A version of the following was originally posted March 27, 2024, on the blog of Edward Mechmann “Stepping Out of the Boat.” It is reprinted with permission.

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The Supreme Court has now heard oral arguments on the case challenging the FDA’s approval of loose rules for prescribing the abortion pill mifepristone. From the start, the case has had some significant problems, and the oral argument did not go well for the doctors. In my view, it’s likely that the Supreme Court will dismiss the case.

Some Background

Chemical abortion is a two-drug process intended to kill and expel a developing child from the womb in the first 10 weeks of pregnancy. The first drug is mifepristone. Its only purpose is to kill a baby in the womb by denying her nutrition and oxygen. The second drug, misoprostol, is used for legitimate purposes but is also used for chemical abortions as well. According to recent reports, over 60% of abortions are currently performed this way.

The FDA originally approved the use of mifepristone in 2000, subject to numerous safety protocols. In 2016, the FDA relaxed some of the safety protocols, including eliminating follow-up visits and allowing non-doctors to prescribe. Most importantly, during the COVID pandemic in 2021, the FDA loosened the rules even further, permitting the drugs to be dispensed through the mail, without any in-person doctor visits. They made this rule permanent later in 2021.

The lawsuit was originally filed in federal court in Texas in 2023. The plaintiffs, an organization of pro-life doctors, were challenging the original approval of mifepristone by the FDA in 2000. They argued that the FDA ignored evidence of risks and that further availability of the drug poses a danger to women.

The district court ruled in favor of the doctors, overturning the FDA’s original approval of mifepristone and the subsequent changes in the protocols. The appeals court, however, scaled that ruling back. They held that the doctors’ challenge to the original approval of mifepristone was too late, but said that they were likely to win their challenge to the FDA’s relaxation of safety protocols in 2016 and 2021.

All of these rulings were eventually put on hold pending the appeal to the Supreme Court.

Getting in the Courthouse Door
The primary issue on appeal to the Supreme Court, which dominated the oral arguments, was not the merits of the FDA’s approval of the abortion pill. Those dangers are very real — obviously to the unborn child but also to the mother — and are routinely underplayed. Instead, it’s clear that this case will be decided on the threshold issue of whether the courts even have jurisdiction to hear the case.

Under Article III of the U.S. Constitution, federal courts have limited authority. They are only permitted to take up “cases” and “controversies” that arise under the constitution or federal laws. They are not permitted to issue mere “advisory opinions” on abstract or hypothetical questions. This is a question of jurisdiction — whether the court has the authority to hear the case and take action.

The key jurisdictional question in this case is whether the doctors have “standing” to challenge the FDA’s decisions. In general, for a party to have “standing,” he has to prove three things: (1) he has suffered or is imminently about to suffer an “injury in fact,” namely some kind of tangible harm that is “concrete,” “particularized,” and “not conjectural or hypothetical”; (2) the injury can be fairly traced to the conduct of the defendant who has been brought into court; and (3) there is a possible remedy that can be ordered by the court in which the case is being heard.

If the doctors can’t prove these three elements, then their case must be dismissed.

Do They Have Standing?

The doctors rely on several grounds for their standing to sue. In the oral arguments, the Supreme Court seemed to focus on the question of whether the doctors had suffered, or were likely to suffer, any actual injury as the result of the FDA decisions.

Their attorney, who was from Alliance Defending Freedom, argued that the FDA’s 2021 rules allowing delivery by mail without a doctor’s supervision have led to an increase in women seeking emergency care after taking the pills. This forces the doctors into an intolerable position, where they may be required to participate in abortions in violation of their religious beliefs.

The government pushed back hard against these arguments. The solicitor general, who is an excellent advocate, repeatedly stressed that the doctors’ argument relied on speculation about multiple levels of independent decisions by other people who are not in court. She insisted that this made the alleged injury to the doctors hypothetical and remote, based on a “long chain of contingencies.” She also insisted that current federal conscience protection laws are sufficient to protect the doctors against any potential injuries.

Supreme Court doctrine on standing is hardly a model of clarity and consistency. The standards used are inherently flexible and can be easily used to allow favored plaintiffs into court while barring the door to those who are unpopular. During oral argument, the justices wrestled with these standards, but overall they seemed skeptical of the doctors’ arguments.

Again, this has nothing to do with the merits of the case. But if a plaintiff can’t prove he has standing, then all the other legal arguments count for nothing and his case will be dismissed. I’m afraid that that may ultimately be the fate of this case.

What Happens Next?

I’m always pessimistic about court cases, but I’m not the only one who listened to oral arguments and believes that the doctors will probably lose. Even if they win, the case will go back to the lower court to litigate the merits of their case. And the FDA can always revise its rules yet again to cure any substantive or procedural weaknesses.

Regardless of how this case comes out, we need to press for greater restriction on the availability of abortion pills, whether at the federal or state levels. Aside from their deadly effect on unborn children, there are very significant risks to women who take these pills, even according to the approved protocol. We need to keep making the case to politicians and regulators that these pills are dangerous and must be kept on a tighter rein.