The opinion in the above-captioned matter filed on December 1, 2011, and published at 665 F.3d 1048, is amended as follows:
At slip opinion page 20561, footnote 12, change the footnote to, <See Pub.L. No. 98-507, sec. 401, 98 Stat. 2339 (1984); 42 U.S.C. § 274k.>
At slip opinion page 20564, footnote 22, change <Fertility and Sterility> to <Fertility & Sterility>.
At slip opinion page 20565, footnote 26, delete <of> after <New Eng. J.>.
At slip opinion page 20567, footnote 32, change <cert. denied> to <cert. denied>.
At slip opinion page 20571, after the paragraph ending with <subpart of the blood.>, insert the following three new paragraphs and seven new footnotes:
<In its petition for rehearing, the government makes a new argument, not made in its initial brief, for the proposition that Congress did indeed intend "bone marrow" to mean something different from ordinary usage. We have amended our opinion to address that argument. The argument is that because Congress defined "bone marrow" in another statute to include cells found in peripheral blood, "bone marrow" should be so understood in the National Organ Transplant Act. This argument is mistaken, for two reasons. First, in the statute the government cites, the definition of "bone marrow" is limited to provisions "[i]n this part."
Second, the "part" prohibiting organ purchases addresses one subject, the part defining bone marrow to include the cells found in peripheral blood quite another. The first provides for organ donations, prohibits purchases of human organs, and defines these organs to exclude blood.
The panel has voted to deny the petition for panel rehearing. Judge Graber has voted to deny the petition for rehearing en banc, and Judges Goodwin and Kleinfeld have so recommended. The full court has been advised of the petition for rehearing en banc and no judge has requested a vote on whether to rehear the matter en banc. Fed. R.App. P. 35. The petition for panel rehearing and the petition for rehearing en banc are denied.
No future petitions for rehearing or rehearing en banc will be entertained.
KLEINFELD, Senior Circuit Judge:
This is a challenge to a criminal statute prohibiting compensation for "bone marrow" donations.
The district court dismissed the complaint for failure to state a claim upon which relief could be granted.
The complaint challenges the constitutionality of the ban on compensation for human organs in the National Organ Transplant Act, as applied to bone marrow transplants.
Some 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. Another plaintiff is a physician and medical school professor, and an expert in bone marrow transplantation. He says that at least one out of five of his patients dies because no matching bone marrow donor can be found, and many others have complications when scarcity of matching donors compels him to use imperfectly matched donors. One plaintiff is a parent of mixed race children, for whom sufficiently matched donors are especially scarce, because mixed race persons typically have the rarest marrow cell types. One plaintiff is an African-American man suffering from leukemia who received a bone marrow transplant from his sister. She was an imperfect match and, though the transplant saved his life, he continues to suffer from life-threatening and disabling
Another plaintiff is a California nonprofit corporation that seeks to operate a program incentivizing bone marrow donations. 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. The corporation, MoreMarrowDonors.org, alleges that it cannot launch this program because the National Organ Transplant Act criminalizes payment of compensation for organs, and classifies bone marrow as an organ.
We generally use the word "marrow" to refer to the soft, fatty material in the central cavities of big bones, what some people suck out of beef bones. Bone marrow is the body's blood manufacturing factory. Bone marrow transplants enable sick patients, whose own blood cells need to be killed to save their lives, to produce new blood cells. For example, patients with leukemia, which is cancer of the blood or bone marrow, may need chemotherapy or radiation to kill the cancer cells in their blood. The treatments kill the white blood cells essential to their immune systems. The patients will die if the killed cells are not quickly replaced with healthy cells. And they cannot be replaced without the stem cells, which we describe below, that can mature into white blood cells. These stem cells can only be obtained through bone marrow transplants.
Until about twenty years ago, bone marrow was extracted from donors' bones by "aspiration." Long needles, thick enough to suck out the soft, fatty marrow, were inserted into the cavities of the anesthetized donor's hip bones. These are large bones with big central cavities full of marrow. Aspiration is a painful, unpleasant procedure for the donor. It requires hospitalization and general or local anesthesia, and involves commensurate risks.
The complaint explains that a new technology has superseded this technique during the last twenty years, after enactment of the National Organ Transplant Act. With this new technique, now used for at least two-thirds of bone marrow transplants, 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, just some of the marrow's "hematopoietic stem cells." These stem cells are seeds from which white blood cells, red blood cells, and platelets grow.
These are not the embryonic stem cells often the subject of controversy. Those stem cells, taken from human embryos, are "pluripotent," that is, they can turn into any kind of cell — brain, blood, retina, toenail, whatever.
Most blood stem cells stay in the bone marrow cavity and grow into mature blood cells there, before passing into the blood vessels. But some blood stem cells flow into and circulate in the bloodstream before they mature. These are called "peripheral" blood stem cells, "peripheral" meaning outside the central area of the 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 some hours in a recliner while the blood passes through the apheresis machine. This same apheresis technique is sometimes used for purposes other than bone marrow donations, such as when the machine is set up to collect plasma or platelets, rather than stem cells, from a donor's blood. When it is used for these other purposes, the identical 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."
Though the new process makes bone marrow donations much like ordinary blood donations, the matching problem remains. Deep genetic compatibility is critical in bone marrow transplants, because our bodies are xenophobic: white blood cells produced from a donor's imperfectly matched blood stem cells treat the recipient patient's body as foreign, attacking it. This is graft-versus-host disease, which can be fatal or can result in lifelong medical problems for the transplant recipient. All donations from another person, except for one's identical twin, produce at least some graft-versus-host disease in the recipient, but the closer the genetic match, the less disease. Matching is easy in ordinary blood transfusions, because there are only four basic blood types. But there are millions of marrow cell types, so good matches are hard to find. The more diverse the patient's genetic heritage, the rarer the match. For example, African-Americans have especially great difficulty finding a compatible unrelated donor, as they tend to have a mix of African, Caucasian, and Native-American genes, and fewer potential donors are registered in the national civilian registry.
The establishment of this registry, the National Marrow Donor Program, which is funded by the federal government to assist in finding matches, was an important aspect
The plaintiff nonprofit proposes to mitigate this matching problem by using a financial incentive. The idea is that the financial incentive will induce more potential donors to sign up, stay in touch so that they can be located when necessary, and go through with the donations. The nonprofit plans to focus its attention initially on minority and mixed race donors, because their marrow cell types are rarer. The financial incentives would be $3,000 in scholarships, housing allowances, or gifts to charities of the donor's choice, which the nonprofit acknowledges would be "valuable consideration" under the statutory prohibition.
Plaintiffs argue that the National Organ Transplant Act, as applied to MoreMarrowDonors.org's planned pilot program, violates the Equal Protection Clause. They claim 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."
We review a 12(b)(6) dismissal de novo.
The core of plaintiffs' argument is that there is no rational basis for allowing compensation for blood, sperm, and egg donations, while disallowing compensation for bone marrow donations, because bone marrow donations can now be accomplished through apheresis without removing marrow, and the donor's body quickly regenerates the donated stem cells. Since the distinction, they argue, is without a rational basis, it violates the Equal Protection Clause, despite highly deferential "rational basis" review.
The Attorney General responds that the statute plainly classifies "bone marrow" as an organ for which compensation is prohibited, and that the congressional determination is indeed rational. The statute makes it a felony "to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation."
As for plaintiffs' argument that there is no rational basis for a distinction between peripheral blood stem cell apheresis and blood donations, the government argues that because it is much harder to find a match for patients who need bone marrow transplants than for patients who need blood transfusions, exploitative market forces could be triggered if bone marrow could be bought. The government also asserts that peripheral blood stem cell apheresis poses greater health risks for the donor than blood donations do, because of the side effects of the medicine used to increase stem cell secretion. The government bases this factual assertion on information taken not from the complaint, which says that there is no significant risk, but from a patient handout called "Now That You Are a Match," published by the National Marrow Donor Program.
Plaintiffs address their arguments largely to the peripheral blood stem cell apheresis method of extracting hematopoietic stem cells, but their complaint appears to challenge the prohibition on bone marrow transplants regardless of method. They do not, in their complaint or their brief, confine their challenge to transplants by means of apheresis. They apparently propose to give compensated donors the choice between aspiration and apheresis. To the extent that plaintiffs challenge the constitutionality of the compensation ban on bone marrow donation by the old aspiration method — where a long needle is inserted into the cavity of the hip bone to extract the soft, fatty marrow — the challenge must fail.
The statute says that the term "human organ" includes "bone marrow."
As for whether the distinction between the organs or other body substances for which compensation is permitted and those for which it is prohibited has a rational basis, there are two classes of rational basis here: policy concerns and philosophical concerns. The policy concerns are obvious. Some are mentioned in the legislative history, though they need not be.
Congress may have had philosophical as well as policy reasons for prohibiting compensation. People tend to have an instinctive revulsion at denial of bodily integrity, particularly removal of flesh from a human being for use by another, and most particularly "commodification" of such conduct,
Kass suggests that the revulsion for commodification of human flesh is reflected in our language:
These reasons are in some respects vague, in some speculative, and in some arguably misplaced. There are strong arguments for contrary views.
The focus, though, of plaintiffs' arguments is compensation for "bone marrow donations" by the peripheral blood stem cell apheresis method. For this, we need not answer any constitutional question, because the statute contains no prohibition. Such 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, just 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. We must construe the words of the statute to see what they imply about extraction of hematopoietic stem cells by this method. This issue has not been addressed by any of our sister circuits.
Since payment for blood donations has long been common, the silence in the National Organ Transplant Act on compensating blood donors is loud. "Blood" is omitted from the list of examples of "human organs" in the statute and the regulation. The statute says "human organ" is defined as a human "kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ ... specified by the Secretary of Health and Human Services by regulation."
We reject this argument, because it proves too much, and because it construes words to mean something different from ordinary usage. If the government's argument that what comes from the marrow is a subpart of the marrow were correct, then the statute would prohibit compensating blood donors. The red and white blood cells that flow through the veins come from the bone marrow, just like hematopoietic stem cells. But the government implicitly concedes that these red and white blood cells are not "subparts" of bone marrow under the statute, because it explicitly concedes that the statute does not prohibit compensation for blood donations.
As for ordinary usage, the bloodstream consists of plasma containing red cells, white cells, platelets, stem cells that will mature into one of these, and other material. We call this liquid as a whole "blood." No one calls it "bone marrow," even though these cells come from the marrow. There is no reason to think that Congress intended "bone marrow" to mean something so different from ordinary usage. Also, the blood contains not only blood cells and stem cells, but also other substances that come from elsewhere in the body. For example, the blood contains vitamin B12, which enters the bloodstream after binding with intrinsic factor and being absorbed from the small intestine.
Likewise, every blood draw includes some hematopoietic stem cells. All that differentiates the blood drawn in peripheral blood stem cell apheresis from the blood drawn from a compensated blood donor, other than the filtration process, is the medicine given to donors in the days before the blood draw to increase hematopoietic stem cell secretion. 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. Taking part of the liver for a liver donation would violate the statute because of the "subpart thereof" language. But taking something from the blood that is created in the marrow takes only a subpart of the blood.
In its petition for rehearing, the government makes a new argument, not made in its initial brief, for the proposition that Congress did indeed intend "bone marrow" to mean something different from ordinary usage. We have amended our opinion to address that argument. The
Second, the "part" prohibiting organ purchases addresses one subject, the part defining bone marrow to include the cells found in peripheral blood quite another. The first provides for organ donations, prohibits purchases of human organs, and defines these organs to exclude blood.
This new argument by the government, like its old arguments, cannot be reconciled with the government's concession that the National Organ Transplant Act does not prohibit buying blood. After all, the Stem Cell Act defines "bone marrow" to include "the" cells, not just stem cells, "found in ... peripheral blood." This definition includes all blood cells found in veins: red, white, and stem. Had Congress said "in this subchapter" instead of "in this part," when it defined all the cells in the bloodstream as "bone marrow," compensation for blood donations would be prohibited.
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. The statute does not prohibit
It may be that "bone marrow transplant" is an anachronism that will soon fade away, as peripheral blood stem cell apheresis replaces aspiration as the transplant technique, much as "dial the phone" is fading away now that telephones do not have dials. Or it may live on, as "brief" does, even though "briefs" are now lengthy arguments rather than, as they used to be, brief summaries of authorities. Either way, when the "peripheral blood stem cell apheresis" method of "bone marrow transplantation" is used, it 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.
REVERSED. The judgment is VACATED and the case REMANDED for such additional proceedings as may be appropriate. Costs on appeal awarded to Plaintiffs-Appellants.
