The National Institutes of Health (NIH) and biomedical research groups are jubilant that a federal appeals court today overturned a preliminary injunction that briefly halted research on human embryonic stem cells (hESCs) last year. The 2-1 ruling allays months of fears that research could be shut down again, at least temporarily. But the legal battle isn't over, and the final outcome is anyone's guess.
The case was filed in 2009 by James Sherley and Theresa Deisher, scientists who study adult stem cells. They claimed that NIH's new guidelines expanding research on hESCs violated the Dickey-Wicker Amendment, a 1996 law barring the use of federal funds for research that destroys embryos. In August 2010, U.S. District Court Judge Royce Lamberth agreed and issued a preliminary injunction that halted hESC funding. The ban held for 2.5 weeks, until the U.S. Court of Appeals for the D.C. Circuit blocked the injunction while a three-judge panel deliberated.
That long-awaited ruling strongly favors NIH. Writing for himself and Judge Thomas Griffith, Judge Douglas Ginsburg disagrees with Lamberth on one condition for allowing the preliminary injunction to stand: that it wouldn't seriously harm hESC scientists. The effects on hESC researchers "would be certain and substantial. ... Their investments in project planning would be a loss, their expenditures for equipment a waste, and their staffs out of a job," the decision says.
Importantly, the judges also weighed in on the underlying issue of whether NIH's interpretation of Dickey-Wicker is incorrect. About half of the 21-page brief is devoted to these arguments, with Ginsburg finding: "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 wasn't unanimous, however. A third judge, Karen LeCraft Henderson, found in a dissenting opinion that her colleagues "strain mightily to find the ambiguity the Government presses." She calls her colleagues' separation of the derivation of hESCs and research on the cells themselves "linguistic jujitsu." (The dissenting opinion is probably why the court took months longer than expected to rule, says professor Hank Greely of Stanford Law School in Palo Alto, California.)