocardiographic Activity after Terminal Cardiac Arrest in Neurocatastrophes, 62 NEUROLOGY 673 (2004).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 33 circulation from a slight degree of retained circulation that is too slight to generate a palpable pulse or an audible heartbeat. Instead, centers carrying out DCDD demonstrate the complete cessation of circulation by the absence of pulsations detected by an indwelling arterial catheter that sensitively and specifically measures arterial pulsations and pressures, the absence of pulsatile flow shown by percutaneous Doppler ultrasound on peripheral arteries, or the absence of blood flow through the aortic valve on echocardiography.68 It is possible to use electrocardiography to show that cardiac electrical activity has ceased (which also establishes mechanical asystole), but such tests are not required.

The duration of mechanical asystole required to prove permanent cessation of circulation has been the subject of study and speculation. The protocol at the University of

Pittsburgh Medical Center, a pioneer in DCDD, continues to specify a 2-minute duration.

Although this is defensible, since 65 seconds is the longest recorded interval of observed asystole followed by auto-resuscitation, the observational studies that produced that datum comprised relatively few patients which as a result has only a modest statistical confidence interval, so it is conceivable that resuscitation could occur spontaneously after more than 65 seconds of mechanical asystole. Therefore, the Ethics Committee of the Society of Critical

Care Medicine suggests an observation period of at least 2 minutes and no more than 5,69 while the Institute of Medicine recommends a 5-minute interval after mechanical asystole, which has been adopted by the majority of United States DCDD programs.70 Pending the collection of further data on auto-resuscitation, this prudent conclusion was endorsed by leaders of the DCDD community at the 2005 National Conference on Organ Donation after

68 The circulatory-respiratory determination, note 60 supra, at 966. 69 Ethics Committee, American College of Critical Care Medicine and Society of Critical Care Medicine. Recommendations for Non-heartbeating Organ Donation. A Position Paper by the Ethics Committee. 29 Crit. Care Med. 1826 (2001). 70 ORGAN DONATION: OPPORTUNITIES FOR ACTION, note xx supra.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 34 Cardiac Death.71 A recent study of auto-resuscitation after withdrawal of life-sustaining therapy found reports of returned cardiac rhythm but none of returned circulation.72

C. Does the Execution of DCDD Contradict the UDDA?

Two particular activities involve the execution of DCDD protocols have drawn particular criticism. One criticism is justified because the actions contradict the standards set by the UDDA, while the other reflects a serious misunderstanding of what is involved in the application of the UDDA’s circulatory-respiratory standard.

1. ECMO and the Connection between the Two Standards. Extracorporeal membrane oxygenation (ECMO) was developed as a bridge to support patients with severe heart or lung dysfunction pending receipt of a transplanted heart,73 lungs,74 or heart and lungs; it has since been used as an adjunct to failed CPR75 and to address prolonged in-hospital cardiac arrest.76 Veno-arterial ECMO shares many features with a typical heart-lung machine used to oxygenate and circulate blood during open-heart surgery with induced asystole except that it is designed to replace cardiopulmonary functions for a few days or weeks rather than for hours.

Controversy arose, however, after surgeons at several transplantation centers reported preliminary results from using ECMO to maintain organ function in DCDD donors following

71 National Conference, note 66 supra. 72 Hornby, Hornby & Shemie, A systematic review of autoresuscitation after cardiac arrest, 38 CRIT. CARE MED. 246 (2010). 73 Cooper, Jacobs, Moore, Stock, Gaynor & Chancy, Cardiac Extracorporeal Life Support: State of the Art in 2007, 17 CARDIOL YOUNG 2007 104 (Suppl 2, 2007). 74 Jackson, Cropper, Pye, Junius, Malouf & Glanville, Use of Extracorporeal Membrane Oxygenation as a Bridge to Primary Lung Transplant: 3 consecutive, successful cases and a review of the literature, 27 J. HEART LUNG TRANSPLANT. 348 (2008). 75 Thiagarajan, Laussen, Rycus, Bartlett & Bratton, Extracorporeal Membrane Oxygenation to Aid Cardiopulmonary Resuscitation in Infants and Children, 116 CIRCULATION 1693 (2007). 76 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 12. Pediatric Advanced Life Support, 112 CIRCULATION IV-167 (24 Suppl 2005).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 35 the declaration of death but prior to organ recovery.77 Immediately after death has been declared under these protocols, the surgeons introduce ECMO support through arterial and venous catheters that had been inserted into the patient-donor before death was declared. The transplant programs want to use ECMO because, by improving organ profusion and oxygenation prior to organ recovery and thereby reducing warm ischemic time, they are able to improve the outcomes in transplanted kidney, livers, and pancreases. The organs recovered from ECMO-perfused DCDD donors function similarly to organs recovered from brain dead donors with intact circulation. This improvement in recovered organs permitted an expansion of the potential organ donor pool by 33% at one institution.78

But the use of ECMO is incompatible with a declaration of death. By providing ongoing cardiopulmonary support, ECMO prevents the donor from being declared dead using circulatory-respiratory tests of death. Moreover, the circulation of oxygenated blood that is effective in supporting continued functioning of the visceral organs that will be transplanted also provides the brain with support. One reason that the irreversible loss of respiration and circulation serves as an adequate test of death is because it leads rapidly and inescapably to destruction of the brain.79 But should this otherwise inevitable progressive brain destruction be prevented by ECMO’s restoration of brain circulation, the patient-donor cannot reliably be declared dead prior to organ recovery. In effect, the use of ECMO in the DCDD donor

77 Koyama, Shinozuka, Watanabe, et al., Utilization of Kidneys from Non-Heart-Beating Donors by Portable Cardiopulmonary Bypass, 29 TRANSPLANT PROC.29 3550 (1997); Ko, Chen, Tsai & Lee, Extracorporeal Membrane Oxygenation Support of Donor Abdominal Organs in Non-Heart-Beating Donors, 14 CLIN. TRANSPLANTATION 152 (2000); Gravel, Arenas, Chenault, et al., Kidney Transplantation from Organ Donors Following Cardiopulmonary Death using Extracorporeal Membrane Oxygenation Support, 9 ANN. TRANSPLANTATION 57 (2004); Magliocca, Magee, Rowe, et al., Extracorporeal Support for Organ Donation after Cardiac Death Effectively Expands the Donor Pool, 58 J. TRAUMA 1095 (2005); Fondevila, Hessheimer, Ruiz, et al., Liver Transplant Using Donors after Unexpected Cardiac Death: Novel Preservation Protocol and Acceptance Criteria, 7 AM. J. TRANSPLANTATION 1849 (2007). 78 Magliocca, Magee, Rowe, et al, note 77 supra. 79 Bernat, Culver & Gert, Defining Death in Theory and Practice, 12 HASTINGS CENT. REPT. 5 (Jan.-Feb. 1982).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 36 “retroactively negates the physiological justification for declaring the DCDD donor dead” and

“also raises the possibility of retaining donor consciousness and the consequent potential for suffering.”80

Investigators at the University of Michigan and elsewhere have modified whole-body donor ECMO in such a way that, if applied successfully, apparently eliminates this problem and therefore may represent a technically acceptable protocol.81 When the arterial and venous

ECMO catheters are inserted (before the patient’s ventilatory support had been withdrawn), a deflated intra-aortic occlusion balloon is also placed in the distal thoracic aorta at the level of the diaphragm. At the moment death is declared and ECMO is initiated, the aortic balloon is inflated which blocks all aortic blood flow above the diaphragm, thereby excluding the thoracic organs and the brain. With the aorta completely occluded, the brain will undergo the same ischemic infarction that would have occurred without ECMO, so this intervention does not retroactively negate the determination of the patient-donor’s death.82 Alternative techniques that successfully exclude brain circulation during ECMO, such as bilateral carotid and vertebral artery ligation or infusing clear prime solutions that do not result in establishing oxygenation and circulation, also can accomplish the goal of not interfering with progressive brain destruction and negating death determination.

However, the techniques that modify ECMO by preventing brain circulation are disturbingly invasive. Interventions before and after death is declared raise ethical issues and some commentators have described these techniques as unjustifiably invasive and have wondered if performing them serves only to satisfy the letter of the UDDA while violating its spirit. If these techniques are used, additional testing to prove the complete absence of intracranial circulation will be necessary, adding further invasive monitoring of the donor. Pre-mortem invasive procedures that aim to improve

80 The circulatory-respiratory determination, note 60 supra, at 967. 81 See Gravel, Arenas, Chenault, et al., note 77 supra; Magliocca, Magee, Rowe, et al, note 77 supra; and Ko, Chen, Tsai & Lee, note 77, supra. 82 Proof of absent brain circulation is necessary but the surgeons using the modified ECMO support do not report performing it.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 37 organ preservation but that do not help the donor also are objectionable and may distract the health care team’s focus from its goal of maintaining optimal palliative care for the patient during withdrawal of life support. At the least, families of DCDD donors must be informed about the procedures that accompany DCDD and, if they object to them, must be allowed to decline DCDD so that the death is managed differently.83

ECMO can be employed to improve the viability of organs for transplantation by using the device to perfuse and oxygenate organs after they have been removed from the body.

Indeed, ex vivo ECMO, has been reported to enhance successful multi-organ donation in

DCDD.84 Besides preserving the legitimacy of the circulatory-respiratory determination of death in DCDD, ex vivo ECMO offers several advantages over using ECMO on the donor>

First, it avoids having to subject the patient-donor with additional catheters prior to the declaration of death, and second, it does not require invasive modifications, such as intra- aortic balloon occlusion, to make it acceptable.

2. Is it Inconsistent to Declare Death in DCDD and Then Transplant a Viable

Heart? A recent report of three successful infant DCDD heart donations ignited a firestorm of controversy about whether the infant donors were truly dead at the moment of organ recovery.

Under an experimental DCDD protocol, hearts recovered at the Denver Children’s Hospital from three infants who had profound brain damage but who were not brain dead were transplanted successfully into three infants with end-stage heart disease.85 In two cases, the investigators reduced to just 75 seconds the 3-minute period of asystole required by the experimental protocol before death was declared. This ad hoc reduction was based on the recommendation of the hospital’s ethics committee to reduce the risk of injury to the

83 The circulatory-respiratory determination, note 60 supra, at 967. 84 Snell, Levvey, Oto, et al., Effect of Multiorgan Donation after Cardiac Death Retrieval on Lung Performance, 78 ANZ J. SURG.;78 262 (2008). 85 Boucek, Mashburn, Dunn, et al., Pediatric Heart Transplantation after Declaration of Cardiocirculatory Death, 359 NEW ENGL. J. MED. 709 (2008).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 38 transplanted heart from warm ischemia. Despite the successful rescue of three doomed babies and the physicians’ technical virtuosity, which drew praise,86 serious criticism was raised against the organ recovery.

First, it is difficult to justify shortening the prevailing 2-5 minute interval of asystole required to determine death, especially since infants are not included in the patient database on auto-resuscitation from which this guideline was derived and infants’ organs are known to be more resilient than adults’. The prevailing practice of waiting for 2 to 5 minutes of asystole has been established at an intentionally conservative level so as to minimize the possibility of false-positive diagnoses. The actions of the Denver Children’s Heart Transplant team do not cast doubt on the UDDA’s circulatory-respiratory standard nor even on the basic

DCDD protocol. Rather, they serve as a reminder that the matter of adopting criteria and tests to implement the statutory standard, though delegated to the medical profession are in no way merely technical matters. Instead, the criteria and even the tests embody value choices, in particular trading certainty against other values, such as avoiding burdens and maximizing convenience and utility. When making judgments about what constitutes the “accepted standards” behind which they can stand, members of the medical profession need to be sensitive not only to employing defensible processes (in terms of use of scientific and clinical evidence and openness to peer and public review) but also not to take actions that create a public sense that the standards for determining death are unreliable or are subject to being manipulated in ways that place patients at risk of premature or mistaken death determinations.

The criticism provoked by the Denver Children’s experiment also serves as a reminder of the importance of carefully assessing, and even conducting formal research on, the criteria used to implement the statutory standards for determining death. Further, physicians need to

86 Curfman, Morrissey & Drazen, Cardiac Transplantation in Infants, 359 NEW ENGL. J. MED. 749 (2008).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 39 achieve uniformity in death determination practices. It is undesirable for physicians at different hospitals to use different standards to declare death. Medical societies should work to establish a uniform medical standard for the circulatory-respiratory determination of death that should be adopted by all DCDD programs, as also has been urged for death determination using neurological tests.87

The second criticism generated by the report of the infant heart transplants sounds at least as severe and perhaps more far reaching as the first, but unlike the first turns out to be unpersuasive. Several leading bioethicists argued that the transplant team’s success in restarting the donor infants’ hearts in the recipient infants retroactively negated the determination of death in the donor infants because it clearly demonstrated that the donors’ heart stoppage was not irreversible. In one commentary, George Annas labeled the DCDD heart recovery protocol illegal on the ground that declaring the donors dead and transplanting and then restarting their hearts clearly violated the UDDA requirement for irreversibility of heart function.88 Robert Veatch raised a broader conceptual challenge to DCDD: “if a heart is restarted, the person from whom it was taken cannot have been dead according to cardiac criteria.”89 Such critiques might be quite telling if they did not misread the statutory standard for determining death which is “irreversible cessation of circulatory and respiratory functions.” The first part of the standard often is misinterpreted as cessation of heartbeat because the heart is the organ ordinarily responsible for circulation, and because the absence of heartbeat is a customary sign of the absence of circulation. But circulation, not heartbeat, is

87 Choi, Fredland, Zachodni, Lammers, Bledsoe & Helft, Brain Death Revisited: The Case for a National Standard, 36 J. Law, Med. & Ethics 824 (2008). 88 Gawande (moderator), Annas, Caplan & Truog, Perspective Roundtable: Organ Donation after Cardiac Death 359 NEW ENGL. J. MED. (2008) http://content.nejm.org/cgi/content/full/359/7/669/DC1 (accessed April 26, 2010). 89 Veatch, Donating Hearts after Cardiac Death: Reversing the Irreversible, 359 NEW ENGL. J. MED. 672 (2008).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 40 the critical function that must be absent when using circulatory-respiratory tests to determine death. For example, we do not declare patients dead on the grounds of absent heartbeat who are on ECMO awaiting heart transplantation (even if they never receive a heart) or supported by ventricular assist devices so long as their circulation remains continuously maintained.

The names we apply to activities or conditions often determine how we conceptualize them. Just as “brain death” has long bedeviled discussions of the neurological standard for determining death, so too the shorthand “cardiac death” leads commentators into error when interpreting both the concept of death and the UDDA. Even the common (and less informal) phrase “donation after cardiac death” is a source of confusion because it misleadingly implies that circulatory death determination is solely the product of heartbeat cessation.90 When CPR will not be attempted, patients can be declared dead once heartbeat (and hence circulation) stops beyond the point when auto-resuscitation will occur. Whether the non-beating heart subsequently is left alone, removed and not restarted, or removed and restarted in another patient is irrelevant to the circulatory status of the dead patient. In DCDD, the removal and restarting of the heart elsewhere simply has no impact on the prior determination of the donor’s death because the patient-donor remains permanently without circulation in exactly the same way as if her non-beating heart had been left in place. Therefore, restarting the heart in another patient does not retroactively negate the determination of the donor’s death.

IV. Conclusion

Even after 30 years of public awareness that the irreversible cessation of brain functions is one means of determining death, substantial confusion persists on the whole subject. Some of the confusion probably has its origins in the linkage of the definition of

90 For this reason, this article has used the term recommended by the Institute of Medicine, DCDD (donation after circulatory determination of death). See note 30 supra and accompanying text.

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 41 death to organ (particularly heart) transplantation, especially when it appears—as in the protocols described previously—that physicians may be altering the standards in order to increase the number of eligible donors. While such efforts may have laudable goals, they also undermine confidence in both the certainty and the uniformity of the standards for determining death. Ironically, uncertainty about death determination decreases the number of people willing to consent to organ donation.91

Although virtually all reported cases of misdiagnoses of death involve determinations based on misreading circulatory and respiratory signs in patients who were not on ventilators, public anxiety focuses on “brain death.” Part of the confusion can be traced to the very terminology, which wrongly suggests the existence of a special, separate category of death-or worse, that brain death is almost but not quite death.

Unfortunately, the difficulty of speaking of "death diagnosed on neurological grounds" or of "a brain-based determination of death" probably means that the term "brain death" will not disappear. Also unfortunately, this term is sometimes used even more loosely to describe a patient who has been unconscious for a long time, though breathing spontaneously; thinking only of the loss of the ability to communicate and to perceive the world, family members and others may understandably feel that their comatose relative is

"brain dead." Indeed, this has even lead to the popular use of the term to describe people

(particularly celebrities) as "brain dead" when they commit some particularly dimwitted act.

But the problems with the present definition of death go beyond its colloquial misuse. It has been shown that even medical and nursing personnel have difficulty in

91 Sanner, A Comparison of Public Attitudes toward Autopsy, Organ Donation, and Anatomic Dissection: A Swedish Survey, 271 J.A.M.A. 284 (1994).

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 42 applying the concept of death to artificially maintained bodies that manifest many of the traditional-and readily perceived-signs of life: a moving chest, pulsing blood vessels, and warm, moist skin. Closer examination by the trained eye reveals the difference between such bodies and living beings (closed eyes or a fixed gaze, the lack of cortical reflexes when the eye or ear is stimulated, and so forth), but that may not always, or not immediately, overcome the sense that death has not occurred.

Clearly, continuing efforts are needed to educate people (including health care workers) that death is a single phenomenon which can be measured at least as accurately by determining that brain functions have permanently ceased in patients who are artificially maintained as by examining for absence of heartbeat and respiration in other persons. Meanwhile, no jurisdiction that has accepted brain-based determinations of death (as virtually all Western countries have done, either through law or through accepted medical practice) has seen fit to abandon this standard either to return to the older, circulatory-respiratory standard alone or, conversely, to incorporate a standard based solely on higher brain functions. In the face of both empirical arguments and conceptual criticism, the dual standards of loss of circulatory and respiratory functions and loss of all functions of the brain have for nearly forty years guided medicine and law in making and applying determinations of death. The standards may not be perfect, but they represent a fair interpretation of the evidence—scientific, clinical and personal—that we have of what happens when human beings die. Both in their formulation and their application, the standards for determining death arise out of good faith and well informed but ultimately fallible efforts to accurately sort the dead from the living. Faced with the

Workshop Draft, April 2010 Not to be cited or quoted without permission Page 43 necessity of acting, our continuing embrace of the UDDA and its related medical criteria may simply represent a triumph of pragmatism over the search for absolute truth..

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