Fourth Circuit Dismisses Challenge To Federal Embryonic Stem Cell Research Funding Citing Lack Of Standing Of Challengers

Jan 28, 2011   
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On January 21, 2011, the United States Court of Appeals for the Fourth Circuit affirmed a decision of the District Court of Maryland dismissing a consolidated case challenging the federal funding of research involving embryonic stem cells. In agreeing with the District Court, the Fourth Circuit found that both plaintiffs lacked standing, an essential constitutional requirement to bringing case before the court. A copy of the decision can be read in full at: Mary Scott Doe v. Obama.

Article III of the United States Constitution provides that the judicial power of the federal court system extends to “cases” and “controversies.” However, in order to bring a case, the plaintiff must have “standing” to assert its claim. To satisfy the constitutional requirement of “standing,” a plaintiff must establish: 1) it has suffered an “injury in fact” which is “concrete and particularized” and “actual or imminent” and not merely “hypothetical;” 2) causation, i.e. the injury is “fairly traceable to the challenged action of the defendant;” and 3) redressability, meaning that “it is likely, as opposed to merely speculative” that the injury will be remedied by a favorable decision. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180-81 (2000).

In Mary Scott Doe, two groups of plaintiffs attempted to challenge the constitutionality of Executive Order 13505 (“EO 13505”) and its implementing National Institute of Health (“NIH”) Guidelines which expanded federal funding of human embryonic stem cell research. NIH Guidelines currently permit funding for research involving stem cells from embryos “donated by individuals who sought reproductive treatment . . . and who gave voluntary written consent for the human embryos to be used for research purposes.” 74 Fed. Reg. 32170, 32174. The plaintiffs alleged that EO 13505 and the NIH Guidelines violated the 13th and 14th Amendments to the U.S. Constitution as well as the Administrative Procedure Act and the Dickey-Wicker Amendment, which prohibits use of federal funds for “research in which a human embryo . . . is destroyed, discarded, or knowingly subjected to risk of injury or death.”

The first named plaintiff, Mary Scott Doe, represented a class of all frozen embryos held throughout the US for either research or adoption purposes. The plaintiffs argued that the class of frozen embryos had standing because EO 13505 and the NIH Guidelines “increase the embryos risk of being reduced to . . . stem cells” thus creating an “injury in fact” necessary to bring a case. However, the Court rejected this argument, stating that in order to establish standing “named plaintiffs who represent a class must allege and show that they personally have been injured, not that injury has been suffered by other, unidentified members of the class to which they belong and which they purport to represent.” (emphasis added). The Court went on to state that because the “complaint provides no basis to conclude that the named plaintiff . . . [will] suffer any injury at all, much less an injury due to the challenge government policy,” “Doe” has failed to allege a “concrete and particularized harm.” Thus, the Court found that “Doe” could not establish an injury in fact.

Furthermore, the Court found that even if “Doe” could assert an injury, “Doe” could not establish causation on the part of the defendant, the US government. Here, the Court found that funding for research was limited to those embryos which were voluntarily donated for research by biological donors. As such, any injury which could have occurred was the result of the independent actions of a third party, not the named defendant. “Where a third party . . . makes the independent decision that causes an injury, that injury is not fairly traceable to the government . . . .The mere fact that the government permits private donors to chose to donate their embryos for research does not . . . make the decision fairly traceable to [EO] 13505 or the NIH Guidelines.”

The Fourth Circuit also affirmed the dismissal for lack of standing for the second group of plaintiffs, parents who have children that were adopted frozen embryos and who are considering adopting embryos again. The Court found that the adoptive parent plaintiffs did not claim that they had already suffered an injury. Rather, the adoptive parent plaintiffs claimed that they faced the treat of a future injury because “EO 13505 will reduce the number of in vitro human embryos available for adoption such that they will be unable to adopt.” However, the Court went on to find that the adoptive parent plaintiffs failed to allege facts to “infer that such injury would be actual or imminent.”

In finding that the adoptive parent plaintiffs lacked standing, the Fourth Circuit relied upon Supreme Court precedent established in Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992). In Lujan, the Supreme Court found that in order for a plaintiff to establish standing through the claiming of a future injury, it must be alleged that future injury is “certainly impending.” Id. at 565 n. 2 (emphasis in original). In this case, the Fourth Circuit found that “the plaintiff parents . . . did not allege that they have already tried and failed to adopt embryos, nor do they allege any concrete plans for future adoption, so the possibility that they will never suffer the alleged injury looms too large.”

Fuerst Ittleman has built a reputation not only in the field of complex litigation but also in the legal aspects of the cutting edge field of stem cell research. If you have any questions pertaining to new NIH guidelines or to contact a complex litigation attorney please contact Fuerst Ittleman PL at For more information on Fuerst Ittlemans experience in the legal aspects of stem cell therapies, age management medicine, food and drug law in general, and FDA regulatory and enforcement actions, please visit our Food, Drug and Cosmetic Law practice page.