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The U.S. Court of Appeals for the D.C. Circuit.

A Legal Win for Stem Cell Research, but Case May Not Be Over

Jocelyn is a staff writer for Science magazine.

A U.S. appeals court today upheld the legality of federally funded research on human embryonic stem cells (hESCs)—the latest in a string of wins for the National Institutes of Health (NIH) in a 3-year legal battle with groups that for moral reasons want to block the use of these cells. But although hESC researchers can breathe easy for now, the 27-page decision suggests the battle over hESCs may not be quite over.

"It's a clear victory for us. We've very happy with the opinion," says Amy Comstock Rick, an attorney and president of the Coalition for the Advancement of Medical Research, which defends hESC work. However, because the three judges in the appeal of Sherley v. Sebelius issued separate opinions in favor of NIH and used different reasoning, the plaintiffs who filed suit against NIH might have a shot at another review, some legal experts say.

Samuel Casey, an attorney for the plaintiffs, said in a statement: "We are disappointed by the Court of Appeals decision and, given the reasoning in the two concurring opinions, we are evaluating whether and on what grounds our clients will be seeking certiorari before the United States Supreme Court."

The case was filed in August 2009, a month after NIH issued guidelines implementing an executive order from President Barack Obama that eased Bush-era limits on hESC research. Pro-embryo groups and others, including two scientists who study adult stem cells, argued that the NIH guidelines violated the Dickey-Wicker Amendment, a 16-year-old law banning federal funds for "research in which ... embryos are destroyed." (Human ESCs are usually derived from days-old embryos in a process that destroys them.)

The two scientists won a preliminary injunction in August 2010 from Chief Judge Royce Lamberth that briefly blocked hESC funding; an appeals court later stayed the injunction. In April 2011, the appeals court threw out the preliminary injunction, finding that NIH was likely to win the case. Then in July 2011, Lamberth granted NIH's request for a summary judgment dismissing the suit, but noted that he was obliged to follow the appeals court ruling. The plaintiffs then appealed to the same appeals court, the U.S. District Court for the District of Columbia.

Now, in his 15-page opinion for the court, Chief Judge David Sentelle notes that the court's earlier ruling relied on a legal principle known as Chevron that says that if a statute is ambiguous, courts must defer to the agency's interpretation. Under Chevron, NIH “had reasonably interpreted” Dickey-Wicker to allow for federal funding of hESC research because research on hESCs and their derivation are "discrete." "We will not revisit the issue," Sentelle wrote. He also rejected the plaintiff's argument that NIH's policy puts embryos at risk because it "incentivizes" their destruction. Sentelle also finds that NIH did not err in ignoring plaintiffs' comments in a public docket calling for an end to all federally funded hESC research.

While the other two judges concurred with the opinion, however, they did so for different reasons. Judge Karen LeCraft Henderson, who dissented from the court's last ruling in the case (she called it "linguistic jujitsu"), writes that she concurs only because the court is bound by its earlier ruling. Henderson argues that Chevron should not apply to NIH's guidelines. "The court should instead have interpreted the statute de novo, according no deference to NIH’s interpretation. … Had we done so, I believe we would have invalidated the Guidelines as contrary to the Amendment’s plain and unambiguous text," she writes.

And Judge Janice Rogers Brown agrees with Henderson that Chevron should not have applied. However, she finds that NIH's interpretation of Dickey-Wicker still holds up because Congress repeatedly passed the amendment and issued reports appearing to support some hESC research. But Brown also notes how scientists, policymakers, and legal experts have struggled with the ethically fraught issue of hESC research. "If this was ever a simple case it long ago ceased to be one. … Disagreement is inevitable when what lies at the core of the dispute is a profound question about the boundaries of science—one that is irreducibly controversial because the slippery slope is precipitous in both directions," she writes.

The three "fractured opinions," as one legal expert put it, increase the chances that the plaintiffs can successfully petition for a new review by the full court, known as an en banc hearing. But Comstock Rick thinks even if the plaintiffs win an en banc review, they are unlikely to prevail—four judges on the appeals court have already ruled in NIH's favor, she notes. Casey says the plaintiffs are more likely to appeal directly to the U.S. Supreme Court.

More from Judge Brown's concurring opinion:

Despite many points of agreement with my colleagues, I write separately because we converge from different paths and there are aspects of this case that—NIH’s insouciance notwithstanding -- should trouble the heart. Even Dr. James Thompson, the researcher credited with being the first to successfully derive human embryonic stem cells, has admitted: “If human embryonic stem cell research does not make you at least a bit uncomfortable, you have not thought about it enough.

And her conclusion:

The challenging—and constantly evolving—issues presented by bioethics are critical and complex. Striking the right balance is not easy and not, in the first instance, a task for judges. What must be defended is ‘the integrity of science, the legitimacy of government, and the continuing vitality’ of concepts like human dignity. Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate.

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