Subject-matter jurisdiction; “Associational standing”; Hunt v Washington State Apple Adver Comm’n; Applicability of Bell Atl Corp v Twombly’s “plausibility” test; Third-party standing; Craig v Boren; Mootness

[This appeal was from the WD-MI.] The court affirmed the district court’s dismissal for lack of standing where plaintiff (an association of physicians) failed to plausibly plead that any of its members had been injured by defendant-FDA’s actions. Although the FDA had not approved hydroxychloroquine to treat COVID-19, it made it available from the government's strategic national stockpile under certain circumstances (the Authorization). Plaintiff believed that the Authorization was not broad enough and that it should be made available for prophylaxis and early treatment. It alleged violations of the First and Fifth Amendments and of the Administrative Procedures Act. It claimed that it had associational standing on behalf of its members where they could not prescribe hydroxychloroquine for COVID-19 patients due to the restrictions. Also, it invoked third-party standing, alleging that its members’ COVID-19 patients could not obtain the drug for treatment. As an initial matter, the court declined to declare the case moot even though the FDA has rescinded the Authorization after finding that “additional data suggested that hydroxychloroquine was ineffective at treating COVID-19.” The court then discussed separation-of-powers concerns and case-and-controversy requirements, and noted that having a “‘disagreement’ with the FDA is not an injury, no matter how ‘sharp and acrimonious’ it may be.” It concluded that it had to apply the associational standing test in Hunt, which requires that an organization’s members must “otherwise have standing to sue in their own right.” It must do more than allege a possible injury—“[t]he organization must instead identify a member who has suffered (or is about to suffer) a concrete and particularized injury from the defendant’s conduct[,]” and that the relief requested will redress the injury. Extending Twombly’s plausibility test to the standing issue, the court held that plaintiff failed to plead either a direct or indirect harm to its members. It further concluded that plaintiff “cannot rely on third-party standing in this case because it has forfeited any argument that it has suffered its own Article III injury[,]" and that its “complaint failed to allege that any of its physician members had Article III standing. Without their own injuries, these members likewise could not rely on third-party standing to invoke the rights of their patients.”