Responding to the government's request for an emergency stay pending appeal of federal district court Chief Judge Royce Lamberth'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," lawyers for adult stem cell scientists this evening timely filed their opposing memorandum of law and evidentiary declarations of Drs. Deisher and Sherley that seek to correct the government's misstatements of law and fact contained in its stay request and accompanying Declaration by National Institutes of Health (NIH) Director, Francis Collins.
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, seeks to maintain the preliminary injunction issued by the United States District Court of the District of Columbia enjoining HHS and NIH from unlawfully expending taxpayer funds on research involving the destruction of living human embryos. The district court's opinion 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.
In their opposition, plaintiffs notified the court that plaintiffs intend to file a motion for summary judgment, seeking permanent injunctive and declaratory relief, by September 10, and will not object to expedited consideration of that motion. Samuel B. Casey, AI's General Counsel, explained plaintiffs' opposition to the stay request, stating that "the government's claims of irreparable harm absent a stay rest on speculation, misinformation, and hyperbole. At every turn, the government presents this case as a choice between spending federal dollars on human embryonic stem cell research -- funding that the district court has previously determined has only speculative benefits and violates federal law against killing or discarding living human embryos -- or nothing at all. To the contrary, the preliminary injunction frees up millions in limited grant dollars that the National Institutes of Health ("NIH") can now award to projects that promise more tangible medical benefits, raise fewer ethical issues, and comport with the law, including adult and induced pluripotent stem cell research."
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 AI's General Counsel, Samuel B. Casey, United States District Court Judge Lambreth's ruling, quoted below, "could not be clearer":
ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo. Despite defendants' attempt to separate the derivation of ESCs from research on the ESCs, the two cannot be separated. Derivation of ESCs from an embryo is an integral step in conducting ESC research. Indeed, it is just one of many steps in the "systematic investigation" of stem cell research. 45 C.F.R. § 46.102(d). Simply because ESC research involves multiple steps does not mean that each step is a separate "piece of research" that may be federally funded, provided the step does not result in the destruction of an embryo. If one step or "piece of research" of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment. Because ESC research requires the derivation of ESCs, ESC research is research in which an embryo is destroyed. Accordingly, the Court concludes that, by allowing federal funding of ESC research, the Guidelines are in violation of the Dickey-Wicker Amendment.
According to GD&C's Thomas G. Hungar, lead trial counsel for the plaintiffs who argued the case before the Court of Appeals and before Judge Lamberth: "We are gratified that the Court agreed with our plain-language reading of the Dickey-Wicker statute. Congress has forbidden federal funding of research that entails the destruction of human embryos, and rather than seek a stay the NIH needs to start complying with the law."
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.
In opposing the government's request for a stay of the preliminary injunction, one of the expert stem cell researcher plaintiffs, Dr. Theresa Deisher, points out that NIH Director Francis Collin's declaration "contains numerous factual assertions and characterizations regarding the nature of and prospects for adult stem research, human embryonic stem cell research, and induced pluripotent stem cell research that are directly contrary to the evidence in the administrative record, and that do not accurately reflect the published literature on those subjects."
Casey, added: "The majority of the almost 50,000 comments that the NIH received were opposed to funding this research, and by its own admission, NIH totally ignored these comments, including the extensive scientific and legal comments submitted by AI as part of a coalition known as Do No Harm. The so-called spare human embryos being stored in IVF clinics around the United States are not 'in excess of need,' as the NIH in its guidelines callously assert. They are human beings in need of biological or adoptive parents."
The lawsuit was initially instituted more than a year ago by a broad coalition of plaintiffs, including Dr. James L. Sherley, a former member of the MIT faculty, currently working as a senior scientist at the Boston Biomedical Research Institute; Dr. Theresa Deisher, the founder, managing member, and research and development director of AVM Biotechnology; Nightlight Christian Adoptions, a non-profit, licensed adoption agency dedicated to protecting and finding adoptive parents for human embryos conceived through in vitro fertilization; all individual human embryos whose lives are now at risk under NIH's guidelines; parents seeking to adopt human embryos; and the Christian Medical Association, a non-profit association of doctors dedicated to improving ethical standards of health care in the United States and abroad. The Alliance Defense Fund, a legal alliance of attorneys and like-minded organizations defending religious freedom and the sanctity of human life, is also serving as co-counsel on the case and providing financial support.
Contact: Samuel B. Casey
Date Published: September 3, 2010
