Earlier this week, the U.S. Court of Appeals for the 5th Circuit heard oral arguments in Alliance for Hippocratic Medicine v. Food and Drug Administration (FDA), a case challenging the FDA’s approval of mifepristone—the first medicine in a two-step regimen used to end a pregnancy.
Previously, U.S. District Court Judge Matthew Kacsmaryk and judges out of the 5th Circuit issued unprecedented—albeit preliminary—rulings in this case, recklessly threatening to halt the decades-old approval of mifepristone, which is highly effective and exceptionally safe and has been used by approximately 5.6 million women in the United States.
However, last month, after the U.S. Department of Justice and Danco, the brand-name manufacturer of mifepristone, filed emergency petitions with the U.S. Supreme Court, the court paused Judge Kacsmaryk’s ruling, meaning that mifepristone will remain available across the country for now as litigation continues to play out in the lower courts.
A doctor shares her reaction to the decision in Alliance for Hippocratic Medicine v. FDA and explains the importance of mifepristone
In a Zoom conversation with a CAP staffer in May 2023, Andrea K. Contreras, a physician and third-year OB-GYN resident in Texas, said:
I felt insulted by the judge’s decision in the mifepristone ruling. It discredits the years of education and training we, physicians, receive. Patients are real people deserving of help and care. For someone with no medical training to imply that we would administer a medication that is unsafe is infuriating. We took an oath to do no harm and to care for the sick. A multitude of studies have shown mifepristone to be safe, effective, and reduce time to delivery in the setting of second-trimester pregnancy loss. If we don’t have access to mifepristone, it will make the induction longer and more dangerous. I mean, it’s just cruel.
Both Judge Kacsmaryk’s opinion and the 5th Circuit’s order, as well as the discussions during oral arguments, relied on significant fallacies and biased scientific studies related to the safety of medication abortion. As the public awaits the next decision in the case, this column lays out what the judges got wrong about emergency care after medication abortion and why it matters—as well as why, ultimately, any rational court should reject such arguments.
The judges accepted misleading studies on medication abortion as fact
In their initial, previous rulings in Alliance for Hippocratic Medicine v. FDA, both the District Court and the 5th Circuit found that the doctors who sued have legal standing in the case—meaning that they have the capacity to bring the suit in court, in part because they were purportedly injured by the entity they are suing. In order to arrive at that point, however, both courts perpetuated meritless claims that medication abortion will result in patients overtaking emergency departments after they take the medication.
For example, in the District Court’s decision, Judge Kacsmaryk appeared to parrot right-wing activists’ arguments by saying that medication abortion will “overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications.” The 5th Circuit made a similar claim, suggesting that patients will seek “emergency care” after taking mifepristone. Both courts relied on a study released by James Studnicki of the Charlotte Lozier Institute, an anti-abortion group, that found an increase in emergency room (ER) visits after medication abortion. Likewise, during oral arguments, the judges did not adequately question the plaintiffs’ use of this study—as well as other claims raised during litigation related to the percentage of women who go to the ER after a medication abortion—as a measure of harm faced by the plaintiffs or safety.
This failure to do so may have real consequences, given that the claims in the study are extremely deceptive if not demonstrably false. To start, the mere existence of an emergency department visit after an abortion does not indicate that doctors will be forced to provide intensive medical intervention—or any medical intervention—to patients. It also does not necessarily mean that medication abortion is unsafe, as these opinions imply. As the Annenberg Public Policy Center of the University of Pennsylvania’s FactCheck.org project recently explained: “[I]t is misleading to cite Studnicki’s study as evidence of a safety risk associated with medication abortions, because it only tracked ER visits, not whether those visits required medical intervention, or if they did, whether the intervention was for a serious adverse event, such as needing a blood transfusion.”
In fact, women often visit emergency departments after an abortion simply to ensure the medications worked correctly; this does not mean that doctors will provide specific medical care or be “overwhelmed.” In addition, Studnicki’s study uses data exclusively from Medicaid patients, who are “more likely to visit emergency rooms for routine medical care because they often lack primary care providers”—meaning that the data overrepresent those who go to the ER after an abortion. In essence, the judges relied on data that cherry-picked a population that is more likely to go to the emergency department for all medical issues—and strategically does not include a population that is less likely to use the emergency department—in an attempt to prove that medication abortion is dangerous.
Using these studies represents a disingenuous attempt to undermine the FDA’s repeated findings on the safety of the medication … thereby politicizing the judiciary and the process of approving medicine.
Relying on these flawed studies creates a false narrative that mifepristone is unsafe and that doctors will undergo an enormous amount of stress dealing with complications from medication abortion; in actuality, that is not the case. Moreover, using these studies represents a disingenuous attempt to undermine the FDA’s repeated findings on the safety of the medication—findings backed by virtually all leading medical associations—thereby politicizing the judiciary and the process of approving medicine.
Medication abortion is safe, with few serious adverse events and complications
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 is incredibly safe and effective. In fact, research shows that mifepristone has fewer serious risks than Tylenol. In addition, as of June 2022, mifepristone has been used by approximately 5.6 million women in the United States, though the number has surged in the wake of Dobbs v. Jackson Women’s Health Organization, the case that overturned Roe v. Wade.
While the Studnicki study does not provide context on how many ER visits resulted in medical intervention, studies on the use of medication abortion have consistently found that the medication leads to few adverse events and serious complications. For example, in its 2016 medical review of mifepristone, the FDA cited a study that found only 0.31 percent of the women who received medication abortion experienced major complications, which it defined in the study as “requiring hospital admission, surgery, or blood transfusion.”
Studies on the use of medication abortion have consistently found that the medication leads to few adverse events and serious complications.
Similarly, the American College of Obstetricians and Gynecologists says that after taking mifepristone, “Serious side effects occur in less than 1% of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3% of patients. The risk of death is almost non-existent.”
A New York Times analysis of more than 100 studies on medication abortion across 26 countries found that more than 85 percent reported that “more than 99 percent of patients who took the pills had no serious complications.”
Given that medication abortion accounts for more than half of all abortion care in the United States, Alliance for Hippocratic Medicine v. FDA could have profound implications on access to abortion across the country. Furthermore, as the American Medical Association president, Dr. Jack Resneck, recently warned, “If the lower courts’ rulings on mifepristone are not reversed entirely, it could also upend the Food and Drug Administration’s drug regulatory process … throw[ing] our health care system into chaos in ways that extend far beyond the specific fight over mifepristone.”
Alliance for Hippocratic Medicine v. FDA makes clear that politicization within the judiciary—demonstrated in the judges’ willingness to embrace far-right claims while discarding demonstrated medical facts and expert opinion—can wreak havoc for the United States. As the 5th Circuit considers this case, and the possibility of a Supreme Court ruling looms in the future, the judiciary must ensure that drug approval and safety are based on science and medical best practices rather than politics.