Federal Court Grants Injunction Against Stem Cell Research

U.S. District Court Judge Royce Lamberth has granted an injunction in a lawsuit backed by a Christian group seeking to prevent the implementation of President Obama's new stem cell research guidelines. The judge ruled the guidelines violate the Dickey-Wicker Amendment and that "ESC research is research in which a human embryo is destroyed."

The opinion is here.

The Plaintiffs originally included Drs. James L. Sherley and Theresa Deisher, and Nightlight Christian Adoptions (“Nightlight”), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and the Christian Medical Association (“CMA”). They sought an injunction and declaratory relief to keep the new NIH "Guidelines for Human Stem Cell Research" from taking effect to prevent funding research involving the destruction of human embryonic stem cells. [More...]

In earlier rulings, the Court of Appeals ruled Drs. Sherley and Deisher had standing under the "competitor standing doctrine" (described at the end below) and the rest of the plaintiffs had no standing. So only Sherley and Dreisher's claims were at issue in today's ruling.

The court begins with an explanation of stem cell research.

There are three types of stem cells available for research: adult stem cells (“ASCs”), induced pluripotent stem cells (“IPSCs”), and human embryonic stem cells (“ESCs”). Each type of stem cell possesses unique capabilities and limitations.

Human embryonic stem cells (ESCs) are the ones some Christians oppose on moral grounds. For more on this, see See Nat’l Insts. of Health, Stem Cell Information: Frequently Asked Questions.

Sherley and Deisher conduct ASC research. "ASCs are found in tissues that are normally discarded after birth, such as the umbilical cord, and in the body."

Now comes the law:

In 1996, Congress enacted the Balanced Budget Downpayment Act, Pub. L. No. 104-99, § 128, 110 Stat. 26, 34 (1996). The Balanced Budget Downpayment Act contained a rider, known as the Dickey-Wicker Amendment, which prohibited the use of federal funds for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under” applicable federal regulations.

Congress has included the Dickey-Wicker Amendment in every appropriations bill for Health and Human Services (“HHS”) since 1996 without substantive alteration. See Omnibus
Appropriations Act 2009, Pub. L. No. 111-8, § 509(a)(2), 123 Stat. 524, 803 (2009).

In 1999, the NIH said ECS research was exempt from the Dickey-Wicker Amendment:

[it determined] the Dickey-Wicker Amendment was not applicable to ESC research because ESCs are not embryos as defined by statute. Specifically, defendants recognized a distinction between deriving ESCs from an embryo, which is prohibited by the Dickey-Wicker Amendment because it results in the destruction of the embryo, and research on ESCs, which does not result in the destruction of an embryo. See Nat’l Insts. of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32170, 32173 (July 7, 2009). Defendants have maintained this interpretation of the Dickey-Wicker Amendment since 1999. (Id.) Congress, however, has not altered the Dickey-Wicker Amendment in response.

In 2001, President Bush announced a policy statement on stem cell research that limited federal funding for research on ESCs.

Specifically, the President prohibited federal funding for research on ESCs that were created after the date of the policy statement. (Id.) Federal funding remained available, however, for research on ESCs that were created by private researchers prior to his policy statement. (Id.) The President formalized this policy statement in Executive Order No. 13,435, which provided federal funding for IPSC research and left the limitations on ESC research unchanged. See Exec. Order No. 13,435, 72 Fed. Reg. 34,591 (June 20, 2007).

In 2009, President Obama issued his own order and removed the Bush order, with this stated purpose:

“to expand NIH support” for human stem cell research and “to enhance the contribution of America’s scientists to important new discoveries and new therapies for the benefit of humankind.” Executive Order No. 13,505, 74 Fed. Reg. 10,667 (Mar.9, 2009)

As a result, the National Institutes of Health (“NIH”) “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem research, to the extend permitted by law.” Id. To achieve that end, the President directed NIH to review the existing stem cell research guidelines and “issue new NIH guidance on such research that is consistent with this order.”

So the NIH published draft guidelines entitled “National Institutes of Health Guidelines for Human Stem Cell Research.” 74 Fed. Reg. 18,578 (Apr. 23, 2009) allowed “funding for research using human embryonic stem cells that were derived from human embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.”

The final guidelines were enacted in July, 2009, after everyone, including Plaintiffs, had the chance to respond. They authorized ESC research using ESCs that were derived from human embryos that “were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose” and “were donated by the individuals who sought reproductive treatment . . . and who gave voluntary written consent for the human embryos to be used for research purposes.” And there's a bunch of rules and some alternative ways to qualify.

But the guidelines also provided: “NIH funding of the derivation of stem cells from human embryos is prohibited by” the Dickey-Wicker Amendment.

The defendants argued that last provision is an acknowledgment in the Guidelines of the difference between types of stem cell research:

....the Guidelines “recognize the distinction . . . between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which Federal funding is prohibited, and research involving ESCs that does not involve an embryo nor result in an embryo’s destruction, for which Federal funding is permitted.”

The Court found in favor of Plaintiffs:

The Court finds that the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of hardships, and public interest considerations each weigh in favor of a preliminary injunction.

It concluded plaintiffs have demonstrated a strong likelihood of success that the Guidelines violate the Dickey-Wicker Amendment.

Congress has spoken to the precise question at issue—whether federal funds may be used for research in which an embryo is destroyed. The Dickey-Wicker Amendment provides that no federal funds shall be used for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. § 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).” Pub. L. No. 111-8, § 509(a)(2). Thus, as demonstrated by the plain language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of federal funds on “research in which a human embryo or embryos are destroyed.” Id.

And, the Court says:

Had Congress intended to limit the Dickey- Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of ESCs, or to research on the embryo itself, Congress could have written the statute that way. Congress, however, has not written the statute that way, and this Court is bound to apply the law as it is written. Accordingly, this Court must “give effect to the unambiguously expressed intent
of Congress” to prohibit federal funding of research in which a human embryo is destroyed.

The defendants maintained:

Defendants argue that the ESC research is not research in which a human embryo is destroyed because ESC research does not involve embryos nor result in their destruction. This argument rests on defendants’ interpretation of “research,” as used in the Dickey-Wicker Amendment, to mean “a piece of research.”

...This interpretation allows defendants to define ESC research and the derivation of ESCs from embryos as separate and distinct “pieces of research.” Thus, the Guidelines, according to defendants, are consistent with Dickey-Wicker Amendment because the Guidelines only allow funding of ESC research, and not the derivation of ESCs, which results in the destruction of an embryo.

The Court's reasoning in rejecting the defendant's position:

ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo. Despite defendants’ attempt to separate the derivation of ESCs from research on the ESCs, the two cannot be separated.

In other words, in the view of the Court:

Simply because ESC research involves multiple steps does not mean that each step is a separate “piece of research” that may be federally funded, provided the step does not result in the destruction of an embryo. 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.

...The Guidelines violate [the Dickey-Wicker Amendment's] prohibition by allowing federal funding of ESC research because ESC research depends up on the destruction of a human embryo.

One added note: The Court says IPSC research is the newest form of stem cell research.

Discovered in 2007, IPSCs “are adult stem cells that have been genetically reprogrammed such that they are virtually identical to embryonic stem cells.” Because research involving IPSCs is at such an early stage, its full potential is unknown. Some researchers, however, believe that IPSCs offers the most promise for advancements in medical research and treatment.

Back to the "competitor standing" -- in the section finding the Plaintiffs showed irreparable injury if the injunction wasn't granted, the Court says:

Plaintiffs are researchers who work exclusively with ASCs. They seek funds for their research projects from defendants and allege “that obtaining NIH funding is necessary for their continued research.” The Guidelines, by allowing federal funding of ESC research, increases competition for NIH’s limited resources. This increased competition for limited funds is an actual, imminent injury....There is no after-the-fact remedy for this injury because the Court cannot compensate plaintiffs for their lost opportunity to receive funds.

What about the injury the injunction would cause to ESC researchers and individuals who suffer from diseases that may be treatable in the future as a result of ESC research? The Court says there isn't any:

The injunction, however, would not seriously harm ESC researchers because the injunction would simply preserve the status quo and would not interfere with their ability to obtain private funding for their research. In addition, the harm to individuals who suffer from diseases that one day may be treatable as a result of ESC research is speculative. It is not certain whether ESC research will result in new and successful treatments for diseases such as Alzheimer’s and Parkinson’s disease.

...Plaintiffs’ injury of increased competition, however, is not speculative. It is actual and imminent. Indeed, the Guidelines threaten the very livelihood of plaintiffs Sherley and Deisher. Accordingly, the irreparable harm that plaintiffs would suffer absent the injunction outweighs the harms to interested parties.

Wow. So the interests of two researchers in competing for grant money outweighs everyone else's interest, including patients who might be helped by the research allowed by the guidelines.

What a wrong-headed opinion.

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