In Association of American Physicians & Surgeons v. United States Food and Drug Administration (“AAPS”), __ F.4th __, 2021 WL 4097325 (6th Cir. Sept. 9, 2021), the Sixth Circuit Court of Appeals recently cast doubt on the continued viability of the associational standing doctrine.

AAPS, which arose during the COVID-19 pandemic, involved hydroxychloroquine, a controversial drug that some believe may be used to treat COVID-19.  In 2020, the FDA issued an emergency Authorization that granted access to the federal government’s national stockpile of the drug “only in limited circumstances.”

The plaintiff, an association of physicians, believed the “Authorization did not offer broad enough access to the federal stockpile.”  It sued the FDA, seeking “declaratory and injunctive relief against the Authorization’s restrictions.”  Attempting to satisfy Article III’s standing requirement, the plaintiff “invoked associational standing on behalf of its physician members.”  Associational standing “permits an entity to sue over injuries by its members even when…the entity itself alleges no personal injury.”

To satisfy the test for associational standing, an association must show “that: (1) its members would otherwise have standing to sue in their own right; (2) the interests that the suit seeks to protect are germane to the organization’s purpose; and (3) neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit.”

In AAPS, the plaintiff claimed that its members “could not prescribe hydroxychloroquine for COVID-19 because of the restrictions.”  The district court held that the plaintiff could not rely on this alleged “injury” to confer associational standing and dismissed the case under FRCP 12(b)(1).

On appeal, the Sixth Circuit agreed that the plaintiff could not rely on associational standing.  The plaintiff, the court reasoned, could not satisfy the doctrine’s first element—“that its members have Article III standing in their own right.”  The court noted the plaintiff did not allege any “direct harm” to its members because the FDA Authorization “did not regulate doctor prescribing habits at all.”  Similarly, the plaintiff did not allege any “indirect harm” to its members because there was no “credible threat of prosecution” for violation of the Authorization.  Accordingly, the Sixth Circuit affirmed dismissal of the plaintiff’s suit.

In reaching its holding, the Sixth Circuit also cast doubt on the continued viability of the associational standing doctrine generally.  Noting the Supreme Court developed the doctrine in the 1960s and 70s, the Sixth Circuit claimed associational standing is “not obviously reconcilable” with the Supreme Court’s “more recent guidance” for three reasons.

First, it recognized that the “‘irreducible constitutional minimum’ of standing requires a plaintiff to allege a particularized injury.”  Recent Supreme Court case law, the Sixth Circuit reasoned, suggests that the “nonparty injury” inherent in associational standing “does not suffice.”  The court claimed that, before authorizing types of “representative” litigation, the Supreme Court has always “ensured that historical practice supported it.”  In the view of the Sixth Circuit, no such historical support exists for associational standing.

The Sixth Circuit also compared associational standing to class actions, posing the following question: “[i]f class actions require the named plaintiffs to identify their own injury, how can associational standing throw this requirement overboard?”

Second, the Sixth Circuit found issue with the doctrine in the context of standing’s redressability requirement.  Specifically, the Sixth Circuit opined that associational standing “is in tension with [] Article III redressability rules because it creates an inherent mismatch between the plaintiff and the remedy.”  Because its members, rather than the association itself, have suffered an injury, an “injunction that bars a defendant from enforcing a law or regulation against the ‘specific’ party before the court—the associational plaintiff—will not satisfy Article III because it will not redress an injury.”

Additionally, the Sixth Circuit suggested that the relief sought in associational standing cases “raises other procedural questions.”  After noting, for example, that FRCP 23(b)(2) governs the rules for injunctions in class actions, the Sixth Circuit claimed it was unclear whether an association must “follow Rule 23 before obtaining relief for its members.”

Third and finally, the Sixth Circuit reasoned that the Supreme Court’s opinion in Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U.S. 118 (2014) “might also necessitate reexamination of the Court’s associational-standing test.”  In Lexmark, SCOTUS raised doubts about the notion of “prudential standing” rules when it examined the “zone of interests” requirement, which it characterized as “a statutory question” rather than “a standing question.”  Lexmark’s “skepticism of prudential standing,” the Sixth Circuit claimed, “suggests that the Court should reexamine all of the doctrines that have grown out of it,” including associational standing.

Judge Eugene E. Siler Jr. concurred with the court’s opinion but declined to join the discussion regarding the viability of associational standing, finding it “unnecessary to the resolution of the case.”

Now that the Sixth Circuit has expressed doubts about the viability of associational standing, it will be interesting to see whether other Circuits weigh in on the issue.  If others do and the Sixth Circuit is correct that recent caselaw has “undercut” the doctrine, the Supreme Court could be confronted with a constitutional challenge to associational standing.  A decision on associational standing from the nation’s highest court could have ramifications for other types of “representative” litigation, including class actions.