AHM v. FDA: A Contrary View and a Rejoinder

ADF's Erin Hawley responds to my post on the jurisdictional problems in AHM v. FDA and I reply.

On March 15, a federal district court in Texas heard arguments in Alliance for Hippocratic Medicine v. Food & Drug Administration, in which AHM is seeking to force the FDA to revoke its approval of mifepristone, a widely use abortion medication. While most commentary on the case has focused on the substance of the suit, the administrative law questions are more likely to control the outcome.

As I noted in this post on the case, there are substantial obstacles to a court properly reaching the merits of the case, including Article III standing and the statute of limitations for suits of this kind. Drawing on an analysis by Adam Unikowsky, I explained why these issues should spell the end of the case. AHM's case relies upon a very aggressive theory of standing and stretching the reopening doctrine to overcome the statute of limitations.

Erin Hawley of the Alliance Defense Fund is one of the attorneys representing AHM in the case. Below the fold I reproduce her response to my post, which largely focuses on the question of standing, and my reply.

Here is Hawley's response:

Without addressing the merits of the FDA's approval of mifepristone in 2000—under regulations requiring the FDA to find that pregnancy is a "serious or life-threatening illness"—or its deregulation of mifepristone to allow mail-in abortions in violation of the FDCA and other federal laws, Professor Adler suggested in these pages that the serious legal issues involved in Alliance for Hippocratic Medicine v. FDA should never see the light of day because the plaintiff doctors filed suit too late and because they failed to identify any particular patient who will come to them for medical help after suffering adverse consequences from a chemical abortion.

Neither procedural hurdle poses a bar here.

First, as to standing. Commentators claim that Plaintiffs' allegations are too "speculative" under the Supreme Court's decision in Clapper v. Amnesty International USA, 568 U.S. 398 (2013). The FDA similarly relies on Clapper, asserting that Plaintiffs seeking prospective relief must demonstrate "certainly impending" harm. Other commentators focus on Clapper, too, criticizing Plaintiff doctors for failing to allege "specific facts demonstrating that any particular patient will come to them." But as that post acknowledges, "these facts are impossible for the doctors to provide."

Were FDA and commentators correct about Clapper, standing to address future injuries would almost never exist. But they are wrong. At the outset, the "certainly impending" standard from Clapper does not stand alone; that case noted that the Supreme Court has also "found standing based on a 'substantial risk' that the harm will occur." Clapper, 568 U.S. at 414 n.5. And Justice Thomas recently explained that the Article III injury inquiry encompasses both: "An allegation of future injury may suffice if the threatened injury is 'certainly impending,' or there is a 'substantial risk' that the harm will occur." Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014) (citing Clapper, 133 S.Ct. at 1147, 1150, n. 5) (emphasis added). In fact, cases proceeding Clapper equated "certainly impending" with the imminence requirement, rather than viewing the former as heightening the Article III inquiry. DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 345 (2006) ("[W]e have no assurance that the asserted injury is 'imminent'—that it is 'certainly impending.'").

The Supreme Court's recent decision in Department of Commerce v. New York puts a fine point on it. There plaintiffs asserted several injuries "all of which turn[ed] on their expectation that reinstating a citizenship question will depress the census response rate and lead to an inaccurate population count." Dept. of Com. v. New York, 139 S. Ct. 2551, 2565 (2019). The Court concluded that Article III standing for the alleged future injuries existed if plaintiffs could show that "the threatened injury is certainly impending, or there is a substantial risk that the harm will occur." Id. (emphasis added). Relying on the latter formulation, the Court upheld the district court's conclusion that trial evidence "established a sufficient likelihood" that the inclusion of a citizen question would depress census response rates which would lead to undercounting of noncitizen households and the loss of federal funds. Id. The Supreme Court did not require plaintiffs to identify a "particular" non-citizen census respondent who would refuse to answer based on the citizenship question.

Department of Commerce also rejected the Clapper-based argument that harm was insufficiently imminent because it depended the independent action of third parties. The Court was "satisfied" that plaintiffs had "met their burden of showing that third parties will likely react in predictable ways to the citizenship question." Id. at 2566. This was based on the lower court's crediting "the Census Bureau's theory" that a lower response rate among noncitizen households "is likely attributable at least in part to noncitizens' reluctance to answer a citizenship question." Id. As a result, the Court fund that the plaintiffs' theory of standing did "not rest on mere speculation about the decisions of third parties; it relies instead on the predictable effect of Government action on the decisions of third parties." Id.

In this case, Plaintiff doctors and medical associations allege facts that show a sufficiently imminent future Article III injury. Plaintiffs point to FDA's own numbers which establish that between 5-8% of women who take chemical abortion drugs will need surgical intervention. When coupled with the fact that over 50% of abortions today are chemical abortions, the injury to plaintiff doctors who routinely treat emergency conditions resulting from chemical abortions is sufficiently imminent. Further, in contrast to the plaintiffs in Clapper who had never suffered harm, here, past is prologue. Plaintiff doctors attest that they "often" treat patients suffering adverse complications from chemical abortions—several doctors treating emergency medical conditions caused by chemical abortion a dozen times. And as the district court noted at the hearing, these injuries will only increase due to the FDA's approval of mail-order chemical abortions. With respect to future injury, plaintiffs have clearly shown that "there is a substantial risk that the harm will occur." Dept. of Com., 139 S. Ct. at 2565. With respect to traceability, the Plaintiff doctor's harm is not speculation but relies on "the predictable effect of Government action on the decisions of third parties." Id.

Some commentators also suggest that there is no limiting principle to Plaintiffs' theory of harm. But the harm suffered by Plaintiff doctors here is not only the harm of being forced to divert time and resources away from their other patients, but also a constitutional injury. They allege that when they are forced to complete an elective abortion by removing unborn children and pregnancy tissue this causes them to feel complicit in that elective abortion and violate their most deeply held moral, medical, and religious beliefs. And Plaintiffs' allegations also fit comfortably within caselaw regarding harm caused to the plaintiff organizations (organizational standing), OCA-Greater Houston v. Texas,867 F.3d 604 (5th Cir. 2017), as well as third-party standing, June Medical Services LLC v. Russo,140 S. Ct. 2103 (2020).

Commentators and the FDA fault the Plaintiff doctors for filing suit too late. But it is the FDA that has repeatedly dragged its feet in this case, taking over a decade to respond to Plaintiffs' 2002 citizen petition. And on the same day in March 2016 that it denied the citizen petition challenging the 2000 approval of mifepristone, the agency completely changed the regulatory framework, potentially mooting any potential court review of its decision. This delay-and-moot strategy is to blame for the decades that an unsafe drug has remained on the market. Indeed, the reopening doctrine applies to situations just like this, where the government has reexamined the necessary safeguards—here, by stripping nearly all of them from the REMS, removing in-person visits, changing the dosage, route of administration, and timing of the drugs, and allowing mail-order abortions—that served as the basis to approve the initial agency action. See Sierra Club v. Environmental Protection Agency, 551 F.3d 1019 (D.C. Cir. 2008).

The federal courts have a virtually unflagging obligation to exercise the jurisdiction given them by the Constitution. All that is required of Plaintiffs in this case, as in any case, is to establish a sufficiently imminent harm. Plaintiffs' claims have merit and they deserve to see the light of day.

I appreciate Hawley's arguments, and her taking the time to respond to my post, but I am not convinced. Starting with standing, AHM relies upon an unbounded theory that would blow apart existing limits on Article III standing. In multiple cases the Court has expressly rejected the argument that an objectively reasonable likelihood of harm is sufficient to show that an alleged injury is "actual or imminent." Indeed, that is the precise standard that a majority rejected in Clapper.

Hawley correctly notes that, in Clapper's footnote 5, the Court noted it had "found standing based on a 'substantial risk' that the harm will occur," but she truncates the quote. What Justice Alito wrote for the Court in Clapper was 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." In other words, there have been cases in which the "substantial risk" prompts a party to take actions, at their own expense, to prevent the harm. Standing is appropriate in such cases because these costs born by the plaintiffs themselves constitute a concrete injury. The "substantial risk," by itself, does not.

More broadly, the standing argument pressed by AHM would effectively declare open season on health, safety and environmental regulations of all stripes. Under AHM's theory, for instance, an auto repair shop would have standing to challenge an allegedly lax NHTSA auto safety regulation on the grounds that it will result in auto accidents that will result in more vehicles for the shop to repair. Standing does not work that way.

Unikowsky makes the same point in his post on the case:

the logical implication of the plaintiffs' position is that medical organizations have standing to challenges literally all rules that are alleged to decrease safety in any way. Suppose OSHA lifts some safety standard. A medical organization can sue claiming that (1) this will make workplaces less safe, (2) hypothetical injured employees will come to the doctor-members, and (3) the doctor-members' attention to their current patients will be diverted. Or suppose EPA alters some pollution rule. A medical organization can sue claiming that (1) this will cause people to breathe in more toxins, (2) hypothetical people who breathe in these toxins will seek medical care and come to the doctor-members, and (3) the doctor-members' attention to their current patients will be diverted.

Usually slippery slope arguments don't work because courts are able to find a limiting principle, but here, none exists—plaintiffs' argument is logically identical to those arguments. It's interesting to note that the defendants' brief makes this slippery-slope argument, and the plaintiffs' reply brief ignores it altogether. They have to ignore it, because there are no responses to it.

I am also unconvinced by Hawley's claim that AHM has filed its suit in time. (For more on why the claims may be time-barred, see this Notice & Comment post by Susan Morse and Leah Butterfield.)

There is a six-year statute of limitations for challenging an FDA action, like its approval of mifepristone. Accepting her claim that the FDA "dragged its feet," AHM's suit is still too late. That is, even if we assume that AHM is challenging the FDA's 2016 petition denial (instead of its 2000 approval of mifepristone), the statute of limitations on that claim ran in March 2022, and AHM's suit was not filed until November.

AHM wants to claim that it can challenge the FDA's 2000 approval of mifepristone because in 2021 the FDA denied their 2019 challenge to FDA's 2016 approval of a supplemental petition loosening restrictions on mifepristone. This argument rests on the claim that the FDA's 2016 action "reopened" the FDA's 2000 approval decision, but (under the relevant reopening doctrine precedents), the FDA did nothing of the kind. For good or ill, the FDA in 2016 was not considering whether it properly approved mifepristone in 2000. It was only considering whether access to mifepristone should be expanded further by loosening the restrictions on its prescription and distribution. Not only can AHM not claim that the FDA actually reopened its prior administrative decision,  it also cannot claim that FDA's actions somehow prejudiced its ability to challenge the FDA's decision (a claim the Sierra Club was able to make in the D.C. Circuit case upon which Hawley relies).

As with my prior post, none of my claims are dependent upon any particular view of the merits. Whether or not the FDA should have approved mifepristone in 2000, and whether or not the FDA should continue to allow mifepristone on the market today, AHM's suit should fail on jurisdictional grounds.