Flynn v. Holder, Markets for Bone Marrow, and Abigal Alliance
posted by Glenn Cohen
Over the summer at the annual health law professors’ conference organized by ASLME, I saw a wonderful presentation on Flynn v. Holder from John Robertson, which I think John will be publishing soon. The case is a challenge to the National Organ Transplant Act (NOTA) of 1984’s ban on selling bone marrow filed in the U.S. District Court, Central District of California, and you can view the complaint here.
My main interest in the case is how it will compare to Abigail Alliance v. Eschenbach, a case I helped litigate at the D.C. Circuit en banc stage when I was at the DOJ. Abigail Alliance involved a challenge by terminally ill patients to have access to drugs that had cleared Phase 1 Clinical Testing but had not gone further in the testing process. There, the plaintiffs succeeded in getting a panel of the D.C. Circuit to to hold that a fundamental right of theirs was being violated by the FDA policy, with a remand for consideration of whether the government could make its showing on strict scrutiny. On rehearing en banc, however, the full D.C. Circuit reversed gears finding no fundamental right (there was no serious argument in the case that the government would not prevail on rational basis review).
In many ways, Flynn is a beautifully set up test case. The primary plaintiff is very sympathetic — a “single mother of five with three daughters who suffer from a deadly bone marrow disease.” Because bone marrow is renewable, and many other renewable “organs” (think sperm and egg) explicitly fall outside of NOTA’s prohibition, there is an air of arbitrariness here. The plaintiffs do not want to buy bone marrow in crass commercial terms, but instead to “create a pilot program that would encourage more bone marrow donations by offering nominal compensation—such as a scholarship or housing allowance.” While I do not think this fact actually allows us to avoid the the corruption form of the anti-commodificationist argument (I may blog more on that topic soon), on a superficial level it does seem to reduce the strength of at least one talking point. The fact that we already tolerate altruistic bone marrow donation suggests that the risk-prevention rationale that was central in Abigail Alliance faces some problems here. Indeed as I , Lori Andrews, and others have argued in the context of reproductive services, in some ways the “coercion” or “exploitation” concerns that are sometimes raised in anti-commodificationist arguments may be more worrisome in the altruistic and familial setting than in arm’s length market arrangements. The case also seems to compare favorably on crowding-out concerns. Although the Abigail Alliance court did not reach the issue (because whether a fundamental right was present dominated the analysis) the government offered a somewhat attenuated crowding out argument: that the availability of experimental drugs outside of clinical trials would reduce the enrollment in clinical trials, and therefore slow either approval of these drugs (and widespread availability) or a demonstration that they were unsafe or ineffective. Though attenuated, this was a concern that many took quite seriously in the run-up and aftermath of the case. Here, by contrast, I think the crowding out argument is more straightforward and is similar to one that people associate with Richard Titmuss’ work as to blood sale, that adding commercial elements will drive altruistic donation out of the market. To be sure that is an empirical claim, but one that seems less plausible to me than the parallel claim in Abigail Alliance, and I think here again the charitable/foundation approach may blunt some concerns about the transformation of the social meaning of bone marrow donation.
While many of these points are not directly relevant to the substantive due process classification as a fundamental right, they are certainly relevant to the system design/policy question, they will make it easier for the court to side with the plaintiffs, and they may become to the analysis under strict scrutiny if the court determines that standard applies. Perhaps cutting the other way is that unlike in Abigail Alliance here allowing the ‘purchase’ introduces risk to a new person (the bone marrow donor who would not have donated but for the new incentive), so it is not merely a right to do what one wants with one’s body, but instead involves the bodies of others, although that distinction does not strike me as particularly important.
On a more doctrinal level, I think this will be a much harder case for the government to win than Abigail Alliance. While in Abigail Alliance we successfully argued that the history of regulating drugs to protect the patient went back to colonial America and thus the opposite right was hard to establish under the Glucksberg framework, here NOTA is of fairly recent vintage and (also unlike Glucskberg) there is no deeply entrenched negation of the right. For most of the levels of briefings all sides in Abigail Alliance as well as the court treated the case as though the Glucksberg’s “Due Process Traditionalist” approach governed, rather than a more intimacy-based view associated with the “mysteries-of-life” passage from Casey. It will be interesting whether the Flynn court also focuses exclusively on Glucksberg, considers both approaches, or (though unlikely) focuses on the intimacy approach.
August 9, 2010 at 10:00 am
Posted in: Bioethics, Civil Rights, Consumer Protection Law, Health Law, Law Practice, Property Law
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Responses (3)
Brett Bellmore - August 9, 2010 at 12:52 pm
Doesn’t the “crowding out” reasoning prove way, way too much? I mean, allowing doctors to be paid presumably crowds out the unpaid provision of medical services. Allowing pharmaceutical manufacturers to be paid presumably crowds out unpaid manufacture of drugs. Allowing people to be paid for ANYTHING ‘crowds out’ the uncompensated provision of that good.
But we allow people to be paid for the provision of goods and services anyway, because we realize that essentially every good and service would be radically undersupplied if nobody could be paid for providing it. Organ and tissue donation are no exception to this. And because it’s perfectly reasonable and just for people to expect payment for providing goods and services. Again, organ and tissue donation are no exception.
I can’t see a rational reason why a tissue donor shouldn’t be compensated, while the doctor should be…
tf - August 9, 2010 at 1:18 pm
Sorry but I see any restrictions on the sale, exxchange or other of a persons own organs (or in the case of a dying person- the one making health care decisions) as morally wrong and almost tantamount to murder by law and society. Doesn’t anyone see the long organ donor lists and the amount of people dying each day.
Glenn Cohen - August 10, 2010 at 9:47 am
Thanks for the comments
Brett — actually the “Crowding Out” argument (and I should signal here that I am a skeptic) claims that in some markets currently characterized by altruistic giving, a move to a market norm would *reduce* supply, since the alteration in the social meaning alienates some current individuals who give without compensation and that diminution is not offset by the the increased number of those who give because of the compensation. Again, it is an empirical claim, one that has received *some* support in blood markets. With the sale of medical services, I think a proponent of the theory would either say (i) this is not a theory of all goods at all times, so she can concede your point as to medical services and maintain her point as to bone marrow; and/or (ii) It is too late with medicine, we already have a system of exchange conceived in market terms, and it may be very hard to reclaim an altruistic social meaning.
TF- Again I should be upfront and signal (as you can gather from the old paper of mine I linked to in the body of the text) that my priors tend to be closer to yours on the issue. That said, (i) if you thought that the crowding-out theory was empirically well-supported as to this market (again I am skeptical), then in fact it is permitting these sales not preventing them that reduces supply and therefore causes more deaths by those on the waiting list; (ii) At least under certain circumstances the exploitation/coercion arguments may prove worrisome enough in the organ context to count as countervailing considerations. Here the Anthropologist Nancy-Scheper Hughes’ work is instructive. Again, as I said in the main post, the fact that bone marrow is renewing may somewhat blunt this concern more than in the organ sale context.
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