If clients get sued by someone where physical or financial injury seems remote, unclear, or speculative, consider raising the defense of lack of standing. Courts are for resolving actual disputes among parties. As we said a little more than a month ago in another post on standing, courts are not debate halls. The standing issue was front and center in the recent case of Center for Responsible Science v. Gottlieb, 2018 WL 1997266 (D.D.C. April 27, 2018). Because the plaintiffs lacked standing, the case was dismissed.
The plaintiffs were three individuals and one organization, the Center for Responsible Science (CRS). They sued over the FDA's rejection of their Citizen Petition, which demanded that three specific warnings be added to standard informed consent forms for clinical trials. The proposed warnings would have told trial participants that (1) animal tests might not be predictive of human safety, (2) some participants in clinical trials for investigative drugs died or were seriously injured, and (3) the drugs in the trial might end up proving to be unsafe or ineffective in humans. The FDA denied the Petition because the additional language applied only to drugs, whereas the standard informed consent forms apply to all clinical trials.
Who were the plaintiffs? How were they harmed by the FDA's denial of the Petition? The three individuals included two people who had previously participated in clinical trials, though it seems nothing bad happened to those two. The third individual lost a son as a result of his participation in a clinical trial. The organization, CRS, is a non-profit, non-member organization that promotes advances in regulatory science and advocates better results for patients.
Did the individuals have standing? No, they did not. The lawsuit sought injunctive relief, so past harm was irrelevant. The problem for the individuals was that they could not establish future harm traceable to the FDA's denial of the Petition. Any future injury would stem from lack of information, but these individuals clearly had the information (that animal tests are not completely predictive of human safety/efficacy, and that clinical trials pose the risk of death/injury). Oddly, just by bringing the lawsuit, the plaintiffs demonstrated their lack of standing. You might put this ruling down to sophistry, but the logic is inescapable.
Does the organization have standing? Not here, not based on the allegations in the complaint. An organization can bring a lawsuit on behalf of itself or its members. But remember that CRS does not have members. So we are thrown back onto organizational standing, the law concerning which is, as the court admits, "not a model of clarity." An organization must show the same things an individual must show: injury, causation, and redressability. The injury must be concrete and demonstrable. There must be a consequent drain on the organization's resources. A setback to the organization's social interests will not suffice. Here, CRS alleged standing "because the interests at stake are germane to [its] purposes, and FDA's response will require further extensive advocacy work on [its] part, placing a significant train on its limited resources, causing a diversion of its resources, and the frustration of its mission." The court held that these allegations, plus others, were too conclusory and vague. You might chalk this conclusion up to TwIqbal, but it is actually a tougher test for plaintiffs to meet because lack of standing is a Rule 12(b)(1) motion that goes to the court's subject matter jurisdiction. Thus, the plaintiff's factual allegations will be subject to "closer scrutiny." CRS's allegations could not survive such closer scrutiny, but the court permitted CRS to amend the complaint to show programmatic, concrete harms that truly would be above and beyond the organization's day-to-day advocacy mission.
We will not speculate as to whether CRS can satisfy this test on the next go around. We leave speculation to plaintiffs.
This article is presented for informational purposes only and is not intended to constitute legal advice.
