Stem cell case is dismissed

WASHINGTON, D.C.—On July 27, a federal judge dismissed acase seeking to end government funding for human embryonic stem cell research(hESC)—the latest event in a much-watched, highly publicized case that has beenat the center of great debate for more than a year.

The case, Sherley, etal., v. Sebelius, et al., took national ethical and moral concerns abouthESCs to the legal arena after these issues fell on three presidentialadministrations to provide an answer. But "for all three such administrations,Democratic and Republican, the answer has been to permit federal funding. Theyhave differed only as to the path forward," said the U.S. District Court forthe District of Columbia in its recent ruling.

Sherley tooksquare aim at a 2009 presidential order that lifted restrictions placed byformer President George Bush on the government funding of stem cell researchprojects in which hESCs were used. Much of the case focused on the language ofthe Dickey-Wicker Amendment, a measure signed into law in 1995 by former PresidentBill Clinton that prohibited the U.S. Department of Health and Human Services(HHS) and the U.S. National Institutes of Health (NIH) from using appropriatedfunds for the creation of human embryos for research purposes, or for researchin which human embryos are destroyed.

The plaintiffs argued that President Barack Obama's orderviolated the provisions of Dickey-Wicker. In April, the appeals court tookissue with whether the word "research" was ambiguous in the language of theamendment.

The case has garnered a lot of attention since August 2010,when Judge Royce Lamberth held that Dickey-Wicker prohibited the federalgovernment from funding hESC research and enjoined the government fromcontinuing such funding. Suddenly, any federal dollars being allocated towardhESC research efforts were frozen—until the government, arguing that theinjunction would impose a substantial hardship on stem cell researchers withmulti-year projects already underway, appealed the injunction and a stay wasgranted while the case moved forward.

The injunction was dismissed altogether in April, when theappeals court ruled that the word "research" in Dickey-Wicker was ambiguousenough that the NIH could choose how to interpret it. In other words, the NIHwas free to interpret that current embryonic stem cell research was not thesame "research" in which the embryos were destroyed.

Lamberth's recent decision in the case came as a surprise tosome, as his preliminary injunction was widely interpreted as a move thatfavored the funding restrictions ordered by Bush. But after considering thearguments, the judge found that, applying the legal analysis of the appealscourt's decision, the statutory language was ambiguous and the NIH'sinterpretation was reasonable.

"The NIH reasonably concluded that the Dickey-WickerAmendment prohibited federal funding for research projects 'in which' humanembryos are knowingly subjected to risk, such as pre-implantation geneticdiagnosis, but did not prohibit research projects, such as embryonic stem cellresearch, that do not involve embryos and so cannot knowingly subject them torisk 'in' the research," Lamberth wrote in his decision.

Commenting on the decision on Stanford Law School's blog,Prof. Hank Greely called the ruling "a graceful, gracious and fullyprofessional opinion by Judge Lamberth."

"The poor man had been reserved twice by the D.C. Circuit,in different directions," Greeley wrote on July 27. "He did not attempt to playgames with the latest circuit decision and follow its letter while avoiding itsintent. While making it clear that he thought he had been right, he did what ajudge is a supposed to do in applying the law in light of his position in thejudiciary hierarchy."

"I was surprised by the decision—but very pleased," agreesAntoinette F. Konski, a partner with the law firm Foley & Lardner LLP."Lamberth wasn't obligated to follow the appeals court's decision, and he alsostated in his decision that his legal reasoning in issuing the injunction wassound. The take-home message here is that this ruling will allow the federalfunding of hESC research to move forward. It validates the NIH's guidelinesregarding stem cell research, and removed a great deal of uncertainty in thisarea.

This case—and others arguing similar points in variouscourts across the country—may still go on with appeals, potentially as high asthe U.S. Supreme Court. Plaintiffs' attorney Samuel B. Casey, general counselfor the Law of Life Project, declines to comment on the case, but tells ddn: "Of course, we will timely appeal."

Greeley noted that the Supreme Court takes on cases likethese "very rarely and only in real emergencies."

"It is tempting to say, 'all's well that ends well,'"Greeley concluded in his blog post. "The judiciary seems to be headed to makinga decision in this matter that is both (in my view) clearly legally correct andgood policy. But those who have suffered from the last 11 months of scrambling,uncertainty and expense might have a different view. It is one of the costs ofour system of government—happily, in this case, so far, not a terribly highcost."

Some have also argued that Congress needs to re-evaluateDickey-Wicker.

"There have been numerous attempts to legislate on what isbasically a policy decision at the state level," notes Konski. "Perhaps as weget closer to the election, or as other pressing issues are addressed, thiswill create more room and attention span for this issue."

While it is unclear whether other court decisions willattempt to place prohibitions on hESC research, as a result of the Sherley decision, the research cancontinue.

Responding to the decision, NIH Director Francis Collinsissued the following statement:

"We are pleased with today's ruling. Responsible stem cellresearch has the potential to develop new treatments and ultimately save lives.This ruling will help ensure this groundbreaking research can continue to moveforward."