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Stem cell case is dismissed
WASHINGTON, D.C.—On July 27, a federal judge dismissed a case seeking to end government funding for human embryonic stem cell research (hESC)—the latest event in a much-watched, highly publicized case that has been at the center of great debate for more than a year.
The case, Sherley, et al., v. Sebelius, et al., took national ethical and moral concerns about hESCs to the legal arena after these issues fell on three presidential administrations to provide an answer. But "for all three such administrations, Democratic and Republican, the answer has been to permit federal funding. They have differed only as to the path forward," said the U.S. District Court for the District of Columbia in its recent ruling.
Sherley took square aim at a 2009 presidential order that lifted restrictions placed by former President George Bush on the government funding of stem cell research projects in which hESCs were used. Much of the case focused on the language of the Dickey-Wicker Amendment, a measure signed into law in 1995 by former President Bill Clinton that prohibited the U.S. Department of Health and Human Services (HHS) and the U.S. National Institutes of Health (NIH) from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed.
The plaintiffs argued that President Barack Obama's order violated the provisions of Dickey-Wicker. In April, the appeals court took issue with whether the word "research" was ambiguous in the language of the amendment.
The case has garnered a lot of attention since August 2010, when Judge Royce Lamberth held that Dickey-Wicker prohibited the federal government from funding hESC research and enjoined the government from continuing such funding. Suddenly, any federal dollars being allocated toward hESC research efforts were frozen—until the government, arguing that the injunction would impose a substantial hardship on stem cell researchers with multi-year projects already underway, appealed the injunction and a stay was granted while the case moved forward.
The injunction was dismissed altogether in April, when the appeals court ruled that the word "research" in Dickey-Wicker was ambiguous enough that the NIH could choose how to interpret it. In other words, the NIH was free to interpret that current embryonic stem cell research was not the same "research" in which the embryos were destroyed.
Lamberth's recent decision in the case came as a surprise to some, as his preliminary injunction was widely interpreted as a move that favored the funding restrictions ordered by Bush. But after considering the arguments, the judge found that, applying the legal analysis of the appeals court's decision, the statutory language was ambiguous and the NIH's interpretation was reasonable.
"The NIH reasonably concluded that the Dickey-Wicker Amendment prohibited federal funding for research projects 'in which' human embryos are knowingly subjected to risk, such as pre-implantation genetic diagnosis, but did not prohibit research projects, such as embryonic stem cell research, that do not involve embryos and so cannot knowingly subject them to risk 'in' the research," Lamberth wrote in his decision.
Commenting on the decision on Stanford Law School's blog, Prof. Hank Greely called the ruling "a graceful, gracious and fully professional opinion by Judge Lamberth."
"The poor man had been reserved twice by the D.C. Circuit, in different directions," Greeley wrote on July 27. "He did not attempt to play games with the latest circuit decision and follow its letter while avoiding its intent. While making it clear that he thought he had been right, he did what a judge is a supposed to do in applying the law in light of his position in the judiciary hierarchy. "
"I was surprised by the decision—but very pleased," agrees Antoinette F. Konski, a partner with the law firm Foley & Lardner LLP. "Lamberth wasn't obligated to follow the appeals court's decision, and he also stated in his decision that his legal reasoning in issuing the injunction was sound. The take-home message here is that this ruling will allow the federal funding of hESC research to move forward. It validates the NIH's guidelines regarding stem cell research, and removed a great deal of uncertainty in this area.
This case— and others arguing similar points in various courts across the country—may still go on with appeals, potentially as high as the U.S. Supreme Court. Plaintiffs' attorney Samuel B. Casey, general counsel for the Law of Life Project, declines to comment on the case, but tells ddn: "Of course, we will timely appeal."
Greeley noted that the Supreme Court takes on cases like these "very rarely and only in real emergencies."
"It is tempting to say, 'all's well that ends well,'" Greeley concluded in his blog post. "The judiciary seems to be headed to making a decision in this matter that is both (in my view) clearly legally correct and good policy. But those who have suffered from the last 11 months of scrambling, uncertainty and expense might have a different view. It is one of the costs of our system of government—happily, in this case, so far, not a terribly high cost."
Some have also argued that Congress needs to re-evaluate Dickey-Wicker.
"There have been numerous attempts to legislate on what is basically a policy decision at the state level," notes Konski. "Perhaps as we get closer to the election, or as other pressing issues are addressed, this will create more room and attention span for this issue."
While it is unclear whether other court decisions will attempt to place prohibitions on hESC research, as a result of the Sherley decision, the research can continue.
Responding to the decision, NIH Director Francis Collins issued the following statement:
"We are pleased with today's ruling. Responsible stem cell research has the potential to develop new treatments and ultimately save lives. This ruling will help ensure this groundbreaking research can continue to move forward."