It was never about safety: Cracking the anti-mifepristone plaintiffs' advantageous façade

"These are not the actions or desires of people who genuinely care about patient and medication safety."

Mar 22, 2024

🔆This is Part VII of a multi-part series examining the mifepristone lawsuit to be heard by the Supreme Court of the United States. Read all of rePro-Truth’s coverage here.

The most important thing to remember ahead of oral arguments on Tuesday: This case is not about safety.

“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” painted by the anti-abortion groups and individuals, who sued the U.S. Food and Drug Administration (FDA) to eliminate/severely restrict access to mifepristone - one of the drugs used in a two-drug regimen for medication abortion (induced miscarriage). [1] They claim, “By eliminating necessary safeguards for pregnant girls and women who undergo the dangerous mifepristone abortion drug regimen, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.” [2] The evidentiary record, however, proves such dire claims to be false: the FDA meticulously analyzed research data to advise its regulatory decision-making, and mifepristone’s safety record is beyond reproach.

The anti-abortion plaintiffs’ lawsuit, Alliance for Hippocratic Medicine v. FDA, is disguised as a dispute over drug safety. In reality, the plaintiffs’ professed saccharine devotion to and cloying concern for the safety of women and girls are merely an advantageous façade.

This case has never been about patient safety, as made obvious by the plaintiffs’ own words and actions:

The plaintiffs’ desired supreme court ruling would triple the patient dose of a medication that the plaintiffs say is so dangerous that it should be severely restricted or pulled from the market altogether.
Plaintiffs wish to deny stabilizing medical care to emergency room patients.

Tripling the dose of mifepristone

Plaintiffs are asking the Supreme Court to uphold the Fifth Circuit Court’s decision (which uncritically relied on the testimony of undeniably dubious witnesses) restricting access to mifepristone by reimposing the FDA's pre-2016 regulations— which would also triple the patient dose of mifepristone. The U.S. Food and Drug Administration (FDA) approved mifepristone in 2000, in a single dose of 600 mg, for use up to 49 days of pregnancy (7 weeks), dating from the first day of the patient’s last menstrual period. In 2016, after 15 years of collecting and analyzing data on the safety and efficacy of mifepristone, the FDA updated and approved a new evidence-based regimen: the dosage of mifepristone was decreased from 600 to 200 mg, and the approved usage window was increased from 49 to 70 days (10 weeks) of pregnancy.

“As a general matter, to lower safety risks and minimize drug exposure leading to adverse events, the FDA advises selecting ‘the lowest dose that will provide a desired therapeutic effect.’ Particular to mifepristone, studies have shown that the current label indications are safe and more effective than those in place prior to 2016.” [4] These studies show that the higher dose of mifepristone used prior to the updated 2016 protocol “led to more bleeding and side effects.” [5] “A court order reimposing outdated labeling with a higher dosage” of mifepristone - raising the risk of bleeding and side effects - would not serve the interest of patient safety; nor would such a court order redress the plaintiffs’ bizarre list of grievances against the FDA. [6]

Denial of care

According to KFF, an independent source for health policy research, the two-drug regimen of mifepristone and misoprostol “terminates pregnancies successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).” [8] Still, a very small percentage of patients may require a simple vacuum aspiration to complete their abortions if the placenta or other tissue fails to be expelled by the uterus. These patients should be treated in order to avoid developing a serious infection in the uterus.

“It grieves Plaintiff doctors and members of Plaintiff medical associations to treat women and girls harmed by [medication] abortion drugs,” the lawsuit states. However, this ostensible expression of concern and compassion is quickly dispelled by the fact that these same supposedly caring anti-abortion doctors want to be able to deny these patients treatment, because they “oppose being forced… to complete an incomplete elective [medication] abortion.”

In the lawsuit, the plaintiffs acknowledge that there's no way for doctors to know whether a miscarriage is natural or induced, because the symptoms are identical. Nevertheless, the plaintiffs claim the FDA's original approval of mifepristone (in the year 2000) harms them because they do not want “to treat women and girls” needing “the completion of an elective [medication] abortion.”

The plaintiffs specifically lament being required to provide this treatment under the federal law called the Emergency Medical Treatment and Active Labor Act (EMTALA), which was passed in 1986 to ensure that patients in emergencies receive treatment. At least two of the plaintiffs in the mifepristone lawsuit consistently oppose providing emergency abortion treatment under EMTALA. Consider the following examples:

Two of the anti-abortion groups who are plaintiffs in the mifepristone lawsuit - the American Association of Pro-Life OBGYNs (AAPLOG) and the Christian Medical & Dental Associations (CMDA) - made the same claim in their Texas lawsuit against the Biden administration’s guidance reminding hospitals that it is their duty to treat obstetric patients in hospital Emergency Rooms, including by performing emergency abortions if that is the treatment necessary to stabilize a patient’s emergent condition. In the Texas lawsuit, AAPLOG and CMDA bemoaned EMTALA’s “application to ‘incomplete medical abortion’ [as] a requirement that pro-life doctors complete abortions started elsewhere,” against these doctors’ wishes. AAPLOG and CMDA argued that hospitals and doctors should be free to deny Emergency Room obstetric patients stabilizing abortion healthcare. On January 2, 2024, the staunchly anti-abortion U.S. Court of Appeals for the Fifth Circuit ruled in favor of the anti-abortion groups and the State of Texas, declaring “that federal emergency room protections do not include abortions — even if an abortion is determined to be the medical care necessary to stabilize the patient.” [9] I wrote about this ruling in the newsletter, Depraved Indifference.

On April 24, 2024, the Supreme Court will hear a similar EMTALA case involving Idaho’s desire to prosecute Emergency Room doctors who perform stabilizing abortions in obstetric emergencies. The same two mifepristone lawsuit plaintiff groups, AAPLOG and CMDA, who joined Texas’s EMTALA lawsuit, have also filed amici curiae briefs supporting Idaho in its EMTALA case before the Supreme Court. You can read more about this case in my newsletter, Equal protection— unless you are pregnant? The high stakes Idaho case before the Supreme Court.

The plaintiffs’ primary argument in their mifepristone lawsuit against the FDA is that, because some patients who take mifepristone may experience complications, then “some of those patients might then seek care from an emergency room in a hospital where one of the plaintiff doctors or a member of the plaintiff organizations is working. That doctor might then have to care for this patient, and might discover that the mifepristone did not successfully terminate the patient’s pregnancy. This anti-abortion doctor might then have to complete the abortion or otherwise provide care” which the doctor doesn't want to provide because the doctor is anti-abortion. [10]

It is abundantly evident that the anti-abortion plaintiffs in the mifepristone lawsuit are concerned about themselves — not with the safety and well-being of the patients who would be denied necessary, stabilizing healthcare by the plaintiffs in the mifepristone lawsuit.

Lawsuit not about safety

The most important thing to remember ahead of oral arguments in this case at the Supreme Court on Tuesday: Alliance for Hippocratic Medicine v. FDA is not about safety.

The anti-abortion plaintiffs - who claim to care about patient safety, and who claim that mifepristone is “so harmful that its distribution must be altered by federal court intervention” - are eager to force patients to consume three times the current dose of that supposedly “dangerous” drug. [11] The anti-abortion plaintiffs - who claim to care about patient safety - wish to deny stabilizing medical care to emergency room patients who may be experiencing complications from medication abortion. These are not the actions or desires of people who genuinely care about patient and medication safety.

This lawsuit is not about safety; it is about restricting access to safe, legal abortion nationwide. The plaintiffs’ professed saccharine devotion to and cloying concern for the safety of women and girls are merely an advantageous façade.

rePro-Truth

It was never about safety: Cracking the anti-mifepristone plaintiffs' advantageous façade

"These are not the actions or desires of people who genuinely care about patient and medication safety."

Tripling the dose of mifepristone

Denial of care

Lawsuit not about safety

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