A Summary of the Preliminary Injunction Issued in Sherley v. Sebelius (decided August 23, 2010)

By Melissa Alfano, George Mason University School of Law, Class of 2012

In an opinion written by Chief Judge Royce Lamberth, the U.S. District Court of D.C. issued a preliminary injunction against the National Institute of Health and the Health and Human Services to prevent their “Guidelines for Human Stem Cell Research” from taking effect.  Sherley v. Sebelius, No. 1:09-cv-1575, 2010 U.S. Dist. LEXIS 86441, at 2 (D.D.C. Aug. 23, 2010).    NIH set forth the Guidelines after President Obama, in Executive Order 13435, lifted the Bush-era ban on embryonic stem cell (ESC) research.  Id. at 3.  Prior to the Obama order, federal funding for stem cell research was limited to adult stem cells, harvested by from tissues normally discarded after birth, and induced pluripotent stem cells, which are adult stem cells that have been genetically reprogrammed so that they are virtually identical to ESCs.   Id. at 5-6.  ESCs, which are derived from an embryo, were only allotted research funding if the research did not result in the destruction of an embryo.  Id. at 6.  The new Guidelines would require that federally funded ESC research projects would have to be on cell lineages that are posted on the NIH registry of cells, or that the cells were created by in vitro fertilization for reproductive services and were no longer needed for that purpose.  Id. at 10. 

The plaintiffs, Drs Sherley and Deisher, specialize in adult stem cell research.  Sherley at 6.  They brought the claim because they (1) sought a declaration that the Guidelines were contrary to the current law, and (2) they wanted to enjoin the NIH from applying the Guidelines to research involving the destruction of embryos.  Id. at 2.  Initially the district court dismissed the claims for lack of standing, but the Court of Appeals reversed the ruling, stating that the plaintiffs did have standing under the competitor standing doctrine.  Id. at 3.  The Court of Appeals also remanded the case for further deliberation on the issue of the injunction.  Id.

On remand, in granting the preliminary injunction, the court balanced the success on the merits, irreparable harm to plaintiffs, balance of hardships, and public interest.  Sherley at 13-14. 

In regards to the success on the merits, the court weighed both the plaintiffs’ and the defendants’ claim.  The plaintiffs claimed that the NIH Guidelines violate the plain language of the 1996 Dickey-Wicker amendments, since it would result in the destruction of an embryo (the amendments were originally a rider on the 1996 Balanced Budget Downpayment Act).  Sherley at 14.  The amendments prohibited the use of federal funds 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.  Id. at 7.  Congress has included the amendments, without substantive alteration, in every appropriation for Health and Human Services since 1996. Id.

The defendants claimed the amendments were vague and as a result their acts should be granted Chevron deference.  Sherley at 14.  This claim failed, as the court reiterated that the amendments were clear about not granting federal funding for research that results in the destruction of embryos and the Congressional intent of the amendments were unambiguous.  Id. at 16.  Since the process of deriving embryonic stem cells from an embryo results in the destruction of an embryo, the Guidelines, which allow for such destruction, are contrary to the amendments.  Id. at 19.  Therefore, the court determined that the plaintiffs demonstrated a strong likelihood of success.  Id. at 20.

The plaintiffs’ demonstrated that they would likely endure irreparable harm and that the balance of harms weigh in their favor because their research on adult stem cells would directly compete with ESCs for limited NIH funding.  Sherely  at 20, 22.  This harm to the plaintiffs was imminent.  Id. at 21.  The harm that the defendants claim, that an injunction would harm the individuals who suffer from ailments that ESC research may be able to treat, was not imminent.  Id. at 22.  Furthermore, the court found that there would be no harm in maintaining the status quo for the scientists who perform research on ESC.  Id.

In regards to the public interest in the injunction, the court held that it was more important to the public interest to carry out the will of the Congress and for an agency to implement statutes properly.  Sherley at 22.  The court makes no mention of the interest of the public in furthering embryonic stem cell research.