Stay in stem cell case?

Judge hears emergency plea to resume work

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Human embryonic stem cells are propagated on synthetic substrates. The cells are stained with human pluripotent stem cell markers (Nanog, Tra-1-60, OCT4-GFP, and SSEA4).
Image courtesy of Y. Mei, K. Saha, R. Langer, R. Jaenisch, and D.G. Anderson

A federal judge may decide in the next week whether to issue an emergency stay of his own injunction against federal funding of human embryonic stem cell research. The stay would temporarily stop the injunction.

The United States Department of Justice filed an appeal and an emergency motion on Tuesday afternoon for a stay in Sherley v. Sebelius, the stem cell case under which an injunction issued last week Monday. That injunction, issued by Chief Judge Royce C. Lamberth, prevents the NIH and other federal agencies from funding or considering to fund stem cell research, and has derailed many grants that were in the pipeline for consideration.

Existing grants to institutions like MIT are allowed to spend funds they have already received, but research within the NIH, called intramural research, is not. That intramural research has already begun to shut down in accordance with the injunction, raising serious questions about how to stop biological work without wasting the millions of dollars already invested in it.

The DOJ requested that the D.C. District Court stay its injunction pending an appeal before the next highest court, the Court of Appeals for the D.C. Circuit.

“The court’s order causes irrevocable harm to the millions of extremely sick or injured people who stand to benefit from continuing research, as well as to the taxpayers who have already spent hundreds of millions of dollars on this research through public funding of projects which will now be forced to shut down,” DOJ spokeswoman Tracy Schmaler said in a statement.

The Court has ordered the plaintiffs must file any opposition to the stay by today, a schedule suggested by the DOJ. The DOJ also asked the Court to rule by Tuesday. Judge Lamberth approved the schedule extremely rapidly, doing so at 3:30 p.m. on Tuesday after the DOJ filed its motion at 2:49 p.m.

Individual MIT scientists who work with stem cells, including Professors Richard A. Young, Daniel G. Anderson, and Robert S. Langer ScD ’74 have all spoken out about how critically important they believe human embryonic stem cell work is, and how horrible the injunction is.

The Academic Council, MIT’s senior leadership, was briefed on these issues during its retreat on Monday by William B. Bonvillian, director of MIT’s Washington Office. MIT appears to be waiting for further developments before engaging the issue in Washington.

The Association of American Universities and the Council on Governmental Relations, both of which MIT is a member, issued a joint statement last week saying the injunction “not only blocks potential life-saving research but also threatens to undermine the system of peer-reviewed science that has helped make America the unquestioned world leader in scientific discovery.”

The legal journey

This case, Sherley v. Sebelius, was originally filed by former MIT professor James L. Sherley, Theresa Deisher, Nightlight Christian Adoptions, and Christian Medical Adoptions. It was also filed on behalf of “embryos,” as well as several individuals. The plaintiffs allege that any human embryonic stem cell research is prohibited by a Congressional appropriations rider, the Dickey-Wicker Amendment, which prohibits federal funding of research that contributes to the destruction of an embryo. All human embryonic stem cell lines funded under Presidents George Bush and Barack Obama do not involve the new destruction of embryos — any embryos were previously destroyed.

The district court originally ruled that none of the plaintiffs had standing to sue, meaning they were not harmed by the law.

The plaintiffs appealed to the Circuit court, which ruled in their favor, saying that plaintiffs Sherley and Deisher, and only those two, had standing. The Court said that their research competed with others’ work for NIH funding.

But the NIH said that Sherley’s work, which is with adult stem cells, was not in direct competition with funding for human embryonic stem cells, and competed with all other NIH work on the basis of peer review.

The NIH also said that Deisher had never applied for NIH funding; it noted that Sherley was currently on the fifth year of an NIH grant, and that his grant success rate of 38 percent betters the NIH-wide average of 20 percent.

The three-judge panel consisting of Judges Douglas H. Ginsburg, Janice R. Brown, and Brett M. Kavanaugh ruled in late June and remanded the case back to Chief Judge Lamberth for further consideration.

Prior to the appeals court decision, the DOJ had filed a brief in opposition to a preliminary injunction. That brief was primarily concerned with standing, the issue the appeals court ruled on. After the case was remanded, the DOJ filed no further briefs.

The emergency motion for a stay filed Tuesday comes eight days after the preliminary injunction. During that week, researchers have been wondering what the decision means for them, how it will affect their further funding, wondering what the NIH will do, and wondering how the DOJ would react.

At the same time as the request for a stay, the DOJ filed an appeal with the Circuit Court. The Circuit Court has issued an expedited schedule, requiring procedural motions to be filed by September 30, and substantive ones by October 15.

On Wednesday, the plaintiffs asked the Circuit Court to assign to this appeal to the same 3-judge panel of Ginsburg, Brown, and Kavanaugh that ruled on the question of standing. The Court denied that motion yesterday afternoon. The plaintiffs had argued that that original panel was “well-versed in the specific facts and law relating to the present appeal,” and both the parties and the Court would benefit from such an assignment.

Neither Shirley nor his lawyers have returned multiple telephone messages and e-mail inquiries sent in the past week. They have also not objected to the briefing schedule proposed by defense, that has them filing their brief today and the court ruling on the stay by Tuesday.