WASHINGTON (CN) – A federal judge on Monday enjoined President Obama’s 2009 executive order that expanded embryonic stem-cell research, finding that the order’s guidelines violate Congress’ Dickey-Wicker Amendment of 1996, which prohibits federal funding of research in which human embryos are destroyed. U.S. District Judge Royce Lambeth issued the 15-page ruling.
Because embryonic stem cells are “pluripotent,” and can develop into a variety of human cells, stem-cell research offers promising treatments and cures for a panoply of diseases and injuries. The research has been made controversial because some groups claim that it destroys a potential human life, even if the stem cells were going to be thrown away anyway.
Plaintiffs, Drs. James L. Sherley and Theresa Deisher, Nightlight Christian Adoptions, the Christian Medical Association and others sued Health and Human Services Secretary Kathleen Sebelius, seeking “an order (a) declaring that the Guidelines are contrary to law, were promulgated without observing the procedures required by law, and constitute arbitrary and capricious agency action; and (b) enjoining [d]efendants from applying the Guidelines or otherwise funding research involving the destruction of human embryonic stem cells.”
The U.S. District Court for the District of Columbia dismissed it on Oct. 27, 2009, finding the plaintiffs lacked standing.
The Court of Appeals reversed, concluding that the doctors “had standing under the competitor standing doctrine. Sherely v. Sebelius, – F.3d -, 2010 WL 2540358, *5 (D.C. Cir. 2010). … The Court of Appeals then remanded this matter back to this Court for consideration of plaintiffs’ motion for a preliminary injunction.”
Lambeth found that the plaintiffs “have established that the preliminary injunction factors-the likelihood of success on the merits, irreparable injury, the balance of hardships, and the public interest-weigh in favor of a preliminary injunction. Accordingly, the Court will GRANT plaintiffs’ for a preliminary injunction. A separate order shall issue this date.”
The ruling recapitulates the scientific, legal and regulatory history of stem-cell research.
The Dickey-Wicker Amendment passed Congress as a rider to the so-called Balanced Budget Downpayment Act of 1996. It prohibited expenditure of federal money for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under” applicable federal regulations,” Judge Lambeth wrote.
President George W. Bush severely limited federal funding for embryonic stem-cell research through Executive Order 13,425 on Aug. 9, 2001, prohibiting expenditure of federal money on stem-cell lines that were created after that date.
President Obama removed the restriction by Executive Order 13, 505 on March 9, 2009, “to expand NIH support” for human stem cell research and “to enhance the contribution of America’s scientists to important new discoveries and new therapies for the benefit of humankind.”
As a result, the National Institutes of Health “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem research, to the extent permitted by law.”
President Obama directed NIH to review the stem-cell research guidelines and “issue new NIH guidance on such research that is consistent with this order.”
In response, the NIH published draft guidelines titled “National Institutes of Health Guidelines for Human Stem Cell Research.” 74 Fed. Reg. 18,578 (April 23, 2009). The draft guidelines allowed “funding for research using human embryonic stem cells that were derived from human embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.”
Judge Lambeth wrote: Plaintiffs assert two independent arguments as to why they are likely to succeed on the merits. First, they argue that the Guidelines violate the plain language of the Dickey-Wicker Amendment. Second, they contend that, in promulgating the Guidelines, defendants violated the Administrative Procedure Act (‘APA’). Because the Court concludes that plaintiffs have demonstrated a strong likelihood of success that the Guidelines violate the Dickey-Wicker Amendment, the Court need not address whether defendants violated the APA.”