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Transplantation and Immortality: A Selective History of Boston University’s Center for Health Law, Ethics & Human Rights

Published online by Cambridge University Press:  24 March 2025

George J. Annas
George J. Annas*
Affiliation:
Boston University School of Public Health, Boston, MA, USA; Boston University School of Law, Boston, MA, USA
*
Email: [email protected]
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Abstract

The celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the “Center”) provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 19581 and that continues to make headlines more than sixty–six years later — organ transplantation. Transplantation is useful as an illustration of the joint fields of health law, bioethics, and human rights. It is a field that grew with us from infancy to maturity during the time of the Center’s growth and that illustrates how several related disciplines — most notably law and medical sciences — are essential to the development of organ transplantation. Additionally, organ transplantation and experiments involving organ transplantation have produced some of the most spectacular cases of human experimentation. Because of both the novelty and human drama these experiments involve, I will use some of them as examples of the pivotal health law and bioethics work the Center engages in. These examples, and others that will be touched on, lead me to conclude that there is no field that matches the life and death drama of health law, especially in the human organ transplantation field. This selective history of health law at the Center, including the definition of death and the limits of surrogate consent, suggest that the legal and bioethical issues brought to us by innovative organ transplantation surgery are unlikely to be exhausted any time soon.

Keywords

health laworgan transplantationinformed consenthuman experimentationbrain death
Type
Articles
Information
American Journal of Law & Medicine , Volume 50 , Issue 3-4 , December 2024 , pp. 168 - 179
Copyright
© 2025 The Author(s). Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics and Trustees of Boston University

Introduction

Boston University’s Center for Health Law, Ethics & Human Rights faculty has studied virtually every major health law issue over more than a half century. Subjects getting the most attention include patient rights, human experimentation, informed consent, transplantation, abortion and reproductive rights, privacy, and genetics. In the health and human rights field in particular, the Center has dealt with the right to health, torture prevention, Guantanamo Bay abuses, breaking hunger strikes, the Nuremberg Code, military medical ethics, and immigration. I could write a series of summaries of publications, courses, and conferences that the Center has sponsored, but that approach to encapsulating history would likely be boring. That would be a shame, since health law is anything but boring. Instead, I will summarize almost seventy–five years of health law at Boston University by concentrating on work in what has been one of the most compelling areas of human experimentation both to scientist-surgeons and to the public: organ transplantation.

There are many reasons for this choice, but the most obvious one is that the transplant is usually done on a terminal patient who would die without it (the organ recipient) and often requires, as a necessary precondition, the death of another person (the organ donor). There is, arguably, nothing as dramatic as this “life from death” scenario in medicine. Heart transplantation ups the drama because the beating heart itself has historically been seen as the key to continued life.Footnote 2 Surgeons who focus on treating the human heart, who hold in their hands this organ that sustains human life, tend to enjoy the most prestige among the medical specialties. But it is not just prestige — cardiac specialists, especially cardiac surgeons, perform some of the most compelling experimental procedures in medicine, which has kept the public enthralled by their work. This work can even prove a bit unnerving. Shortly after performing the world’s first two human heart transplants, the surgeon, Christiaan Barnard, asked the second recipient, Philip Blaiberg, to pose for a photograph holding a jar in which his old heart was preserved”Footnote 3 Barnard then asked him: “Dr. Blaiberg, do you realize that you are the first man, in the history of mankind, to be able to sit, as you are now, and look at his own, dead, heart?”Footnote 4 What kind of a question is that for a surgeon, especially a cardiac surgeon, to ask his recovering patient? Perhaps more important, why does the public find such a question irresistible? Novelty is often compelling, as illustrated by the fact that “firsts” in transplantation almost always produce headlines. But more important, I think, is that using a dead person’s heart to give life to a dying person seems to produce a type of “resurrection” that brings with it a hint of immortality that is irresistible.

Before concentrating on organ transplantation, I will set the stage by describing the early years of the Center and the work it was doing before the first human heart transplant was performed in 1967.

The Center’s Birth

The Center was born in 1958 as the Law-Medicine Research Institute, with Professor William Curran as its head.Footnote 5 I have been the Center’s Director since 1973. From the moment of its inception, the Center concentrated on the area of regulating human experimentation. The Center’s first major publication on this subject was Clinical Investigation in Medicine: Legal, Ethical and Moral Aspects, published in 1963.Footnote 6 It was prepared by two lawyers — Irving Ladimer and Robert W. Newman — and was the first U.S. book-length publication dedicated to regulating human experimentation. The Center’s second publication was Curran’s first law school casebook in 1960, Law and Medicine: Text and Source Materials on Medico-Legal Problems, the first health law text.Footnote 7 The text contains no materials on transplantation and reflects a time in which health law was relegated to “medicine in the courtroom,” also termed “forensic medicine,” which was largely devoted to determining an individual’s cause of death or to examining psychiatric conditions that might affect criminal culpability.Footnote 8 Within a decade, the world had changed. The 1970 second edition of the Curran text included references to the Nuremberg Code, the Declaration of Helsinki, and the U.S. Food and Drug Administration’s (“FDA”) new drug amendments, as well as notes on cardiac transplantation and the consent forms for the world’s first human heart transplant.Footnote 9 My own 1990 health law text, American Health Law (written with my colleagues Sylvia Law, Rand Rosenblatt and Ken Wing), had an entire chapter devoted exclusively to organ transplants.Footnote 10 The field had arrived.

Commentary and controversy related to transplantation have continued. The period from 1989 to 1990, for example, was consumed with debate over the use of fetal tissues for transplantation into the brain.Footnote 11 The search for more organs to transplant has often overwhelmed other aspects of organ transplantation, including by leading to the search for increased supply in xenografts and artificial organs and by driving a change in the definition of death to permit an expanded supply of donor organs.Footnote 12 It is also impossible to overlook the glory and publicity that comes from being first in the world, country, or even city to perform a novel transplant. The surgeon who performed the first human heart transplant became an instant global celebrity, much more famous than the patient-recipient of the heart.Footnote 13

Expanding the Definition of Death

By the mid-1960s, a number of surgeons throughout the world were preparing to perform the first human heart transplant. The Center’s primary role during that period was furthering the discussion of how it would be possible to extract a beating heart from a potential heart donor without being guilty of murdering the donor. One way to accomplish this was by creating a new definition of “death.” The argument for a new definition of death was utilitarian: a new definition could permit ending expensive treatment on those whose brain had been irreversibly damaged and could mitigate the controversies surrounding obtaining organs for transplant. A committee at Harvard Medical School, under the leadership of anesthesiologist Henry K. Beecher, was tasked with articulating a definition of “brain death.”Footnote 14 Unfortunately, the committee decided that determining a patient was in an “irreversible coma” was the method to determine the patient was dead.Footnote 15

The committee’s approach was to expand the established definition of death — irreversible cessation of cardiac and respiratory function — by adding an alternative definition: irreversible cessation of brain activity, also termed “brain death.”Footnote 16 The majority of the text of the Definition of Irreversible Coma article was addressed to the law, and, because Curran was the only lawyer on the Committee, it seems reasonable to conclude that he wrote the “legal sections” himself.Footnote 17 It also seems reasonable to conclude that the committee was engaged in a two-step process: first, define “irreversible coma;” second, apply the new definition to patients who might be used as organ donors because people in their condition (in a confirmed “irreversible coma”) can now be considered “brain dead.” This raises the question of whether a new panel, or even a new law, is needed to adopt this two-step process to brain death. Curran argued, “No statutory change in the law should be necessary since the law treats this question [whether the person is dead] essentially as one of fact to be determined by physicians.”Footnote 18

Curran’s legal analysis was spot on. He accurately explained to the committee, and later on the committee’s behalf, why new laws were not necessary to enable physicians as a profession to adopt the committee’s new definition of “irreversible coma.” The reason, in short, is that irreversible coma is a matter of medical fact, and physicians could make this fact determination without resort to new laws or court approval.Footnote 19 Put another way, “heart death” laws were not needed to permit physicians to declare death based on “heart death” criteria, and thus no brain death laws were needed. Determination of death, even in the era of heart transplantation, was left by judges to physicians.

Nonetheless, many physicians wanted the assurance of immunity legislation, and, after many meetings and compromises, the majority of states adopted the final version of “The Uniform Determination of Death Act” in some form.Footnote 20 The Act’s definition of death is precise: “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.”Footnote 21

Uniform state laws became an almost routine way to accomplish legal change or “reform” of specific items governed by state police powers and therefore by state law. The Uniform Determination of Death Act was followed, for example, by the Uniform Anatomical Gift Act, which governs organ donation and provides wide immunity provisions for “good faith” acts done in pursuit of organs for transplantation.Footnote 22 A federal law was later enacted to prohibit the purchase and sale of human organs for transplant.Footnote 23 I testified against the federal statute in front of Al Gore’s committee, because I believed outlawing organ sales, like other regulation of transplantation, should be a matter of state law. The Center sponsored the first seminar in the US on “The Dying Patient: Medical, Ethical and Legal Issues” in 1974, which I co-taught with psychiatrist, Jesuit, and friend of the Center Ned Cassem and which included classes defining death and organ transplantation.Footnote 24

Organ Transplant Health Policy

In 1983, the Massachusetts Commissioner of Public Health established a Task Force to recommend how Massachusetts should introduce heart and liver transplantation, procedures which were not yet performed in the state.Footnote 25 These procedures were widely supported by the public, physicians, and hospitals.Footnote 26 The State’s concern was that these procedures were arguably the most expensive medical treatments available, and the State’s health planners wanted to ensure they were offered in a way to maximize benefit to the transplant recipient while still being economically efficient. I was named the Chair of the Task Force, and I had the privilege of having Leonard Glantz, one of my colleagues at the BU Center, as my de facto co-chair. With more than 100 individuals and groups providing input, the sixteen multidisciplinary members of the Task Force made six basic recommendations, excerpted or paraphrased below:Footnote 27

  1. 1. “Liver and heart transplantation should be introduced into the Commonwealth in a controlled, phased manner that provides the opportunity for effective evaluation and review of its clinical, social, and economic aspects by a publicly-accountable body[.]”

  2. 2. “The decision of when extreme and expensive medical technologies, like heart and liver transplantation, should be generally available should be made only after the clinical, social, and economic consequences of introducing the procedure, including cost-effectiveness, ethical implications, and long-term effects on society, are studied and reviewed by a publicly-accountable body.”

  3. 3. “In making a decision regarding an application for a determination of need (“DON”) for heart and liver transplantation, the Public Health Council should attempt to minimize and track the total incremental cost of adding these procedures to the health care system.”

  4. 4. Hospitals should not be permitted to offer heart or liver transplants unless they attempt to minimize and track cost, should be regulated under a certificate of need, and all transplant protocols reviewed by an Institutional Review Board (“IRB”).

  5. 5. “Patient selection criteria should be public, fair, and equitable. Primary screening should be based on medical suitability criteria made available to the public which is designed to offer transplantation to those who can benefit the most from it in terms of probability of living for a significant period of time with a reasonable prospect for rehabilitation.”

  6. 6. “If more than one hospital is granted a certificate of need to perform heart or liver transplantation, all hospitals so involved should be required to coordinate services in a way that comes as close as possible to a single, integrated medical service.”

It is not necessary to be an expert in Massachusetts medical care policy or politics to guess that this set of recommendations would be largely ignored by all four major hospitals, each of which decided that to be a “full services” hospital, it would have to offer both heart and liver transplants. Thus, in less than two years, Boston went from having no hospitals offering liver or heart transplants to having four hospitals offering or preparing to offer these procedures.Footnote 28 Prestigious medical institutions do not want to be denied the ability to offer “cutting-edge” medical practices, especially with the public perception that more, and newer, is better.

The Massachusetts experience also shows how individual transplant stories can overwhelm public policy. In this case, the story of an eleven-month-old little girl named Jamie Fiske, as well as her parents Charles and Marilyn Fiske, proved particularly compelling.Footnote 29 Jamie had biliary atresia, a disease that was uniformly fatal absent a liver transplant.Footnote 30 Charles went everywhere he could think of to look for a surgeon who would provide Jamie a liver transplant, then an experimental surgery not even available to adults in Boston.Footnote 31 Ultimately, Charles convinced surgeon John Najarian of the University of Minnesota to do the procedure.Footnote 32 In my position on the Organ Transplant Task Force, I got to know Charles a little (though maybe not well enough to call him “Charlie”), and I was with him on one occasion when he was asked, “Why didn’t you stop traveling around looking for what seemed to be the unachievable?” His response was telling. He said, “If any liver surgeon had told me to stop because my quest was futile, I would have stopped. But none ever did.” The surgery was successful, and Jamie is still alive today.Footnote 33 Of course the story did not end there. The story of Jamie Fiske being forced to travel to Minnesota (even though the University of Minnesota was a world leader in transplants) for a liver transplant was embarrassing. Her story showed that steps would have to be taken to make sure residents of Massachusetts could be treated for their conditions in Massachusetts, and that they would not have to travel nearly halfway across the United States to get treatment.

The Organ Shortage and Xenografts

The organ “shortage” seems to intensify when a surgeon-innovator needs a rationale for attempting an extraordinary procedure that would substitute for a human organ. In 2024, for example, the Massachusetts General Hospital (“MGH”) announced that it had transplanted the world’s first genetically-edited pig kidney into a living recipient, Richard Slayman,Footnote 34 who died two months after the transplant.Footnote 35 The press release announcing the pig kidney transplant employed wildly exaggerated terms, typical of past “first-of-their-kind” transplants: “Our hope is that this transplant approach will offer a lifeline to millions of patients worldwide who are suffering from kidney failure.”Footnote 36 Slayman had received a human kidney transplant in 2018 that his body rejected five years later, forcing him to begin dialysis treatments.Footnote 37 Slayman is Black, and the hospital argued that while there has been unequal access to kidney transplants for minorities, use of pig kidneys for humans “may go far to finally achieve health equity and offer the best solution to kidney failure — a well-functioning kidney — to all patients in need.”Footnote 38 We had heard this argument before.

It has been more than twenty-five years since xenografts have been on the front pages of newspapers and, based on the results from genetically modified pig hearts (Maryland, two) and pig kidneys (MGH, one), it may be some time before there are any other attempts.Footnote 39 All of the experimental subjects died within months, and, based on interviews with the patients, one could argue that the consent process was at best incomplete, the surgeons all having a conflict of interest in determining that the recipients were not eligible for human organs. In this regard, it is worth reviewing a series of three unrelated xenografts, two from the 1960s and one from the mid-1980s, that span almost three decades of the Center’s transplant work in this area to see what we can learn from these xenografts.

Dr. James D. Hardy of the University of Mississippi performed the world’s first lung transplant on John Richard Russell, a poor, uneducated, dying patient who was serving a life sentence for murder.Footnote 40 Russell survived for seventeen days following the transplant.Footnote 41 Less than seven months later, in 1964, Hardy performed the world’s first heart transplant on a human being using a chimpanzee heart.Footnote 42 The recipient of the heart, Boyd Rush, did not provide consent.Footnote 43 Like Russell, Rush was poor and dying.Footnote 44 He was brought to the hospital unconscious and never regained consciousness.Footnote 45 A search for relatives turned up only a stepsister, who signed a consent form authorizing “the insertion of a suitable heart transplant” if it should prove necessary.Footnote 46 Rush survived only two hours with the chimpanzee heart.Footnote 47

Hardy’s justifications for using the chimpanzee heart relied on the difficulties of obtaining a human heart and the apparent success of Dr. Keith Reemtsma in transplanting chimpanzee kidneys into Jefferson Davis.Footnote 48 Davis was a forty-three-year-old black man dying of kidney disease.Footnote 49 Davis describes his consent: “You told me it gonna be animal kidneys. Well, I ain’t had no choice.”Footnote 50 The operation took place on November 5, 1963; on January 6, 1964, Davis died.Footnote 51 Apparently, Hardy thought of this as a “success.”Footnote 52

In 1984, an infant known as Baby Fae was born in California.Footnote 53 Three weeks later, she died.Footnote 54 Dr. Leonard Bailey was preparing to attempt a baboon heart transplant on an appropriate recipient and he decided Baby Fae would be the subject.Footnote 55 Center faculty were actively involved in publicly commenting on the Baby Fae case.Footnote 56 Theoretically, two advances had been made since the chimpanzee transplants by Hardy and Reemtsma two decades earlier and these were used as justifications for the new xenografts: new tissue matching procedures, and a new anti-rejection drug (cyclosporin).Footnote 57 The IRB voted to approve the baboon transplant, and Baby Fae’s parents did not object to the transplant, although it is difficult to call what they provided Bailey as consent.Footnote 58 Moreover, without previously testing the xenograft on an adult patient who could consent for him or herself, it was at best premature to test it on a child. At a transplantation conference at which we both spoke, Dr. Bailey leaned over to me and said, “Tell me again why I have to wait until someone does the transplant in an adult before I can do it on a child.” The answer is that an adult can consent for themselves.

So far, xenografts have shown no promise in resolving the organ shortage, and the use of pig organs is discussed mostly in the business section of major newspapers.Footnote 59 This is a forum where people selling stock in their biotech companies do not have to present any facts to encourage people to sign up for whatever they are selling, and where people expect gross exaggeration of their prospects (e.g., looking forward to millions of pig transplants).Footnote 60 There have been two other approaches to increasing the supply of organs for transplant, one on hold (at least for now) and the other a subject of experimentation in a number of countries: artificial hearts and “heart dead” donors, respectively.

Informed Consent to Heart Transplantation: Human and Artificial

The world’s first human-to-human heart transplant was carried out in South Africa by Dr. Christiaan Barnard in 1967.Footnote 61 It was an extraordinary “first of its kind” experiment that caught the imagination of the world.Footnote 62 The most important legal question, in addition to the death of the donor, was the quality of the consent by the patient-recipient, Louis Washkansky. For that analysis we could rely on the late Yale Law School psychiatrist Dr. Jay Katz, a friend of the Center and the world’s foremost expert on informed consent. Katz applied a psychoanalytic explanation of the doctor-patient relationship, complete with transference and countertransference.Footnote 63 He noted that “[m]agical and hopeful expectations exist side-by-side with expectations of cruel disappointment.”Footnote 64 Barnard ultimately decided not to press his subject about the risks of what could (and was likely to) go wrong.Footnote 65 According to Barnard’s appraisal of the matter, Washkansky really had no choice but to accept the heart transplant or die. In Barnard’s own words:

For a dying man, it is not a difficult decision because he knows he is at the end.

If a lion chases you to the bank of a river filled with crocodiles, you will leap into the water convinced you have a chance to swim to the other side. But you would never accept such odds if there were no lion.Footnote 66

About twenty years later, Surgeon William DeVries, then at the University of Utah, was faced with the question of how to obtain informed consent for an implantable artificial heart from his prospective patient-recipient Barney Clark.Footnote 67 Although the machine was often referred to as a fully implantable heart, the pumping system was external and about the size of a small refrigerator, severely limiting a patient’s mobility.Footnote 68 Asked to explain why he was willing to proceed despite the mobility problems imposed by the external pumping system, DeVries responded, “The key is informed consent. Why should I let people die when I can give them a chance to live— if they are willing to accept the limitations of the external pumping system?”Footnote 69 After Clark signed an elaborate consent form and had his heart replaced by a mechanical Jarvik-7 artificial heart, he spent the rest of his life in an intensive care unit.Footnote 70

Don DeLillo published his meditation on technology masterpiece, White Noise, shortly before Bill Schroeder got his artificial heart.Footnote 71 Although they did not know each other, DeLillo and Schroeder were united by a quest to use modern technology to confront death. As DeLillo encourages all of us:

You could put your faith in technology. It got you here, it can get you out. This is the whole point of technology. It creates an appetite for immortality on the one hand. It threatens universal extinction on the other… . It’s what we invented to conceal the terrible secret of our decaying bodies. But it’s also life, … it provides new organs for those that wear out. New devices, new techniques every day. Lasers, masers, ultrasound… . God’s own goodness.

Humans are not, of course, immortal— but we can pretend that technology is, and we seem to have a religious faith that technology will be there to take care of us when we need it.Footnote 72

The experiment testing the ability of the Jarvik-7 to sustain life was planned to include seven subjects.Footnote 73 After Barney Clark died, the experiment was terminated at Utah and transferred to Humana Heart Institute in Louisville.Footnote 74 It was in Louisville that I met with Dr. DeVries to discuss the experiment, which I was critical of. I also spoke with the second subject in the series, William Schroeder. I met with him and his wife at an apartment built for him across the street from the hospital. Ultimately, none of the four people DeVries implanted the Jarvik-7 into were able to recover sufficiently to go about any semblance of normal life, and the experiment was ended.Footnote 75 The field moved back to where it had been before Barney Clark: transplanting human hearts.

The night Bill Schroeder died, Nightline dedicated its program to discussing the future of the artificial heart.Footnote 76 I appeared together with surgeon Denton Cooley.Footnote 77 Cooley had performed the first artificial heart as a “bridge” to a human heart prior to DeVries using the Jarvik-7 as a permanent device.Footnote 78 I argued that we should halt all artificial heart implants at least until the pumping system was made portable and recipients could return to normal activity.Footnote 79 Cooley, unsurprisingly, did not agree.Footnote 80 In real life, the Jarvik-7 experiment effectively ended with Bill Schroeder’s death. At the Center, we began paying more attention to fiction in imagining our future. I wrote a play, titled “Shelley’s Brain,” about a brain transfer, which we produced both in the classroom (were our students coerced?) and at a variety of national bioethics meetings. Michael Grodin, meanwhile, offered a “Literature and Medicine” seminar for more than thirty years that gave medical students a chance to, among other things, use poetry to explore medicine.

Still Looking for More Organs to Transplant

Few readers will be surprised that the search for an answer to the “organ shortage” continues with no end in sight. Currently, the most popular method is to revert to “cardiac death” followed by various types of circulatory support to preserve organs for transplant. These new methods are both confusing and controversial, and there is simply insufficient clarity (and space) to explain these considerations in sufficient detail here. An example of the current confusion is, however, offered by NPR, whose science reporter accompanied a transplant surgeon who used “cardiac death” to declare a patient dead in the operating room.Footnote 81 Calling some of the suggested attempts to go back to heart (circulation) death “normothermic regional perfusion” (“NRP”) does not make the experimental organ retrieval method easier to understand. The justification for using cardiac death is that it can “save more lives” by increasing the supply of organs for transplantation and/or the quality of the organs because, after death is declared, the heart is resuscitated so that the organs can be perfused in the now-deceased person.Footnote 82 NPR listeners would have had to use at least some imagination to picture what was being described from inside a Tennessee Hospital:Footnote 83

[The] hospital staff silently line the hallway for an ‘honor walk.’ The donor is slowly wheeled past them on the way to a room adjacent to the OR where doctors will remove her breathing tube. Her family quietly walks behind her bed.

The organ donor’s family could be forgiven for being confused. The donor, we later learn, is not dead during the “honor walk” and will not be declared dead until her breathing has stopped for at least five minutes after she is removed from the ventilator (some protocols require up to ten minutes, others as little as three).Footnote 84 Following this, the two nurses will say, “She has passed.”Footnote 85

NRP uses donors who are comatose but not dead, and whose family agrees to allow health care providers to withdraw life support and harvest organs.Footnote 86 Once the person is removed from life support, the goal is for the heart to cease beating, then death (based on cardiac death criteria) is declared and the person’s heart is restored to provide oxygenated blood to the organs, which will then be transplanted (hopefully) more successfully due to the added circulation provided to the organ prior to transplant.Footnote 87 Re-starting the heart after declaring death seems to negate the declaration of death because the heart did not “irreversibly” cease to function, but has seemingly been “brought back to life.” At the very least this is “kind of a creepy thing to be doing,” comments Dr. V. Eric Thompson, a heart transplant surgeon from Yale.Footnote 88

It seems there will always be new suggestions to increase the supply of human organs, and surgeons ready to try them out on potential organ donors. It is one of the many challenges to health law and bioethics to help set the rules for such trials, including the continuing relevance of the “dead donor rule,” which states simply that it is unlawful to kill a potential donor for their organs.Footnote 89 The only rationale for these new cardiac death procedures is to increase the number of donated organs for transplant. But how? This method, even if it did not violate the “dead donor rule,” could not possibly “solve” the organ donor shortage any more than various approaches before have failed, including “required request.”Footnote 90 The organ recipient list is an arbitrary construct built on two easily manipulable variables: recipient selection criteria and donor selection criteria.Footnote 91 As the number of organs available for transplant increases, the selection criteria will naturally expand, and the organ shortage will appear to get worse. It is as if the organ donor “shortage” is more of an advertising strategy to encourage organ donation. We appear to be focusing our public relations effort on increasing organ donations, rather than on redirecting more of our resources into disease prevention. As one organ transplant official suggested in the midst of an epidemic of opioid overdose deaths, the increase of organs from newly deceased drug overdose victims is “an unexpected silver lining to what is otherwise a pretty horrendous situation.”Footnote 92

Transporting Organs

I conclude this romp through a brief history of the Center for Health Law, Bioethics & Human Rights with a line from Bob Dylan’s “My Own Version of You”Footnote 93 and a flight on Air France to Paris.Footnote 94 The Dylan line can be seen as an overview of the article: “Looking for the necessary body parts. Limbs and livers and brains and hearts.”Footnote 95 The Air France fight can be seen as transplantation’s unending quest: flying around the world in search of fresh organs to transplant and novel procedures to perform. Transplant surgeons, patients, and donors have all contributed to health law and bioethics, especially by becoming the primary characters in the often-interwoven histories of the fields. The most recent “substantial advancement” in the field of organ transplantation was reported in mid-2024 in the Lancet: “[f]or the first time, a heart transplant has been successfully performed after transport of a donor heart across the Atlantic Ocean, marking a substantial advancement in the realm of organ transplantation.”Footnote 96 By now we know the claim will always be that a new development will reduce the organ donor shortage, and here we were not disappointed. To save money, the organ collectors flew coach on Air France.Footnote 97 In their words, “The successful outcome in our report may be a monumental breakthrough in heart transplantation allowing for increased access to unused donor hearts that can now be used and safely transported across vast distances [from Guadeloupe and Martinique to Paris].”Footnote 98 It is, of course, good that a few more organs can be made available for transplant at a reasonable cost. But “monumental breakthrough” indeed. I’m more persuaded by DeLillo’s characterization of technology tasked to prolong life as “God’s own goodness.”Footnote 99 Or is it the creation of a mad scientist, as Dylan suggests?Footnote 100

It has been a privilege to have spent most of my life working with my colleagues at the Boston University Center for Health Law, Ethics & Human Rights. In this article, I have summarized some of the legal and ethical issues we have studied and commented on over the past seventy years. It is notable how often similar ethical and legal quandaries present themselves in multiple contexts, yet are treated in both the popular press and academic journals as almost entirely new. A good example is the organ shortage which is regularly revived as a justification to attempt novel experiments, including using xenografts and artificial organs to prevent death. We have very short memories, and often prefer to be entertained rather than educated. The Center is dedicated to maintaining a health law field that incorporates bioethics and human rights while avoiding the traps of super-specialization and sensationalism.

References

1 See Law-Medicine Research Institute, Bos. Univ., https://www.bu.edu/timeline/1958/02/28/law-medicine-research-institute/ [https://perma.cc/3X6K-6VCA] (last visited Sept. 26, 2024); see also William J. Curran & Donald Hayes Russell, The Boston University Law-Medicine Institute After Ten Years, 49 B.U. L. Rev. 1 (1969); Law School Newsletter, Student Law. J., Nov. 1970, at 36, 38 (describing the inaugural 1970 pilot program of the newly renamed Center for Law and Health Sciences); Stephen M. Wiener, Guest Organization: Report on the Center for Law and Health Sciences, 5 Am. J.L. & Med. 125 (1979) (providing an overview of the Center’s activities in the 1970s).

2 See, e.g., Vincent M. Figueredo, The Curious History of the Heart: A Cultural and Scientific Journey (2023).

3 Philip Blaiberg, Looking at My Heart 133–34 (1968).

4 Id. at 134.

5 See Curran & Russell, supra note 1, at 1.

6 Law-Med. Rsch. Inst., Clinical Investigation in Medicine: Legal, Ethical, and Moral Aspects (Irving Ladimer & Roger W. Newman eds., 1963).

7 William J. Curran, Law and Medicine: Text and Source Materials on Medico-Legal Problems (1960) [hereinafter Curran, Law and Medicine]; William J. Curran, Law-Medicine Institute at Boston University, 79 Pub. Health Rep. 743, 744 (1964), (explaining that this “first teaching text” in the field of health law was developed in response to early medico-legal courses and seminars at Boston University).

8 See Curran, Law and Medicine, supra note 7; see also Arnold J. Rosoff, Health Law at Fifty Years: A Look Back, 14 Health Matrix 197, 198 (2004).

9 These topics are addressed in Chapter 10, entitled “Innovations in Medicine,” of William J. Curran & E. Donald Shapiro, Law, Medicine, and Forensic Science (Little, Brown & Co., 2d ed. 1970) (1960).

10 George J. Annas, Sylvia A. Law, Rand E. Rosenblatt & Kenneth R. Wing, American Health Law 855–920 (1990).

11 George J. Annas & Sherman Elias, The Politics of Transplantation of Human Fetal Tissue, 320 New Eng. J. Med. 1079, 1079 (1989).

12 See discussion infra p. 7 (chronicling the expanded determination of death); discussion infra pp. 11–12 (discussing xenotransplantation and artificial organs).

13 See discussion of Doctor Christiaan Barnard, infra text accompanying notes 61–66.

14 Ad Hoc Comm. of the Harv. Med. Sch. to Examine the Definition of Brain Death, A Definition of Irreversible Coma, 205 J. Am. Med. Ass’n, 85, 85 (1968) [hereinafter A Definition of Irreversible Coma]; see also Michael Nair-Collins, Expanding the Social Status of “Corpse” to the Severely Comatose: Henry Beecher and the Harvard Brain Death Committee, 65 Perspectives Biology & Med. 41, 43 (2022) (describing Beecher’s leadership role).

15 A Definition of Irreversible Coma, supra note 14, at 85–86.

16 Id. at 85, 87.

17 See id.; see also Nair-Collins, supra note 14, at 46–47, 49–50, 52, 54 (discussing Curran’s contributions to the Committee).

18 A Definition of Irreversible Coma, supra note 14, at 87.

19 See i d. at 87.

20 Forty-one states, the District of Columbia, and the U.S. Virgin Islands have enacted the Uniform Determination of Death Act. Determination of Death Act, Unif. L. Comm’n, https://www.uniformlaws.org/committees/community-home?CommunityKey=155faf5d-03c2-4027-99ba-ee4c99019d6c [https://perma.cc/TQ9K-EJQB] (last visited Sept. 23, 2024).

21 See Unif. Determination of Death Act § 1 (Nat’l Conf. of Comm’rs on Unif. State L. 1980); see also President’s Comm’n for the Study of Ethical Problems in Med. & Biomed. & Behav. Rsch., Defining Death: A Report on the Medical, Legal and Ethical issues in the Determination of Death (1981).

22 See Unif. Anatomical Gift Act (Nat’l Conf. of Comm’rs on Unif. State L. 1987).

23 See National Organ Transplant Act, 42 U.S.C § 274e (1984).

24 See Ned H. Cassem & Rege S. Stewart, Management and Care of the Dying Patient, 6 Int’l J. Psychiatry Med. 293, 298–302 (1975).

25 Mass. Task Force on Organ Transplantation, Report of the Massachusetts Task Force on Organ Transplantation 3 (1984).

26 Id. at 5–6.

27 I d. at 1.

28 See 70 Years of Groundbreaking Transplants, Mass. Gen. Brigham (Apr. 25, 2024), https://www.massgeneralbrigham.org/en/about/newsroom/articles/transplant-milestones [https://perma.cc/7WDT-UG8B]; History and Milestones, Brigham & Women’s Hosp., https://www.brighamandwomens.org/surgery/history-and-milestones [https://perma.cc/3BNN-EU6P] (last visited Oct. 7, 2024); A History of Improving Care for All, Beth Israel Lahey Health, https://www.bidmc.org/about-bidmc/a-history-of-improving-care-for-all [https://perma.cc/6H8P-5KTQ] (last visited Oct. 7, 2024); Tripp Underwood, Spring 2024: 30 Years of Saving Lives, Bos. Child.’s Hosp. Pediatric Transplant Ctr., https://transplanttalk.childrenshospital.org/lifestyle/spring-2014-30-years-saving-lives/ [https://perma.cc/P92W-88EJ] (last visited Oct. 7, 2024).

29 Univ. of Minn. Dep’t of Surgery, She Needed a New Liver. Her Parents Made Her Famous, YouTube (June 13, 2023), https://www.youtube.com/watch?v=D0vkBoB4Dmk.

30 Id.

31 Clark C. Havighurst & Nancy M. P. King, Liver Transplantation in Massachusetts: Public Policymaking as Morality Play, 19 Ind. L. Rev. 955, 955, 957 (1986); Infant Girl Undergoes a Liver Transplant, N.Y. Times (Nov. 6, 1982), https://www.nytimes.com/1982/11/06/us/around-the-nation-infant-girl-undergoes-a-liver-transplant.html.

32 Univ. of Minn. Dep’t of Surgery, supra note 29.

33 Id.

34 Brandon Chase, World’s First Genetically-Edited Pig Kidney Transplant into Living Recipient Performed at Massachusetts General Hospital, Mass. Gen. Hosp. (Mar. 21, 2024), https://www.massgeneral.org/news/press-release/worlds-first-genetically-edited-pig-kidney-transplant-into-living-recipient.

35 An Update on Mr. Rick Slayman, World’s First Recipient of a Genetically-Modified Pig Kidney, Mass. Gen. Hosp. (May 11, 2024), https://www.massgeneral.org/news/rick-slayman-family-and-mgh-statements [https://perma.cc/A5EL-FW3B].

36 Chase, supra note 34.

37 Id.

38 Id.

39 David Bennett received the first ever pig-heart transplant at the University of Maryland Medical Center on January 7, 2022. He died on March 8, 2022. Muhammad M. Mohiuddin, Graft Dysfunction in Compassionate Use of Genetically Engineered Pig-to-Human Cardiac Xenotransplantation: A Case Report, 402 Lancet 397, 397, 408 (2023); A Man Who Got the 1st Pig Heart Transplant Has Died After 2 Months, NPR (Mar. 9, 2022, 10:58 AM), https://www.npr.org/2022/03/09/1085420836/pig-heart-transplant [https://perma.cc/G8M5-RHT8]. Lawrence Faucette received the world’s second pig-heart transplant at the University of Maryland Medical Center on September 20, 2023. He died on October 30. Aliya Uteuova, World’s Second Human Recipient of Pig Heart Dies Six Weeks After Operation, Guardian (Nov. 1, 2023, 1:29 PM), https://www.theguardian.com/society/2023/nov/01/pig-heart-transplant-faucette-dies [https://perma.cc/7TAG-8VBA].

40 Jürgen Thorwald, The Patients 217–18 (1972).

41 Id. at 230.

42 Id. at 247–48.

43 Id. at 242.

44 Id. at 234–35, 238–39, 242.

45 See id. at 234–48.

46 Id. at 246.

47 Id. at 248–49.

48 Id. at 239–40.

49 Id. at 201–03.

50 Id. at 205.

51 Id. at 206, 211.

52 Id. at 239.

53 George J. Annas, Baby Fae: The ‘Anything Goes’ School of Human Experimentation, Hastings Ctr. Rep., Feb. 1985, at 15.

54 See id. at 17.

55 See id. at 16

56 See id. at 15.

57 Id.

58 Id. at 16.

59 See, e.g., Brian Gormley, EGenesis Raises $191 Million for Transplants of Genetically Edited Pig Organs, Wall St. J. (Sept. 4, 2024, 6:00 AM), https://www.wsj.com/articles/egenesis-raises-191-million-for-transplants-of-genetically-edited-pig-organs-522cbd98, [https://perma.cc/473A-UKTB].

60 See Chase, supra note 34.

61 David K. C. Cooper, Christiaan Barnard: The Surgeon Who Dared 187 (2018).

62 See id. at 199–204.

63 Jay Katz, The Silent World of Doctor and Patient 142–48 (John Hopkins Univ. Press 2002).

64 Id. at 144.

65 Christiaan Barnard & Curtis Bill Pepper, One Life 261 (1969).

66 Id. at 261-62.

67 NOVA: The Artificial Heart, at 5:20 (PBS television broadcast Oct. 13, 1983).

68 Id. at 32:20 (showing Robert Jarvik demonstrating the original 375-pound cart model).

69 Id. at 5:25.

70 Id. at 8:21; Lawrence K. Altman, Barney Clark Dies on 112th Day with Permanent Artificial Heart, N.Y. Times (Mar. 24, 1983), https://www.nytimes.com/1983/03/24/obituaries/barney-clark-dies-on-112th-day-with-permanent-artificial-heart.html [https://perma.cc/RQ22-JBA2].

71 Don DeLillo, White Noise (1985).

72 See id. at 285. See id. § 37.

73 Phillip M. Boffey, F.D.A. Sets Rules on Artificial Heart Implants, N.Y. Times (Jan. 9, 1986), https://www.nytimes.com/1986/01/09/us/fda-sets-rules-on-artifical-heart-implants.html [https://perma.cc/V9TY-K627].

74 See Renée C. Fox & Judith P. Swazey, Spare Parts: Organ Replacement in American Society 112, 117 (1992) (discussing the death of Barney Clark on March 23, 1983 and the experiment’s relocation to Kentucky on July 31, 1984).

75 F.D.A. Withdraws Approval for Jarvik-7 Heart, N.Y. Times (Jan. 11, 1990), https://www.nytimes.com/1990/01/11/us/fda-withdraws-approval-for-jarvik-7-heart.html [https://perma.cc/DR4F-EVLF].

76 Nightline: Fate of the Mechanical Heart (ABC television broadcast Aug. 6, 1986).

77 Id.

78 See Charles Marwick, Pondering Past, Future of Implantable Heart, 254 J. Am. Med. Ass’n. 3288, 3291 (1985) (discussing Cooley’s view that the main role of the implants was to serve as an intermediate before a human heart transplant).

79 Nightline: Fate of the Mechanical Heart, supra note 76.

80 Id.

81 See Rob Stein, Doctors Try a Controversial Technique to Reduce the Transplant Organ Shortage, NPR (July 8, 2024, 5:44 AM), https://www.npr.org/sections/shots-health-news/2024/07/08/nx-s1-4896568/transplant-organ-shortage-nrp-normothermic-regional-perfusion [https://perma.cc/2HP6-D6A].

82 See id.

83 Id.

84 See id. James L. Bernat et al., The Circulatory-Respiratory Determination of Death in Organ Donation, 38 Critical Care Med. 963, 967, 969 (2010) (concluding that the routine waiting time of 2 to 5 minutes is appropriate for best practices in organ donation).

85 Id.

86 See Joseph Goldstein, When Does Life Stop? A New Way of Harvesting Organs Divides Doctors, N.Y. Times (Nov. 22, 2023), https://www.nytimes.com/2023/11/22/nyregion/organ-donors-transplants-legally-dead.html [https://perma.cc/AQP3-AV89].

87 See id.

88 Id.

89 John A. Robertson, The Dead Donor Rule, Hastings Ctr. Rep., Nov.–Dec. 1999, at 6, 6.

90 See Laura A. Siminoff et. al., Consent to Organ Donation: A Review, 23 Progress Transplantation 99, 99–101 (2013) (describing complete failure of the “required consent” rule to increase consent rates).

91 See 42 C.F.R. § 482.90 (2024).

92 See Katharine Q. Seelye, As Drug Deaths Soar, a Silver Lining for Transplant Patients, N.Y. Times (Oct. 6, 2016), https://www.nytimes.com/2016/10/06/us/as-drug-deaths-soar-a-silver-lining-for-organ-transplant-patients.html (quoting Alexandra K. Glazier, Chief Executive of the New England Organ Bank).

93 Bob Dylan, My Own Version of You, on Rough and Rowdy Ways (Columbia 2020).

94 Guillaume Lebreton & Pascal Leprince, Successful Heart Transplant After 12h Preservation Aboard a Commercial Flight, 403 Lancet 1019 (2024).

95 Dylan, supra note 93, at 00:17.

96 Lebreton & Leprince, supra note 94, at 1019.

97 Id.

98 Id.

99 See DeLillo, supra note 71, at 285.

100 Dylan, supra note 93.