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Stem Cell Madness – Judge Lamberth's Opinion and Order Enjoining hESC Research

I was shocked last week when I learned that Judge Royce Lamberth had enjoined the NIH embryonic stem cell research program. As a lawyer, I was even more shocked when I read the opinion, which seems to me, when considered solely as a legal matter, clearly wrong. This very long blog post explains why, first providing some background, then looking at Judge Lamberth’s conclusions on the merits of the claims, his findings on the other requirements for issuing a preliminary injunction, and the unclear meaning of the order he issued, before a few concluding remarks.

Background

The lawsuit was originally brought by a heterogeneous group of plaintiffs, including two adult stem cell researchers, James Sherley and Theresa Deisher; the Christian Medical Association; Nightlight Christian Adoptions (which arranges embryo “adoptions); four clients of Nightlight; and all embryos created for reproductive purposes but no longer needed for those purposes. Judge Lamberth initially dismissed the entire suit, holding that none of the plaintiffs had “standing” – that real and personal stake in the case that is required for someone to be able to sue in federal court. All of the plaintiffs appealed, but they argued the standing only of the two scientists. Last June the U.S. Court of Appeals for the District of Columbia Circuit reversed Judge Lamberth on this point, holding that the two scientists had standing because their chances of getting NIH funding were reduced when funds were spent on embryonic stem cell research. The appellate court remanded the case to Judge Lamberth for a decision on the merits of the scientists’ claims.

At the time, I commented that this was a novel and debatable decision – not, as far as I could tell, either clearly right or clearly wrong – but unlikely to make much difference in this particular lawsuit. On remand, I predicted confidently, Judge Lamberth would dismiss the suit on the merits. I was badly wrong.

The decision last week was not a final decision on the merits of the case, but instead a decision on the remaining plaintiffs’ motion for a preliminary injunction. No trial has yet been held and Judge Lamberth could change his mind. A preliminary injunction gives the plaintiffs relief until the trial is held and the ultimate decision is made. The law allows a judge to issue a preliminary injunction when the moving party (almost always the plaintiff) establishes, in Judge Lamberth’s words:

(1) that there is a substantial likelihood of success on the merits; (2) that the plaintiff would suffer irreparable injury absent an injunction; (3) that an injunction would not substantially injure other interested parties; and (4) that an injunction would further public interest.

The Merits of the Case

The most important of these criteria for present purposes is the first – that the plaintiffs have a substantial likelihood of success on the merits, which requires the judge to somewhat “prejudge” the case.

In this case, the merits turn on the so-called Dickey-Wicker amendment. This amendment was first added to the HHS annual appropriations bill in 1996. Appropriations bills are good for only one year, so every year Dickey-Wicker needed to be added again to the appropriations . . . and, every year from 1996 to the present, it was.

Dickey-Wicker prohibits HHS from funding research that destroys or causes a risk of harm to human embryos. Named after two of its proponents in the House of Representative, Jay Dickey from Arkansas and Roger Wicker from Mississippi, the amendment was originally passed as a rider to the Balanced Budget Downpayment Act in 1996. Congress has included this amendment, in substantially similar language, in every appropriations bill covering the Department of Health and Human Services (HHS) since then. The wording of the current version, adopted as part of the fiscal year 2009 Omnibus Appropriations Act, is

(a) None of the funds made available in this Act may be used 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 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act . . . .

For 11 years, the Clinton, Bush, and Obama administrations have agreed that this language allows funding of research using hESC lines as long as that funded research project does not itself destroy embryos. Judge Lamberth held that this language not only prohibited government funding of any embryonic stem cell research, but did so clearly and unambiguously.

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.

In 1996, this interpretation might have been reasonable, though, I believe, still wrong. In 2010, the decision clearly and unambiguously wrong, for at least three reasons.

First, and true in 1996 as well, it misunderstands the nature of government funding of scientific research. The NIH does not say “Here’s a pool of $100 million for embryonic stem cell research; come and get it.” It says “Please write us a long and complicated application for a grant to do some specific research and if, against long odds, we accept your grant, we’ll give you some percentage of the amount you asked for to do the work you said you would do.” What NIH funds is a “piece of research,” one defined by the grant application. The Guidelines at issue do not allow the destruction (or harming) of embryos as one of the actions to be undertaken as part of any grant. That is the research that NIH funds and it does not violate Dickey-Wicker.

Second, this is not 1996. In 1996, there were no human embryonic stem cell lines. Dickey-Wicker was not passed in response to concerns about embryonic stem cell research but to more general concerns about human embryo research raised by an earlier NIH committee. James Thomson of the University of Wisconsin did not announce the first successful derivation until November 1998. Shortly thereafter, in January 1999, the General Counsel of HHS, Harriet Rabb, concluded that Dickey-Wicker forbade only funding specific research in which embryos were destroyed (or threatened), but allowed funding of research with embryonic stem cell lines that had been created other than as part of that particular research. This position has been maintained by HHS through the Clinton, Bush, and by Obama Administrations, three very different administrations with different embryonic stem cell research policies.

This is important in part because it is evidence against the self-evident clarity of Judge Lamberth’s reading of the amendment. If his answer is so clear, why have three different Administrations rejected it? And if the language is, in fact, unclear, then under the ruling Supreme Court administrative law doctrine, the so-called Chevron doctrine, Judge Lamberth has to give deference to the interpretation placed on the statute by the government agency charged with administering it – HHS.

And third, this is not 1996 in another way. The version of the Dickey-Wicker amendment that Judge Lamberth was supposed to apply was passed in 2009 . . . by a Congress that had, for ten years, seen three different Administrations interpret the rider to permit federal funding of hESC research. If Congress had disagreed with that interpretation, it could have changed the wording of Dickey-Wicker to make that disagreement clear. It did not. In fact, twice Congress passed new legislation to overturn President Bush’s relatively restrictive policy on use of federal funding only to see its bills vetoed. The combination of Congress’s inaction – not inaction by failing to amend an existing law, but inaction by failing to change the language in any of ten independently passed appropriations riders – and Congress’s action in approving broader human embryonic stem cell research makes it very hard to interpret the 2009 action of Congress in passing the 2009 version of this rider as clearly and unambiguously rejecting federal funding for any hESC research.

The Other Criteria

Judge Lamberth’s “pre-decision” on the merits – his conclusion that the plaintiffs have shown they are likely to win at trial – seems the most important part of his holding, but there other aspects are also troubling. Remember, to grant a preliminary injunction, he must find that the plaintiffs have shown not only that they are likely to win, but that they would suffer irreparable injury without an injunction, that they other parties would not be substantially injured by an injunction, and that the injunction would further the public interest. His decision on every point seems wrong and, on two out of three, seems quite wrong.

First, Judge Lamberth found that Drs. Sherley and Dreiser would suffer irreparable injury between now and the trial of this case if human embryonic stem cell research were allowed to continue. Ironically, in light of his earlier (now reversed) decision that the plaintiffs didn’t have standing, he found that they met the “high standard” for proving irreparable injury, an injury that “is both certain and great; it must be actual and not theoretical” (quoting from a DC Circuit opinion). Judge Lamberth says they allege getting NIH funding is necessary for their research; he further finds that competition from embryonic stem cell researchers is “an actual, imminent injury” and that they cannot be compensated after the fact for their failure to receive funding.

He completely avoids any analysis of the reality of their claimed injury. They must be saying that they are irreparably injured because, between now and the resolution of this case at trial, they will not get crucial funding they otherwise would get. Do they have any grant applications pending? Are their applications any good? Would they be funded anyway in the face of competition from embryonic stem cell researches? Would they be funded without such competition, if all the money spent on embryonic research were diverted to adult stem cell research? Would NIH even choose to use money that it had planned to spend on embryonic stem cell research on adult stem cell research? If, in fact, they were really injured by this competition, would their injury be “irreparable” if their applications were considered without such competition in three months, or six months, or as long as it would take Judge Lamberth to resolve this case on the merits? (It does not seem likely to be a long trial, as the questions are overwhelmingly legal, not factual.) Granted, those are difficult things to prove, but if the standard for irreparable is as high as he says it is, one would at least show some interest in them.

Second, Judge Lamberth concludes that the other parties would not be substantially injured by an injunction. He states that

The injunction, however, would not seriously harm ESC researchers because the injunction would simply preserve the status quo and would not interfere with their ability to obtain private funding for their research. In addition, the harm to individuals who suffer from diseases that one day may be treatable as a result of ESC research is speculative.

This statement raises some questions, discussed more below, about the scope of the injunction, but, fundamentally, Judge Lamberth does not seem to recognize that the status quo includes many federal grants for hESC research and lots and lots of applications for more such grants. The researchers with such grants or expecting such grants surely suffer concrete harms. Scientists doing embryonic stem cell research with federal grants are now facing the prospect of stopping research in midstream, ending long-term experiments, and laying off staff. That they might be able to get private funding seems weak compensation – and, of course, if that is an important consideration, Sherley and Dreiser also might be able to get private funding. Finally, although the harm to those whose diseases might be treated is speculative, it seems no more speculative than the idea that Sherley and Dreiser would get funded but for the competition they face from embryonic stem cell research – and the magnitude of the one speculative harm far outweighs the magnitude of the second.

The last point required for issuance of a preliminary injunction is that the public interested would be furthered by such an action. In three sentences, Judge Lamberth concludes it is in the public interest because it is in the public interest for the Congressional will to be carried out. Given his confidence in his reading of the statute (opposite though it is from the readings given it by the Clinton, Bush, and Obama Administrations and, implicitly, by every Congress since 1999), that conclusion may follow. A less self-confident judge might well reflect on the havoc the preliminary injunction may wreak on existing research and conclude that the public interest is not so clear.

The Order

Judge Lamberth’s 15 page opinion explains his decision, but the operative part of this decision, like any judicial decision, is the order that accompanies it. His order is both short and confusing.

ORDERED that defendants and their officers, employees, and agents are enjoined from implementing, applying, or taking any action whatsoever pursuant to the National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009), or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines.

What does that mean?

It could be that Judge Lamberth intends only to prevent the changes in federal funding for stem cell research (largely, but not entirely, expansions) allowed in the Guidelines. That would be (somewhat) consistent with the statement in his opinion that he is only maintaining the status quo. But there are problems with that interpretation.

First, nothing in the opinion distinguishes the research newly allowed under the Obama Guidelines from research allowed under the Bush policy – both allow research that, in Judge Lamberth’s interpretation, destroys embryos. The logic of his opinion stops all federal funding for embryonic stem cell research, funding that has been going on for over eight years.

The language of the order, I think, does the same, particularly in its last clause. One might read the first part of the crucial sentence – “implementing, applying, or taking any action whatsoever pursuant to” the Guidelines – as applying only to new research allowed under the Guidelines, but then there’s that trailing bit: “or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines.” The Guidelines “contemplate” funding not only new research, not previously fundable under the Bush Administration policy, but also funding research allowed under the Bush Administration. This partial sentence seems to incorporate the logic of the opinion and forbid any federal funding of any research involving human embryonic stem cells.

And what does that mean? It surely means that the NIH cannot issue new grants for such research, but it has already issued many grants, both under the Bush Administration policy and, already, under the expanded Obama Administration policy. What happens to those grants? Do they have to stop? Do they have to stop when it comes time for an annual renewal? Do they have to stop when the institution that got the grant needs another tranche of money from the grant to be transferred to it? NIH has announced its preliminary interpretation of the order – all existing grants continue up until the moment of their renewal date, no pending grants will be considered – but it is not clear that the NIH interpretation is correct. (And we know, from past experience, that Judge Lamberth won’t defer to an NIH interpretation he thinks is clearly wrong.) So one can add to the certainty of some chaos to be caused by this order, the additional chaos of uncertainty about the order’s scope.

Conclusion

I support human embryonic stem cell research and federal funding for it as a matter a good public policy. I hope such research will lead, directly or indirectly, to cures and preventions of disease, but even if, in the end, it disappoints, it is an extremely promising approach that should be followed. I am unhappy about Judge Lamberth’s decision in part because it blocks a good policy.

But I am also a lawyer and law professor. I try to teach law students to recognize and to respect good, logically sound, judicial opinions. I am troubled by illogical, unsound judicial opinions, whether or not they favor the policies I like. Judge Lamberth’s opinion is disappointingly bad, in its interpretation of the Dickey-Wicker amendment’s meaning, in its application of the requirements for a preliminary injunction, and in its vague and ambiguous order. I do not know Judge Lamberth and I do not know whether this decision is the result of ideological or political bias or whether it is just an example of the occasional bad opinion one must expect from even a good judge. Either way, I hope –and expect – that the District of Columbia Circuit will quickly first stay the order and then reverse the decision.

Hank Greely

10 Responses to “Stem Cell Madness – Judge Lamberth's Opinion and Order Enjoining hESC Research”

  1. Naomi Most says:

    Why is there no one bringing up the seemingly-obvious and quite lawyerly point that no one’s doing stem cell research on EMBRYOS at all? These are BLASTOCYSTS. An “embryo” is attached to a uterine wall; a blastocyst is just a cluster of cells.

    http://en.wikipedia.org/wiki/Blastocyst

    These are the same clusters that self-destruct all the time when they fail to implant in a uterus — a total natural occurrence.

    If the root of this issue is ethical — which is most certainly is, given that there’s NO OTHER REASON to deny “embryonic” stem cell research from occurring — then why isn’t anyone questioning the factual basis of the situation that the ethics are supposed to be operating on??

  2. Jesse says:

    The legal interpretation from the NIH/DOJ seems to be that current research has to stop. This seems to conflict directly with the ruling of the preliminary injunction: that current researchers would not be significantly harmed.

  3. L. S. says:

    Thank you very much for this very informative yet accessible article. I’ve been looking for something just like this since the ruling was announced.

  4. Jamie says:

    This is a fantastic post. As a scientist who doesn’t know much about law, it’s really nice to see that the reverse isn’t always true.

  5. [...] Shared Stem Cell Madness â Judge Lamberthâs Opinion and Order Enjoining hESC Research. [...]

  6. [...] lawyer Hank Greely disagrees in this cogent, legal argument against the ruling. Filed under biotech, biotechnology [...]

  7. bruce quinn says:

    (A) If you construe the restriction very narrowly, only on the specific creation of stem cell lines with embryo destruction, then it might seem a bit quirky, because a huge pipeline of federal funding would reward (encourage?) the destruction of embryos. This seems to be Lamberth’s concern. I can sort of see that. But…

    (B) But if you construe the term ‘research’ broadly, it raises an opposite problem. When exactly does research related to the original, distinct destruction of the embryo stop? What about a monoclonal antibody biologic crucially depending in a major way on ESC research during its development? What if the ESC are exposed to some condition, RNA is extracted, and the RNA studied in another laboratory? Is that related research? Once you “go broad” with the definition of research you will eventually have to draw a line that various stakeholders will still argue over.

  8. [...] Imagine my surprise when, eight weeks later – as soon as the mandate was returned from the Court of Appeals – Judge Lamberth, without seeking briefing or argument from the parties, granted a preliminary injunction to the two scientist-plaintiffs on the ground that the policy violated the plain language of the Dickey-Wicker amendment, an appropriations rider added annually since 1995 that forbids HHS from funding any research “in which” embryos are harmed.  I blogged on that, too, expressing my surprise – and echoing the surprise and shocked of stem cell researchers and the NIH.   August 2010 decision post. [...]

  9. Mark says:

    I think ethics is just a smokescreen top prevent stem cell research it will not happen in America because big pharma cannot patent it big pharma and the FDA don’t want a cure for anything at all there is no money in it open your eyes to the American lie !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

  10. [...] A much more detailed version of this discussion can be found here. [...]

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