Organ Donation Law

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ORGAN DONATION LAW

Dramatic developments in organ and tissue transplantation have allowed persons with life-threatening illnesses a chance to live. The successful transplantation of kidneys, livers, hearts, lungs, eyes, and skin has been enhanced by better surgical techniques and new drugs, such as cyclosporin, that prevent the body from rejecting a transplanted organ. Success, however, has led to an undersupply of organs for the estimated 30,000 patients each year who need a transplant. Laws have been enacted at the state and local level that attempt to provide a better system of organ donation and distribution and to encourage individuals to volunteer to be organ donors.

The Uniform Anatomical Gift Act that was drafted in 1968 was the first effort at providing a national organ and tissue donation policy. The act created a uniform legal procedure for persons who wish to donate organs and for hospitals and medical institutions that want to accept them. Under this model act, which has been adopted in some form by all 50 states, a person of sound mind, who is at least 18 years of age, may donate all or part of his or her own body. There are several ways for a donor to record the wish to make a donation. The donor may include the donation in a will. If part of a will, the provision becomes effective immediately upon death, unlike other provisions of the will, which need to go through probate before they become effective. In practical terms, however, a will may be ineffective. Time is of the essence in organ donation, and if the will is not read for several days, it may be too late to make an effective donation.

The uniform act provides for a more common form of recording a person's intention to make an organ donation: a donor card that may be carried in a wallet. States also allow this donor information to be imprinted on a driver's license. When a person applies for a driver's license, she or he has the option of including a desire to donate organs. Despite the simplicity of this option, it has not generated the quantity of donors that proponents of the procedure expected.

A written donation must be signed by the donor and witnessed by at least two other people. A donation can be made orally, but it too must be witnessed by at least two other people. A dying patient can communicate his or her wish to donate organs to an attending physician, who can act as one of the witnesses. However, the attending physician cannot be the doctor who removes or transplants the organ.

A person can revoke in writing or orally her or his intent to make an organ or tissue donation. If a dying person is unable to communicate and has not expressed an intent to donate, a family member or guardian can make a gift of all or part of the person's body, within certain limitations. In general, even if a person has expressed the intent to donate, physicians still ask permission of a family member or guardian.

The uniform act forbids the sale of body parts. The recipient cannot pay for the donated organ but must pay for the cost of transportation and transplant. Organs and tissue can only be received by hospitals, surgeons, physicians, educational institutions involved in medical or dental research, a storage facility for these institutions, or any specified individual who needs the organ personally for therapy or transplantation.

A 1986 federal law (42 U.S.C.A. § 1320b–8) requires all hospitals participating in medicare or medicaid to implement a "required request" policy. Hospitals are required to discuss with potential donors and their families "the option of organ and tissue donation and their option to decline."

The 1984 National Organ Transplant Act (42 U.S.C.A. §§ 273 et seq.) initiated a national healthcare policy regarding organ transplantation. The act provided funds to help establish "qualified organ procurement organizations", banned the interstate sale of organs, and created a task force to study organ transplantation policy issues. The 1986 task force report was an exhaustive examination of the medical, legal, social, and economic implications of organ procurement and transplantation. The 1986 required "request law" came from one of the task force's recommendations.

Despite these legal and medical mechanisms that seek to encourage organ donation, demand has continued to exceed supply. In 1996 it was estimated that eight people died every day waiting for a transplant that never came because of the donor shortage. In response, Congress enacted the Organ Donor Insert Card Act in 1996 (Pub. L. No. 104-91, 110 Stat. 1936). The act directed the secretary of the treasury to enclose with each tax refund check in 1997 an organ donor card. It was estimated that these

cards would reach 70 million U.S. families and would result in increased donations.

The location of a potential donee of a transplant has had a significant effect on whether the donee receives an organ. In 1998, for instance, a patient awaiting a kidney transplant could expect to be on a waiting list for only 107 days in Oregon, but as long as 1,680 days in New York. A severely ill patient in one state could die while waiting, even though a patient in another state could receive a transplant before he or she was even sick enough to be hospitalized.

Because of this disparity, the health and human services department (HHS) in 1998 issued the Organ Procurement and Transplantation Network, which changed the distribution and allocation of organs by broadening transplant areas. The old system of distribution and allocation allowed organs to be distributed locally first. This policy was based on the belief that local distribution gave states and local medical institutions an incentive to promote organ donation. If the organs were to be distributed regionally or nationally, states and hospitals might conclude that successful promotion of organ donations turned the state into a supplier for other states that were not as successful in encouraging donations.

Should Dying Babies Be Organ Donors?

As many as half of the approximately 1,500 children waiting for organ transplants each year die before donors can be found. The shortage of donors has led to calls for permitting the organs of children born with the birth defect anencephaly to be donated before the children die. The issue has proved controversial, as doctors and medical ethicists debate the legality and morality of allowing the harvesting of organs from a person who is not legally dead.

Anencephaly is a birth defect that prevents the skull and brain from fully developing. While the heart and other internal organs of anencephalic infants often develop normally, most of the brain is missing. The anencephalic infant possesses a brain stem, which can keep breathing and heartbeat going temporarily. But because the cerebral cortex is missing, the infant has no thought or sensory functions and will never be conscious. Most of these infants die within hours or days of birth. Because of these bleak prospects, most of each year's 2,500 anencephalic pregnancies are aborted.

Some parents have forgone abortion but have sought to have their child's organs donated. Because the brain stem gradually fails after birth, an infant's heartbeat and breathing gradually slow until the infant dies of heart failure or stops breathing. The vital organs deteriorate, however, leaving them useless as transplants. The only way the organs can be used is if they are removed while the infant is still alive. This requirement cannot be met under current law because organ donation is premised on the dead donor rule: donors must be declared brain dead before their organs can be removed. An anencephalic infant exists in a gray area between life and death, but because the brain stem functions, he cannot be declared brain dead. Therefore, the harvesting of organs of anencephalic infants would require stretching the definition of death.

Some physicians, medical ethicists, and parents of anencephalic infants believe that such a redefinition should occur and that organ retrieval from an anencephalic infant at birth should be permitted. They argue that an anencephalic infant's profound abnormality makes it permissible to make an exception to the dead donor rule. It is a unique abnormality: the infant never experiences consciousness.

Proponents contend that, because these infants are never conscious, they do not meet the most minimal criteria for becoming a person. In 1995 the American Medical Association's (AMA) Council on Ethical and Judicial Affairs supported the idea of organ retrieval from anencephalic infants at birth on the basis that the infants' lack of consciousness meant that they could not suffer harm.

Proponents point out that it has been the parents of anencephalic infants who have sought to donate the babies' organs. As long as the harvesting of organs is done at the request of the parents and with their consent, the interests of the parents are not harmed. For these parents the desire to have some good come from the tragedy of giving birth to an anencephalic infant is the driving force in making their decision.

Finally, proponents note the shortage of organs for transplantation in children. Because of this shortage, many children die who might otherwise live a normal life if given a transplant. Some experts believe that using organs from anencephalic infants could mean up to an additional three hundred transplants a year. Faced with this prospect, proponents contend that society's interests are advanced by making a narrow exception to the dead donor rule.

Opponents are horrified at the idea of removing organs from a living infant. They contend that the dead donor rule is an important boundary in medical science. Crossing this line in the case of anencephalic infants, they contend, will cause a "slippery slope" effect. Physicians might ask to harvest organs from coma victims or from children with other severe, but nonfatal brain defects. Opponents argue that blurring the definition of brain death will have detrimental consequences to society greater than the benefit of obtaining organs from several hundred infants each year.

Critics further argue that anencephalic infants are human beings who deserve the protection of the law. They point out that, to be an organ donor, a person's entire brain must be declared dead. This means that the brain stem completely ceases to function and to produce electrical impulses and that the person has no reflexes or responses. Anencephalic infants do not meet all these criteria. They are not brain dead because the brain stem functions, they support their respiration independently, and they have responses and reflexes. These critics note that, only six months after its support of harvesting organs from anencephalic infants at birth, the AMA's Council on Ethical and Judicial Affairs reversed its decision, citing questions as to whether anencephalic infants are truly unconscious and whether they feel pain.

Though most of the critics ground their objections in ethical, moral, and religious concerns about the sanctity of human life, others have more pragmatic arguments. These critics argue that the debate itself over harvesting organs from anencephalic infants at birth harms the effort to recruit the general public as organ donors. The public may become fearful that the medical community is seeking ways to change the definition of death. The few hundred organs a year that could be gained through a change in law, these critics contend, is not worth the loss of thousands of potential donors.

Critics respect the desire of parents who wish to do something good through organ donation. Yet they contend that making parents feel better does not rank higher than society's interest in preserving human life. Unless a state passes a law that makes an exception to the dead donor rule, the use of anencephalic infants as organ sources immediately upon birth will not occur.

The new regulations angered a number of states and hospitals. The state of Wisconsin, the University of Wisconsin Hospitals, and Froedert Memorial Lutheran Hospital filed a lawsuit in federal district court, claiming that the regulations would severely reduce the number of organs available to their patients. The plaintiffs alleged that the HHS lacked legislative authority to broaden the regional organ sharing networks. In addition, the plaintiffs claimed that the regulations would injure the hospitals financially because they would have to pay a larger amount of the transplantation network's operating costs. However, in an unpublished decision, a federal district court in Wisconsin dismissed the case because the plaintiffs lacked standing to file the lawsuit.