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Why Mifepristone Might Not Be Doomed at the Supreme Court

On abortion medication, the justices would have very good reasons to leave the status quo intact for FDA drug approvals.

Leah Millis/Getty Images
Justice Brett Kavanaugh and Chief Justice John Roberts

Last Friday, a federal judge in Texas overturned the Food and Drug Administration’s 23-year-old approval of mifepristone, a widely used abortion drug. The highly consequential ruling will likely come before the Supreme Court in some form, not least because a federal judge in Washington issued a ruling on the same drug that appeared to directly contradict the Texas one that same night.

It would not be a complete surprise if the Supreme Court let the Texas decision stand. Since Justice Amy Coney Barrett joined the court in 2020, there has been a reliable majority to erase abortion rights from the country’s legal landscape. This is the same court, after all, that allowed Texas to effectively nullify Roe v. Wade in the fall of 2021 after that state passed an unusual bounty-style law to evade the federal courts’ review. It is also the same court that finished the job by overturning Roe itself last summer in Dobbs v. Jackson Women’s Health Organization.

But there are a few reasons that the court might be willing to overturn this particular ruling. Judge Matthew Kacsmaryk’s decision rests on some imaginative interpretations of various precedents that govern who can bring a lawsuit to court, as well as when and how they can do it. Friday’s ruling also threatens to upend the FDA’s approval process for new drugs—a process that courts are historically reluctant to disrupt. If the justices want to reject his decision, Kacsmaryk gave them ample grounds to do so.

The stakes are high: Allowing the ruling to stand would severely reduce abortion access for Americans, even in states where it remains legal after Dobbs. Between 30 and 40 percent of abortions performed in the United States are medically induced. (The remainder are surgical.) Mifepristone is the most commonly used drug in the U.S. for induction. During pregnancy, the body produces a hormone called progesterone that maintains the lining of the uterus while a fetus develops. Mifepristone interrupts this process by disrupting the production of progesterone, which causes the uterus to shed its lining along with the fetus. The drug is most commonly administered early in the first trimester of pregnancy.

Mifepristone was first developed in the 1980s by a French pharmaceutical company and was approved for use in European countries over the course of the 1980s and 1990s. U.S. approval by the FDA did not occur until 2000, delayed in part by political wrangling and difficulty in finding a U.S.-based manufacturer of the drug. FDA regulators approved mifepristone under a provision known as Subpart H, which is reserved for certain new drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses.” By using Subpart H, the FDA was also able to attach additional restrictions on the drug’s use.

The Texas lawsuit, Alliance for Hippocratic Medicine v. FDA, began in 2021 when a group of anti-abortion medical practitioners sought to challenge the FDA’s original approval of the drug in 2000. They argued, among other things, that the agency had ignored purported evidence of the drug’s harms to pregnant women and had gone beyond what the Food and Drug Administration Act authorized under Subpart H to approve it. Much of their case is also grounded in broader anti-abortion arguments that would not necessarily be welcome before most federal judges.

We’ll start with the procedural reasons. While every lawsuit is different, they must all meet the same basic conditions or a judge will throw them out. One of those conditions is that whoever files the lawsuit must have the legal standing to bring it. People generally can’t file lawsuits to right wrongs on behalf of their friends, their neighbors, or total strangers. If you’re going to sue, you have to have a legal injury to do it. And if you’re going to sue based on something that might happen, you have to show that whatever you are theorizing might happen will almost certainly occur.

The Justice Department, which appeared on behalf of the FDA, told the Fifth Circuit Court of Appeals in a brief on Monday that the plaintiffs’ claims were too speculative and hypothetical to meet those thresholds. “Plaintiffs do not prescribe mifepristone,” the department noted in its brief. “Instead, they speculate that other doctors will prescribe mifepristone; that those doctors’ patients will experience exceedingly rare serious adverse events; that those patients will then seek out plaintiffs—doctors who oppose mifepristone and abortion—for care; and that they will do so in sufficient numbers to burden plaintiffs’ medical practices.”

Despite this, Kacsmaryk concluded that this was enough for the plaintiffs to meet the standing threshold. His explanation largely consisted of restating the plaintiffs’ assertions without further analysis. At one point, he concludes that the plaintiffs have standing because they “allege adverse events from chemical abortion drugs can overwhelm the medical system.” It would be one thing if those claims were made about a brand-new drug that hadn’t been adopted on a national scale before. But if that were true about mifepristone, then the medical system would already be overwhelmed because it has been on the market for a quarter-century. Someone would have noticed by now.

Another threshold for the typical lawsuit is timeliness. Just as there are statutes of limitations on minor and semi-serious crimes, federal law often imposes a cutoff point for when someone can bring a civil lawsuit. There is a six-year statute of limitations on challenging final FDA approval. In the time since the drug was approved in 2000, the FDA denied a timely citizen petition challenging that approval in 2016. The timing of these moves should theoretically doom the plaintiffs’ lawsuit since it was filed roughly six months after the six-year limit expired in 2022.

Not so, said the plaintiffs. The FDA modified some of the conditions of use for mifepristone in 2016 and then denied a citizen petition about that action in 2021. Accordingly, they say the clock began running in 2021. The Justice Department countered by noting that the FDA didn’t reconsider the original approval of mifepristone itself in 2016, so at most they could challenge the 2016 modifications. Kacsmaryk disagreed and, after largely regurgitating the plaintiffs’ arguments without further analysis, concluded that the lawsuit was still valid.

One might think that the plaintiffs got extraordinarily lucky to have their case end up before such a sympathetic judge who uncritically accepted so many of their arguments. But luck had nothing to do with it. The anti-abortion activists who organized the case specifically filed it in the Amarillo division of the Northern District of Texas, which has exactly one federal judge assigned to it. And they had pretty good reason to believe he’d side with them. Before Donald Trump appointed Kacsmaryk to his seat in 2019, he worked for a conservative Christian legal group and was unabashed about his opposition to abortion in general and to Roe v. Wade in particular.

That may be why Kacsmaryk’s opinion does not pretend to be neutral about the issue before him. He adopted anti-abortion claims that the procedure is about eugenics and population control and announced he would eschew the term “fetus” in favor of “unborn human” when describing it. Kacsmaryk also made some extremely dubious claims about abortions and the women who obtain them. Abortion-related cases often feature claims of third-party standing where doctors can sue to vindicate rights on behalf of their past, present, and future patients. Some conservative legal scholars and judges have criticized that practice, including Justice Clarence Thomas.

In Friday’s opinion, Kacsmaryk completely inverted third-party standing to bolster the arguments of the anti-abortion doctors who brought the case. He claimed that doctors who perform abortions, whom he described simply as “abortionists,” had a financial and personal stake in keeping the procedure free of regulation. “Unlike abortionists suing on behalf of women seeking abortions, here there are no potential conflicts of interest between the Plaintiff physicians and their patients,” he then concluded.

It would be hard for the doctors to have a conflict of interest when there is no interest at all. They are suing on behalf of hypothetical women who might be potentially harmed by exceedingly rare complications from a drug that’s been available on the market for 23 years, forcing them to seek hypothetical treatment before these doctors at some indefinite point in the future. Kacsmaryk not only concluded that these doctors had standing to bring the lawsuit but also asserted that it wasn’t a conflict of interest for them to sue to deny patients access to a drug based solely on their own personal opposition to abortion.

Exactly how much procedural messiness the Supreme Court will stomach to limit abortion access is uncertain right now. The court’s three liberal justices would likely vote to overturn Kacsmaryk’s ruling if given the opportunity. It’s worth noting that Chief Justice John Roberts opposed the court’s handling of the Texas bounty law in 2021 on the grounds that the law was a barely disguised attempt to nullify a Supreme Court ruling. He also only partially joined Dobbs because while he agreed with the court’s ultimate ruling, he disagreed with its decision to overturn Roe on procedural grounds.

Justice Brett Kavanaugh also wrote a concurring opinion in Dobbs where he appeared to signal that future decisions about abortion would have to be made by the democratic branches of government, writing that he and his colleagues “do not possess the constitutional authority to override the democratic process and to decree either a pro-life or a pro-choice abortion policy for all 330 million people in the United States.” His emphasis on the court’s finished role could make him more inclined to overturn Kacsmaryk’s ruling for bringing the issue back to the judicial sphere.

One final factor might make the court less willing to uphold Kacsmaryk’s ruling: Doing so would upend the FDA’s drug approval process and a significant portion of the American health care system along with it. On Monday, more than 250 top pharmaceutical and biomedical executives signed an open letter denouncing Kacsmaryk’s ruling for overturning FDA approval of a drug they described as “safer than Tylenol, nearly all antibiotics, and insulin.” They urged the appellate courts to overturn a ruling that “ignores decades of scientific evidence and legal precedent.”

“Judicial activism will not stop here,” they warned. “If courts can overturn drug approvals without regard for science and evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.” Among the signatories were top scientists and executives at companies like Pfizer, Biogen, Merck, and Bayer.

Their outrage is justified. Friday’s ruling is the first time that a federal court has ever overturned the FDA’s approval of a particular drug. Even in an age when the courts are increasingly skeptical of federal regulatory authority, judges have typically recognized that the FDA’s scientific and medical experts are better suited to decide which drugs are sold in the U.S. than they are. Between the risk of changing that approach and the overall sloppiness of Kacsmaryk’s ruling, it would not be surprising if the Supreme Court chose to overturn his decision for reasons that, at their core, have nothing to do with abortion at all.