On December 1, 2011, in Flynn v. Holder, a panel of the US Court of Appeals for the Ninth Circuit upheld the National Organ Transplant Act of 1984 (NOTA) (1) from a constitutional challenge, but interpreted the act as not prohibiting that sale of “peripheral blood stem cells” obtained through apheresis (2). The ruling was then challenged by the Department of Justice, which asked the panel and/or a larger bench of the Ninth Circuit to rehear the case (3). The decision provides the ideal vantage point from which to evaluate the regulation of the sale of organs and other tissues in the United States, as well as its future legal trajectory. After briefly setting out the history of this regulation, I turn to the Flynn case and what it augurs for the future.
On December 1, 2011, in Flynn v. Holder, a panel of the US Court of Appeals for the Ninth Circuit upheld the National Organ Transplant Act of 1984 (NOTA) from a constitutional challenge, but interpreted the act such that its prohibition on sale did not encompass “peripheral blood stem cells” obtained through apheresis. Rehearing of the case was denied on March 27, 2012. The Obama administration must now decide whether to pursue its challenge in the US Supreme Court. This article explains the litigation, its significance and uses it as a backdrop against which to understand the history and future trajectory of the laws governing selling organs and other human tissue.
National Organ Transplant Act of 1984
Uniform Anatomical Gifts Act
The Law of Organ Sales in the United States: A Brief History
Following successful liver, heart and pancreas transplants in 1967 and 1968, the National Conference of Commissioners on Uniform State Laws promulgated the Uniform Anatomical Gifts Act (UAGA) in 1968, which governed procurement of organs from deceased organ donors and established ethical and legal guidelines for organ transplantation (5,6). UAGA, like other “uniform laws”, is a kind of model law offered to state legislatures to adopt, possibly with amendments, at their discretion. The act covered “organs, tissues, eyes, bones, arteries, blood, other fluids and any other portions of a human body”, and made many important strides in clarifying that relatives had authority to contract with organ procurement organizations, hospitals, or doctors to donate deceased donor and their organs (5). For our purposes, though, its most important feature was its failure to ban the sale of organs: its Drafting Chair, E.B. Stason, suggested that the matter of compensation “should be left to the decency of human beings”, because the drafters did not expect this to become a major problem and because crafting a prohibition on compensation would “not be easy” (5,7). By 1973, all US states had adopted this version of the UAGA (5).
By the early 1980s, however, it was clear that the UAGA was outdated. First, it required consent for donation, either in a will or a testamentary document (including donor cards), and, in the absence of an objection by the deceased, authorized a hierarchy of next-of-kin consent (6). This made consent for organ procurement too cumbersome when weighed against the need to transplant viable organs shortly after death (5). Second, the drafters of the UAGA had not anticipated a large rise in nonrelated living donations and expected that relatives would not seek compensation in exchange for deceased donations (5). This proved to be naive, as demonstrated in 1983, when H. Barry Jacobs, a physician with a revoked medical license, testified before Congress regarding his International Kidney Exchange, Ltd. that planned to “commission kidneys from persons living in Third World countries or in disadvantaged circumstances in the United States for whatever price would induce them to sell their organs” (5,9).
Jacobs' testimony before Congress sank his program, but inspired Congress to enact NOTA in 1984 (5,9). NOTA made it “unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce” (1). NOTA's prohibition extends to “human organ”, defined as “human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation” (1). By its statutory text, NOTA therefore excludes from its prohibitions all animal organs, uses of organs for research and other nontransplantation activities, blood, ova and sperm (1,10). The act does not itself define “valuable consideration”, except in the negative sense of making it clear that the term does not include “the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ” (1). This is, however, a common term used in the law to mean not only money but anything that “confers a pecuniarily measurable benefit on one party” (11). So broad is the term that for decades it was interpreted to prohibit paired kidney donations, requiring a 2007 statutory amendment to permit such exchanges (1,5,12). Individuals who violate NOTA's ban on sale “shall be fined not more than $50,000 or imprisoned not more than five years, or both” (1).
Following the introduction of NOTA, the UAGA was also amended in 1987. For our purposes, the most important change was its provision that a person may not “knowingly, for valuable consideration, purchase or sell a part for transplantation or therapy, if removal of the part is intended to occur after the death, of the decedent” (6). The 1987 UAGA version has so far only been adopted by 26 states (5). Importantly, as federal law, NOTA trumps any conflicting provisions of state law. In particular, to the extent they conflict, NOTA trumps the UAGA, remaining the key legal document prohibiting organ sale in the United States.
As mentioned above, by their explicit statutory text neither act prohibits the sale of sperm, ovum, fertilized embryos, blood, nonhuman tissue and tissue used for research. As of 2007, 13 states independently banned either the sale of human embryos for research purposes and/or the sale of human ova to produce embryos for research purposes (1), while New York has now explicitly allowed it (13). Louisiana appears to be the only state that currently explicitly bans the sale of eggs for reproductive purposes, while Virginia is the only state to explicitly permit their sale, although the practice goes on unimpeded in all other states (14). Two pending lawsuits allege antitrust violations due to price fixing in the market for ova (16,17).
There have been some attempts to do end-runs around these statutes, such as in the market for deceased donor corneas (15). More importantly, in its current form NOTA (like almost all US laws) does not apply extraterritorially, meaning that if a US citizens travels abroad to buy a kidney or other organ (a form of medical tourism faced by several US transplant centers) his act is not prohibited by NOTA, and it is generally accepted that more general US laws prohibiting trafficking do not apply to organ sale (18–20). That said, the existing law does discourage transplant tourism to some extent via a rule promulgated by the Centers for Medicaid & Medicare Services (CMS), requiring that as part of the informed-consent process, patients seeking transplantation must be informed that “if a transplant is not provided in a Medicare-approved transplant center it could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid for under Medicare Part B” (21,22). Moreover, Congress could, consistent with international and domestic law, amend NOTA to apply to organ sale and purchase by US citizens done outside of the United States (18).
Legal Challenges to Prohibitions on Organ Sale
With that understanding of the law governing the sale of organs and other tissue, we can better understand the recent legal challenges to the scheme.
In Flynn v. Holder, a group of plaintiffs brought suit seeking to have NOTA's prohibition on the sale of bone marrow struck down as in violation of the US federal constitution (2,23). The plaintiffs represented those with quite varied interests in allowing the sale of bone marrow, including http://MoreMarrowDonors.org-–a California nonprofit corporation that wanted to offer scholarships, housing allowances, or gifts to charities selected by donors, initially to minority and mixed race donors of bone marrow cells-–and parents of children with leukemia and aplastic anemia (2,4,23). While NOTA has occasionally been challenged before, in both of those prior instances the arguments were dismissed for technical reasons resulting in no judgment on the merits of the issue (24,25).
The substantive due process challenge
Before the district court, the Flynn plaintiffs pressed two primary arguments: first, they argued that NOTA's prohibition on selling bone marrow violated the substantive Due Process protections of the Constitution (2,4). This portion of the Constitution protects an individual's power to possess or do certain things despite the desire of the government to the contrary, and formed the basis of the Supreme Court's jurisprudence on abortion and assisted suicide (26–28). The plaintiffs argued that NOTA violated this portion of the Constitution by interfering with transactions between a patient who needs bone marrow to survive and someone willing to sell it to the patient.
Whether a challenge like this succeeds will depend on the constitutional burden the Supreme Court requires the government to meet. Although the terminology sounds somewhat technical, in essence the courts here are determining whether the statute being challenged goes to the heart of the liberty protected by the United States Constitution. Under settled constitutional doctrine, those rights that a court determines are “fundamental” get heightened protection (called “strict scrutiny”) under substantive Due Process such that the government can only infringe those rights when it has a “compelling state interest” and the law in question is “narrowly tailored” to serve that interest (23,26,28). By contrast, all other rights are reviewed only for “rational basis”, where the statute must only bear a “reasonable relationship” to the attainment of a “legitimate” state objective (23,26,28). In practice, when the right is fundamental and strict scrutiny applies the statute is almost always struck down and almost always upheld where rational basis applies (28).
For this reason, the plaintiffs tried to convince the district court that the right NOTA infringed was a fundamental one, such that strict scrutiny applied. In doing so, they borrowed a strategy championed by law professor Eugene Volokh in an academic article, where he suggested that a dying individuals’ right to purchase organs should be treated as a fundamental right in analogy to long-established laws allowing self-defense against someone who threatens your life, as well as a woman's right to abortion when her life is at stake (29). Trading on the fact that “some forms of a constitutional right to self-defense have won support from the right as well as the left”, Volokh argued that the state should not be able to violate an individual's “right to medical self-defense” by banning organ sales, at least absent a showing by the government that allowing such sales “would cause grave harm that can't be averted in any other ways” (29).
The district court ultimately sided with the government and rejected this argument in a single paragraph, finding no fundamental right to purchase or sell bone marrow, and drawing an analogy to a decision by the US Court of Appeals for the D.C. Circuit en banc in Abigail Alliance v. Eschenbach (23,30). In that case terminally ill patients sued the federal government to declare unconstitutional a portion of the Food, Drug and Cosmetics Act that prohibited the sale, outside of clinical trials, of experimental drugs that had cleared Phase I clinical testing but had not yet passed Phase II. The court rejected their claim, finding that the patients had “not provided evidence of a right to procure and use experimental drugs that is deeply rooted in our Nation's history and traditions” such that it could not be a fundamental right (30). (In the interest of full disclosure, I represented the government in portions of that case). The Flynn court found that Abigail Alliance stood for a broader “proposition that there is no general fundamental right to obtain one's preferred type of medical treatment”, and that plaintiffs provided “no supporting law and describe insufficient specific evidence to show that organ sale involved a fundamental right, such that the case would be judged only under rational basis review” (23). The district court then found that the government had amply demonstrated a rational basis for a ban on selling bone marrow, for reasons that parallel the ones I will discuss as to the Equal Protection claim (23). The plaintiffs did not resuscitate their substantive Due Process claim on appeal, such that the district court's decision remains the final holding on the matter.
The equal protection challenge
The plaintiffs' second primary argument was that NOTA's prohibition of sale for bone marrow, while permitting the sale of blood, sperm and eggs, constituted an unconstitutional classification under the Equal Protection Clause, an argument they repeated on appeal. To simplify slightly, the court reviews all nonrace nongender classifications under rational basis review (31). Applying the rational basis test in Flynn, both the district court and the court of appeals again found that NOTA amply met the standard because the government could have concluded that: it is morally wrong to sell bone marrow (just as it is wrong to sell other body parts) because doing so would turn human beings into commodities; that poor people would be coerced by financial pressure into selling their organs; that the rich would be at a substantial advantage in obtaining organs; that donors would have a strong incentive to provide an inaccurate medical history; and that although blood can legally be sold, certain differences between blood and bone marrow justify the view of Congress that providing financial incentives would reduce altruistic donation and undermine voluntary donation (2,4,23).
Therefore, the Ninth Circuit panel held that there was no constitutional problem with NOTA's prohibition on selling organs. However, it also found as a matter of statutory interpretation that NOTA's prohibition on selling “bone marrow” did not apply to blood stem cells obtained through apheresis (2). It described apheresis as
[b]eginning with five days of injections of a medication called a “granulocyte colony-stimulating factor” into the donor's blood. The medication accelerates blood stem cell production in the marrow, so that more stem cells go into the bloodstream.. .. Blood is withdrawn from the vein and filtered through an apheresis machine to extract the blood stem cells. The remaining components of the blood are returned to the donor's vein. The blood stem cells extracted in the apheresis method are replaced by the donor's bone marrow in three to six weeks. Complications for the donor are exceedingly rare…. (2)
The court found that, notwithstanding the statute's inclusion of “bone marrow”, “Congress could not have had an intent to address the apheresis method when it passed the statute, because the method did not exist at that time” (2). Instead, it held that because NOTA does not prohibit the sale of blood, that the sale of peripheral-blood stem cells should not be prohibited because they are found in blood (2,4). It rejected the government's argument that derivatives are encompassed in “bone marrow”, noting that this argument “proves too much” in claiming that the “red and white blood cells that flow through the veins come from the bone marrow, just like hematopoietic stem cells” (2,4). It also found that these cells fit within the ordinary-language meaning of “blood” (2,4). Therefore, it concluded that “when the ‘peripheral blood stem cell apheresis’ method of ‘bone marrow transplantation’ is used”, NOTA does not criminalize sales of these cells, unlike sales of bone marrow derived through aspiration (2,4).
The rehearing petition
On January 17, 2012, the Department of Justice filed a petition for rehearing by the panel and/or by a larger “en banc” bench of the Ninth Circuit (3). They argued that the initial decision of that court as to the statutory interpretation was flawed for four reasons. First, they carped that the court reached out to decide the meaning of “bone marrow” on its own without adequate briefing from either side, and in doing so “substituted its own understanding of medical procedures and medical policy for that of the agency charged with implementing” NOTA (3). Here they emphasized that legislative history in the Congressional Conference Report that accompanied NOTA showed that Congress was particularly worried about markets in live bone marrow, and that neither Congress nor the Secretary of Health and Human Services had ever suggested the distinction drawn by the court (3). Second, they suggested that there was no reason to assume that NOTA's prohibition on the sale of “bone marrow. .. and any subpart thereof” was meant to exclude hematopoietic cells derived through apheresis, since “Congress's judgment that the biological material for lifesaving transplants should not be subject to market forces does not admit of the distinctions now drawn by the” court (1,3). Third, the government pointed to a 2005 Amendment to another part of NOTA pertaining to the National Registry where Congress specified that “the term ‘bone marrow’ means the cells found in adult bone marrow and peripheral blood” (3). While conceding that this definitional provision did not on its face apply to the portion of NOTA prohibiting sale, the government argued that it was relevant because “the National Registry and the criminal prohibition work in tandem to implement Congress's national policy of encouraging voluntary bone marrow donations” (3). Finally, the government argued that the statutory interpretation argument was not properly put before the court, because the challengers did not face a “a realistic danger of sustaining a direct injury as a result of the statute's operation or enforcement” (3,33).
On March 27, 2011, the Ninth Circuit denied rehearing or rehearing en banc, amending the original opinion slightly to respond to the government's third argument but leaving the rest of the opinion untouched (34). The government will now have to decide whether to seek review in the US Supreme Court. Even if they seek such review, the Court must agree to hear the case and it hears very few cases.
The Future of Organ Markets in the United States
What is the future of litigation over markets for bone marrow or other tissue in the United States?
First, whatever happens with the review of this decision, markets in blood, sperm, ova and embryos will persist (except in states where separate regulations prohibit them) since NOTA's own text makes it clear that the statute does not prohibit their sale.
Second, if the Ninth Circuit's decision is upheld, the end result is only a narrow change in the law: that peripheral blood cells derived through apheresis are not covered by NOTA's prohibition. Congress could easily amend NOTA to make clear that the prohibition on selling “bone marrow” refers to peripheral blood cells as well.
Third, the decision in fact affirms that NOTA's prohibition on selling other organs is constitutionally well grounded and stands as a significant obstacle to more robust organ markets. That said, the plaintiffs retain the ability to press before other courts in other circuits their claim that NOTA's prohibition on selling bone marrow violates the equal protection clause-–a claim that failed before the district court and the Ninth Circuit.
Further, they may also bring a new case asking another district court and ultimately the Ninth Circuit or other Courts of Appeals to revisit their substantive due process claim-–this failed before the district court, but was not challenged before the Court of Appeals. This latter challenge may be particularly fruitful for them since the district court rejected their claims based on Abigail Alliance, a decision that is only binding precedent in one of 12 regional courts of appeals. Moreover, other courts may be able to distinguish Abigail Alliance. The majority opinion in Abigail Alliance was careful to emphasize that it reached its decision because “this case is not about using reasonable force to defend (as in most cases involving self-defense), nor is it about access to life-saving medical treatment” (30). Instead, the Abigail Alliance majority found that the case is about “a constitutional right to assume, in the Alliance's own words, ‘enormous risks,’ in pursuit of potentially life-saving drugs”, and that “[u]nlike the cases in which the doctrine of self-defense might properly be invoked, this case involves risk from drugs with no proven therapeutic effect” (30). That distinction is much fuzzier as to purchasing bone marrow or other organs, in that the patient has a much stronger anticipation of therapeutic benefit and is not merely seeking a right to take enormous risk for a speculative gain. This suggests that the district court may have been too quick to dismiss this claim by citing Abigail Alliance. Further, the prohibition on organ sale is not nearly as deeply rooted in the traditions of this country as is the FDA regulation of experimental drugs, something the courts have indicated is highly relevant in determining whether a right is fundamental (28,30).
In sum, Flynn may be more important for what it leaves in place than what it changes. It affirms the constitutionality of the prohibition on selling organs that is central to NOTA and leaves open only the narrower question of whether that prohibition covers peripheral blood stem cells derived through apheresis, a question that Congress can answer through statutory amendment of NOTA at any time if it is dissatisfied with the ultimate result of this litigation.
I thank Yoni Schanker and Kaitlin Burroughs for their research and editing assistance.
The author of this manuscript has no conflicts of interest to disclose as described by the American Journal of Transplantation.