The Shadow Medical Community Behind the Attempt to Ban Medication Abortion

The Alliance for Hippocratic Medicine, a new anti-abortion umbrella group that is spearheading a sweeping federal challenge to medication abortion, incorporated in Texas just months before filing suit. The incorporation documents, obtained from the Texas secretary of state, provide further evidence that the plaintiffs cherry-picked a court they believed would be amenable to their arguments, an act of forum shopping that was orchestrated to land the case before Judge Matthew Kacsmaryk, a Trump-appointed darling of the far right.

The Alliance incorporated in Amarillo in August 2022, bringing together five out-of-state anti-abortion groups: the Catholic Medical Association, the Coptic Medical Association of North America, the American College of Pediatricians, the Christian Medical & Dental Associations, and the American Association of Pro-Life Obstetricians and Gynecologists. Three months later, the lawsuit was filed in the same Texas Panhandle city where Kacsmaryk hears all federal civil cases.

The lawsuit alleges that in 2000, the Food and Drug Administration, or FDA, wrongly approved mifepristone, the first of two drugs that make up the standard medication abortion protocol. The groups also argue that sending abortion medications through the mail violates federal criminal law. To advance their argument, the plaintiffs have assembled a raft of dubious evidence to allege that the FDA is anti-science and mifepristone is a wildly dangerous drug, despite decades of scientific research and hundreds of medical studies that demonstrate otherwise. They have dished it all up for a federal judge who, in just a short time on the bench, has developed a reputation for factitious legal opinions. A ruling in their favor could see medication abortion all but banned across the U.S., sparking a new round of chaos after the fall of Roe v. Wade and laying the groundwork for the dispute to land before the U.S. Supreme Court.

Mifepristone and misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic in Santa Teresa, N.M., on June 17, 2022.

Suspect Assertions

Medication abortion is a two-drug protocol designed for use in early pregnancy termination. The first drug, mifepristone, blocks progesterone (a hormone needed to maintain pregnancy) and softens the uterine lining; the second drug, misoprostol, is taken 24 to 48 hours later and causes the uterus to contract, expelling the pregnancy.

The regimen was developed in France in the late 1980s, but it wasn’t until 2000 that the FDA finally approved it for use in the United States. Medication abortion accounted for just 5 percent of abortions in 2001 but has steadily grown in popularity; today, medication abortion accounts for more than half of all pregnancy terminations in the country. The protocol is also commonly used for miscarriage management.

The FDA has enforced a slew of restrictions tied to mifepristone that advocates and providers have long argued are medically unnecessary — including a rule that it must be dispensed in person, even though misoprostol is not taken until later at a place of the patient’s choosing. During the pandemic, the in-person dispensing rule was blocked, and in December 2021, the FDA announced that it was permanently lifting the requirement. The agency has since taken additional steps to expand access to medication abortion by allowing mail-order and brick-and-mortar pharmacies to dispense it to patients with prescriptions in states where abortion is legal.

It was against this backdrop that the Alliance for Hippocratic Medicine, its partner organizations, and several individual doctors — represented by lawyers with the Christian-right Alliance Defending Freedom — filed suit in Texas, arguing that the FDA never should have approved mifepristone in the first place, let alone expand its use or loosen dispensing requirements.

The filing is a jumbled mess of suspect assertions, cloaked in inflammatory and medically inaccurate language. The filing refers to medication abortion as “chemical” abortion and claims that mifepristone “starves the baby to death.” It alleges that medication abortion is far riskier than procedural abortion or carrying a pregnancy to term, which the plaintiffs argue “rarely” leads to threatening complications. They call mifepristone an “endocrine disrupter” that could threaten the normal development of adolescents who take it. And they assert that individuals suffering complications from medication abortion could “overwhelm” the health care system, leading to a flood of blood transfusions that “exacerbates the current critical national blood shortage.”

These allegations are baseless. An endocrine disrupter is a chemical that mimics or interferes with the body’s hormones, such as PFAS, a class of toxic “forever” chemicals found in dozens of common products that has been linked to cancer and other illnesses. The notion that mifepristone — taken in a single dose — falls into this camp because it “briefly blocks progesterone receptors in the uterus is completely unfounded,” according to an amicus brief filed in the case by the American College of Obstetricians and Gynecologists, the American Medical Association, the American Academy of Family Physicians, and eight other leading U.S. medical groups. “There is no reason to think, nor is there evidence to show, that preventing the absorption of progesterone for a brief window would have any effects on adolescent development,” the brief states.

“Mifepristone’s safety profile is on par with common painkillers like ibuprofen and acetaminophen, which more than 30 million Americans take in any given day.”

The assertion that medication abortion is a risky and understudied endeavor recklessly approved by the FDA is equally spurious. To date, mifepristone has been used in more than 630 published clinical trials, including more than 420 randomized, controlled studies, which the amicus brief notes are the “gold standard of research design.” At less than 1 percent, the risk of serious complications is exceedingly low. The likelihood of any complication at all is about 5 percent; the most common is an incomplete expulsion, which may require a procedural abortion to complete. Meanwhile, the risk of death associated with carrying a pregnancy to term is 14 times higher than the risk associated with abortion.

“Mifepristone’s safety profile is on par with common painkillers like ibuprofen and acetaminophen, which more than 30 million Americans take in any given day,” according to the amicus brief. Procedures like wisdom teeth removal, colonoscopy, and plastic surgery have higher complication and death rates, as does the use of Viagra. “Put simply,” the brief states, “medication abortion is among the safest medical interventions in any category — related to pregnancy or not.”

Behind the Scenes

The fight over abortion has long featured a shadow medical community that exists to promote counterfactual narratives about risks associated with the procedure. To Mary Ziegler, a law professor and legal historian at the University of California, Davis, the fact that the Alliance for Hippocratic Medicine was established to go after medication abortion isn’t surprising.

“There’s a tradition of groups like this forming,” Ziegler said. Back in the 1990s, for example, a group called the Physicians Ad Hoc Committee for Truth sprang up for the purposes of advocating for a ban on dilation and extraction abortion, which anti-abortion forces dubbed “partial-birth abortion.” Once Congress passed the ban, the committee disappeared.

While the Alliance for Hippocratic Medicine itself is a new entity, presumably incorporated to bolster the pending lawsuit, the groups organized under it have been around for a long time. The American Association of Pro-Life Obstetricians and Gynecologists, known as AAPLOG, formed in the wake of the 1973 Roe decision, initially as an affinity group of anti-abortion physicians who belonged to the American College of Obstetricians and Gynecologists, or ACOG, the country’s leading professional membership organization for OB-GYNs.

Over time, AAPLOG began to push back against the medical and scientific establishment, developing a narrative that abortion was not only immoral, but also dangerous. The group focused more on disputing the “factual premises of things ACOG was saying, rather than just disputing the morality or ethics of those decisions,” Ziegler said. “Medical arguments against abortion bans were effective enough that they needed to be met with medical arguments for abortion bans,” she explained. “There’s an appetite for these organizations to have their own narratives.”

AAPLOG has since split from ACOG and now has roughly 7,000 members compared to ACOG’s more than 60,000 (anyone can join the former, while the latter’s membership is limited to medical professionals). Despite its size, AAPLOG has successfully pressed its counternarrative in legislative and legal crusades to restrict or ban abortion, even when the scientific underpinning for its position is shaky.

Take the work of George Delgado, one of the named plaintiffs in the Alliance for Hippocratic Medicine lawsuit. A doctor in Southern California, Delgado developed so-called abortion pill reversal: the notion that a person who changes their mind about going through with a medication abortion after taking mifepristone (but before taking misoprostol) can interrupt the process by taking a large dose of prescription progesterone to reestablish the pregnancy. There is no evidence that the protocol is safe or effective; the only controlled study designed to interrogate it was halted based on “safety concerns” after three of 12 participants hemorrhaged and were taken to the hospital. Still, AAPLOG has deemed medication abortion reversal a “medically sound choice” and supported state efforts to mandate counseling on reversal for anyone seeking abortion.

“When you have arguments about science that are not based that much in evidence, not only is it confusing and obviously can lead to really bad outcomes, but it’s also disenfranchising.”

While the alternate narratives pushed by groups like AAPLOG may be politically powerful, they are also dangerous, offering the imprimatur of science without sound foundational support. “When you have arguments about science that are not based that much in evidence, not only is it confusing and obviously can lead to really bad outcomes, but it’s also disenfranchising,” Ziegler said. “Because normal people don’t know anything about these topics, right? They don’t know about the relative rate of complications of mifepristone. And so if what’s really going on here is a struggle over constitutional values and ethics and so on, we should be telling the truth about that.”

The shadow medical community’s efforts to legitimize various abortion restrictions have been effective — like a requirement that abortion doctors maintain hospital admitting privileges, which groups including AAPLOG claimed was a best practice designed to ensure patient safety. Broadly speaking, such efforts worked in front of state lawmakers but typically failed at the Supreme Court.

Now, with Roe in the rearview mirror and no immediately obvious need to keep pressing such pseudoscience, Ziegler suspects that groups like AAPLOG are still leaning into these arguments because their real aims — like establishing fetal personhood rights — “are still not popular,” she said. Anti-abortion ballot measures have repeatedly failed with voters, and a significant majority of Americans say abortion should be legal in all or most cases. “And so they’re having to take their claims to courts and to judges like Judge Kacsmaryk … and they’re having to rely on weird interpretations of FDA regulations.” This is “not a window into what they think is the most important,” she said, but “what they think will work.”

The J. Marvin Jones Federal Building and Mary Lou Robinson United States Courthouse where U.S. District Judge Matthew Kacsmaryk will rule in a lawsuit challenging medication abortion, on Feb. 11, 2023, in Amarillo, Texas.

A Slippery Slope

Before being tapped to serve as the federal district court judge in Amarillo, Kacsmaryk worked at the religious-right First Liberty Institute, which, among other things, opposes the separation of church and state. Kacsmaryk has been vocal about his disdain for gay marriage, reproductive rights, and transgender people. In 2016, he signed onto a letter that called being transgender an “irrational … delusion” (the Catholic Medical Association, which is a party in the mifepristone lawsuit, was also a signatory). And he’s written that the sexual revolution was destructive, seeking “public affirmation of the lie that the human person is an autonomous blob of Silly Putty unconstrained by nature or biology, and that marriage, sexuality, gender identity, and even the unborn child must yield to the erotic desires of liberated adults.”

Trump-appointed Judge Matthew Kacsmaryk at his Senate confirmation hearing in 2017.

While on the bench, Kacsmaryk has made a string of controversial rulings: He declared Biden administration protections for transgender workers unlawful; twice ordered the administration to enforce the Trump-era “Remain in Mexico” policy; and attacked Title X, the only federal program designed to provide birth control to low-income and uninsured people.

In the Title X case, Deanda v. Becerra, Kacsmaryk sided with Texas father Alexander Deanda, who was challenging the program based on its guarantee of patient confidentiality. Deanda claimed that the program violated his rights as a parent raising his daughters according to “Christian teaching on matters of sexuality.” With Title X in place, he argued, he had no assurance that his daughters would be “unable to access … contraception” and other services that “facilitate sexual promiscuity.”

Among the criticisms leveled at Kacsmaryk in the wake of his ruling in favor of Deanda was that he lacked power to consider the case in the first place. To bring a federal lawsuit, a plaintiff must show they’ve been injured by the law they’re challenging, but Deanda — who never alleged that his children attempted to avail themselves of Title X services — hadn’t been harmed. Deanda had no standing to bring the suit, in other words, and Kacsmaryk had no cause to hear it. Nonetheless, Kacsmaryk ruled that the Title X program as administered violated the “constitutional right of parents to direct the upbringing of their children.”

In response to the pending mifepristone lawsuit, the federal government has argued that the FDA’s approval of the drug in 2000 was based on years of solid research, that the statute of limitations to challenge that approval has since run out, and that, like Deanda, the plaintiffs have no standing.

The FDA argues that neither the medical associations nor the individual doctors bringing the suit have suffered any injury related to the drug’s approval. And indeed, the plaintiffs’ claims of injury are tenuous. While the doctors who are party to the lawsuit don’t provide medication abortion, they argue that they may one day find themselves in a situation where a person allegedly harmed by mifepristone comes to them for treatment, thus drawing their attention away from existing patients. And they say that these impaired patients may present with an incomplete abortion, which would conscript the doctors into providing services that violate their conscience. Meanwhile, the organizations argue that the approval of mifepristone has forced them to divert time and energy away from other priorities, like advocating for fetal personhood, forcing them to focus instead on “educating” their members about the dangers of medication abortion.

To the FDA, this theory of legal injury is nonsense — and a slippery slope: Allowing the case to go forward would greenlight other baseless legal complaints, it argues in response to the Alliance lawsuit. “If FDA approved a new heart medicine, emergency physicians would have standing to challenge the approval on the theory that some patients would experience adverse events under the new treatment; in contrast, cardiologists would have standing to challenge the approval on the theory that some patients would no longer require their services.”

A Zombie Law

In a response filed in early February, the Alliance Defending Freedom lawyers brushed off the government’s arguments about standing — the doctors and organizations bringing the suit had “standing six ways from Sunday,” they asserted. They doubled down on their fearmongering, arguing that medication abortion had never been studied under “real-world conditions,” and that the doctors bringing the suit actually “treat and care for countless victims of this dangerous drug regimen.”

The plaintiffs also leaned into allegations that allowing medication abortion to be mailed to patients violates the 19th-century law known as the Comstock Act, which outlawed sending anything considered “obscene, lewd, lascivious, indecent, filthy or vile” through the mail, including contraceptives and “every article or thing” that could be used for abortion. Over the years, judicial and congressional actions have largely neutered the act, and in late December, the Department of Justice penned an opinion noting that the law does not apply where abortion is legal or when the sender doesn’t intend that the recipient would use the drugs illegally. But the Comstock Act is still on the books, a zombie law that the Alliance plaintiffs are trying to raise from the dead.

If Kacsmaryk agrees that the Comstock Act applies to medication abortion, the impact could be far-reaching. The act forbids the mailing of any device that may be used for abortion, which would include countless medications and routine gynecological instruments. It could also impact the availability of misoprostol, which absent mifepristone, can be used alone to accomplish an abortion. It is not as effective as the two-drug regimen but has for decades been used safely for that purpose; the Alliance lawsuit does not attack FDA approval of misoprostol.

A hearing in the case has yet to be scheduled. Meanwhile, a coalition of 12 states, led by Washington and Oregon, filed their own lawsuit last week asking another federal judge to rule that mifepristone is safe and effective and that its FDA approval is “lawful and valid.” The states are asking the judge to eliminate all remaining FDA-imposed restrictions on mifepristone, which they argue impermissibly impede access to the drug.

On February 24, Vice President Kamala Harris met with reproductive rights advocates and medical experts, including from ACOG and the American Academy of Family Physicians. The Alliance lawsuit is not just an attack on “women’s fundamental freedoms,” she warned. “It is an attack on the very foundation of our public health system.”

“Those who would attack … the ability of the FDA to make a decision” about approving a drug like mifepristone “ought to look in their own medicine cabinets to figure out whether they’re prepared to say those medications … should no longer be available to them,” she said. “Because that is what we are talking about.”