December 4, 2011

9th Circuit: Bone Marrow Donation Technology Avoids Compensation Ban on Organ Donation

The 9th Circuit has ruled that the law which prohibits commerce in organ donation does not extend to modern techniques for hematopoietic (blood) stem cell donation. This is an important ruling which is likely to result in an increase in potential donors for blood stem cells. Flynn v. Holder challenged the applicability of the federal statute which prohibits compensation for organ donation to modern blood stem cell donation. The National Organ Transplant Act (NOTA), passed in 1984, prohibits any sale of human organs in interstate commerce. This has traditionally been interpreted to forbid any compensation for bone marrow donors. The treatment of many blood diseases, including cancers such as leukemia, involves the destruction of the patient’s own blood cells and replacement with blood stem cells from bone marrow provided by a genetically matched donor. (Note that this technology is unrelated to the controversy over embryonic stem cell research; this is a kind of adult stem cell donation). The plaintiffs included cancer patients seeking bone marrow stem cells and a bone marrow registry which intends to offer financial incentives for donations and to increase efforts to target ethnic groups that may be underrepresented in current banks. The plaintiffs argued that modern cell sorting technologies now allow the harvesting of hematopoietic stem cells directly from blood, and thus avoid the traditional procedure of bone marrow withdrawal to recover these cells. In essence, these technical advances mean that the donation of bone marrow stem cells can be accomplished through blood donation (which can be legally compensated) and no longer requires the painful and risky medical procedure of bone marrow aspiration (which could not be compensated). The distinction was critical to the analysis of whether the new stem cell donation technology avoids the label of “organ donation” and thus escapes the compensation ban. Several constitutional claims were also advanced. One claim was an equal protection claim which alleged unequal treatment of bone marrow as opposed to blood donations, arguing that compensation for renewable biological specimens is legal, and bone marrow should fall within that description. Another constitutional claim was rooted in a substantive due process claim of a violation of the right to seek medical treatment. The 9th Circuit avoided the constitutional questions, but decided that the modern blood-based method of stem cell donation did not qualify as an “organ donation” for which compensation is prohibited. One of the plaintiffs has announced the availability of scholarships and other financial remuneration to recruit stem cell donors, strategies that can now proceed legally, according to the 9th Circuit. 

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