Another Round of Filings in Stem Cell Court Case

by Jocelyn Kaiser on 29 October 2010, 5:01 PM | 0 Comments

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The paperwork continues to pile up in the lawsuit challenging the legality of the National Institutes of Health's (NIH's) stem cell guidelines, the latest installments being two more briefs from attorneys on both sides. A district court judge could rule on the underlying case very soon, potentially halting research again—at least briefly.

In the U.S. District Court for the District of Columbia, federal lawyers expand on why they think Chief Judge Royce Lamberth should decide the case in their favor without a trial. Their brief explains that NIH has, with Congress's support, correctly concluded that a ban on federally funded research that destroys embryos does not extend to human embryonic stem cell (hESC) research. NIH also argues that it properly developed the stem cell guidelines.

The brief takes a jab at plaintiff James Sherley, who had claimed that the fact that four of his recent NIH grant applications to study adult stem cells were rejected in the first stage of peer review shows that the hESC guidelines have made it harder for him to win funding. "The fact that Sherley's applications were unscored demonstrates that ... Sherley's peers did not deem them scientifically worthy enough to be considered for funding," the brief says. And applications that "were not even eligible for consideration for funding" are not competing with hESC applications, the brief says.

Meanwhile, the U.S. Court of Appeals for the D.C. Circuit is considering the government's appeal of Lamberth's 23 August preliminary injunction that temporarily shut down NIH-funded hESC research. In a brief filed yesterday, the plaintiffs' attorneys ask the appeals court to reinstate the injunction, repeating their argument that NIH's guidelines violate the law protecting embryos. The plaintiffs dispute the University of California's claim in an amicus brief that the plaintiffs lack legal standing because NIH awards grants to institutions, not individual scientists. Sherley's research funding all comes from NIH, and he receives no salary from his employer, Boston Biomedical Research Institute, the brief says. And plaintiff Theresa Deisher, as the founder and R&D director of a biotech company, "benefits directly from any research funding," the brief argues.

The last deadline in the appeals court is 4 November, when the government must reply to the plaintiffs' latest brief. That court today scheduled oral arguments for 6 December. The three-judge panel differs from the set that heard oral arguments for a stay in September. One judge, George W. Bush-era appointee Thomas Griffith, is the same, but two are different—Karen LeCraft Henderson (appointed by the first Bush Administration) and Douglas Ginsburg, a Reagan appointee.

Some onlookers expect Lamberth to hold off until the appeals court has ruled on the preliminary injunction. But Lamberth, who isn't expected to schedule oral argument because neither side requested it, could instead rule in the next few days. If he sides with the plaintiffs and issues a permanent injunction, the appeals court will likely stay the ban during an appeal. But getting the stay could take a few days, so hESC research could be halted again.

Only two things are certain at this point, says plaintiffs attorney Samuel Casey of Advocates International in Fairfax, Virginia: "Judge Lamberth can rule at any time," and the appeals court will hear oral arguments on 6 December at 9:30 a.m.

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