Can Emergency Room Doctors Sue the FDA for Failing to Regulate Mifepristone More Aggressively?

March 26, 2024   |   Tags: , , ,

This morning the Supreme Court will hear oral argument in FDA v. Alliance for Hippocratic Medicine, a challenge to the manner in which the Food and Drug Administration regulates mifepristone, a medication that is used to terminate pregnancies.

The biggest challenge for AHM, the group challenging the FDA, is demonstrating that federal courts have jurisdiction to hear its claims. AHM would like the FDA to regulate mifepristone more stringently, or prohibit its use altogether. In effect, AHM is arguing that the FDA needs to regulate someone else (in this case, mifepristone manufacturers and prescribers) more stringently than it has done. As always in standing cases, asking the courts to force the government to treat a third party differently can be a heavy lift.

AHM's standing claim is based on the argument that AHM's members are injured when women who take mifepristone face complications and seek assistance in emergency rooms. Having to observe and treat such complications causes a cognizable injury, AHM argues, because providing treatment in such cases makes doctors feel complicit in abortion, violates their conscience, and may even expose them to liability.

Assuming that actions by third parties (in this case, the FDA) that force individuals to do their jobs (in this case, anti-abortion ER doctors treating patients) constitutes a cognizable injury for Article III purposes, AHM faces the larger problem of being unable to identify specific doctors who will face specific instances. Rather, they are claiming that the risk of these things has increased because mifepristone is available. The problem here is that AHM is alleging precisely the sort of speculative injuries the Court held were insufficient in Clapper v. Amnesty International. Thus allowing this case to go forward would, in effect, allow groups of doctors to challenge any agency decision that could conceivably result in an increase in injuries among an identifiable group of people. AHM tries to address this problem by citing the comment in Clapper footnote 5 that standing can sometimes be shown "based on a 'substantial risk' that the harm will occur," yet manages to conveniently truncate the quote every time it this argument is made. What footnote 5 actually says is that: "In some instances, we have found standing based on a 'substantial risk' that the harm will occur, which may prompt plaintiffs to reasonably incur costs to mitigate or avoid that harm." That latter requirement—costly anticipatory actions to prevent harm—is not met here.

In effect, AHM is making the sort of probabilistic injury claim that the Supreme Court routinely rejects (as in Clapper and Summers). As I explained in this post critiquing the Fifth Circuit's acceptance of this argument:

[The court] tries to argue that an injury to one of the plaintiffs is certain because there are so many women that have taken mifepristone, and complications are so common, that it is inconceivable that some of AHM's members will not be called upon to provide emergency room care. This stacks the deck though in the way it presents the numbers, however. For instance, it notes that five million women have taken the drug since 2000. Based on the FDA's acknowledgement that in two-to-seven percent of cases will involve potential complications from the drug not fully working, this means there have been between 100,000 to 350,000 cases in which women have needed additional treatment. But note that these numbers are for a twenty-plus-year period. On an annual basis, this represents 5,000 to 17,000 cases. Even making the demonstrably 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 plaintiff doctors will handle one of these cases, as these cases represent a tiny fraction of the over 130 million emergency department visits each year.

Were that not enough, AHM's standing hurdle is even greater because, as the case reaches the Supreme Court, AHM's claims have been narrowed. As initially filed, AHM sought to argue that the FDA wrongly approved mifepristone in the first place. Accordingly, AHM argued that it faced a reasonable likelihood of harm from the availability of mifepristone on the market. In making this argument, it could use all instances of mifepristone complications nationwide to help make its case. Yet AHM cannot make such arguments any more.

In the proceedings below, the U.S. Court of Appeals for the Fifth Circuit (correctly) held that AHM's challenges to the the FDA's initial approval of mifepristone were made too late, so all that is at issue is the FDA's slight loosening of the rules governing mifepristone's administration in 2016 and 2021. This means in order to demonstrate standing AHM needs to demonstrate injury to one of its members based upon the additional complications caused by these regulatory changes. Complications that would or could have happened prior to the 2016 and 2021 revisions are not enough. From my prior post:

It is well established that standing is not dispensed in gross. As the Supreme Court has repeatedly reaffirmed, a plaintiff "must demonstrate standing for each claim he seeks to press and for each form of relief that is sought." Standing to challenge one agency action does not necessarily establish standing to challenge another. More specifically, even if the plaintiffs can establish that they will suffer an actual or imminent injury from one FDA action (such as the 2000 approval of mifepristone) that does not mean that they will suffer an actual or imminent injury from another FDA action (such as the 2016 or later revisions to the rules governing mifepristone).

All of this should be fatal to AHM's claims for Article III standing. Whatever one thinks of mifepristone or the FDA's conduct regulating this product over the past 25 years, AHM has not demonstrated that it gets to invoke the jurisdiction of 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 prior blog posts about this case and the issues it raises:

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