A three-judge panel of the 9th U.S. Circuit Court of Appeals in California ruled unanimously that because the process of donating bone marrow is now so similar to that of donating blood plasma -- which people are paid for -- bone marrow should no longer be considered an organ for which payment is illegal under the National Organ Transplant Act.
A newer method of marrow extraction called peripheral blood stem cell apheresis removes stem cells from a donor's bloodstream in a process similar to donating blood, except that patients must take medication to spur greater production of hematopoietic stem cells, the donation process takes several hours, and instead of collecting bags of blood, the hematopoietic stem cells from the donor's bloodstream are filtered out and collected.
The 1984 National Organ Transplant Act included bone marrow in its list of "organs and parts thereof" for which donors could face criminal charges and five years in prison for providing them in exchange for money or other "valuable consideration."
Though bone marrow is naturally replenishable, unlike livers, kidneys and other whole organs, its sale was barred because the extraction method used at the time the law was passed was painful and risky for the donor and authorities feared the poor would be induced to submit to the procedure to earn money.
In the last 20 years, though, medical advances have brought about a less intrusive method by which the life-saving marrow stem cells are harvested from a donor's bloodstream in much the same way as blood is drawn at a blood bank. The new process, known as apheresis, filters out excess marrow stem cells that circulate in the bloodstream, as opposed to the surgical extraction method, known as aspiration, which inserts a large needle into the hip bone and siphons out the cells.
A unanimous three-judge panel of the 9th U.S. Circuit Court of Appeals ruled that the marrow cells taken from a donor's blood were blood parts, not organ parts, and that a donor is therefore free to accept compensation for a donation.
"This is a fundamental change to how deadly blood diseases will be treated in the country," said Jeff Rowes, the Institute for Justice attorney who argued the case before the 9th Circuit panel in February. "Compensation will expand the donor pool by at least hundreds and potentially thousands each year."
More than 3,000 Americans die each year waiting for a suitable marrow donor, Rowes told the court, representing a group of cancer patients and their families, a Minnesota doctor specializing in bone marrow treatments and the California nonprofit MoreMarrowDonors.org.
The lead plaintiff in the case is Doreen Flynn of Lewiston, Maine, a single mother of five trying to ensure that a broader field of potential donors is available when her three daughters suffering from Fanconi anemia need marrow transplants after treatment for the potentially fatal genetic disorder.
"That is, like, the best Christmas news ever!" said a jubilant Flynn upon hearing that the 9th Circuit had ruled to exclude marrow from the compensation ban. Her 13-year-old daughter is already on medication to stave off the need for a marrow transplant while waiting for a well matched donor, and Flynn must decide soon whether to put one of her 7-year-old twins on the same medication, she said.
MoreMarrowDonors.org wanted the organ transplant law struck down or amended to allow the nonprofit to offer $3,000 scholarships or housing payments to attract new registrants to the National Marrow Donor Program. The registry has more than 7 million members, but many joined years ago during donor drives for friends or family members and are often reluctant to donate to a stranger.
Although the extraction procedure has been greatly simplified, it remains difficult to find the right genetic match between donor and recipient, the plaintiffs argued. Unlike blood, of which there are only four types, marrow comes in millions of types.
The plaintiffs sued U.S. Atty. Gen. Eric H. Holder Jr., alleging that the federal law treating bone marrow in the same way as organs that can't be regenerated violates the Equal Protection Clause of the Constitution. The appeals court panel ruled that the older extraction method directly drawing cells from the marrow was reasonably included in the ban on compensation but that the marrow cells filtered out of a donor's blood were blood parts, not marrow parts.
"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, an appointee of President George H.W. Bush. "The statute does not prohibit compensation for donations of blood and the substances in it, which include peripheral blood stem cells."
Justice Department spokesman Charles S. Miller said the government hasn't decided yet whether to appeal.
"We're going to have to review it to make a determination about what the government's next step will be," Miller said, declining to comment on the ruling.
The 9th Circuit interpretation applies to its nine-state jurisdiction, but because it is the only federal appeals court to have ruled on the question, its judgment could guide future decisions nationwide.
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