An Abortion Drug Tests the Supreme Court

The Supreme Court may have thought it excused itself from the business of reviewing abortion laws last summer when it overturned Roe v. Wade and declared that there is no constitutional right to terminate a pregnancy. But this week the issue is back before the justices. The Biden administration and Danco Laboratories, the pharmaceutical company that makes mifepristone—a drug that induces abortion in early pregnancy and is used for more than half of all abortions in the US every year—have asked the Court to block lower court orders that would deny access to it nationwide, even in states where abortion is legal. The Food and Drug Administration (FDA) has approved mifepristone as safe and effective over the course of five different administrations, including those of George W. Bush and Donald Trump. And among the more than five million women who have used it, the FDA states, “serious adverse events” have been exceedingly rare.

Yet on April 7 a federal district judge in Texas, Matthew Kacsmaryk, declared the FDA’s two-decade-long approval of the drug unlawful in response to a suit by doctors and medical groups opposed to abortion. He delayed his order for seven days to allow the parties to seek a stay from the US Court of Appeals for the Fifth Circuit. Just before midnight on Wednesday, April 12, and only hours after the briefing was complete, a divided panel of the court of appeals issued a forty-two-page decision. It stayed one part of the district court’s order but left the rest in place, effectively requiring the generic version of the drug to be taken off the market altogether and precluding distribution of the original drug until it is relabeled to comply with reimposed restrictions the FDA deemed unnecessary years ago. (Among other things, the ruling would have the perverse effect of requiring the drug to be labeled for a years-old dosage three times higher than the FDA has since concluded is required.) Meanwhile, in a separate case, a federal district court in Washington State has ordered the FDA not to alter its procedures or requirements for mifepristone, leaving the FDA vulnerable to contempt charges from one court if it changes its approach and from another court if it doesn’t. 

How the Supreme Court resolves the application for a stay will reveal a great deal about the justices. If they are so personally committed to obstructing access to abortion that the law doesn’t matter, they will deny the stay and allow the lower court orders to remain in place; few judicial acts could do more to deny women effective access to abortion. But if they are committed to conservative principles of judicial restraint and the separation of powers, they will grant the Biden administration’s request for a stay and reject the challenge altogether. 

The underlying case, which Liza Batkin aptly described in these pages last month, charges that the FDA acted illegally both when it approved mifepristone in 2000 and when it later allowed women to obtain the drug by mail or from certified pharmacies, authorized state-approved health care providers (beyond physicians) to prescribe it, reduced the recommended dosage, extended its use from seven to ten weeks of pregnancy, and approved a generic version of the drug. The challengers claim that all of these decisions were illegal, and that allowing the drug to be sent in the mail violates a nineteenth-century federal law, the Comstock Act, which prohibits the interstate shipment of any item to be used for abortions but has been interpreted for a century as limited only to shipments intended for use in unlawful abortions. 

Kacsmaryk, a Trump appointee, has become the judge of choice for all causes conservative. (On April 15 The Washington Post reported that while under consideration for judicial nomination he removed his name from a law review article he had submitted that expressed opposition to abortion and transgender rights, substituted the names of other authors, and then failed to disclose the article to the Senate during his confirmation process.) Because Kacsmaryk is the only judge who sits in the federal district in Amarillo, Texas, litigants can ensure he will preside over their case by filing there. Before filing, the plaintiffs created a local corporation so that they would have an excuse to file in Amarillo. Kacsymaryk’s decision, which accepted practically every argument the challengers made, ran roughshod over the many substantive and procedural hurdles to hearing a challenge to a twenty-three-year-old decision by a federal agency brought by individuals who can claim no concrete injuries.

In response to the FDA’s request for a stay, the court of appeals reasoned that the statute of limitation likely barred the challenge to the agency’s original approval in 2000 of the patented version of mifepristone, Mifeprex, and therefore stayed the district court’s order on that issue. But by a 2-1 vote, with two Trump appointees outvoting a George W. Bush appointee, the panel declined to stay the rest of the order, which declared that all the FDA’s subsequent changes to its mifepristone rules were unlawful—including approving the generic form of the drug, which accounts for two thirds of its market. The result, according to the FDA and the drug manufacturer, is that if the court of appeals decision takes effect, all existing doses of mifepristone would “immediately become misbranded” and the generic version would lose its approval. If the Supreme Court doesn’t step in, the majority of the mifepristone supply will “disappear overnight.”  

Upon the Biden administration’s appeal, Justice Alito granted a limited “administrative stay” only until Wednesday at midnight to give the Court some—but not much—time to consider the matter. The fate of the drug used for most abortions now rests in the hands of the nine justices. 

Except for its subject, this is exactly the kind of case judicial conservatives hate. It was brought by an ideological organization on behalf of doctors who have no real stake in the dispute; they do not prescribe or use the drug, much less provide abortions. They claim it requires immediate preliminary relief, even though the drug has been in use for two decades. The suit invites federal judges with no medical expertise to second-guess the expert judgment of an agency Congress expressly authorized to make such decisions. And it challenges the FDA’s decisions on the basis not of the record the agency actually considered, which included scores of peer-reviewed studies and clinical trials showing that the drug is very safe, but on the basis of articles that lack even superficial reliability. To take just one example, the plaintiffs argued, and the district court agreed, that “fourteen percent of women and girls reported having received insufficient information” about medication abortion based on a study that consisted of reviewing fifty-four anonymous blog posts by women who apparently regretted having an abortion and wrote about it for an antiabortion website. 

To even take up the doctors’ challenge, the justices would have to abandon their commitment to the doctrine of “standing,” which Justice Antonin Scalia described as “an essential element of the separation of powers” and a critical check on judicial power. This doctrine requires plaintiffs to demonstrate that they face a concrete injury. Absent one, the courts lack power to act, because the Constitution gives them the authority only to decide actual “cases or controversies.” Even though the doctors do not prescribe the drug or perform abortions, they argue that they face the risk of future injury because someone who is prescribed mifepristone by someone else might develop one of the “exceedingly rare” complications and seek care in an emergency room, and one of the objecting doctors might have to provide that care. But the Supreme Court has ruled that to sue based on future injury “the threatened injury must be certainly impending,” and here the asserted injury is entirely hypothetical, as it rests on a speculative chain of events involving the independent decisions of multiple third parties. Under similar circumstances the Court has consistently rejected standing to sue. As the Biden administration argues, if this is sufficient for standing, there’s no limit:

Pulmonologists could sue the Environmental Protection Agency to challenge regulations that increased (or reduced) air pollution; pediatricians could sue the Department of Agriculture to challenge standards that imperiled (or improved) student nutrition; and emergency room doctors could sue the government to challenge regulations that loosened (or restricted) access to firearms.

The challengers’ arguments on the merits fare no better. Administrative law does allow affected parties to challenge FDA approval of a drug, but it requires judges to apply a very deferential standard and overrule the FDA only when the agency’s actions are “arbitrary or capricious” or “contrary to law.” The federal courts cannot substitute their judgment for that of the FDA. And for good reason: the FDA is staffed by experts in reviewing and approving medications. The courts’ review, moreover, must generally be based on the “administrative record” the FDA relied on in making its decision. Yet in this case neither the district court nor the court of appeals have even reviewed that record, much less established that the FDA’s decision is arbitrary.

Finally, in deciding whether to grant a stay, courts must consider the “balance of the equities.” If the order being appealed will cause great harm, the courts will generally stay it pending appeal to preserve the status quo until the dispute is resolved. But if the government practice itself threatens “irreparable harm” to those challenging its legality, a stay pending appeal will generally be denied. Here the equities could not be more out of balance. As the Biden administration’s brief explains, the court of appeals’ decision has essentially the same effect as the lower court’s—forcing the medication off the market. Thousands of women will be denied access to the most common method of abortion, and many will be unable to get an abortion at all. (While the court orders do not apply to misoprostol, the drug used in combination with mifepristone in a medication abortion, on its own it is less effective—and the plaintiffs’ complaint seeks to bar it as well.)

And on the other side of the scale? Doctors who don’t prescribe mifepristone and don’t provide abortions fear the possibility that someone somewhere might experience one of the vanishingly rare complications after taking the medication, have nowhere else to turn, and ask their assistance. These doctors have been facing that “risk” for two decades, yet only now claim that it requires immediate judicial redress. 

In short, the mifepristone case is an illegitimate attempt to use the courts to achieve an end that the plaintiffs could not achieve through the political process. That’s exactly what the conservative justices said was wrong with Roe v. Wade. A consistent conservative would therefore grant the stay and reject the underlying lawsuit; any other result will indicate that the justices have let their personal opposition to abortion override their institutional commitment to judicial conservatism.