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.