Supreme Court of the United States (SCOTUS): While considering instant matter wherein 4 pro-life medical associations and several individual doctors sought preliminary injunction that would require Food and Drug Administration (FDA) to either rescind approval of mifepristone (abortion pill) or to rescind FDA’s 2016 and 2021 regulatory actions providing easy access to mifepristone; the Full Bench of the Court, unanimously held that the pro-life medical associations lack locus standi under Article III of the US Constitution to challenge FDA’s actions regarding the regulation of access to mifepristone. Brett Kavanaugh, J.*, authored the unanimous opinion of the Court.
Background and Legal Trajectory: In 2000, the FDA approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex for use in terminating pregnancies up to seven weeks. To ensure that Mifeprex would be used safely and effectively, FDA placed additional restrictions on the drug’s use and distribution, such as requiring doctors to prescribe or to supervise prescription of Mifeprex, and requiring patients to have three in-person visits with the doctor to receive the drug.
In 2016, FDA relaxed some of the afore-stated restrictions thereby deeming Mifeprex safe to terminate pregnancies up to 10 weeks and allowing healthcare providers to prescribe Mifeprex; and approving a dosing regimen that required just one in-person visit to receive the drug.
In 2019, FDA approved an application for generic mifepristone. In 2021, the FDA announced that it would no longer enforce the afore-stated initial in-person visit requirement.
Several pro-life medical associations and doctors challenged the FDA’s regulatory actions in 216 and 2021 that ensured easy access of mifepristone for termination of pregnancies and sought a preliminary injunction for the FDA to rescind these regulatory actions.
Danco Laboratories, which sponsors Mifeprex, intervened to defend FDA’s actions. The District Court agreed with the respondents and ordered mifepristone off the market. FDA and Danco appealed and moved to stay the District Court’s order pending appeal.
The SCOTUS, in an earlier order, stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit and in SCOTUS. On the merits, the Court of Appeal for the Fifth Circuit held that medical associations had standing and were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful.
The respondents contended that FDA’s relaxed regulation of mifepristone may cause downstream conscience injuries to the individual doctors. The respondents argued that FDA’s 2016 and 2021 changes to mifepristone’s conditions of use, would cause more pregnant women to require emergency abortions and that some women would likely seek treatment from the respondent doctors.
Court’s Assessment: The Bench comprising of John Roberts, CJ., and Clarence Thomas, Samuel Alito, Sonia Sotomayor, Elena Kagan, Neil Gorsuch, Brett Kavanaugh*, Amy Coney Barrett and Ketanji Brown Jackson, JJ., unanimously ruled that the respondents lacked any legal standing under Article III to challenge the impugned regulations of the FDA.
The Court stated that Article III standing is a “bedrock constitutional requirement that this Court has applied to all manner of important disputes”. It was stated that Article III confines the jurisdiction of Federal Courts to “Cases” and “Controversies.” Federal Courts do not operate as an open forum for citizens “to press general complaints about the way in which government goes about its business.”
The Court pointed out that to establish standing, a plaintiff must demonstrate (i) that he/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. The Court further pointed out that the two key questions in most standing disputes are injury in fact and causation. 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. Causation requires the plaintiff to establish that the plaintiff ’s injury likely was caused or likely will be caused by the defendant’s conduct.
Referring to several precedents on the point, the Court noted that Causation is ordinarily substantially more difficult to establish when a plaintiff challenges the government’s “unlawful regulation (or lack of regulation) of someone else”, because unregulated parties often may have more difficulty linking their asserted injuries to the government’s regulation (or lack of regulation) of someone else.
The Court noted that the respondents are pro-life and oppose elective abortion and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. However, since the respondents do not prescribe or use mifepristone, they are unregulated parties who seek to challenge FDA’s regulation of others.
The Court further pointed out that the respondents advanced several complicated causation theories to connect FDA’s actions to alleged injuries in fact; however, none of the presented theories suffice to establish Article III standing.
Taking note of the afore-stated contentions raised by the respondents, the Court pointed out that they have not been able to show 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. Federal law protects doctors from repercussions when they have “refused” to participate in an abortion”.
The Court further pointed out that the respondents did not identify 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 since mifepristone’s 2000 approval. Furthermore, the Court noted that Emergency Medical Treatment and Labor Act (EMTALA) neither overrides federal conscience laws nor requires individual emergency room doctors to participate in emergency abortions. Thus, the Court found that there is a break in any chain of causation between FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors.
Vis-a-vis respondents’ contentions regarding economic injuries to the doctors, the Court pointed out that the causal link between FDA’s regulatory actions in 2016 and 2021 and those alleged injuries is too speculative, lacks support in the record, and is otherwise too attenuated to establish standing. It was noted that, “The law has never permitted doctors to challenge the government’s loosening of public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries. Citizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions”.
Vis-a-vis the respondents’ organizational standing, the Court pointed out that organizations must satisfy the usual standards for injury in fact, causation, and redressability that apply to individuals. Like an individual, an organization may not establish standing simply based on the “intensity of the litigant’s interest” or because of strong opposition to the government’s conduct. Therefore, the respondent associations cannot establish standing simply because they object to FDA’s actions. Furthermore, the Court rejected the argument raised by the respondents that standing exists when an organization diverts its resources in response to a defendant’s actions.
Finally, the Court referring to another of its precedents on locus standi, said that the “assumption” that if the respondents “lack standing to sue, no one would have standing”, is not a reason to find standing.
[Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 23—235, decided on 13-06-2024]
*Judgment authored by Justice Brett Kavanaugh