The Uniform Determination of Death Act is Not Changing. Will Physicians Continue to Misdiagnose Brain Death?

Efforts to revise the Uniform Determination of Death Act in order to align law with medical practice have failed. Medical practice must now align with the law. People who are not dead under the law that defines death should not be declared dead. There is no compelling reason to continue the practice of declaring legally living persons to be dead.

The Language of the UDDA is Sufficiently Precise and Pragmatic.

We have a reason to value the Uniform Determination of Death Act (UDDA). Since enactment, the UDDA has been of paramount importance to US citizens, families of comatose patients, and the health care professionals who care for them. The UDDA sets forth two standards for determining death and leaves to the medical community to elaborate criteria by which physicians can determine when those standards have been met. Neurologists and neurocritical care experts always have been center stage in this effort. Perfectly established, why change it? What ignited the recent review of the UDDA were lawsuits questioning medical (neurological) authority leading to the wording and accuracy of the UDDA being revisited. The major objections to the language of the UDDA by several groups led a committee appointed by the Uniform Law Commission to consider several substantial changes in the Act. After several years of discussion without reaching a consensus, the committee's chair suspended the effort. Upending the UDDA will lead to a legal crisis and confusion across the states. We present our main arguments against revising this statute and argue that the committee's failure to revise the UDDA should actually be seen as a necessary success.

The Unified Brain-Based Determination of Death Conceptually Justifies Death Determination in DCDD and NRP Protocols.

Organ donation after the circulatory determination of death requires the permanent cessation of circulation while organ donation after the brain determination of death requires the irreversible cessation of brain functions. The unified brain-based determination of death connects the brain and circulatory death criteria for circulatory death determination in organ donation as follows: permanent cessation of systemic circulation causes permanent cessation of brain circulation which causes permanent cessation of brain perfusion which causes permanent cessation of brain function. The relevant circulation that must cease in circulatory death determination is that to the brain. Eliminating brain circulation from the donor ECMO organ perfusion circuit in thoracoabdominal NRP protocols satisfies the unified brain-based determination of death but only if the complete cessation of brain circulation can be proved. Despite its medical and physiologic rationale, the unified brain-based determination of death remains inconsistent with the Uniform Determination of Death Act.

An Ethics Committee's Evaluation of Normothermic Regional Perfusion (NRP) in 2018-Unsatisfactory Answers Then-and Now.

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.

Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.

Brain Death: Ethical and Legal Challenges.

Although the fundamental principle behind the Uniform Determination of Death Act (UDDA), the equivalence of death by circulatory-respiratory and neurologic criteria, is accepted throughout the United States and much of the world, some families object to brain death/death by neurologic criteria. Clinicians struggle to address these objections. Some objections have been brought to court, particularly in the United States, leading to inconsistent outcomes and discussion about potential modifications to the UDDA to minimize ethical and legal controversies related to the determination of brain death/death by neurologic criteria.

Neurology ethics at the end of life.

Ethical challenges in medical decision making are commonly encountered by clinicians caring for patients afflicted by neurological injury or disease at the end of life (EOL). In many of these cases, there are conflicting opinions as to what is right and wrong originating from multiple sources. There is a particularly high prevalence of impaired patient judgment and decision-making capacity in this population that may result in a misrepresentation of their premorbid values and goals. Conflict may originate from a discordance between what is legal or from stakeholders who view and value life and existence differently from the patient, at times due to religious or cultural influences. Promotion of life, rather than preservation of existence, is the goal of many patients and the foundation on which palliative care is built. Those who provide EOL care, while being respectful of potential cultural, religious, and legal stakeholder perspectives, must at the same time recognize that these perspectives may conflict with the optimal ethical course to follow. In this chapter, we will attempt to review some of the more notable ethical challenges that may arise in the neurologically afflicted at the EOL. We will identify what we believe to be the most compelling ethical arguments both in support of and opposition to specific EOL issues. At the same time, we will consider how ethical analysis may be influenced by these legal, cultural, and religious considerations that commonly arise.

Should the Revised Uniform Determination of Death Act Address Objections to the Use of Neurologic Criteria to Declare Death?

In response to concerns about the declaration of death by neurologic criteria, the Uniform Law Commission created a drafting committee to update the Uniform Determination of Death Act (UDDA) in the Fall of 2021. One of the key questions for the committee to address was the following: Should the revised UDDA address objections to the use of neurologic criteria to declare death? This article (1) provides historical background and survey results that demonstrate the need to address this question; (2) summarizes the ethical principles that support and oppose accommodation of objections to the use of neurologic criteria to declare death; (3) reviews accommodation in other areas of medicine and law; (4) discusses existing legal and hospital guidance on management of these objections; (5) examines perspectives of stakeholder medical societies and expert health care professionals, lawyers, ethicists, and philosophers on whether the revised UDDA should address these objections; (6) identifies some questions for the drafting committee to consider when deciding whether the revised UDDA should address objections to the use of neurologic criteria to declare death; and (7) summarizes the potential downstream effects of the drafting committee's decision.

cDCDD-NRP is consistent with US legal standards for determining death.

Donation after circulatory determination of death (DCDD) has increased organ donation rates in the US over the past decade within an established legal framework, which is consistent with and supports individual and family decisions regarding organ donation in the context of end-of-life care. A new application, controlled DCDD donation utilizing thoracoabdominal normothermic regional perfusion (NRP) protocols (cDCDD-NRP), provides the opportunity to maximize a donation decision by recovering additional organs for transplant, including the heart, and to limit the detrimental impact of warm ischemic time by perfusing organs in situ following the declaration of circulatory death. In this viewpoint, we narrate our rationale for why cDCDD-NRP is consistent within the existing legal framework for organ donation in the United States and recommend no changes to the Uniform Determination of Death Act.

Current Practice Diagnosing Brain Death Is Not Consistent With Legal Statutes Requiring the Absence of All Brain Function.

The legal standard for the determination of death by neurologic criteria in the United States is laid out in the Uniform Determination of Death Act (UDDA), which requires the irreversible cessation of all functions of the entire brain. Most other nations endorse a "whole-brain" standard as well. However, current practice in the determination of death by neurologic criteria is not consistent with this legal standard, because some patients who are diagnosed as brain-dead, in fact retain some brain function, or retain the capacity for the return of some brain function. In response, the American Academy of Neurology published updated guidelines, which assert that hypothalamic function is consistent with the neurological standard enshrined in the UDDA. Others have suggested that it is an open question whether the hypothalamus and pituitary are part of "the entire brain," as delineated in the UDDA. While we agree that determination of death practices are worthy of continued dialogue and refinement in practice that dialogue must adhere to reasonable standards of logic and scientific accuracy.

Statement in Support of Revising the Uniform Determination of Death Act and in Opposition to a Proposed Revision.

Discrepancies between the Uniform Determination of Death Act (UDDA) and the adult and pediatric diagnostic guidelines for brain death (BD) (the "Guidelines") have motivated proposals to revise the UDDA. A revision proposed by Lewis, Bonnie and Pope (the RUDDA), has received particular attention, the three novelties of which would be: (1) to specify the Guidelines as the legally recognized "medical standard," (2) to exclude hypothalamic function from the category of "brain function," and (3) to authorize physicians to conduct an apnea test without consent and even over a proxy's objection. One hundred seven experts in medicine, bioethics, philosophy, and law, spanning a wide variety of perspectives, have come together in agreement that while the UDDA needs revision, the RUDDA is not the way to do it. Specifically, (1) the Guidelines have a non-negligible risk of false-positive error, (2) hypothalamic function is more relevant to the organism as a whole than any brainstem reflex, and (3) the apnea test carries a risk of precipitating BD in a non-BD patient, provides no benefit to the patient, does not reliably accomplish its intended purpose, and is not even absolutely necessary for diagnosing BD according to the internal logic of the Guidelines; it should at the very least require informed consent, as do many procedures that are much more beneficial and less risky. Finally, objections to a neurologic criterion of death are not based only on religious belief or ignorance. People have a right to not have a concept of death that experts vigorously debate imposed upon them against their judgment and conscience; any revision of the UDDA should therefore contain an opt-out clause for those who accept only a circulatory-respiratory criterion.

Does the Uniform Determination of Death Act Need to Be Revised?

Prompted by concerns raised by the rise in litigations, which challenge the legal status of brain death (BD), Lewis and colleagues recently proposed a revision of the Uniform Determination of Death Act (UDDA). The revision consists of (i) narrowing down the definition of BD to the loss of specific brain functions, namely those functions that can be assessed on bedside neurological examination; (ii) requiring that the determination of BD must be in accordance with the specific guidelines designated in the revision; and (iii) eliminating the necessity for obtaining consent prior to performing the tests for BD determination. By analyzing Lewis and colleagues' revision, this article shows that this revision is fraught with difficulties. Therefore, this article also proposes two approaches for an ethical revision of the UDDA; the first is in accordance with scientific realism and Christian anthropology, while the second is grounded in trust and respect for persons. If the UDDA is to be revised, then it should be based on sound ethical principles in order to resolve the ongoing BD controversies and rebuild public trust. SUMMARY: This article critically examines the recent revision of the Uniform Determination of Death Act (UDDA) advanced by Lewis and colleagues. The revision only further reinforces the status quo of brain death without taking into account the root cause of the litigations and controversies about the declaration of death by neurological criteria. In view of this deficiency, this article offers two approaches to revising the UDDA, both of which are founded on sound moral principles.

Controversies in Brain Death Declaration: Legal and Ethical Implications in the ICU.

Purpose of review: This article provides a brief overview of the history and complexities of brain death determination. We examine a few legal cases that highlight some of the controversies surrounding the validity of brain death tests in light of varying state laws and institutional policy, the appropriateness of making religious accommodations, the dilemma of continuing organ-sustaining support in a pregnant brain-dead patient, and the issue of whether to obtain informed consent from surrogate decision makers before proceeding to testing. Recent findings: In response to physician concerns about navigating these complex cases, especially with laws that vary from state to state, the American Academy of Neurology has published a position statement in January of 2019 endorsing brain death as the irreversible loss of all functions of the entire brain. It provides positions on the determination of brain death as well as guidance surrounding requests for accommodation. Summary: Although death by neurologic criteria has been accepted as death medically for over 40 years, legal variance exists throughout the states, especially regarding religious accommodations and in pregnancy. Questions of whether to obtain informed consent from surrogate decision makers prior to brain death testing remain, and there is no guideline regarding obtaining ancillary testing. We expect to see continued cases that cause medical, legal, and ethical controversies in our ICUs. As such, uniform training in proper methodology in performing the brain death examination and appropriate use of ancillary testing is crucial, and there is a need for legal consistency in the acceptance of the medical standard.

Ethical and Legal Concerns With Nevada's Brain Death Amendments.

In early 2017, Nevada amended its Uniform Determination of Death Act (UDDA), in order to clarify the neurologic criteria for the determination of death. The amendments stipulate that a determination of death is a clinical decision that does not require familial consent and that the appropriate standard for determining neurologic death is the American Academy of Neurology's (AAN) guidelines. Once a physician makes such a determination of death, the Nevada amendments require the withdrawal of life-sustaining treatment within twenty-four hours with limited exceptions. Neurologists have generally supported Nevada's amendments for clarifying the diagnostic standard and limiting the ability of family members to challenge it. However, it is more appropriate to view the Nevada amendments with concern. Even though the primary purpose of the UDDA is to ensure that all functions of a person's entire brain have ceased, the AAN guidelines do not accurately assess this. In addition, by characterizing the determination of death as solely a clinical decision, the Nevada legislature has improperly ignored the doctrine of informed consent, as well as the beliefs of particular faiths and cultures that reject brain death. Rather than resolving controversies regarding brain death determinations, the Nevada amendments may instead instigate numerous constitutional challenges.

In re guardianship of Hailu: The Nevada Supreme Court casts doubt on the standard for brain death diagnosis.

In the recent court case of In Re Guardianship of Hailu, the Nevada Supreme Court cast doubt on the acceptability of the American Academy of Neurology's guidelines as a medical standard for determining brain death. The Uniform Determination of Death Act, which has been adopted in every state, requires that brain death diagnoses be made in accordance with accepted medical standards. The Court expressed concern that the guidelines fail to ensure that there is an irreversible cessation of all functions of a person's entire brain, which is a component of the Act's definition of death. Although the Nevada Supreme Court remanded the case to the District Court to hear more expert evidence concerning whether the guidelines constitute "accepted medical standards," the patient who was the subject of the case met the criteria for cardiopulmonary death several weeks prior to the hearing and the legal case became moot. As a result, the issue of whether the American Academy of Neurology guidelines, or some other criteria for determining brain death, are accepted medical standards for determining whether all brain function has ceased remains unresolved.

When Brain Death Belies Belief.

The case of Jahi McMath has reignited a discussion concerning how society should define death. Despite pronouncing McMath brain dead based on the American Academy of Neurology criteria, the court ordered continued mechanical ventilation to accommodate the family's religious beliefs. Recent case law suggests that the potential for a successful challenge to the neurologic criteria of death provisions of the Uniform Determination of Death Act are greater than ever in the majority of states that have passed religious freedom legislation. As well, because standard ethical claims regarding brain death are either patently untrue or subject to legitimate dispute, those whose beliefs do not comport with the brain death standard should be able to reject it.

Determination of Death and the Dead Donor Rule: A Survey of the Current Law on Brain Death.

Despite seeming uniformity in the law, end-of-life controversies have highlighted variations among state brain death laws and their interpretation by courts. This article provides a survey of the current legal landscape regarding brain death in the United States, for the purpose of assisting professionals who seek to formulate or assess proposals for changes in current law and hospital policy. As we note, the public is increasingly wary of the role of organ transplantation in determinations of death, and of the variability of brain death diagnosing criteria. We urge that any attempt to alter current state statutes or to adopt a national standard must balance the need for medical accuracy with sound ethical principles which reject the utilitarian use of human beings and are consistent with the dignity of the human person. Only in this way can public trust be rebuilt.

Legal Standards for Brain Death and Undue Influence in Euthanasia Laws.

A major appellate court decision from the United States seriously questions the legal sufficiency of prevailing medical criteria for the determination of death by neurological criteria. There may be a mismatch between legal and medical standards for brain death, requiring the amendment of either or both. In South Australia, a Bill seeks to establish a legal right for a defined category of persons suffering unbearably to request voluntary euthanasia. However, an essential criterion of a voluntary decision is that it is not tainted by undue influence, and this Bill falls short of providing adequate guidance to assess for undue influence.

Hypothalamic-Pituitary Function in Brain Death: A Review.

The Uniform Determination of Death Act (UDDA) states that an individual is dead when "all functions of the entire brain" have ceased irreversibly. However, it has been questioned whether some functions of the hypothalamus, particularly osmoregulation, can continue after the clinical diagnosis of brain death (BD). In order to learn whether parts of the hypothalamus can continue to function after the diagnosis of BD, we performed 2 separate systematic searches of the MEDLINE database, corresponding to the functions of the posterior and anterior pituitary. No meta-analysis is possible due to nonuniformity in the clinical literature. However, some modest generalizations can reasonably be drawn from a narrative review and from anatomic considerations that explain why these findings should be expected. We found evidence suggesting the preservation of hypothalamic function, including secretion of hypophysiotropic hormones, responsiveness to anterior pituitary stimulation, and osmoregulation, in a substantial proportion of patients declared dead by neurological criteria. We discuss several possible explanations for these findings. We conclude by suggesting that additional clinical research with strict inclusion criteria is necessary and further that a more nuanced and forthright public dialogue is needed, particularly since standard diagnostic practices and the UDDA may not be entirely in accord.