Last night, when much of the nation was asleep, the unusually right-wing United States Court of Appeals for the Fifth Circuit issued its closely watched decision on the legality of mifepristone, a common abortion drug.
The good news for abortion providers and their patients is that even this Fifth Circuit panel realized that Matthew Kacsmaryk, the Trump-appointed judge who attempted to ban mifepristone nationwide, went too far. Mifepristone remains legal in the US, though the Fifth Circuit attempts to impose some restrictions on its use.
The bad news is that the decision is otherwise pure chaos. It imposes restrictions on mifepristone use that no court has the authority to impose. And it wrongly claims that the judiciary has the power to override the FDA’s scientific judgments.
The panel included Judges Kurt Engelhardt and Andrew Oldham, Trump appointees who are among the most reactionary judges in the entire federal system. A third judge, Judge Catharina Haynes, voted to temporarily block Kacsmaryk’s decision in its entirety until the case can be considered by another panel of judges that will have more time to weigh the case. But her vote was in the minority, so Engelhardt and Oldham’s approach prevailed, at least in the Fifth Circuit.
Realistically, this Fifth Circuit decision is unlikely to matter in the long run. The Justice Department will almost certainly bring this case to the Supreme Court, seeking an order that blocks Kacsmaryk’s decision in its entirety.
The statute of limitations to file a lawsuit challenging the FDA’s approval of mifepristone, which happened 23 years ago, is six years. The Fifth Circuit’s decision recognizes that the Hippocratic Medicine plaintiffs waited too long to file a lawsuit challenging the 23-year-old approval of mifepristone, although it does so only reluctantly. Accordingly, the Fifth Circuit temporarily blocked Kacsmaryk’s attempt to suspend the FDA’s approval of mifepristone altogether.
But the plaintiffs also challenged the FDA’s decisions in 2016, 2019, 2021, and 2023 to make it easier for abortion providers to prescribe mifepristone. Among other things, these decisions by the FDA allowed mifepristone to be used up to the 70th day of a pregnancy (previously, it could only be used up to the 49th day). They reduced the number of in-person visits for patients seeking mifepristone from three to one. And they allowed some non-physician health providers to prescribe the medication.
The Fifth Circuit’s decision effectively invalidates all of these changes, thus attempting to reset the rules governing mifepristone to where they were before 2016. In reaching this conclusion, the Fifth Circuit offers a deeply flawed argument for why it even has jurisdiction over this case to begin with. And it announces a new legal rule which would allow federal judges to second guess the FDA’s scientific judgments based on the judiciary’s own opinions about how scientific research should be conducted.
Engelhardt and Oldham’s decision, it should be noted, concerns only the Justice Department’s request for a temporary stay of Kacsmaryk’s decision while this case is being litigated on appeal. The full appeal will eventually be heard by a different Fifth Circuit panel, and potentially by the Supreme Court.
One additional wrinkle in this case is that a different federal judge in Washington State, in a case called Washington v. FDA, forbade the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.” That decision obviously conflicted with Kacsmaryk’s original order to ban mifepristone, and it also conflicts with the Fifth Circuit’s decision to dismantle many of the FDA’s changes to how and when mifepristone may be dispensed.
Indeed, these conflicting court orders will most likely force the Supreme Court to rule on this case, and soon. The alternative is that the FDA must violate at least one court order.
The Fifth Circuit’s decision would seriously disrupt the entire pharmaceutical industry if it is allowed to stand
The most obvious error in the Fifth Circuit’s reasoning is that the two judges in the majority, in the words Justice Samuel Alito used in a 2020 dissent, “took it upon [themselves] to overrule the FDA on a question of drug safety.” This is not allowed.
To be clear, the Fifth Circuit’s decision halts Kacsmaryk’s attempt to block the FDA’s 23-year-old approval of mifepristone altogether. But the decision also second-guesses the FDA’s scientific judgment about when and how mifepristone should be prescribed.
Engelhardt and Oldham, the two Trump judges behind the Fifth Circuit’s decision, argue that the FDA was wrong to ease the rules governing when mifepristone may be prescribed because the FDA eliminated preexisting restrictions after examining scientific “studies that included those very safeguards.” Essentially, the two judges claim that, before the FDA may announce a new protocol governing mifepristone use, it must rely on a study which perfectly mirrors the new protocol it wants to implement.
But that’s not at all how scientific research works. Scientific studies into drug safety and efficacy typically involve enhanced safety protocols and enhanced data-gathering requirements because the entire point of this study is to explore whether the drug can be used in previously untested ways. Once such a study has been conducted, however, it will provide new data which may show that these enhanced safety protocols and reporting requirements are unnecessary.
Think of it this way: Suppose that researchers want to explore whether a drug that has historically only been prescribed to people under the age of 65 can be prescribed to elderly patients. The researchers want to make sure that the drug will not damage elderly patients’ hearts, so their study calls for enhanced monitoring of the patient’s heart health during the study period.
Now suppose that the study reveals that the drug has no impact whatsoever on patients’ heart health. The FDA reasonably could rely on this study to conclude that, when doctors prescribe this drug to elderly patients, they do not need to engage in the same enhanced heart monitoring that was used in the study itself.
The idea that Engelhardt and Oldham, two lawyers with no medical or scientific training, somehow know more about how to interpret scientific research about pharmaceuticals than the FDA is ridiculous. And, if their decision is allowed to stand, it could have catastrophic public health consequences because it would force the pharmaceutical industry to conduct expensive and unnecessary research before its drugs could be marketed, and before the FDA could update the protocols for prescribing a particular drug.
As many leading figures in the pharmaceutical industry warned in an amicus brief filed in the Fifth Circuit, Engelhardt and Oldham’s “approach would have ripple effects across FDA’s programs for drugs intended to treat serious and life-threatening diseases and conditions.” Their approach would “narrow eligibility for these programs, delay patient access to life-saving medications, and discourage development in the first instance.”
That’s bad news for the industry, but it’s also terrible news for patients, who would “lose access to potentially lifesaving and life-improving treatments.”
Ultimately, someone has to be the final authority on which drugs are safe to be marketed within the United States, and on when and how those drugs should be prescribed. That final authority can either be the FDA, which has considerable scientific expertise on the matter. Or it can be amateurs like Engelhardt and Oldham.
No court has jurisdiction to hear this case
There’s one other glaring issue about this case: Like Kacsmaryk, the Fifth Circuit asserts jurisdiction over a case that no federal judge has the lawful authority to hear.
As a general rule, a plaintiff who wishes to challenge a federal policy in federal court must show that they’ve been injured in some way by that policy — a requirement known as “standing.” A plaintiff can sometimes allege that they have standing to sue because they will experience an injury in the future unless a policy is changed. But, as the Supreme Court held in Clapper v. Amnesty International (2013), such a future injury must be “certainly impending” and not merely speculative.
The Hippocratic Medicine plaintiffs are doctors and organizations representing doctors. They claim that they will be injured if mifepristone stays on the market because patients who were prescribed mifepristone by other doctors might experience complications, which might cause them to switch doctors and seek care from the plaintiff physicians. This then might cause the plaintiff doctors to divert their attention from other patients, or it might cause them to provide treatments to their new patients that they would prefer not to provide.
That’s a whole lot of mights. The plaintiffs’ standing argument is so speculative as to be ridiculous. And, for that reason alone, this case should be dismissed.
The Fifth Circuit attempts to get around this problem by exaggerating how often mifepristone leads to complications. Specifically, they point to a document that informs patients that medication abortions do not succeed in terminating a pregnancy between 2 to 7 percent of the time, and thus a surgical abortion will be necessary in these cases to terminate the pregnancy.
It is true that medication abortions do not always work — according to Planned Parenthood, the two-drug regime that is ordinarily used to terminate pregnancies works “approximately 95-99% of the time.” But the fact that medication abortions sometimes fail does not mean, as the Fifth Circuit claims, that plaintiff doctors who work in emergency rooms will “with certainty” wind up providing care to patients who need a surgical abortion after taking mifepristone.
To show that emergency room doctors are certain to treat patients who experience complications after taking the drug, the Fifth Circuit would have to show that the drug has a high rate of complications and that patients will go to the emergency room after experiencing these complications — rather than seeking care from the same provider who provided them with mifepristone in the first place.
Nor could the Fifth Circuit show that the drug has a high rate of complications, because it simply does not. Data shows that complications such as vaginal bleeding, pelvic pain, and infection do rarely occur, but only in about 3 in 1,000 patients.
The Fifth Circuit, in other words, attempts to inflate the likelihood that emergency room doctors will have to treat mifepristone patients by confusing the drug’s failure rate with the rate of complications that could plausibly lead to an emergency room visit. That is not enough to show that the plaintiff doctors will “certainly” experience an injury in the future.
In any event, this Fifth Circuit decision is likely only a stepping stone along the way to Supreme Court review. The Fifth Circuit’s decision is at odds with the pro-mifepristone decision in Washington, and the Supreme Court is the only body that can resolve that conflict. That most likely means that the justices will get involved fairly soon.