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Unanimous Supreme Court Finds No Standing to Challenge FDA Regulation of Mifepristone (UPDATED)

Not a single justice was impressed by the unimpressive standing theories offered in Alliance for Hippocratic Medicine v. FDA.

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Today the Supreme Court held that anti-abortion doctors lack standing to challenge the Food and Drug Administration's regulations governing mifepristone. This was as expected. Justice Kavanaugh wrote the opinion for a unanimous Court in Alliance for Hippocratic Medicine v. Food & Drug Administration. Justice Thomas also wrote a separate concurrence on third-party and associational standing.

As I documented in a series of posts (linked here and below) the arguments offered in support of standing by AHM and the lower courts were never particularly strong, particularly once courts concluded that challenges to the FDA's initial approval of mifepristone in 2000 were time barred. There was never much question that the Supreme Court would conclude that the plaintiffs lacked Article III standing in this case. The only question was whether it would be unanimous (as opposed to 8-1 or 7-2). Access to mifepristone was never at risk from this litigation.

Here is how Justice Kavanaugh summarizes his unanimous opinion for the Court:

In 2016 and 2021, the Food and Drug Administration relaxed its regulatory requirements for mifepristone, an abortion drug. Those changes made it easier for doctors to prescribe and pregnant women to obtain mifepristone. Several pro-life doctors and associations sued FDA, arguing that FDA's actions violated the Administrative Procedure Act. But the plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything. Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. Under Article III of the Constitution, a plaintiff 's desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs' other standing theories suffice. Therefore, the plaintiffs lack standing to challenge FDA's actions

As Justice Kavanaugh explains, AHM offered a variety of theories for Article III standing to challenge the FDA's decision to loosen the regulation of mifepristone, but none were adequate.

The plaintiffs do not allege the kinds of injuries described above that unregulated parties sometimes can assert to demonstrate causation. Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone or sponsor a competing drug, the plaintiffs suffer no direct monetary injuries from FDA's actions relaxing regulation of mifepristone. Nor do they suffer injuries to their property, or to the value of their property, from FDA's actions. Because the plaintiffs do not use mifepristone, they obviously can suffer no physical injuries from FDA's actions relaxing regulation of mifepristone.

Rather, 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 appear to recognize that those general legal, moral, ideological, and policy concerns do not suffice on their own to confer Article III standing to sue in federal court. So to try to establish standing, the plaintiffs advance several complicated causation theories to connect FDA's actions to the plaintiffs' alleged injuries in fact.

The standing theory Justice Kavanaugh addresses first, and that received the most attention at oral argument, was that the FDA's decision to loosen restrictions on mifepristone would result in more emergency room visits by women suffering complications, and that this would result in conscience injuries to anti-abortion doctors forced to provide care in such situations. Without being dismissive of the genuine conscience-based objections some doctors may have to facilitating abortions, Justice Kavanaugh explained why these claims were insufficient to demonstrate standing.

The doctors contend that FDA's 2016 and 2021 actions will cause more pregnant women to suffer complications from mifepristone, and those women in turn will need more emergency abortions by doctors. 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 Government correctly acknowledges that a conscience injury of that kind constitutes a concrete injury in fact for purposes of Article III. . . So doctors would have standing to challenge a government action that likely would cause them to provide medical treatment against their consciences. But in this case—even assuming for the sake of argument that FDA's 2016 and 2021 changes to mifepristone's conditions of use cause more pregnant women to require emergency abortions and that some women would likely seek treatment from these plaintiff doctors—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.

That is because, as the Government explains, federal conscience laws definitively protect doctors from being required to perform abortions or to provide other treatment that violates their consciences.

As Justice Kavanaugh notes, "plaintiffs have not identified any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or to provide other abortion-related treatment that violated the doctor's conscience. Nor is there any evidence in the record here of hospitals overriding or failing to accommodate doctors' conscience objections." (And, as he notes, EMTALA does not require otherwise.)

Conscience injuries were not the only theories offered by the plaintiffs, but they were no more successful.

In addition to alleging conscience 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.

Those standing allegations suffer from the same problem—a lack of causation. The causal link between FDA's regulatory actions and those alleged injuries is too speculative or otherwise too attenuated to establish standing

As I noted in several of my posts, the claims that the FDA's decision to allow mifepristone on the market would result in cognizable injuries to any doctors who were part of the suit was always speculative, and made much more so once the case was narrowed to the consideration of the FDA's modification of mifepristone prescribing requirements.

Writes Kavanaugh:

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. Stated otherwise, there is no Article III doctrine of "doctor standing" that allows doctors to challenge general government safety regulations. Nor will this Court now create such a novel standing doctrine out of whole cloth. . . .

We recognize that many citizens, including the plaintiff doctors here, have sincere concerns about and objections to others using mifepristone and obtaining abortions. But citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities— at least without the plaintiffs demonstrating how they would be injured by the government's alleged underregulation of others.

Justice Kavanaugh also (in a footnote) explains why third-party standing cannot solve the standing puzzle for doctors here.

The doctors also suggest that they can sue in a representative capacity to vindicate their patients' injuries or potential future injuries, even if the doctors have not suffered and would not suffer an injury themselves. This Court has repeatedly rejected such arguments. Under this Court's precedents, third-party standing, as some have called it, allows a narrow class of litigants to assert the legal rights of others. See Hollingsworth v. Perry, 570 U. S. 693, 708 (2013). But "even when we have allowed litigants to assert the interests of others, the litigants themselves still must have suffered an injury in fact, thus giving them a sufficiently concrete interest in the outcome of the issue in dispute." Ibid. (quotation marks and alterations omitted). The third-party standing doctrine does not allow doctors to shoehorn themselves into Article III standing simply by showing that their patients have suffered injuries or may suffer future injuries.

Note that this footnote leaves in place the form of third-party standing that doctors relied upon to challenge abortion restrictions pre-Dobbs (and to which Justice Thomas objects in his concurrence).

AHM also sought to establish organizational standing, relying upon Havens Realty.  This too failed. Justice Kavanaugh explains why AHM's invocation of Havens Realty falters, and does so in a way that may correct the overly generous interpretation of Havens Realty adopted in some circuits and academics.

According to the medical associations, FDA has "impaired" their "ability to provide services and achieve their organizational missions." … That argument does not work to demonstrate standing. . . .

They claim to have standing not based on their mere disagreement with FDA's policies, but based on their incurring costs to oppose FDA's actions. They say that FDA has "caused" the associations to conduct their own studies on mifepristone so that the associations can better inform their members and the public about mifepristone's risks. Brief for Respondents 43. They contend that FDA has "forced" the associations to "expend considerable time, energy, and resources" drafting citizen petitions to FDA, as well as engaging in public advocacy and public education. Id., at 44 (quotation marks omitted). And all of that has caused the associations to spend "considerable resources" to the detriment of other spending priorities. Ibid.

But 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. The medical associations respond that under Havens Realty Corp. v. Coleman, standing exists when an organization diverts its resources in response to a defendant's actions. 455 U. S. 363. That is incorrect. Indeed, that theory would mean that all the organizations in America would have standing to challenge almost every federal policy that they dislike, provided they spend a single dollar opposing those policies. Havens does not support such an expansive theory of standing. . . .

Havens was an unusual case, and this Court has been careful not to extend the Havens holding beyond its context. So too here.

Of note, Justice Kavanaugh observes that AHM had not made an informational standing claim, and perhaps they or some other organization may file such a claim in the future, but I am not sure that would make a difference in the outcome.

Finally, Justice Kavanaugh addresses the objection that if AHM cannot sue the FDA then no one can sue (a point I addressed here).

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. For starters, it is not clear that no one else would have standing to challenge FDA's relaxed regulation of mifepristone. But even if no one would have standing, 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; Richardson, 418 U. S., at 179–180. The "assumption" that if these plaintiffs lack "standing to sue, no one would have standing, is not a reason to find standing." Schlesinger, 418 U. S., at 227. Rather, some issues may be left to the political and democratic processes: The Framers of the Constitution did not "set up something in the nature of an Athenian democracy or a New England town meeting to oversee the conduct of the National Government by means of lawsuits in federal courts." Richardson, 418 U. S., at 179; see Texas, 599 U. S., at 685.

I will address Justice Thomas' concurrence in a separate post.

Finally, it is worth noting that this opinion says nothing about whether or not any of the FDA's decisions concerning mifepristone were proper, nor does it address whether the Comstock Act limits the distribution of abortifacients. As a matter of administrative law, I found the challenges to the FDA's mifepristone decision-making unpersuasive, and the FDA is not tasked with enforcing the Comstock Act, so that was never really a part of this case.

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For those interested, here are my prior blog posts about the AHM mifepristone litigation and the issues it raises: