On the Stem Cell Injunction
On Monday, Judge Royce Lamberth of the D.D.C. issued a preliminary injunction holding that NIH’s funding of embryonic stem cell research violated an act of Congress. Our story begins in 1996, with The Balanced Budget Downpayment Act that contained a rider, known as the Dickey-Wicker Amendment, which prohibited the use of federal funds for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under” applicable federal regulations. Pub. L. No. 104-99, § 128, 110 Stat. 26, 34 (1996). That rider has been included unchanged in every HHS appropriations bill since.
Under BOTH President Bush and Obama, NIH has used federal funds to fund Embryonic Stem Cell (ESC) research. The Bush approach allowed for federal funds to be used for ESC research for ESCs created before his policy was announced (August 9, 2001). In 2009, President Obama changed that policy: on the one hand expanding the ESC lines for which researchers could receive federal funds beyond the 2001 cut-off of the Bush policy, but on the other hand restricting the available lines through NIH draft guidelines that speak to inter alia the provenance of the ESCs, including the conditions of consent from embryo donors. These guidelines have proven controversial, but for present purposes my larger point is that BOTH the Obama and Bush administration approaches assumed that some ESC research was consistent with the Dickey-Wicker Amendment (thus what Judge Lamberth does would apply equally to both).
This lawsuit was brought by Drs. James L. Sherley and Theresa Deisher, Nightlight Christian Adoptions, Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association.
The relevant paragraph of Judge Lamberth’s order (speaking to likelihood of success on the merits) is as follows:
Congress has spoken to the precise question at issue—whether federal funds may be used for research in which an embryo is destroyed. The Dickey-Wicker Amendment provides that no federal funds shall be used for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. § 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).” Pub. L. No. 111-8, § 509(a)(2). Thus, as demonstrated by the plain language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of federal funds on “research in which a human embryo or embryos are destroyed.” Id.
Contrary to defendants’ argument, the term “research” as used in the Dickey-Wicker Amendment has only one meaning, i.e., “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 45 C.F.R. § 46.102(d); see also Random House Dict. (listing the first definition of research as “diligent and systematic inquiry or investigation into a subject in order to discover or revise facts, theories, applications, etc.”). This is the most common definition of research, and no other definition of research is supported by the language of the statute. The language of the statute does not support defendants’ alternative definition of research as “a piece of research.” (Def.’s Opp’n  at 31 (citing RANDOM HOUSE DICT. (2009).) Indeed, the Dickey-Wicker Amendment does not contain any language to support such a limited definition of research. Rather, the language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed.
This prohibition encompasses all “research in which” an embryo is destroyed, not just the “piece of research” in which the embryo is destroyed. Had Congress intended to limit the Dickey- Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of ESCs, or to research on the embryo itself, Congress could have written the statute that way. Congress, however, has not written the statute that way, and this Court is bound to apply the law as it is written. Accordingly, this Court must “give effect to the unambiguously expressed intent of Congress” to prohibit federal funding of research in which a human embryo is destroyed. Chevron, 467 U.S. at 843.
Lamberth then rejects the government’s argument “that the ESC research is not research in which a human embryo is destroyed because ESC research does not involve embryos nor result in their destruction,” more specifically that the Amendment defines “ESC research and the derivation of ESCs from embryos as separate and distinct ‘pieces of research'” from the destruction of embryos. Lamberth finds that the statute unambiguously (in Chevron terms) precludes that reading, arguing that “[s]imply because ESC research involves multiple steps does not mean that each step is a separate “piece of research” that may be federally funded, provided the step does not result in the destruction of an embryo. If one step or “piece of research” of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment.” He then finds the other requirements of a preliminary injunction satisfied.
Reactions after the jump….
This ruling is certainly a disaster for the Obama administration. They have already announced their intention to appeal, and if my own experience in the USDOJ Civil Division’s Appellate Staff (who presumably is handling this case) is any guide, the request for a stay will be filed first with Lamberth, and then a request for an emergency stay with D.C. Circuit by tomorrow at the latest. This is a disaster for the Obama administration, in part, because even though more and more Americans support ESC research, heading into the November mid-term elections this is not the topic they want to dominate their media time. Just when the President seemed ably reclaiming message time from the BP disaster, this threatens to again dominate political discourse for a week.
The decision is also a disaster for ESC researchers, who depend not only on this funding stream, but certainty about the rules under which they play.
Judge Lamberth is a very able judge, but has also been somewhat aggressive in his injunction practice over the last few years and has had a series of (in my biased view) overreaching injunctions stayed and overturned by the D.C. Circuit. In the long-running Indian Trust Fund Cobell v. Norton (and successive Interior Secretaries) litigation which, full disclosure, I was part of the appellate team that handled the litigation while at DOJ, he inter alia held the Secretary of the Interior (and huge numbers of lawyers) in contempt, ordered a 6-14 billion dollar accounting be done, ordered much of the department of the interior to disconnect itself from the internet, and ultimately the case was re-assigned to a different judge after 8 reversals of his decisions. Thus his opinion here may be going into the D.C. Circuit with the deck stacked against it.
I disagree with some of my bioethics colleagues who are going on record calling the decision “crazy.” That said, I do think that it is hard to find that the statute is “unambiguous” in Chevron terms in the way Lamberth says. Note that since the flaw he identifies is one that both the Bush and Obama policies share, the implication is that both policies exceeded what the statute permitted. The relevant phrase is “research in which a human embryo or embryos are destroyed…” It seems to me this is more clearly a Chevron step 2 case. If NIH had interpreted the statute as Lamberth did through Notice and Comment rulemaking, I think under Chevron deference that interpretation should stand. But it is not so clearly the only reasonable interpretation of the statute that we do not get to step 2 — whether research on things derived from destroyed embryos is “research in which a human embryo or embryos are destroyed…” seem ambiguous to me. If so, given Chevron deference to NIH’s current interpretation I think this is a pretty clear win for the government. The case would be even easier for the government if non-textual evidence (for example Congress’ constant re-passing of the Amendment unchanged in the face of the Obama and Bush stem cell policies) were thought relevant as to the Chevron step 1 inquiry. The last time I handled a case like this it was unclear in the D.C. Cir. whether such cues could come in to make an otherwise unambiguous statute ambiguous, but I will defer to my Admin Law colleagues on where the law is now. Even without those cues this seems ambiguous enough on the text to merit Chevron Stage 2.
Thus, I think an emergency stay from the D.C. Circuit will be swiftly forthcoming. NIH will ultimately prevail. But in the meantime the administration suffers some of the political fallout from this.