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Center For Responsible Science v. Gottlieb

United States District Court, District of Columbia

April 27, 2018




         Plaintiffs - three individuals and the Center for Responsible Science - believe that everyone who participates in a clinical-drug trial should be aware of differences in the data between preclinical animal testing and clinical human-subject experimentation. To that end, in May 2014, they submitted a Citizen Petition to the Commissioner of the Food and Drug Administration requesting that three specific warnings be added to the standard informed-consent materials. When the FDA denied the Petition, Plaintiffs brought this one-count Administrative Procedure Act suit against the current Commissioner, Scott Gottlieb. Defendant now moves to dismiss, contending that none of the Plaintiffs has standing, thus robbing the Court of subject-matter jurisdiction. For the reasons discussed below, the Court agrees and will grant the Motion, but permit Plaintiffs an opportunity to amend.

         I. Background

         Few understand the long and arduous road a new drug takes to finally come to market. After the drug is developed, researchers often test its safety on laboratory animals in preclinical trials. See Compl., ¶¶ 91-92. If it can clear the preclinical stage, the drug sponsor submits an investigational new-drug application to the FDA, the agency responsible for regulating research on human subjects. Id., ¶¶ 88, 93. If approved, clinical research - i.e., testing conducted on humans rather than animals - begins. As part of its duty to protect human subjects, the FDA requires the drug sponsor to obtain “legally effective informed consent” for each participant. See 21 C.F.R. § 50.20. Under current Agency regulations, informed-consent documents must contain eight elements, one of which describes “any reasonably foreseeable risks or discomforts to the subject.” Id. § 50.25(a)(2).

         It is on this last point that Plaintiffs believe the FDA is abdicating its duty. Two of the Plaintiffs, Hal Garcia-Smith and John Tessmer, have previously participated in clinical trials and believe that informed consent should include warnings about the differences between animal and human testing. See Compl., ¶¶ 11, 15-16, 20, 24. The third individual Plaintiff, Michael Vokhgelt, lost a son as a result of his participation in a clinical trial. Id., ¶¶ 25-28. Because Vokhgelt has other children who he fears may need experimental cancer treatments, he also would like the FDA to mandate that drug sponsors alert people of the risks of using data from preclinical animal testing before they decide to do a clinical trial. Id., ¶ 36. CRS is a non-profit, non-member organization that seeks to “promote advances in regulatory science” by “advocat[ing] for better results for patients” and “bringing policy up to date with existing science.” Id., ¶¶ 1-4. As part of its mission and activities, CRS “monitors serious adverse events . . . in clinical trials.” Id., ¶ 4.

         On May 30, 2014, the organization and two of the individual Plaintiffs petitioned the FDA to amend its informed-consent regulation to include information about preclinical animal testing. Id., ¶¶ 65, 68. Specifically, the Petition requested that the FDA add three informed-consent elements to the eight extant ones:

(9) The drug you will be given has been tested in animals and by other laboratory methods to determine whether it is likely to be safe and effective in humans. The decision to allow testing of this drug on humans relies heavily on the presumption that animal tests predict human response. Due to differences between animals and humans, animal tests may not predict whether a drug is safe and/or effective for use in humans.
(10) Some participants in clinical trials in which other investigative drugs were tested have died or have been seriously injured by the drug that was tested.
(11) The drug you will be given may later prove to be either unsafe for humans or ineffective in treating the condition for which it is being tested. You should not assume the drug will treat a medical condition you may have, because a determination of efficacy in an animal study does not necessarily predict efficacy in humans.

         Compl., Exh A at 7. On April 12, 2017, the FDA denied the Petition, stating that the additional elements pertain to drug trials only, while the informed-consent regulations apply to all clinical trials. The Petition's warnings, therefore, “raise[d] broader concerns that make them inappropriate for inclusion in FDA's existing informed consent regulations.” Compl., Exh. D at 3.

         Six months later, Plaintiffs brought this suit for declaratory and injunctive relief, alleging that the FDA's denial was “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law, in violation of 5 U.S.C. § 706(2)(a).” Compl., ¶ 215. Defendant, contending that all Plaintiffs lack standing, now moves to dismiss for want of jurisdiction.

         II. Legal Standard

         In evaluating Defendant's Motion to Dismiss, the Court must “treat the complaint's factual allegations as true . . . and must grant plaintiff ‘the benefit of all inferences that can be derived from the facts alleged.'” Sparrow v. United Air Lines, Inc., 216 F.3d 1111, 1113 (D.C. Cir. 2000) (quoting Schuler v. United States, 617 F.2d 605, 608 (D.C. Cir. 1979)) (internal citation omitted); see also Jerome Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1253 (D.C. Cir. 2005). The Court need not accept as true, however, “a legal conclusion couched as a factual allegation, ” nor an inference unsupported by the facts set forth in the Complaint. Trudeau v. Fed. Trade Comm'n, 456 F.3d 178, 193 (D.C. Cir. 2006) (quoting Papasan v. Allain, 478 U.S. 265, 286 (1986) (internal quotation marks omitted)).

         To survive a motion to dismiss under Rule 12(b)(1), Plaintiffs bear the burden of proving that the Court has subject-matter jurisdiction to hear their claims. See Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992); U.S. Ecology, Inc. v. U.S. Dep't of Interior, 231 F.3d 20, 24 (D.C. Cir. 2000). A court has an “affirmative obligation to ensure that it is acting within the scope of its jurisdictional authority.” Grand Lodge of the Fraternal Order of Police v. Ashcroft, 185 F.Supp.2d 9, 13 (D.D.C. 2001). For this reason, “‘the [p]laintiff's factual allegations in the complaint . . . will bear closer scrutiny in resolving a 12(b)(1) motion' than in resolving a 12(b)(6) motion for failure to state a claim.” Id. at 13-14 (quoting 5A Charles A. Wright & Arthur R. Miller, Fed. Practice & Procedure ยง 1350 (2d ed. 1987)) (alteration in original). Additionally, unlike with a motion to dismiss under Rule 12(b)(6), the Court ...

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