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Published online by Cambridge University Press: 24 March 2025
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.
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).
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.