Today, the Supreme Court ruled that anti-abortion doctors do not have standing to challenge the Food and Drug Administration’s regulation of mifepristone. This is as expected. Justice Kavanaugh wrote a unanimous opinion for the court in 2017 Hippocratic Medical Alliance v. Food and Drug Administration. Justice Thomas also wrote a separate concurrence for association status.
As I have documented in a series of posts (links here and below), the arguments in favor of the AHM and the lower courts were never particularly strong, especially when the courts concluded that the FDA’s original 2000 approval of mifedi The statute of limitations has expired on keto. There is no doubt that the Supreme Court will conclude that the plaintiffs lack Article III standing in this case. The only question is whether it will pass unanimously (as opposed to 8-1 or 7-2). Obtaining mifepristone never carries the following risks: this litigation.
Judge Kavanaugh concluded his unanimous opinion for the Court:
In 2016 and 2021, the Food and Drug Administration relaxed regulatory requirements for the abortion drug mifepristone. These changes make it easier for doctors to prescribe the drug and for pregnant women to obtain mifepristone. Some anti-abortion doctors and associations sued the FDA, arguing that the FDA’s actions violated the Administrative Procedure Act. But the plaintiff did not prescribe or use mifepristone. The FDA is not asking them to do or not do anything. Instead, the plaintiffs want the FDA to make mifepristone more difficult to use, making it more difficult for other doctors to prescribe it and for pregnant women to obtain it. A plaintiff’s desire to reduce others’ access to a drug does not constitute standing under Article III of the Constitution. Plaintiff’s other valid theories are also insufficient. Therefore, the plaintiff does not have standing to challenge the FDA’s actions
As Judge Kavanaugh explained, the AHM advanced multiple theories regarding Title III to challenge the FDA’s decision to relax regulation of mifepristone, but none were sufficient.
Plaintiffs are not alleging the types of harm that unregulated parties can sometimes claim to prove causation. Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone, nor do they sponsor competing drugs, the FDA’s action to deregulate mifepristone has not caused direct monetary losses to the plaintiffs. Nor have their property or property values been harmed by FDA’s actions. Because the plaintiffs do not use mifepristone, they apparently will not suffer physical harm as a result of the FDA’s actions to relax its regulation of mifepristone.
Instead, the plaintiffs claim they are pro-life, oppose elective abortion, and have sincere legal, moral, ideological and policy objections to the prescribing and use of mifepristone by others. Plaintiffs appear to realize that these general legal, ethical, ideological, and policy issues are not, by themselves, sufficient to confer Article III standing to bring a lawsuit in federal court. Therefore, in an attempt to establish standing, plaintiffs advanced several complex causation theories linking FDA’s actions to plaintiffs’ alleged factual harm.
The long-standing theory first raised by Justice Kavanaugh and that received the most attention during oral arguments is that the FDA’s decision to relax restrictions on mifepristone will lead to more emergency room visits for women with complications that will lead to women’s Wounded conscience. Justice Kavanaugh did not deny the genuine objections some doctors may have to conscientious reasons to facilitate abortions, and he explained why these claims were insufficient to justify his position.
Doctors believe the FDA’s actions in 2016 and 2021 will result in more pregnant women developing complications from mifepristone, and those women will in turn require doctors to perform more emergency abortions. Plaintiff doctors said they could therefore be required, against their conscience, to provide emergency treatment to complete an abortion or provide other abortion-related care.
The Government rightly acknowledged that such harm to conscience in fact constituted concrete harm for the purposes of Article 3. . . Physicians therefore have standing to challenge government actions that may cause them to provide medical services against their conscience. But in this case, even assuming for the sake of argument that the FDA’s 2016 and 2021 changes to the conditions for use of mifepristone resulted in more pregnant women needing emergency abortions, and that some women might seek care from these plaintiffs’ doctors, the plaintiffs’ doctors have not shown They may be forced to participate in abortions or provide abortion-related medical care due to conscientious objections.
That’s because, as the government explains, federal conscience laws explicitly protect doctors from being required to perform abortions or provide other treatments that violate their conscience.
As Judge Kavanaugh noted, “Plaintiffs have found no circumstances in which a physician, despite conscientious objections, would be required to perform an abortion or provide other abortion-related treatment that would violate the physician’s conscience. Nor is there any evidence in the record here that The hospital disregarded or disregarded the physician’s conscientious objections (and, as he pointed out, EMTALA did not require otherwise.)
Injury of conscience was not the only theory advanced by the plaintiffs, but they were no more successful.
In addition to claiming a wounded conscience, the physicians stated that the FDA’s actions would cause them to suffer various monetary and related harms, particularly the diversion of other patients’ resources and time to treat patients with mifepristone complications; treating these Patients are at increased risk of liability lawsuits; and may increase insurance costs.
These longstanding accusations all suffer from the same problem – a lack of causation. The causal link between FDA’s regulatory actions and these alleged injuries is too speculative or too weak to establish a position
As I have pointed out in several articles, the suggestion that the FDA’s decision to allow mifepristone on the market would cause significant harm to any physician involved in the litigation is always speculative, and once the case is narrowed down to considering the FDA’s Modifications to steroid prescribing requirements.
Kavanaugh wrote:
The law never allows doctors to challenge the government’s relaxation of general public safety requirements because more people may show up to emergency rooms or doctors’ offices with subsequent injuries. In other words, there is no third “physician qualifications” principle that allows doctors to challenge general government safety regulations. This House would not now create such a novel standing doctrine out of thin air.
[Developing . . . I will add to this post as I work through the opinion]
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For those who are interested, here is my previous blog post about the AHM mifepristone lawsuit and the issues it raises:
- “The Next Abortion Battleground,” June 22, 2022;
- “Assessing legal claims Hippocratic Medical Alliance v. FDA”, March 8, 2023;
- “AHM v. FDA: Contrary views and rebuttals,” March 28, 2023;
- “Blue-State AG also has its own mifepristone lawsuit,” March 29, 2023;
- “Two (wrong) mifepristone court rulings in one day,” April 8, 2023;
- “The Good and the Bad of 5th Circuit’s Abortion Pill Ruling,” April 13, 2023.
- “Breaking News: Supreme Court to consider 5th Circuit’s abortion pill decision,” December 13, 2023.
- Supreme Court denies red state effort to intervene in mifepristone case, February 20, 2024.
- Can emergency room doctors sue the FDA for failing to regulate mifepristone more aggressively?
- Mifepristone in the Supreme Court—Oral Argument Comments (Updated), March 26, 2024.
- Who can sue the FDA?
