The case Alliance for Hippocratic Medicine v. the Food and Drug Administration (FDA) serves as an illustration of how politicized the U.S. judicial system and drug safety approval process have become, threatening access to a demonstrably safe abortion medication—mifepristone—as judges attempt to roll back FDA approval of the drug.
One dangerous aspect of this case is the degree to which the judges have been willing to upend basic legal procedures, particularly the statute of limitations, to allow it to enter—let alone proceed through—the American judicial system. Currently, the previous rulings from U.S. District Court Judge Matthew Kacsmaryk and the U.S. Court of Appeals for the 5th Circuit that rolled back the FDA’s approval of mifepristone are on pause per a U.S. Supreme Court order, as litigation plays out at the lower level—the most recent step in that litigation being the oral arguments at the 5th Circuit that took place on May 17.
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 either a preliminary or emergency basis. At the same time, while this means that any future 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 country awaits a decision from the 5th Circuit, here is what to know about how the courts thus far interpreted key legal questions, particularly as they concern the statute of limitations.
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 statute of limitations is critical to maintaining a separation of powers
A statute of limitations is the legal version of a “time limit,” or the basic principle that the plaintiff must bring their case within a specified period of time. Although there are different time limits for different kinds of cases, generally, the time limit to bring a case against a federal agency, such as the FDA, is six years. Those six years begin whenever the final agency action in question—arguably the approval of mifepristone, in the case of Alliance for Hippocratic Medicine v. FDA—occurred.
A statute of limitations is foundational to the Western legal system; its existence can be traced back to ancient Greece, the Roman Empire, and 17th century English law. In the United States, it’s essential in the system of checks and balances between the legislative and judicial branches. Notably, Congress—and not the federal agency itself—sets the statute of limitations for cases against the federal government. Additionally, plaintiffs can only bring cases against an agency if the government agrees to waive its “sovereign immunity”—the idea referring to the fact that the government cannot be sued without its express permission. The courts then ensure that all parties are properly adhering to the statute of limitations. The combination of the statute of limitations and the waiving of sovereign immunity secures a distinctly American value: that there are checks and balances on all powers in a democracy.
In this case, the facts on timing alone illustrate how Judge Kacsmaryk and the 5th Circuit judges disregarded basic legal norms essential to upholding the system of check and balances. Mifepristone was first approved by the FDA in 2000, but the plaintiffs did not file this case until November 18, 2022—16 years outside the statute of limitations.
The judges disregard basic legal norms to override the statute of limitations
Judge Kacsmaryk and the 5th Circuit panel judges largely came to different conclusions on the most basic questions related to the statute of limitations in Alliance for Hippocratic Medicine v. FDA. The very fact that the judges ruled so differently on the same case—despite being bound by the same set of laws—may imply just how little legal precedent mattered in their decisions.
Legal precedent dictates that the clock should begin at the time of the alleged “injury” —the 2000 approval of mifepristone—time-barring the case from even entering Judge Kacsmaryk’s chambers. Still, both courts allowed the case to move forward, albeit in different ways.
The judges rolled back the approval of mifepristone by “reopening” (a legal term described more in depth below) for review several time-barred FDA actions, thereby disregarding the statute of limitations. To do this, the judges focused on the dates of multiple iterations of the FDA’s approval of mifepristone, changes to how it was approved for use, and plaintiffs’ attempts to voice concerns to the FDA over the past 20 years in what is called a “citizenship petition”—a process provided by the FDA for individuals to make requests to amend the agency’s policies.
Legal precedent dictates that the clock should begin at the time of the alleged “injury”—the 2000 approval of mifepristone—time-barring the case from even entering Judge Kacsmaryk’s chambers. Still, both courts allowed the case to move forward.
In its stay, the 5th Circuit ruled that everything from 2016 onward satisfied the statute of limitations and therefore could be challenged, while leaving open the question of whether actions taken prior to 2016, including the original 2000 approval of mifepristone, could be challenged. Judge Kacsmaryk, however, ruled that even the original 2000 approval, and everything that came after, could be challenged.
It’s impossible to overstate the importance of the blatant disregard for the statute of limitations in this case, particularly for those who need mifepristone.
It’s impossible to overstate the importance of the blatant disregard for the statute of limitations in this case, particularly for those who need mifepristone. The further back in time the judges can review the FDA’s approval of mifepristone, the more likely it is that they can make mifepristone less available—if they allow it remain lawful at all.
Misusing the reopener and the equitable tolling doctrines
Although they landed on different points in the timeline, all the judges misused the reopener doctrine to get to the same result: dismantling the approval of mifepristone, despite the FDA’s independent determination.
Under the reopener doctrine, a case that is normally time-barred under the statute of limitations can be brought into court if it has been “reopened.” To be reopened, a federal agency must seriously reconsider an existing rule and reevaluate it in a substantive way. If a rule qualifies as being reopened, the clock on the statute of limitations for a case that would have otherwise been time-barred starts again—this time, at the time of the reopening action, rather than the original decision.
The 5th Circuit held that all FDA actions on mifepristone from 2016 onward are reviewable and not time-barred; using the reopener doctrine, the court can track the denial of the second citizenship petition in 2021 back to the 2016 FDA safeguard changes. This move allowed the clock on the statute of limitations to restart for the 2016 decision. Similarly, Judge Kacsmaryk held that because the denial of the first citizenship petition in 2016 is connected to the original 2000 FDA approval, everything from 2000 on reviewable.
Both the 5th Circuit’s and Judge Kacsmaryk’s use of the reopening doctrine is easily dismissed as meritless.
Both the 5th Circuit’s and Judge Kacsmaryk’s use of the reopening doctrine is easily dismissed as meritless: The FDA has never reconsidered—let alone in a substantive manner, as required under the reopener doctrine—the approval of mifepristone after 2000, including when it made changes to how it could be used. As the U.S. Department of Justice explained in its emergency motion to stay the appeal, “[T]he FDA had already found in 2000 that mifepristone was safe and effective with those conditions; the question in 2016 [and 2021] was whether mifepristone would remain safe and effective without them.”* The FDA predicated its review of the proposed changes on the understanding that mifepristone was properly approved.
Even after Judge Kacsmaryk misused the reopener doctrine to get the clock to start on the date of the FDA denial of the first citizenship petition—March 29, 2016—the case, which was filed on November 18, 2022, still fell outside the six-year statute of limitations. And so, Judge Kacsmaryk independently used a second legal doctrine—the equitable tolling doctrine—to expand the statute of limitations an additional six months. “Equitable tolling” allows the time limit to be extended, or “tolled,” if there were extraordinary circumstances that prevented the filing of the lawsuit, despite the efforts of the litigant. However, the 5th Circuit did not appear to find this argument persuasive in its previous ruling, and plaintiffs did not appear eager to pursue Kacsmaryk’s argument during oral arguments.
Laying out arguments for judges and plaintiffs to use in future efforts to roll back the approval of mifepristone
Another alarming aspect of both Judge Kacsmaryk’s and the 5th Circuit judges’ orders is how explicitly they lay out arguments to upend the statute of limitations, for the plaintiffs and future judges to use. Indeed, the plaintiffs seemed aware of these road maps during oral arguments, as they sharpened their arguments before the 5th Circuit in light of these earlier decisions.
Most notably, the 5th Circuit laid out a path for plaintiffs and future judges to follow, albeit in a nuanced manner. Although the 5th Circuit panel judges ultimately noted that the 2000 approval and the 2002 citizenship petition were time-barred for purposes of their initial order, as noted above, they also made a point to say they were “unsure” about their own holding. Instead of providing more details on why their initial ruling was correct despite the hesitation, they spent four pages detailing why the 2000 FDA approval could potentially fall within the statute of limitations. it remains to be seen where the 5th Circuit will ultimately draw the line.
As Alliance for Hippocratic Medicine v. FDA highlights, the fight for abortion access is also a fight for an independent judiciary. Ahead of the next steps in this case in the 5th Circuit, and most likely the Supreme Court—with safe and meaningful access to abortion care across the country at stake—judges must uphold their responsibility to interpret law and not fashion it for what appears to be their own personal ideology.
* Author’s note: This quote comes from the U.S. Department of Justice’s emergency motion to stay the appeal at the 5th Circuit, filed on April 10, 2023. The document is on file with the author.