When is the Donation of Bone Marrow Not Considered the Donation of a Human Organ?

Plaintiffs filed a complaint challenging the constitutionality of the ban on compensation for human organs in the National Organ Transplant Act (Flynn v. Holder, No. 10-4009, 6th Circ., 2012 U.S. App. LEXIS 6255).

  Plaintiffs are comprised of a group of parents with children suffering from leukemia and other diseases that require bone marrow transplants for survival, adults suffering side effects from transplants using imperfect genetic matches, and a nonprofit corporation seeking to operate a program incentivizing bone marrow donations.  Specifically, the corporation proposes to offer $3,000 awards in the form of scholarships, housing allowances, or gifts to charities selected by donors, initially to minority and mixed race donors of bone marrow cells, who are likely to have the rarest marrow cell type.

Plaintiffs sought declaratory and injunctive relief to allow the harvesting of hematopoietic stem cells, including cells extracted by "peripheral blood stem cell apheresis," which is a new method of bone marrow transplant that avoids the invasion of the bone to extract the marrow.

The district court dismissed plaintiffs' complaint for failure to state a claim upon which relief could be granted, and plaintiffs filed an appeal.

In plaintiffs' complaint, they describe a new technology that has surpassed typical bone marrow transplantation and which was discovered after the enactment of the National Organ Transplant Act.  "The new bone marrow donation technique, developed during the past twenty years, is called 'peripheral blood stem cell apheresis.'  'Apheresis' means the removal or separation of something.  This procedure begins with five days of injections of a medication called a 'granulocyte colony-stimulating factor' into the donor's blood.  The medication accelerates blood stem cell production in the marrow, so that more stem cells go into the bloodstream.  Then, with no need for sedatives or anesthesia, a needle is inserted into the donor's vein.  Blood is withdrawn from the vein and filtered through an apheresis machine to extract the blood stem cells.  The remaining components of the blood are returned to the donor's vein.  The blood stem cells extracted in the apheresis method are replaced by the donor's bone marrow in three to six weeks.  Complications for the donor are exceedingly rare."

However, although the new procedure makes bone marrow donations much like ordinary blood donations, the matching problem remains.  The plaintiff nonprofit corporation proposes to mitigate this matching problem by using a financial incentive.  Plaintiffs argue that the National Organ Transplant Act, as applied to plaintiff nonprofit corporation's planned pilot program, violates the Equal Protection Clause.  Plaintiffs contend that blood stem cell harvesting is not materially different from blood, sperm, and egg harvesting, which are not included under the statutory or regulatory definitions of "human organ."  Plaintiffs further claim that any rational basis that Congress had when it passed the statute no longer exists with respect to the pilot program, because of the subsequent development of the apheresis method. 

Defendant, the attorney general, contends that inasmuch as bone marrow is considered an organ under the statute, it is not permissible to provide for compensation for the donation of bone marrow.  Defendant further argued that because it is more difficult to find a match for patients who need bone marrow transplants than for patients who need blood transfusions, market forces could be "triggered" if bone marrow could be purchased.

The appellate court held that to the extent that plaintiffs challenge the constitutionality of the compensation ban on bone marrow donation by the old aspiration method, the challenge must fail inasmuch as bone marrow is included in the definition of human organs pursuant to the statute.  In addition, the appellate court determined that Congress had a rational basis, under policy and philosophical concerns for making a distinction between human organs and other body substances that are compensable and those that are not.  Because the distinction has a rational basis, the court held that the prohibition on compensation for bone marrow donations by the aspiration method did not violate the Equal Protection Clause. 

However, the appellate court held that the compensation for bone marrow donations by the peripheral blood stem cell apheresis method was not in violation of the National Organ Transplant Act.  Specifically, the court stated that although "such donations of cells drawn from blood flowing through the veins may sometimes anachronistically be called 'bone marrow donations,' none of the soft, fatty marrow is donated, just cells found outside the marrow, outside the bones, flowing through the veins."  The court held that inasmuch as the aspheresis method did not exist when Congress passed the Act, it could not have intended to address the method.

The court determined that because the "peripheral blood stem cell aspheresis" method of "bone marrow transplantation" 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" for donating the organ through the aspheresis method.  The court vacated the district court's judgment and remanded the case for additional proceedings.

Lexis.com subscribers can access the Lexis enhanced version of the Flynn v. Holder, 2012 U.S. App. LEXIS 6255, decision with summary, headnotes, and Shepard's.

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Comments

lexoraldrin
  • 04-09-2012

cool