Yesterday, on remand from the Supreme Court, the U.S. Court of Appeals for the Fifth Circuit remanded Alliance for Hippocratic Medicine v. FDA (the mifepristone case) to the district court. As readers likely recall, a unanimous Supreme Court concluded that AHM lacked standing to sue the FDA for loosening the rules governing mifepristone. Indeed, it was not a particularly close call.
As Josh Blackman notes in a post below, Judge James Ho wrote a separate concurrence defending the panel's initial decision as a faithful application of applicable Supreme Court precedent that relied upon the federal government's prior representations about whether federal conscience laws protect doctors from having to perform abortions where doing so would violate their consciences. I accept that the Solicitor General offered the Court a more robust reading of federal conscience protections than may have been provided in other cases, and that this argument provided the Court with a basis for concluding that the plaintiffs lacked standing, but this concession by the SG was not necessary to resolve the case.
I reject Judge Ho's claim that the Fifth Circuit (and district court) "applied governing Court precedent to determine whether Plaintiffs have standing to bring this suit." For reasons I explained in multiple posts (see listing below), even if one assumes that federal laws would not have protected members of AHM from having to perform abortions in emergency settings, AHM still failed to satisfy the requirements of Article III standing under existing doctrine.
As the Supreme Court explained in its AHM decision, in order to establish standing the plaintiff doctors would have to establish that the FDA's loosening of restrictions on mifepristone was "likely" to "cause them to provide medical treatment against their consciences." Even without the protection of federal conscience laws, this was a showing none of the plaintiffs could make, and this was doubly so once the case was limited to the FDA's loosening of the restrictions on mifepristone, and no longer encompassed the decision to approve mifepristone for sale in the first place. So narrowed, it was entirely speculative that any member of AHM would ever even witness an emergency room visit occasioned by the FDA's less stringent regulation of mifepristone, let alone that one would have been threatened with having to violate his or her conscience.
As I explained in a post about the Fifth Circuit's initial ruling in the case:
Article III standing requires, among other things, that plaintiffs have suffered an injury-in-fact that is both "concrete and particularized" and "actual or imminent." Speculative injuries or those based on a mere probability of future harm are insufficient. As the Supreme Court explained in Clapper v. Amnesty International USA, a "threatened injury must be certainly impending to constitute injury in fact, and that allegations of possible future injury are not sufficient."
Here the plaintiffs argue that some of their member doctors suffer an injury because they have to provide medical care to women who suffer complications from mifepristone. Assuming that this constitutes an injury (a contestable assumption), the plaintiffs have a problem of identifying that this injury is actually going to happen to them as a result of the government's action.
The Fifth Circuit panel seeks to overcome this hurdle by arguing that plaintiffs "are statistically certain" to suffer their alleged injury of having to provide emergency room care to women suffering complications from mifepristone. But to make this argument, the panel has to sidestep existing doctrine and play a bit of sleight of hand with the relevant allegations and claims.
For starters, the claim that an organization can claim standing because there is a strong statistical probability that some of its members will suffer an injury from a government action has been expressly considered and rejected by the Supreme Court in prior cases, most notably Summers v. Earth Island Institute in 2009. There the environmental plaintiffs had sought to argue that it was virtually certain that some among their hundreds of thousands of members would be harmed by the U.S. Forest Service's failure to allow for public comment on a salvage timber sale. Four justices found this to be sufficient for standing; five did not.
Writing for the Court in Summers, Justice Scalia explained that even accepting the probability that "some (unidentified) members have planned to visit some (unidentified) small parcels affected by the Forest Service's procedures and will suffer (unidentified) concrete harm as a result," that was not enough to satisfy the requirements of Article III. Such an approach to standing would, Justice Scalia explained, "make a mockery of our prior cases, which have required plaintiff-organizations to make specific allegations establishing that at least one identified member had suffered or would suffer harm."
The Fifth Circuit does not even mention Summers, but does try to suggest that there is standing here because the injuries are not merely probabilistic, but "statistically certain." Alas, this claim does not hold up to scrutiny, as it is based on a bit of sleight of hand.
The panel 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. The panel 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.
There is an even deeper problem with the panel's analysis, however. 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).
This aspect of standing matters in AHM v. FDA because, as the panel correctly concluded, the plaintiffs' claims against the FDA's 2000 approval of mifepristone are barred by the statute of limitations. All that's on the table are the later actions—those in 2016 or later—which merely altered the restrictions placed upon the distribution and administration of mifepristone. And in order to demonstrate standing, the plaintiffs needed to show that they will suffer an actual or imminent injury from these later actions. Yet this is not the analysis the Fifth Circuit panel conducted.
Rather than consider whether the plaintiffs could demonstrate even a reasonable likelihood that the FDA's changes to rules governing mifepristone would cause an injury-in-fact, the Fifth Circuit instead focuses on alleged injuries attributable to the approval of mifepristone. This is the wrong inquiry. In order to challenge the 2016 and later regulatory revisions, the plaintiffs need to show an actual or imminent injury that is fairly traceable to these specific actions—the FDA's loosening of the restrictions on mifepristone—which necessarily only represent a fraction of all the mifepristone-related complications requiring emergency care relied upon in the Fifth Circuit's opinion.
This is fatal to the Fifth Circuit's analysis, as there is nothing in the pleadings to support the claim that it is even reasonably likely, let alone "statistically certain," that one of the plaintiffs will be forced to provide care as a consequence of the FDA's 2016 and later modifications to the rules governing mifepristone. Put another way, even accepting that "emergency room care is statistically certain in hundreds of thousands of cases" resulting from the use of mifepristone (over a span of decades), this does nothing to establish the likelihood of such consequences from the FDA actions the plaintiffs are actually able to challenge.
The Fifth Circuit's later opinion in the case gestured at addressing these concerns (and sought to distinguish Summers) but never engaged with the inherently speculative nature of AHM's claims (nor addressed AHM's repeated misrepresentation of Clapper). As I noted in another post:
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.
This may all mean that no one may ever sue the FDA for failing to regulate a drug more stringently (a point I address here), but that is an accepted consequence of existing standing doctrine.
It may also be the case that existing standing law is a mess (as some jurists have argued), but that does not change the fact that AHM lacked standing to sue the FDA under current doctrine, and it was not a particularly close call.
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For those interested, here are my prior blog posts about the AHM mifepristone litigation and the issues it raises:
- "The Next Abortion Battlegrounds," June 22, 2022;
- "Assessing the Legal Claims in Alliance for Hippocratic Medicine v. FDA," March 8, 2023;
- "AHM v. FDA: A Contrary View and a Rejoinder," March 28, 2023;
- "Blue-State AGs Have A Mifepristone Lawsuit of Their Own," March 29, 2023;
- "Two (Wrong) Mifepristone Court Rulings in One Day," April 8, 2023;
- "The Good and Bad of the Fifth Circuit's Abortion Pill Ruling," April 13, 2023.
- "BREAKING: Supreme Court to Consider Fifth Circuit's Abortion Pill Decision," Dec. 13, 2023.
- Supreme Court Denies Red State Effort to Intervene in Mifepristone Case, Feb. 20, 2024.
- Can Emergency Room Doctors Sue the FDA for Failing to Regulate Mifepristone More Aggressively?, Mar. 26, 2024.
- Mifepristone in the Supreme Court—Comments on Oral Argument (Updated), March 26, 2024.
- Who Can Sue the FDA?, April 2, 2024.
- Unanimous Supreme Court Finds No Standing to Challenge FDA Regulation of Mifepristone (UPDATED), June 13, 2024.
- Struggling with Standing, July 30, 2024.
The post Alliance for Hippocratic Medicine on Remand—Still Struggling with Standing appeared first on Reason.com.
