The stakes in the Supreme Court’s mifepristone case go way beyond abortion.
For more than a year, a specter named Matthew Kacsmaryk has loomed over abortion access in the United States. Kacsmaryk, a former lawyer for Christian right causes who Donald Trump appointed to the federal bench, attempted to ban the drug mifepristone, a medication used in about half of all US abortions, in the spring of last year.
Now this case, known as FDA v. Alliance for Hippocratic Medicine, will receive a hearing before the Supreme Court on Tuesday — though there’s not a lot of suspense regarding the outcome. The Court blocked Kacsmaryk’s decision last April, temporarily leaving mifepristone on the market while this case worked its way through the appellate process.
That’s a strong sign that even this very conservative Supreme Court — the same Court that overruled Roe v. Wade — wants no part of this attack on mifepristone.
Kacsmaryk’s opinion was, to put it mildly, sloppy. He allowed the plaintiffs to challenge the FDA’s 23-year-old approval of mifepristone, even though the statute of limitations for such claims is six years and there was no valid reason to extend it by nearly two decades. He relied on two discredited studies that have since been retracted by their publisher. He cited another “study” that collected “data” entirely from anonymous blog posts published on an anti-abortion website. According to a brief filed by the ACLU and two other organizations, Kacsmaryk relied on testimony by a “doctor” who isn’t actually a physician at all — the man in question’s only advanced degree is a masters in theological studies.
Also, Kacsmaryk didn’t even have jurisdiction to hear the case in the first place.
The United States Court of Appeals for the Fifth Circuit, a court dominated by MAGA Republicans, did toss out part of Kacsmaryk’s decision: It acknowledged that the statute of limitations to challenge the FDA’s 2000 decision to approve mifepristone has expired. But the Fifth Circuit’s ruling would still have the same effect as a ban.
That’s because the Fifth Circuit invalidated changes that the FDA made in 2016 and 2021 to the protocol health providers must use when prescribing mifepristone. Among other things, the FDA allowed mifepristone to be used up to the 70th day of a pregnancy (previously, it was only allowed up to 49 days), and it reduced the amount of mifepristone dispensed to abortion patients from 600 mg to 200 mg.
Requiring health providers to return to pre-2016 protocols would prevent mifepristone from being prescribed for at least several months. As the drug’s manufacturer explained to the Supreme Court, it must “revise product labels, packaging, and promotional materials; recertify providers; and amend its supplier- and distributor-contracts and policies” to comply with the old protocols, under the Fifth Circuit’s approach.
In the unlikely event that the Supreme Court affirms the Fifth Circuit, moreover, that would have devastating effects on the entire US health system.
The Fifth Circuit faulted the FDA for looking at multiple scientific studies to justify the changes to how mifepristone is prescribed, rather than relying on one grand study that examined every potential change at once. But the FDA has never been required to make this inquiry when approving any other drug. Moreover, as a brief filed by pharmaceutical executives and investors warns, if all medications have to clear this bar, “thousands of drugs, including numerous transformative medicines,” would likely fall short.
Kacsmaryk and the Fifth Circuit, in other words, were willing to jeopardize Americans’ access to hundreds or even thousands of potentially lifesaving drugs, all to spite a single drug that is used to provide abortions. And now it’s up to a Supreme Court that is quite hostile to abortion rights to clean up this mess.
No federal court has jurisdiction to hear this case
No one is allowed to bring a federal lawsuit unless they can show that they were injured in some way by the party they are suing, a requirement known as “standing.” Federal plaintiffs may sometimes allege that they have standing to sue because they will experience an injury in the future unless a government policy is changed. But the Supreme Court held in Clapper v. Amnesty International (2013) that this future injury must be “certainly impending” and not merely “speculative.”
The plaintiffs in the Alliance case are anti-abortion doctors and organizations representing anti-abortion doctors, and their theory of why they have standing changed significantly after this case arrived at the Supreme Court for the second time. But none of their shifting standing arguments are persuasive.
In the lower courts, the plaintiffs’ primary argument was that, if mifepristone remains on the market, some patients who take the drug will experience complications. Some of those patients might then seek care from an emergency room in a hospital where one of the plaintiff doctors or a member of the plaintiff organizations is working. That doctor might then have to care for this patient, and might discover that the mifepristone did not successfully terminate the patient’s pregnancy. This anti-abortion doctor might then have to complete the abortion or otherwise provide care that violates their conscience.
That’s a whole lot of mights. And it’s far too many to establish the “certainly impending” injury that is required by Clapper.
Nevertheless, the Fifth Circuit bought this argument. It reasoned that “millions of women take mifepristone” and “hundreds” of the plaintiff organizations’ members “are OB/Gyns and emergency-room doctors.” So, statistically, the Fifth Circuit claimed, it was likely that at least one of these doctors would have to provide care they do not want to provide to a mifepristone patient.
There are many problems with the Fifth Circuit’s reasoning, but the most glaring one is that the court’s decision is directly at odds with the Supreme Court’s ruling in Summers v. Earth Island Institute (2009). Summers rejected the idea that a membership organization can establish standing by demonstrating that “there is a statistical probability that some of those members are threatened with concrete injury.”
Perhaps recognizing that the Fifth Circuit’s standing theory is inconsistent with Summers, the Alliance plaintiffs offer several alternative theories in the Supreme Court. Their new lead argument, for example, is that some of their members “consider any participation in an elective abortion objectionable,” and so these doctors are injured if they are made to “feel complicit” in an abortion by providing care to someone who took mifepristone.
But even if this feeling of complicity is enough to establish standing, the Alliance plaintiffs still haven’t shown that it is “certainly impending” that an anti-abortion doctor who belongs to one of the plaintiff organizations will be made to feel complicit in an abortion in the future. At most, they’ve just shown a greater statistical likelihood that a doctor who belongs to a plaintiff organization might experience some future injury.
All of which is a long way of saying that the Supreme Court should toss this case out without even reaching the merits. No plaintiff has standing to bring this case in a federal court.
The plaintiffs’ arguments could destroy US patients’ access to countless medications
Because the six-year statute of limitations prevents these plaintiffs from challenging the FDA’s decision to approve mifepristone way back in 2000, the only question before the Supreme Court is whether various changes that the FDA started to roll out in 2016, which make it easier for health providers to prescribe mifepristone, are invalid.
Those changes include a new protocol which allows mifepristone to be prescribed up to the 70th day of a pregnancy. They allowed some non-physician health providers to prescribe the drug. And they include two separate decisions to relax a previous requirement that mifepristone patients make in-person visits to the doctor’s office. In 2016, the FDA reduced that requirement from three visits to one. It later eliminated the requirement that the drug be dispensed during an in-person visit.
When the FDA approves a drug, or when any federal agency takes any action that falls within the heartland of that agency’s responsibilities, courts are supposed to defer to the agency’s judgment. As the Supreme Court said in Bowman Transportation v. Arkansas-Best Freight System (1974), a “court is not empowered to substitute its judgment for that of the agency.”
Instead, the FDA’s decision to approve a drug, or to change how it is prescribed, should be upheld by the courts so long as the agency articulated a “rational connection between the facts found and the choice made.”
There’s no serious question that the FDA cleared this low bar in the Alliance case. When the FDA decided to allow mifepristone to be prescribed up to 70 days into a pregnancy, for example, it reviewed several studies, which collectively involved over 30,000 mifepristone patients, that “evaluated the exact proposed dosing regimen through 70 days gestation.” Based on this data, the FDA concluded that the drug works just as effectively after 70 days as it does under the previous protocol, which allowed it to be used only up to 49 days.
Similarly, the FDA relied on 11 studies, which together examined tens of thousands of mifepristone patients, to determine that home-use of mifepristone is safe and that the number of in-person visits could be reduced. And it relied on “data on the efficacy of medical abortion provided by non-physician healthcare providers, including four studies with 3,200 women in randomized controlled clinical trials and 596 women in prospective cohorts” to determine that non-physician health providers such as nurse practitioners should be allowed to prescribe the drug.
All of this data, which supported the FDA’s decision to relax restrictions on the drug, shows a “rational connection” between the facts and FDA’s ultimate decision. So how did the Fifth Circuit justify ruling against the FDA?
The answer is that, while the FDA examined many studies involving thousands of women who took mifepristone, the Fifth Circuit faulted FDA because “none of the studies it relied on examined the effect of implementing all those changes together.” This appears to be an entirely novel new requirement, and the Fifth Circuit cited no caselaw or any other legal decision that has ever imposed such a requirement on the FDA.
Nevertheless, the Alliance plaintiffs urge the Supreme Court to adopt this novel limit on FDA’s authority in their brief to the justices.
Again, there is no legal support for the Fifth Circuit’s position. And the Fifth Circuit didn’t simply construct a new hoop that the FDA must jump through whenever it approves a new drug or modifies the protocol for an existing drug — it applied this new requirement retroactively to decisions the FDA made years ago.
The implications of such a decision are astounding. As the pharmaceutical executives warn in their amicus brief to the justices, the FDA used a more flexible framework “in approving thousands of drugs, including numerous transformative medicines, and in updating those approvals as science evolves.” Moreover, “had those drugs been developed or reviewed by FDA under the Fifth Circuit’s approach, it is likely that few, if any, would have been approved and avoided legal challenges to those approvals.”
In other words, if the FDA suddenly must comply with much more restrictive rules, and if those new rules apply retroactively to its past decisions, countless existing medications would immediately be subject to legal challenge. Every court in the country would be required to retroactively apply the new restrictions to a long list of drugs that currently are widely available in the United States.
It would be a chaotic, catastrophic blow to US public health, as a wide range of medicines would suddenly be unavailable — and the specific medications that were removed from pharmacies’ shelves would be chosen almost entirely at random, based on whether a court determined that the FDA jumped through a new, arbitrary hoop when it originally approved these drugs.
It is unlikely that even the current, very conservative Supreme Court will allow such a thing to happen. The Court already blocked Kacsmaryk and the Fifth Circuit’s attempt to shut down mifepristone use once, and there’s no reason to believe that any justice has changed their views since then.
Nevertheless, the Alliance case is significant because it shows just how far some judges are willing to go in order to achieve their ideological goals. Judges like Kacsmaryk are so single-mindedly opposed to abortion that they are willing to upend the existing process for approval, potentially disrupting the availability of lifesaving drugs to millions of Americans in order to make it more difficult for American women to obtain an abortion.
And, if Trump wins in November and has the chance to appoint more Kacsmaryks to the federal bench, there could very well be a Supreme Court majority at some point in the future that shares Mr. Kacsmaryk’s recklessness.
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