Court upholds federal hESC research funding

Plaintiff’s arguments in contentious Sherley v. Sebelius case rejected

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WASHINGTON, D.C.—On Aug. 24, the U.S. Court of Appeals forthe District of Columbia Circuit delivered a crushing blow to two scientists'three-year quest to reverse President Barack Obama's 2009 executive ordergiving the federal government his blessing to provide funding to stem cellresearch projects using human embryonic stem cells (hESCs).

The controversial legal battle has been waged in the courtsfor nearly all of Obama's term, as the president issued the executive ordershortly 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 ResearchInstitute, 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.
Theircontentious case has focused on the language of the Dickey-Wicker Amendment, ameasure signed into law in 1995 by former President Bill Clinton that prohibitedthe U.S. Department of Health and Human Services and the NIH from usingappropriated funds for the creation of human embryos for research purposes, orfor research in which human embryos are destroyed.

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

As 2010 came to a close, the court heard oral arguments, andin April 2011, the court completely reversed Lamberth's ruling, saying it wouldimpose a substantial hardship on stem cell researchers who have multi-yearprojects already underway. The court's 2-1 decision also found that the fundingof hESC research is permissible under Dickey-Wicker, as Congress has renewedthe amendment every year with the knowledge that it funds such research. InJuly 2011, the court dismissed the suit altogether, finding that after applyingthe legal analysis of the appeals court's decision, the statutory language wasambiguous and the NIH's interpretation was reasonable. Sherley and Deisherappealed.

In the latest court proceedings, "the question raised … iswhether we should apply the preliminary-injunction exception to thelaw-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, thoughon preliminary-injunction review, was established in a definitive, fullyconsidered legal decision based on a fully developed factual record and adecision-making process that included full briefing and argument withoutunusual time constraints, why should we not follow the usual law-of-the-casejurisprudence?"

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

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

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

However—and quite notably—the court did show support for anargument currently garnering favor in the research community that Congressshould 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 encounterbetween science and ethics, relying on an increasingly Delphic, decade-oldsingle paragraph rider on an appropriations bill hardly seems adequate," wroteJudge Janice Rogers Brown.

The court's latest ruling may not be the final chapter inthis ongoing saga, as Samuel Casey, an attorney for the plaintiffs, said in astatement: "We are disappointed by the Court of Appeals decision and, given thereasoning in the two concurring opinions, we are evaluating whether and on whatgrounds our clients will be seeking certiorari before the United States SupremeCourt."

The plaintiffs and Casey did not respond to requests forcomment on the case.

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