22. The Mifepristone Mess

In Dobbs, the Court claimed that it was returning abortion access to the states. After Friday's dueling mifepristone rulings, the Justices may have to revisit that promise as early as this week

Welcome back to “One First,” a weekly newsletter that aims to make the U.S. Supreme Court more accessible to all of us.

Every Monday morning, I’ll be offering an update on goings-on at the Court; a longer introduction to the Court’s history, current work, or key players; and some Court-related trivia. If you’re enjoying the newsletter, I hope that you’ll consider sharing it (and subscribing if you don’t already):

---

On the Docket

What started as a fairly quiet week at the Court ended as a noisy one. Monday’s regular Order List included a host of denials of certiorari, one of which (over the scope of a prosecutor’s obligation to disclose potentially exculpatory evidence to a criminal defendant) came over a dissenting opinion from Justice Jackson, joined by Justices Sotomayor and Kagan. Jackson is now tied with Justice Gorsuch for the most dissents from denials of certiorari so far this Term (they each have four).

On Thursday, the Court finally ruled on West Virginia’s emergency application to put back into effect the state’s ban on transgender women participating on public school girls’ and women’s sports teams. With no explanation, the Court denied the application. In a brief dissent that was joined by Justice Thomas, Justice Alito argued that the Court should have intervened at least in part because the Fourth Circuit (which had put the law on hold pending appeal) had not explained its reasoning. Of course, that hasn’t stopped the Supreme Court…

Some of the online reaction portrayed the ruling as if the Justices were taking sides in the debate over transgender student participation on single-sex sports teams. I think that that’s a mistake. There were obvious procedural problems with West Virginia’s application, not the least of which is that West Virginia had sat around for 18 months after the district court had preliminarily blocked the law from going into effect without seeking any relief from the court of appeals or the Supreme Court. That procedural delay was likely enough for some of the other conservative Justices (we don’t know which ones, of course) to join the more liberal Justices in denying relief.

Justice Alito responded to that (rather serious) procedural obstacle by arguing that, “If we put aside the issue of the State’s delay in seeking emergency relief and if the District Court’s analysis of the merits of this case is correct, the generally applicable stay factors plainly justify granting West Virginia’s application.” Yes, if we “put aside” the reasons why West Virginia might not have been entitled to emergency relief, it was “plainly” entitled to emergency relief. “Assume a can opener,” indeed.

Later on Thursday came the blockbuster ProPublica story detailing Justice Thomas’s relationship with real estate magnate and Republican megadonor Harlan Crow, and the lavish gifts, trips, and other hospitality that Thomas has received from Crow over the years. Perhaps not surprisingly, the Thomas story has sorted everyone into their usual camps about the need for ethics reform on the Supreme Court. (Dahlia Lithwick and I talked about how this story dovetails with some of the broader criticisms of the current Court in this week’s episode of Slate’s “Amicus” podcast.)

I’ll just say for now that (1) compared to what the other Justices have routinely disclosed even before recent revisions to the travel and hospitality disclosure rules, what’s documented in the ProPublica story (and not reported previously by Thomas) seems deeply problematic; and (2) I had initially been planning to use this week’s issue to introduce the 1969 resignation of Justice Abe Fortas—whose nomination to be chief justice was thwarted, and then whose resignation was compelled, after public reports surfaced about his financial relationship with financier Louis Wolfson. Folks are going to have their own views about Thomas’s behavior; it seems to me, though, that the Fortas comparison ought to be instructive. I’m still planning to write about that for next week; it’s just that … intervening events … seemed to call even more urgently for discussion today.

Finally, no Conference last week means no Order List today. But the Justices are already set to hand down one or more decisions in argued cases this Friday at 10 ET. Of course, those, too, may get drowned out by the other developments that are the focus of this week’s “Long Read.”

---

The One First Long Read: The Future of Mifepristone

[Note: I’m grateful to my sensational UT colleague Liz Sepper for helpful clarifications reflected in what follows.]

A pair of dueling district court decisions late Friday afternoon could have enormous ramifications for the future availability of mifepristone—one of the two drugs used in the most common (and safest) method of early-stage abortions, but also a drug that is commonly used to treat (1) medical management of miscarriage; (2) cervical preparation for later-second-trimester abortions; and (3) management of second- and third-trimester pregnancies when the fetus has died before birth. (It’s also used as a treatment for Cushing’s syndrome.)

And as explained in more detail below, the mifepristone issue also puts the Justices right back on the abortion hot seat less than one year after the Dobbs decision, in which both Justice Alito’s majority opinion and Justice Kavanaugh’s concurrence claimed to be returning the question of abortion access to the states. Given that, without some appellate intervention, it will become unlawful to market (i.e., introduce into interstate commerce) mifepristone at midnight CDT on Friday night, the Justices may have to revisit that promise before the week is out.

As ever, let’s start at the beginning. In 2000, after years of complex, behind-the-scenes lobbying and jousting (and three phases of clinical trials), the FDA approved mifepristone (often referred to as “RU-486,” its original designation by the French researchers who developed it)¹ for medication abortion care within the first seven weeks of pregnancy (later extended to the first ten weeks)—as part of a two-drug regimen that also includes misoprostol. Those who would like to know more about the full history would do well to start with Lauren Collins’s July 2022 essay in The New Yorker. As Collins summarizes,

The abortion pill—not to be confused with the morning-after pill, which delays ovulation, is typically taken in two stages. First, mifepristone blocks the body’s receptor for the hormone progesterone, thereby disrupting the gestation process in its early stages. Misoprostol then provokes contractions so that the uterus expels what’s left of the pregnancy, causing heavy bleeding and cramping. (According to Planned Parenthood, medication abortion feels, for most people, “like having an early miscarriage.”) In 2020, medication abortions accounted for an estimated fifty-four per cent of reported American abortions, making it, for the first time, the most common means for ending pregnancies in this country.

Originally, the FDA imposed tight constraints on how mifepristone could be obtained and dispensed, including, among other things, requiring that both prescriptions and dispensation occur in-person and from specially certified providers. (These constraints were themselves controversial given the absence of evidence that mifepristone posed the kinds of risks that usually justified such measures.)

These prescription and dispensation limits are known today as “REMS” (Risk Evaluation and Mitigation Strategies), and we’ll come back to them shortly. Eventually (after a case challenging that rule during the COVID pandemic went to the Supreme Court and the Justices put the in-person requirements back into effect), the FDA relaxed those requirements—making it easier to have Mifepristone prescribed remotely (and, later, to have it dispensed by brick-and-mortar pharmacies). In between those developments, the Supreme Court decided Dobbs—overruling Roe v. Wade and rejecting its central holding that the Constitution protects a pregnant person’s right to pursue a pre-viability abortion.

Fast forward to November 2022, when a shadowy entity formed only after Dobbs (and named the “Alliance for Hippocratic Medicine”), represented by the Alliance Defending Freedom, filed a lawsuit challenging the FDA’s 2000 approval of mifepristone and its subsequent revisions to the approvals. The Alliance appeared to operate out of, of all places, Amarillo, Texas—almost surely so that its lawsuit could be filed there. And as I explained in a previous issue of “One First,” that was no accident; by filing in Amarillo, the plaintiffs had a 100% chance of having their suit assigned to Judge Matthew Kacsmaryk—a Trump-appointed district judge who, as Caroline Kitchener documented Saturday in the Washington Post, had spent at least part of his pre-confirmation legal career as an anti-abortion advocate. (For Kacsmaryk’s rather unbecoming reaction to accusations that plaintiffs have steered cases to his courtroom on purpose, see this piece of mine from Slate.)

Late Friday afternoon, Kascmaryk made clear why the plaintiffs had chosen him. In a 67-page ruling laced with anti-abortion rhetoric, Kacsmaryk purported to “stay” the FDA’s 2000 approval of Mifepristone—the first time that a federal judge has blocked approval of a drug for humans over the FDA’s objections … ever. The heart of his analysis is that the FDA failed to fully account for all of the possible health and safety complications that those taking Mifepristone might face. Perhaps, if this were a brand-new drug that just came on the market, it would be easier to accept that analysis at face value. In this case, though, there’s 23 years of data that just don’t back that up. And that’s assuming it was appropriate for Kacsmaryk to second-guess the FDA’s analysis on the merits in the first place.

Instead, as lots of folks have spent all weekend explaining, Kacsmaryk’s analysis leaves more than a little to be desired. Among other things, the ruling runs roughshod over an array of procedural obstacles (including the plaintiffs’ lack of standing and some fairly serious statute-of-limitations problems documented by my UT colleague Susie Morse and one of her students). It thumbs its nose at 23 years of public health data (which shows that Mifepristone is significantly safer than both Penicillin and Viagra, among other drugs no judge would pull off the market). And it fashions relief that seems deliberately intended to insulate it from certain responses (more on this shortly),

The specific relief Kacsmaryk ordered is to “stay” (really, wipe out) the FDA’s various approvals of Mifepristone—which (1) doesn’t seem to require the FDA to do anything; but (2) does directly harm the two pharmaceutical companies that continue to manufacture and produce the drug; without the FDA’s approvals, it would instantly become illegal to introduce the drug into interstate commerce. (Had Kacsmaryk simply issued an injunction against the FDA, the agency could theoretically have moved slower in implementing it; by vacating the approvals directly, the order creates the specter of immediate criminal liability once it goes into effect.)

Recognizing the enormous chaos his ruling would create, Kacsmaryk agreed to stay the ruling for seven days to allow the FDA (and Danco Laboratories, one of the two U.S. companies with FDA approval, which intervened in the district court) to appeal and to seek emergency relief (in the form of a stay of Kacsmaryk’s ruling) pending that appeal. In other words, Kacsmaryk’s ruling will go into effect at midnight (CDT) on Saturday, April 15 unless either the Fifth Circuit or the Supreme Court freezes it in the interim. Both the Justice Department and Danco Labortatories have already announced their intent to appeal (and both have now formally appealed), and I expect one or both will seek a stay from the Fifth Circuit later today.

Suffice it to say, the argument for a stay will be more than a little compelling—not just because of the … weaknesess … of much of Judge Kacsmaryk’s analysis, but because the “balance of the equities” (that is to say, the question of which status quo will cause less harm) points decisively in one direction here. Mifepristone has been widely available for 23 years. It accounts for more than half of the abortions currently provided in the United States. The alternatives if it suddenly becomes unavailable are either (1) misoprostol-only medication abortions, which are less effective and more likely to have side effects (assuming no similar challenge is brought to misoprostol); (2) surgical abortions, with all of the risks that come with them; or (3) carrying pregnancies to term (with their own concomitant risks). If that’s not irreparable harm, I’m not sure what is. In the other direction, those who believe in fetal personhood can certainly argue that the continuing availability of mifepristone causes irreparable harm to unborn fetuses, but that’s about it—and at least under current law, that shouldn’t be sufficient.

But wait, there’s more. About an hour after Judge Kacsmaryk’s Good Friday bombshell, Judge Thomas Rice in the Eastern District of Washington issued his own ruling—a 31-page decision enjoining the FDA from taking any steps to restrict access to Mifepristone. That case, brought by 18 (blue) states and the District of Columbia, ostensibly sought to block a new 2023 addition to the REMS for Mifepristone (a pharmacy certification requirement), but also sought to enjoin the FDA from taking any further steps to restrict access to Mifepristone. Rice’s ruling has some problems of its own; it holds that the plaintiff-states have standing because of the downstream economic effects that would result from increased surgical abortions and pregnancy case (a theory that other lower courts have embraced, but wrongly, in my view); the restrictions on state medical providers; and other downstream costs, and it doesn’t enjoin the 2023 REMS amendment (the putative basis for seeking relief); it enjoins FDA from doing anything else. That said, unlike Kacsmaryk’s injunction, Rice limited his relief to the plaintiffs before him—a 16-state-plus-D.C. injunction rather than a truly nationwide order. And even though the FDA could theoretically appeal, one suspects it won’t be in a hurry to do so.

The specific analyses in the two district court rulings aside, together, they raise two messy sets of questions. First, how can the FDA comply with both of these injunctions? And second, what happens next?

On compliance, University of Pittsburgh Law Professor Greer Donley has a helpful summary (as part of a broader conversation with Professor Rachel Rebouche and author Jessica Valenti) of how it’s actually possible for the FDA to at least theoretically comply with both—entirely because of how Kascmaryk structured the relief he ordered. Recall that Kacsmaryk’s ruling doesn’t formally require the FDA to do anything; it purports to automatically “stay” (i.e., undermine) the approvals of Mifepristone, which will most directly affect the manufacturers, not the government. As for Rice’s ruling, as Donley notes, so long as the federal government doesn’t prosecute anyone who complies with the FDA’s 2023 REMS requirements, it may not technically be violating that injunction, either. (I’d add that prosecutions might also be consistent with Rice’s injunction so long as they take place outside of the 16 plaintiff states or the District of Columbia). In other words, the issue here isn’t the formal conflict between these two rulings; it’s the practical gulf between them—between a district court decision that, in deferring to the FDA’s findings, tries to ensure the continuing availability of mifepristone; and a different decision that, taking the science into its own hands, tries to ensure the categorical unavailability of the same. The FDA may be able, at least temporarily, to comply with both; the more important point is that only one of these views is sustainable in the long term.

As for what comes next, that’s where the Supreme Court (may) come in. As I noted above, the federal government and Danco Laboratories are sure to ask the Fifth Circuit for a stay as soon as today. That request can (and likely will) come in two forms: (1) A request for a stay pending appeal (that freezes Kacsmaryk’s ruling for as long as it takes to conclusively resolve an appeal of it, including a potential appeal to the Supreme Court); and (2) a request for an “administrative” stay, which would temporarily freeze the ruling for long enough for the Fifth Circuit to decide whether to stay Kacsmaryk’s ruling for the full duration of the appeal. If the Fifth Circuit grants either form of relief before the end of the day Friday, then this probably stays out of the Supreme Court for now; it seems more than a little unlikely that the plaintiffs in the Amarillo case would try to ask the Supreme Court to vacate such a stay.

But there are reasons to be wary of the Fifth Circuit in this context. It has generally been very reluctant to grant emergency relief to the Biden administration (one of the few examples of it doing so with which I’m familiar was reversed en banc). And in the abortion context, specifically, part of why the SB8 case got to the Supreme Court so quickly in August 2021 (and so close to Texas’s six-week abortion ban’s September 1 effective date) is because the Fifth Circuit panel just sat on a ruling on a stay application for more than 10 days, even as the clock was ticking to—and past—September 1.

If I’m the Biden administration, I’m wary about the specter of history repeating. So we might also see the federal government, in addition to seeking the relief described above, ask the Fifth Circuit to rule up or down on an administrative stay (the temporary one) by, say, no later than Wednesday—to make sure it still has time to seek the same relief from the Supreme Court. Thus, it’s possible that the mifepristone issue makes its way to the Court this week, either because the Fifth Circuit refuses to even temporarily pause Kacsmaryk’s ruling, or because it takes too long to do anything.

At that point, or if the issue doesn’t get to the Court until later, the question would become whether the Justices who stressed the importance of returning the question of abortion access to the states meant what they said in Dobbs. Here’s a case in which a single federal judge has claimed the power to dramatically curtail abortion access on a nationwide basis, even in states in which it’s not only legal, but protected by the state constitution. And he did so in an opinion that is suffused with both procedural and substantive flaws that even conservative appellate judges may find difficult to endorse. It’s easy to imagine that there are four votes to, at the very least,² put the ruling on pause for however long it takes for the case to make its way through the lower courts (including Chief Justice Roberts and the three dissenters in Dobbs). The question to which we might have an answer by the end of the week, an answer that will have implications far beyond the specific (but massively important) future of mifepristone, is whether there are five.

---

SCOTUS Trivia: The Strict Scrutiny Intro

Subscribers to the “Strict Scrutiny” podcast will be familiar with the opening audio—a male advocate opening his oral argument before the Supreme Court by saying that “It’s an old joke, but when a man argues against two beautiful ladies like this, they are going to have the last word.”

As inappropriate and off-putting as that opening would have been in any oral argument, folks who haven’t heard the Strict Scrutiny hosts (or others) identify it might be even more surprised to learn the specific oral argument in which it was given: The (first) argument in Roe v. Wade itself, on December 13, 1971. The lawyer was Jay Floyd, then the Assistant Attorney General for the State of Texas.

---

I hope that you’ve enjoyed this installment of “One First.” If you have feedback about today’s issue, or thoughts about future topics, please feel free to e-mail me. And if you liked it, please help spread the word!:

If you’re not already a paid subscriber and are interested in receiving regular bonus content (or, at the very least, in supporting the work that goes into this newsletter), please consider becoming one! This week’s bonus issue will drop Thursday morning at 8 ET. And I’ll also have some exciting news to share tomorrow (Tuesday, April 11) about the pre-order campaign for my forthcoming book on the Court’s “shadow docket,” so stay tuned for that, as well.

Happy Monday, everyone! I hope you have a great week.

1. It is most commonly manufactured and sold as “mifeprex,” and often referred to in shorthand as “MiFe.” For consistency, I refer to the drug as “mifepristone” throughout this post.

2. If the matter does get to the Supreme Court this week, another question is whether the Justices are content to rule up or down on a stay while leaving the appeal to the lower courts in the first instance, or whether any ruling on a stay comes alongside a decision to expedite full consideration of the merits—by granting “certiorari before judgment.”