The plaintiffs in this case include parents of sick children who have diseases such as leukemia, a physician and medical school professor, a parent of mixed race children for whom it is very rare to find matching donors, an African-American man suffering from leukemia, and a California non-profit organization seeking to operate a program incentivizing bone marrow donations through its website called MoreMarrowDonors.org. They challenged the constitutionality of NOTA's ban on compensation for bone marrow donations. Specifically, they argued that cells extracted through "peripheral blood stem cell apheresis," a relatively new method that avoids the need to invade the donor's bone for marrow, should not be prohibited.
Blood stem cells, also known as hematopoeitic stem cells, are non-pulripotent stem cells which can differentiate into white blood cells, red blood cells, and platelets.
The older method consisted of extracting bone marrow from the donor by inserting long needles into the donor's hip bones. This transplantation by "aspiration" is painful, involves risks, and requires the hopitalization of the donor.
The complaint explained that peripheral blood stem cell apheresis, which was developed after the enactment of NOTA, avoids the difficulty, pain, and potential risks associated with transplantation by aspiration.
While most blood stem cells mature into blood cells in the bone marrow, some circulate in the bloodstream before they mature, in which case they are referred to as "peripheral" blood stem cells. The new transplantation technique injects the donor with a medication to increase blood stream cell production and then extracts blood from the donor's veins without sedatives or anesthesia. Next, blood is filtered in an apheresis machine to separate stem cells from mature blood cells which are returned to the donor's blood stream. Complications are exceedingly rare and the extracted stem cells are replaced by the donor's bone marrow in three to six weeks. To a large extent, peripeheral stem cell apheresis is very similar to an ordinary blood donation.
Unlike mature blood cells which exist in just four types, there are millions of blood stem cell types, making it very difficult to find matching donors.
The plaintiff nonprofit would like to mitigate the matching problem by providing financial incentives to donors in the form of scholarships, housing allowances, or gifts to charities of the donor's choice. It plans to focus initially on minorities and mixed race donors because their blood stem cells are rarer.
However, the government's position has been that NOTA prohibits compensation for all blood stem cell donations.
NOTA makes it a crime punishable by up to five years in prison "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." 42 U.S.C section 274e(a). It defines a human organ as "the human kidney, liver, heart, pancreas, bone marrow, cornea, eye, bone, and skin, and any other human organ specified by the Secretary of Health and Human Services by regulation." 42 U.S.C. section 274e(c).
The plaintiffs argued that NOTA, as applied to MoreMarrowDonors.org, violates the Equal Protection Clause because there is no rational basis supporting the differential treatment of blood stem cells on the one hand, and blood, sperm, and eggs, on the other. (NOTA does not prohibit compensation blood, sperm, or egg donations.) They pointed out that, like blood, sperm, and egg donors, blood stem cells donors undergoing peripheral apheresis suffer no permanent harm, experience no significant risks, and quickly regenerate what is donated.
The district court dismissed for failure to state a claim upon which relief may be granted.
On appeal, the government reiterated that compensation for blood stem cell donations is prohibited because NOTA classifies "bone marrow" as an organ under 42 U.S.C. section 274e(c)(1).
The court first discussed bone marrow transplants by aspiration because the plaintiffs' complaint appeared to argue that all prohibitions on compensation for bone marrow transplants are unconstitutional. It held that the plaintiffs' challenge must fail with respect to the old aspiration method.
The court rejected a distinction based on the human tissue's capacity to regenerate. The distinction, it explained, cannot be sustained because Congress chose to include liver in NOTA's definition for "human organ" even though it must have known that human livers are capable of regenerating.
As to the question of whether there was a rational basis for prohibting compensation for the transplantation of certain human tissues and not others, the court identified two considerations. First, Congress could have been concerned about the policy implications in so far as compensation could produce a situation where poor people are pressured into selling their organs to rich patients. Compensation could also lead, the court said, to a degradation in the quality of organ supply if donors lied about their medical histories in order to make their organs more marketable.
Second, Congress also could have been swayed by philosophical reasons such as the widespread revulsion against the commodification of human flesh.
In sum, Congress had a rational basis for making only certain human tissue donations compensable.
The court then turned to bone marrow transplants through apheresis. Here, the court sidestepped the constitutional issue by focusing instead on statutory interpretation. (Under the doctrine of constitutional avoidance, courts try to resolve cases on non-constitutional grounds whenever possible.) It explained that NOTA did not prohibit blood stem cell donations through the apheresis method because "none of the soft, fatty marrow is donated, just cells found outside the marrow, outside the bones, flowing through the veins."
On this point, the government's argument was that NOTA's prohibition applies because blood stem cells should be treated as a subpart of "bone marrow" and because NOTA not only prohibits compensation for trasnplant of an organ, but aslo "any subpart thereof." The court rejected this argument because if accepted it would have also prohibited compensation for ordinary blood donations since mature blood cells are also "subparts" of bone marrow.
The court added that the government's argument went against the ordinary meaning of "bone marrow." Blood stem cells are subparts of blood, not bone marrow because "the word 'subpart' refers to the organ from which the material is taken, not the organ in which it was created."
Thus, because it does not prohibit compensation for blood donations and the substances in it, NOTA does not prohibit compensation for blood stem cell aphoresis.
Writing for the New England Journal of Medicine, Harvard University assistant law professor Glenn Cohen says the Ninth Circuit's decision represents both a win and a loss for advocates of organ markets. Although patients will now be able to buy and sell peripheral-blood stem cells derived through aphoresis, Congress may at any time amend NOTA and put an end to the practice because the Ninth Circuit's ruling was based on statutory interpretation.
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