Human Organ Transplantation In The U.S. - Crossing New Lines?

Human Organ Transplantation in the U.S. – Crossing New Lines?

By Bruce Patsner, M.D., J.D.

Successful human organ transplantation is one of the great achievements of the medical profession in the past half-century. Unfortunately, the track record of medical ethicists in confronting the myriad of ethical issues involving human organ transplantation, and of the medical profession itself in self-regulating its participation in the procurement of organs, is less than stellar. Recent articles1 in the medical literature indicate that things could get a lot worse in the near future as physicians continue to push to increase the supply of available solid organs for pediatric and adult patients needing heart and kidney transplants.2

The Scope of the Problem

Since 1995 more than 85,000 U.S. citizens have died waiting for a solid transplant organ,3 and the current waiting list in the U.S. is close to 100,000.4 Perhaps the only thing everyone – patients, transplant surgeons, hospital and transplant program administrators, and state and federal officials – agrees on is that there is an inadequate supply of acceptable good-quality healthy solid organs (e.g. kidney, liver, lung, pancreas, heart) to meet current demand in the United States.5 As a result, it is not uncommon for patients to spend prolonged periods of time on organ transplant waiting lists. Invariably, and inevitably, some patients die while waiting to receive a transplant.6 In 2007 more than 6,000 people died while waiting to receive an organ transplant.7

All parties might also agree that the primary reason for this state of affairs in the United States is the fact that our solid organ donation system, whether from a cadaver or a living person, is purely voluntary.8 Our current system is also non-random in the sense that individuals who have magnanimous friends or relatives have a distinct advantage as potential recipients.9 Wealthier individuals also have the option of “opting out” of the U.S. system completely and securing a needed solid organ quickly by becoming medical

1 Mark M. Boucek, Christine Mashburn, Susan M. Dunn, et. al., Pediatric Heart Transplantation after Declaration of Circulatory Death, 359 N. ENGL. J. MED. 709 (2008) [hereafter Boucek].

2 James L. Bernat, The Boundaries of Organ Donation after Circulatory Deaths, 359 N. ENGL. J. MED. 669 (2008).

3 The Associated Press, N.J. licenses to require organ donation decision. First law of its kind asks residents to make a choice at time of renewal, July 23, 2008, available at http://www.msnbc.msn.com/id/25816523/print/1/displaymode/1098/ (last accessed August 6, 2008)[hereafter New Jersey law].

4 Id.

5 Id.

6 Id.

7 David Orentlicher, Mary Anne Bobinski, and Mark A. Hall, BIOETHICS AND PUBLIC HEALTH LAW (2nd Ed. 2008).

8 Neal R. Barshes, Carl S. Hacker, Richard B. Freeman, Jr., John M Vierling, and John A. Goss, Justice, Administrative Law, and the Transplant Clinician: The Ethical and Legislative Basis of a National Policy on Donor Liver Allocation, 23 THE JOURNAL OF CONTEMPORARY HEALTH LAW AND POLICY (2007).

9 Id.

tourists and traveling overseas to a foreign country where their currency will buy priority organ transplantation with a negligible increase in risk of complications.10

Three questions immediately come up. First, is there a “problem” with organ transplantation which requires that the current system be changed, or should the relative scarcity of medical resources be accepted as a fact of life in the U.S. and the current system preserved? This is a normative question. Either one accepts that a significant shortage of organs is acceptable or one doesn’t; there is little point in reforming the system unless one accepts that a relative shortage of transplantable organs is a problem, and not everyone agrees that there is a “problem” with the current organ transplant system in the U.S.11 Second, what are the various new proposals for “fixing” our current under-supply of solid organs for transplantation for infants and adults? Lastly, which of these new proposals are acceptable, and which should be rejected?

The Current U.S. Regulatory Framework

The regulation of solid organ transplantation from both cadavers and healthy living donors was formally removed from the jurisdiction of the United States Food and Drug Administration (FDA) by Congress with the passage of the National Organ Transplantation Act (NOTA).12 This legislation established the framework for whole organ recovery and allocation which operates today. Prior to passage of this Act, there was some controversy as to whether FDA had authority to regulate the marketing of human organs. Although transplantation of human organs began in the 1960’s, the regulatory oversight lagged behind the medical practice for decades, and it was not until 1983 that Congress formally asked FDA to address its authority under existing law to oversee whole organ transplantation.13

The most important provisions of NOTA were that it14 (1) provided federal funding for regional federal procurement agencies; (2) established a national organ procurement and transplantation network (OPTN) to manage the procurement and distribution of solid donor organs; (3) mandated funding of transplant-related medication and surgical transplant procedures by Medicaid/Medicare; (4) established a task force to formally study organ transplant allocation problems; and (5) specifically prohibited the sale of donor organs for transplantation though the ban does not apply to blood, sperm or ova.

10 Bruce Patsner, Medical Tourism: A Serious Business Undergoing Serious Change, University of Houston Law Center, Health Law Perspectives January 2008, available at http://www.law.uh.edu/healthlaw/perspectives/homepage.asp (last accessed August 18, 2008).

11 JoNel Aleccia, Dislosing organ transplant risks: Now or later? MSNBC Health News June 25, 2008, available at http://www.msnbc.msn.com/id/25354022/print/1/displaymode/1098/ (last accessed June 25, 2008). “This proposal (allowing patients to decide in advance whether they’re willing to take substandard organs, including those at risk for infectious disease such as HIV or hepatitis C) is a solution in search of a problem”, said Dr. Benjamin Hippen, a transplant surgeon on the UNOS ethics committee.

12 NATIONAL ORGAN TRANPLANTATION ACT, Pub. L. 98-607, 98 Stat. 2339 (1984), codified as amended at 42 U.S.C. §§ 273-274 (2000) [hereafter NOTA].

13 Peter Barton Hutt, Richard A. Merrill,

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