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Stem Cell Briefs Probe Whether Grants 'Incentivize' Embryo Destruction

The two sides in a high-stakes legal battle over stem cells expanded on their arguments in briefs filed today in a case being heard by Chief Judge Royce Lamberth of the U.S. District Court for the District of Columbia.

The case, Sherley v. Sebelius, was brought by two researchers who argue that the National Institutes of Health's (NIH's) 2009 guidelines lifting restrictions on federally funded research on human embryonic stem cells (hESCs) violate a law banning federally funded research that destroys human embryos. Last August, Lamberth issued a preliminary ruling in favor of the plaintiffs that briefly halted hESC research funding.

On 29 April in a 2-1 ruling, the appeals court overturned the injunction, finding that NIH "seems reasonably to have concluded that" the law bars the derivation of hESCs but doesn't bar funding research that uses the cells. That ruling sent the suit back to Lamberth to rule on the merits of the case.

The plaintiffs then asked for a chance to respond to the appeals court decision. (They originally requested that they take turns and get a chance to reply to the government's brief; Lamberth instead decided both sides should file a single 10-page brief by 24 June.)

Both sides devote most of their briefs to a second argument made by the plaintiffs that was not considered by the appeals court: that the guidelines "incentivize" the destruction of embryos by creating demand for more hESC lines.

From the plaintiffs' brief:

The federally sponsored hESC research that the Guidelines support inevitably creates a substantial risk—indeed, a virtual certainty—that more human embryos will be destroyed in order to derive more hESCs for research purposes.

As evidence, the brief includes a statement from plaintiff James Sherley that points out that researchers are increasingly developing new lines in order to study genetic diseases and ethnic diversity.

The government counters in its brief:

Plaintiffs' theory that the Guidelines "incentivize" the donation of future embryos casts no doubt on whether NIH had reasonably interpreted the statute, both because future donors would not be engaging in "research in which" an embryo is subject to a risk of injury, and because it is not plausible to claim that NIH funded researchers "knowingly" create the incentive for future donation.

The plaintiffs also argue that NIH didn't follow proper procedures when it developed the guidelines. The two sides have both asked Lamberth for a summary judgment, which means they want him to decide the case quickly without a trial. Onlookers are predicting Lamberth could rule anytime between this fall and the end of the year.

UPDATE: A decision from Lamberth could come very soon, according to Stanford Law School professor Hank Greely. He notes that last summer after an appeals court decision granting legal standing to the plaintiffs reached his court on a Thursday, Lamberth issued a preliminary injunction the following Monday, 23 August. That suggests that if Lamberth does not order oral arguments or call for a trial (which seems unlikely, Greely says), he could rule on summary judgement within the next 2 to 4 weeks. If Lamberth orders oral argument, it would probably take place in August with a decision soon after, Greely says.

If Lamberth rules in favor of the plaintiffs and orders a permanent injunction (which would halt hESC funding again), the appeals court is expected to quickly stay (suspend) the injunction until it hears the case.