In Association of American Physicians & Surgeons v. United States Food and Drug Administration (“AAPS”), __ F.4th __, 2021 WL 4097325 (6th Cir. September 9, 2021), the Sixth Circuit Court of Appeal recently questioned the continued viability of the associative statute doctrine.
AAPS, which emerged during the COVID-19 pandemic, involved hydroxychloroquine, a controversial drug that some believe could be used to treat COVID-19. In 2020, the FDA issued an emergency clearance that granted access to the federal government’s national drug stock “only under limited circumstances.”
The applicant, an association of physicians, considered that “the authorization did not provide sufficiently wide access to the federal stock”. He sued the FDA, asking for “a declaratory and injunctive relief against the authorization restrictions.” Attempting to satisfy the standing requirement of Article III, the plaintiff “invoked the quality of association on behalf of its medical members”. Associative status “allows an entity to take legal action for injuries to its members even when … the entity itself does not allege any personal injury.”
To meet the criterion of association quality, an association must demonstrate “that: (1) its members would otherwise have standing to sue on their own initiative; (2) the interests the prosecution seeks to protect relate to the purpose of the organization; and (3) neither the claim asserted nor the remedy sought requires the participation of individual members in the legal action. “
In AAPS, the complainant claimed that its members “could not outlaw hydroxychloroquine for COVID-19 due to the restrictions.” The district court ruled that the plaintiff could not rely on this alleged “injury” to confer association status and dismissed the case under FRCP 12 (b) (1).
On appeal, the Sixth Circuit agreed that the plaintiff could not avail himself of the quality of association. The plaintiff, the tribunal explained, could not satisfy the first element of the doctrine – “that its members have Article III in their own right”. The court noted that the plaintiff had alleged no “direct harm” to its members because the FDA clearance “did not regulate doctors’ prescribing habits at all.” Likewise, the Applicant did not allege any “indirect harm” to its members as there was no “credible threat of prosecution” for violation of the Authorization. Accordingly, the Sixth Circuit upheld the dismissal of the plaintiff’s action.
In reaching its conclusion, the Sixth Circuit also questioned the continued viability of the doctrine of associative status in general. Noting that the Supreme Court developed the doctrine in the 1960s and 1970s, the Sixth Circuit asserted that association status was “obviously not reconcilable” with the “more recent directions” of the Supreme Court for three reasons.
First, he recognized that the “” irreducible constitutional minimum “of standing requires a plaintiff to allege particular prejudice”. Recent Supreme Court case law, explained the Sixth Circuit, suggests that the “non-party prejudice” inherent in associative status “is not enough”. The court said that before allowing “representative” types of litigation, the Supreme Court always “assured that historical practice supports it”. In the opinion of the Sixth Circuit, no historical support of this type exists for associative status.
The Sixth Circuit also compared association status to class actions, asking the following question: “[i]If class actions require named plaintiffs to identify their own harm, how can the quality of the association push this requirement overboard? “
Second, the Sixth Circuit found the doctrine at odds in the context of the standing remedy requirement. More precisely, the sixth circuit considered that the associative status “is in tension with  The remedies rules of Article III, because it creates an inherent mismatch between the claimant and the remedy. Because its members, rather than the association itself, have suffered prejudice, an “injunction that prohibits a defendant from enforcing a law or regulation against the” specific “party in court — the associative applicant“Will not satisfy Article III because it will not repair damage.” “
In addition, the Sixth Circuit suggested that the remedy sought in the status of association cases “raises other procedural issues”. After noting, for example, that FRCP 23 (b) (2) governs injunction rules in class actions, the Sixth Circuit asserted that it was not clear whether an association should “follow rule 23 before to obtain redress for its members ”.
Third and finally, the Sixth Circuit held that the opinion of the Supreme Court in Lexmark Int’l, Inc. v Static Control Components, Inc., 572 US 118 (2014) “may also require a reconsideration of the test of the association status of the Court”. In Lexmark, SCOTUS raised doubts about the notion of “prudential request” rules when examining the “area of interest” requirement, which he characterized as a “statutory issue” rather than a “standing issue” . Lexmark’s “skepticism with regard to the prudential position”, according to the Sixth Circuit, “suggests that the Court reconsider all the doctrines which result from it”, including the associative position.
Judge Eugene E. Siler Jr. agreed with the court’s opinion but refused to join the discussion regarding the viability of the association’s statute, deeming it “unnecessary to the resolution of the case”.
Now that the Sixth Circuit has expressed doubts about the viability of associative status, it will be interesting to see if other Circuits intervene on the issue. If others do, and the Sixth Circuit is correct in saying that recent case law has “undermined” the doctrine, the Supreme Court could face a constitutional challenge to the quality of association. A decision on the association’s status of the country’s highest court could have ramifications for other types of “representative” litigation, including class actions.