Yesterday the U.S. Court of Appeals for the Fifth Circuit issued an unpublished order in Alliance for Hippocratic Medicine v. Food and Drug Administration, partially staying last week's district court order effectively suspending the FDA's approval of mifepristone, a widely used abortion medication. The 42-page order was considered and produced on an extremely tight schedule, and managed to correct some of the more egregious errors in the lower court's decision. But the Fifth Circuit panel's decision still has some problems, some of which I highlight below.
The stay requests were filed by the FDA and Danco Laboratories, a manufacturer of mifepristone. The panel considering the stay applications consisted of Judges Oldham, Engelhardt, and Haynes. The unsigned per curiam order granted a stay pending appeal covering parts of the district court's order. Basically, the panel stayed those portions of the order suspending the FDA's 2000 approval of mifepristone, but not those concerning actions taken by FDA concerning mifepristone in 2016 or later. Judge Haynes concurred only in part, as she would have granted an administrative stay of the lower court ruling in its entirety, and deferred consideration of the stay pending appeal to the merits panel ultimately assigned the case. (Note that, contrary to some reports, this does not mean that Judge Haynes disagreed with her colleagues on any points. It could instead merely indicate that she did not want to resolve some of these questions on an expedited basis.)
As for the substance of the opinion, there are some good things about the Fifth Circuit's order, particularly when compared to the work of the district court. For starters, the Fifth Circuit recognized that AHM's challenges to the FDA's 2000 approval of mifepristone are barred by the applicable statute of limitations, even when one considers the reopening doctrine. The panel also did not buy the creative equitable tolling argument advanced by the district court. It further rejected AHM's too-clever argument that the FDA's appeal should be dismissed because the district court's stay was insufficient to grant the Fifth Circuit interlocutory appellate jurisdiction. This argument was quickly and correctly dispatched in a brief footnote.
While the Fifth Circuit's order was an improvement over that of the district court, it still had some problems, most notably with standing. The standing arguments adopted by the panel were more narrow and focused than those put forward by the district court, but they still misapplied precedent and would throw open the door to expansive standing arguments. I addressed my concerns about the plaintiffs' standing in my prior posts on this litigation. I will not reiterate those points. Adam Unikowsky has also surveyed some of the problems with the Fifth Circuit's standing analysis in a post highlighted by Orin below. If anything, he understates 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 panel also concluded that the plaintiff associations "have also suffered independent injuries because FDA's actions have frustrated their organizational efforts to educate their members and the public on the effects of mifepristone." This conclusion, relying upon an expansive interpretation of the Supreme Court's decision in Havens Realty Corp. v. Coleman, effectively concludes that any time a government agency takes an action contrary to the mission of a public interest group, that group suffers an Article III injury. Such a conclusion is inconsistent with core principles of Article III standing, would blow open the doors for interest-group standing, and is not supported, let alone compelled, by Havens Realty.
This Havens-based standing theory is quite similar to that pushed by CREW in its emoulments clause litigation against Donald Trump, and suffers some of the same flaws. In Havens Realty, the Supreme Court held that a local non-profit, Housing Opportunities Made Equal (HOME), had standing to challenge violations of the Fair Housing Act because such violations frustrated HOME's purpose. Specifically, HOME operated counseling and referral services to help individuals find homes and advance the cause of increasing housing opportunity, and argued that unlawful housing discrimination made it more difficult and costly to perform those functions. This is distinguishable from the injuries alleged by AHM.
Whereas HOME had to spend more resources because unlawful discrimination made it more difficult to find homes for those it served, the Fifth Circuit panel claims AHM has standing because it has "expended time energy and resources" to collect information on mifepristone "to the detriment of other advocacy and educational efforts." Whereas HOME could allege "concrete and demonstrable" injuries to its core activities that were "far more than simply a setback to the organization's abstract social interests," AHM has not.
It is also worth noting that Havens Realty concerned a statute with provisions expressly authorizing private suits to enforce its requirements. With this provision, Congress made clear it wanted to do as much as possible to facilitate more stringent enforcement of the FHA's terms through private litigation, a point Justice Brennan stressed in his opinion for the court. AHM relies upon no comparable provision creating a cause of action under the Food, Drug and Cosmetic Act.
The standing analysis is not the only problem with the panel's opinion, but it strikes me as the most serious, as it is a threshold, jurisdictional issue. Without standing, there is no basis for the court to consider the remaining claims.
As for other issues reached by the panel, I am concerned it misapplied the arbitrary-and-capricious standard under the Administrative Procedure Act. Under MVMA v. State Farm, an agency action is arbitrary and capricious if an agency fails to consider the "relevant factors" or "an important aspect of the problem." The panel interprets this to mean that an agency cannot base a regulatory change on studies that examine the effects of the regulatory status quo, and must instead rely upon studies of the effects of changes that have not yet been made. That is simply not how the relevant analysis works.
Contrary to the panel's suggestion, there is nothing wrong with an agency basing a decision to modify or eliminate regulatory requirements upon studies of the status quo. What matters is whether the agency's analysis addresses and accounts for that aspect of the relevant studies (and this is precisely what State Farm holds). Put another way, the requirement of reasoned decisionmaking focuses more on the analyses and rationales offered by the agency, including how the agency assessed and evaluated available data and its implications for various policy options, than on what data was available. Indeed were it otherwise, agencies would be effectively precluded from relying upon empirical studies of actual conditions when making decisions to alter existing rules and might be precluded from making meaningful regulatory changes altogether.
This does not mean that the FDA's rationale for revising the rules governing mifepristone were adequate under the APA. On that question, I have no opinion. My point is rather that the standard the Fifth Circuit applied is not that which is required by current law, nor one that can be derived from general principles of agency decision-making.
It is certainly possible that the FDA made errors in judgment or failed to engage in reasoned decisionmaking when approving and setting policies concerning mifepristone in 2000, 2016 or later. It also may well be the case that distributing mifepristone through the mail is prohibited by the Comstock Act. But before a court can consider such claims, there needs to be a plaintiff who can satisfy the requirements of Article III standing.
The Department of Justice has announced it will seek further relief from the Supreme Court, so there is at least one more opportunity for the federal courts to get the jurisdictional questions in this case right.
