Pro-lifers are applauding the recent decision by a federal district court in Texas to ban the abortion pill mifepristone. But the celebration is premature. The decision has many legal problems, there’s a significant chance it won’t survive appellate scrutiny, and a final decision is far in the future.

The lawsuit, entitled Alliance for Hippocratic Medicine v. Food and Drug Administration, was filed in federal court in Texas. 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 judge issued a preliminary ruling in favor of the plaintiffs, overturning the FDA’s approval of mifepristone. The judge put his order on hold so the government could appeal. The case now moves on to the Fifth Circuit Court of Appeals and ultimately to the Supreme Court.

Unfortunately, the next phases of the litigation won’t involve a real debate over 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. But this case will be ultimately decided not on the substance but on procedural issues.

To help understand this, it’s important to look at the threshold legal issue that must be satisfied before any case can go forward. I am not an expert in federal procedure, but I’ll try to make this complex area comprehensible.

Who Can Sue?

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. Nor can they pass judgment on constitutional issues as a general or academic matter. This is a question of jurisdiction – whether the court has the authority to hear the case and take action.

There are several legal doctrines that have developed to determine if a case or controversy can be taken up by a federal court. They go by the names of “ripeness” (is the case ready?), “mootness” (is the case already over?), and “standing” (can you sue?). It’s the last of these that is critical to the abortion pill case.

In general, for a party to have “standing” to bring a lawsuit in federal court (so-called “Article III 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.

Take, for example, a claim about employment discrimination on the basis of religion, brought under the federal Civil Rights Act. You would have standing to bring a lawsuit in federal court if you could prove that: (1) you were improperly fired because you declined to participate in an abortion on the basis of your religious beliefs, (2) you sued the actual employer who fired you and not some other company, and (3) the court can award you monetary damages for lost wages or order that you be reinstated to my job.

If a plaintiff can’t prove these three elements, then his case must be dismissed because the court lacks jurisdiction. It has nothing to do with the merits of his claim. The court just doesn’t have the authority under the constitution to hear his case.

There are other doctrines that allow an organization to bring a case on behalf of its members. One is “organizational standing”, when you can prove that the association itself has been harmed. Another is “associational standing”, where the group’s members were harmed. That is a very common way that federal constitutional lawsuits are brought. For example, most abortion litigation is brought by associations of abortionists (like Planned Parenthood) on behalf of its affiliated clinics, and most Second Amendment cases are filed by groups of gun owners like the National Rifle Association.

But associations don’t have carte blanche to bring lawsuits any time their members have some kind of interest in the outcome. The organization still has to prove that  either itself or its individual members can satisfy all three elements for standing listed above.

Do the Doctors Have Standing?

In this case, the district judge found that the individual doctors and the association had satisfied the standing test. But this finding is far from clear-cut and will be very vulnerable to being reversed on appeal.

The plaintiffs rely on several grounds for their standing to sue. They argue that complications from the abortion pill may lead to emergency treatments that could consume resources and overwhelm the medical system. They also argue that women may come to them for help after taking the drugs, which will force them to divert their attention from their other patients. They also cite the possibility that treating these mothers may require them to complete the abortion, which would violate their religious beliefs. Further, they argue that the FDA’s failure to study all the potential risks impairs their ability to practice evidence-based medicine, thus exposing them to potential malpractice cases. And finally, they say that these injuries will only increase now that the FDA has approved the delivery of mifepristone by mail.

These are good arguments, but they appear to run afoul of Supreme Court decisions. In the most significant recent case, Clapper v. Amnesty International USA, the Court stated that plaintiffs have to prove that the injury is “certainly impending”. The threat can’t be purely hypothetical and potential, and it can’t be based on speculation about independent decisions by other people who are not in court. And an organization can’t manufacture standing by incurring the cost of preemptive measures against the possibility of some future injury.

The plaintiffs’ theory of standing clearly has problems under “certainly impending” Clapper test. It’s filled with speculation about what might happen in the future, about hypothetical  impacts on medical resources, and the possibility that they may be sued someday for some harm done to some mother. It also depends heavily on potential independent decisions made by mothers, who were not previously their patients, who seek their help after taking the drugs.

The doctors did allege that they had treated a dozen women who did so. But that was over a twenty-plus-year period since the FDA first approved mifepristone, which is hardly a strong argument for imminent injury. It also does not appear that they alleged a single case where any of them had to complete an abortion after a mother took the drugs.

Supreme Court doctrine on standing is hardly a model of clarity and consistency, and the standards used are inherently flexible. There are other decisions that have permitted a challenge to a law if there is a “substantial risk” that it will be enforced against the plaintiff and he has incurred costs in anticipation. But to my knowledge the Court has not allowed a challenge when there is nothing but speculation about possible future enforcement or injuries.

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

What Happens Next?

There are other difficult issues involved in the case, dealing with the statute of limitations and judicial deference to agency decisions within their area of expertise. I will discuss those in a later blog post. There was also an odd decision by a federal district court in the District of Columbia, ordering the FDA to continue to permit the abortion drug without any changes. Having two conflicting decisions adds to the uncertainty.

The government has already filed an appeal in the Fifth Circuit, asking to put the district court’s ruling on hold. They will likely hear the case on an accelerated schedule, but there won’t be any ruling for months. Then it will undoubtedly go the Supreme Court, either on the emergency calendar or for full briefing and argument next term.

Litigation is always a roll of the dice. That’s especially the case in the current legal climate, where the judiciary has become a thinly-veiled political branch of government. The upside can be a major victory – as we saw with the Dobbs decision last year. But the downside may be to make the law worse or to expend scarce legal resources for nothing. It’s a cliché to say so, but we won’t know for a long time where the dice will fall in this case.

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[Disclosure: Alliance for Hippocratic Medicine and the other plaintiffs are represented by Alliance Defending Freedom. I am a member of ADF’s Allied Attorney Network, but had no involvement in this litigation.]