September 9, 2010


WASHINGTON, DC (September 9, 2010)  Advocates International (AI), part of the public interest legal team along with the Alliance Defense Fund (ADF) and Gibson, Dunn & Crutcher (GD&C) who brought the case before the court more than a year ago, announced this evening that their clients have now filed a comprehensive summary judgment motion in the federal district court, including evidentiary declarations by plaintiffs Dr. James Sherley and Theresa Deisher along with an attorney’s declaration providing the administrative record, asking Chief Judge Royce Lamberth based upon the undisputed evidence in the case to enter a final declaratory judgment declaring invalid the government’s controversial guidelines for public funding of embryonic stem cell research that the National Institutes of Health (NIH) issued on July 7, 2009 on the grounds that these guidelines violate federal law expressly barring such funding and were in any event improperly promulgated in violation of the Administrative Procedure Act.
AI’s General Counsel, Sam Casey, said that “the summary judgment motion we have filed today demonstrates that plaintiffs are entitled to entry of summary judgment in their favor on their request for declaratory and injunctive relief against the National Institutes of Health Guidelines for Human Stem Cell Research (“NIH Guidelines”), 74 Fed. Reg. 32170 (July 7, 2009), because the NIH Guidelines violate the Dickey-Wicker Amendment, Consolidated Appropriations Act, 2010, Pub. L. No. 111-117, 123 Stat. 3034, 3280-81, § 509(a), and are arbitrary, capricious, and contrary to law, and were promulgated without observance of procedures required by law, in violation of the Administrative Procedure Act.” Plaintiff’s chief trial counsel, GD&C’s Thomas Hungar, added: “We have asked the federal district court to permanently enjoin the government from implementing, applying, or taking any action whatsoever pursuant to the NIH Guidelines or otherwise funding research involving human embryonic stem cells as contemplated in the NIH Guidelines. We have also asked the Court to order the government to immediately inform any NIH grant recipients in possession or control of federal funds granted under the Guidelines for human embryonic stem cell research that any remaining and unspent NIH-granted funds may not be spent on human embryonic stem cell research but must be returned to NIH to fund lawful research.”
Earlier in the week Judge Lamberth, in his 2-page Order, denied the government’s request for an emergency stay pending the government’s appeal of the court’s August 23rd decision and preliminary injunction enjoining unlawful federal funding of “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.”  Earlier today the federal Circuit Court of Appeals for the District of Columbia issued a short “administrative stay” order to give it time to review the government’s request for the emergency stay that the federal district court has already denied. As the Court of Appeal’s Order states: “The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay and should not be construed in any way as a ruling on the merits of that motion.”
Plaintiffs will be filing their opposition to the government’s emergency stay request next Tuesday and a ruling from the Court of Appeals on the government’s request for an emergency stay would most likely issue sometime during the week of September 20. Click here for a copy of Americans for Ethical Stem Cell Research’s press release responding to the “administrative stay” order issued today by the Court of Appeals.
The district court’s opinions issuing the preliminary injunction and denying the government’s request for a stay of that injunction pending its appeal followed the decision by the United States Court of Appeals earlier this summer finding that doctors doing adult stem cell research have ‘competitive standing’ to sue. Therefore, the court reinstated the doctors’ federal lawsuit, filed last summer that seeks to preliminarily enjoin and ultimately overturn the controversial guidelines for public funding of embryonic stem cell research that the NIH issued on July 7, 2009.  
 Since 1996, in what has been popularly known as its Dickey-Wicker Amendment to each HHS Appropriations Bill, Congress has expressly banned NIH from funding research in which human embryos “are destroyed, discarded, or knowingly subjected to risk of injury or death.”
            According to GD&C’s Thomas G. Hungar: "We are gratified by the federal district court’s conclusion that any further funding of human embryonic stem cell research under the NIH guidelines would ‘flout the will of Congress.’  As the Court recognized, ‘the public interest is served by preventing taxpayer funding of [such] research,’ so that taxpayer funds can be preserved for more productive research that will actually yield cures, such as ‘activities related solely to adult or induced pluripotent stem cell research.’”
The plaintiffs contend that the NIH guidelines violate the congressional ban because they “necessarily condition funding on the destruction of human embryos.” In addition, the plaintiffs also allege that the NIH guidelines were invalidly implemented, because the decision to fund human embryonic stem cell research was made without the proper procedures required by law and without properly considering the more effective and less ethically problematic forms of adult and induced pluripotent stem cell research. 
President Obama, in his March 11, 2009 Executive Order announcing his Administration’s policy stated he was determined to fund ethically “responsible, scientifically worthy human stem cell research…to the extent permitted by law”. Sadly, said AI’s Casey, “these guidelines while claiming to ‘implement’ the President’s directions, failed his own test because they are not only unlawful, they are based upon an ethically irresponsible misunderstanding of available scientific evidence.” 
            As acknowledged by Judge Lamberth in his Order earlier this week, “the length of time this preliminary injunction will be in place should be limited” because, as confirmed by plaintiffs’ legal counsel Hungar and Casey, “plaintiffs are hopeful that the federal district court will favorably rule on our just filed motion for summary judgment and issue its permanent injunction before the end of the year.”
A copy of the Court of Appeals and District Court decisions, the President’s Executive Order, and the challenged NIH Guidelines and the comments thereon, as well as the plaintiffs’ summary judgment motion, can be obtained by clicking the hyperlinks in the paragraphs above.
OITHER CONTACTS:   Thomas G. Hungar, Gibson, Dunn & Crutcher, 202-887-3648
                                       Steven H. Aden, Alliance Defense Fund, 202-393-8690
                                       Dr. Theresa Deisher, AVMBiotech, 206-906-9922 (bio)
                           Peter Robbio, CRC Public Relations, (703) 683-5004, Ext. 116
                           Dr. James L. Shirley, (bio)