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Legal Analysis: Parsing the Stem Cell Case

8 September 2010 5:30 pm
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Does human embryonic stem cell (hESC) research violate the law? And does it make sense to halt federal funding of the work while the courts weigh this question?

Yesterday, Chief Judge Royce Lamberth of the U.S. District Court in Washington, D.C., ordered that the funding ban he imposed 2 weeks ago stick for now . The Department of Justice is expected to appeal this ruling, making the case even more convoluted. Meanwhile, scientists nationwide, and especially at the National Institutes of Health (NIH), where all hESC work is at a standstill, are incensed and deeply unsettled by the case.

Although moral opposition to hESC research is certainly helping drive Sherley v. Sebelius, the case also includes some tricky legal questions. Legal scholars say there are three separate parts to the case, and dissecting each one makes it easier to understand where the judge is coming from—and where the ambiguities lie.

First, do the plaintiffs, scientists studying adult stem cells, have the right to bring this case? Second, is their argument—that hESC research violates the Dickey-Wicker Amendment, which prohibits federal funding for research that destroys or harms embryos—reasonable? And third, what’s behind Lamberth’s preliminary injunction halting funding while he decides the case?

Here’s ScienceInsider’s stab at parsing each of these questions.

In the legal world, the first point is referred to as “standing,” that is, whether plaintiffs have a right to bring a particular case to court. To have standing, the plaintiff “has to have suffered an actual harm caused by the defendant’s action,” says expert Suzanna Sherry of Vanderbilt University Law School in Nashville. Initially, Lamberth didn’t take favorably to the standing of the plaintiffs, who at first were a broader group including embryos as well as an organization, Nightlight Christian Adoptions, that provides embryo-adoption services. He dismissed the case and the plaintiffs appealed. The D.C. Court of Appeals agreed in part with Lamberth, but it held that two of the original plaintiffs—scientists James Sherley and Theresa Deisher—were being harmed by NIH's funding of hESC research. Those two remained on the suit while the rest were removed.

This may seem a stretch to scientists who argue, correctly, that NIH funds far more research into adult stem cells than embryonic ones. But “harm” from a legal standpoint doesn’t always have to be grievous to count in the courts. “The court has wavered on how direct and immediate the harm has to be,” says Sherry. Here, she believes, “the harm is pretty clear—their pool of funds is reduced.” This may still be speculative—Sherry agrees that it’s not as though Sherley’s grant was denied because it went directly to an ES cell researcher. But, she adds, some courts believe “standing should be interpreted very liberally because we don’t want to kick people out of court” who might have a case.

Standing requires not only that someone has been harmed but also that with a court ruling favorable to them, the harm will dissipate. And that’s hardly certain here, says Erwin Chemerinsky, dean of the University of California, Irvine, School of Law. “I was very surprised that they found standing in this instance,” he says. There’s no indication that Sherley and Deisher (who has never applied for an NIH grant) would be awarded funding if support for hESC research was terminated.

Harm also must be viewed through the prism of wrongdoing. It’s not as though any scientist whose grant goes unfunded can successfully sue NIH. However, says Sherry, if they claimed that the agency was flipping a coin to award grants or doling out funds to the friends of NIH officials, then they’d have a case.

Here, Sherley and Deisher are alleging that NIH is violating a 1995 Congressional statute called the Dickey-Wicker Amendment. Dickey-Wicker prohibits the Department of Health and Human Services (HHS), which encompasses NIH, from funding the destruction of human embryos or funding research in which embryos are destroyed. When Dickey-Wicker was written 15 years ago, hESC research hadn’t yet begun. “Everything we talked about was about research directly on the embryo,” for example, to improve on infertility treatment or better understand cancer biology, says R. Alta Charo, a law professor and bioethicist at the University of Wisconsin Law School who was a member of the NIH Human Embryo Research Panel in the mid-1990s, which considered how embryos might be used in research. “Dickey-Wicker was a reaction to that.”

In 1999, Harriet Rabb, who was then the general counsel at HHS, concluded that Dickey-Wicker didn’t preclude government support for hESC research. The funding prohibition, she wrote, “would not apply to research utilizing human pluripotent stem cells because such cells are not a human embryo within the statutory definition.” This argument was accepted by the Clinton, Bush, and Obama Administrations, and Congress appropriated money for hESC research. Rabb declined to comment for this story.

Whether Sherley and Deisher have a case that funding hESC research violates Dickey-Wicker is tricky, say some scholars. On the one hand, “you could say there’s a tension” that comes from separating embryo destruction from research on the resulting cells, says John Robertson, who studies law and bioethics at the University of Texas School of Law. Another problem is that in its July 2009 Guidelines on Human Stem Cell Research, NIH spelled out specific requirements about embryo donation for newly derived lines, says Pilar Ossorio, a legal scholar who studies research ethics at the University of Wisconsin Law School. The donation process is entirely separate from the research on the resulting cells. But NIH included this information in its guidelines to ensure that there was no undue influence on embryo donations for research, says Ossorio. One unintended consequence is that some may wonder, “If NIH doesn’t even fund destruction of embryos, why do these guidelines even talk about that?” she says.

The plaintiffs’ lawyers highlighted that point in their brief submitted on Friday. The Dickey-Wicker Amendment prohibits funding of research in which embryos are “knowingly subjected to risk of injury or death,” they note. They then argue that “By creating a financial incentive for embryonic stem cell research—an incentive that by NIH’s own admission involves investments of “hundreds of millions of dollars”—and by specifying the precise means by which embryos must be destroyed in order to qualify for federal funding, the NIH necessarily and knowingly subjects embryos to a substantial risk of injury or death.”

On the flip side, to agree with the plaintiffs “is to say that the [federal] agencies got it wrong” for all these years, says Charo. Courts tend to defer to federal agencies on interpreting statutes like Dickey-Wicker, and the fact that the HHS interpretation has been consistent and wasn’t challenged in court until now may weaken the plaintiffs’ case.

Ultimately, Robertson says, whether you agree with Lamberth comes down to how you define “research.” Lamberth, he says, is “a lumper, not a splitter.” In his preliminary injunction on 23 August, Lamberth wrote that “if one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment.”

This is “mushing things together that in the real world of science are quite separate,” says Robertson. How hESCs are cultured, which genetic or chemical signals cause them to differentiate into different cell types, how their pluripotency is preserved—“each of those is almost a mini-world to itself among researchers.” Whether that separation matters is one key to assessing the case.

One of the most confusing elements of Sherley v. Sebelius is whether the Bush rules, which allowed for research on hESC lines that existed in 2001, violates Dickey-Wicker. In yesterday’s order, Lamberth wrote that they did not: “The prior [Bush Administration] guidelines, of course, allowed research only on existing stem cell lines, foreclosing additional destruction of embryos.”

The current NIH guidelines allow research with newly derived lines, which Lamberth sees as inseparable from the destruction of embryos. “By its own logic,” says Charo, Lamberth’s ban on funding “should only apply to ... cell lines that are being derived now.” Cell lines derived 3 months or a year ago “should still be eligible for funding,” she argues.

One spot where Lamberth is on shaky ground, legal scholars believe, is in his decision to issue a preliminary injunction 2 weeks ago. An earlier case cited by Lamberth calls preliminary injunctions “an extraordinary remedy.” They’re granted only when it’s considered very likely that the parties seeking them are likely to succeed in their case; when they will suffer irreparable injury without one; and when an injunction won’t “substantially” injure the other parties with a stake in the outcome and will further the public good.

Experts are particularly dubious about the harm suffered by Sherley and Deisher if funding of hESC research were to continue while the judge considers the case.

The interests of the plaintiffs here “seem very slight indeed, [and] do not seem harmful enough ... to justify a preliminary injunction,” says Robertson. That’s especially true when one considers the harm to NIH and scientific programs that are now in chaos, he adds.

Resolution may need to come from Congress, but it’s unclear exactly what it would entail. Undoing Dickey-Wicker altogether could, legally speaking, be the safest bet—but it may not be politically palatable to lawmakers, especially in an election year.

See our complete coverage of this issue.

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