There’s something that has puzzled me about the recent stem cell decision that led to an injunction that prevents the NIH from spending any funds on research involving human embryonic stem cells. I’ve read the decision (pdf), and it appears to be incredibly broad and damaging to NIH funding in general.
I could understand an injunction based on a finding that the policy violated federal law: I think that’s stupid, but I get it. What I don’t understand is the finding that NIH policy causes harm to the plaintiffs (the researchers who brought the suit):
Plaintiffs are researchers who work exclusively with ASCs. They seek funds for their research projects from defendants and allege “that obtaining NIH funding is necessary for their continued research.” (Pls.’ Mot.  at 44.) The Guidelines, by allowing federal funding of ESC research, increases competition for NIH’s limited resources. This increased competition for limited funds is an actual, imminent injury.
Why couldn’t this be applied to any decision by NIH to reallocate funding at the programmatic level? If, for instance, NIH were to reallocate funding from bioterror agents (microbes used in biological warfare) to other microbiological areas, would those researchers be able to sue?
Am I missing something here (I very well could be)? Because if I’m not, this could lead to all sorts of mischief. I could definitely imagine universities suing over large program grants worth millions or tens of millions of dollars.
That got me to, I wrote about it a couple of weeks ago for the same reason! I took my lead from comments in Nature News and on a legal blog; like you I’m not very knowledgeable about law, but it does seem an odd call.
The issue of competition for funding was raised to establish that the plaintiffs had legal standing to bring their case.
Other plaintiffs, including a Pro-Life group, had their cases rejected because they could not establish that they have legal standing. My understanding is that the issue of injury to the plaintiffs arises only if the allocation of funding violates the law, if the Judge hadn’t decided that NIH funding of ESC work violated the Dickey-Wicker Amendment then injury to the plaintiffs wouldn’t be an issue.
So in your example the biodefense researchers might be able to prove that they are entitled to bring a case against fundng of other microbiology projects, but they would still have to prove that funding those other microbiology projects broke the law.
It’s a sucky situation, and I fear that the only realistic way out is to repeal (or not renew) the Dickey-Wicker Amendment. That won’t be easy if the Republicans win in the forthcoming elections:-(
Paul @2, I get that the plaintiffs had to establish standing. The real stretch that I see is the finding of potential for immediate and irreparable harm to the plaintiffs, which is normally required for such an injunction. It typically takes several months for a proposal to get reviewed and funding decisions made (at least with NSF and NASA; I have no experience with NIH), and it is generally possible to resubmit a revised grant proposal if the initial application is unsuccessful. They might get there if they can show a proposal which fell just short of the funding cutoff in a previous round, but that’s the only scenario that even comes close to being both immediate and irreparable.
I’d agree with you there Eric. Given the very small proportion of the total NIH budget that is spent on ESC research it seems a bit of a stretch to claim that it is taking funds from ASC research, though I dare say that legally any potential competition, no matter how insignificant, would count.
What are the legal options for challenging the decision concerning standing and injury? If it was decided on appeal that the plaintiffs did not in fact have standing, would that affect the ruling on the violation of the Dickey-Wicker Amendment? Is it too late for that now the ruling has been made?
Any lawyers out there available to comment.
Paul: IANAL, but as I understand it the issue of standing is separate from the issue of obtaining a preliminary injunction. The standing issue looks like a no-brainer to me. But for the judge to issue a preliminary injunction, he has to find not only that the plaintiffs suffer harm under the contested policy but that such harm is both immediate and irreparable. That the plaintiffs legally suffer harm is what gives them standing. Whether the harm is immediate and irreparable, as the judge has presumably ruled, is the key issue.
The other point that normally has to be satisfied for a preliminary injunction is that the plaintiffs have to demonstrate substantial likelihood of prevailing on the issues at trial. This one is less of a stretch, but it’s not airtight either. There is supposedly a Supreme Court precedent (the “Chevron” case) which requires courts to defer to Executive agency interpretations of laws as long as such interpretations are plausible. The government (who as defendants are the ones who have standing to appeal) could prevail on this point, either at trial or on appeal, but they have to make the case.
It is a worrying precedent, although I think common sense will prevail soon.
Hank Greely wrote a good post on it too: http://scopeblog.stanford.edu/archives/2010/08/judge-lamberths-opinion.html
I would point out that the ruling itself addresses the ‘Chevron’ precedent, but notes that it is applicable only if the statute to be interpreted is ambiguous.
As noted above, the matter of funding for a proposal arises only when there is an issue of law related to the funding. One does not have any sort of ‘right’ to have their research funded — but one -does- have the right to have their requests for research funding evaluated under proper legal procedures. If the procedures used are unlawful, then one would seem to have legitimate grounds for complaint.
The issue of ‘irreperable harm’ is somewhat harder to judge, but the argument would be that, if evaluations are made unlawfully in year XXXX, then there is no way to go back in time and re-make them at a later date. Even if one were to provide additional funds to some set of researchers in the future, that would not correct the improper process of year XXXX.