Opponents of federally funded human embryonic stem cell (hESC) research returned to a U.S. appeals court today to argue that such research should be banned, despite two earlier court decisions that it is legal. The discussion suggested that the three-judge panel's decision may turn on a technical question: whether the court is obliged to defer to its own previous ruling.
The high-stakes case goes back to August 2009, when adult stem cell researchers James Sherley, Theresa Deisher, and others sued to block new guidelines lifting Bush-era limits on hESC research that the National Institutes of Health (NIH) crafted in response to an order from President Barack Obama. The suit argued that the guidelines violate the Dickey-Wicker Amendment, a 1996 law banning federal funding for research that harms or destroys human embryos. A year later, Chief Judge Royce Lamberth of the U.S. District Court in Washington, D.C., issued a preliminary injunction that halted NIH funding for hESC research for more than 2 weeks.
But the U.S. Court of Appeals for the D.C. Circuit stayed the injunction, then threw it out in April 2011. In a 2-to-1 ruling, the panel found NIH was likely to win because Dickey-Wicker is ambiguous and the agency had reasonably concluded that the law did not forbid funding for research using hESCs. The case went back to Lamberth, who last July reluctantly ruled in NIH's favor. The plaintiffs then appealed.
At today's 35-minute hearing before a different three-judge panel that included one judge who had heard the earlier case, the questioning was dominated by Chief Judge David Sentelle, a gruff, white-haired man with a Southern drawl. He and Judge Janice Rogers Brown asked several times whether the appeals court's previous ruling was binding. Plaintiffs' attorney Ryan Watson said it should not be because it involved a preliminary injunction. But NIH's attorney, Beth Brinkmann of the Department of Justice, later said the earlier ruling should be binding because the court had already considered all the issues and there is "nothing new" in the plaintiffs' arguments.
Watson noted that the appeals court hasn't yet ruled on the plaintiff's argument that the NIH policy violates Dickey-Wicker by creating "demand" for new hESC lines. He said that researchers have derived at least four new lines since July 2009. Brinkmann pointed out that during the Bush years when NIH funds could only be used to study existing lines, dozens of new lines were created, suggesting NIH funds don't drive derivation.
Also new to this court was the question of whether NIH should have disregarded some 30,000 comments from opponents of hESC research when it issued the 2009 guidelines. Watson argued that because President Obama's executive order said NIH "may" fund hESC research and the agency asked for input on ethics, the comments should have been considered. Brinkmann, however, pointed to Lamberth's decision, which agreed that NIH didn't have to consider the comments because the president asked "how," not "whether" to fund hESC research.
Although Chief Judge Sentelle asked some prickly questions of Brinkmann (e.g.: If the majority of funding for hESC research doesn't come from NIH, why are you bothering to litigate?), at several points he seemed sympathetic to the government. He asked whether NIH should have considered comments that were opposed "180 degrees." He also brought up NIH's argument that if Congress didn't like NIH's interpretation of Dickey-Wicker, it would not have repeatedly passed the law without changes.
Judge Brown was interested in Congress's intentions. She asked Brinkmann to clarify that Dickey-Wicker came about in the 1990s not because Congress was concerned about hESC research (which didn't exist), but because it didn't want to fund research on in vitro fertilization that harmed embryos.
Judge Karen LeCraft Henderson, who dissented from the court's April 2011 decision (she called her colleagues' arguments "linguistic jujitsu"), did not ask any questions. All three judges were appointed by Republican presidents: Henderson by George H. W. Bush; Sentelle by Ronald Reagan; and Brown by George W. Bush.
One observer who supports NIH said it was hard to draw any conclusions about which way the judges were leaning. "I thought the government did a good job, but you really can't tell anything from the questions," said Amy Comstock Rick, CEO of the Parkinson's Action Network.
Both she and Samuel Casey, an attorney for the plaintiffs, predicted a ruling could come within 4 to 6 months, based on the timing of the court's last two decisions. If NIH loses, the court could shut down hESC research again. But another possibility is that it will merely ask NIH to revise the guidelines taking into account the opponents' comments.
No matter the outcome, many expect the case to end up before the Supreme Court.