April 4, 2012

9th Circuit Rejects DOJ Challenge to Ruling on Stem Cell Donation

Technological advances can shift the legal characterization of a practice in medical care from prohibited to allowed – the case of compensation for bone marrow donation makes this point. Bone marrow donations are sought by many patients with blood and other disorders who require an infusion of new stem cells that can resupply critical blood types (bone marrow is a rich source of such cells). Typically, this has been done by bone marrow aspiration, where a donor undergoes aspiration of bone marrow directly, later processed for its stem cells; hence the term “bone marrow transplant” was often used. In Flynn v. Holder, the 9th Circuit ruled last December that the modern methods for recovering stem cells from bone marrow now allow for the procedure to be characterized as a kind of blood donation, rather than an organ donation; now, a donor goes to a facility and undergoes a kind of blood filtration to remove stem cells (peripheral blood stem cell apheresis), which is painless and non-invasive. The consequences of this shift are significant in that the the National Organ Transplant Act (NOTA), passed in 1984, prohibits any sale of human organs in interstate commerce. That legislation attempts to frustrate any markets for human organs by criminalizing the payments for human organ donations. In contrast, blood donations are not affected by this prohibition; payments for blood donations are routine. Thus, for the first time, the 9th Circuit ruling allows bone marrow donors to be paid; this has been championed by patient advocacy groups for those need genetically matched bone marrow. Surprisingly, after the ruling in December, Attorney General Eric Holder asked the court to rehear the case en banc (full panel of the 9th Circuit). This has now been denied. According to the court, the government’s argument that “bone marrow” in NOTA was to be understood to apply to the stem cells – however recovered – is not correct. The court has reaffirmed its ruling, and donors may be recruited with financial incentives without running afoul of NOTA. This is a wise decision; the pushback from the Department of Justice might be understood in view of what they may have viewed as a slippery slope toward the introduction of commerce into organ donation, but this apprehension does not require that the law fail to understand when technology really does shift. From the court opinion
It may be that “bone marrow transplant” is an anachronism that will soon fade away, as peripheral blood stem cell apheresis replaces aspiration as the transplant technique, much as “dial the phone” is fading away now that telephones do not have dials. Or it may live on, as “brief” does, even though “briefs” are now lengthy arguments rather than, as they used to be, brief summaries of authorities. Either way, when the“peripheral blood stem cell apheresis” method of“bone marrow transplantation” is used, it is not a transfer of a “human organ” or a “subpart thereof” as defined by the statute and regulation, so the statute does not criminalize compensating the donor.

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