Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 23 of 67 PageID 4445
strategy notwithstanding. FDA has the authority to withdraw an approved drug application on this basis. See 21 U.S.C. § 355(e). Because the agency reaffirmed its prior actions after undertaking a substantive reconsideration of those actions, the limitations period for those actions starts in 2021. See Pub. Citizen, 901 F.2d at 152 (an agency reconsidering and reaffirming original policy “necessarily raises the lawfulness of the original policy, for agencies have an everpresent duty to insure that their actions are lawful”).[1]
Alternatively, the Court finds Plaintiffs’ claims are not time-barred under the equitable tolling doctrine. See United States v. Patterson, 211 F.3d 927, 931 (5th Cir. 2000) (courts “must be cautious not to apply the statute of limitations too harshly”); P & V Enters. v. U.S. Army Corps of Engr’s, 466 F. Supp. 2d 134, 149 (D.D.C. 2006), aff’d, 516 F.3d 1021 (D.C. Cir. 2008) (a “rebuttable presumption of equitable tolling” applies to lawsuits governed by the six-year limitations period of Section 2401(a)); Bornholdt v. Brady, 869 F.2d 57, 64 (2d Cir. 1989) (“The existence of § 2401 as a catchall provision … does not necessarily mean that Congress intended the six-year period to be applied whenever a substantive statute does not specify a limitations period.”). “[A] litigant is entitled to equitable tolling of a statute of limitations only if the litigant establishes two elements: (1) that he has been pursuing his rights diligently, and (2) that some extraordinary circumstance stood in his way and prevented timely filing.” Menominee Indian Tribe of Wis. v. United States, 577 U.S. 250, 255 (2016) (internal marks omitted); see also Holland v. Florida, 560 U.S. 631, 650 (2010) (“The flexibility inherent in equitable procedure enables courts
- ↑ To date, it is unclear whether the reopening doctrine has been applied in the precise context of FDA’s approval of an NDA. However, much of the rationale courts have applied in both the rulemaking and adjudication context applies here. And the Court is unaware of any legal principle that would preclude the doctrine from being applied to these facts. Assuming arguendo Plaintiffs’ allegations are true, a contrary holding would mean there is no judicial remedy to FDA’s insistence on keeping an unsafe drug on the market, so long as enough time has passed.
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