Health Law Keyed to Furrow
Flynn v. Holder
The Plaintiffs are parents of sick children who have diseases such as leukemia and a rare type of anemia, which can be fatal without bone marrow transplants. They, along with a doctor and professor, claim that one out of five patients die because no matching bone marrow donor can be found, and many other patients have complications when scarcity of matching donors compels the use of imperfectly matched donors. Another Plaintiff, a non-profit organization, wants to operate a program incentivizing bone marrow donations. The corporation would like to offer $3,000 awards in the form of scholarships, housing allowances, or gifts to charities selected by donors. The initial donors are to be minority and mixed race donors of bone marrow cells, who are likely to have the rarest marrow cell type. The Plaintiffs claim that the program cannot be launched because the National Organ Transplant Act (NOTA) criminalizes payment of compensation for organs, and classifies bone marrow as an organ. Originally, bone marrow was removed from a donor's bones by "aspiration." Long needles, thick enough to suck out the soft, fatty marrow, were inserted into the cavities of the anesthetized hipbones of the donor. These are large bones with big central cavities full of marrow. Aspiration was a painful, unpleasant procedure for the donor. It required the donor to be hospitalized and under general or local anesthesia, as well as involving commensurate risks. With a newer and less invasive procedure, none of the soft, fatty marrow is actually donated. Patients who need bone marrow transplants do not need everything that the soft, fatty substance from bone cavities contains, only some of the marrow's "hematopoietic stem cells." Some blood stem cells flow into and circulate in the bloodstream before they mature. These are called "peripheral" blood stem cells. ["Peripheral" in this context means outside the central area of the body.] The new bone marrow donation technique is called "peripheral blood stem cell apheresis." ["Apheresis" uses a machine to separate one element of the blood from the rest and then return the remainder to the donor's body.] The main difference between an ordinary blood donation and apheresis is that instead of just filling up a plastic bag with whole blood, the donor sits for several hours in a recliner while the blood passes through the apheresis machine. This same apheresis technique is sometimes used for reasons other than bone marrow donations, such as setting the machine up to collect plasma or platelets, rather than stem cells, from a donor's blood. When used for these other purposes, the exact same technique is called a "blood donation" or "blood plasma donation." When used to separate out and collect hematopoietic stem cells from the donor's bloodstream, apheresis is called "peripheral blood stem cell apheresis" or a "bone marrow donation." Despite the establishment of the NOTA registry, which is funded by the federal Government (Defendant), many times good matches cannot be found. Even when a good match is found in the registry, tracking down the potential donor from what may be an outdated address may be impossible to accomplish in time to save the life of the patient—assuming the potential donor is willing to go through with the process when found. The Plaintiff nonprofit proposes to mitigate this matching problem with a financial incentive. The idea is that the financial incentive will encourage more donors to sign up and to stay in touch so they can be located when necessary, and go through with the donations. The nonprofit planning to give financial incentives acknowledges that it would be "valuable consideration" under the statutory prohibition. Plaintiffs argue that NOTA violates the Equal Protection Clause. They claim that blood stem cell harvesting is not very different from blood, sperm, and egg harvesting, which are not included under the statutory or regulatory definitions of "human organ." A bone marrow donor undergoing apheresis, same as a blood or sperm donor, suffers no permanent harm, experiences no significant risk, and quickly regenerates what is donated. Regarding the pilot program, Plaintiffs also argue that any rational basis Congress had when it passed the statute no longer exists because of the later development of the apheresis method. Plaintiffs seek declaratory and injunctive relief to proceed with the initiative. The district court dismissed the Plaintiffs suit, which was then appealed.
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