NEWS ANALYSIS Court rules for NIH in stem cell case

Embryonic stem cell research can continue, Sherley may appeal

The latest battle over human embryonic stem cell research is over, and the National Institutes of Health has won — the research can continue. The war can still go on with appeals, potentially as high as the Supreme Court, but researchers are unlikely to face court-ordered prohibitions on research as that multi-year process continues.

Last week Wednesday, the United States District Court for the District of Columbia dealt a decisive victory to the NIH. Chief Judge Royce C. Lamberth ruled in favor of the NIH and human embryonic stem cell (hESC) researchers. The losers were adult stem cell researchers James L. Sherley and Theresa A. Deisher, who had argued that government funding of human embryonic stem cell research violated a congressional appropriations rider (the Dickey-Wicker amendment) that bans funding “research in which a human embryo or embryos are destroyed.”

The case has twisted in and out of court several times since it was first filed almost two years ago on Aug. 19, 2009. Sherley and Deisher sued the NIH, but there were several additional co-plaintiffs: including Nightlight Christian Adoptions (“individually and as next friend for Plaintiff Embryos”), Christian Medical Association, and, in a bizarre legal maneuver, “embryos” themselves.

Sherley is a former MIT professor who now works at the Boston Biomedical Institute in Watertown. He was denied tenure by MIT by the Department of Biomedical Engineering in December 2004, engaged in a dispute process with the Institute in 2005 and 2006, and then threatened and executed a hunger strike in 2007 before leaving MIT. Sherley, who is black, alleged racial discrimination on the part of his department and senior Institute officials.

Deisher is an adult stem researcher based in Seattle, Wash.

When the case was first filed, it was not considered a serious impediment to ongoing stem cell research. That came much later.

The case was initially dismissed on Oct. 27, 2009. Lamberth ruled that the plaintiffs lacked standing — that they were not actually harmed by the government’s funding of embryonic stem cell research, so they lacked the right to sue. Sherley, Deisher, and the others appealed to the United States Court of Appeals for the District of Columbia, and there it sat, quietly, for half a year. Most scientists who had paid some attention to the case forgot about it, and apparently so did the NIH. It was utterly unprepared for what happened next.

On June 25, 2010, the Appeals Court partially reversed Lamberth’s dismissal. It ruled that “the Doctors” — Sherley and Deisher — indeed did have standing, though the other plaintiffs (including the adoption agency and the embryos themselves) did not. The court found that Sherley and Deisher faced increased competition for research funding — despite the fact that Deisher had not then and still has not applied for NIH funding. The case was remanded back to Lamberth’s court for further consideration.

But no one seemed to pay attention. Because of a court clerical error, notice of the appeal’s court decision did not appear in the district court’s docket until Aug. 19, 2010. This meant anyone who was following the case only at the district level did not know of the appeal’s court’s decision — though anyone paying attention to the appeal’s court’s docket would have seen it.

Research funding halted

On Aug. 23, 2010, just over a year after the case was first filed, Lamberth issued a preliminary injunction in favor of Sherley and Deisher. Lamberth said that Sherley and Deisher were likely to succeed in the case, that they would “suffer irreparable injury” if hESC research were allowed to continue, that the balance of harms favored them, and that the public interest weighed in favor of a preliminary injunction. His decision rested on the belief that Dickey-Wicker was unambiguous, and that “research” using an existing embryonic stem cell line was the same “research” in which that embryo was destroyed, though the destruction could have taken place years prior by other researchers.

The preliminary injunction enjoined the NIH from funding hESC research and caused a huge stir. The NIH was apparently entirely unprepared for this possibility, and stem cell researchers were blindsided. Most had not even been aware of the Sherley case, and those that had did not know it was still alive.

The preliminary injunction caused major disruption. Researchers were uncertain whether they could continue to keep living stem cells in their labs and whether they could continue to do their work. The NIH issued guidelines saying that existing research could continue, though it wasn’t even clear their interpretation of the injunction was correct.

Then the court situation got complicated.

The NIH scrambled and requested an emergency stay — a request to suspend the order and permit hESC research to continue — on Aug. 31. Lamberth denied it on Sept. 7.

The NIH took their emergency stay request to the appeals court on Sept. 8. The appeals court granted a temporary “administrative” stay for the purpose of considering whether a stay was appropriate. They granted it the next day, on Sept. 9, so the NIH-funded hESC research was allowed to resume.

But at this point, the grant pipeline had already been disrupted. The NIH had stopped approving grants for new stem cell research because of the preliminary injunction. The landscape was quite uncertain. No one knew how the appeals court would rule, or ultimately how the district court would rule. Labs facing uncertain funding situations were ill-equipped to make decisions about hiring or keeping staff.

On Sept. 28, the appeals court ruled that a stay was appropriate. Their administrative stay became a normal stay for the duration of the NIH’s appeal.

On April 29, 2011, the appeals court finally ruled: it dismissed the preliminary injunction against the NIH by a 2-1 vote. The appeals court wrote that the word “research” in the Dickey-Wicker amendment was ambiguous, and that the NIH could choose how to interpret the word. Specifically, that the NIH could choose to interpret that current embryonic stem cell research was not the same “research” in which the embryos were destroyed.

With the preliminary injunction dismissed, the case went back to Lamberth in the district court to decide. Both sides filed briefs on the implications of the appeals court decision, but a fatal blow had been dealt to Sherley and Deisher’s argument. The ambiguity of the word “research” was the crux of the decision favoring them and Lamberth’s belief that they were likely to succeed. Without that, their case fell apart.

Last week Wednesday, July 27, 2011, Lamberth ruled in favor of the NIH. Lamberth wrote that his court was bound by the appeals court’s determination, and acknowledged a criticism from the dissenting opinion in from the appeals court: “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.”

The case could well be appealed back to the appeals court and then to the Supreme Court. In May, Samuel B. Casey, one of Sherley’s lawyers, said that no matter who won the case, he expected the case to reach the Supreme Court. In the interim, though, stem cell research can probably continue unabated. Neither the appeals court nor the Supreme Court is likely to issue another preliminary injunction barring stem cell research.

1 Comment
Paul Knoepfler about 12 years ago

Thanks for the article. Most of us stem cell researchers are relieved by this turn of events and feel optimistic about the future, but seek a more permanent resolution.