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Injuries to Women Largely Ignored in Supreme Court Discussions of FDA Actions on Abortion Pill

by | Mar 27, 2024

By Randall K. O’Bannon, Ph.D., Director of Education & Research

In all the arguments that were made in the court Tuesday about “standing” – whether the doctors from the Alliance for Hippocratic Medicine (AHM) as a group or individuals could sufficiently prove past injury or probable injury from the Food and Drug Administration’s lax abortion pill regulations – one thing was noticeably absent: any conclusive refutation of significant safety issues remaining with mifepristone.

Of course, there were usual assertions in the Court and in the press that the FDA had based its decisions on studies which showed the drug to absolutely “safe and effective.” But FDA and Danco lawyers offered little in the way of a substantive rebuttal of multiple cases and statistics presented by AHM and others that illustrate significant and ongoing complications associated with mifepristone.

Justices certainly would have read the opinion of the Fifth Circuit, whose ruling they were considering, and the accounts of pro-life doctors who treated women who visited their emergency rooms with life-threatening complications.

Dr. Christine Francis is a board certified Obstetrician-Gynecologist who works as a hospitalist in Fort Wayne, Indiana and is the current CEO of AAPLOG (the American Association of Pro-Life Obstetricians and Gynecologists).

In testimony reviewed by the Fifth Circuit, Dr. Francis relayed horrific stories of women she treated.

[T]he patient presented back at our emergency room with heavy vaginal bleeding and unstable vital signs as a result of taking chemical abortion drugs… Due to the amount of bleeding that she was experiencing and evidence of hemodynamic instability, however, my partner had no choice but to perform an emergency D&C. The patient needed to be hospitalized overnight for close observation after the D&C.

 

Not only did my partner need to provide several hours of critical care for this patient, but my partner also needed to call in a back-up physician to care for another critically ill patient. And because the preborn baby still had a heartbeat when the patient presented, my partner felt as though she was forced to participate in something that she did not want to be a part of — completing the abortion.

In another case, Francis related:

After taking the chemical abortion drugs, [the patient] began having very heavy bleeding followed by significant abdominal pain and a fever. When I saw her in the emergency room, she had evidence of retained pregnancy tissue along with endometritis, an infection of the uterine lining. She also had acute kidney injury, with elevated creatinine. She required a dilation and curettage (D&C) surgery to finish evacuating her uterus of the remaining pregnancy tissue and hospitalization for intravenous (IV) antibiotics, IV hydration, and a blood transfusion.

Dr. Ingrid Skop, an obstetrician/gynecologist who practiced in San Antonio for over 25 years and currently serves as Vice President and Director of Medical Affairs for Charlotte Lozier Institute, testified of cases she had encountered in her practice:

In my practice, I have cared for at least a dozen women who have required surgery to remove retained pregnancy tissue after a chemical abortion. Sometimes this includes the embryo or fetus, and sometimes it is placental tissue that has not been completely expelled. I have cared for approximately five women who, after a chemical abortion, have required admission for a blood transfusion or intravenous antibiotics or both.

 

For example, in one month while covering the emergency room, my group practice admitted three women to the hospital. Of the three women admitted in one month due to chemical abortion complications, one required admission to the intensive care unit for sepsis and intravenous antibiotics, one required a blood transfusion for hemorrhage, and one required surgical completion for the retained products of conception (i.e., the doctors had to surgically finish the abortion with a suction aspiration procedure).

The justices did talk about Francis’ and Skop’s testimony during oral arguments, but only in relation to whether or not they were forced by circumstances to participate in abortions. They did not dispute or discuss the examples above.

In other words, they did not directly deny the fact that these two doctors, just doing their jobs, “happened” to encounter a number of women dealing with serious life-threatening complications after taking these “safe” abortion drugs. This clearly argues for a wider prevalence of problems than FDA and abortion industry assurances that serious complications are, in the words of the solicitor general arguing the FDA’s case, “incredibly rare.”

AHM Counsel Erin Hawley mentioned several times the FDA’s concession in official drug labeling that between 2.9 and 4.6% of mifepristone patients will end up in the emergency room and that up to 7% will require some form of surgical intervention. But the justices tended to generally ignore this or take the conversation in other directions.

One exception was a conversation between Justice Samuel Alito and the U.S. Solicitor General Elizabeth Prelogar where they discussed whether changes the FDA made to the official protocol in 2021 (e.g., dropping the required in person delivery of the pills) resulted in increased complications.

 JUSTICE ALITO: Okay. One — one last question. The plaintiffs say that the studies that the FDA relied on for the 2021 amendments say that mail order mifepristone suggests more frequent trips to the emergency room. Now this is what I see as the FDA’s response to that. “Although the literature suggests there may be more frequent emergency room care visits related to the use of mifepristone when dispensed by mail from the clinic, there are no apparent increases in other serious adverse events related to mifepristone use.”

 

Does that really count as a reasoned explanation to the suggestion that the data shows there are going to be more emergency room visits? This is — the — the increase in emergency room visits is just of no consequence?

 

It doesn’t even merit some — some comment?

 

SOLICITOR GENERAL PRELOGAR: That is a reasoned explanation. What FDA was observing in that passage is that although it acknowledged the fact that some of the studies reported additional emergency room visits, that didn’t equate to additional serious adverse events.

 

And, in fact, one of the studies, half of the women who went to the emergency room didn’t get any treatment at all. Many women might go because they’re experiencing heavy bleeding, which mimics a miscarriage, and they might just need to know whether or not they’re having a complication. But, in that kind of circumstance, the woman is not having a — a – a serious adverse event from mifepristone, and so it doesn’t call into question the safety determinations regarding the drug.

 

And, you know, at the end of the day, FDA carefully parsed those studies. It made specific determinations about the results to be gleaned with respect to safety and efficacy. It fully explained its decision-making, and I think it falls well within the zone of reasonableness under arbitrary and capricious review.

Note that the dispute is not over whether the protocol change resulted in more ER visits – Prelogar, speaking for the FDA, grants that it did. However, she dismisses the seriousness of those complications. She essentially said that those visits were unnecessary, apparently supposing that women gushing blood or doubled over in pain really could have just gutted the abortion out without troubling the hospital emergency staff.

Those women didn’t stay overnight at the hospital, they didn’t receive, as far as we know, surgery, transfusion or other special treatment. So their concerns, their “adverse events,” can be (and were) dismissed by FDA evaluators.

Note a few things not mentioned here. They are critical. Prelogar keys on how many women didn’t receive treatment. So was the increase in ER visits entirely made up of these unduly terrified women? If so, there’s obviously something flawed about the new pill delivery option when screenings and counseling system suddenly lead a much larger contingent to unnecessarily seek emergency care at the ER.

If there has always been a certain percentage of mifepristone patients unnecessarily visiting the ER — if that percentage was stable across the board before and after the protocol change — that would mean more women with serious complications as part of the overall surge.

In either case, there is clearly something troubling about an increase of ER visits after the FDA’s 2021 change, and it does not say much about the agency’s objectivity or concern for women to dismiss this so cavalierly.

Prelogar’s tactic of dismissing the increase in ER visits as being no indication of more complications recalls a tactic often used by abortion pill researchers and advocates. Instead of denying the data, they dismiss the complications as minor, of no consequence.

A 2015 study by Ushma Upadhyay often cited by abortion advocates (and referenced in FDA documents) is often used to support the contention that serious adverse events are “less than one percent.” We have discussed this elsewhere, but the observations bear repeating showing how this spin is accomplished:

First, Upadhyay specifically limits what can be counted as a “serious” or “major” complication.

 

“Major complications were defined as serious unexpected adverse events requiring hospital admission, surgery, or blood transfusion,” the article asserts. “Minor complications were all other expected adverse events.”

 

While this sounds reasonable, consider the things included in Upadhyay’s “minor complications”: hemorrhage, infection, incomplete or “failed” abortion requiring “uterine aspiration” (i.e., surgical abortion). Even things like “uterine perforation” were classified as “minor.”

 

Second, with this knowledge, consider that when Upadhyay added in and counted both major and “minor” complications, the complication rate for chemical abortions was 5.19% – considerably higher than the “less than one percent” advertised.

 

Finally, calling these complications “minor” diminishes the significance of the fact that these incidents were sufficiently serious to prompt more than one out of every twenty abortion pill patients to visit their local emergency room.

The Supreme Court justices spent most of their time arguing over whether or not these doctors had the legal standing to sue the FDA and the abortion pill distributor Danco and whether or not the consciences of the AHM doctors were harmed by having to complete the abortions other anonymous prescribers started with FDA approved mifepristone.

The women who suffered these life-threatening complications were largely ignored, their fate clearly an afterthought for Danco, the FDA, and sadly, many of the Court.

Categories: Abortion Risks