Yesterday, the 5th Circuit Court of Appeals remanded the case from the Supreme Court. Send off Hippocratic Medical Alliance vs FDA (Mifepristone case) was brought in the district court. As readers may recall, the Supreme Court unanimously concluded that AHM had no standing to sue the FDA for relaxing its rules governing mifepristone. In fact, it wasn’t a particularly close decision.
As Josh Blackman notes in his post below, Justice James Ho wrote a separate concurrence, defending the panel’s earlier decision as a faithful application of that Supreme Court precedent, which relied on the federal government’s prior representations that the federal conscience law protects doctors from performing abortions that violate their consciences. I accept that the Solicitor General provided the Court with a stronger interpretation of the federal conscience protection than it might have provided in other cases, and that this argument provided the Court with a basis for concluding that the plaintiffs lacked standing to sue, but that SG’s concession was not necessary to resolve the case.
I reject Judge Ho’s argument that the Fifth Circuit (and the district court) “applied the precedents of the courts of competent jurisdiction to determine whether Plaintiff had standing to bring this action.” For reasons I have explained in several posts (see list below), even if we assume that federal law does not protect AHM members from performing abortions in emergency situations, AHM still fails to meet the Article III standing requirement under established doctrine.
The Supreme Court explained in its ruling: Ahmad According to the decision, in order to establish the plaintiffs’ position, they had to show that FDA’s loosening of restrictions on mifepristone “was likely to cause them to provide treatment that was contrary to their conscience.” Absent the protections of federal conscience law, this was something none of the plaintiffs could do, especially since the case was limited to FDA’s loosening of restrictions on mifepristone and no longer included the decision to approve the sale of mifepristone in the first place. So narrow was the likelihood that any member of AHM would have witnessed an emergency room visit as a result of FDA’s less stringent restrictions on mifepristone, much less been threatened with a violation of their conscience.
As I explained in my post about the Fifth Circuit’s initial ruling on this case:
The Article 3 position requires, in particular, that the plaintiff has suffered “specific and concrete” factual harm. and “Actual or imminent.” Injuries based on speculative injury or the possibility of future harm are not sufficient. As the Supreme Court explained: Clapper v. Amnesty International USA“A threatening injury must be: It’s definitely imminent The damages constitute actual damages, and the claim is as follows: possible “There is not enough protection against future injuries.”
Here, the plaintiffs claim that some of the member physicians were injured because they had to provide medical care to women who suffered complications from mifepristone. Assuming that this constitutes an injury (a controversial assumption), the plaintiffs have difficulty identifying that the government’s actions actually caused this injury to them.
The Fifth Circuit panel seeks to overcome this hurdle by arguing that plaintiffs are “statistically certain” to suffer injuries as a result of their claims that women suffering complications from mifepristone should be provided emergency room treatment. But to make this claim, the panel must avoid established doctrine and employ some trickery in the relevant claims and arguments.
First, the argument that an organization can claim standing because some of its members are statistically more likely to be harmed by government action has been explicitly considered and rejected by the Supreme Court in previous cases. Summers v. Earth Island Institute In a 2009 environmental lawsuit, plaintiffs argued that some of the hundreds of thousands of members would almost certainly be harmed by the U.S. Forest Service’s refusal to allow public comment on the sale of scrap wood. Four judges ruled that was enough to bring the lawsuit, while five did not.
write in court ageJustice Scalia explained that even if we accept the possibility that “some (unidentified) members planned to visit a small number of (unidentified) sites affected by the Forest Service procedures and that (unidentified) members would be specifically harmed as a result,” that is not enough to satisfy Article III requirements. Justice Scalia explained that this approach “makes a mockery of prior cases that required plaintiff organizations to make specific allegations that at least one identified member was or will be harmed.”
The Fifth Circuit doesn’t even mention it. ageBut I would like to suggest that the injury is not simply probabilistic, but “statistically certain.” Unfortunately, this argument is based on a bit of sleight of hand, and it doesn’t hold up when examined closely.
The panel is trying to argue that it is certain that one of the plaintiffs suffered an injury. Because so many women have taken mifepristone and complications are so common, it is hard to believe that some AHM members would not be called upon to provide emergency room care. However, the panel stacks the deck in the way it presents the numbers. For example, it states that 5 million women have taken the drug since 2000. Based on the FDA’s acknowledgement that in 2 to 7 percent of cases, the drug is not fully effective, resulting in potential complications, this means that between 100,000 and 350,000 cases have required additional treatment. Note, however, that this is over a 20-year period. On an annual basis, this equates to between 5,000 and 17,000 cases. Even assuming that every case requires a visit to one of the thousands of U.S. emergency rooms, it is far from a “statistical certainty” that one of the plaintiffs’ physicians will handle one of these cases. These cases represent only a tiny fraction of the more than 130 million emergency room visits each year.
But there is a much more serious problem with the panel’s analysis. It is well known that standing to litigate is not distributed in the aggregate. As the Supreme Court has repeatedly reaffirmed, a plaintiff “must establish standing to litigate for each claim and each relief sought.” Standing to challenge one agency action does not necessarily establish standing to challenge another agency action. More specifically, even if a plaintiff can demonstrate that he or she will suffer actual or imminent injury as a result of one FDA action (e.g., the approval of mifepristone in 2000), that does not mean that he or she will suffer actual or imminent injury as a result of another FDA action (e.g., the 2016 or later revision of the mifepristone rule).
This aspect of the position is important. AHM vs FDA Because, as the panel correctly concluded, plaintiffs’ claims against FDA’s 2000 approval of mifepristone are barred by the statute of limitations. All that is at issue is subsequent actions that changed restrictions on the distribution and administration of mifepristone in 2016 or later. And plaintiffs had to show that subsequent actions would result in actual or imminent injury in order to establish standing to sue. But that is not the analysis the Fifth Circuit panel conducted.
Instead of considering whether plaintiffs can demonstrate that FDA’s mifepristone regulation changes were likely to result in actual injury, the Fifth Circuit instead focuses on the alleged injuries attributable to the mifepristone approval. This is a flawed inquiry. To challenge the 2016 and subsequent regulatory changes, plaintiffs must demonstrate that these specific actions (FDA’s relaxation of mifepristone restrictions) resulted in or threatened injury, which is only a small subset of all mifepristone-related complications requiring emergency medical treatment relied upon in the Fifth Circuit’s opinion.
This is fatal to the Fifth Circuit’s analysis, because the complaint does not support any assertion that it is substantially likely or “statistically certain” that one of the plaintiffs will be forced to provide treatment as a result of FDA’s 2016 and subsequent changes to the rules governing mifepristone. In other words, even if we accept that mifepristone use (over decades) has “statistically certain” that emergency room treatment has occurred in hundreds of thousands of cases, that does nothing to establish the likelihood that such an outcome will occur as a result of FDA actions that plaintiffs can actually challenge.
The Fifth Circuit’s later opinion in this case was meant to address (and distinguish) these concerns. age) but never mentioned the essentially speculative nature of AHM’s claims, nor did it address AHM’s repeated misrepresentations. clapper) As mentioned in other posts:
The problem here is that AHM is alleging precisely the kind of speculative damages that the court found insufficient. Clapper v. Amnesty International. So if we allow this case to proceed, it would effectively allow a group of doctors to challenge any agency decision that would likely result in increased injury in an identifiable group of people. AHM attempts to address this issue by citing the following commentary: clapper Footnote 5 sometimes states that standing as a party to a suit can be established “on the basis of a ‘substantial risk’ of harm occurring,” but whenever this argument is made, the quotation has been conveniently cut out. What footnote 5 actually says is: “In some cases, standing as a party to a suit has been established on the basis of a ‘substantial risk’ of harm occurring. This may force the plaintiff to incur reasonable costs to mitigate or avoid the damage.” The latter requirement, namely expensive precautions to prevent damage, is not met here.
This may mean that no one can sue the FDA for failing to regulate drugs more strictly (a point I’m making here), but it’s an accepted result based on existing principles.
The current litigation law may be a mess, as some legal scholars have argued, but that doesn’t change the fact that AHM had no standing to sue FDA under current rules, and it wasn’t that difficult of a case.
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For those interested, here is a previous blog post about the AHM Mifepristone lawsuit and the issues it raises:
- “The Next Abortion Battleground,” June 22, 2022;
- “Legal Claims Assessment Hippocratic Medical Alliance vs FDA” March 8, 2023;
- “AHM vs FDA: Dissenting Opinions and Rebuttals, March 28, 2023;
- “Blue State AG Files Mifepristone Lawsuit.” March 29, 2023;
- “Two (erroneous) Mifepristone court rulings in one day”, April 8, 2023;
- “The Pros and Cons of the Fifth Circuit’s Abortion Pill Ruling,” April 13, 2023.
- “Breaking: Supreme Court Considers Fifth Circuit’s Abortion Pill Ruling,” December 13, 2023.
- Supreme Court rejects Red State intervention efforts in mifepristone case, February 20, 2024.
- Can an ER doctor sue the FDA for failing to more aggressively regulate mifepristone?, March 26, 2024.
- Supreme Court Mifepristone—Comments on Oral Arguments (Updated), March 26, 2024.
- Who Can Sue the FDA?, April 2, 2024.
- Supreme Court Unanimously Rules That FDA Regulation on Mifepristone Is Not Standing for Challenge (Updated), June 13, 2024.
- Difficulty standing, July 30, 2024.
