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Stem Court Ruling a Decisive Victory for NIH
27 July 2011 4:21 pm
The biomedical research community is elated by today's federal court decision to throw out a lawsuit that threatened to shut down federally funded research on human embryonic stem cells (hESCs). U.S. District Court for the District of Columbia Chief Judge Royce Lamberth, who earlier had ruled against the National Institutes of Health, this time came down on NIH's side in several key arguments in the case.
The plaintiffs expect to appeal, and could end up at the U.S. Supreme Court. But their chances seem slim given that the 38-page opinion strongly favors NIH, say some who have read it. "This was a pretty slam dunk decision even though Lamberth clearly did it a bit grudgingly," says Anthony Mazzaschi of the Association of American Medical Colleges in Washington, D.C. "They can keep some uncertainty alive for another 2 to 3 years, but [their suit] is on life support," says Stanford University law professor Hank Greely.
Harvard Medical School stem cell researcher George Daley is more cautious. "I hope we're done for now, but nothing surprises me anymore," Daley says.
The suit, Sherley v. Sebelius, was filed in 2009 by groups that included two scientists who study adult stem cells. They argued that NIH's July guidelines implementing an order from President Barack Obama to lift limits on hESC research violated the Dickey-Wicker Amendment, a law that prohibits federal funding for "research in which a human embryo or embryos are destroyed."
In an early ruling, Lamberth concluded that the plaintiffs were likely to win. He issued a preliminary injunction in August 2010 that briefly halted NIH funding for hESC research before an appeals court stayed the injunction. But that court, the U.S. Court of Appeals for the D.C. Circuit, in a 2-1 decision in April overturned the preliminary injunction, allowing research to continue until Lamberth ruled on the merits of the underlying case.
And this time, Lamberth has sided with NIH. Much of his decision rests on deference to the appeals court's finding that NIH can interpret Dickey-Wicker to allow funding for research on hESCs but not on their derivation because the definition of "research" in the law is ambiguous. "Absent a compelling reason to depart from that holding, the Court is constrained to adopt it at this stage of the proceedings," the opinion says.
However, Lamberth doesn't seem happy about it. Quoting from the dissenting opinion of the appeals court judge, he writes: "While it may be true that by following the Court of Appeals' conclusion as to the ambiguity of 'research,' this Court has become a grudging partner in a bout of 'linguistic jujitsu,' ... such is life for an antepenultimate court."
Lamberth did not buy the plaintiffs' argument that research on hESCs puts embryos at risk by creating demand for hESCs. By that reasoning, even research involving a propane tank that took place in a lab adjacent to a place where embryos were stored would violate the law, the opinion says.
Finally, Lamberth threw out the plaintiffs' claim that NIH had improperly ignored tens of thousands of comments from opponents of hESC research when it developed the guidelines. President Obama had ordered NIH to loosen limits on hESC research imposed by President George W. Bush. To ban hESC research instead of changing the rules "would have violated the law," Lamberth writes.
Steven Aden of the Alliance Defense Fund in Washington, D.C., one of the plaintiffs' attorneys, said in a statement that they "are weighing all of their options for appeal." The plaintiffs' first recourse would be to go back to the appeals court, where the same three-member panel would probably hear the case, says Greely. If they lose again, which seems likely, the plaintiffs can appeal to the Supreme Court. "I think they will lose [in the Supreme Court], but it's probably worth it for them to give it a shot," says Greely.