Ass'n of Am. Physicians & Surgeons v. FDA

RECOMMENDED FOR PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)
File Name: 21a0212p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
┐
ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS,
│
Plaintiff-Appellant, │
│
v. │
> No. 20-1784
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UNITED STATES FOOD AND DRUG ADMINISTRATION; │
JANET WOODCOCK, M.D., Acting Commissioner of │
Food & Drugs, in her official capacity; BIOMEDICAL │
ADVANCED RESEARCH & DEVELOPMENT AUTHORITY; │
GARY L. DISBROW, PH.D., Director, Biomedical │
Advanced Research & Development Authority, in his │
official capacity; U.S. DEPARTMENT OF HEALTH AND │
HUMAN SERVICES; XAVIER BECERRA, Secretary of │
Health & Human Services, in his official capacity, │
Defendants-Appellees. │
┘
Appeal from the United States District Court
for the Western District of Michigan at Grand Rapids.
No. 1:20-cv-00493—Robert J. Jonker, District Judge.
Decided and Filed: September 9, 2021
Before: SILER, THAPAR, and MURPHY, Circuit Judges.
_________________
COUNSEL
ON BRIEF: Andrew L. Schlafly, Far Hills, New Jersey, for Appellant. Scott R. McIntosh,
Lewis S. Yelin, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for
Appellees.
MURPHY, J., delivered the opinion of the court in which SILER and THAPAR, JJ.,
joined. SILER, J. (pg. 22), delivered a separate opinion concurring in all but Part III.A.1 of the
majority opinion.
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 2
_________________
OPINION
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MURPHY, Circuit Judge. In Flast v. Cohen, 392 U.S. 83 (1968), the Supreme Court
suggested that plaintiffs broadly have “standing” to sue over actions taken by the political
branches whenever the litigants are sufficiently “adverse.” See id. at 100–01. The standing at
issue in this case—associational standing—grew out of the same “judicial thinking” as Flast.
Nat’l Automatic Laundry & Cleaning Council v. Shultz, 443 F.2d 689, 693 (D.C. Cir. 1971). It
permits an association that has suffered no injury to sue on behalf of members who have. Yet
the Court has since criticized Flast for overlooking that standing (and, in particular, its
requirement that a plaintiff identify a personal injury) represents a key part of the Constitution’s
separation of powers. Lewis v. Casey, 518 U.S. 343, 353 n.3 (1996). It is not clear how
associational standing comports with this more recent guidance. At the least, the guidance
should lead us to vigilantly ensure that an association’s members have incurred a personal injury.
And here, the plaintiff (an association of physicians) failed to plausibly plead that any member
has been injured by the actions of the Food and Drug Administration (FDA) that it criticizes.
We thus affirm the dismissal of its complaint.
I
Under the Federal Food, Drug, and Cosmetic Act, a drug manufacturer cannot distribute a
drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the
drug’s official label. See 21 U.S.C. § 355(a). To obtain FDA approval, a manufacturer generally
must conduct clinical trials establishing that the drug is safe and effective for those
intended uses. See id. § 355(d). In emergency situations, however, the FDA may allow the
distribution of an unapproved drug or of an approved drug for an unapproved use. See id.
§ 360bbb-3(a)(1)–(2).
Although the Act regulates a manufacturer’s distribution of drugs, it does not go further
by regulating a doctor’s practice of medicine. See Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 350–51 (2001). The Act thus does not prohibit doctors from prescribing an
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 3
FDA-approved drug (say, a chemotherapy drug approved to treat leukemia) for an “off-label”
use (say, treatment of other cancers). See United States v. Caronia, 703 F.3d 149, 153 (2d Cir.
2012). It instead leaves the regulation of doctors to the states. Cf. Dent v. West Virginia, 129
U.S. 114, 121–24 (1889).
This case involves “hydroxychloroquine.” The FDA approved this drug for distribution
in 1955. It has now approved the drug to treat malaria, lupus, and arthritis. A CDC fact sheet
describes the drug as “relatively well tolerated” and lists its most common side effects as
“stomach pain, nausea, vomiting, and headache.” Fact Sheet, R.8-14, PageID 286. Still, a
patient may not use hydroxychloroquine unless a doctor prescribes it.
The FDA has not approved hydroxychloroquine to treat COVID-19. Early in the
pandemic, the FDA relied on the then-available data to conclude that the drug might help treat
the disease. In March 2020, the agency issued an Emergency Use Authorization
(“Authorization”) under § 360bbb-3(a). The Authorization permitted the hydroxychloroquine in
the federal government’s strategic national stockpile to be distributed for treatment of COVID-19
patients. Yet it granted access to this large stockpile only in limited circumstances. The
Authorization stated that the drug “may only be used to treat adult and adolescent patients who
weigh 50 kg or more hospitalized with COVID-19 for whom a clinical trial is not available, or
participation is not feasible.” Auth., R.8-8, PageID 262.
The Association of American Physicians & Surgeons, a nonprofit organization with
physician members, believed that the Authorization did not offer broad enough access to the
federal stockpile. It sued the FDA and its Commissioner, the Biomedical Advanced Research
and Development Authority and its Director, and the Department of Health and Human Services
and its Secretary. (For simplicity, we will refer to all defendants as the FDA.) The Association
alleged that hydroxychloroquine can help patients if taken as a prophylaxis before they get
COVID-19 or as an initial treatment after such a diagnosis. It thus sought declaratory and
injunctive relief against the Authorization’s restrictions barring use of hydroxychloroquine to
treat COVID-19 except for hospitalized patients.
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 4
The Association pleaded three claims. It alleged that these restrictions violated the
implied equal-protection guarantee in the Fifth Amendment’s Due Process Clause. Compl., R.1,
PageID 17, 20–22. It alleged that the restrictions violated the First Amendment right to associate
by limiting access to medication useful for meeting in groups during a pandemic. Id., PageID
22–23. And it alleged that the restrictions violated the Administrative Procedure Act. Id.,
PageID 22.
The Association also pleaded three injuries. It alleged an injury to itself: The Association
was considering canceling a conference purportedly due to the Authorization’s restrictions. Id.,
PageID 23. It next invoked associational standing on behalf of its physician members: It claimed
that the members could not prescribe hydroxychloroquine for COVID-19 because of the
restrictions. Id., PageID 19. The Association lastly invoked third-party standing: It alleged that
its members’ patients could not obtain the drug for the treatment of COVID-19. Id.
The district court held that none of these injuries plausibly pleaded the Association’s
standing to challenge the Authorization. The court dismissed the complaint for lack of subject-
matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1). See Ass’n of Am. Physicians
& Surgeons v. FDA, 479 F. Supp. 3d 570, 579–85 (W.D. Mich. 2020). We review this decision
de novo. See CHKRS, LLC v. City of Dublin, 984 F.3d 483, 488 (6th Cir. 2021).
Before doing so, we flag a mootness issue. The Authorization had a short shelf life.
Within months, the FDA had rescinded it because additional data suggested that
hydroxychloroquine was ineffective at treating COVID-19. 85 Fed. Reg. 56,231, 56,232 (Sept.
11, 2020). Must we ensure that these new facts do not moot the Association’s suit before
addressing its standing? No, the Supreme Court has told us that we have discretion to choose
between non-merits grounds for dismissing a suit. See Sinochem Int’l Co. v. Malaysia Int’l
Shipping Corp., 549 U.S. 422, 431 (2007). We thus exercise our discretion to begin with
standing, which, as it turns out, moots any mootness issue. See In re 2016 Primary Election,
836 F.3d 584, 587 (6th Cir. 2016).
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 5
II
The Association spends much of this appeal attacking the FDA’s actions on their policy
and legal merits. It says that it should have standing because the FDA has engaged in “anti-life
conduct” that has contributed to the “deaths of many thousands of innocent Americans.”
Appellant’s Br. 28–29. It adds that it should have standing because the FDA has committed
“wrongdoing” by making “false and misleading” claims about hydroxychloroquine. Id. at 33,
41. These merits arguments misunderstand standing’s basic function, so we start with first
principles.
The Constitution separates the general powers of government: Article I vests “legislative
Powers” in the Congress; Article II vests the “executive Power” in the President; and Article III
vests the “judicial Power” in the Supreme Court and inferior courts. By doing so, the
Constitution at once both protects and restrains the judiciary. It protects the courts from efforts
by the political branches to interfere with their duty to resolve disputes between litigants. The
legislative branch, for example, cannot reverse a court’s final judgment. Plaut v. Spendthrift
Farm, Inc., 514 U.S. 211, 225–26 (1995). And the executive branch cannot render a final
judgment in a case of the type traditionally resolved by courts. Stern v. Marshall, 564 U.S. 462,
484 (2011).
Yet this separation of powers also protects the political branches from the courts. Courts
have a specific power: to decide “Cases” or “Controversies” between litigants. U.S. Const. art.
III, § 2. They do not have a standalone power to evaluate the constitutionality of every law
passed by Congress or every initiative implemented by the President. See Ariz. Christian Sch.
Tuition Org. v. Winn, 563 U.S. 125, 146 (2011). A court may engage in such judicial review and
issue a remedy regulating the political branches only “when necessary in the execution of” its
duty to decide a case. Summers v. Earth Island Inst., 555 U.S. 488, 492 (2009). It may not issue
an advisory interpretation of the Constitution or an advisory injunction regulating those branches
whenever a concerned citizen thinks they have acted unlawfully. See Valley Forge Christian
Coll. v. Ams. United for Separation of Church & State, Inc., 454 U.S. 464, 473 (1982).
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 6
But this limit on the courts would be meaningless if the words “Case” and “Controversy”
covered any challenge to government action dressed up in a complaint with an official-looking
caption. That is where “standing” comes in. See TransUnion LLC v. Ramirez, 141 S. Ct. 2190,
2203 (2021). It ensures that the disputes resolved by courts today are the same kinds of disputes
“traditionally amenable to, and resolved by, the judicial process.” Steel Co. v. Citizens for a
Better Env’t, 523 U.S. 83, 102 (1998). At its core, the judiciary has existed as the venue in
which a party may seek relief for an injury caused by another party’s invasion of its rights. See
Warth v. Seldin, 422 U.S. 490, 499 (1975). That insight leads to standing’s three elements. To
establish a “case,” a plaintiff must show that the plaintiff has suffered an injury, that the
defendant’s conduct likely caused the injury, and that the relief sought will likely redress the
injury. TransUnion, 141 S. Ct. at 2203.
These separation-of-powers principles should make it obvious that the Association does
nothing to establish an Article III “case” merely by criticizing the wisdom or legality of the
FDA’s actions. The Association’s belief that the FDA has engaged in wrongdoing does not
prove its standing because its “disagreement” with the FDA is not an injury, no matter how
“sharp and acrimonious” it may be. Hollingsworth v. Perry, 570 U.S. 693, 704 (2013) (citation
omitted). And its belief that the FDA’s policies have harmed thousands does not prove its
standing unless it adequately shows that it is “among the injured.” Sierra Club v. Morton,
405 U.S. 727, 735 (1972).
III
Given these standing ground rules, it is notable that the Association has abandoned the
only personal injury it alleged: It claimed that the restrictions on hydroxychloroquine in the
FDA’s Authorization might force it to cancel a conference. The district court rejected this
argument because the Association failed to plausibly plead that the Authorization—as opposed to
state limits on large gatherings—would cause the injury. Because the Association does not
challenge this conclusion on appeal, we need not consider whether it alleged an injury to itself.
The Association instead argues that it may sue over injuries incurred by others not before the
court. It claims that it may pursue this suit based on “associational standing” on behalf of its
physician members or “third-party standing” on behalf of its members’ patients.
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 7
A. Associational Standing
The Association first seeks to invoke “associational standing” to sue for injuries incurred
by its physician members. This doctrine sometimes permits an entity to sue over injuries
suffered by its members even when (as here) the entity itself alleges no personal injury. See,
e.g., Summers, 555 U.S. at 494; United Food & Com. Workers Union Loc. 751 v. Brown Grp.,
Inc., 517 U.S. 544, 552–58 (1996); Int’l Union, United Auto., Aerospace & Agric. Implement
Workers of Am. v. Brock, 477 U.S. 274, 281–82 (1986); Hunt v. Wash. State Apple Advert.
Comm’n, 432 U.S. 333, 342–43 (1977). The Court in Hunt adopted the current test for this type
of proxy suit. 432 U.S. at 343. An organization may sue on behalf of its members if it shows
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.” Id.
1Before applying this test to the Association’s claims, it is worth taking a fresh look at
where the test came from. The Supreme Court developed it in the 1960s and 70s. At that time,
its cases left unclear which standing elements were “prudential” limits rooted in judicial
discretion and which were “constitutional” limits rooted in Article III. See Valley Forge,
454 U.S. at 471–76. The Court has since clarified things. But it has yet to reconcile its
associational-standing test with its more recent guidance. For three reasons, moreover, the two
are not obviously reconcilable.
Reason One: The “irreducible constitutional minimum” of standing requires a plaintiff to
allege a particularized injury. Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992). How, then,
can the Association sue in this case if it has not suffered an injury? The Court previously said
that the first associational-standing factor (that an entity’s members have suffered an injury that
would give them standing if they sued) satisfies this element. Brown Grp., 517 U.S. at 555–56.
Yet the Court’s recent cases suggest that this nonparty injury alone does not suffice.
These cases hold that historical practice should guide courts when deciding whether an injury
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 8
satisfies Article III’s requirements. See TransUnion, 141 S. Ct. at 2204. So before authorizing
other types of “representative” litigation (in which one party sues over another’s injury), the
Court has ensured that historical practice supported it. Cf. Hollingsworth, 570 U.S. at 707–14.
The Court, for example, held that a private “relator” may bring a “qui tam” suit on behalf of the
government based on pages of history showing that courts had long permitted that litigation.
Vt. Agency of Nat. Res. v. U.S. ex rel. Stevens, 529 U.S. 765, 773–78 (2000). It likewise
held that an assignee of a claim may sue over the claim even if the assignor receives the
proceeds—again based on the history surrounding those assignments. Sprint Commc’ns Co. v.
APCC Servs., Inc., 554 U.S. 269, 274–85 (2008). And it held that a party may sometimes sue as
the “next friend” of a person subject to a legal disability based again on that practice’s pedigree.
Whitmore v. Arkansas, 495 U.S. 149, 162–66 (1990).
Did the Court follow this approach when allowing associations to sue for their members?
Far from it. Its trail of case citations suggests that this standing arose more from historical
accident than practice. When adopting the associational-standing test in Hunt, the Court cited
Warth, not any common-law analog. 432 U.S. at 342–43. But Warth, too, included no
justification rooted in tradition. It instead cited National Motor Freight Traffic Association v.
United States, 372 U.S. 246 (1963) (per curiam). Warth, 422 U.S. at 511. There, a lower court
had held that motor-carrier associations could not challenge an agency order harming their
members because they lacked standalone injuries. Nat’l Motor Freight Traffic Ass’n v. United
States, 205 F. Supp. 592, 593–94 (D.D.C. 1962) (Burger, J.). The Supreme Court disagreed in a
one-paragraph opinion, finding that the associations were “proper representatives” of their
members. 372 U.S. at 247. For a third time, the Court identified no historical support. It merely
cited NAACP v. Alabama ex rel. Patterson, 357 U.S. 449 (1958), and FCC v. Sanders Brothers
Radio Station, 309 U.S. 470 (1940).
But these two cases did not address when an entity that has sustained no injury may sue
on behalf of those who have. In Patterson, the NAACP was sued in state court by state officials
who sought its membership list. 357 U.S. at 452–54. The Court held that the NAACP
could invoke the constitutional rights of its members in defense against producing this list. Id. at
458–60. These facts show that Patterson concerned third-party standing, not associational
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 9
standing. Third-party standing sometimes allows one party to rely on the rights of others. See
Powers v. Ohio, 499 U.S. 400, 410–11 (1991). Critically, though, this standing (unlike
associational standing) requires the plaintiff to suffer its own injury. See Hollingsworth,
570 U.S. at 707–09. Patterson even recognized that the NAACP would likely incur a standalone
injury (“diminished financial support and membership”) if it were forced to disclose its list of
members. 357 U.S. at 459–60.
Sanders Brothers is equally irrelevant. A radio station challenged the FCC’s grant of a
license to a competitor because the competition would cause the station economic loss. 309 U.S.
at 471–72. The Court held that this financial harm made the station an aggrieved party under a
statute. Id. at 476–77; see Sierra Club, 405 U.S. at 737. Thus, neither Patterson nor Sanders
Brothers jettisoned the usual rule that the plaintiff before the court must have suffered an injury.
Perhaps an unidentified common-law practice could nevertheless justify the cursory
conclusion from National Motor Freight Traffic Association that an association may assert its
members’ injuries? The law of equity’s “bill of peace” (the precursor to the modern class action)
might help fill in the logical void. See Samuel L. Bray, Multiple Chancellors: Reforming the
National Injunction, 131 Harv. L. Rev. 417, 426–27 (2017); 7A Charles Alan Wright et al.,
Federal Practice & Procedure § 1751 (3d ed. 2005); Joseph Story, Commentaries on Equity
Pleadings §§ 107–19 (1838). Yet that analogy would raise distinct questions. The Constitution,
for example, permits class members to represent a class only if they suffer their own injury.
Frank v. Gaos, 139 S. Ct. 1041, 1046 (2019) (per curiam). If class actions require the named
plaintiffs to identify their own injury, how can associational standing throw this requirement
overboard?
More fundamentally, federal courts have yet to justify associational standing with this (or
any other) historical practice—as the Supreme Court’s recent cases suggest they must. Instead,
the Court’s foundation for allowing an uninjured association to sue is a paragraph-long opinion
citing cases on different subjects. Similarly, early lower-court cases do not rely on any historical
analogy when permitting associational standing. They instead describe associational standing as
part of the then-ongoing “revision of judicial thinking on the standing question” that had
“deprived [standing] of meaningful vitality.” Nat’l Automatic Laundry & Cleaning Council v.
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 10
Shultz, 443 F.2d 689, 693 (D.C. Cir. 1971). The Supreme Court has since overturned this
judicial thinking—epitomized by cases like Flast v. Cohen, 392 U.S. 83 (1968)—and
reinvigorated standing as a core part of the separation of powers. Lewis v. Casey, 518 U.S. 343,
353 n.3 (1996). Associational standing thus may be nothing more than an outdated relic from
Flast’s short-lived age.
Reason Two: The “irreducible constitutional minimum” of standing also requires a
plaintiff’s requested relief to redress the plaintiff’s injury. Lujan, 504 U.S. at 560–61. How can
any relief in this case satisfy this element if the Association has not been injured by the FDA’s
Authorization and if its allegedly injured members are not parties? The Supreme Court has said
that this redressability element will not impede an organization’s standing if the organization
requests injunctive relief against the law or agency order that it challenges (as the Association
has done in this case). Warth, 422 U.S. at 515. The Court reasoned that one can “suppose[]”
that such an injunction “will inure to the benefit of those members of the association actually
injured.” Id. It thus simply assumed that injunctions will regularly prevent the defendant from
enforcing a law or agency order not just against the associational plaintiff but also against
nonparties.
This broad view of the remedies permitted by Article III also clashes with the Court’s
more recent guidance. The Court has held that a valid Article III remedy must “operate with
respect to specific parties,” not with respect to a law or regulation “in the abstract.” California v.
Texas, 141 S. Ct. 2104, 2115 (2021) (quoting Murphy v. Nat’l Collegiate Athletic Ass’n, 138
S. Ct. 1461, 1486 (2018) (Thomas, J., concurring)). This party-focused rule means that a
“remedy must be ‘limited to the inadequacy that produced [a plaintiff’s] injury in fact.’” Gill v.
Whitford, 138 S. Ct. 1916, 1930 (2018) (quoting Lewis, 518 U.S. at 357). The plaintiff must
show that each requested remedy will redress some portion of the plaintiff’s injury. See
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 352–53 (2006). Conversely, the plaintiff cannot
seek a remedy that has no ameliorative effects on that injury. See California, 141 S. Ct. at 2116.
While, for example, a completed injury may give a plaintiff the right to seek damages, it does not
alone give the plaintiff the right to seek an injunction. See City of Los Angeles v. Lyons, 461
U.S. 95, 109 (1983). Likewise, a plaintiff cannot “combin[e] a request for injunctive relief for
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 11
which he has standing with a request for injunctive relief for which he lacks standing.” Salazar
v. Buono, 559 U.S. 700, 731 (2010) (Scalia, J., concurring in the judgment); see Lewis, 518 U.S.
at 357.
Associational standing is in tension with these Article III redressability rules because it
creates an inherent mismatch between the plaintiff and the remedy. 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. See
California, 141 S. Ct. at 2115. The association, by definition, has not suffered the injury. Its
members have. To satisfy Article III’s redressability requirement, then, the injunctive relief in
an associational-standing case must benefit (and ameliorate an injury to) the association’s
members. That fact generates an alternative problem. Article III requires the remedy to be
“limited” to the plaintiff’s injury. Lewis, 518 U.S. at 357. Yet, unlike with a certified class
action in which the unnamed class members “are considered parties to the litigation in many
important respects,” United States v. Sanchez-Gomez, 138 S. Ct. 1532, 1538 (2018), the Supreme
Court has not characterized an association’s members as “parties” to the suit. So relief to these
nonparties might also exceed constitutional bounds. Cf. Doran v. Salem Inn, Inc., 422 U.S. 922,
931 (1975).
Even if the association may constitutionally seek remedies for its nonparty members, that
relief raises other procedural questions. Consider the injunction’s proper scope. See Michael T.
Morley, Disaggregating Nationwide Injunctions, 71 Ala. L. Rev. 1, 25–27 (2019). Should an
injunction cover only the members that an organization identified as having standing? Or should
it cover all members? If the latter, should it apply only to existing members on the date of the
judgment? Or should it cover future members—seemingly allowing an organization to advertise
the injunction in its marketing materials? Next consider the litigation’s proper procedure.
Federal Rule of Civil Procedure 23(b)(2) sets forth the ground rules for a party who seeks an
injunction for a class. See Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 360–63 (2011). Must
an association follow Rule 23 before obtaining relief for its members or did the Court create an
implied exception to the rule? Cf. Morley, supra, at 27. Lastly consider the judgment’s proper
scope. If members may rely on the injunction if an organization wins, should they be bound by
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 12
the judgment if it loses? Would that satisfy due process? See Taylor v. Sturgell, 553 U.S. 880,
892–95 (2008).
The Court’s associational-standing cases have not squarely confronted these questions.
Cf. Brown Grp., 517 U.S. at 556 n.6. The timing of associational standing might explain why.
The doctrine’s emergence in the 1960s overlaps with the emergence of another remedial
phenomenon that the Court has yet to squarely confront—the “universal” or “nationwide”
injunction. See Bray, supra, at 437–45. That type of defendant-focused injunction
“transcends” the case by barring a defendant from enforcing a challenged law or regulation
against anyone—not just the plaintiff. See Dep’t of Homeland Sec. v. New York, 140 S. Ct. 599,
600 (2020) (Gorsuch, J., concurring in the grant of stay).
Associational standing appears more workable in a world with universal injunctions.
Some courts have used this standing as a “backdoor” way to grant a universal injunction and
avoid the difficult task of crafting member-limited relief. Morley, supra, at 25. Take Hunt,
which involved a North Carolina law that barred apple sellers from listing state-specific grades
on their apple containers. 432 U.S. at 337. The Washington State Apple Advertising
Commission challenged this law on behalf of in-state growers. See id. at 335–39. After finding
the law unconstitutional, a district court did not grant an injunction to the Commission or identify
the nonparties entitled to one. Wash. State Apple Advert. Comm’n v. Holshouser, 408 F. Supp.
857, 858, 861–62 (E.D.N.C. 1976). Rather, it seemed to broadly “enjoin” the law’s
“enforcement as applied to state grade markings on closed containers.” Id. at 858. But Justices
(and commentators) have started to question the constitutionality of these types of broad
defendant-focused injunctions. See New York, 140 S. Ct. at 600–01 (Gorsuch, J., concurring in
the grant of stay); Trump v. Hawaii, 138 S. Ct. 2392, 2425–29 (2018) (Thomas, J., concurring);
see also Bray, supra, at 469–72; Morley, supra, at 28–29, 31. If the Court decides to rein them
in, it may need to reassess associational standing along with them.
Reason Three: The Supreme Court at one time regularly followed “prudential standing”
rules that arose from what it viewed as the judiciary’s discretionary case-management power
rather than from any mandatory constitutional command. See Elk Grove Unified Sch. Dist. v.
Newdow, 542 U.S. 1, 11–12 (2004). The Court recently called this line of precedent into doubt
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 13
on the ground that prudential standing sits uncomfortably next to the courts’ “virtually
unflagging” duty to decide cases within their jurisdiction. Lexmark Int’l, Inc. v. Static Control
Components, Inc., 572 U.S. 118, 126 (2014) (citation omitted). Lexmark recharacterized one of
these prudential doctrines—that a plaintiff must fall within the “zone of interests” of a statute to
sue under it—as being about something else. See id. at 126–28. Rather than raise a standing
question implicating the court’s discretion to refuse to consider a claim, this doctrine raises a
statutory question about whether a court should interpret the statute’s cause of action to cover the
plaintiff. See id.Lexmark might also necessitate reexamination of the Court’s associational-standing test.
The Court’s second associational-standing requirement asks whether the interests that an
association’s suit seeks to vindicate are “germane” to its purpose. Hunt, 432 U.S. at 343.
Although the Court has said (in potential dicta) that this element is rooted in Article III, it has
described the element as ensuring that an association has enough “adversarial vigor” to litigate
the legal issues well. Brown Grp., 517 U.S. at 555–56. And the Court has elsewhere described
concerns about whether a party will provide a proper “adversarial presentation” as prudential
(not constitutional). United States v. Windsor, 570 U.S. 744, 759–60 (2013); see Sec’y of State
of Md. v. Joseph H. Munson Co., 467 U.S. 947, 956 (1984). The Court has similarly described
the third associational-standing requirement—that neither the claim nor the relief necessitates a
member’s participation—as prudential only. See Brown Grp., 517 U.S. at 556–57.
If Article III otherwise permits associations to seek redress for their members’ injuries,
what legal source gives a court the power to decline jurisdiction on the ground that an association
lacks sufficient “vigor”? Cf. Island Creek Coal Co. v. Bryan, 937 F.3d 738, 747–49 (6th Cir.
2019). And why should the “administrative convenience” that arises from having the
association’s members participate in a suit trump an association’s right to bring it if their
participation is not necessary to make out a case or controversy? Brown Grp., 517 U.S. at 557.
Lexmark’s skepticism of prudential standing suggests that the Court should reexamine all of the
doctrines that have grown out of it—which would include part of the associational-standing test.
Cf. June Med. Servs. L.L.C. v. Russo, 140 S. Ct. 2103, 2144 (2020) (Thomas, J., dissenting).
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 14
* * *
In sum, it is hard to see how the Supreme Court’s more recent caselaw on standing has
not undercut its associational-standing test. In these circumstances, though, the Court has told
lower courts that they must stick to its directly on-point precedent even if the logic from other
cases has called that precedent into doubt. See State Oil Co. v. Khan, 522 U.S. 3, 20 (1997);
Agostini v. Felton, 521 U.S. 203, 237 (1997). We thus must apply that associational-standing
test here.
2
Still, the Court’s more recent guidance on the “irreducible constitutional minimum” of
standing clarifies what an organization must plead to establish the first element of
associational standing—that its members have Article III standing in their own right. Lujan,
504 U.S. at 560–61; see Shelby Advocs. for Valid Elections v. Hargett, 947 F.3d 977, 982 (6th
Cir. 2020) (per curiam). To satisfy this element, an organization must do more than identify a
likelihood that the defendant’s conduct will harm an unknown member in light of the
organization’s extensive size or membership base. See Summers, 555 U.S. at 498–99. The
organization must instead identify a member who has suffered (or is about to suffer) a concrete
and particularized injury from the defendant’s conduct. See id. And the organization must show
that its requested relief will redress this injury. See Waskul v. Washtenaw Cnty. Cmty. Mental
Health, 900 F.3d 250, 257–58 (6th Cir. 2018); Friends of Tims Ford v. Tenn. Valley Auth.,
585 F.3d 955, 970–71 (6th Cir. 2009).
The Association’s complaint in this case includes allegations with respect to two
physician members. It alleges that the FDA’s Authorization has harmed a “Dr. John Doe” who
practices in Michigan. Compl., R.1, PageID 19. Dr. Doe, and another unidentified physician
who practices in an unidentified state, allegedly want to prescribe hydroxychloroquine for
patients who do not have COVID-19 or who have just been diagnosed with it. Id. But the
Authorization has allegedly prevented them from doing so. Id. Why? The Association offers
two theories—one direct, the other indirect. The Association initially argues that the
Authorization directly restricts its physician members from prescribing the drug in their preferred
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 15
fashion. It alternatively argues that the Authorization could indirectly cause the members to face
state-level sanctions for prescribing the drug in this fashion. Neither theory pleads the physician
members’ standing.
Before reaching these theories, we must identify the legal standards for assessing whether
a complaint’s standing allegations suffice. The FDA brought what is known as a “facial” (as
opposed to “factual”) challenge to the Association’s standing and the district court’s
jurisdiction under Federal Rule of Civil Procedure 12(b)(1). See Gentek Bldg. Prods., Inc. v.
Sherwin-Williams Co., 491 F.3d 320, 330 (6th Cir. 2007). A party raising a facial challenge
argues that a complaint does not adequately plead standing even accepting its facts as true. See
Mosley v. Kohl’s Dep’t Stores, Inc., 942 F.3d 752, 756 (6th Cir. 2019). Under the old pleading
test from Conley v. Gibson, 355 U.S. 41 (1957), a court considering such a challenge assumed
that the complaint’s “general allegations embrace[d] those specific facts that [were] necessary to
support the claim.” Shelby Advocs., 947 F.3d at 982 (quoting Lujan, 504 U.S. at 561). In Bell
Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), however, the Court retired this lenient test in
favor of a “plausibility” test—at least in the context of a motion to dismiss on the merits under
Rule 12(b)(6). Id. at 560–61.
Should Twombly’s plausibility test apply to a motion to dismiss on standing grounds too?
We think so. The Supreme Court has held that standing’s elements “must be supported in the
same way as any other matter on which the plaintiff bears the burden of proof,” which indicates
that the same rules apply at this pleading stage. Lujan, 504 U.S. at 561. The Court has also
made clear that a complaint must “clearly . . . allege facts demonstrating” standing. Spokeo, Inc.
v. Robins, 136 S. Ct. 1540, 1547 (2016) (citation omitted). And many other circuit courts have
extended Twombly’s plausibility test to this standing context. See Silha v. ACT, Inc., 807 F.3d
169, 174 (7th Cir. 2015) (citing cases); see also, e.g., Hawse v. Page, 7 F.4th 685, 688–89, 689
n.6 (8th Cir. 2021); Kareem v. Haspel, 986 F.3d 859, 865–66 (D.C. Cir. 2021); Dantzler, Inc. v.
Empresas Berríos Inventory & Operations, Inc., 958 F.3d 38, 46–47 (1st Cir. 2020); Ctr. for
Biological Diversity v. Bernhardt, 946 F.3d 553, 560 (9th Cir. 2019). We will do the same.
Accepting as true the complaint’s factual allegations (as opposed to its legal conclusions), we
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 16
must ask whether either of the Association’s two theories asserts a “plausible claim” that one of
its members has standing. Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009).
Did the Association plead a direct harm to its members? The Association first argues
that the Authorization barred its physician members from prescribing hydroxychloroquine for
their patients in the prophylactic manner that they would like. That is allegedly because the
Authorization restricted use of hydroxychloroquine only for hospitalized COVID-19 patients, not
for patients who have yet to be hospitalized or get COVID-19. This theory failed to plausibly
plead an Article III injury because it rests on a misinterpretation of the Authorization.
If the Authorization noted that the FDA would punish doctors for prescribing
hydroxychloroquine outside its narrow guidelines, that type of punishment might well create an
Article III injury—assuming that enforcement of the policy against the Association’s members
was sufficiently imminent. See Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158–59
(2014). But the Authorization said no such thing. It nowhere barred physicians from prescribing
hydroxychloroquine to non-hospitalized patients. Indeed, it did not regulate doctor prescribing
habits at all. Rather, it governed distribution of the hydroxychloroquine specifically in the
federal stockpile, not of hydroxychloroquine generally. Auth., R.8-8, PageID 259, 262–65. The
Authorization thus did not limit the ability of the Association’s members to prescribe the drug to
their patients, who could seek to fill those prescriptions through nongovernmental channels.
This reading of the Authorization comports with the background understanding of the
Federal Food, Drug, and Cosmetic Act. The Act regulates drug distribution; it does not bar
doctors from prescribing an approved drug (like hydroxychloroquine) for an off-label use (like
COVID-19). See Caronia, 703 F.3d at 153. The Association’s complaint thus alleges that the
Act permits off-label prescriptions. Compl., R.1, PageID 5–6. And the FDA even
acknowledged this narrow reading of the Authorization’s scope on appeal. Appellees’ Br. 21;
cf. Driehaus, 573 U.S. at 165.
The Association responds that the Authorization’s restrictions made hydroxychloroquine
practically (if not legally) unavailable to its members’ patients. That is so, the Association
claims on appeal, because the federal government has a monopoly on the drug. It is unclear why
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 17
this argument would show that the Association’s physician members have suffered any type of
injury. Without a threat of punishment for prescribing the drug, the Association has not
identified a harm to physicians merely because the drug may not be available to patients.
Cf. California, 141 S. Ct. at 2114–16. Ultimately, though, we need not decide the point. The
Association’s complaint did not factually allege that hydroxychloroquine was unavailable
outside the federal stockpile. To the contrary, it alleged that a “plentiful supply” exists of the
“easy-to-manufacture” drug. Compl., R.1, PageID 15. The complaint added that “it is feasible
for manufacturers to produce a million new doses of [hydroxychloroquine] daily.” Id., PageID
17–18. Because we assess the Association’s standing based on the complaint’s allegations on
this appeal, see Mosley, 942 F.3d at 756, the allegations about the drug’s wide availability doom
this argument.
Did the Association plead an indirect harm to its members? The Association
alternatively argues that the Authorization could cause its physician members to face discipline
in a distinct way if they prescribe hydroxychloroquine in the broad fashion that they would like.
How? According to the complaint, state medical boards have allegedly relied on the
Authorization in their regulation of doctors. Compl., R.1, PageID 18. The Association’s
members thus allegedly fear prescribing hydroxychloroquine due to the threat of “retaliation”
from these state boards. Id., PageID 19. This theory failed to plausibly plead standing’s injury
and causation elements.
Start with the injury. A state medical board’s threatened disciplinary action against a
doctor may well qualify as a valid Article III injury to the doctor. See, e.g., Driehaus, 573 U.S.
at 158–59; McKay v. Federspiel, 823 F.3d 862, 867–70 (6th Cir. 2016). But a yet-to-happen
“injury must be certainly impending to constitute injury in fact”; the mere possibility that the
injury will arise in the future does not suffice. Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409
(2013) (quoting Whitmore, 495 U.S. at 158). And a plaintiff claiming that a government agency
might bring an enforcement action against the plaintiff usually must show a “credible threat of
prosecution” under the challenged law or regulation to establish that this type of enforcement
action is certainly impending. McKay, 823 F.3d at 867 (quoting Driehaus, 573 U.S. at 159).
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 18
Here, however, the Association’s complaint identifies nothing but speculation that a state
medical board might pursue discipline against one of its physician members for prescribing
hydroxychloroquine to treat COVID-19. The Association alleged details for only one physician
member—the Dr. Doe who practices in Michigan. Yet its complaint did not make a single
allegation that the state medical board in Michigan has made statements or taken actions against
the use of hydroxychloroquine to treat COVID-19. The complaint, for example, did not allege
any prior enforcement actions against Michigan doctors. Cf. Driehaus, 573 U.S. at 164. Nor did
it allege that the Michigan board had circulated warning letters critical of the prescriptions that
the Association’s members would like to write. Cf. Berry v. Schmitt, 688 F.3d 290, 296 (6th Cir.
2012). And unlike when a plaintiff alleges that a challenged law or regulation bars the conduct
in which the plaintiff would like to engage, the complaint did not even tell us the Michigan law,
regulation, or common-law standard that the physician members’ prescribing habits would
allegedly infringe. See Glenn v. Holder, 690 F.3d 417, 421–24 (6th Cir. 2012). In sum, the
complaint’s conclusory allegations that an unknown state medical board might bring disciplinary
charges against an unknown physician member for conduct violating an unknown standard did
not suffice to plausibly allege the required credible threat of prosecution. See McKay, 823 F.3d
at 869.
Turn to causation. Even if an unknown state medical board would discipline an unknown
physician member for prescribing hydroxychloroquine to treat COVID-19, the Association did
not sue a state board (the entity that would cause this harm). It sued the FDA. Yet the Supreme
Court has “been reluctant to endorse standing theories that require guesswork as to how
independent decisionmakers” (like the state medical board in this case) would “exercise their
judgment.” Clapper, 568 U.S. at 413; see Warth, 422 U.S. at 505. Many cases thus hold that a
plaintiff failed to establish that an injury was traceable to a defendant when the injury would
arise only if some third party decided to take the action triggering the injury. See Simon v. E. Ky.
Welfare Rts. Org., 426 U.S. 26, 41–43 (1976); Binno v. Am. Bar Ass’n, 826 F.3d 338, 344–45
(6th Cir. 2016); Ammex, Inc. v. United States, 367 F.3d 530, 533–34 (6th Cir. 2004).
The Association’s alternative standing theory requires this sort of guesswork. Its
complaint conclusorily alleged that unknown state medical boards had “imitated or relied upon
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 19
the unjustified FDA” Authorization. Compl., R.1, PageID 18. Yet the complaint did not allege
that these state boards were somehow bound by the Authorization or that they would fail to
exercise “independent” judgment about the propriety of their physicians’ prescribing practices.
Simon, 426 U.S. at 42. Indeed, the complaint did not even identify any state medical board that
had cited the Authorization in its own guidance to regulated physicians. Nor did it plausibly
allege that a state medical board would have adopted a different regulatory approach if the
Authorization had not existed. The Association instead relies on rank speculation to suggest that
the Authorization might have influenced the actions of state medical boards. But this
“speculation about ‘the unfettered choices made by independent actors not before the court’”
does not suffice to plead the Association’s standing. Clapper, 568 U.S. at 414 n.5 (quoting
Lujan, 504 U.S. at 562).
In response, the Association argues that it has shown a credible threat of prosecution
based on a press release from the Federation of State Medical Boards. The press release
identified the Authorization’s permitted uses of the federal hydroxychloroquine stockpile and
reminded doctors that “deviating from the standard of care could put their license at risk.”
Compl., R.1, PageID 18. This statement does the Association no good. For one thing, it did not
criticize prescribing hydroxychloroquine to treat COVID-19. Rather, it highlighted reports of
physicians “inappropriately prescribing” hydroxychloroquine “to prevent or treat COVID-19 for
themselves or their family members” rather than for patients who might need the drug.
Statement, R.8-13, PageID 281. Nothing in the statement warned against prescribing
hydroxychloroquine for COVID-19 (as compared to prescribing it to favored family members).
For another thing, the Federation of State Medical Boards is an advocacy organization for state
medical boards; it is not a sovereign regulatory body. So the Association’s reliance on this
separate entity’s press release confirms the central problem with its standing theory: The theory
rests on pure guesswork about the decisions of parties not before the court. See Clapper, 568
U.S. at 413.
The Association also cites Association of American Physicians & Surgeons, Inc. v. Texas
Medical Board, 627 F.3d 547 (5th Cir. 2010). In that case, the Association sued the Texas
Medical Board on behalf of its physician members because the board had allegedly been
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 20
disciplining physicians in illegal ways. See id. at 549–50. Because this discipline qualified as an
injury and because the board would have undoubtedly caused it, the board did not even dispute
that the Association’s members had standing. Id. at 550 & n.2. Here, by contrast, the
Association sued the FDA for harm that would be caused by other entities—the unknown state
medical boards. This theory of indirect harm is nothing like the theory of direct harm in Texas
Medical Board.
B. Third-Party Standing
The Association lastly seeks to invoke third-party standing to sue for injuries allegedly
incurred by its physician members’ patients. Third-party standing permits a plaintiff to assert the
constitutional or statutory rights of parties not before the court if the plaintiff has a close
relationship to those parties and if they are hindered in protecting their own rights. See Kowalski
v. Tesmer, 543 U.S. 125, 129–30 (2004). The Supreme Court held, for example, that a merchant
could invoke the equal-protection rights of her male customers who were under the age of 21
when she challenged a law that barred her from selling beer to these customers. See Craig v.
Boren, 429 U.S. 190, 195–97 (1976). As noted, however, this theory (unlike associational
standing) does not relieve plaintiffs of the need to independently establish their own Article III
standing. See Hollingsworth, 570 U.S. at 708; Powers, 499 U.S. at 411. The merchant in Craig,
for example, had suffered (and sought a remedy for) her own “economic injury” from the law
barring beer sales to male customers under 21. See 429 U.S. at 194.
The Association cannot rely on third-party standing in this case because it has forfeited
any argument that it has suffered its own Article III injury. To be sure, some cases suggest that
the Association might have been able to “borrow” its physician members’ third-party standing to
assert the separate rights of their patients. 13A Charles Alan Wright et al., Federal Practice &
Procedure § 3531.9.5, at 890–92 (3d ed. 2008); cf. New York State Club Ass’n, Inc. v. City of
New York, 487 U.S. 1, 9–10 (1988); Pa. Psychiatric Soc’y v. Green Spring Health Servs., Inc.,
280 F.3d 278, 291–93 (3d Cir. 2002); Ohio Ass’n of Indep. Schs. v. Goff, 92 F.3d 419, 421–22
(6th Cir. 1996). But we need not decide in this case whether we would have allowed this double
“stacking” of the standing exceptions to the general rule that a party must assert its own rights.
Pa. Psychiatric Soc’y, 280 F.3d at 295–96 (Nygaard, J., dissenting). As already explained,
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 21
the Association’s 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.
We affirm.
No. 20-1784 Ass’n of Am. Physcians & Surgeons v. FDA, et al. Page 22
_________________
CONCURRENCE
_________________
SILER, Circuit Judge, concurring. I concur with the majority opinion, but I decline to
join the discussion of associational standing in Part III.A.1, as I believe it is unnecessary to the
resolution of the case.