23-10362
requested stay will not harm the opposing appellees or other interested parties.
Applicants discuss at length their view that the district court’s order might harm various persons, but mostly decline to address the apposite question, which is why the requested stay would not harm relevant persons. What points the applicants do make on this relevant question distill down to two arguments.
First, applicants briefly argue that the injuries the plaintiffs would suffer from a stay are speculative or minimal. But we have already addressed why plaintiffs’ injuries are non-speculative. See supra Part III.A. We have also addressed the specific risks impacting women and the plaintiffs that stem from the 2016 Major REMS Changes and other post-2016 FDA decisions that the district court enjoined. See supra Part III.A, D. The applicants’ abbreviated argument focuses on consequences flowing from the district court’s treatment of the 2000 Approval and largely ignores plaintiffs’ alternative arguments regarding the 2016 Major REMS Changes and what followed.
Second, the applicants argue that the plaintiffs’ failure to bring litigation sooner undercuts any contention that they would be harmed from a stay. That contention is untenable given FDA’s fourteen-year delay in adjudicating the 2002 Citizen Petition. But, even setting aside FDA’s own delays, the applicants do not explain why the plaintiffs’ alleged procrastination warrants a stay of the entirety of the district court’s order, rather than just the portion of the order impacted by long litigation delay (the 2000 Approval).
To the extent applicants make any showing that the third Nken factor favors a stay, they do so only with respect to the 2000 Approval and do not address plaintiffs’ alternative arguments.
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