23-10362
Even so, we ultimately hold at this early and emergency stage that these alterations didn’t constructively reopen the 2000 Approval for review. That’s because there’s at least a colorable argument that plaintiffs “could have … reasonably anticipated” changes like those in 2016 and 2021 by dint of the statutorily defined supplemental application process and other similar revision mechanisms. NRDC v. EPA, 571 F.3d at 1266 (quotation omitted); see, e.g., 21 C.F.R. § 314.71(b). We also recognize that it’s somewhat of a strain to say that the 2016 Major REMS Changes and 2021 Petition Denial (and related changes) altered the regulatory landscape to such a degree that the prior rule is only now “worth challenging” when it otherwise might “not have been.” Sierra Club, 551 F.3d at 1025–26 (quotation omitted). After all, plaintiffs did challenge the 2000 Approval well before the 2016 and 2021 changes were even proposed. But again, plaintiffs could very well prevail on this reopening claim.
In the alternative, the district court held that plaintiffs were entitled to equitable tolling of the statute of limitations. FDA Add. 23–25. We are unpersuaded. “[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) (quoting Holland v. Florida, 560 U.S. 631, 649 (2010)). Here, no “extraordinary circumstance” prevented plaintiffs from filing within six years of FDA’s 2016 Petition Denial. The district court is of course correct that FDA took “13 years, 7 months, and 9 days” to render that March 2016 ruling, FDA Add. 24, but that delay had no impact on the length of the statute-of-limitations period or plaintiffs’ capacity to challenge the 2016 Petition Denial.
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