Almost two years ago to the day, Chief Judge Royce Lamberth of the D.C. District Court shocked the human embryonic stem cell (hESC) research community by preliminarily enjoining NIH funding of that research, on the grounds that plaintiffs were likely to succeed on the merits of their argument that hESC research violates the so-called Dickey-Wicker Amendment (on which more below). Today, the D.C. Circuit affirmed Chief Judge Lamberth’s (reluctant) grant of summary judgment for the government, a holding that he had been essentially forced into by an earlier panel of the D.C. Circuit. (My co-guest blogger covers the other big decision coming out of the D.C. Circuit today, below.) Since it is extremely unlikely that the D.C. Circuit will review the decision en banc or that the U.S. Supreme Court will accept cert., today’s decision effectively ends litigation that caused utter chaos to erupt in labs all over the country in the wake of the preliminary injunction, and continued to cause significant uncertainty even after the D.C. Circuit quickly stayed that preliminary injunction. Congress could, of course, act to clarify the ambiguity in Dickey-Wicker. But this seems highly unlikely given the current partisan split between the House and the Senate. Indeed, the draft HHS appropriation bill that passed the subcommittee, on which I blogged previously, contains Dickey-Wicker’s familiar language, to the letter. The ambiguity regarding the legality of federal funding of hESC research seems, then, to have reached its low water mark during the past couple of years, and should stay that way…at least until November.
For those of you who are close observers of this litigation: as you were (or skip to the section on today's opinions, below). For the uninitiated-but-interested: Some background. Federal policy regarding funding for hESC research has, since the beginning of this research in 1998, been extremely contentious, wrapped up as it is with ethical, political and diverse religious positions on the moral status of human embryos and other aspects of “abortion politics.” An embryonic stem cell line is so called because the line is derived from an embryo (really, a five-day or so blastocyst), and this process necessarily destroys that embryo. Despite that — or because of it — the funding policies under the Clinton, Bush and Obama administrations have been remarkably similar. In this article, published in September 2009 — one month after the litigation that no one thought would have legs had commenced — political scientist James Fossett and I analyzed these extent to which the Obama Administration’s guidelines for funding hESC research, then just announced by NIH, were likely to achieve two of their stated goals: (1) expanding NIH support for hESC research after what had been widely perceived by the science community as strict limits on it during the Bush Administration, and (2) ameliorating the patchwork of state and private regulatory standards that had come to govern this research in the absence of federal funding.
With respect to the second goal of NIH’s hESC research funding policy, ameliorating the “patchwork” of standards governing that research, Fossett and I argued that, although the Guidelines centralize crucial aspects of federal policy and may exert influence even over non-NIH-supported researchers and other research funders and regulators, they almost certainly would not substantially reduce the multiple standards for conducting hESC research that exist in the U.S., much less in the world. Multiple funders and regulators, and so multiple sets of rules, will continue to exist, with none clearly dominant. In short, we concluded that our best guess for the short-term future of U.S. stem cell policy in the aftermath of the guidelines was that, for better or worse, it would look very much like the recent past.
To a large extent, these predictions about the effect of the Obama Administration’s policy were rendered moot by litigation challenging the legality of that policy under the Dickey-Wicker “Amendment.” In reality, Dickey-Wicker is a rider, named not to induce giggling (I once appeared on regional public radio to discuss the litigation and both the host and more than one caller succumbed to tittering as they stumbled over the name of the rider) but after its authors, that Congress has attached each year since 1996 to the annual appropriations bill governing HHS spending. Dickey-Wicker prohibits HHS from funding “research in which a human embryo or embryos are destroyed.” When Dickey-Wicker first appeared in 1996, it was directed at embryo research; hESC research became a real possibility only in 1998. At that time, HHS counsel opined that Dickey-Wicker prohibits federal funds from being used to create embryonic stem cell lines, since that process destroys the embryo, but not from being used to support subsequent research on those stem cell lines, once created with state or private funding. NIH has operated under that interpretation of Dickey-Wicker ever since, with both Bush and Obama adopting the Clinton administration’s reading and issuing executive orders directing HHS to fund hESC research accordingly. Meanwhile, each year Congress passed budgets containing HHS appropriations without ever rewriting Dickey-Wicker to make clear its intent to prohibit HHS from funding research on hESC lines. (Twice, in fact, Congress even passed legislation to expand HHS funding of hESC research, though those expansions were vetoed by President Bush.)
And so it was quite surprising when, in 2010, Chief Judge Lamberth granted a preliminary injunction against the NIH to prohibit it from funding research on hESC lines, predicting plaintiffs’ success on the merits on the grounds that such funding violates the “plain meaning” of Dickey-Wicker. Lamberth had overseen almost identical litigation, involving some of the same plaintiffs, during the Clinton Administration, only to have it voluntarily dismissed by plaintiffs when President Bush was elected and stayed the Clinton policy before it went into effect. Then, when plaintiffs’ objections to hESC research mysteriously reemerged after President Obama was elected, despite the considerable similarities among the Clinton, Bush and Obama policies, Lamberth had initially dismissed the current suit on standing grounds. The D.C. Court of Appeals surprised most observers by reversing; although it agreed that several plaintiffs lacked standing, it held that two plaintiffs morally opposed to hESC research, James Sherley and Theresa Deisher, had “competitive economic standing” as adult stem cell researchers competing with hESC researchers for scarce federal funding. (Sherley is an interesting character in his own right. He once embarked upon a hunger strike to protest his denial of tenure at MIT, a decision he alleged was based in racial discrimination.)
The litigation ball back in his court, Lamberth on remand turned to the quasi-merits and, as I said, shocked everyone in 2010 by doing a 180 and granting plaintiffs’ request for a preliminary injunction. He reasoned that “research in which . . . embryos are destroyed” applies to the whole trajectory of research, from the embryo-destroying derivation process to research using the stem cell lines that result to (presumably) clinical trials testing stem cell treatments in patients with paralysis or Parkinson’s or any number of other diseases and conditions. Although it wouldn’t be my own policy choice, this interpretation of Dickey-Wicker isn’t crazy, given the underlying goal of Dickey-Wicker to avoid taxpayer complicity with embryo destruction. (There's at least a plausible story one can tell about the incentives for privately-funded embryo destruction that result from federal willingness to fund upstream research dependent on that earlier destruction.)
But, assuming that the Chevron doctrine applies (at least two judges on the D.C. Circuit do not; more below), Lamberth had to defer to any reasonable interpretation by NIH of any ambiguous language in DW. As Fossett and I explained in a commentary on the litigation here, his only way around NIH’s interpretation, on that assumption, was to hold that Dickey-Wicker is unambiguous, and that — contrary to the readings it has been given by three presidential administrations and several Congresses — it unambiguously prohibits federal funding of both research that is per se embryo-destroying (such as some embryo research and the derivation of hESC lines) and research that could not be conducted without an embryo having been destroyed at some point (such as research that uses previously derived hESC lines), no matter how long ago the destruction took place, or with whose funds. According to Lamberth, NIH’s interpretation rests on an artificial distinction between the embryo-destroying “piece of research” that creates a stem cell line and the subsequent “research” on that line. Both are part of the same stream of research, he said, and for HHS to fund either violates the “plain language” of Dickey-Wicker. (For an argument that DW is unambiguous and correctly interpreted by NIH, such that neither court should ever have reached a Chevron analysis, see Russell Korobkin’s series of excellent prior posts over at Volokh. Hank Greely has also had extensive and very insightful posts on the litigation here. For an argument that Chevron deference doesn't apply to any single agency's interpretation of Dickey-Wicker, no matter how ambiguous its language, see today's opinions by Judges Henderson and Brown, discussed below.)
NIH appealed to the D.C. Circuit, where first one three-judge panel stayed the injunction, and then a second panel, in a 2-1 opinion issued in 2011, vacated the preliminary injunction. (You have to feel for Chief Judge Lamberth, one of the more interesting members of the federal judiciary. The guy can’t get a break.) Employing Chevron deference analysis, the majority (Judge Ginsburg, joined by Judge Griffith) held that the plaintiffs were unlikely to prevail on the merits because Dickey-Wicker was ambiguous as to the term “research,” and NIH’s interpretation of it was reasonable. “Research,” they said, might mean what the plaintiffs and Judge Lamberth believe it means: a lengthy stream of scientific work, conducted by many scientists, whose work is supported over the years by many sources of funding. But, equally plausibly, it might mean what NIH has always said it means: the discrete research project described in a particular scientist’s grant application. Judge Henderson’s strong dissent, in which she adopted Judge Lamberth’s interpretation of Dickey-Wicker, and Chief Judge Lamberth’s reputation for being something of a judicial cowboy, helped prolong uncertainty about what Lamberth would do on second remand.
The majority’s holding sent a strong message to Lamberth about how that panel, at least, would rule on the merits. And so earlier this year, Lamberth reluctantly, but not that surprisingly, ruled for NIH on those merits, granting it summary judgment. He also ruled for NIH with respect to two additional arguments. First, the plaintiffs had argued that NIH’s funding policy violates Dickey-Wicker’s second prong, which prohibits funding any “research in which a human embryo or embryos are ... subjected to risk of injury or death.” According to plaintiffs, HHS funding of research on hESC lines creates an incentive for researchers to create such lines, which, in turn, puts embryos at risk since deriving a stem cell line requires destroying the embryo. In rejecting this argument, Judge Lamberth explained that, under the D.C. Circuit’s reasoning, Dickey-Wicker prohibits only research in which, not research because of which, embryos are placed at risk. Finally, the plaintiffs claimed that NIH violated the Administrative Procedure Act by ignoring many public comments it received before formally adopting its hESC regulations. Judge Lamberth held that NIH merely obeyed President Obama’s executive order to expand hESC research; the comments urging HHS not to do so were irrelevant.
Today, yet another three-judge panel of the D.C. Circuit (Chief Judge Sentelle and Judges Henderson and Brown) unanimously upheld Lamberth’s decision granting summary judgment to the government. The court ruled against plaintiffs on their Dickey-Wicker interpretation argument — somewhat surprisingly (to me, at least), based on the law-of-the-case doctrine. In an issue of first impression in the D.C. Circuit, the panel followed the First and Eleventh Circuits in rejecting the preliminary injunction exception when “time constraints and [a] limited record available to the court . . . are not present.” The panel then upheld Lamberth’s ruling on the two issues not previously litigated at the appellate level, largely for the reasons Lamberth himself offered.
Both Judge Henderson and Judge Brown wrote concurring opinions. Judge Henderson wrote to make clear that, while she agrees that the instant panel is bound by the law-of-the-case doctrine, she continues to believe that the prior panel, from which she dissented, erred. Specifically, she writes, NIH’s interpretation of Dickey-Wicker is not entitled to Chevron deference because that doctrine is limited to statutes that are entrusted to agencies to administer. The rider, she notes, is attached to a spending bill governing the Departments of “Labor, Health and Human Services, and Education, and Related Agencies Appropriations,” and so Congress cannot be said to have entrusted Dickey-Wicker to NIH, or even HHS, to administer, and courts need not defer to any one agency’s interpretation of it. Moreover, she said, an appropriations rider is not within an agency’s area of expertise. She would have accorded no deference to NIH’s interpretation and, upon the court’ own de novo review of that interpretation, would have rejected it as contrary to the “plain and unambiguous text” of Dickey-Wicker. “This conclusion is compelled by the dictionary definition of ‘research’ as a ‘systematic inquiry or investigation,’ which necessarily includes not only ‘the first sequence of hESC research [involving] the derivation of stem cells from the human embryo’ but also ‘the succeeding sequences of hESC research.’”
Judge Brown concurred to note that, while she agrees with Judge Henderson that Chevron is inapplicable, she is less certain “how to define ‘research’ in light of the many layers of executive orders, agency interpretation, and legislative acquiescence with which we must now deal.” She noted that, “whatever the Amendment’s original purpose, President Clinton’s decision in 1999 to announce a policy of federal funding for embryonic stem cell research— and Congress’s decision to pass the Amendment unchanged the following year—altered the interpretive calculus. In the same vein, Congress’s decision to pass the Amendment unchanged for all eight years of the Bush Administration seems to confirm its acquiescence to some federal funding of research involving human embryonic stem cells.” As a result, she said, although she, like Judge Henderson, would have reviewed NIH’s interpretation de novo, in her view, such review “would not change the outcome of the prior decision to affirm NIH’s interpretation of the act.”
Judge Brown then took up what most commentators have viewed as a throw-away argument: the one based on NIH’s failure to seriously consider and respond to public comments about its funding guidelines. While agreeing with the majority that, under D.C. Circuit precedent, an agency is only required to respond to comments to the extent that they are relevant to the agency’s decisionmaking, she questions the majority’s definition of “‘relevance’ as coextensive with the President’s Executive Order,” which thereby imposes no “clear limits on an agency’s ability to ignore comments that contravene the executive’s policy goals. I fear that without such boundaries there remains the distinct possibility that the executive power will expand at the expense of the APA’s regulatory scheme and judicial review will be reduced to rubberstamping preordained results.”
Judge Brown concluded as follows:
The challenging—and constantly evolving—issues presented by bioethics are critical and complex. Striking the right balance is not easy and not, in the first instance, a task for judges. What must be defended is ‘the integrity of science, the legitimacy of government, and the continuing vitality’ of concepts like human dignity. Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate.
Hear that, Congress?
Update: Russell has a post on today's decision here.