Retrospective on the Future: Brain Death and Evolving Legal
Regimes for Tissue Replacement Technology
Derek J. Jones*
In North America, the medico-legal defini-
tion of death has played an important role in
facilitating organ transplantation. In the quar-
ter century since the initial proposal of “brain
death” criteria, acceptance of the criteria has
helped standardize medical practice for the ter-
mination of life support, organ procurement
and post-mortem donor patient management.
In the author’s view, it has provided a founda-
tion for the reflection and judgments of North
American courts in so-called “right to die”
cases and even criminal trials; it has helped
some families with loved ones who lie in a
coma. Some would say that the new death
standard has, in practice, advanced the societal
value for human life. The author argues, how-
ever, that even with such benefits the new
standard raises daunting “second generational
questions” for law, medicine and bioethics.
Seen in a broader perspective, brain death
stands as one of the many fundamental pillars
in the legal regime which North American
society has erected to govem modem tissue
replacement technology. The author demon-
strates how this currently evolving regime par-
allels previous and foreshadows emerging
legal regimes for the therapeutic transfer of
human tissue, bodily parts and substances.
En Am6rique du Nord, la d6finition m6di-
cale et juridique de la mort joue un r6le
important dans les transplantations d’organes.
Depuis vingt-cinq ans, l’adoption du concept
de < mort c6r6brale >> a aid6 ]a m6decine dans
plusieurs domaines, comme Ia cessation de
traitement, l’obtention et le don d’organes.
L’auteur nous dit que ce concept a guid6 ]a
r6flexion et les jugements des tribunaux nord-
am6ricains dars des causes dites << droit de
mourir >> et m~me dans des proc~s criminels; il
a 6galement aid6 des families dont un des
membres 6tait dans le coma. Certains seraient
tent6s de dire que l’adoption du crit~re de ]a
mort c6rdbrale a eu pour effet de prot6ger
davantage la vie. L’auteur pr6tend cependant
que cette d6finition de la mort n’est pas sans
poser d’importants problmes en droit, en
m6decine et en bio6thique. Dans une perspec-
tive plus large, la mort c6r6brale constitue un
06ment fondamental du r6gime juridique
nord-am6ricain r6gissant
la technologie
modeme de remplacement des tissus. L’auteur
termine en examinant les liens entre le r6gime
actuel et les r6gimes pr6c6dents et futurs en
mati~re de transplantation th6rapeutique de tis-
sus, parties et substances du corps humain.
* Former Senior Legal Adviser, Law Reform Commission of Canada; Lecturer, McGill Univer-
sity Faculty of Law; Visiting Fellow, University of Montreal Law School Centre of Public Law
Research. I wish to thank Madam Justice Ellen I. Picard for her insightful commentary on a draft
of this essay. An earlier version of it was presented to an International Symposium on the Defi-
nition of Death and Organ Transplantation at the European Centre of Tokai University (Japan) in
Vedbaek, Denmark in August 1991.
McGill Law Journal 1993
Revue de droit de McGill
To be cited as: (1993) 38 McGill L.J. 394
Mode de r6fdrence: (1993) 38 R.D. McGill 394
19931
BRAIN DEATH
Synopsis
Introduction
I.
Brain Death: Humankind and Its Machines
A. Origins
B. Cultural Needs and Consensus
C. Limits and Consequences
H. A Broadened Perspective on Brain Death and Tissue Transfer
Regimes: Three Waves of Legal Reform
A. Anatomy Age
B. Transplant Age
C. Biotechnology Age
Conclusion
Appendix
Introduction
Brain death,’ it would seem, is a generally accepted concept in the medical
and legal communities in North America. Evidence of the acceptance comes
from the fact that hospitals, neurologists and transplant specialists now routinely
rely on brain death protocols for the determination and timing of death.’ More-
over, the concept has been adopted by provincial and model uniform legislation3
and the Law Reform Commission4 in Canada, some forty-nine states5 and the
“‘Brain death” generally refers to the irreversible cessation of brain function(s); see infra notes
4, 6, 24. For commentary on the specific criteria relied on by the medical community in diagnosing
brain death, see infra note 21.
2 See e.g. G.B. Young, “Checklist for Brain Death” (1991) 145 Can. Med. Assoc. J. 294. But see
S. Youngner et al., “Brain Death and Organ Retrieval: A Cross-Sectional Survey of Knowledge
and Concepts among Health Professionals” (1989) 261 J.A.M.A. 2205.
3Uniform Human Tissue Donation Act (1989), ss. 1, 11, in Consolidation of Uniform Acts (Fred-
ericton: Uniform Law Conference of Canada, 1991) 22-1 (1992 Supp.) [hereinafter Donation Act].
See also infra note 24.
4 Law Reform Commission of Canada, Criteria for the Determination of Death (Report 15)
(Ottawa: Supply & Services Canada, 1981) [hereinafter Report 15] (defining death as the irrever-
sible cessation of all brain functions). For a dissenting view on the need for brain death legislation,
see R.P. Kouri, “Rdflexions sur la nrcessit6 d’une ddfinition de la mort” (1983) 13 R.D.U.S. 448.
5 New Jersey Commission on Legal and Ethical Problems in the Delivery of Health Care, Prob-
lems and Approaches in Health Care Decisionmaking: The New Jersey Experience (New Jersey:
The Commission, 1990) at 11 [hereinafter New Jersey Experience]. Over half of the U.S jurisdic-
tions have enacted laws based on a model law of the National Conference of Commissioners on
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President’s Commission6 in the United States and several judicial decisions and
bioethical commissions.
But if brain death protocols and laws today enjoy general support and help
facilitate the life-saving process of transplanting organs from the deceased into
the living, it has not always been so in North America. If we cast our minds
back to national and international events of more than a quarter of a century ago,
what lessons may be drawn from the development of medico-legal reforms of
the definition of death? What, if anything, does this story counsel in terms of
the reform of laws and policies on modem tissue transplant and tissue replace-
ment technologies?
In the discussion that follows, these and like questions are examined. Part
I explores the origins, cultural rationales and current limits of brain death in
North America. Part II suggests a broader perspective on these reforms by com-
paring them with prior and more recent legal initiatives to facilitate medical
uses of the human body.
I. Brain Death: Humankind and Its Machines
Science is committed to the universal. A sign of this is that the more successful
a science becomes the broader the agreement about its basic concepts … As the
corollary of science, technology also exhibits the universalizin F tendency … If
humans create machines, machines in turn shape their creators.
May it accurately be said of modem medicine that humankind is in the
process of disappearing into the machines we have created?9 The origins of,
need for and consequences of the brain death standard portray something of a
modem effort to live outside of and harmoniously with our technological cre-
ations.
A. Origins
The origin of the brain death criteria in Canada is a story that probably par-
allels those experienced by many countries in the 1960s. Then, a series of rather
dramatic international events cumulatively forced the medical and legal com-
munities to question, rethink and then propose modifying the traditional stand-
ard of death –
irreversible heart-lung cessation.
The harbinger of change had entered the medical community decades
before the 1960s in the form of an advance in critical care technology to treat
severely impaired respiratory function. The mechanical respirator, or what the
public would initially call the “iron lung,” became part of our early techno-
Uniform State Laws; see the Uniform Determination of Death Act, 12 U.L.A. 338 (1991 Supp.).
6 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research, Defining Death: A Report on the Medical, Legal and Ethical Issues in the
Determination of Death (Washington, D.C.: U.S.G.P.O., 1981) [hereinafter Defining Death].
7See e.g. supra note 5 and infra notes 25-36.
80.B. Hardison, Disappearing through the Skylight: Culture and Technology in the 20th Century
(New York: Viking Penguin, 1988) at 142, 143, 144.
9See ibid. at 347.
1993]
BRAIN DEATH
logical response to the treatment of disabling or paralytic forms of respiratory
failure like polio:
Prolonged mechanical ventilation first became a reality in the midst of the world-
wide epidemics of poliomyelitis during the first half of this century. In Europe and
the United States, thousands of victims who suffered respiratory paralysis were
sustained for months or years with “iron lungs” and other early types of ventila-
tors.
10
How much suffering was alleviated, how many lives were saved by these
medical devices, we may never know. By the 1950s, when the advent of safe
and effective vaccines helped eliminate polio as a major public health problem,
more sophisticated and efficient respirators had made their way into critical care
areas such as the emergency units, operating theatres and anaesthesia depart-
ments of hospitals. Thus, artificial respiration technology was becoming a mod-
em standard of care when Boston doctors first successfully transplanted a
human organ –
from one twin to his ailing brother in 1954.”
a kidney –
The therapeutic benefits imparted by these machines, however, had already
begun to impose clinical and even moral burdens. What, as an eminent theolog-
ical authority of the day asked, were doctors to do when artificial respiration and
mechanical life support seemed to be the true source of life in a severely brain-
damaged individual who had been resuscitated?
If the lesion of the brain is so serious that the patient will very probably, and even
most certainly, not survive, the anesthesiologist is then led to ask himself the dis-
tressing question as to the value and meaning of the resuscitation process … Out
of this situation there arises a question that is fundamental … When … has death
occurred in patients on whom modem methods of resuscitation have been used? 12
Doctors turned to the moral authority of the Church for answers to such dilem-
mas. Pope Pius XII’s 1957 response framed the issue, its implications and chal-
lenge for decades:
The question of the fact of death and that of verifying the fact itself … or its legal
authenticity … have … in the field of morals and of religion, an even greater impor-
tance … [Tihe importance of the question extends also to effects in matters of
inheritance, marriage and matrimonial process … and to many other questions of
private and social life.
It remains for the doctor … to give a clear and precise definition of “death” and
“the moment of death” of a patient …13
These words reverberated in the early legal controversies over the medical
and legal definition of death. One of the first controversies in common law
countries arose in 1963 out of a British inquest into the death of John D. Potter,
a 32-year-old man who had received extensive brain damage during a fight.’4
‘0U.S. Congress, Office of Technology Assessment, Life Sustaining Technologies and the
Elderly (Washington, D.C.: U.S.G.P.O., 1987) at 207.
“1J.P. Merril et al., “Successful Homotransplantation of the Human Kidney between Identical
Twins” (1956) 160 J.A.M.A. 277.
12Pope Pius XII, “Prolongation of Life” (1958) 4:4 The Pope Speaks 393 at 394-95.
‘3 bid. at 396.
14R. v. Potter (1963), (U.K.) [unreported] [hereinafter Potter], discussed in (1963) 2 Brit. Med.
J. 394; “The Moment of Death: Re Potter” (1963) 31 Medico-Legal J. 195; B. Hogan, “A Note
on Death” [1972] Crim. L. Rev. 80.
McGILL LAW JOURNAL
[Vol. 38
Fourteen hours after admission to a hospital, Potter stopped breathing. To pre-
serve the possibility of transplanting his organs, doctors attached Potter to a res-
pirator for a day, secured familial consent and removed a kidney. The doctors
thereafter withdrew the respirator and Potter evidenced no signs of spontaneous
respiration. Unfortunately, the transplant recipient died within a month, though
this was the year in which Boston doctors were to perform one of the first suc-
cessful kidney transplants between a deceased unrelated donor and a living
recipient.’-
In the ensuing inquest, some of the reports adduced as evidence apparently
set the time of Potter’s death as occurring before the transplant; other reports set
the time of death afterwards. Despite such uncertainties, the neurological and
pathological medical testimony presented led a coroner’s jury to conclude that
transplantation had not contributed to death. The jury returned a verdict of man-
slaughter against Potter’s assailant. Thus was first presented what might be
called the “Potter defense”: namely, an accused’s argument that death was
caused not by the accused’s assault, but by the doctors who removed the vic-
tim’s kidneys for transplantation or by the doctors who turned off the respirator.
Though in this instance the argument had unsuccessfully exploited the diver-
gence between the traditional designation of death and modem medical prac-
tices, it still bluntly highlighted the criminal liability concerns for transplant sur-
geons, neurosurgeons and critical care medical personnel.
Some of the broader issues surrounding the Potter defense were explored
in an international multidisciplinary symposium on ethics and transplantation in
1966. Was modem society, in fact, working with two definitions of death, the
traditional “legal” one and a new “medical” one? Some conference participants
remarked that conventional death criteria created clinical and “moral” problems
for the termination of mechanical support. Others saw the criteria as impeding
transplantation, while still others debated whether five proposed criteria for
irreversible brain damage, based on neurological and pathological studies dating
from 1959, established “incontrovertible evidence of death.”‘ 6
Neither the conference nor the Potter case was explicitly mentioned two
years later, in the threshold summer of 1968, when an ad hoc committee at Har-
vard University proposed a new definition of death. The proposal spoke to the
core concerns raised by the conference two years earlier, by the Potter case in
1963 and by the Pope in 1957:
Our primary purpose is to define irreversible comas as a new criterion for death.
There are two reasons why there is a need for a definition: (1) Improvements in
resuscitative and supportive measures have led to increased efforts to save those
who are desperately injured. Sometimes these efforts have only partial success so
that they result in an individual whose heart continues to beat but whose brain is
irreversibly damaged. The burden is great on patients who suffer permanent loss
in intellect, on their families, on the hospitals … (2) Obsolete criteria for the
J.A.M.A. 347.
I5L.P. Merril et al., “Successful Transplantation of Kidney from a Human Cadaver” (1963) 185
16See G.E. Wolstenholme & M. O’Connor, eds., Ethics in Medical Progress: With Special Ref-
erence to Transplantation (London: Churchill, 1966) at 68, 74, 157.
19931
BRAIN DEATH
definition of death may lead to controversy in obtaining organs for transplanta-
tion…
More than medical problems are present. There are moral, ethical, religious and
legal issues. Adequate definition here will prepare the way for better insight into
all of these matters as well as for better law than is currently applicable. [emphasis
added]
17
The historical import and meaning of the Harvard proposal may be seen in
the fuller light of events that made 1968 a milestone year in transplant history.
In January, South African surgeon Christiaan Barnard – who had recently star-
tled the world by performing the first successful human heart transplantation –
drew further international scrutiny to the transplant community by performing
a second one less than two weeks after the death of the first recipient. The first
recipient survived 18 days; the second survived over 18 months.’
In April,
France became one of the first countries to give legal effect to a new definition
of death by adopting brain death criteria in a ministerial decree. 9 In June and
August, two international medical assemblies issued declarations on the role of
irreversible cessation of cerebral function(s) as criteria for death and in the
selection of transplant donors.2″ In November, the Canadian Medical Associa-
tion endorsed the need for new death criteria based on “cerebral function.”2 1
Hence, while the Harvard criteria were not the first to proclaim a revised stand-
ard, nor the first to give brain death legal effect, the criteria proved of such tell-
ing effect, in part, because they were so timely; in part, because they spoke
authoritatively and cogently for an emerging consensus of experience and
thought in the international medical community.
Canada was not immune from the international events and reflection, as
evidenced by the 1968 declaration of the Canadian Medical Association. The
Canadian medical community performed kidney and then heart transplants
through the 1960s. These modem practices and medical technologies eventually
combined with man’s ancient combatant rituals to oblige the Canadian legal
community to question, study and then reform the definition of death.
A criminal court room in the western province of Manitoba provided the
initial forum for change in 1970. In facts similar to those that had arisen seven
years earlier in Britain, a man named Page invoked the “Potter defense” to
1TAd Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death,
“A Definition of Irreversible Coma” (1968) 205 J.A.M.A. 337.
18C.N. Bamard, “Human Cardiac Transplantation: An Evaluation of the First Two Operations
Performed at the Groote Schuur Hospital, Cape Town” (1968) 22 Am. J. Cardiol. 584.
19Circular No. 67 of 24 April 1968 of the Minister of Social Affairs, C. Sant6 Pub. Ann. VI (Dal-
loz, 1991), reprinted in “Autopsies and Removal of Organs for Scientific or Therapeutic Purpose:
Criteria for Determining Whether Death Has Occurred” (1968) 19 Int’l Dig. Hlth. Legis. 628.
2See Council for International Organizations of Medical Sciences, CIOMS Round Table (13-14
June 1968): Heart Transplantation (Liege, Belgium: Desoer, 1969) at 51; “XXII World Medical
Assembly” (1968) 15 World Med. J. 131 at 133, 134.
2′”The Canadian Medical Association Statement on Death, November 1968″ (1968) 99 Can.
Med. Assoc. J. 1266, later revised by “Guidelines for the Diagnosis of Brain Death” (1987) 136
Can. Med. Assoc. J. 200A. See also Young, supra note 2; B. Young, W. Blume & A. Lynch, “Brain
Death and the Persistent Vegetative State: Similarities and Contrasts” (1989) 16 Can. I. Neurol.
Sci. 388.
REVUE DE DROIT DE McGILL
[Vol. 38
refute a charge that he had killed a man whom he had severely beaten.22 Page
argued that the hospital treatment of the injured man –
specifically, the
removal of decedent’s kidneys for transplant and the subsequent withdrawal of
the respirator –
had caused death. The Page jury followed the initial Potter jury
and rejected this first invocation of the “Potter defense” in Canada: it returned
a conviction for manslaughter.
Due in part to Page, the Manitoba Law Reform Commission recommended
in 1974 that Manitoba enact a legislative definition of death based on the irrev-
ersible cessation of brain function.’ The Manitoba Legislature heeded the
advice in 1975.24 A year later, the highest court of Manitoba upheld a jury’s
implicit reliance on brain death criteria after the jury rejected the Potter defense
the second time when it was raised in a Canadian criminal trial.’ Influenced by
the reforms in Manitoba and foreign jurisdictions, the Law Reform Commission
of Canada studied the issues in 197926 and recommended the enactment of a fed-
eral statutory definition of death in 1981,7 the same year that the U.S. Presi-
dent’s Commission issued its influential report which drew similar conclu-
sions.”
B. Cultural Needs and Consensus
Any narrative of the origins of brain death criteria in Canada and the
United States seems unlikely to capture the full story if it fails to speak of the
human impact that ambiguity and reform may have on cultural identity. For
22R. v. Page (6 November 1970), (Man. Q.B.) [unreported] [hereinafter Page], described in
Manitoba Law Reforn Commission, Report on A Statutory Definition of Death (Winnipeg: Man-
itoba Law Reform Commission, 1974) at 18-19.
231bid.
24An Act to Amend the Vital Statistics Act, S.M. 1975, c. 5, s. 1:
When death occurs:
2.1 For all purposes within the legislative competence of the Legislature of Manitoba
the death of a person takes place at the time at which irreversible cessation of all that
person’s brain function occurs.
15See R. v. Kitching and Adams, [1976] 6 W.W.R. 697 at 700-704, 32 C.C.C. (2d) 159 (Man.
C.A.) [hereinafter Kitching cited to W.W.R.], leave to appeal den’d (1976), 32 C.C.C. (2d) 159 note
(S.C.C.) (affirming manslaughter conviction and jury’s finding that the appellants’ assault – not
doctor’s subsequent removal of the kidneys from the brain-dead patient –
caused death). For more
recent Canadian cases, see R. v. Lenny & Lenny (6 January 1992), (Alta. Prov. Ct.) [unreported]
[hereinafter Lenny] (preliminary inquiry ordering alleged assailants of comatose 1-year-old to stand
trial for homicide); “Murder Charges against Couple Stayed in Death of Toddler” The [Toronto]
Globe and Mail (13 February 1992) A6 (homicide charge amended to aggravated assault charge
since child victim rendered comatose, but not brain dead); R. v. Green (1988), 43 C.C.C. (3d) 413
(B.C.S.C.) [hereinafter Green] (rejecting brain death standard). For a critique of Green, see Law
Reform Commission of Canada, Procurement and Transfer of Human Tissue (Working Paper 66)
(Ottawa: Supply & Services Canada, 1992) at 98 note 591 [hereinafter Working Paper 66]. For a
review of U.S. cases, see D.B. Sweet, “Annotation: Homocide by Causing Victim’s Brain-Dead
Condition” 42 A.L.R.4th 742 (1985).
23) (Ottawa: Supply & Services Canada, 1979) [hereinafter Working Paper 23].
26Law Reform Commission of Canada, Criteria for the Determination of Death (Working Paper
27See Report 15, supra note 4 at 10.
28See Defining Death, supra note 6. Compare one of the early leading legal analyses, A. Capron
& L. Kass, “A Statutory Definition for Determining Death” (1972) 121 U. Pa. L. Rev. 87.
1993]
BRAIN DEATH
within the shared customs, beliefs, values and knowledge that help identify the
culture of given peoples lie diverse communities and individuals. Even within
particular cultures, communities will often subscribe to thinking, customs and
attitudes that make them distinct. It is in this sense that the technological imper-
atives of modem respiratory therapy and transplantation bound diverse commu-
nities –
patients and their families, nurses and neurologists, theologians and
lawyers –
in a new, ill-defined technological culture that needed norms, com-
mon language and beliefs and more clearly defined roles and expectations, to
enable affected individuals and communities to interact more easily and mean-
ingfully.
Indeed, we in the technologically-laden culture of North America still need
some minimally common ways of viewing, thinking about and interacting with
our neighbour who lies hospitalized and maintained by artificial respirators and
circulators with no brain functions. Surely it matters that, under traditional cri-
teria of respiring lungs, circulating blood and a normal body temperature, we
would regard her as alive. Surely it also matters that the mechanical support she
receives has obscured and eroded the utility of the traditional standards. The
questions, suffering and uncertainty provoked by countless such scenarios in
hospitals on different continents over the last three decades have helped forge
at least four points of consensus on the substance and process of formulating a
modem concept of death in the West.
First, death is a religious, moral and legal concept,29 even if the early calls
for revised norms were sounded initially by the medical community. An emerg-
ing consensus on the clinical need for and scientific basis of revised death cri-
teria made the medical community a leading proponent of change. But Pope
Pius the XII’s 1957 discourse and the Harvard Committee’s 1968 proposal”
illustrate the early consciousness that these matters transcend the confines of
medicine and must include reflection from the theological, ethical and legal
communities.
Secondly, the removal of legal ambiguity over the modem life-death line
proved to be a major catalyst for law reform. The confusion and challenge
raised by the “Potter defense” in Britain in the early 1960s prodded legislatures
to enact and courts to adopt or affirm brain death criteria in numerous jurisdic-
tions, including Manitoba and Kansas32 in the 1970s, New York’
in 1984 and
most recently in Minnesota 4 in 1989. Beyond the criminal liability concerns,
legal reform was needed because the timing and determination of death affects
individuals’ rights and duties in inheritance, wrongful death, civil liability, fam-
29See Defining Death, ibid. at 1, 31-36; New York State Task Force on Life and the Law, The
Determination of Death, 2d ed. (New York: N.Y. State Task Force on Life and the Law, 1989) at
6 [hereinafter Determination of Death]; Report 15, supra note 4 at 15-16.
3 0Supra note 12.
3 1Supra note 17.
32 An Act Relating to and Defining Death (1970 Kan. Sess. Laws 378), upheld in State v. Shaffer,
574 P.2d 205 (Kan. 1977).
33People v. Eulo, 472 N.E.2d 286 (N.Y. 1984) [hereinafter Eulo].
34State v. Olson, 435 N.W.2d 530 (Minn. 1989); R. Cranford, “Minnesota Enacts a Brain Death
Law” (1989) 72 Minn. Med. 717.
McGILL LAW JOURNAL
[Vol. 38
ily law matters, and medical examiner and coroner cases.35 Such considerations
have persuaded the Law Reform Commission of Canada, the U.S. President’s
Commission and other public analysts to premise reform on a “unitary concept”
of death, which is to say that the revised criteria shall apply uniformly in diverse
legal contexts. 6
Thirdly, and as something of a corollary to the unitary concept of death,
many analysts agreed on the need for fair and neutral principles and procedures
in defining and applying the criteria for determining death. One professor cri-
tiqued the first brain death statute in North America,37 for example, as being
unduly biased towards transplantation, because it might lend the public percep-
tion that the law was “being re-written in favour of the potential recipient and
against the interests of the moribund donor.”3 The concern raises basic issues
of bioethical justice and the role of the law in distributing benefits and burdens
in the process of reform. These neutrality principles have helped to structure the
now routine procedural requirement that doctors involved in determining brain
death not be involved with transplant procedures.39 They have also persuaded
some legal analysts that while legal reforms might facilitate organ transplanta-
tion, transplant concerns alone did not justify modifying the legal definition of
death.4” Such concerns have more recently persuaded North American analysts
to reject amending the definition of death solely to facilitate organ procurement
from moribund anencephalic newborns.4
35See Working Paper 23, supra note 26 at 18-22. See also text accompanying note 13.
36See e.g. Report 15, supra note 4 at 12; Defining Death, supra note 6 at 60. But see the New
Jersey Declaration of Death Act, 1991 N.J. Laws 90, 5 (exemption for religious purposes),
enacted following the recommendations of the New Jersey Experience, supra note 5 at 34, 35.
37See supra note 32.
38I.M. Kennedy, “The Kansas Statute on Death – An Appraisal” (1971) 285 New Eng. J. Med.
39See e.g. Donation Act, supra note 3, s. 11(2). See also World Health Organization, “Guiding
40See Determination of Death, supra note 29 at 6. See also Report 15, supra note 4 at 12; Defin-
ig Death, supra note 6 at 1.
Principles on Human Organ Transplantation” (1991) 337 Lancet 1470, Principle 2.
946 at 947.
41Proponents of designating moribund anencephalic newborns as legally “dead” tend to ground
their proposal on the primacy of saving life and on a view that the mental and medical status of
anencephalic newborns disqualifies them from being’moral or legal “persons.” See M. Harrison,
“The Anencephalic Newborn as Organ Donor” (1986) 16:2 Hastings Centre Rep. 21. Opponents
of designating moribund anencephalic newborns as legally “dead” also place high value on saving
life. However, they reject the proposition on the basis of the general unitary and neutrality prin-
ciples outlined in the text accompanying notes 37-41 above and on the specific grounds of (a) med-
ical uncertainty in the diagnosis of brain death and anencephaly; (b) violating deontological
humanitarian ethical injunctions against treating patients as a mere means to an end; (c) slippery
slope concerns, or precedential momentum, about designating other severely disabled humans as
dead simply to expand the organ donor pool; (d) concerns about discriminating against severely
disabled persons; and (e) the alternative of donating non-vital organs or tissues after the infant has,
in fact, died. See Working Paper 66, supra note 25 at 95-106, 176; New Jersey Experience, supra
note 5 at 21-22. For the most recent North American case, see In re T.A.C.P., 609 S.2d 588 (Fla.
1992) (declining to declare live-born anencephalic infant dead for purposes of vital organ dona-
tion). For contrasting perspectives on the transplantation of anencephalic organs from a Canadian
donor to a Californian recipient, see G. Annas, “From Canada with Love: Anencephalic Newborns
as Organ Donors?” (1987) 17:6 Hastings Centre Rep. 36; T. Frewan et aL, “Anencephalic Infants
and Organ Donation: The Children’s Hospital of Western Ontario Experience” (1990) 22 Transpl.
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BRAIN DEATH
Finally, the confluence of medical, legal and theological support for reform
owed, in part, to a process that fostered multidisciplinary and intercultural edu-
cation and consensus-building. The early consensus-building process may not
have been conscious or well orchestrated. But the early Papal discourse, a2 inter-
national conferences,43 legal pronouncements’
and medical declarations,45
helped identify competing views and issues, establish a common language and
develop working relations upon which consensus builds. Later recourse to
formal public deliberations via bioethical and law reform commissions reveals
a purposive consensus-building process for defining revised norms and stand-
ards acceptable to the diverse communities affected by our technological cul-
ture.
C. Limits and Consequences
Over the two decades after they -were initially proposed, brain death criteria
have become a standard that has imparted both beneficial and untoward effects
in North America. On the positive side, the reform removes legal uncertainty,
helps specify rights and duties and facilitates modem transplant therapy. The
legal clarity aids individuals, families, the courts and medical professionals,
who may now make difficult decisions about comatose patients on the basis of
a medico-legal standard more consonant with the realities of our times.46
Despite such benefits, limitations of the standard have meant that legal
uncertainty continues in some life-death cases for minors, for some coma
patients and even for some brain-dead “cadaver-patients.” For example, the con-
tinuing lack of certainty in applying the brain death criteria to young children47
tends to breed legal conflict over whether some mechanically-sustained children
are brain dead, as illustrated by a recent case in which the New York courts
reached different conclusions on whether an infant was brain dead.”
Nor has a whole brain death standard removed burdensome legal and
moral uncertainty about whether to terminate life support for comatose patients
who retain lower brain activity, but who may lie indefinitely in a persistent
vegetative state (PVS) with no medical likelihood of recovery.49 While some
Proc. 1033; Canadian Paediatric Society Bioethics Committee, “Transplantation of Organs from
Newborns with Anencephaly” (1990) 142 Can. Med. Assoc. J. 715. For a general medical perspec-
tive, see the Medical Task Force on Anencephaly, “The Infant with Anencephaly” (1990) 322 New
Eng. J. Med. 669.
42See supra notes 12, 13.
43See supra note 20.
44See supra notes 14, 19, 22.
45See supra notes 17, 21.
46See Working Paper 66, supra note 25 at 99.
47See D.A. Shewmon, “Commentary on Guidelines for the Determination of Brain Death in
Children” (1988) 24 Annals Neurol. 789; Task Force for the Determination of Brain Death in Chil-
dren, “Guidelines for the Determination of Brain Death in Children” (1987) 37 Neurol. 1077.
4SAlvarado v. City of New York, 550 N.Y.S.2d 353 (App. Div. 1990) (reversing initial finding
that infant was brain dead). See also Dority v. Sup. Ct. San Bernardino Cnty., 193 Cal. Rptr. 287
(Cal. App. 1983).
49See Council on Scientific Affairs and Council on Ethical and Judicial Affairs, “Persistent Veg-
etative State and the Decision to Withdraw or Withhold Life Support” (1990) 263 J.A.M.A 426.
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[Vol. 38
commentators have suggested that such PVS patients – who have been esti-
mated at some 5,000-10,000 in Canadian and U.S. hospitals” –
ought to be
considered legally dead,”‘ North American public analysts have consistently
rejected the proposition.52 These circumstances helped to provoke the famous
Quinlan case53 over the withdrawal of a respirator in 1976 in the United States.
They have more recently provoked major “right to die” sequels from the
U.S. Supreme Court and the British House of Lords,54 as well as some confu-
sion in Canada over whether criminal assault that causes PVS constitutes
homicide.”
50See P. Taylor, “MDs Ponder What to Do with up to 10,000 ‘Living Dead”‘ The [Toronto]
Globe and Mail (23 August 1989) Al.
5 ISee e.g. D.R. Smith, “Legal Recognition of Neocortical Death” (1986) 71 Cornell L. Rev. 850.
52See Report 15, supra note 4 at 15-16; New Jersey Experience, supra note 5 at 13; Determi-
nation of Death, snpra note 29 at 10; Defining Death, supra note 6 at 1, 38-40.
531n Re Quinlan, 355 A.2d 647 (N.J. 1976), cert. denied 429 U.S. 922 (1976).
54See Airedale NHS Trust v. Bland, [1993] 1 All E.R. 821 (H.L.) (authorizing withdrawal of
feeding tube) and Cruzan v. Director of Missouri Health Dept., 497 U.S. 261 (1990) (patient’s con-
stitutionally protected liberty interest to decline life-sustaining treatment). The Cruzan case was
reviewed in “Symposium: Medical Decision Making and the Right to Die after Cruzan” (1991)
19:1-2 L. Med. & Hlth. Care 5. For critical analysis of U.S. right to die case law, see N. Rhoden,
“Litigating Life and Death” (1989) 102 Harv. L. Rev. 375.
55See Lenny, supra note 25. The decision in Lenny to change the initial charge from homicide
to assault seems correct on the facts presented. Variants on the case might initially seem more
vexing for the law, however. Should courts, for example, grant an injunction to prevent the termi-
nation of life-supporting medical technology for victims who lie in PVS, based on an assailant’s
fear that termination of life support would result in death and thereby subject the assailant to hom-
icide charges? Compare D. Brahmas, “Delayed Disconnection of Dead Baby from Ventilator”
(1992) 340 Lancet 1154. The logic behind the consistent rejection by the courts of the “Potter
defense” indicates that a motion for such an injunction should be denied. See Potter, supra note
14; Kitching, supra note 25; Ettlo, supra note 33. Such cases stand for the proposition that but for
the assailant’s assault one would not have suffered injury that “substantially causes” death; see E.
Colvin, Principles of Criminal Law, 2d ed. (Toronto: Carswell, 199 1) at 84-90; D. Stuart, Canadian
Criminal Law, 2d ed. (Toronto: Carswell, 1987) at 112-13. For purposes of criminal law respon-
sibility, medical (non)treatment of an injury does not generally constitute a supervening cause that
breaks the chain of causation flowing from assault to death. In Canada, see Criminal Code, R.S.C.
1985, c. C-46, ss. 224-25 [hereinafter Criminal Code]; in the United Kingdom, see R. v. Cheshire,
[1991] 3 All E.R. 670 (C.A.). To grant an injunction, moreover, might authorize nonconsensual
invasion of the patient’s person, bodily integrity and autonomy, which are protected by civil law,
common law, and Charter rights to decline life-supporting medical intervention (see the Canadian
Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Can-
ada Act 1982 (U.K.), 1982, c. 11). See Nancy B. v. L’H6tel-Dieu de Quibec, [1992] R.J.Q. 361,
86 D.L.R. (4th) 385 (Sup. Ct.); Malette v. Shulman (1990), 67 D.L.R. (4th) 321, 2 C.C.L.T. (2d)
I (Ont. C.A.); Fleming v. Reid (1991), 4 O.R. (3d) 74, 82 D.L.R. (4th) 298 (Ont. C.A.). Such non-
consensual invasion exacts the greatest injustice when the evidence indicates no likelihood of
recovery and withdrawal is either what the patient would have wanted or is in the patient’s best
interests. For many of the same reasons, nor should life-supporting medical technology necessarily
immunize criminal assailants from homicide charges, when life support is withdrawn from victims
in PVS and results in death more than a year after the initial assault. Criminal defendants might
then seek to apply the “year and a day rule,” which traditionally requires death within a year and
a day of the instigating event for culpable homicide; in Canada, see Criminal Code, s. 227. Modem
forensic sciences and life-supporting medical technology have made this 13th century rule an
anachronism that warrants abrogation or legislative reform. Some U.S. jurisdictions have in fact
abrogated the rule; see State v. Vance, 403 S.E. 2d 495 (N.C. 1991). In the meantime, purposive
and functional application of the rule should help to avoid miscarriages of justice. See generally,
19931
BRAIN DEATH
Finally, brain death criteria have helped to create a new class of mechanically-
sustained dead patients, who would seem to require new ethical and legal rules
for when they are pregnant, 6 when they are considered for gamete donation, 7
when they are used in non-consensual medical research58 and when they become
the object of dispute between hospitals and families unwilling to consent to
donation of the patients’ organs. 9 Such are some of the second generation legal
issues presented in North America after decades of reform on the legal defini-
tion of death.
II. A Broadened Perspective on Brain Death and Tissue Transfer
Regimes: Three Waves of Legal Reform
In many respects the process, merits and principles that guided the devel-
opment of brain death criteria in North America illustrate many of the dynamics
that compel modem medico-legal reforms. A look beyond brain death towards
the broader texture of Canadian laws that govern modem therapeutic transfers
of human tissues reveals a legal regime largely structured by three waves of
legal reform. The reforms began in the anatomy age, accelerated in the trans-
plant age and have continued into the biotechnology age.’
A. Anatomy Age
The first wave began three centuries after the Italian medical professor
Andreas Vesalius published his 1543 treatise De Humani Corporis Fabrica,
which ushered in the modem anatomical age:
In the autumn of 1843, some two decades after McGill University established the
first medical school in Canada, the Medical Board of Montreal petitioned the Leg-
islative Assembly of the Province of Canada to pass an Anatomy Act. The petition
was submitted after nightly episodes in which the securing, by medical school stu-
dents, of dead bodies from Montreal graveyards had provoked public outcry and
D. Walther, “Taming a Phoenix: The Year-and-Day Rule in Federal Prosecutions for Murder”
(1992) 59 U. Chi. L. Rev. 1337.
56See A. Tuffs, “Germany: Keeping a Brain-Dead Pregnant Woman ‘Alive”‘ (1992) 340 Lancet
1029; D.R. Field et al., “Maternal Brain Death during Pregnancy: Medical and Ethical Issues”
(1988) 260 J.A.M.A. 816. See also J.M. Jordan I, “Incubating for the State: The Precarious
Autonomy of Persistently Vegetative and Brain-Dead Pregnant Women” (1988) 22 Ga. L. Rev.
1102.
57See K. Nolan, “Live Sperm, Dead Bodies” (1990) 20:1 Hastings Centre Rep. 33.
58See Working Paper 66, supra note 25 at 113-17, 191; J.P. Orlowski, G.A. Kanoti & M.J. Mehl-
man, “The Ethics of Using Newly Dead Patients for Teaching and Practising Intubation Tech-
niques” (1988) 319 New Eng. J. Med. 439; J. La Puma, “Discovery and Disquiet: Research on the
Brain-Dead” (1988) 109 Ann. Intern. Med. 606; S. Martyn, “Using the Brain Dead for Medical
Research” [1986] Utah L. Rev. 1.
59Strachan v. John F. Kennedy Memorial Hospital, 538 A.2d 346 (N.J. 1988), reviewed by G.
Annas, “Brain Death and Organ Donation: You Can Have One without the Other” (1988) 18:3
Hastings Centre Rep. 28. Legal disputes over the treatment of brain-dead patients, who are iden-
tified as transplant “donors,” are by no means restricted to North America. See “L’Affaire des pr6-
lvements d’organes abusifs” Le Monde [Paris] (20 May 1992) 13 (parental suit, alleging post-
mortem theft and violation of sepulchres, against university hospital that procured organs from
brain-dead adolescent accident victim).
60For a chronological overview of these ages, see the Appendix, below.
McGILL LAW JOURNAL
[Vol. 38
calls for solutions… Accordingly, the petitioners sought an Anatomy Act to estab-
lish a regulated, legal system for supplying cadaver bodies for dissection and ana-
tomical study in the medical schools. The absence of an existing system, they
argued, hampered medical education and the practice of the healing arts, to the
public detriment. A regulated system of supply would rid the community of grave
robbing, body-selling and like black market abuses. Opponents countered that a
more appropriate source would be the bodies of criminals, that the proposed leg-
islation would legalize a “traffic in corpses,” and make public property of cadav-
ers. The debate resulted in passage of An Act to regulate and facilitate the study
of Anatomy, in December 1843.
This initiative bears striking resemblance to the dynamics and process of
reform that led to the enactment of brain death legislation. First, the initiation
came from the medical community whose needs and practices were seen as
being impeded by existing law. In this instance, an 18th century British common
law misdemeanour of indecencies62 involving dead bodies applied in Canada
and subjected medical practitioners to legal liability.63
Secondly, local and international incidents helped dramatize the need for
a public solution. The mid-19th century medical literature reported black market
shipments of cadavers between Canada and the United States and between
countries of the British Isles.’ So-called “grave robbing” incidents in Canada65
and the United States66 drew local attention to the problem. The conviction of
William Burke, for murdering individuals whose bodies he intended to sell to
anatomists, in a sensational criminal trial in 19th century Scotland67 intensified
support for a solution in the United Kingdom.
Thirdly, some consensus on legal remedies began to emerge after study of
the problem. In this instance, the model advanced in a British Parliamentary
study influenced anatomy laws in Massachusetts in 1830, in Britain in 1832 and
in Canada in 1843.6′ Canada today may thus trace its anatomy acts to the 18th
61Working Paper 66, supra note 25 at 2-3 [citations omitted].
62R. v. Lynn (1788), 2 Term Rep. 733, 100 E.R. 394 [hereinafter Lynn] (establishing disinterment
of the dead, to supply anatomy teachers, as a common law indecency offense); R. v. Davies (1828)
(Lancaster Assizes) (convicting doctor of possessing, for dissection, cadaver known to have been
unlawfully disinterred), described in U.K., H.C., Report of the Select Committee on Anatomy at
6,148 (22 July 1828) [hereinafter Select Committee Report (U.K.)].
63See F.J. Sheppard, Reminiscences of Student Days and Dissecting Room (Montreal: 1919) at
25 [printed for private circulation, available at Osler Library of McGill University Medical School]
(fining anatomy professor for “indecencies” involving the receipt of disinterred bodies). This com-
mon law misdemeanour appears to have been codified in Criminal Code, s. 182(b).
61See Erinensis, “On the Exportation of Dead Bodies from Ireland to England and Scotland”
(1828-29) 1 Lancet 774. See also D.G. Lawrence, “Resurrection and Legislation, or Body Snatch-
ing in Relation to the Anatomy Act in the Province of Quebec” (1958) 32 Bull. Hist. Med. 408
at 414 (“[T]he ‘regular channel’ was from the United States where ‘plenty of negroes were
obtained cheap, packed in casks and passed over the border as provisions, or flour’ …”).
65See Lawrence, ibid.
66See F. C. Waite, “Grave Robbing in New England” (1945) 33 Bull. Med. Libr. Assoc. 272;
.C. Waite, “The Development of Anatomical Laws in the States of New England” (1945) 233
New Eng. J. Med. 716.
67 V. Roughhead, Burke and Hare (Edinburgh: William Hodge, 1921).
68For the reports and laws of the respective jurisdictions, see Report of the Select Committee of
the House of Representatives on Legalizing the Study of Anatomy (Boston: Dutton & Wentworth,
19931
BRAIN DEATH
407
century Paris model adopted in the British Parliamentary study. Fourthly, Cana-
dian debates over whether to use executed criminals or abandoned dead immi-
grants as a source of anatomical supply, even after a general model of reform
had been identified,69 again reveal the significant role which the law may play
in allocating the benefits and burdens of medico-legal reforms.
B. Transplant Age
The technical ability of medical professionals to transfuse blood cells,
transplant tissues and implant whole organs generated a second wave of legal
reform in Canada beginning in the 1950s. The new transplant technology dif-
fered from and paralleled anatomical technology. Both created new medical
demand for the human body. But while anatomical demand emanates from the
need to study and practice interventions on the dead human body, transplant
needs emanate from direct surgical therapy for the living.
The distinction translates into practical, safety, legal and moral conse-
quences. Practically, since transplantation does not require the use of whole
human bodies, both deceased or living individuals may provide the transpfanted
material. With regard to safety, the transfer of human tissues raises concerns
both on transmitting disease through transplanted material and on protecting the
health and bodily integrity of living donors7″ and recipients.7 Legally, transplan-
tation involves the law on dead bodies, on living recipients and on non-
traditional patients: donors who undergo medical interventions not for personal
illness or injury, but for the benefit of another.72 The life saving and health pro-
Printers for the State, 1831); An Act More Effectively to Protect the Sepulchres of the Dead and
to Legalize the Study of Anatomy in Certain Cases, General Laws of the Commonwealth of Mas-
sachusetts, ch. 57 (1831); Select Committee Report (U.K.), supra note 62; Anatomy Act, 1832
(U.K.), 2 & 3 Will. 4, c. 75; Debates of the Legislative Assembly of United Canada (1843), vol.
3 (Montreal: Presses de l’tcole des hautes 6tudes commerciales, 1972) at 464-67, 1051, 1207; An
Act to Regulate and Facilitate the Study of Anatomy, S. Prov. C. 1843, c. 5.
69Working Paper 66, supra note 25 at 127-29.
7 0See e.g. Cox v. Saskatoon, [1942] 2 D.L.R. 412, [1942] 1 W.W.R. 717 (Sask. C.A.) (blood
donor injury/infection). As in other areas of medicine involving competent patients, the informed
consent doctrine functions partially to help protect the patient-donor from the involuntary assump-
tion of risk. For children, the incompetent, or others who lack the capacity to understand the nature,
risks, benefits and consequences of the intervention, rigorous substantive and procedural safe-
guards must be strictly adhered to. See E.(Mrs.) v. Eve, [1986] 2 S.C.R. 388, 31 D.L.R. (4th) 1,
61 Nfld. & P.E.I.R. 273 (rejecting substitute judgment doctrine); Cayouette et Mathieu, [1987]
R.J.Q. 2230 (Sup. Ct.) (authorizing minor’s donation of bone marrow to brother); Saskatchewan
(Minister of Social Services) v. P.(F.) (1990), 69 D.L.R. (4th) 134, 83 Sask. R. 161 (Prov. Ct.)
(upholding parental authority not to consent to liver transplant); Curran v. Bosze, 566 N.E.2d 1319
(Ill. 1990) [hereinafter Bosze] (finding parentally disputed bone marrow “donation” not in the best
interests of 3
-year-old twins); Donation Act, supra note 3, ss. 4-8; Working Paper 66, supra note
25 at 174-75; World Health Organization, supra note 39, Principle 4.
7 1See e.g. Nesom v. Tri Hawk, 985 F.2d 208 (5th Cir. 1993) (internationally contaminated tissue
used in reconstructive brain surgery); R. Simonds et al., “Transmission of Human Immunodefi-
ciency Virus Type I from a Seronegative Organ and Tissue Donor” (1992) 326 New Eng. J. Med.
726 (3 transplant recipient deaths owing to AIDS).
7 2See L. R. Shaw et al., “Ethics of Lung Transplantation with Live Donors” (1991) 338 Lancet
677. In the legal context, Canadian society must reconcile the physician’s traditional legal respon-
sibilities to ensure that patients reasonably “benefit” from surgical interventions, with the modem
REVUE DE DROIT DE McGILL
[Vol. 38
moting goals of transplantation also tend to endow these interventions with par-
ticular moral force in societies that rank human life high in the hierarchy of pub-
lic values. Could the added needs and dimensions of these new therapeutic prac-
tices be accommodated by the anatomy acts?
In Canada, the new needs inspired new law. As transplant successes moved
from simple tissues to more complex organs, the law evolved. To facilitate the
supply of cadaveric tissue, the Uniform Law Conference of Canada proposed
model comeal grafting legislation in 1959, seven years after Britain did so.73
The law, inter alia, incorporated principles from the Anatomy Acts and pro-
posed a modem tissue transfer principle whereby individuals might henceforth
bequeath their eye tissue for transplant purposes. Six years later, by the time
kidney transplants had joined comeal transplants as relatively routine therapies,
the Uniform Law Conference of Canada proposed a model human tissue act.74
It expanded the bequeathal principle into the concept of giving tissue from
either deceased or living donors, which has become the express consent model
of donation. The 1971 revision of the Act further entrenched the “gift of life
ethic” for tissue transfers by generally prohibiting the sale of tissue.75 The 1989
revision continues this ethic and expressly adopts the brain death concept.76
C. Biotechnology Age
Advances in cell fusion, cell culture and genetic engineering technologies
in the last 20 years have begun to prompt a third wave of legal reform aimed
at accommodating the advent of biotechnology. Several features of these new
tissue transfer and replacement technologies distinguish them from those of the
transplant and anatomical ages: (1) they are typically derived, by dint of sub-
stantial research and development, from human tissues or bodily substances and
genetic material; (2) they may often be preserved or “banked” indefinitely; (3)
they may yield increased quantities of natural human substances like hormones,
reality that kidney, partial lung or liver and bone marrow donors undergo varying risks and inva-
sions of their bodies with no physical benefit. See Civil Code of Qudbec, S.Q. 1991, c. 64, art. 19.
See also Criminal Code, ss. 14, 45, 268, 269, discussed in Working Paper 66, supra note 25 at
87-94 and by M. A. Somerville, “Medical Interventions and the Criminal Law: Lawful or Excus-
able Wounding?” (1980) 26 McGill L.J. 82. Compare Bosze, supra note 70 (applying psycholog-
ical benefit theory for intra-familial tissue donation).
73Compare the Uniform Cornea Transplant Act in Uniform Law Conference of Canada, Pro-
ceedings of the 41st Annual Meeting of the Conference of Commissioners on Uniformity of Leg-
islation in Canada (Victoria, B.C.: The Conference of Commissioners on Uniformity of Legisla-
tion in Canada, 1959) at 77 and the Corneal Grafting Act, 1952 (U.K.), 15 & 16 Geo. 6 & 1 Eliz.
2, c. 28 [hereinafter Corneal Grafting Act]. See also J.-G. Castel, “Some Legal Aspects of Organ
Transplantation in Canada” (1968) 46 Can. Bar Rev. 345 at 393-94.
74Human Tissue Act (1965) in Uniform Law Conference of Canada, Proceedings of the 47th
Annual Meeting of the Conference of Commissioners on Uniformity of Legislation in Canada
(Niagara Falls, Ont.: The Conference of Commissioners on Uniformity of Legislation in Canada,
1965) at 31, 104.
75 Uniform Human Tissue Gift Act (revised 1971), s. 10, in Uniform Law Conference of Canada,
Proceedings of the 53rd Annual Meeting of the Conference of Commissioners on Uniformity of
Legislation in Canada (Jasper, Alta.: The Conference of Commissioners on Uniformity of Legis-
lation in Canada, 1971) at 76, 152.
76See Donation Act, supra note 3, s. 15.
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BRAIN DEATH
which naturally occur in small quantities; and (4) as a result of the potential
therapeutic supply and initial research and development, they may prove finan-
cially lucrative and more closely associated with commerce.77
These and other features of biotechnology have already begun to generate
therapeutic advances, scrutiny and reform of the law. Consider the recent licen-
sure in North America of genetically engineered human growth hormone
(HGH), which is used to treat childhood growth disorders.” Genetically engi-
neered HGH yields purer and larger quantities of the hormone. Indeed, reports
in the international literature that cadaveric HGH was contaminated with a
lethal virus, prompted Canada and other nations to expedite the availability of
genetically engineered HGH.79 Its availability tends to make obsolete those pro-
visions in North American tissue transfer laws that have traditionally facilitated
the procurement of cadaveric pituitaries for distilling HGH. 0 The advance is not
unique. Biotechnology companies have developed or are developing genetically
engineered insulin for treating diabetes,8 blood factors for treating haemo-
philia,”2 biosynthetic skin for bum therapy, 3 genetically altered animals to prod-
uce human tissue constituents’ and cultivated human bone 5 for therapeutic
grafts and reconstructive surgery.
While such technological advances may help meet the modem therapeutic
demand for human tissues and bodily substances, they may also raise novel
legal questions. Four contexts convey the flavour of novelty. First, for instance,
who shall have predominant rights over banked human tissue? Prodded in part
77See Working Paper 66, supra note 25 at 16-18, 22, 25, 121-24; U.S. Congress, Office of Tech-
nology Assessment, Biotechnology in a Global Economy (Washington, D.C.: U.S.G.P.O., 1991) at
73-96 [hereinafter Biotechnology]. For a discussion of some early legal responses to biotechnolog-
ical concerns, including moratoria on genetic engineering research, see “Symposium: Biotechnol-
ogy and the Law: Recombinant DNA and the Control of Scientific Research” (1978) 51 S. Cal.
L. Rev. 969.
78See Genentech v. Bowen, 676 F. Supp. 301 (D.D.C. 1987).
79H.j. Dean & H.G. Friesen, “Growth Hormone Treatment in Canada: End of One Era and
Beginning of Another” (1986) 153 Can. Med. Assoc. J. 297-301. For international commentary on
contaminated cadaveric HGH and the litigation it has prompted, see J.E. Fradkin et al.,
“Creutzfeldt-Jakob Disease in Pituitary Growth Hormone Recipients in the United States” (1991)
265 J.A.M.A. 880; C. Dyer, “Families of Creutzfeldt-Jakob Disease to Sue Government” (1992)
305 Br. Med. J. 73.
8See e.g. An Act to Amend the Coroners Act, 1972, S.O. 1978, c. 95, s. 1, codified in Coroners
Act, R.S.O. 1990, c. C.37, s. 29; An Act to Amend the Public Health Law in Relation to Removal
of Pituitary Gland Tissue for the Extraction of Growth Hormone, c. 242, 1981 McKinneys Session
Laws (codified at New York Public Health Law, 4222).
81See Biotechnology, supra note 77 at 77-78.
82See Scripps Clinic v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991).
83E. Bell & M. Rosenberg, “The Commercial Use of Cultivated Human Cells” (1990) 22
Transpl. Proc. 971; L.M. Fisher, “3 Companies Speed Artificial Skin” The New York Times (12
September 1990) Dl.
84See P.J. Hilts, “Gene-Altered Pigs Produce Key Part of Human Blood: Search for Substitute”
The New York Times (16 June 1991) 1; B.J. Feder, “‘The Pharmers’ Who Breed Cows that Can
Make Drugs” The New York Times (9 February 1992) 3:9 (transgenic pigs that produce human hae-
moglobin).
85E.L. Andrews, “Next: Artificial Bone to Repair Fractures” The New York Times (24 October
1990) D10.
McGILL LAW JOURNAL
[Vol. 38
by lawsuits in the United States86 and France87 over the control and transfer of
banked reproductive tissues, some tissue banks have begun to specify more
rights and duties under different eventualities in their informed consent forms
for tissue donors and depositors.” Secondly, what legal standards shall govern
physician and patient rights and duties in an era when physicians may cultivate
the therapeutically excised tissue or cells of their patients into patented “bio-
tech” drugs or similarly commercial therapeutic agents?89 If reform analysts
tend to agree on the need for consent90 to protect a patient’s bodily integrity,
autonomy and dignity in this context, they tend to disagree over whether
express9′ or implied92 consent standards should govern. Thirdly, is processed
human eye tissue –
procured from a cadaver, purified, frozen and cut for
implantation into needy recipients as a “living contact lens” –
to be considered
natural tissue or an implantable medical device,93 for purposes of national safety
standards? The same may be asked about some 250 cadaveric human heart
valves, which were procured in Canada between 1988-1992, processed and fro-
zen in the United States and then shipped back to Canada for use in reconstruc-
tive heart surgery.94 Such questions recently prompted proposed reforms in Can-
ada95 and regulations in the United States.96 Finally, what of a $500.00 fee
charged by a company that specializes in processing such tissue? Does the fee
86York v. Jones Institute, 717 F. Supp. 421 (E.D. Va. 1989) (parental litigation to compel the
transfer of frozen embryo from one fertility clinic to another).
87Trib. gr. inst. Crdteil, 1 August 1984, Parpalaix v. CECOS, Gaz. Pal. 1984, 2e Sem. Jur.560
[hereinafter Parpalaix] (ordering restitution of deceased husband’s frozen sperm to widow),
reviewed by D.J. Jones, “Artificial Procreation, Societal Reconceptions: Legal Insight from
France” (1988) 36 Am. J. Comp. L. 525.
88Trib. gr. inst. Toulouse, 26 March 1991, Gallon v. CECOS, J.C.P. 1992.11.21807 (Annot. P.
Pddrot). In this sequel to Parpalaix, ibid., the French sperm bank successfully argued that the
informed consent form provisions instituted after Parpalaix, and agreed to by the sperm depositor,
precluded post-mortem restitution of the deceased depositor’s sperm to his widow.
89See Moore v. University of California, 793 P.2d 479 (Cal. 1990) [hereinafter Moore]; W.J. Cur-
ran, “Scientific and Commercial Development of Human Cell Lines: Issues of Property, Ethics and
Conflict of Interest” (1991) 324 New Eng. J. Med. 998. See also United States Congress, Office
of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues
and Cells (Washington, D.C.: U.S.G.P.O., 1987); C.S. Campbell, “Body, Self & the Property Par-
adigm” (1992) 22:5 Hastings Centre Rep. 34.
90See Civil Code of Quebec, supra note 72, arts. 11, 22.
91Moore, supra note 89 at 483-84. See also Working Paper 66, supra note 25 at 188-99.
92Comit6 consultatif national d’tthique pour les sciences de la vie et de la sant6, Ethique et
recherche biomidicale: Rapport 1987 (Paris: La Documentation Frangaise, 1988) at 18-21.
93See Medical Devices Regulations, C.R.C., c. 871, as amended, adopted under the Food and
Drug Act, R.S.C. 1985, c. F-27, ss. 2, 30. For U.S. commentary, see generally A.L. Schwartz,
“Annotation” 3 A.L.R. Fed. 843 (1970).
94Communication with Health and Welfare Canada and the Canadian Organ Replacement Reg-
ister. The heart valves were shipped to and processed at Cryolife, Inc., a U.S company that spe-
cializes in tissue preservation techniques and technologies. See E. Andrews, “Patents: Preserving
Tissue in Deep Freeze” The New York Times (21 December 1992) D2.
95Working Paper 66, supra note 25 at 183-84.
9656 Fed. Reg. 29177 (1991) and 57 Fed. Reg. 29001 (1992), which delay the effective date of
21 C.F.R. 870.3925. Tissue banks in the United States have instituted litigation to challenge the
new regulations. Alabama Tissue Centre of University of Alabama v. Sullivan, 975 F.2d 373 (7th
Cir. 1992) (upholding government view that processed human cadaveric heart valves constitute
implants/medical devices, subject to federal safety regulations).
19931
BRAIN DEATH
constitute a “sale” of human tissue in violation of Canadian97 and U.S.9″ law, or
are we satisfied that the monetary exchange is a legitimate fee for medical ser-
vices? The State of Minnesota recently attempted to reconcile such new techno-
logical developments with existing tissue transfer law by exempting the sale of
cell lines from its tissue sales prohibition.99 Such examples indicate that biotech-
nological advances may generate legal uncertainty, potential for conflict and
eventual reform by blurring the definitions and standards of existing legal
regimes that govern tissue transfer and replacement technologies.
Conclusion
From the broadened perspective of laws adopted in the anatomy, transplant
and biotechnology ages, brain death laws and criteria stand as a fundamental
pillar that North America has erected in a legal regime that governs the thera-
peutic transfer of human tissues and tissue replacement technology. This regime
is, perforce, structured with pillars and imbued with lessons from the three ages.
Indeed, the recent biotechnology case of Moore,” the decades old brain death
case of Potter 101 and the centuries old grave robbing case of Lynn” collectively
indicate that societal tensions and uncertainties associated with medical
advances in a particular age may erupt into legal controversies that tellingly
symbolize the need for clarity and reforms in that age. In this way, advances in
medicine regularly prod the legal regime to evolve. Changes in societal thought
and attitudes help restructure and refine the regime.
It is, thus, not surprising that nearly a quarter of a century after some of the
first jurisdictions in the West gave legal effect to a new definition of death, pro-
posals and reforms again are under way to clarify the ethico-legal status of the
human body in medicine. Much of the current activity to regulate modem tissue
transfer and replacement technologies centres, inter alia, on refining familiar
notions of consent, defining the precise role of the family in the transplant proc-
ess and addressing bodily property issues, commerce and safety, human rights
and biotechnological implications. 1″3
As medicine continues its creative therapeutic use of the human body, what
legal rules and public policies shall structure the natural, artificial and bio-
prosthetic tissue replacement technologies of the future? While a precise answer
obviously cannot be known, the lessons and broader context of the brain death
reforms suggest at least three insights about emerging and future regimes.
97 Uniform Human Tissue Gift Act, supra note 75 at s. 10 (adopted in most Canadian provinces),
as revised by s. 15 of the Donation Act, supra note 3.
9 National Organ Transplantation Act of 1984, 42 U.S.C.A. 274e, as amended (West 1991).
99Minn. Stat. Ann. 145.422 (West Supp. 1988).
‘0Supra note 89.
101Supra note 14.
“2Supra note 62.
103See e.g. World Health Organization, supra note 39, the development of which is described
by World Health Organization, “Human Organ Transplantation: A Report on Developments under
the Auspices of WHO (1987-91)” (1991) 42 Int’l Dig. Hlth. Legis. 389; Working Paper 66, supra
note 25; Donation Act, supra note 3.
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[Vol. 38
First, the merits of particular reforms shall depend on an ability to define,
articulate and rank the public principles and values that shall guide reform. Sec-
ondly, public deliberations shall prove more effective if they are cultivated
through a process that consciously attempts to identify the conflicts, ambigui-
ties, language and cultural underpinnings of reform options. Such a process has
facilitated multidisciplinary and transcultural understanding in the brain death
reforms in North America. Indeed, the process has helped to structure problem-
solving and consensus-building models relied on today for addressing other
pressing bioethical issues before society. Finally, future reforms promise more
success if they unfold with a sensitivity to the role of the law in establishing new
medico-legal norms –
its strengths and limits; its hand in clarifying and allo-
cating rights and duties; its ability to regulate, facilitate or impede the healing
arts.
Appendix
Corpus Humanum: Chronology
Anatomy Age (Circa 1540 – 1950)
1540
1543
1746
1752
1788
1815
Act authorizing Barbers and Surgeons Guild of London to receive
four executed felons annually for dissection and anatomical
study-“o
De Humani Corporis Fabrica: The father of modem anatomy
Andreas Vesalius’ anatomical treatise formed the basis of anatom-
ical study in Europe for some two centuries. The treatise on which
modem anatomy is founded.
Dr. William Hunter establishes first British anatomical and dissect-
ing school.
Act authorizing bodies of all murderers executed in London and
Middlesex to be given to Hall of Surgeons for dissection and ana-
tomical study.”0 5
R. v. Lynn, established common law criminal misdemeanour for
disinterring bodies for dissection: though exhumation for purposes
of dissection is not explicitly forbidden by the felony prohibition
on exhuming cadavers for witchcraft, such practice is still highly
indecent, “contra bonos mores,” and an indictable offence.”
Massachusetts Act to Protect Sepulchres of the Dead: $1000 fine
or one year imprisonment for exhuming or knowingly and wilfully
receiving or concealing exhumed dead bodies.’0 7
104For Barbers & Surgeons (U.K.), 32 Hen. 8, c. 42.
It5An Act for Better Preventing the Horrid Crime of Murder (U.K.), 25 Geo. 2, c. 37.
106Supra note 62.
107General Laws of the Commonwealth of Massachusetts, ch. 174 (1815).
19931
1824-29
1828
1829
1831
1832
1843
1867
1870s
1882
1892
BRAIN DEATH
Montreal Medical Institution integrates into McGill University to
become first university medical school in Canada.
R. v. Davies (Lancaster Assizes) involving common law criminal
misdemeanour for receiving and possessing corpses known to
have been illegally disinterred.’
The conviction and execution of William Burke for murdering
individuals for the sake of selling their bodies to Edinburgh anat-
omists (whence the verb “to burke,” to suffocate, to dispose of in
a disguised manner).
Massachusetts Anatomy Act, amending 1815 Act, to authorize
cadavers to be used for medical study.1″9
British Anatomy Act.”‘
Province of Canada Anatomy Act.”‘
Canadian Confederation.
McGill University Medical School Demonstrator of Anatomy
fined $50 for receiving dead bodies, as “offenses against decency.”
Bodies often obtained from Crte-des-Neiges Cemetery in ex-
change for $30-$50.
Williams v. Williams, regarded as establishing no property in
corpse rule.”2
Criminal Code of Canada enacted.”3 Section 206 (currently s.
182) criminalizes misconduct respecting dead human bodies and
remains.
Transplant Age (Circa 1950 – 2000+)
1950
1952
1954
Corneal transplant era begins.
British Corneal Grafting Act.”4
First successful organ (kidney) transplant performed in Boston
between twins, some seven years after the introduction of the arti-
ficial kidney.
First Canadian Eye Bank established in Toronto.
Uniform Law Conference of Canada proposes Uniform Cornea
Transplant Act.”5
1955
1959
‘sSupra note 62.
‘WgAn Act More Effectively to Protect the Sepulchres of the Dead and to Legalize the Study of
Anatomy in Certain Cases, supra note 68.
“Anatomy Act, 1832, supra note 68.
“‘An Act to Regulate and Facilitate the Study of Anatomy, supra note 68.
112(1882), 20 Ch. D. 659, [1881-5] All E.R. Rep. 840.
13An Act Respecting Procedure in Criminal Cases and Other Matters Relating to Criminal Law,
S.C. 1869, c. 29; An Act Respecting the Criminal Law, S.C. 1892, c. 29.
n4Supra note 73.
“5 See supra note 73.
1961
1963-65
1965
1967
1968
1970
1971
1975
1976
1981
McGILL LAW JOURNAL
[Vol. 38
British Human Tissue Act 16 repeals Corneal Grafting Act.”7
Ontario, Nova Scotia, New Brunswick enact legislation similar to
the British Human Tissue Act.”8
Uniform Law Conference of Canada, Human Tissue Act’ 9 repeals
Uniform Cornea Transplant Act.’20
First successful heart transplant performed in South Africa. Recip-
ient survives 18 days.
(1) Uniform Anatomical Gift Act proposed in U.S.
(2) Harvard University ad hoc Committee proposes “brain death”
criteria of death, which will facilitate organ donation.
Kansas becomes first North American jurisdiction to enact brain
death legislation, which the Kansas Supreme Court would uphold
six years later’ 2′
Revised Uniform Human Tissue Gift Act of Canada. 122
Manitoba legislates brain-death definition of death.”2
Multi-centre organ retrieval system established between Ontario
hospitals.
(1) First Canadian adult liver transplants undertaken. Heart trans-
plant renaissance, following general worldwide moratorium in
the 1970s.
(2) Law Reform Commission of Canada proposes brain death leg-
islation for all federal laws in Canada.
1982
Cyclosporin, an anti-rejection drug, dramatically increases sur-
vival rates for transplants.
Biotechnology Age (Circa 1980 – 2000+)
1984
Six years after one of the first medical biotechnology companies
is founded (Genentech), a California cancer patient institutes suit
against the company and his doctor, alleging that they misappro-
priated his cells and patented derivative elements thereof (a cell
line) without his knowledge or consent. The California Supreme
Court would issue its landmark ruling in the case six years later,
Moore v. University of California.24
116Human Tissue Act, 1961 (U.K.), 9 & 10 Eliz. 2, c. 54.
‘”Supra note 73.
I”8Supra note 116. See Castel, supra note 73.
“9Supra note 74.
120Supra note 73.
121Supra note 32.
‘2 2Supra note 75.
123Supra note 24.
124Supra note 89.
19931
1985
1989
1990
1991
BRAIN DEATH
(1) First Canadian paediatric liver transplant performed.
(2) Canadian patent office grants patent application for human
cell lines.
(3) Genetically-engineered human growth hormone receives fed-
eral licensure, replacing human growth hormone derived from
cadaver pituitaries.
Uniform Law Conference of Canada revises Uniform Human Tis-
sue Donation Act.”
(1) Biotechnology companies begin clinical trials on genetically
engineered blood products, skin equivalents and cell growth
factors.
(2) Following a major ruling of the Canadian Supreme Court,12 6
the Canadian Manual of Patent Office Practice is amended to
recognize, officially, that cell lines and other new microbial
life forms may be patentable subject. The amendment comes
nearly 15 years after the Canadian Patent Office granted one
of its first patents for human cell lines (#999, 546 of 9 Nov.
1976).
(1) World Health Organization adopts Guiding Principles for
Human Organ Transplants.
(2) A U.S. biotechnology company successfully breeds a transge-
nic pig to produce human blood products, and applies for pat-
ent protection for the process.
125Supra note 3.
12 6pioneer Hi-bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623, 60 D.L.R.
(4th) 223.
