Flynn v. Holder

• Decision Date: 27 March 2012
• Docket Number: No. 10–55643.,10–55643.
• Citation: 12 Cal. Daily Op. Serv. 3454,684 F.3d 852,2012 Daily Journal D.A.R. 3964
• Parties: Doreen FLYNN; Akiim Deshay; Mike Hamel; Mark Hachey; Kumud Majumder; MoreMarrowDonors.org; John Wagner, M.D., Plaintiffs–Appellants, v. Eric HOLDER Jr., Attorney General of the United States, sued in his Official Capacity, Defendant–Appellee.
• Court: U.S. Court of Appeals — Ninth Circuit

684 F.3d 852

12 Cal. Daily Op. Serv. 3454

2012 Daily Journal D.A.R. 3964

Doreen FLYNN; Akiim Deshay; Mike Hamel; Mark Hachey; Kumud Majumder; MoreMarrowDonors.org; John Wagner, M.D., Plaintiffs–Appellants,

v.Eric HOLDER Jr., Attorney General of the United States, sued in his Official Capacity, Defendant–Appellee.

No. 10–55643.

United States Court of Appeals,Ninth Circuit.

Argued and Submitted Feb. 15, 2011.

Filed Dec. 1, 2011.

Amended March 27, 2012.

Jeff Rowes, Institute for Justice, Arlington, VA, for the appellants.

Helen L. Gilbert, U.S. Department of Justice, Washington, D.C., for the appellee.

Aneal R. Ganta, Gibson, Dunn & Crutcher LLP, Irvine, CA, for the amici curiae.

Appeal from the United States District Court for the Central District of California, Valerie Baker Fairbank, District Judge, Presiding. D.C. No. 2:09–cv–07772–VBF–AJW.

Before: ALFRED T. GOODWIN, ANDREW J. KLEINFELD, and SUSAN P. GRABER, Circuit Judges.

ORDER

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, line 17, change to to .

At slip opinion page 20561, footnote 12, change the footnote to, SeePub.L. No. 98–507, sec. 401, 98 Stat. 2339 (1984); 42 U.S.C. § 274k.>

At slip opinion page 20564, footnote 22, change to .

At slip opinion page 20565, footnote 26, delete after .

At slip opinion page 20567, footnote 32, change to cert. denied >.

At slip opinion page 20571, after the paragraph ending with , insert the following three new paragraphs and seven new footnotes:

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.” ⁴⁷ Title 42 of the United States Code is divided into chapters, subchapters, parts, subparts, and sections. The prohibition on organ purchases is in a different “part” of the title, not “this” part.⁴⁸ Had Congress meant to say “title,” “chapter,” or “subchapter,” no doubt that is what it would have said.

I. Facts.

The district court dismissed the complaint for failure to state a claim upon which relief could be granted.² We take the facts from the allegations in the complaint to determine whether, if proved, they would state an actionable claim.³

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.⁴ Plaintiffs seek declaratory and injunctive relief to allow harvesting of “hematopoietic stem cells.” The complaint is not crystal clear on whether plaintiffs claim that compensation for all bone marrow transplantation is constitutionally protected, but the focus of the arguments is on cells extracted by “peripheral blood stem cell apheresis.” This is a relatively new method of bone marrow transplant that avoids the need to invade the bone for marrow.

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 disablingcomplications on account of the slight genetic mismatch.

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.⁵

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. ⁶ The stem cells at issue in this case are “hematopoietic stem cells.” “Hema” refers to blood, and “poietic” means “pertaining to production.” ⁷ Hematopoietic stem cells turn into blood cells and nothing else. Humans and other large mammals produce these blood stem cells constantly in vast numbers, because our blood cells die within a few months and need continual replacement.⁸ The dead blood cells are flushed out in the spleen, the body's garbage disposal for used-up blood cells, ⁹ and new ones are made in the bone marrow, as long as we live.

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.¹⁰ 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.¹¹ 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.

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...