Congress established the Organ Procurement and Transplantation Network (OPTN) in 1987 to improve the efficiency of the nation’s transplantation system. OPTN includes all transplant hospitals and organ procurement organizations (OPO’s) in the United States. It is governed by a board of directors that can adopt binding policies for members, subject to approval by the Secretary of HHS. United Network for Organ Sharing is currently under contract to operate the system.
Several changes to OPTN policy were submitted for public comment this spring. One would substitute “Donation after Circulatory Death” for “Donation after Cardiac Death” (DCD). The aim was to conform terminology to accepted definitions of death. The proposal, however, would permit each transplant hospital to set the interval for determining when cessation of circulatory function was irreversible. As a result, hospitals could establish shorter periods between withdrawal of life-support and declaration of death than the five minutes recommended by the Institute of Medicine. This would better ensure that organs remained suitable for transplant, but at the expense of patients’ spontaneous revival.
The proposal would also require OPO’s to consider as potential DCD donors patients whose “disease” rendered them irreversibly dependent on life-support, even though their condition was not terminal and irreversibility was often an educated guess.
Commenters challenged the proposal’s refusal to keep separate the decision to donate organs from that to withdraw life-support. The potential for undue influence this creates is obvious. Those surviving catastrophic injuries, for example, often adjust to their condition over time and, despite dependence on life-support, can lead meaningful lives. They and their families are most vulnerable at the onset of the injury and most open to the suggestion of those required to identify “unrealized donor potential” that they can salvage some good through ending their lives and giving their organs to others. Even the OPTN Ethics Committee did “not agree with the OPO approaching the family prior to decision to withdraw treatment or support.”
As Dr. Joseph Fins, a leading neurologist, described the problem in a posting this March on the American Medical Association’s Virtual Mentor:
One of the most powerful scenes, often repeated, occurs early in the course of care, when patients are still in the ICU: surrogates are approached for organ donation. After the patients survive and recover to varying degrees of function, these families still resent what is often described as the predatory behavior of OPO representatives. Many families report zealous attempts at procurement and a near-certainty about their loved one’s prognosis: death was inevitable, ventilators should be withdrawn, and organs should be redirected for some greater good. But with valuable hindsight, families later ask, how did they know? And how could they have been so wrong, both medically and perhaps ethically?
The proposal contains no safeguards to ensure that such patients, when conscious, are competent to make donation decisions. There are no safeguards to ensure that such patients are not clinically depressed. There are no safeguards to ensure that members of the OPO or primary health care team are trained to identify such depression. In fact, there are virtually no safeguards at all to ensure that the donation decision by patients or families is voluntary.
What safeguards there are, that “no member of the Organ Recovery team or OPO staff may guide or administer palliative care, or declare death” and that “no member of the Transplant Center surgical team may be present for the withdrawal of life-sustaining medical treatment or ventilated support [,]” provide no real security from undue influence. The former applies after the decision to withdraw life-support is made; the latter comes at a time when family may not even be present rather than the time they are most susceptible to pressure, when they are wrestling with whether to withdraw life-support. It is difficult to avoid the conclusion that effective safeguards were thought unnecessary because such patients were considered more valuable when dead.
Further, by extending DCD candidacy to patients whose “disease” is not necessarily terminal but that otherwise renders them dependent on life-support, the proposal singles out a class of persons, disabled under federal civil rights law, for adverse treatment. Commenters warned this could jeopardize UNOS’ relation with HHS which is forbidden from entering into contractual arrangements with the purpose or effect of discriminating against people with disabilities.
Only Seven days after the comment period for the DCD changes ended, OPTN proposed a 225 page “plain-language” rewrite of its transplantation policies. The announcement claimed that the rewrite had altered nothing of substance. That claim was false. The rewrite incorporated the proposed changes to DCD policy that had been the subject of public comment and that the OPTN Board had yet to consider. It is hard not to believe that a decision was made to leave the proposed DCD changes unaltered well before their comment period ended and that those who took the time to submit substantive comments were drawn into a futile gesture.
At its meeting this June, the OPTN Board adopted a committee recommendation to substitute “authorization” for INFORMED “consent” throughout its transplantation policies. The duty of informed consent requires physicians to give patients or families all the information needed for understanding the risks, benefits, and costs of a particular treatment, including, for example, whether procedures and drugs could accelerate an organ donor’s death. The committee represented, however, that it was recommending no change to existing DCD policy. Nevertheless, the rewrite provided that “The patient who authorizes being an organ donor candidate” is one person who can “give authorization before administering drugs or procedures for the purposes of organ donation [.]” To the extent this suggests that only authorization and not informed consent is now required for DCD donation, it would evidence a distressing indifference to the vulnerability of patients on life-support and their families.
The OPTN Board is scheduled to meet again this November 12-13 in St. Louis. It could adopt the proposed DCD policy changes outright or by approving the plain-language rewrite. Doing either will validate the premise underlying the proposal, that certain people with disabilities are only dignified when dead. The Board should emphatically reject the offending provisions instead and send the unequivocal message that patients on life-support are not merely the sum of their parts but whole persons whose lives demand respect.
Readers can email OPTN at publiccomment@unos.org, referencing “Proposed Changes to the DCD Model Elements” on the subject line. They should urge the OPTN Board to ensure at the least that OPO representatives do not discuss DCD donation with patients or families before the decision to withdraw life-support is made and only with assurances that any consent is voluntary and informed, do not administer drugs or procedures for the purpose of organ donation without such consent, and do not recover organs without a five minute interval between cessation of circulation and the declaration of death.
Stephen L. Mikochik is professor emeritus at Temple University Law School in Philadelphia, where he taught Constitutional law and related subjects for thirty years. He is presently a visiting professor at Ave Maria Law School in Naples Florida, where he teaches Jurisprudence and Fourteenth Amendment. Before coming to Temple, he was a trial attorney with the Civil Rights Division, U.S. Department of Justice, where he litigated to enforce the civil rights of people with disabilities. He is also chair emeritus of the National Catholic Partnership on Disability, established in 1982 to implement the U.S. Bishops’ Pastoral Statement on People with Disabilities.
