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Flynn v. Holder

    Brief Fact Summary. A suit was brought against Attorney General “Holder” (Government) (Defendant) by Flynn, parent of a sick child, other parents of sick children, a doctor and a medical school professor, an expert in the field of bone marrow transplantation, and a non-profit organization (Plaintiffs), claiming the ban on compensation for human organs in the National Organ Transplant Act was unconstitutional as applied to bone marrow transplants.

    Synopsis of Rule of Law. The compensation of bone marrow donors, conducted through newer, less invasive procedures, is not a violation of the National Organ Transplant Act.

    Facts. 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.

    Issue. Is the compensation of bone marrow donors, conducted through newer, less invasive procedures, a violation of the National Organ Transplant Act?

    Held. (Kleinfeld, J.)  No.  The compensation of bone marrow donors, conducted through newer, less invasive procedures, is not a violation of the National Organ Transplant Act (NOTA).  Under NOTA, it is a felony “to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation.”  And it defines the term “human organ” to include “bone marrow.”  Therefore, the statute specifically prohibits compensating bone marrow donors.  According to the Government (Defendant), Congress took the view that “human body parts should not be viewed as commodities,” and had several policy reasons for disallowing compensation to donors, which suffice to serve as a rational basis for the prohibition.  The Defendant argues that since it is much harder to find a match for patients who need bone marrow transplants than for patients who need blood transfusions, it could trigger exploitive market forces if bone marrow could be bought.  The Defendant also claims that peripheral blood stem cell apheresis is a greater health risk for the donor than a blood donation, because of the side effects of the medicine used to increase stem cell secretion.
      To the extent that plaintiffs challenge whether the compensation ban on bone marrow donation by the old aspiration method is constitutional, the challenge must fail.  It is not relevant that the legislative history indicates that Congress viewed certain types of regenerable tissue, such as blood, as falling outside the statutory definition of “human organ.”  The statute does not say that compensation is permitted for organs or body parts that regenerate but is prohibited for those that do not, and it is not consistent with such a construction.  The statute defines the liver “or any subpart thereof” as an organ for which compensation is prohibited.  Surely the drafters knew that a partial resection of a liver can yield a donation that will save the recipient’s life, and that the donor’s liver will grow back.  So the statute does not specifically prohibit compensation for at least one explicitly denoted “human organ” that will regenerate.
      The Defendants argument focuses on compensation for “bone marrow donations” by the peripheral blood stem cell apheresis method.  The court does not need to answer any constitutional question for this because the statute contains no prohibition.  The donations of cells drawn from blood flowing through the veins may sometimes anachronistically be called “bone marrow donations,” but none of the soft, fatty marrow is donated, only cells found outside the marrow, outside the bones, flowing through the veins.  Congress could not have had an intent to address the apheresis method when it passed the statute because the method did not exist at that time.  The court must interpret the words of the statute to see what they imply about using this method for the extraction of hematopoietic stem cells.
      Since payment for blood donations has been common for some time, the silence in NOTA regarding the compensation of blood donors is loud.  The Defendant concedes that the statute does not prohibit the common practice of compensating blood donors.  The Defendant claims that hematopoietic stem cells in the veins should be treated as “bone marrow” because “bone marrow” is a statutory organ, and the statute prohibits compensation for donation of an organ or “any subpart thereof.”  The court rejects this argument.  Every blood draw includes some hematopoietic stem cells.  Once the stem cells are in the bloodstream, they are a “subpart” of the blood, not the bone marrow.  The word “subpart” refers to the organ from which the material is taken, not the organ in which it was created.  Reversed.

    Discussion. This case raises a sad statistic, that bone marrow donors are available, but may not be motivated to donate.  Instead, Plaintiffs suggested establishing a program, not unlike the payment for blood donations, to make bone marrow donations increase by offering compensation.  The logic of NOTA to forbid payment for organs was not in dispute, but the application on bone marrow donations specifically through a newer and less invasive procedure was struck down by the court.


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