In an after-hours opinion late Friday, federal District Judge Matthew Kacsmaryk donned his scrubs to rescind the Food and Drug Administration’s 2000 approval of mifepristone, the first drug in the most common medication abortion protocol.
The ruling by the far-right, Trump-appointed judge was lawless and should come as no surprise to anyone who has been paying attention to the ratcheting up of tensions over the legality of abortion since the United States Supreme Court upended constitutional protection for the procedure last summer in Dobbs v. Jackson Women’s Health Organization.
In fact, Kacsmaryk’s ruling in the mifepristone case, known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, has a lot in common with the Dobbs opinion penned by Justice Samuel Alito: It ignores science, wholly reimagines facts, and cites less-than-credible sources to arrive at a preordained destination.
The opinion threatens to block access to mifepristone nationwide. Kacsmaryk stayed his ruling for seven days to give the federal government a chance to appeal to the 5th U.S. Circuit Court of Appeals, perhaps the most conservative and results-oriented appeals court in the country, which is expected to bless Kacsmaryk’s decision. On Monday, the Justice Department filed its appeal, writing that Kacsmaryk had “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”
Meanwhile, on the heels of Kacsmaryk’s ruling, Washington state District Judge Thomas O. Rice issued his own opinion in a separate mifepristone-related lawsuit brought by 17 states and the District of Columbia, barring the FDA from taking any action that would make mifepristone unavailable in those jurisdictions.
The two opinions deploy diametrically opposed approaches. Kacsmaryk has positioned himself as a scientist in a black robe, free to second-guess the FDA and medical experts whenever and however he chooses, while Rice has made it clear that his job is to respect the science and stay in his lane, considering only whether the agency has satisfied its legal obligations.
Whether the government will find reason to appeal Rice’s decision remains to be seen. But if the 5th Circuit does what it usually does — that is, rubber-stamp even the most extreme and unhinged interpretations of the law — then it will be up to the Supreme Court to decide whether science or ideology will prevail.
Second-Guessing the Science
Mifepristone is the first drug in a two-drug protocol approved for early pregnancy termination. Mifepristone blocks progesterone, a hormone needed to continue pregnancy, and softens the uterine lining; the second drug, misoprostol, is taken 24 to 48 hours later and causes the uterus to contract, expelling the pregnancy. Today, the regimen accounts for more than half of all pregnancy terminations in the U.S. and is also used for miscarriage management.
In 2021, after two decades of enforcing a slew of restrictions tied to mifepristone that advocates and providers had long argued were medically unnecessary, the FDA lifted a requirement that the drug be dispensed in person and has since taken steps to expand access in states where abortion is legal.
Mifepristone is one of the most widely studied medications out there; it has been used in more than 630 published clinical trials, including more than 420 randomized, controlled studies, the “gold standard for research design,” according to a friend-of-the-court brief filed in support of the FDA by the American College of Obstetricians and Gynecologists, the American Medical Association, the American Academy of Family Physicians, and eight other leading U.S. medical groups. The risk of serious complications is less than 1 percent.
“Mifepristone’s safety profile is on par with common painkillers like ibuprofen and acetaminophen, which more than 30 million Americans take in any given day,” the brief read. Procedures like wisdom teeth removal, colonoscopy, and plastic surgery have higher complication and death rates, as does the use of Viagra. “Put simply,” the brief stated, “medication abortion is among the safest medical interventions in any category — related to pregnancy or not.”
“Medication abortion is among the safest medical interventions in any category — related to pregnancy or not.”
Kacsmaryk wasn’t buying any of this. In his 67-page ruling, he lifted talking points from the legal filings of the Alliance for Hippocratic Medicine, which incorporated itself in the Texas Panhandle city of Amarillo in August for the express purpose of challenging the approval of mifepristone. The Alliance argued that medication abortion was wildly unsafe, that the FDA recklessly approved its use in 2000, and that it has since lowered the guardrails to the detriment of anyone who might consider taking it. Because of the way the federal judiciary is organized in North Texas, filing in Amarillo guaranteed that the Alliance’s lawsuit would land on Kacsmaryk’s desk.
The five out-of-state groups that make up the Alliance represent a shadow medical community that exists to promote counterfactual narratives about the risks associated with abortion. In his opinion, Kacsmaryk added his own spin to the Alliance’s baseless assertions, liberally deploying italics to convey his righteous indignation at the very notion that the FDA approved mifepristone in the first place.
Kacsmaryk routinely used medically incorrect and inflammatory terminology beloved by the anti-abortion movement. In his first footnote, he declared that “jurists” often use the word “fetus” in “unscientific ways.” Had he meant that other judges used the word “fetus,” which denotes the developmental stage beginning around eight weeks, when they should have used “embryo,” which encompasses gestation from two to eight weeks, he might have had a point. But instead of using the proper medical terms, he declared he would instead adopt the terms “unborn human” and “unborn child” to encompass all stages of gestation, terms that are not only unscientific, but also oxymoronic. (Accuracy isn’t the point here; rather, it is a none-too-subtle nod toward the goal of many anti-abortion groups, which is to deem a pregnancy at any stage of gestation a “person” under the law, otherwise known as “fetal personhood.”)
To support the proposition that medication abortion is wildly unsafe, he cited almost exclusively anti-abortion sources, including an analysis of anonymous posts to an anti-abortion website and at least one academic whose work has been repeatedly challenged. He also dropped in the opinions of former GOP lawmakers, including disgraced and now deceased former Indiana Rep. Mark Souder, who offered his take on the dangers of medication abortion during a 2006 House subcommittee hearing, and deceased former Oklahoma Sen. Tom Coburn, who, in 2007, said he’d heard a story about a woman whose medication abortion allegedly failed and led her to give birth to an infant with congenital disorders.
Kacsmaryk concluded that the scientists at the FDA haven’t been doing their job right, leaving him no choice but to usurp their authority and enter a ruling to block access to mifepristone across the country.
“The court does not second-guess FDA’s decision-making lightly,” he wrote. Nonetheless, he determined that the scientific studies the agency relied on to approve the drug in 2000 were “unsound,” forcing him to offer a course correction. Quoting directly from the Alliance for Hippocratic Medicine’s lawsuit, he wrote that the “physical and emotional trauma that chemical abortion inflicts on women and girls cannot be reversed or erased.”
Unsatisfied by merely turning the clock back two decades on medical progress, Kacsmaryk’s opinion also tried to breathe new life into the prudish zombie law known as the Comstock Act, which, in 1873, outlawed sending via the mail anything considered “obscene, lewd, lascivious, indecent, filthy or vile”— which at the time included contraceptives — and “every article or thing” that could be used for abortion. The law has not been enforced since the 1930s; Congress removed references to contraceptives in the 1970s; and over the years, judicial actions have largely neutered its reach. Last year, the Department of Justice told the U.S. Postal Service that the dormant law did not prohibit sending medication abortion to patients in places where abortion is legal.
Kacsmaryk disagreed with all of this, calling the act’s provisions “important public policy,” meaning that sending medication abortion pills anywhere for any reason would violate federal law. “The Comstock Act plainly forecloses mail-order abortion,” he wrote.
The Status Quo
Rice’s opinion in the Washington case stands in stark contrast to Kacsmaryk’s ruling. While both are preliminary opinions in advance of further litigation, Rice’s is by far the more conservative.
In that case, the plaintiff states asked the judge to bar the FDA from enforcing the remaining administrative restrictions on the provision of mifepristone, including an unwieldy “prescriber agreement” doctors are required to file with each pharmacy that might fill the prescriptions they write. Rice declined to do so, saying it was too early to make such a call. He concluded that to preserve the “status quo,” he would leave in place the remaining restrictions but block the agency from imposing any new restrictions on access to mifepristone in the 18 jurisdictions that are parties to the lawsuit.
In contrast, Kacsmaryk concluded that preserving the status quo meant going back to the era preceding the FDA’s approval of mifepristone in 2000. “Chemical abortion is only the status quo insofar as defendants’ unlawful actions … have made it so,” he wrote.
Unlike Kacsmaryk, Rice specifically noted that it was not his job to play scientist: “It is not the court’s role to review the scientific evidence,” he wrote. “That is precisely FDA’s role.” Rice noted that there are questions about whether the remaining restrictions are being imposed legally; the agency has said they’re needed to ensure the drug is used safely, while it has also declared mifepristone supremely safe. But sorting out the underlying legal details, Rice concluded, was a task for another day. He declined to issue a nationwide ruling, which are reserved for “exceptional cases.”
Kacsmaryk’s approach has been widely criticized as unhinged. “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” American Medical Association President Jack Resneck Jr. said in a statement. “Substituting the opinions of individual judges and courts in place of extensive, evidence-based, scientific review of efficacy and safety through well-established FDA processes is reckless and dangerous.”
Whether the U.S. Supreme Court will agree is an open question. The three Trump-appointed justices — Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett — were promoted to the bench based on their anti-abortion bona fides. All three joined in Alito’s opinion overturning Roe v. Wade, a screed similar in tone and intellect to Kacsmaryk’s mifepristone ruling.
Given the Supreme Court remains an unfortunate wild card, scholars have pointed out several key details impacting the state of play. Kacsmaryk’s conclusion that the Comstock Act forbids mailing medication abortion applies only to the FDA, noted David Cohen, a law professor at Drexel University. “NO ONE ELSE in the country is required to follow that ruling,” he wrote in a Twitter thread. And, as Cohen and law professors Greer Donley and Rachel Rebouche pointed out in a recent piece for Slate, the FDA has the power to ignore Kacsmaryk’s ruling. Because the agency doesn’t have the capacity to police “every nonapproved product on the market,” they wrote, “it has long been settled law, decided in a unanimous 1985 Supreme Court decision, that the agency has broad enforcement discretion, meaning the agency, not courts, gets to decide if and when” it will pursue such a ban.
In the wake of the Texas ruling, Oregon Democratic Sen. Ron Wyden encouraged the Biden administration to simply ignore Kacsmaryk’s mandate. “The FDA, doctors, and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America,” he said.
Still, advocates caution that ignoring Kacsmaryk’s decree won’t solve the larger problem he has created. If the Supreme Court allows the ruling to stand, it “will radically alter the process for approving drugs and will chill innovation in bringing new drugs to market,” Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project, said on Monday. “If the courts allow this decision to stand, they will be, in essence, telling every fringe group with an opposition to a medication or vaccine, ‘Just go find a politically aligned judge who can then, with the stroke of a pen, deny Americans the ability to get the critical, life-saving treatment they need.’”