The National Institutes of Health (NIH) and biomedical research groups are jubilant that an appellate court Federal canceled today a preliminary injunction that briefly halted research on human embryonic stem cells (hESCs) last year. The decision allays 2-1 months of fears that the research could be stopped again, at least temporarily. But the legal battle is not over, and the end result is an enigma.
The complaint was filed in 09 by James Sherley and Theresa Deisher, scientists who study adult stem cells. They claimed that the new NIH guidelines expanding research on hESCs violated the Dickey Amendment, a 1996 law banning the use of federal funds for research that destroys embryos. In August 2010, a judge of the US District Court Royce Lamberth agreed and issued a preliminary injunction that stopped the funding of hESC. The ban was held for 2.5 weeks until the US Court of Appeals for the D.C. Circuit blocked the injunction while a panel of three judges deliberated.
The long-awaited decision strongly encourages NIH. Writing for himself and Thomas Griffith judge, Judge Douglas Ginsburg disagreed with Lamberth in a condition to allow the preliminary injunction to stay: it would not hurt seriously hESC scientists. The effects on hESC research "would be certain and substantial. ... Their investment in project planning would be a loss, their expenditures for equipment a waste, and their staff on a job," said the ruling.
importantly, the judges also weighed on the underlying question of whether the interpretation of the Dickey-Wicker NIH is incorrect. about half of the 21 memory pages is devoted to these arguments, with Ginsburg conclusion: "We conclude the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used. "
the decision was not unanimous, however ,. a third judge, Karen LeCraft Henderson, found in a dissenting opinion that his colleagues "strain mightily to find the ambiguity presses the government." She called the separation of the derivation of hESCs and research on the cells themselves of his colleagues "linguistic jujitsu . "(the dissenting opinion is probably why the court has taken months longer than expected to the rule, said the professor Hank Greely of Stanford Law School in Palo Alto, Calif.)
the split decision gave the plaintiffs a little hope that the full court is ready to hear the case, according to Samuel Casey comments, one of their lawyers, made Nature blog. (This is known as a bench hearing.) Greely think they would have little chance of winning, though: ". Much lower" Ginsberg's decision "was very well written and clear" while Henderson was also notes that three or more active members of the full court appointed Clinton who are more likely to another with the government.
Greely also thinking of the Supreme Court of the United States refused to hear an appeal of the decision to Ginsburg because the case has no disagreement among the circuit courts.
that still leaves the underlying case before Lamberth. last fall, two plaintiffs and the government have filed briefs asking Lamberth for "summary judgment," which means that the facts are not in dispute and they want to decide the case quickly without trial. Because the appellate court found that NIH correctly interpreted Dickey-Wicker, "it is much more difficult now" for Lamberth to rule on the contrary, since his decision would "almost certainly be slapped down" by the same court of appeal, said Greely.
However, the door is still open a crack to the plaintiffs because the appellate court did not weigh on another of their arguments: that the guidelines are unlawful because NIH did not follow the appropriate procedures when he developed them. (Greely think that argument is weak.)
How long these decisions and appeals take to play? Applicants should ask the appeals court to bench notice within 45 days, says Greely. Lamberth could rule on the underlying case a day or it could decide to hold a trial, which could take several months. Yet Lamberth of rules, its decision would be appealed to the appellate court and eventually the Supreme Court of the United States.
Greely scientists think can breathe easy. "No matter how you look at it was a very good day for the research community on human embryonic stem cells. The best chance seekers had was with this [appeals court] panel, and all by a low likelihood for them" says Greely. Tony Mazzaschi of the Association of American Medical Colleges are not as optimistic. "it will be a long fight," he predicted. "it will be a long time before it's over."
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