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.

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.