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Court upholds federal hESC research funding
October 2012
by Amy Swinderman  |  Email the author
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WASHINGTON, D.C.—On Aug. 24, the U.S. Court of Appeals for the District of Columbia Circuit delivered a crushing blow to two scientists' three-year quest to reverse President Barack Obama's 2009 executive order giving the federal government his blessing to provide funding to stem cell research projects using human embryonic stem cells (hESCs).

The controversial legal battle has been waged in the courts for nearly all of Obama's term, as the president issued the executive order shortly after he took office, reversing an order laid down by his predecessor, George W. Bush, that restricted federal funding for hESC research endeavors. Plaintiffs James L. Sherley, a scientist at the Boston Biomedical Research Institute, and Theresa Deisher, the founder of AVM Biotechnology in Seattle, have since 2009 been seeking to enjoin the U.S. National Institutes of Health's (NIH) resulting guidelines for the application of federal hESC funding.
 
Their contentious case has focused on the language of the Dickey-Wicker Amendment, a measure signed into law in 1995 by former President Bill Clinton that prohibited the U.S. Department of Health and Human Services and the NIH from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed.

In October 2009, Judge Royce C. Lamberth granted the government's motion to dismiss the plaintiff's case on the ground that they lacked standing. In June 2010, the D.C. circuit court reversed this decision, finding that the plaintiffs had alleged sufficient competitive injury, and granted a preliminary injunction against federal hESC funding. The NIH appealed this injunction, and just a few weeks later, the Court of Appeals issued a stay while the appeal was pending. 

As 2010 came to a close, the court heard oral arguments, and in April 2011, the court completely reversed Lamberth's ruling, saying it would impose a substantial hardship on stem cell researchers who have multi-year projects already underway. The court's 2-1 decision also found that the funding of hESC research is permissible under Dickey-Wicker, as Congress has renewed the amendment every year with the knowledge that it funds such research. In July 2011, the court dismissed the suit altogether, finding that after applying the legal analysis of the appeals court's decision, the statutory language was ambiguous and the NIH's interpretation was reasonable. Sherley and Deisher appealed.

In the latest court proceedings, "the question raised … is whether we should apply the preliminary-injunction exception to the law-of-the-case preclusion where the reasons for its application are absent," said the court in its recent ruling. "That is, where the earlier ruling, though on preliminary-injunction review, was established in a definitive, fully considered legal decision based on a fully developed factual record and a decision-making process that included full briefing and argument without unusual time constraints, why should we not follow the usual law-of-the-case jurisprudence?"

In response to the plaintiffs' further claims that Dickey-Wicker also bans "research in which a human embryo or embryos are … knowingly subjected to risk of injury or death," the court responded, "It is established that 'research' as used in Dickey-Wicker is an ambiguous term, and that NIH's interpretation of the term 'research' as a discrete project rather than an extended process is reasonable. Under that definition of 'research,' the destruction of embryos that occurs in the ESC derivation process is not a part of individual ESC research projects using already derived ESCs. Therefore, ESC research is no more research in which … embryos are … subjected to risk than it was research in which … embryos are … destroyed."

Sherley and Deisher had also argued that federal funding for ESC research "incentivizes" future destruction of embryos, but the court responded, "The language of Dickey-Wicker does not ban funding for, e.g., 'research which provides an incentive to harm, destroy or place at risk human embryos.' As we have held before, the NIH interpretation of the statute's actual language is reasonable."

Finally, the plaintiffs had also contended that the NIH violated procedural rules by issuing its guidelines without addressing comments categorically objecting to ESC research, but the court concluded that the NIH "reasonably limited the scope of its guidelines to implement the executive order. And because the executive order's entire thrust was aimed at expanding support of stem-cell research, it was not arbitrary or capricious for NIH to disregard comments that instead called for termination of all ESC research (including research that the executive branch has permitted since 2001). Such comments simply did not address any factor relevant to implementing the executive order."

However—and quite notably—the court did show support for an argument currently garnering favor in the research community that Congress should clarify some of the ambiguous provisions of Dickey-Wicker, stating, "there are aspects of this case that … should trouble the heart."

"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," wrote Judge Janice Rogers Brown.

The court's latest ruling may not be the final chapter in this ongoing saga, as 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 plaintiffs and Casey did not respond to requests for comment on the case.
 
Code: E101202

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