On Friday evening, U.S. District Judge Matthew Kacsmaryk of Texas issued an unprecedented decision withdrawing the FDA’s approval of mifepristone, the first drug used in medication abortion, 23 years after it was first approved. His order, which applies nationwide, marks the first time in history that a court has claimed the authority to single-handedly pull a drug from the market, a power that courts do not, in fact, have. Kacsmaryk’s ruling is indefensible from top to bottom and will go down in history as one of the judiciary’s most shocking and lawless moments. It goes even further than expected, raising the possibility that he will impose “fetal personhood,” which holds that every state must ban abortion because it murders a human. Within an hour of its release, the decision also spurred the start of a constitutional crisis: A federal judge in Washington swiftly issued a dueling injunction compelling the FDA to continue allowing mifepristone in 17 states and District of Columbia, which brought a separate suit in Washington.
Kacsmaryk stayed his decision for one week to let the Biden administration appeal, but his ruling stands a good chance of being upheld at the radically conservative 5th U.S. Circuit Court of Appeals. If his order takes effect, the FDA will be faced with competing, mutually exclusive court orders requiring the agency to simultaneously suspend mifepristone nationwide and preserve access to the drug in 18 blue jurisdictions. The agency cannot comply with both orders at once. And because Kacsmaryk’s is broader, covering all 50 states, it guarantees that mifepristone will be suspended in much of the country. Only the Supreme Court can resolve this looming crisis, and it has a very limited window of time in which to do so. It has been less than a year since the court claimed to rid itself of the abortion issue. Now it must decide whether American patients will lose access to an abortion drug that has been on the market for 23 years and proven safer than Tylenol—on the order of a single, rogue judge.
It is probably impossible to count how many errors, exaggerations, and lies Kacsmaryk, a Donald Trump appointee, put in his decision. The judge appears to have largely copied and pasted the briefs filed by the anti-abortion group that filed the suit, the Alliance Defending Freedom, rephrasing their arguments as his own analysis. (This was predictable—Kacsmaryk himself is a staunch anti-abortion activist—and might be why ADF handpicked him specifically to hear the case for them.) His decision repeats the ridiculous and objectively false conspiracy theory about mifepristone—that the FDA illegally rushed its approval in 2000 at the behest of former President Bill Clinton, the pharmaceutical industry, and population control advocates. Kacsmaryk flyspecked the FDA’s assessment of the drug, concluding that its studies were insufficient and that the agency “acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety.” And he claimed that he had authority to revisit an FDA approval that occurred 23 years ago because the agency happens to have changed rules around the dispensation of the drug several times since.
This is all completely absurd, an outrageous abuse of power that no judge has ever even attempted before. Challenges to agency actions have a six-year statute of limitations. That means plaintiffs get a full six years to file a lawsuit, after which point they’ve waited too long. It has, just to reiterate, been more than two decades since the FDA approved mifepristone. Kascmaryk ignored that limitation in his quest to block the drug because, he insisted, the agency hadn’t responded quickly enough to citizen petitions opposing the drug. That is not the law.
His entire theory of standing is also offensively nonsensical. Kascmaryk said physicians who may treat patients who have side effects from medical abortions prescribed by someone else are sufficiently injured by mifepristone to sue. But time and again, the Supreme Court has said that a plaintiff must have a particularized and concrete injury to obtain standing. A doctor can’t sue the government for approving a drug that they claim harms somebody else; otherwise, every doctor could file an endless stream of lawsuits against every drug approval of all time. Kacsmaryk’s logic would essentially abolish the standing requirement for lawsuits against drug approvals by creating a special exception out of thin air. That is not the law.
If anyone could sue here, it would be women who took mifepristone—but they are absent. Why? Kacsmaryk speculated: “Women who have aborted a child—especially through chemical abortion drugs that necessitate the woman seeing her aborted child once it passes — often experience shame, regret, anxiety, depression, drug abuse, and suicidal thoughts because of the abortion.” These women’s abortion were so “deeply traumatizing” that they simply couldn’t file a suit, forcing doctors to, instead. No party put forward any evidence of this claim; Kacsmaryk just drew it from a handful of anti-abortion propaganda tracts. That is not the law.
From start to finish, Kacsmaryk’s opinion reads like a screed penned by an anti-abortion activist—because it largely is. At one point, he deemed fetuses to “arguably” be “people” who are killed by mifepristone, seeking to establish the “fetal personhood” that has always been the end goal of the movement. For support, he cited a brief by anti-abortion advocate Robert P. George asserting that the Constitution compels every state to outlaw abortion. Kacsmaryk also repeatedly drew from notoriously untrustworthy anti-abortion activists’ work to support major premises of his opinion. For instance, Kacsmaryk wrote that many women are uninformed that they may face torturous side effects before and after “expelling the aborted human.”
These assertions—the likelihood of awful side effects and the lack of information about them—are just untrue; medication abortion is extraordinarily safe, and patients cannot access it without onerous restrictions that include major warnings about (rare) side effects. So where did Kacsmaryk get this idea from? Tessa Longbons, a research assistant at the Charlotte Lozier Institute, a pro-life advocacy group that tries to build up scientific scaffolding under anti-abortion lies. To give one example: The Lozier Institute rejects the fact that some fetuses are, tragically, “incompatible with life” and will not survive beyond birth, if they even get that far. It argues that women should be forced to carry a fetus to term even if has a lethal condition that will ensure its own demise and potentially endanger the mother. This is one of Kacsmaryk’s leading authorities. (No surprise there: In footnote one, he declares he’ll use the phrase “unborn human” instead of fetus, claiming the later term is “unscientific.”)
There’s more: Kacsmaryk didn’t just revoke the 2000 approval, he overturned multiple changes to mifepristone access since, including those that reduced barriers to the drug and one that allowed it to be prescribed through the mail. The judge declared that mailing any abortion drug is a federal crime under the Comstock Act, not only prohibiting mail-order mifepristone but raising the possibility that any provider who mails mifepristone—or misoprostol, which is used with mifepristone but can work on its own—could be prosecuted and incarcerated. The Comstock Act is an unenforced 19th century law designed to censor the U.S. mail that bans, as Kacsmaryk cited approvingly, the mailing of “[e]very obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device, or substance.” It has long been read to allow actual, legal medication to be mailed even if it terminates a pregnancy. Kacsmaryk’s new interpretation would threaten the nationwide transport of mifepristone even if a higher court overturns his suspension of the 2000 approval.
In truth, the reasoning goes beyond that. Through the combination of Comstock Act enforcement and fetal personhood, Kacsmaryk is laying the groundwork for a federal ban on abortion imposed through the courts. He knows such a ban could never be enacted through the democratic process. So he is apparently intent on delivering it through the judiciary, instead.
Just after Kacsmaryk dropped this bomb, Judge Thomas O. Rice, a Barack Obama appointee in Washington State, issued a clashing decision ordering the FDA to continue providing mifepristone in the 18 jurisdictions that brought the lawsuit. Rice concluded that the FDA’s current restrictions on accessibility of the drug go too far, which, from a scientific standpoint, is obviously correct: The remaining obstacles, mainly complex certification requirements for pharmacies, serve zero medical benefit to doctors or patients. The Biden administration will probably appeal both orders, but on different timelines: Kacsmaryk’s decision would radically alter the status quo while Rice’s would maintain it. So while the administration must appeal it to the 5th Circuit, it can also leapfrog over the extremely conservative court and ask SCOTUS for an immediate emergency stay to resolve the conflict between the Washington ruling and the Texas one while awaiting a 5th Circuit decision. That is obviously the correct course of action here, because the 5th Circuit will almost certainly drag this out and ultimately side with Kacsmaryk.
What will the Supreme Court do? Most obviously, it has to act quickly. There are two imminent crises afoot: First, Sen. Ron Wyden has already urged the FDA to ignore the decision, and more Democrats will soon join him. Wyden is right: Kacsmaryk does not have the power to force the FDA to “stay” mifepristone or remove it from the market in any other way. That would be quite literally against the law. But a department of the executive branch ignoring a court order would be a very dramatic escalation between two branches of government that SCOTUS will want to avoid. Second, the threat of competing and contradictory court orders should spur the justices to act quickly so the executive branch need not be forced into a situation where it is breaking the law.
The case is a test of the Supreme Court’s promise, when overturning Roe v. Wade, to treat abortion like any other subject and leave the issue to “the people and their representatives” rather than unelected judges. Justice Brett Kavanaugh, in particular, swore he would chart a sensible course forward, refusing to let either side of the abortion debate manipulate the courts to achieve their agenda. But that’s exactly what ADF and Kacsmaryk are doing here, and anyone who is not profoundly biased against reproductive rights can see it plain and simple. Chief Justice John Roberts will likely not buy what Kacsmaryk is selling, and even Justice Amy Coney Barrett may realize how dangerous, lawless, and unprecedented this decision is.
Both the Texas and Washington cases will eventually pass through SCOTUS. They give the majority an opportunity to strike a dose of evenhandedness by overturning both decisions—a settlement abortion advocates should take, since it would preserve the status quo in effect right now. This is a moment of truth for the justices, like Kavanaugh and Barrett, who avowed that their opposition to Roe was rooted in constitutional principles rather than religious belief. If they do not put a stop to Kacsmaryk’s madness, they will show the country that their goal is not to leave abortion up to the democratic process, but to use every tool in their power to outlaw abortion in every state.
