Food and Drug Administration, et. al. v Alliance for Hippocratic Medicine, et al. AND Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, et al.

Follow Up

• 2024-09-16: U.S. Court of Appeals for the Fifth Circuit remanded Alliance for Hippocratic Medicine v. FDA (the mifepristone case) to the district court. (Jonathan Adler article.

Referenced Articles:

• Roberts: Article III Limits on Statutory Standing.
• Scalia: The Doctrine of Standing as an Essential Element of the Separation of Powers.

Issue(s) Before the Court:

Plaintiff's Claim(s):

Respondent's Claim(s):

Holding(s) and Disposition:

Material Facts:

• In 2016, .... FDA deemed Mifeprex safe to terminate pregnancies up to 10 weeks rather than 7 weeks.
• FDA allowed healthcare providers such as nurse practitioners to prescribe Mifeprex. And FDA approved a dosing regimen that reduced the number of required in-person visits from three to one—a single visit to receive Mifeprex.
• In 2021, FDA again relaxed the requirements for Mifeprex and generic mifepristone. ... without an in-person visit to a healthcare provider, FDA announced that it would no longer enforce the initial in-person visit requirement.
• A full recounting of the facts is available below

Procedural History:

• I B
• This case began in 2022. Four pro-life medical associations, as well as several individual doctors, sued FDA ....
• Plaintiffs brought claims under the Administrative Procedure Act.
• They challenged the lawfulness of FDA’s 2000 approval of Mifeprex; FDA’s 2019 approval of generic mifepristone; and FDA’s 2016 and 2021 actions modifying mifepristone’s conditions of use.
• Danco Laboratories, which sponsors Mifeprex, intervened to defend FDA’s actions
• The District Court agreed with the plaintiffs and in effect enjoined FDA’s approval of mifepristone, thereby ordering mifepristone off the market. 668 F. Supp. 3d 507 (ND Tex. 2023).
• FDA and Danco promptly appealed and moved to stay the District Court’s order pending appeal.
• The U. S. Court of Appeals for the Fifth Circuit granted the stay motion in part and temporarily reinstated FDA’s approval of Mifeprex. 2023 WL 2913725, *21 (Apr. 12, 2023).
• FDA and Danco then sought a full stay in this Court.
• This Court stayed the District Court’s order in its entirety pending the disposition of FDA’s and Danco’s appeals in the Court of Appeals and ultimate resolution by this Court.
• The Court of Appeals first concluded that the individual doctors and the pro-life medical associations had standing.
• The Court of Appeals next concluded that plaintiffs were not likely to succeed on their challenge to FDA’s 2000 approval of Mifeprex and 2019 approval of generic mifepristone.
• But the Court of Appeals agreed with the District Court that plaintiffs were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful.
• This Court then granted certiorari with respect to the 2016 and 2021 FDA actions held unlawful by the Court of Appeals.

Rationale

Majority Opinion

• ... the plaintiffs advance several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact.
• ... that FDA’s relaxed regulation of mifepristone may cause downstream conscience injuries to the individual doctor plaintiffs and the specified members of the plaintiff medical associations, who are also doctors.
• ... nothing in the record since 2000 supports plaintiffs’ speculation that doctors will be unable to successfully invoke federal conscience protections in emergency circumstances.
• ... that FDA’s relaxed regulation of mifepristone may cause downstream economic injuries to the doctors.
• The doctors have not offered evidence ... diversion of the doctors’ time and resources ... where they have been sued or required to pay higher insurance costs ... any persuasive evidence or reason to believe that the future will be different. (18)
• ... that FDA’s relaxed regulation of mifepristone causes injuries to the medical associations themselves, who assert their own organizational standing.
• The medical associations say ... that FDA has “caused” the associations to conduct their own studies on mifepristone ... that FDA has “forced” the associations to “expend considerable time, energy, and resources” drafting citizen petitions ....
• ... an organization that has not suffered a concrete injury caused by a defendant’s action cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action. An organization cannot manufacture its own standing in that way.
• Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact.
• ... the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.
• A full description of the rationale is available below

Thomas Concurrance

• Our third-party standing precedents allow a plaintiff to assert the rights of another person when the plaintiff has a “close relationship with the person who possesses the right” and “there is a hindrance to the possessor’s ability to protect his own interests.” Kowalski v. Tesmer, 543 U. S. 125, 130 (2004)
• But, there is a far simpler reason to reject this theory: Our third-party standing doctrine is mistaken. As I have previously explained, a plaintiff cannot establish an Article III case or controversy by asserting another person’s rights.1 See June Medical Services LLC. v. Russo, 591 U. S. 299, 366 (2020)
• I write separately to highlight what appear to be similar problems with another theory of standing asserted in this suit. The Alliance and other plaintiff associations claim that they have associational standing to sue for their members’ injuries. (See Warth v. Seldin, 422 U. S. 490, 511 (1975)).
• Under the Court’s precedents, “an association has standing to bring suit on behalf of its members when:
  • (a) its members would otherwise have standing to sue in their own right;
  • (b) the interests it seeks to protect are germane to the organization’s purpose; and
  • (c) neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit.” Hunt v. Washington State Apple Advertising Comm’n, 432 U. S. 333, 343 (1977).
• Associational standing, however, is simply another form of third-party standing. And, the Court has never explained or justified either doctrine’s expansion of Article III standing.
• I
• First, associational standing conflicts with Article III by permitting an association to assert its members’ injuries instead of its own.
• Second, our associational-standing doctrine does not appear to comport with the requirement that the plaintiff present an injury that the court can redress.
• In addition to these Article III concerns, there is tension between associational standing and other areas of law.
• First, the availability of associational standing subverts the class-action mechanism.
• Second, associational standing creates the possibility of asymmetrical preclusion.
• II
• In NAACP v. Alabama ex rel. Patterson, 357 U. S. 449 (1958), the Court permitted an association to assert the constitutional rights of its members to prevent the disclosure of its membership lists. While the Court allowed the NAACP to raise a challenge on behalf of its members, it also acknowledged that the NAACP had arguably faced an injury of its own. Id., at 459–460.
• The Court, however, soon discarded any notion that an association needed to have its own injury, creating our modern associational-standing doctrine. (National Motor Freight Traffic Assn., Inc. v. United States, 372 U. S. 246 (1963) (per curiam))

Full Recounting of Facts

• I A
• In 2000, FDA approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex.
• FDA approved Mifeprex for use to terminate pregnancies, but only up to seven weeks of pregnancy.
• ... FDA placed further restrictions on the drug’s use and distribution. For example, only doctors could prescribe or supervise prescription of Mifeprex. Doctors and patients also had to follow a strict regimen requiring the patient to appear for three in-person visits with the doctor.
• In 2016, .... FDA deemed Mifeprex safe to terminate pregnancies up to 10 weeks rather than 7 weeks.
• FDA allowed healthcare providers such as nurse practitioners to prescribe Mifeprex. And FDA approved a dosing regimen that reduced the number of required in-person visits from three to one—a single visit to receive Mifeprex.
• In 2019, FDA approved an application for generic mifepristone.
• In 2021, FDA again relaxed the requirements for Mifeprex and generic mifepristone. ... without an in-person visit to a healthcare provider, FDA announced that it would no longer enforce the initial in-person visit requirement.
• A list of the material facts is available above

Majority Full Argument

• II
• The threshold question is whether the plaintiffs have standing to sue under Article III of the Constitution.
• II A (standing)
• To establish standing, as this Court has often stated, a plaintiff must demonstrate (i) that she has suffered or likely will suffer an injury in fact, (ii) that the injury likely was caused or will be caused by the defendant, and (iii) that the injury likely would be redressed by the requested judicial relief.
• First is injury in fact. An injury in fact must be “concrete,” meaning that it must be real and not abstract. TransUnion LLC v. Ramirez , 594 U. S., at 424.
• The injury also must be particularized; the injury must affect “the plaintiff in a personal and individual way” and not be a generalized grievance. Lujan v. Defenders of Wildlife, 504 U. S., at 560, n. 1.
• Moreover, the injury must be actual or imminent, not speculative—meaning that the injury must have already occurred or be likely to occur soon. Clapper, 568 U. S., at 409
• By requiring the plaintiff to show an injury in fact, Article III standing screens out plaintiffs who might have only a general legal, moral, ideological, or policy objection to a particular government action. Valley Forge Christian College v. Americans United for Separation of Church and State, Inc. 454 U. S., at 473.
• Second is causation. The plaintiff must also establish that the plaintiff ’s injury likely was caused or likely will be caused by the defendant’s conduct.
• ... when (as here) a plaintiff challenges the government’s “unlawful regulation (or lack of regulation) of someone else,” “standing is not precluded, but it is ordinarily substantially more difficult to establish.” Lujan, 504 U. S., at 562 (quotation marks omitted)
• ... the plaintiff must show that the “ ‘third parties will likely react in predictable ways’ ” that in turn will likely injure the plaintiffs. California v. Texas, 593 U. S., at 675.
• The causation requirement precludes speculative links ....
• The causation requirement also rules out attenuated links—that is, where the government action is so far removed from its distant (even if predictable) ripple effects that the plaintiffs cannot establish Article III standing. Allen v. Wright, 468 U. S., at 757– 759
• ... [T]he Court has identified a variety of familiar circumstances where government regulation of a third-party individual or business may be likely to cause injury in fact to an unregulated plaintiff.
  • when the government regulates (or under-regulates) a business, the regulation (or lack thereof) may cause downstream or upstream economic injuries to others in the chain, such as certain manufacturers, retailers, suppliers, competitors, or customers. (12)
  • [w]hen the government regulates parks, national forests, or bodies of water, for example, the regulation may cause harm to individual users.
  • [w]hen the government regulates one property, it may reduce the value of adjacent property. The list goes on.
• II B (third-pary(?) standing)
• Here, the plaintiff doctors and medical associations are unregulated parties who seek to challenge FDA’s regulation of others.
• The plaintiffs do not allege the kinds of injuries described above that unregulated parties sometimes can assert to demonstrate causation. ... no direct monetary injuries .... Nor do they suffer injuries to their property .... ... they obviously can suffer no physical injuries from FDA’s actions relaxing regulation of mifepristone.
• ... the plaintiffs say that they are pro-life, oppose elective abortion, and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others.
• ... the plaintiffs advance several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact.
• ... that FDA’s relaxed regulation of mifepristone may cause downstream conscience injuries to the individual doctor plaintiffs and the specified members of the plaintiff medical associations, who are also doctors.
• ... that FDA’s relaxed regulation of mifepristone may cause downstream economic injuries to the doctors.
• ... that FDA’s relaxed regulation of mifepristone causes injuries to the medical associations themselves, who assert their own organizational standing.
• As we will explain, none of the theories suffices to establish Article III standing.
• II B 1 (conscience injuries)
• The plaintiff doctors say that they therefore may be required—against their consciences—to render emergency treatment completing the abortions or providing other abortion-related treatment.
• ... the plaintiff doctors have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment over their conscience objections.
• ... federal conscience laws definitively protect doctors from being required to perform abortions or to provide other treatment that violates their consciences.
• As the Government points out, that strong protection for conscience remains true even in a so-called healthcare desert, where other doctors are not readily available.
• ... nothing in the record since 2000 supports plaintiffs’ speculation that doctors will be unable to successfully invoke federal conscience protections in emergency circumstances.
• In short, given the broad and comprehensive conscience protections guaranteed by federal law, the plaintiffs have not shown—and cannot show—that FDA’s actions will cause them to suffer any conscience injury.
• II B 2 (economic injuries)
• ... the doctors cite various monetary and related injuries that they allegedly will suffer as a result of FDA’s actions—in particular, diverting resources and time from other patients to treat patients with mifepristone complications; increasing risk of liability suits from treating those patients; and potentially increasing insurance costs.
• The doctors have not offered evidence ... diversion of the doctors’ time and resources ... where they have been sued or required to pay higher insurance costs ... any persuasive evidence or reason to believe that the future will be different.
• The causal link between FDA’s regulatory actions and those alleged injuries is too speculative or otherwise too attenuated to establish standing.
• ... the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries.
• Allowing doctors or other healthcare providers to challenge general safety regulations as unlawfully lax would be an unprecedented and limitless approach and would allow doctors to sue in federal court to challenge almost any policy affecting public health.
• II B 3 (medical association injuries)
• ... organizations must satisfy the usual standards for injury in fact, causation, and redressability that apply to individuals. Havens Realty Corp. v. Coleman, 455 U. S. at 378–379.
• According to the medical associations, FDA has “impaired” their “ability to provide services and achieve their organizational missions.”
• The medical associations say ... that FDA has “caused” the associations to conduct their own studies on mifepristone ... that FDA has “forced” the associations to “expend considerable time, energy, and resources” drafting citizen petitions ....
• ... an organization that has not suffered a concrete injury caused by a defendant’s action cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action. An organization cannot manufacture its own standing in that way.
• Finally, it has been suggested that the plaintiffs here must have standing because if these plaintiffs do not have standing, then it may be that no one would have standing to challenge FDA’s 2016 and 2021 actions.
• ... this Court has long rejected that kind of “if not us, who?” argument as a basis for standing. See Clapper, 568 U. S., at 420–421; Valley Forge, 454 U. S., at 489
• * * *
• Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact.
• ... the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.
• A full description of the rationale is available below