Federal Court Says Bone Marrow Stem Cells Are Not Organs, Allows Compensation to Donors

A federal appeals court in California said for the first time that people can be compensated for donating blood stem cells to help cancer patients, overturning a decades-old law that made such compensation a crime.

In a unanimous ruling, the Ninth U.S. Circuit Court of Appeals ruled December 1, 2011 that the bone marrow cells filtered out of a donor’s blood are considered blood parts, not organ parts, and that a donor is therefore free to accept compensation. The National Organ Transplant Act of 1984 (P.L. 98-507) (42 U.S.C. section 274e) prohibits compensation for human organs, such as kidneys, but allows payment for renewable tissues such as blood, sperm and eggs.

The lawsuit was brought against the federal government by a coalition that included patients seeking bone marrow transplants, a physician and medical school professor, an expert in bone marrow transplantation and MoreMarrowDonors.org, a California nonprofit group that wants to offer donors $3,000 in scholarships, housing allowances or gifts to charities selected by donors.

The plaintiffs argued the National Organ Transplant Act violates the Equal Protection Clause of the Constitution because it criminalizes payment for compensation for organs – and classifies bone marrow as a “human organ” – while allowing payments for blood, sperm and eggs.

The Justice Department responded that the statute plainly classified “bone marrow” as an organ for which compensation is prohibited. The statute makes it 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.” (42 U.S.C. section 274e(c)(1). The government argued that stem cells in the blood were subparts of the bone marrow and the ban should apply.

The government also conceded that the common practice of compensating blood donors is not prohibited by the statute. A California district court sided with the government, but the Ninth Circuit Court of Appeals disagreed.

New technology has superseded a traditional technique for extraction of bone marrow since the National Organ Transplant law was enacted. When the organ act was passed, marrow was extracted from patients with an invasive needle in a much more dangerous and painful procedure. That material, from inside the bone, was treated as an organ.

The new bone marrow donation technique, “peripheral blood stem cell aspheresis,” accelerates blood stem cell product in the bone marrow, so that more stem cells go into the bloodstream. Then, the blood is withdrawn from the vein and filtered through an aspheresis machine to extract the blood stem cells. The same aspheresis technique is used for blood donations. The court said that new technologies for transplanting bone marrow make the tissue more like blood and less like an organ. “We construe ‘bone marrow’ to mean the soft, fatty substance in bone cavities, as opposed to blood, which means the red liquid that flows through the blood vessels,” said the opinion written by Judge Andrew J. Kleinfeld. “The statute does not prohibit compensation for donations of blood and the substances in it, which include peripheral blood stem cells.”

The court said that the new technique which collects stem cells from the donor’s blood stream rather than the bone did not amount to an organ transfer. Because the donors are not literally donating their bone marrow, and because existing law permits payment for blood donations, compensating donors who undergo this procedure is legal, the court found. “Once the stem cells are in the bloodstream, they are a ‘subpart’ of the blood, not the bone marrow,” Judge Kleinfeld wrote. He acknowledged that “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.”

“Blood” is omitted from the list of examples of “human organs”’ in the statute prohibiting compensation and that “silence….is loud,” said the judge. If Congress had intended to include blood as an organ, it would done so explicitly. Since the law was enacted in 1984, “the Secretary of Health and Human Services has not exercised regulatory authority to define blood or peripheral blood stem cells as organs,” he added.

Because the court found the stem cells to be “blood” and not “organs,” allowing donors to be compensated, Judge Kleinfeld concluded that that determination obviated a ruling on whether prohibiting compensation for such donations would be unconstitutional.

The Ninth Circuit interpretation applies only to its jurisdiction, of course, but because it is the only federal appeals court to have ruled on the question, its judgment could guide future decisions nationwide and the new reading of the federal prohibition could also attract thousands more donors.

 

Flynn v. Holder, 9th Circuit Court of Appeals, No. 10-55643, December 2, 2011.