Alliance for Hippocratic Medicine v. Food and Drug Administration (FDA) can be summed up in one word: unprecedented. The case—initially ruled on through a nationwide preliminary injunction issued by U.S. District Court Judge Matthew Kacsmaryk and then appealed to the U.S. Court of Appeals for the 5th Circuit, which issued its own ruling that questioned parts of the District Court’s injunction while still allowing severe restrictions on mifepristone to go into effect—threatens access to medication abortion and the safety of Americans nationwide. The 5th Circuit recently heard oral arguments after the U.S. Supreme Court sent the case back to the lower courts, and the country awaits its decision, which can come at any time. However, regardless of the next outcome, it remains unprecedented for a judge with no medical or scientific expertise to attempt to find a drug unsafe despite the FDA’s approval, as is the extent to which both Judge Kacsmaryk and the 5th Circuit judges attempted to upend basic legal procedure to ensure that the case moves forward.
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The facts on mifepristone
Mifepristone—first approved by the FDA in 2000—is the first medicine in a two-step regimen used to end a pregnancy. Medication abortion accounts for more than half of all abortion care in the United States, and the frequency of medication abortion via telehealth has increased in the wake of Dobbs v. Jackson Women’s Health Organization, the case that overturned Roe v. Wade.
In the more than two decades since the FDA first approved mifepristone, the agency has evaluated the safety of mifepristone at least four times, and the results are conclusive: Mifepristone has proved safe and effective and has been used by approximately 5.6 million women in the United States. In fact, research shows that mifepristone has fewer serious risks than Tylenol.
The case is now operating under an order from the U.S. Supreme Court, which held that all restrictions on mifepristone must be paused until the case plays out in the lower courts. While this case is critical in the fight to preserve meaningful access to abortion, it has also raised an important issue unrelated to mifepristone: the judges’ misapplication of legal principles to grant the plaintiffs legal standing. These plaintiffs come from two groups: individual doctors opposed to abortion care and organizations made up of medical professionals opposed to abortion.
Read more on what the judges have gotten wrong so far in Alliance for Hippocratic Medicine v. FDA
It is important to note that neither the two lower-court decisions nor the Supreme Court’s order were final decisions on the merits of the case, despite having a nationwide impact. Instead, the decisions all ruled on matters from a preliminary or emergency basis. At the same time, while this means that any final decision may differ from these initial rulings, the judges’ rhetoric suggests a strong willingness to bend legal norms to benefit the far-right activists who are challenging the FDA’s long-standing approval of mifepristone.
As the nation awaits a decision from the 5th Circuit, here is what to know about how the courts thus far interpreted key legal questions.
The importance of legal standing in the U.S. Constitution
Legal standing is a common legal procedure that determines whether a case can be brought to court. Before a judge even decides on the substantive legal issues, the party bringing a case to court—the plaintiff—has to prove two things: that the injury is real and that whoever is being sued caused the injury. Legal cases define a real injury—or injury in fact—as one that is particularized and imminent. In short, legal standing is about where the two parties in a lawsuit “stand” in relation to one another.
The concept of legal standing is central to the American system of governance. Legal standing is rooted in the U.S. Constitution and protects the separation of powers between the judicial, executive, and legislative branches of government. Article 3 of the Constitution states that judges are limited to using their power in only “cases and controversies.” The Constitution’s writers intended to limit this power to ensure that judges did not issue decisions when there was no actual dispute to resolve because doing so would encroach on the powers of the legislative and executive branches of government—and could lead to decisions based on personal ideology or politics rather than legal rationale. U.S. Supreme Court Justice Antonin Scalia wrote extensively on how the Constitution’s writers viewed legal standing as core to the independence of the judicial branch.
In Alliance for Hippocratic Medicine v. FDA, the question of legal standing is: Did the plaintiffs—the entities suing the FDA—suffer a real injury caused by the FDA’s approval of mifepristone?
The plaintiffs
The list of plaintiffs who brought this case reveals just how politicized the U.S. judiciary system has become. While they can be largely divided into two groups—organizations of various sizes and individuals—there are eight plaintiffs in Alliance for Hippocratic Medicine v. FDA: one umbrella organization, three medical associations, and four doctors. The umbrella organization—Alliance for Hippocratic Medicine—comprises five anti-abortion groups, the members of which purport to be medical professionals. The organization was recently formed in 2022 and incorporated in Amarillo, Texas, even though none of the five anti-abortion groups has members there. Notably, the single-judge District Court over which Judge Kacsmaryk presides is in Amarillo, suggesting that the plaintiffs cherry-picked a judge whose ideology aligned with the desired outcome of their case.
Departing from precedent to bypass legal standing
If a drug has been on the market for more than 20 years, been used successfully by more than 5 million women, been hailed as one of the safest drugs available, and been scrutinized and reapproved by the FDA more than four times, can a judge suddenly find that it has caused an injury that is particularized or imminent?
Both Judge Kacsmaryk and the 5th Circuit granted legal standing at the preliminary stage to all the plaintiffs. In fact, during the recent oral arguments at the 5th Circuit, the judges seemed even more open to the idea of individual doctors having legal standing than previously thought. All grants of legal standing are based on these three kinds of purported injuries: hypothetical medical treatment, hypothetical financial treatment, and hardship to organizations.
Hypothetical medical treatment
The judges found that emergency care doctors and doctors in medical associations were harmed because they might have treated hypothetical mifepristone users who required emergency care, spending time and resources that would have been spent on other patients The basis of their reasoning was in part that a mifepristone user could require emergency care for any adverse symptoms associated with the medication. And just because both Judge Kacsmaryk and the 5th Circuit judges could, they allege that mifepristone “can overwhelm the medical system.” Yet medical and health professionals with actual experience in the medical system filed an amicus brief arguing the opposite: Eradicating access to mifepristone would exacerbate the burden on the nation’s health care system with far-reaching impacts on wait times for patients, their families, and practitioners.
This is not just a simple misapplication of legal procedure, but a departure from basic legal norms so extreme that siding with the plaintiffs’ outlandish arguments—“breathtaking in their absurdity”—implies a bias in favor of the plaintiffs’ arguments.
Legal scholars across the spectrum of political ideologies have noted that the ruling is not just a simple misapplication of legal procedure, but a departure from basic legal norms so extreme that siding with the plaintiffs’ outlandish arguments—“breathtaking in their absurdity”—implies a bias in favor of the plaintiffs’ arguments. This again highlights the ongoing accusations that the plaintiffs have cherry-picked judges whose personal ideologies are well documented and suggest that they may be more likely to find reason to rule in the plaintiffs’ favor.
This raises the question: What does a real injury for legal standing actually look like, particularly in abortion-related cases? Medical providers in abortion-related cases have endured a long list of tangible injuries, including death threats, gunshot wounds, destruction of medical facilities via Molotov cocktails, and more. These real harms contrast sharply with the vague, hypothetical injuries claimed by the plaintiffs in Alliance for Hippocratic Medicine v. FDA, making more apparent how the judges’ ideological leanings seem to have affected their rulings on the case.
Hypothetical financial liability
The judges on the District Court and at the 5th Circuit found that the doctors and medical associations in the case have standing due to financial injury on the basis that the hypothetical mifepristone users coming to the emergency room could sue them for malpractice or expose them to other forms of liability.
However, across all the plaintiffs and the more than 7,600 physicians registered in these medical associations, none has come forth with an actual malpractice case in the entire legal record, even though mifepristone has been on the market for more than 20 years.
Conversely, drug manufacturers such as Danco Laboratories LLC have listed the actual financial harm they would face if mifepristone were banned by the courts, including shutting down their operations, halting all clinical trials, and laying off their employees.
Hardship to organizations
The judges on the District Court and at the 5th Circuit found that the organizations in the case have also sustained injuries. An organization can have legal standing on its own—independent of the experiences of its members—if counteracting the effects of a defendant’s actions drains its resources.
The plaintiffs in Alliance for Hippocratic Medicine v. FDA claimed that the FDA’s approval of mifepristone was a “setback” for their organizational activities because they were forced to spend “time, energy, and resources” to educate their members on the so-called dangers of mifepristone. Notably, Judge Kacsmaryk specifically said that in addition to conducting independent studies on these dangers, the plaintiffs have had to “recalibrate their outreach efforts” and cannot undertake activities they normally would, such as “membership recruitment and retention.”
Even more alarming is the fact that the plaintiffs did not have to provide any tangible proof of the setback. In the thousands of pages of legal record, the organizations never bothered to quantify or qualify how much money or time they had spent “counteracting” the effects of the FDA’s approval of mifepristone.
This is both nonsensical and without established legal precedent. Other cases have shown that plaintiffs need some tangible proof to be granted organizational standing. For example, the 5th Circuit denied organizational standing in two other cases because the plaintiffs did not provide evidence that their members were required to forgo other work as a result of the challenged conduct.
Yet, in an egregious departure from legal precedent, the judges declared that the description of the purported setback was sufficient; no additional proof was required. Both the plaintiffs’ omission of proof and the judges’ granting of organizational standing is telling. Mifepristone has been on the market for 20 years, and the plaintiffs have had more than enough time to gather evidence. Not requiring a shred of quantifiable proof only underscores the judges’ underlying bias.
Judge Kacsmaryk and the 5th Circuit panel of judges have seemingly revealed how far they are willing to go to effectuate their personal ideologies.
Conclusion
In attempting to bypass the legal standing requirements, Judge Kacsmaryk and the 5th Circuit panel of judges have seemingly revealed how far they are willing to go to effectuate their personal ideologies. The rulings in favor of the plaintiffs on the ground of legal standing contrasts with the vision of the writers of the Constitution, who intentionally minimized the scope of the power of federal judges to ensure that judges could not make politically biased decisions and to maintain the basic function of an independent judiciary.
As the next steps in the case approach, likely to include another Supreme Court ruling on abortion access, judges must be bound by the rule of law and the reach of the Constitution—just like all Americans.