Judge Denies Stay on Stem Cell Research Injunction

Following the August 23 preliminary injunction issued by federal District Court Judge Royce Lamberth to block NIH funding of embryonic stem cell research, the Justice Department filed a motion requesting that the injunction be stayed pending an appeal to the D.C. Circuit. In a very short, 2-page order this afternoon, Judge Lamberth denied the stay motion.

Lamberth’s decision is not surprising, given that the issues at the root of both a motion for a preliminary injunction and a motion for a stay order are essentially the same: the court must weigh (1) the relative harm that each side would suffer if they ultimately prevail on the underlying merits of the dispute but are precluded from acting in the way desired while the underlying issue wends its way through the legal system and (2) the “irreparable” nature of such harm. I believe Lamberth’s ruling today is legally incorrect, for the same reasons articulated in my August 25 post analyzing the preliminary injunction. I won’t rehash those arguments in their entirety, but a couple of points bear noting in light of today’s order.

For practical purposes, the most important point in today’s order — and the one that should be the lead in tomorrow’s newspapers — is Lamberth’s surprising statement that his injunction does not prohibit the NIH from continuing to fund embryonic stem cell research that was permitted by the Bush Administration under its restrictive rules. This is a silver lining for some stem cell researchers, because it means that research projects on the 21 Bush-approved stem cell lines that has been ongoing for as long as eight years need not be shut down. But it completely undermines the reasoning of Lamberth’s decision on the merits of the case, and helps to illustrate why it should be overturned on appeal.

To briefly review, Lamberth ruled that the Congressionally approved, recurring Dickey-Wicker Amendment, which prohibits federal funding of “research in which…embryos are destroyed…” extends to the funding of research on embryonic stem cell lines, which are created by removing cells from 5-day old human embryos (thereby destroying the embryos) but thereafter replicate themselves in culture without any further involvement of embryos. Lamberth’s reasoning is that “research” is a very broad concept, such that a grant applicant seeking to work with embryonic stem cells is engaged in the same “research” as the non-applicant who, at a prior date, created the original stem cell line.

The Bush Administration funded embryonic stem cell research only when the cell lines used had been created prior to 2001, whereas the Obama Administration last year expanded funding to embryonic stem cell research that uses cell lines that the government has verified were originally created from embryos left over from in vitro fertilization efforts, regardless of when the cell lines were produced. There is nothing in Lamberth’s reasoning that would distinguish between cell lines created before or after 2001. If researchers who work Obama-approved cell lines are engaged in the same “research” as the scientists who created the cell lines, researchers who work on the 21 Bush-approved cell lines are engaged in the same “research” as the scientists who created those lines.

Judge Lamberth apparently recognizes this logical inconsistency, because he attempts two subtle rhetorical devices in today’s order to try to blunt this criticism. First, he notes that the “Plaintiffs agree that this Court’s order does not even address the Bush administration’s guidelines.” But if Bush allowed funding of A, Obama allowed funding of A and B, and Judge Lamberth finds that the law prohibits funding of A and B, it is hard to understand how the NIH may continue to legally fund A, just because the plaintiffs’ complaint was focused on the Obama rules rather than the Bush rules. Second, Lamberth points out that the Bush rules allowed research only on “existing stem cell lines, foreclosing additional destruction of embryos.” This distinction might matter if Lamberth’s underlying reasoning were that the Dickey-Wicker Amendment prohibits funding of research projects that might create an incentive to destroy embryos in the future, but this is not at all his reasoning. His entire argument is retrospective, not prospective: that research on a stem cell line is the same research project as the prior creation of the line. (By the way, Lamberth’s attempted distinction is factually questionable as well, because the Obama rules only allow funding of research on lines derived from embryos that would otherwise be destroyed anyway; thus, they do not actually create an incentive to increase the number of embryos destroyed).

Lamberth’s order today also attempts to narrow the scope of his August 23 decision by saying that the injunction does not prohibit NIH from maintaining its Human Embryonic Stem Cell Registry and from funding induced pluripotent stem cell (iPSC) research. (iPSCs are adult cells reprogrammed to behave like embryonic stem cells). Again, this is hard to square with the breadth of his reasoning. Embryonic stem cell lines are necessary for the maintenance of a registry, and they are necessary for iPSC research, because the iPSC cells must be compared to embryonic stem cells to determine if the former are behaving like the latter (as is the goal). Lamberth’s reasoning is that it is illegal for NIH to fund any research that uses embryonic stem cells. It logically follows from this premise that funding the registry and iPSC research are illegal.

One other interesting element of today’s order is a point on which Lamberth is completely silent. In its brief requesting the stay, the Justice Department compared the potential harm to the plaintiffs if the stay were granted pending appeal to the potential harm that would result if the stay were not granted. On the former side of the equation, the Justice Department presented two new facts, of which I was not previously aware: that one of the two plaintiffs claiming harm from having to face increased competition for grants from allegedly illegal embryonic stem cell research grant proposals has recently been awarded an NIH grant, and that the other plaintiff who claimed the harm of increased competition has never applied for an NIH grant! These facts, provided in an affidavit by NIH head Francis Collins, suggest that the likelihood that the plaintiffs would suffer any real harm if the stay were lifted until the merits of the case are resolved is vanishly slight. Yet Lamberth completely ignores them.

The only defense of today’s decision offered by the order is that “a stay would flout the will of Congress, as this Court understands what Congress has enacted in the Dickey-Wicker Amendment.” The problem with resting the denial of the stay solely upon his interpretation of Dickey-Wicker is that, if the legal question concerning whether a stay were appropriate were supposed to be exactly the same as the question concerning the proper interpretation of Dickey-Wicker, we wouldn’t need a separate legal process for considering the stay.

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