On August 23, 2010, Chief Judge Royce C. Lamberth of U.S. District Court for the District of Columbia granted a preliminary injunction in a lawsuit challenging the new Guidelines for Human Stem Cell Research, which provided for federal funding of human embryonic stem cell (hESC) research. Sherley v. Sibelius, No. 09-cv-1585, 2010 WL 3296974 (D.D.C. August 23, 2010) (Sherley III). The preliminary injunction states that

defendants [the Secretary of Health and Human Services, the Department of Health and Human Services (HHS), the Director of the National Institutes of Health (NIH), and the NIH] and their officers, employees, and agents are enjoined: from implementing, applying, or taking any action whatsoever pursuant to the National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009), or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines.

Sherley v. Sibelius, No. 1:09-cv-1585, Order (D.D.C. August 23, 2010) (setting forth terms of the preliminary injunction, docket no. 45) (Sherley IV).

Judge Lamberth's order forbids essentially all federal funding of research involving hESCs. While the government is likely to continue its defense of the Guidelines in an appeal, the preliminary injunction halts, for the time being, federal support for this research. Indeed, if Judge Lamberth's conclusions are not reversed on appeal, Congress will have to pass new legislation before federal funding can resume.

Background

Human stem cells can develop into any one of the large number of specialized cells found in the human body. For that reason, stem cells are thought to have great potential for the development of new treatments for a wide range of diseases. Scientists, often using funds provided by the NIH, have been performing research on adult stem cells (ASCs) for about 50 years. These cells can be isolated from tissue samples taken from living donors or from discarded tissues such as umbilical cords.

In 1998, Dr. James Thompson discovered a way to create stem cell lines from primate embryos and later extended these results to work with human embryos. Although the embryos are destroyed in this process, the resulting ESCs can be maintained in cell culture essentially indefinitely. Like other research involving the creation and destruction of human embryos, the use of hESCs has generated a great deal of ethical controversy.

In 2007, researchers developed techniques to reverse adult cells into an immature or embryonic stage of development. These cells, called induced pluripotent stem cells (iPSCs) have great promise, but research into their use is at a very early stage. Therefore, the risks and potential of iPSCs are yet to be determined.

Every year since 1996, Congress has addressed the ethical concerns surrounding the use of human embryos in research by including language in the HHS appropriation bill that prohibits HHS from using federal funds to support research involving “(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. The language does not, however, prohibit hESC research supported by non-federal (e.g., state or private) funds.

In 1999, HHS and the NIH interpreted this language as allowing it to separate hESC research into stages. The agencies determined that Congress had prohibited the federally funded creation of the hESCs—the process that requires the creation and destruction of a human embryo—but had not prohibited federal support for research that uses hESCs previously created using non-federal funds.

In 2001, President George W. Bush issued an executive order limiting federal funding involving hESCs. In particular, the government would only fund research using hESCs that meet certain strict criteria regarding their creation. To implement this executive order, NIH created the Human Embryonic Stem Cell Registry, a list of hESC lines that meet the eligibility criteria.

In 2009, President Barack Obama signed a new executive order that directed NIH to issue new guidelines for funding hESC research that removed the limitations imposed by the 2001 executive order. The resulting guidelines authorized federal funding of research using a wider range of hESCs, including new hESCs derived from embryos that had been created for use in in vitro fertilization treatments but were no longer needed for that purpose.

A group of plaintiffs filed this lawsuit, seeking to invalidate the Guidelines. The original plaintiffs included Drs. James L. Sherley and Theresa Deisher, Nightlight Christian Adoptions, Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and the Christian Medical Association. The District Court initially dismissed the entire lawsuit for lack of jurisdiction, holding that none of the plaintiffs had standing to challenge the Guidelines. Sherley v. Sebelius, 686 F. Supp. 2d 1 (D.D.C. 2009) (Sherley I). On appeal, this holding was reversed with respect to Drs. Sherley and Deisher. Sherley v. Sibelius, 610 F.3d 69 (D.C. Cir. 2010) (Sherley II). The Court of Appeals held that Drs. Sherley and Deisher, who perform research using ASCs, had standing to challenge the Guidelines' adoption because they compete for funding from the limited federal money supporting stem cell research generally. Sherley II, 610 F.3d at 75. Because the guidelines increase the number of projects that can compete for this limited resource, they directly harm Drs. Sherley and Deisher. Id.

The Preliminary Injunction

On remand, the District Court granted Plaintiffs' motion for a preliminary injunction. Sherley III, 2010 WL 3296974. The Court's opinion analyzed the four standard factors used to determine whether a preliminary injunction should issue: (1) whether the party seeking the injunction has a substantial likelihood of success on the merits, (2) whether the party seeking the injunction will suffer irreparable harm if the injunction is not entered, (3) whether entry of the injunction would substantially injure other interested parties, and (4) whether the grant of the injunction is in the public interest. Sherley III, 2010 WL 3296974 at *5-*9.

In this case, the District Court found that each of these factors favored entry of the preliminary injunction. First, it found that Drs. Sherley and Deisher had a substantial likelihood of success on the merits of the case. Id. at *5-*7. In the District Court's view, the statutory language is unambiguous: Federal funds may not be used to support any “research in which a human embryo or embryos are destroyed.” The District Court held that this language unambiguously prohibits any use of funds to support hESC-related research. Id. at *6. Relying on the ordinary meaning of “research,” the District Court rejected the attempt by NIH and HHS to separate the derivation of hESCs from their subsequent use in research. Id. at *7.

Second, the Court determined that Drs. Sherley and Deisher might suffer irreparable injury in the absence of a preliminary injunction. The Court found that the inclusion of illegal projects using hESCs in the competition for NIH money would harm Drs. Sherley and Dr. Deisher by reducing their chances to receive grants in ways that are impossible to measure or value. Id. at *8.

Third, the District Court determined that the balance of the hardships favors issuance of the preliminary injunction. In the Court's view, plaintiffs' harm from the increased competition for NIH grant money is not speculative, while the potential harm imposed by a preliminary injunction would be minimal because the injunction merely preserved the status quo. Id.

Fourth, the District Court concluded that the injunction was in the public interest because the public always has an interest in having the law enforced. Id. at *9.

Because all four factors favored granting the preliminary injunction, the District Court determined that the government should be immediately enjoined from conducting or funding any research using hESCs.

Conclusions

The court's order halts further federal funding or government research involving hESCs, including the research previously funded after the 2001 executive order that limited research to a select number of cell lines that meet the 2001 eligibility criteria.

The immediate effects of the District Court's order on non-federal government (e.g., university and research foundation) laboratories that have received federal support of hESC research are unclear. Each laboratory will have to determine whether it has previously received and is currently using federal research grants under conditions that make it an HHS or NIH agent that is immediately subject to the Court's injunction.

Even if a non-federal laboratory determines that its research is not immediately prohibited, the District Court's order renders future funding of all entities currently receiving federal support uncertain. The order, for example, cuts off future disbursements of funds awarded as part of a multi-year grant and prohibits awards of new grants. Unless the District Court is reversed, either on appeal or through legislation, federal support for hESC research has been returned to the conditions that prevailed before 2001, when no federal funds were available.