Suspect science and claims at center of abortion-pill lawsuit
The FDA’s 2016 scientific review of mifepristone was based on a dozen studies and on data from more than 30,000 patients, and found low rates of “serious adverse events”
Emergency rooms across America are teeming with women and girls bleeding from abortion drugs in such copious amounts that it’s exacerbating the national blood shortage.
Or, at least, that’s the grim – but false – narrative a group of small conservative Christian medical associations have painted for a federal judge in Texas. Their mountain of evidence, they say, shows abortion via a specific drug regimen is incredibly dangerous and should never have been approved by the Food and Drug Administration more than 20 years ago.
The openly anti-abortion federal judge presiding over Alliance for Hippocratic Medicine v. FDA could, at least temporarily, ban abortion drugs any day now. But if he does, reproductive-health care experts say it will be based on deeply flawed evidence that largely rests on cherry-picked studies and a handful of anecdotes from a handful of anti-abortion doctors. And it will have immediate consequences for pregnant people in America, many of whom have begun to rely on this method to terminate pregnancies early and safely, especially in states that banned abortion after the U.S. Supreme Court overturned Roe v. Wade last year.
“The attempt to reverse the FDA’s approval of mifepristone has absolutely nothing to do with the safety of this drug,” Dr. Kristyn Brandi, a family-planning subspecialist and fellow with the American College of Obstetricians and Gynecologists, said in an email. “This is a highly safe and effective medication that should be available to patients. The use of mifepristone for medication abortion improves patient outcomes. We know this based on evidence from numerous medical studies and data from millions of uses in the twenty-three years since the FDA first approved the use of mifepristone for medication abortion.”
Many of the doctors who brought this case are with the American Association of Pro-Life Obstetricians and Gynecologists, which represents about 7,000 members compared to ACOG’s 60,000 members. Despite its small stature, AAPLOG wields an enormous amount of power when it comes to reproductive-health policy. The group has spent decades in the courts and legislatures selling a narrative unsupported by the predominating medical consensus: Abortion is not only immoral, but should be banned because it’s dangerous.
That strategy helped codify hundreds of state anti-abortion laws and paved the legal pathway for the reversal of federal abortion rights. Now, AAPLOG is back in court as part of the Alliance for Hippocratic Medicine, a consortium of medical associations that practice Christian-right beliefs when it comes to reproductive-health care, health care for trans people, and end-of-life care. They are represented by the nonprofit Christian-right legal shop Alliance Defending Freedom, which also represented plaintiffs in Dobbs v. Jackson Women’s Health Organization. ADF has previously leaned on shaky science in the courts to defend anti-abortion and anti-LGBTQ policy, including the widely discredited practice of conversion therapy to change people’s sexual orientation and gender identity.
One of conversion therapy’s biggest advocates, Dr. Quentin Van Meter, also testifies in this lawsuit, arguing that long-term effects of mifepristone on minors have not been adequately studied (HHS disagrees).
And the evidence in this case couldn’t be shakier. The data footnoted in the 113-page complaint don’t actually support plaintiffs’ horrifying scenario. At most, plaintiffs show there are sometimes complications associated with medication abortion, which sometimes require medical attention – but they don’t present convincing data to show high rates of life-threatening incidences.
Instead, plaintiffs cast doubt on the safety data collected and monitored by the FDA since it approved mifepristone under the brand-name Mifeprex in 2000, and then approved an abortion-drug regimen of mifepristone and an ulcer medicine called misoprostol. In more than two decades, there have been 28 reported deaths associated with mifepristone and a generally low rate of adverse events, according to the FDA.
Plaintiffs conjecture about high levels of under-reporting of adverse events. And they speculate that with increased availability of abortion drugs – especially as more people have begun self-managing their abortions – health issues will skyrocket.
“We represent OBs, emergency-room doctors, medical associations, the doctors who every day care for women and see the harms of these dangerous chemical abortion drugs in their practice,” ADF senior counsel Julie Blake said last month on “Washington Watch with Tony Perkins,” produced by the conservative Christian Family Research Council. “And we are confident that once we get our claims in front of a judge, that he’ll say, ‘Hey you didn’t follow the law, you didn’t follow the science. And it’s time to withdraw these drugs from the marketplace.’”
In addition to relying on flawed research manufactured by the anti-abortion movement, the plaintiffs mix religion with their science.
For example, California family doctor George Delgado, who practices medicine based on “teachings of the Catholic Church,” invented a controversial protocol to “reverse” an abortion, which has raised safety flags. Another plaintiff is Republican Indiana Sen. Tyler Johnson, an emergency room doctor, who last year campaigned as “a pro-life physician, not a politician.” He’s spoken out against the COVID-19 vaccine and against exceptions to Indiana’s legally challenged abortion ban.
This is the second time group-plaintiff Christian Medical & Dental Associations tapped the Detroit-based Dr. Regina Frost-Clark to be a party in an abortion-related lawsuit. She considers God to be the ultimate authority in her medical practice and works for a Catholic hospital system whose guidelines deny access to miscarriage management in the absence of life-threatening infection.
Like CMDA, AAPLOG is always scouting for new expert witnesses to lend credibility to their lawsuits and has been regularly hosting expert-witness trainings around the country, including this Sunday in Tucson, Arizona. Upcoming trainings are scheduled in Georgia, Kentucky, Florida, Wisconsin, Iowa, Michigan, and North Carolina.
“The voices of medical professionals carry great weight in the public square,” reads a recent AAPLOG member email advertising this training program. “We want to provide you with the training and confidence you need to give the evidence-based rationale for prolife medical practice to the media, to your state legislators, and in court.”
So, what are some of the most serious medical claims plaintiffs are making, and will their medical degrees be able to sell them in the absence of robust evidence?
CLAIM: Abortion drugs are dangerous.
The FDA-approved medication abortion regimen involves taking mifepristone, which blocks the hormone progesterone, needed for the pregnancy to grow and develop normally. That’s followed a day or two later by misoprostol, which stimulates the uterus to empty the pregnancy, essentially inducing a miscarriage. The FDA approves this regimen for early abortion and miscarriage management through 10 weeks of pregnancy, while the World Health Organization says the drug regimen can be safely taken through 12 weeks.
Cramping and bleeding are expected symptoms after taking medication abortion. Just as with menstruation and pregnancy and childbirth, women report various experiences after taking medication abortion. Some report horrifying pain, while others compare the experience to a heavy period. Other potential side effects, which the FDA says are reportedly rare, are incomplete abortion (which then requires surgical intervention) and life-threatening bleeding and infection. The drug’s warning label instructs patients to seek medical attention if their blood soaks two thick full-size sanitary pads per hour for two consecutive hours, or if they experience fever, vomiting, or diarrhea in the days after taking the medicine.
In their opposing brief, general counsel for the U.S. Department of Health and Human Services cites the FDA’s 2016 scientific review of mifepristone, which was based on a dozen studies and on data from more than 30,000 patients, and found low rates of “serious adverse events”: 0-0.1 percent for needed blood transfusions; less than 0.01 percent for sepsis; 0-0.7 percent for hospitalization; 0.1 percent for hemorrhage.
But according to AAPLOG CEO-Elect Dr. Christina Francis in a recent Newsmax interview, “These drugs are extremely dangerous.”
To bolster this assertion, the main statistic plaintiffs cite in their complaint is that 1 in 5 women “will have an adverse event after taking chemical abortion drugs. … This includes over fifteen percent (15%) of females experiencing hemorrhaging and two percent (2%) having an infection during or after taking chemical abortion drugs.”
It comes from a 2009 Finnish study comparing adverse events associated with medication abortion compared with surgical abortion. As if they haven’t spent decades trying to ban surgical abortion on the premise that it’s also dangerous to women, plaintiffs have also glommed onto another statistic from the Finnish study: that the complication rate for medication abortions is four times higher than surgical abortions.
The HHS attorneys claim the plaintiffs have misconstrued the Finnish study’s findings, noting that that percentage encapsulates instances of expected and necessary bleeding. The Finnish researchers ultimately conclude that “both methods of abortion are generally safe,” but that counseling should address all the risks.
“Plaintiffs do not even attempt to allege facts supporting the chain of causation,” the government’s legal team argues. “They do not corroborate any of the pecuniary harms that they purport to fear, nor any of the intangible concerns that they raise. That omission is particularly telling given the more than two decades that mifepristone has been in use. If Plaintiffs’ injuries had an evidentiary basis, then Plaintiffs would be able to marshal allegations grounded in fact rather than conjecture.”
CLAIM: Medication abortion is riskier than full-term pregnancy and childbirth
Plaintiffs in their complaint boldly claim, “Pregnancy rarely leads to complications that threaten the life of the mother or the child.”
Their source that medication abortion is deadlier than pregnancy and childbirth is a 2013 research paper published in a journal produced by one of the plaintiff groups, the Catholic Medical Association.
The paper’s author, Dr. Byron Calhoun, is a longtime anti-abortion activist and a high-risk OB-GYN in West Virginia who says abortion is never necessary to save a life. He’s also made false claims to the West Virginia attorney general about high rates of abortion complications in his state for which he never produced evidence. Calhoun tries to take down the often-cited statistic that the risk of death associated with childbirth is approximately 14 times higher than with abortion. But his evidence boils down to assumptions that abortion-related deaths are vastly under-reported. The bulk of his argument relies on discredited studies showing links between abortion and suicide and cancer.
The footnote that abortion is deadlier than pregnancy also links to a National Review Online article by James Studnicki and Tessa Longbons, who work for the anti-abortion research group the Charlotte Lozier Institute. They also assume vast under-reporting of abortion-related complications. But their main evidence is a red herring.
“Depending on the assumptions in estimating and accounting for miscarriages and the simple recognition that abortion is a death, abortion could be as much as 4,500 times more likely to result in a human death than giving birth,” Studnicki and Longbons write.
Arguing that abortion is more dangerous than giving birth because it ends a pregnancy omits the well-documented evidence that maternal mortality in the U.S. is the highest among developed countries and is three times higher for non-Hispanic Black women (about 55 maternal deaths per 100,000 live births in 2020) compared with non-Hispanic White women. There were 861 total reported maternal deaths in 2020, but the rate was three times higher for non-Hispanic Black women (about 55 maternal deaths per 100,000 live births in 2020) compared with non-Hispanic White women.
CLAIM: ERs are flooded with medication abortion cases that are overwhelming the blood supply.
To argue that they have legal standing in this case and are directly impacted by its outcome, plaintiffs speculate that the FDA’s most recent rule changes — allowing for patients to obtain medication abortion via telemedicine and allowing retail pharmacies to dispense the drugs directly to patients — will lead to a burdensome increase in workload in emergency rooms.
“The increased occurrence of complications related to chemical abortions also multiplies the workload of healthcare providers, including AHM and AAPLOG members, in some cases by astronomical amounts,” writes outgoing CEO Dr. Donna Harrison in a legal declaration. “This is especially true in maternity care ‘deserts.’”
She argues that some of the FDA’s previously relaxed regulations resulted in “the explosion of Mifeprex complications including hemorrhage, adding to the current shortage of blood and blood products across the United States.”
These claims are baseless, says Dr. Nikki Zite, a board-certified OB-GYN and complex-family-planning specialist at the University of Tennessee Graduate School in Knoxville, who submitted a legal declaration on behalf of the federal government.
“Given the demonstrably low rate of complications from the Mifepristone/Misoprostol regimen, it is inconceivable to me that medication abortion could have a measurable impact on the blood supply in any location,” Zite writes, noting that ACOG has been monitoring a nationwide problem of hemorrhage following childbirth. “If hemorrhage or transfusions from medication abortion was a significant issue, ACOG would be addressing it as well.”
The plaintiffs also offer anecdotes.
Dr. George Delgado, who spearheaded a network of anti-abortion doctors willing to perform his experimental abortion-pill reversal protocol, claims he has “treated women suffering complications from chemical abortion and seeking to reverse the effects of chemical abortion,” but he gives no details.
The one attempt at a controlled study of Delgado’s protocol – which amounts to instructing women who have taken mifepristone to throw away their misoprostol and receive progesterone injections – stopped prematurely because the OB-GYN and mifepristone expert leading the study determined it was unsafe after three patients hemorrhaged. Neither in his declaration, nor in response to a media inquiry does Delgado explain if these complications were from the FDA’s approved regimen, or from women only taking the mifepristone.
Dr. Regina Frost-Clark of Michigan said she has “treated several women who have suffered complications from chemical abortions,” which she clarifies amounts to about dozen women who were suffering “significant bleeding,” which is inherent in a medication abortion.
Dr. Shaun Jester, an OB-GYN from Dumas, Texas, recounts one example to back up his claim that unsupervised medication abortion is dangerous and “potentially life-threatening.” He says he treated a Texas woman, where abortion is currently banned, who obtained the medication abortion regimen in New Mexico but was still heavily bleeding two weeks later and had developed an infection. “IF she had waited a few more days before receiving care, she could have been septic and died,” Jester writes, noting that he reported the adverse event to the FDA.
Similarly, Indiana state Sen. Tyler Johnson gives a concerning example: an Indiana woman who obtained abortion drugs in Chicago and bled heavily on the drive home, needed a blood transfusion. “I have seen multiple cases similar to this one,” he writes.
But their testimony does not contradict the medication abortion’s reported safety record, which does account for some incidences of serious adverse events. Neither of the doctor-plaintiffs or their attorneys responded to requests for comment.
Outside of the lawsuit, plaintiffs have simultaneously claimed abortion bans haven’t and won’t lead to denial of emergency medical care in the case of pregnancies that need to be terminated for health reasons – despite ample evidence to the contrary.
Family physician Dr. Linda Prine, who co-founded the Miscarriage and Abortion Hotline to help pregnant people navigate self-managing medication abortions post-Roe, said it’s the anti-abortion movement putting women in riskier, more traumatizing abortion situations. She said her hotline has been hearing more from people taking abortions drugs later than 12 weeks – because it’s the earliest they could get them.
“What leads to using abortion drugs past the first trimester are the abortion bans and the difficulties in getting the medications,” Prine said in an email. “It is medically less risky to use the medications earlier, and it is medically less risky to have an abortion rather than an ongoing pregnancy. The bottom line is that people should be able to get the medical care they need, whenever it is that they determine that they need it.”
There are other ongoing legal cases aimed at preserving access to abortion drugs, even in states that have passed abortion bans. But as early as this month, U.S. District Judge Matthew Kacsmaryk could rule that the FDA must ban the drugs, or resume its old protocols. From there the case would go to the conservative Fifth Circuit Court of Appeals. And if it goes to the U.S. Supreme Court, the scale is tipped by anti-abortion hard-liners.
As the decision date for Alliance v. FDA has gotten closer, more providers have begun discussing how to help pregnant people terminate pregnancies using only misoprostol, which is used in other countries, but not as effective and more risky than the current regimen. Abortion-rights advocates and health professionals are scared for patients and frustrated.
“The scenario of people being scared and traumatized by a later abortion could be prevented by giving people access to the pills early and legally, not by forcing them to continue an unwanted pregnancy,” Prine said.
Our stories may be republished online or in print under Creative Commons license CC BY-NC-ND 4.0. We ask that you edit only for style or to shorten, provide proper attribution and link to our web site. Please see our republishing guidelines for use of photos and graphics.