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Ninth Circuit Holds National Organ Transplant Act Does Not Prohibit the Sale of Hematopoietic Stem Cells

Tuesday, December 6, 2011

Michael L. Calder | Bloomberg Law Flynn v. Holder, No. 10-55643, 2011 BL 302580 (9th Cir. Dec. 1, 2011) The U.S. Court of Appeals for the Ninth Circuit, in a unanimous three-judge opinion, held that the National Organ Transplant Act, 42 U.S.C. § 273 et. seq. (NOTA), does not prohibit compensation for donations of blood and the substances in it, including hematopoietic stem cells donated through the process of apheresis. The decision has been hailed as a victory for cancer patients by the Institute for Justice, which represented the plaintiffs in the case.

Bone Marrow Transplants

Patients suffering from certain diseases like leukemia—cancer of the blood or bone marrow—often undergo chemotherapy or radiation treatments which kill cancer cells and white blood cells essential to the immune system. Unless the patients receive an infusion of hematopoietic stem cells, which mature into healthy white blood cells, the patients will die. Hematopoietic stem cells can only be obtained through bone marrow transplants. The traditional bone marrow extraction process—aspiration—is painful and requires hospitalization. As a result, donors were scarce. About twenty years ago, a new method was developed—apheresis—a process similar to plasma or platelet donation. Using apheresis, a donor’s blood passes from a vein through a machine that separates hematopoietic stem cells from the blood, and returns the unused portion back into the donor. This process is possible because, although most hematopoietic stem cells remain in the bone marrow and mature into blood cells there, some stem cells flow into and circulate into the bloodstream.

The National Organ Transplant Act

Section 274e of NOTA makes it unlawful to “knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation.” NOTA defines “human organ” as “the 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).” (emphasis added).

The Constitutional Challenge

Plaintiffs are parents of sick children, a doctor, a medical school professor and a California non-profit organization, MoreMarrowDonors.org, which sought to operate a bone marrow donation program that would provide incentives worth $3,000 to potential donors. Plaintiffs filed suit for declaratory and injunctive relief arguing that NOTA, as applied to bone marrow transplants, violated the Due Process Clause of the Fifth Amendment because blood stem cell harvesting is not materially different than blood, sperm, and egg harvesting, which are not included under NOTA’s definition of “human organ.” Therefore, plaintiffs argued, there was no rational basis for allowing donors to receive payment for blood, sperm and egg donations but not bone marrow donations. The district court dismissed the claim. On appeal, the Ninth Circuit noted that the plaintiffs’ complaint focused on, but was not confined to apheresis, and appeared to challenge NOTA as applied to either apheresis or aspiration.

Aspiration

The court held that NOTA’s prohibition on bone marrow transplants using the aspiration method was constitutional, noting that NOTA expressly includes bone marrow in its definition of “human organs.” The court rejected the plaintiffs’ argument that Congress did not intend to include regenerable body parts, such as blood, in its definition. It noted that NOTA includes the liver “or any subpart thereof,” and that a partial resection of the liver can yield a life-saving donation, and the liver will grow back. The court explained that there were rational policy and philosophical concerns that could have spurred Congress to enact the legislation. Among the many possible policy concerns, the court noted that rich patients might be inclined to induce poor people to sell their organs, and donors could be inclined to make “your money or your life” demands from sick patients. The court also explored philosophical reasons for prohibiting compensation for bodily organs, including people’s “instinctive revulsion at denial of bodily integrity.” Thus, the court held that Congress had a rational basis to prohibit compensation for bone marrow transplants using the aspiration process, which was the only process available for bone marrow transplants at the time NOTA was passed.

Apheresis

The court explained that it was not necessary to conduct an analysis of whether hematopoietic stem cell donation using the apheresis method was constitutional because NOTA does not prohibit such donations. The court distinguished bone marrow transplantation using the aspiration method with apheresis, a process in which the bone marrow itself is not transplanted. Rather, hematopoietic stem cells, a product of the bone marrow, is transplanted. The government argued that the court should treat hematopoietic stem cells as “bone marrow” because NOTA covers bone marrow and “any subpart thereof.” The court rejected this argument because if “what comes from the marrow is a subpart of the marrow were correct, then the statute would prohibit compensating blood donors.” The government also conceded that NOTA does not prohibit compensation for blood donations. The court concluded that once the stem cells enter the blood stream, they become a subpart of the blood, not the marrow, and that “[t]he word ‘subpart’ refers to the organ from which the material is taken, not from the organ in which it was created.” Accordingly, the court held that NOTA does not prohibit compensation for donations of blood and the substances contained in the blood, including hematopoietic stem cells.
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