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Long court battle over stem cell research continues
WASHINGTON, D.C.—On April 23, attorneys for the parties in the Sherley v. Sebelius stem cell research lawsuit appeared before the U.S. Court of Appeals for the District of Columbia Circuit to offer oral arguments in the controversial ongoing legal battle over whether the federal government should fund human embryonic stem cell (hESC) research projects.
Much of the case questions 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 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.
During his presidency, President George W. Bush issued an executive order providing for the government support of "research on the isolation, derivation, production and testing of stem cells … derived without creating a human embryo for research purposes or destroying, discarding or subjecting to harm a human embryo or fetus." The order—and the resulting lack of funding—placed many stem cell research projects on the shelf.
Shortly after taking office in 2009, President Barack Obama issued an order of his own that was intended to reverse Bush's policy. The order was quickly followed by new NIH guidelines for hESC research and a public comment period.
The plaintiffs filed a lawsuit shortly thereafter, seeking to enjoin the NIH's new guidelines, and a long court volley ensued.
After a federal judge in July dismissed their legal battle to end government funding for hESC research, the plaintiffs in September filed a notice of appeal in the U.S. District Court for the District of Columbia. The broad coalition of plaintiffs includes Dr. James L. Sherley, a scientist at the Boston Biomedical Research Institute, and Dr. Theresa Deisher, the founder, managing member and research and development director of AVM Biotechnology in Seattle.
In the oral argument hearing, attorneys for both sides appeared before Chief Judge David B. Sentelle and Circuit Court judges Karen L. Henderson and Janice Rogers Brown. Brian J. Watson, attorney for the plaintiffs, argued that the NIH's guidelines are invalid for three reasons: "First, by admittedly disregarding 30,000 comments addressing the scientific and ethical merits of human embryonic stem cell research, NIH blatantly violated the Administrative Procedure Act (APA) by ignoring important issues in failing to use an adequate notice and comment process. Second, NIH's guidelines violate Dickey-Wicker's prohibition on funding research in which a human embryo is knowingly subjected to risk of injury or death, which is an issue that was not before this court in Sherley II. And finally, NIH's guidelines violate Dickey-Wicker's prohibition on funding research in which a human embryo is destroyed."
When questioned by the judges about whether the law of the case is binding, Watson responded in part, "The case doctrine is relevant to one out of the three claims that we're making here, which is the first prong of Dickey-Wicker. But, even with respect to that claim, we believe that the law of the case does not bind us penal at this stage of the case."
Watson further argued, "It's arbitrary to decide which types of scientific research to fund without considering the scientific worthiness, and the president cannot simply sign an executive order that grants the APA a coupon good for one APA violation."
Beth S. Brinkmann, attorney for the appellees, countered, "We urge the court to affirm the judgment below on both points. This court's earlier opinion provided an authoritative construction of the statutory question here, a question of pure law, and plaintiffs have not presented anything new to challenge the reasoning of that opinion."
She continued, "Also, as the court has already pointed out, this has been the consistent interpretation of this statute over three presidential administrations. It's the agency's interpretation, and it's also supported by the history against, the backdrop against which this provision was enacted, the type of research on embryos that the rider was intended to prohibit funding of. And as we pointed out before, this type of research is research that uses cells as a research tool and differentiates them for different types of 16 research projects that are looking forward. That's what NIH is looking at when they get the application for the funding. They're looking at that research, what they will be funding going forward."
In his rebuttal, Watson responded, "First, there's nothing inconsistent with establishing categorical eligibility criteria upfront as to which types of research are eligible for funding and then using a case-by-case process to apply those criteria and to prioritize particular research grants. Second, NIH cannot credibly dispute that here … NIH cannot now switch gears and argue that it has to resolve everything through peer review. Also … to the extent that the government tries to tie that point in with the executive order, they're citing just a boilerplate phrase in the executive order that says that it does not affect pre-existing statutory authority. That doesn't prove their point in any way."
The appeals court is not expected to rule on the case for several months. Attorneys for the plaintiffs have indicated they are willing to take the case all the way to the Supreme Court.