Sherley V. Sebelius: Federal Appeals Court Vacates Preliminary Injunction on NIH Funding for Embryonic Stem Cell Research

Apr 29, 2011   

Today, the United States Court of Appeals for the District of Columbia overruled, 2-1, a district court judges preliminary injunction on federal funding of research using embryonic stem cells (ESCs). Two scientists brought this suit to enjoin the National Institute of Health (NIH) from funding research using ESCs pursuant to the NIHs 2009 Guidelines. Opinion ( Opin.) at 2.

The district court had granted the plaintiffs motion for a preliminary injunction, reasoning that the scientists would likely prevail in demonstrating that the NIH Guidelines violated the Dickey-Wicker Amendment. The Dickey-Wicker Amendment is an appropriations rider that the NIH from funding:

  • (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 45 C.F.R. 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

Opin. at 4.

The plaintiffs in this case, Dr. Sherley and Dr. Deisher, are scientists who conduct research using only adult stem cells. These scientists assert that the NIH violated the Dickey-Wicker Amendment by funding ESC research projects. Id. The plaintiffs had originally filed suit with several other individuals and organizations in August 2009. As we previously reported, the district court granted the Governments motion to dismiss due to a lack of standing. However, the plaintiffs appealed and the federal appeals court held that the doctors alone had standing because they competed with ESC research for funding from the NIH. Opin. at 7.

On remand, the district court granted the doctors motion for a preliminary injunction “providing Ëœthat defendants and their officers, employees, and agents are enjoined from implementing, applying, or taking action whatsoever to the [2009 Guidelines], or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines.” Id.

The Government appealed the district court decision. The appeals court found that the NIH reasonably concluded that government funding for ESC research pursuant to the 2009 Guidelines is not prohibited by the Dickey-Wicker Amendment. The Court reasoned that barring funding would be detrimental to ESC research by preventing new research projects and hindering projects that are currently underway. Circuit Judge Ginsburg, writing for the Court, reasoned that the NIH Guidelines accounted for the Dickey-Wicker Amendment by making distinctions between stem cells and embryos. Opin. at 6. Additionally, Judge Ginsburg reasoned that the Guidelines allow for federal funding of research on ESCs that are already in existence or have been created by private funding. The Guidelines state that federal funding cannot be used to fund the derivation of new cells lines which are obtained through the destruction of embryos.

The courts analysis turned on the ambiguity of the Dickey-Wicker Amendment, specifically, a lack of definition for the word “research.” Opin. at 13. The court determined that the present tense of the Amendment, with no reference to embryos that “were destroyed,” implied that the Amendment did not ban ESC research on stem cell lines in existence at the time of the Amendments enactment. Opin. at 11. Judge Ginsburg also pointed out that Congress has continued to leave the Dickey-Wicker Amendment unchanged every year since 1996 even though Congress has had “full knowledge” that the Department of Health and Human Services has been funding ESC research since 2001. Opin. at 16.

For now, the courts decision to vacate the preliminary injunction means that federal funding can continue while pending lawsuits challenging the expansion of ESC research continue.