D.C. District Court Rules Against Challenger of Embryonic Stem-Cell Funding

Aug 01, 2011   

On July 27, 2011, the case of Sherley v Sebelius drew to a close as U.S. District Judge Royce Lambeth of the United States District Court for the District of Columbia granted the United Statess Motion for Summary Judgment. As we have previously reported, Sherley v Sebelius challenged the legality of government funding of human embryonic stem cell research. As a result of this decision, the Department of Health and Human Services (“HHS”) and the National Institutes of Health (“NIH”) may continue to provide federal funds for the study of embryonic stem cells. A copy of the District Courts Order can be read here.

The origins of Sherley v. Sebelius can be traced back to Executive Order 13,505 issued by President Obama which removed previous limitations on NIHs ability to fund human embryonic stem cell research and directed the NIH to publish new guidelines to govern federal funding of embryonic stem cell research projects. Upon issuance of the Guidelines by the NIH, the plaintiffs, Drs. Sherley and Deisher, brought suit to prohibit the NIH from funding research using human embryonic stem cells and alleged that the NIH Guidelines violated the 1996 Dickey-Wicker Amendment, which prohibits funding for research “in which a human embryo or embryos are destroyed.” The plaintiffs also alleged that the promulgation of the Guidelines violated the APA by failing to address several comments in opposition to the proposed guidelines.

On October 27, 2009, the D.C. District Court dismissed the plaintiffs case for lack of standing. However, in June of 2010, the United States Circuit Court of Appeals for the District of Columbia Circuit reversed, because an “actual, here-and-now injury” was present, and that both plaintiffs met the requirements for standing under Article III of the Constitution. As such, the D.C. Circuit Court of Appeals remanded the case back to the District Court.

On August 23, 2010, the District Court granted the plaintiffs motion for preliminary injunction, stopping the NIH from funding embryonic stem cell research. However, as we previously reported, on April 29, 2011, the Court of Appeals for the D.C. Circuit vacated the preliminary injunction finding that plaintiffs would not likely prevail on the merits of their claims. In reaching its conclusion, the D.C. Circuit engaged in a Chevron analysis and found that the term “research” was ambiguous in the Dickey-Wicker Amendment as it could describe either a discrete project or an extended process. As a result, the Court found that the NIH reasonably concluded that “although Dickey-Wicker bars funding for the destructive act of deriving an [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an [embryonic stem cell] will be used.” These findings would serve as the bases for the District Court ultimately dismissing the case. The Court of Appeals then remanded the case to the D.C. District Court to be decided on its merits.

In granting the governments Motion for Summary Judgment and dismissing the plaintiffs case Judge Lamberth first found that the NIH Guidelines, which provide for spending federal funds on research involving human embryonic stem-cells, do not violate the Dickey-Wicker Amendment for several reasons. First, Judge Lambeth found that the determination that the term “research” in the Dickey-Wicker Amendment is ambiguous by the Circuit Court of Appeals is binding upon the District Court. As a result, the Judge Lamberth stated “this Court, following the D.C. Circuits reasoning and conclusions must find that defendants reasonably interpreted the Dickey-Wicker Amendment to permit funding for human embryonic stem cell research because such research is not Ëœresearch in which a human embryo or embryos are destroyed. . . .” Second, because Dickey-Wicker is ambiguous as to whether embryonic stem cell research is research in which a human embryo or embryos are knowingly subjected to risk, “[t]he NIH reasonably concluded that the Dickey-Wicker Amendment . . . did not prohibit research projects, such as embryonic stem cell research, that do not involve embryos and so cannot knowingly subject them to risk Ëœin the research.”

The District Court also found that the promulgation of the NIH Guidelines did not violate the APA. The plaintiffs argued that the NIH Guidelines violated the notice and comment requirements of the APA by: 1) “failing to respond to relevant and significant public comment;” and 2) entering rulemaking with an “unalterably closed mind.” However, the Court rejected these arguments. First, President Obamas Executive Order directed the NIH to develop standards for funding embryonic stem cell research, not to determine whether embryonic stem cell research should be federally funded. As a result, “the NIH wasnt obligated to respond to comments [such as the plaintiffs] on the topic of whether to fund human embryonic stem cell research.” Additionally, because the NIH was tasked solely with developing standards for embryonic stem cell research and not with the question of whether to federally fund embryonic stem cell research, NIHs failure to consider comments regarding whether to fund such research reasonable and the NIH did not act with an “unalterable closed mind.”

Fuerst Ittleman will continue to closely monitor the progress of issues regarding funding for stem cell research. If you have any questions pertaining to new NIH guidelines, or the application process for receiving NIH grants, contact Fuerst Ittleman PL at contact@fidjlaw.com.