Stem Cell Ruling Brings Relief for Now, But Legal Battle Continues

by Jocelyn Kaiser on 29 April 2011, 5:35 PM |

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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.)

The split decision has given the plaintiffs some hope that the full court would be willing to hear the case, according to comments Samuel Casey, one of their attorneys, made to Nature's blog. (This is known as an en banc hearing.) Greely thinks they would be unlikely to win, however: Ginsberg's decision "was very well written and clear," while Henderson's was "much weaker." He also notes that three or so of the active members of the full court are Clinton appointees who are more likely to side with the government.

Greely also thinks the U.S. Supreme Court would refuse to hear an appeal of Ginsburg's ruling because the case doesn't involve a disagreement among circuit courts.

That still leaves the underlying case before Lamberth. Last fall, both the plaintiffs and the government filed briefs asking Lamberth for "summary judgment," which means the facts aren't in dispute and they want him to decide the case quickly without a trial. Because the appeals court has found that NIH has properly interpreted Dickey-Wicker, "it's much harder now" for Lamberth to rule to the contrary since his decision would "almost certainly be slapped down" by the same appeals court, says Greely.

However, the door is still open a crack to the plaintiffs because the appeals court didn't weigh in on another of their arguments: that the guidelines are illegal because NIH didn't follow proper procedures when it developed them. (Greely thinks that argument is weak.)

How long will these various rulings and appeals take to play out? The plaintiffs need to ask the appeals court for en banc review within 45 days, Greely says. Lamberth could rule on the underlying case any day—or he could decide to hold a trial, which could take many months. And however Lamberth rules, his decision would likely be appealed to the appeals court and possibly the U.S. Supreme Court.

Greely thinks scientists can breathe easy. "No matter how you look at it this was a very good day for the human embryonic stem cell research community. The best chance plaintiffs had was with this [appeals court] panel, and everything from here out is low probability for them," says Greely. Tony Mazzaschi of the Association of American Medical Colleges isn't so sanguine. "This will be a protracted fight," he predicts. "It's going to be a long time before this is over."

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