Justices likely to keep medication abortion available on current terms

The argument that courts should overrule the FDA's mifepristone decisions faced a skeptical Supreme Court. But, the Comstock Act waits in the wings.

Mifepristone — one of two drugs prescribed in the U.S. for medication abortion — appears likely to remain available on current terms for now following Tuesday’s arguments at the U.S. Supreme Court.

In a case that has been closely watched by abortion rights supporters and opponents, almost all of the justices were skeptical of the challengers’ request that the courts, in effect, overrule the U.S. Food and Drug Administration’s decisions on drug safety. But, Justices Sam Alito and Clarence Thomas did raise questions about whether an 1873 law, the Comstock Act, could restrict abortion access.

A strong majority of the justices questioned whether the group challenging mifepristone’s access on Tuesday has legal standing to bring their challenge. Even if they do, a majority nearly as strong similarly questioned whether the remedy ordered by U.S. District Judge Matthew Kacsmaryk and the U.S. Court of Appeals for the Fifth Circuit — blocking the FDA’s actions nationwide that have eased access to the drug since 2016 — was appropriate.

The justices, who last April kept the drug available on current terms during the litigation, aggressively challenged the Alliance for Hippocratic Medicine’s lawyer, Erin Hawley, on how and why the group was even before the court — investigating legal facts in a way that they have allowed to fall to the wayside in some other cases in recent terms.

AHM — a recently formed group of anti-abortion doctors — and its Alliance Defending Freedom lawyers wanted to end access to medication abortion after the Supreme Court overturned Roe v. Wade. They brought a case in late 2022 challenging the FDA’s original approval of the drug in 2000, as well as decisions in 2016 and 2021 loosening restrictions on the drug. Although Kacsmaryk went along with AHM on virtually all of its claims, even the Fifth Circuit rejected the group’s challenge to the 2000 approval as untimely. The justices declined to reconsider that ruling.

As such, the case before the justices on Tuesday had already been pulled back to one over the eased access to the drug under terms decided by the FDA. Specifically, in 2016, the FDA increased the gestational age at which mifepristone can be prescribed, decreased the dosage required, and decreased the number of in-person medical provider visits required. In 2021, later made permanent, the FDA ended the in-person dispensing requirement.

Nonetheless, and particularly in light of the end of Roe, the Fifth Circuit’s ruling remains one that would have profound effects if allowed to go into effect. As Solicitor General Elizabeth Prelogar said of the lower courts’ order in closing:

It harms the agency, which had the federal courts come in and displace the agency's scientific judgments. It harms the pharmaceutical industry, which is sounding alarm bells in this case and saying that this would destabilize the system for approving and regulating drugs. And it harms women who need access to medication abortion under the conditions that FDA determined were safe and effective.

The closest Chief Justice John Roberts came to challenging Prelogar on Tuesday was asking about the scope of her standing argument. In noting that she “emphasized the remote nature of the injury” claimed by AHM, he asked her, “Is there a number at which your argument would change? A significant number of consequences? A higher likelihood of an emergency room visit?”

Prelogar responded directly. “It's hard for me to imagine that it could,” she said, noting that, even if one or two facts would change in hypotheticals, “we have an objection here to the underlying theory as a legal matter because it rests on so many different things that would have to happen one on top of another and that turn on independent decisions made by third parties who are strangers to this litigation, who are not part of the suit.”

At one point toward the end of her argument, meanwhile, Hawley inadvertently summed up the incredible scope of AHM’s request when Justice Amy Coney Barrett asked her about the fact that ultrasounds had never been required under the FDA’s rules for prescribing mifepristone.

“[W]hat's allowed under FDA's rules currently is to be able to order these online with a couple of screening questions,” Hawley said. “And I don't think that's nearly as good as an in-person exam.”

That’s really it: AHM and ADF oppose abortion, and they think the FDA should require more than it does — and that their preferred rule should apply to all people nationwide.

The majority of the court appeared to believe that’s not enough for standing here and, even if it were, that’s too much for a remedy.

In fact, only Alito — the author of the Dobbs v. Jackson Women’s Health Organization opinion that overturned Roe and unleashed Tuesday’s litigation — really pushed forth arguments defending AHM’s position.

Lashing out at Prelogar at one point, Alito said, “So your argument is that it doesn't matter if FDA flagrantly violated the law, it didn't do what it should have done, endangered the health of women, it's just too bad nobody can sue in court?”

When Prelogar began responding, Alito interjected: “The American people have no remedy for that?

Prelogar, ever the professional, answered once Alito let her do so.

“I think that it would be wrong to suggest that if FDA had made a mistake and a drug were actually producing safety consequences that there would be nothing to be done,” she said, but that it would not be through these challengers in court.

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A Comstock warning

In a flashing warning sign, though, both Alito and Thomas asked about the applicability of the Comstock Act — the 1873 law that bars mailing “[e]very article, instrument, substance, drug, medicine, or thing“ advertised as for use in an abortion — that could be important going forward, as anti-abortion figures argue it could justify what would amount to a nationwide abortion ban.

On Tuesday, though, Alito and Thomas raised the Comstock Act in the context of whether the law should have figured into the FDA’s decision-making and whether it applies to the actions of Danco Laboratories, the maker of Mifeprex. The drugmaker was represented by Jessica Ellsworth, a partner at Hogan Lovells, on Tuesday. While the Justice Department’s Office of Legal Counsel, along with lower courts, have determined that the law only bans mailing such materials for “unlawful” abortions, anti-abortion leaders have argued in the wake of Dobbs that the law doesn’t contain the word “unlawful” and should be applied more broadly.

And while Ellsworth initially echoed DOJ’s position, essentially deferring to DOJ, Thomas pushed back, saying that Comstock is “fairly broad, and it specifically covers drugs such as yours.”

Ellsworth responded that she disagreed with that interpretation, but that, regardless, “[W]e think that in order to address the correct interpretation, there would need to be a situation in which that issue was actually teed up.”

Hawley, meanwhile, defended the broad interpretation of the law on Tuesday: “[W]e think that the plain text of that, Your Honor, is pretty clear.”

It did not appear likely to be a key issue Tuesday, however, in light of the court’s apparent dim view of AHM’s standing — but it did seem possible that Alito or Thomas could raise the issue in an opinion they write in connection with the case and did signal where future cases, particularly in a future Republican administration, could go.

Among the attendees at the Supreme Court on Tuesday, was Hawley’s husband, Republican Sen. Josh Hawley — who was one of 145 Republicans in Congress who submitted a brief arguing in support of AHM’s case, including on Comstock.

Although the senator was seated in the court before the arguments began, he did not wait for the arguments to end — getting up and leaving the courtroom immediately after his wife’s arguments concluded.

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On standing

The first question out of the gate for Hawley was from Thomas and it was over standing. Specifically, he asked how AHM’s organizational standing claim about “diverted time and resources” wasn’t “just the cost of litigating, of pursuing this litigation?”

After Hawley tried to explain why AHM should have organizational standing, Thomas responded that her answer would apply to “anyone who is aggressive or vigilant about bringing lawsuits.”

It went downhill for her from there. All three liberal justices challenged Hawley repeatedly on standing, as did Barrett. Roberts, as well as Justice Brett Kavanaugh, had already signaled discomfort with the challengers’ standing argument as well.

At one point, Justice Elena Kagan pushed Hawley far on the associational standing claim. Standing requires that a party show an injury, causation (the idea that the injury is appropriately “traceable” to the defendant’s conduct), and redressability (the idea that the remedy sought will actually address the injury).

Kagan went through AHM’s alleged grounds for standing, positing that it is “something along the lines of we represent a lot of doctors, and there are a lot of women out there taking mifepristone, and some fraction of them are going to have adverse events, and some fraction of those are going to come to the emergency room, and so there's some probability or likelihood that one of our doctors who has a conscience objection is going to come face-to-face with one of these women who has an adverse event.”

After some back and forth with Hawley, Kagan asked whether AHM has pointed to any doctor who is a member of AHM and has justified that they should be in court, a factor that they had essentially reached agreement was necessary for standing.

When Hawley pointed to two doctors’ declarations, Kagan responded, “[W]hat about those two doctors gives you the kind of imminent injury, let alone the traceability, that we've typically required?”

The sign of how far the case had gotten away from her was that Alito then jumped in, not to suggest that Hawley’s answer was sufficient, but instead to backtrack and argue that the court has relied on “probabilistic determinations” for standing in the past.

Of course, there is a difference between “probabilistic determinations” and the extremely speculative chain of events being claimed here.

Barrett and then Justice Ketanji Brown Jackson followed up on the specifics of the declarations that Kagan had discussed with Hawley, with Barrett pushing on the scope of the conscience objection being claimed and the number of “OB-GYNs who practice in hospitals who might be called into these ERs” who are members of AHM. On that last point, Hawley responded, “There are hundreds of them.”

As to the scope of the objection, though, Barrett said, “I think the difficulty here is that at least to me, these affidavits do read more like the conscience objection is strictly to actually participating in the abortion to end the life of the embryo or fetus.” Then, she said, “And I don't read either [of the doctors that Hawley highlighted] to say that they ever participated in that.”

In the only significant moment addressing Kacsmaryk’s initial April 2023 decision purporting to end nationwide access to mifepristone, Hawley referenced that decision in saying that Kacsmaryk had viewed the “conscience harm” more broadly.

Later, when Kagan followed up, she raised the question by saying, “[I]s there any broader conscience objection that appears — I'm not sure I care all that much about the district court — but that appears in the declarations?”

Hawley attempted to give a response, but Kagan and Jackson’s questions continued unabated.

For his part, Kavanaugh’s only question of the day was “to confirm on the standing issue” from Prelogar that “under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”

“Yes,” Prelogar responded.

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On the remedy

When discussion turned to the scope of the remedy, Hawley fared no better.

A “significant mismatch,” Jackson called it in a discussion with Prelogar, between the plaintiffs’ claimed injury — that they don’t want to have to participate in hypothetical abortions that might be required following hypothetical complications from use of mifepristone — and the remedy they are seeking.

“The obvious common-sense remedy would be to provide them with an exemption, that they don't have to participate in this procedure,” Jackson said, noting that the Biden administration says that medical providers already have that exemption. What the plaintiffs are seeking, then, is “more than that,” she explained. “They're saying, ‘Because we object to having to be forced to participate in this procedure, we're seeking an order preventing anyone from having access to these drugs at all.’ And I guess I'm just trying to understand how they could possibly be entitled to that given the injury that they have alleged.”

Prelogar agreed.

Later, Jackson raised this with Hawley, noting the exemptions highlighted by the Biden administration and ultimately asking, “Do we have to also entertain your argument that no one else in the world can have this drug — or no one else in America should have this drug in order to protect your clients?”

After Hawley began repeating her answer that the emergency nature of these situations makes objections “not possible,” Justice Neil Gorsuch, who previously has expressed dissatisfaction with “nationwide injunctions” and other broad relief issued by lower courts, began raising the issue himself.

“Recently, I think what Justice Jackson's alluding to, we've had one might call it a rash of universal injunctions or vacaturs. And this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule ….”

She said that it was “impracticable to raise a conscience objection,” but that, on the merits, the remedy of blocking the eased access nationwide was appropriate.

Roberts then jumped in: “Why can't the court specify that this relief runs to precisely the parties before the court, as opposed to looking to the agency in general and saying, ‘Agency, you can't do this anywhere?’”

Again, Hawley responded, “I think, Your Honor, that might be impracticable,” adding that a more narrow ruling wouldn’t stop “mail-order abortions.”

Gorsuch wasn’t satisfied.

“I went back and looked, and there are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt's 12 years in office, pretty consequential ones,” he said. “And over the last four years or so, the number is something like 60 — and maybe more than that.”