American women, who have in recent years been given plenty to worry about, can, it seems, breathe easier in one respect—it seems less likely that they will wake up one morning in June and find Samuel Alito, M.D., ready to discuss their reproductive choices. Not that the justice would object to such duty—indeed, he is quaveringly eager for it—but his fellow Supreme Court justices’ questions during argument on Tuesday in Food and Drug Administration v. Alliance for Hippocratic Medicine suggest they are not quite ready to assign it to him. Even other members of the hard-right conservative bloc on this post-Trump Court seemed less than eager to exchange their black robes for white coats.
Hippocratic Medicine concerns mifepristone, a drug approved by the FDA in 2000 and made more widely available in 2016. The drug—marketed in the United States as Mifeprex—is part of a two-drug regimen that is used to induce a medical abortion (that is, not one involving surgery). The drug is in wide use in the U.S.—according to the latest figures from the Guttmacher Institute, last year there were 642,700 medication abortions—63 percent of all abortions nationwide. The use of medication abortion has sharply increased since the Supreme Court overruled Roe v. Wade. Because it is available by mail after a telehealth consultation, medication abortion offers access to abortion to some women who live in states with abortion bans. For this reason, it is a stench in the nostrils of the anti-abortion movement, which fought its initial approval for more than a decade before the FDA finally gave its go-ahead in 2000 and remains determined to put an end to its use.
Both here and worldwide (France and China approved the drug as early as 1988), it has proved safe and effective when used together with a second drug called misoprostol. But an article of faith for the anti-abortion movement is the claim that abortion—any kind of abortion, for any reason, by any method—harms the women who choose it. They have insisted for a quarter century that medical abortion—brought about by a combination of the two drugs—has unacceptable safety risks. During this time, no court agreed—partly because the evidence doesn’t support the claim, but in larger part because American courts have been pretty reluctant to jump in and substitute their scientific judgment for that of an agency dedicated to scientific and medical policy. “To the government’s knowledge,” the U.S. wrote in a brief in Hippocratic Medicine, “this case marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.”
Here’s some background, shorn of some intricate litigation details: When it first approved mifepristone in 2000, the FDA required doctors to prescribe it after an in-person visit with the pregnant patient (one of three in-person visits required) and to verify that she was no more than seven weeks pregnant. In 2016, the agency, based on statistics compiled since the original approval, loosened these restrictions: mifepristone could now be prescribed without required second and third visits, could be prescribed by a physician’s assistant rather than only by a doctor, and could be used to terminate a pregnancy as late as ten weeks.
Then came COVID-19. In 2020, reacting to the pandemic, a federal judge ordered the FDA to allow telehealth sessions instead of in-person visits. The Supreme Court overruled that order and in 2021, the agency itself decided that telehealth was a safe way to dispense the drug.
It should not escape notice that the 2021 rule change came about after the Biden administration took over from its predecessor, and the federal attitude toward abortion shifted. But Donald Trump had left behind some booby traps for the FDA, in the person of radical anti-abortion judges at the trial and appeals court levels. One of these, Matthew Kacsmaryk, is a former Christian-right activist who became a U.S. District Judge for the Northern District of Texas. He located his chambers in its Amarillo Division—where he is the only sitting judge. That means conservative litigation groups can file their agenda lawsuits there, knowing they will get a friendly ear.
In June 2022, as the world knows, the newly dominant conservative bloc on the Supreme Court decided Dobbs v. Jackson Women’s Health Organization, ostentatiously voiding any possible claim that the constitution protects individuals’ decisions about abortion. By a bizarre coincidence, it was only two months later that a group of anti-abortion doctors and activists chose Amarillo as the headquarters for a new organization called the Alliance for Hippocratic Medicine. Again, by a striking happenstance, they filed suit in November 2022 against the FDA, seeking the complete removal of mifepristone from legal use. Kacsmaryk was happy to grant a sweeping nationwide order doing just that. The FDA had made scientific errors in approving the drug at all, Kacsmaryk wrote, and thus, no one in the United States could prescribe or use it. For good measure, Kacsmaryk also decided that having a drug that could be mailed violates the 1873 Comstock Act, a “vice” law that bans the mailing of dirty books or “abortifacients” and has not been enforced for more than 50 years.
The government and Danco Labs, the manufacturer of Mifeprex, appealed to the Fifth Circuit. This is probably the federal appeals court most thoroughly destabilized by the arrival of a coterie of far-right Federalist Society picks. A three-judge panel held that Kacsmaryk had gone too far in voiding FDA approval altogether (too much time had passed to challenge the 2000 decision, they said) but upholding his injunctions against the 2016 and 2021 decisions that made the drug easier to obtain and use.
The Supreme Court put the order on hold pending its own consideration. Meanwhile, in the wake of Dobbs and the apparent extremism of the new conservative majority, the decisions below spread consternation among both advocates for reproductive choice and the pharmaceutical industry in general. In the U.S. brief, Solicitor General Elizabeth Prelogar told the high court: “To the government’s knowledge, this case marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.” If that habit caught on, of course, it could lead to wacky lower-court decisions voiding approval of contraceptive pills and devices or drugs used for other medical procedures on the far-right hit list (e.g., in-vitro fertilization or IVF).
Important Supreme Court arguments often (as generations of stupefied law students know) turn on staggeringly dull issues of jurisdiction. Tuesday’s argument centered on the question of who can sue a federal agency to void a regulatory decision, what kind of evidence is needed to do that, and what injury is inflicted on doctors who object to abortion if women are permitted to take drugs—found to be safe and effective by the Food and Drug Administration—that induce abortions and on very rare occasions may cause complications. Notably absent was much discussion of the effect of a mifepristone ban on the safety, and indeed survival, of American women.
Federal courts can’t hear a lawsuit that, in effect, says, Those people are doing something I don’t like. Please make them quit. The issue is called standing to sue, and ordinarily objecting to a government action doesn’t qualify. Instead, courts ask whether the plaintiff has an “injury in fact,” whether the government caused the injury and whether a court’s order could remedy it.
By those standards, the Alliance for Hippocratic Medicine hasn’t got much going for it. The injury to AHM’s members, as I puzzle it out, is that some woman somewhere may take mifepristone and suffer one of the exceedingly rare complications that would require doctors to treat her by aborting a viable fetus. And that woman may come into an emergency room where an AHM member works, and the AHM member will be the only doctor who can treat this woman—or must help the doctor who does. This, explained religious right superstar lawyer Erin Hawley, on behalf of AHM, would make them “complicit in the process that unnecessarily takes an unborn life.”
The operative words are “someday may.” AHM cites two doctors as suffering this injury—but neither doctor, according to their own declarations, has ever actually been forced to intervene with a mifepristone complication that led to the termination of a pregnancy that was viable at the time the patient came to them.
As injury goes, the argument that someday something unlikely but bad might happen to me if something unlikely but bad happens to somebody else and that person happens to come where I am is ordinarily regarded as pretty thin-standing gruel. The association’s real complaint is the claim that the FDA shouldn’t have loosened its mifepristone rules in 2016 and 2021 because the FDA relied on the wrong studies or had drawn the wrong inferences from them.
Despite some years in my wasted youth as a science writer, I have no more expertise in interpreting studies of this sort than anyone else—which is to say, roughly as much as the lawyers for AHM or the justices. I will not nitpick this claim except to say that making judgments like this is what we, the people, acting through Congress, create agencies like the FDA to do. The agency, which has a budget of $6.5 billion and employs 18,000 people, is almost certainly more likely to be right on a drug-safety question than Matthew Kacsmaryk figuring on the back of an envelope. Of course, mistakes occur, and unsafe drugs slip through initial approval—but the agency’s own procedures and the requirements it imposes on drug manufacturers require both to track the safety and effectiveness of drugs even after approval. The agency regularly steps in to void an earlier approval or tighten its rules for use. This suggests that something is working.
Even if one assesses the agency’s performance more harshly than I do, the plaintiffs in Hippocratic Medicine have provided no evidence that they could do the job better. The pharmaceutical industry is terrified of a takeover of drug regulation by the Alitos and Kacsmaryks of the world. As Jessica Ellsworth, representing Danco Laboratories, told the court Tuesday, a victory for AHM “would upend not just Mifeprex but virtually every drug approval and REMS modification FDA has made for decades.”
The standing issue, which would permit the Court to finesse the scientific one, seemed to fascinate justices on both sides of the ideological divide. Justice Amy Coney Barrett quizzed Solicitor General Prelogar about federal statutes and regulations that protect medical personnel from being required to perform actions that violate their consciences. “It is your position that such doctors would have recourse to the conscience protections of federal law?” she asked—and followed up by asking whether that would be true despite a separate federal statute, the Emergency Medical Treatment and Active Labor Act, which requires hospitals to treat pregnant patients in emergency rooms. EMTALA, Prelogar said. “imposes obligations on hospitals”—not individual doctors. Hospitals, she noted, can and do work around the conscience objections of staff. “I understand, as a matter of best practices, they often ask for doctors to articulate their conscience objections in advance so they can take account of that in staffing,” she went on.
Justice Brett Kavanaugh made the same point: “Just to confirm on the standing issue, under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”
Prelogar happily agreed.
Justice Elena Kagan told Alliance lawyer Hawley that for AHM to have standing, “You need a person to be able to come in and meet the courts’ regular standing requirements.” When Hawley agreed, Kagan asked, “So, who’s your person?” None of the doctors’ declarations, she noted, actually said that the doctor making the statement had been forced to perform an abortion of a viable fetus on a mifepristone patient in an emergency room. “I don’t think you have it for either one of those doctors.”
Justice Ketanji Brown Jackson, too, pointed out that, rather than try to shut down medical abortion coast to coast, the plaintiffs could have just asked for a ruling that they themselves didn’t have to work with mifepristone patients. “There is a significant mismatch in this case between the claimed injury and the remedy that’s being sought and that that might or should matter for standing purposes,” she said, adding:
I see it that the injuries that the respondents allege, as you’ve articulated them, are a conscience injury, that they are being forced to participate in a medical procedure that they object to. The obvious common-sense remedy would be to provide them with an exemption so that they don’t have to participate in this procedure. And you say, and you’ve said here several times, that federal law already gives them that. So, I guess then what they’re asking for in this lawsuit is more than that. 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.
But nobody seemed as taken with the standing issue as Justice Neal Gorsuch, who has defended expansive standing rules in agenda cases like 303 Creative v. Elenis (a Christian web designer who claimed she might be asked to do a wedding page for a gay couple someday) or Kennedy v. Bremerton School District (a praying football coach who complained of being fired even though he hadn’t actually been, you know, fired). Sounding vaguely like an Old Testament prophet, Gorsuch lectured Hawley:
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 or any other federal government action. . .. 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. And over the last four years or so, the number is something like 60 and maybe more than that. They’re a relatively new thing. And you’re asking us to extend and pursue this relatively new remedial course, which this Court has never adopted itself.
All told the disposition on the bench seemed to be to toss the case on the standing issue. Whether justices should play doctor would be left for another day.
But even if the case is thrown out on standing grounds, we can at least be sure that America’s very own Doogie Howser, J.D., Samuel Alito, stands ready to regulate any and all health and safety conditions that catch his eye. He rather plaintively asked Prelogar, the Solicitor General, “Is there anybody who can sue and get a judicial ruling on whether what the FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?” In disbelief, he went on, “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? There’s no remedy? The American people have no remedy for that?”
“The American people,” in this context, seem to consist of, from left to right, Alito himself. He would be a curious choice as tribune of the people. There’s no real question that a large majority of the public disagrees with him profoundly on the issue of abortion.
As of now, the American people have no remedy for that.
