The Supreme Court will hear oral arguments this morning FDA v. Hippocratic Medicine Alliancea challenge to the way the Food and Drug Administration regulates mifepristone, a drug used to terminate pregnancies.
The biggest challenge for AHM, the group challenging the FDA, is proving that federal courts have jurisdiction to hear its claims. The AHM would like to see the FDA regulate mifepristone more strictly or ban its use altogether. In fact, the AHM argues that the FDA needs to regulate someone else (in this case, the manufacturers and prescribers of mifepristone) more rigorously than it has done to date. As always in ongoing cases, asking courts to force the government to treat a third party differently can be a daunting task.
The AHM’s standing claim is based on the contention that AHM members suffer injuries when women taking mifepristone face complications and seek emergency room care. Having to observe and treat such complications causes significant harm, AHM argues, because providing treatment in these cases makes doctors feel complicit in the abortion, violates their conscience, and may even expose them to liability.
Assuming that the actions of third parties (in this case, the FDA) who force individuals to do their jobs (in this case, anti-abortion emergency room doctors who treat patients) constitute cognizable harm for purposes of ‘Article III, AHM faces the broader problem of being unable to identify specific physicians who will face specific instances. Rather, they argue that the risk of these things is increased because mifepristone is available. The problem here is that the AHM claims precisely the type of speculative damages for which the Court found they were not sufficient Clapper against Amnesty International. Therefore, allowing this case to move forward would, in effect, allow groups of doctors to challenge any agency decisions that could conceivably result in an increase in injuries among an identifiable group of people. AHM tries to address this issue by quoting the comment in Clapper in footnote 5 that standing can sometimes be demonstrated “on the basis of a ‘substantial risk’ of harm occurring,” yet he manages to conveniently truncate the quote whenever this argument is made. What footnote 5 actually says is that: “In some cases, we have found a ‘substantial risk’ that harm will occur, that could cause claimants to reasonably incur costs to mitigate or avoid such harm.“This last requirement – costly preventive actions to prevent damage – is not met in this case.
In fact, AHM is making the kind of probabilistic harm claim that the Supreme Court routinely rejects (as in Clapper AND Summers). As I explained in this post criticizing the Fifth Circuit’s acceptance of this argument:
[The court] seeks to argue that an injury to one of the plaintiffs is certain because there are so many women who have taken mifepristone, and complications are so common, that it is inconceivable that some AHM members would not be called upon to provide emergency room care. However, this stacks the deck in the way it presents the numbers. For example, it is noted that five million women have taken the drug since 2000. Based on the FDA’s recognition that 2-7% of cases will result in potential complications due to the drug not being fully effective, this means that there have been between 100,000 and 100,000 women. 350,000 cases where women needed additional care. But keep in mind that these numbers refer to a period of more than twenty years. On an annual basis there are 5,000-17,000 cases. Even under the patently false assumption that all of these cases require a visit to one of the thousands of emergency rooms in the United States, it is far from a “statistical certainty” that one of the recurring doctors will attend to one of these cases, as these cases they represent a small fraction of the more than 130 million emergency room visits each year.
If that wasn’t enough, the obstacle for the AHM is even greater because, by the time the case reaches the Supreme Court, the AHM’s claims have been narrowed. As initially presented, the AHM attempted to argue that the FDA had wrongly approved mifepristone in the first place. As a result, AHM argued that it faced a reasonable probability of harm arising from the availability of mifepristone on the market. In making this argument, he could use all the cases of mifepristone complications nationwide to make his case. However, AHM can no longer support these arguments.
In the following proceedings, the U.S. Court of Appeals for the Fifth Circuit (correctly) held that AHM’s challenges to the FDA’s initial approval of mifepristone were filed too late, so all that is at issue is the FDA’s slight easing of the rules governing the use of mifepristone administration in 2016 and 2021. This means that, to prove its case, the AHM must demonstrate harm to one of its members based on the additional complications caused by these regulatory changes. Complications that would or could have occurred before the 2016 and 2021 revisions are not sufficient. From my previous post:
It is now well established that standing is not dispensed on a gross basis. As the Supreme Court has repeatedly reaffirmed, the plaintiff “must demonstrate that he has standing for every claim he intends to make and for every form of compensation that is requested.” The standing to contest the action of one agency does not necessarily establish the standing to contest another. More specifically, even if plaintiffs can demonstrate that they will suffer actual or imminent harm from one FDA action (such as the approval of mifepristone in 2000), that does not mean that they will suffer actual or imminent harm from another FDA action (such as the 2016 or later revisions to the regulations governing mifepristone).
All of this should be fatal to the AHM’s Article III claims. Whatever one thinks of mifepristone or the conduct of the FDA in regulating this product for the past 25 years, the AHM has not demonstrated that it can invoke the jurisdiction of the Article III courts to challenge the FDA’s decision.
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I will have more to say after the oral argument. In the meantime, here are my previous blog posts about this case and the questions it raises:
- “Abortion Battlefields Coming,” June 22, 2022;
- “Evaluation of legal claims in Hippocratic Medicine Alliance vs. FDA,” March 8, 2023;
- “AHM v. FDA: A Contrary View and a Rejoinder,” March 28, 2023;
- “Blue-State AGs Have Lawsuit of Their Own Against Mifepristone,” March 29, 2023;
- “Two (wrong) court rulings on mifepristone in one day,” April 8, 2023;
- “The Good and the Bad of the Fifth Circuit’s Abortion Pill Ruling,” April 13, 2023.
- “BREAKING: Supreme Court to Consider Fifth Circuit Abortion Pill Decision,” December 13, 2023.
- Supreme Court Denies Red State Attempt to Intervene in Mifepristone Case, February 20, 2024.