Case: 23-10362 Document: 543-1 Page: 42 Date Filed: 08/16/2023
the 2021 Petition Denial reevaluated FDA’s decision in 2000 to approve mifepristone. The reopening doctrine therefore does not permit the Medical Organizations and Doctors to challenge the 2000 Approval after the prescribed limitations period.
2. Equitable Tolling
The Medical Organizations and Doctors also point to equitable tolling as a justification for considering the 2000 Approval claim even though it is untimely. But that is a very narrow exception. See Jones v. Lumpkin, 22 F.4th 486, 490 (5th Cir. 2022) (reiterating that equitable tolling “is warranted in only ‘rare and exceptional circumstances’”) (quoting Davis v. Johnson, 158 F.3d 806, 811 (5th Cir. 1998)). It applies only if the plaintiff satisfies two conditions: “(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) (citation omitted).
Supposing that the Medical Organizations and Doctors could meet the first condition, they cannot meet the second. This court has stressed that equitable tolling does not apply if the party seeking its benefit could have complied with the relevant deadline. Jones, 22 F.4th at 490 (“[A] petitioner’s failure to satisfy the statute of limitations must result from external factors beyond his control; delays of the petitioner’s own making do not qualify.”) (quoting In re Wilson, 442 F.3d 872, 875 (5th Cir. 2006)). Here, the Medical Organizations and Doctors offer no reason why they could not have filed their lawsuit within the six-year limitations period. See All. for Hippocratic Med., 2023 WL 2913725, at *15 (explaining that FDA’s delay in ruling on the 2002 Citizen Petition “had no impact on the length of the statute-of-limitations period or plaintiffs’ capacity to challenge the 2016 Petition Denial”). Their failure to do so forecloses any possibility of relief.
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