Doctors suing FDA say agency is responsible for ‘two decades of dangerous medical negligence’

Doctors involved in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), a federal abortion pill lawsuit, claim they see women with severe complications — “many who presented to the emergency room” — and they are requesting that the FDA pull the drug from the market. The case was heard this week by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas.

The lawsuit was initially filed in November of 2022 on behalf of the Alliance for Hippocratic Medicine (AHM), a nonprofit membership organization representing nearly 30,000 health-care professionals including major medical groups such as the American College of Pediatricians, the American Association of Pro-Life Obstetricians and Gynecologists, and the Christian Medical & Dental Associations. The group sued the federal government for “illegally approving chemical abortion drugs that harm women and girls.”

At a press conference following arguments before the court, Alliance Defending Freedom senior counsel Erik Baptist and Dr. Donna Harrison (Chair of AHM), reiterated their case against the FDA.

Baptist stated, “Yesterday, I represented the Alliance for Hippocratic Medicine and seven other clients in federal court to correct a wrong that is long overdue… As time has gone on, the FDA has ignored the warnings from our clients about these drugs and has rolled back safeguards that make these drugs even more dangerous to take.”

He added, “The FDA never studied the safety of the drug regimen and disregarded clear evidence that the pills cause life threatening complications. As a result of ignoring the science, women and girls became victims of the FDA’s reckless, agenda-driven approval.”

Baptist argued that the FDA “stonewalled” his clients requests in their Citizen Petition warnings to the FDA about the drug “with procedural games for nearly two decades” and Baptist added that “These drugs cause harmful complications in women that the FDA blatantly ignored.”

 

Why did these medical professionals file the lawsuit?

According to Baptist, shortly after President Clinton signed an executive order directing the FDA to expedite marketing of RU-486, now known as Mifeprex, the agency exploited “its fast-track approval authority” and “approved these drugs by classifying pregnancy as an ‘illness’ and arguing that the drugs provide a ‘meaningful therapeutic benefit,'” Baptist wrote.

“To add to this problem, the FDA did not have any evidence or studies on the potential harms of the drug regimen before approving it,” he said.

In response to these concerns and the FDA’s actions, “ADF’s clients submitted a citizen petition to challenge the FDA’s approval in 2002. Fourteen years later, the FDA denied their petition,” ADF wrote. According to ADF, years went by without sufficient response by FDA to the doctor’s concerns — and combined with what ADF described as an “evisceration of the few protections for this drug regimen,” the lawsuit was filed.

Other countries’ meticulous record-keeping reveals serious dangers 

In a previous interview, Baptist claimed that complication reporting outside the United States was more “robust and reliable” than the U.S. As such, “ADF pointed to that research as a “guidepost” for what is likely occurring here.

“One area we look at is Finland, because Finland has a national reporting registry. So, it knows every woman and girl who has ever taken Mifepristone for chemical abortion purposes,” he said. Finland has a nationalized healthcare system which allows a patient’s medical history to be tracked after the abortion. As a result, Baptist claimed that studies from Finland show “upwards of one in five women will have severe complications requiring subsequent medical intervention due to chemical abortion drugs.”

In a recent op-ed, Baptist discussed additional safety concerns about the drug, citing a review of 42,000 first-trimester chemical abortions which found that more than 1 in 6 women suffered from severe bleeding after taking the abortion pill, and “[a]nother review of 18,000 chemical abortions found that nearly 8 percent of first-trimester chemical abortions failed to kill the baby—meaning that a woman would need surgery if she wanted to complete the abortion,” he wrote.

“And, as ADF’s clients have seen firsthand, an alarming number of women end up in the emergency rooms across the country after taking chemical abortion drugs. One study found that more than 35 percent of women who had a chemical abortion visited the ER within 30 days after taking these drugs,” Baptist added in the op-ed.

Doctors see abortion pill complications

Dr. Donna Harrison, serving as Chair of the Board of the AHM, said the lawsuit was filed to “hold the FDA accountable after over two decades of dangerous medical negligence.”

Harrison, former CEO of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and current AAPLOG Director of Research, pointed out in the aforementioned press conference that “Roughly one in 20 women who undergo a chemical abortion very early in pregnancy suffer from complications that require further medical attention, and that number increases to one out of three women for abortions done after 13 weeks of pregnancy.”

“Our doctors have treated women who faced severe bleeding and life-threatening infections from tissue left in their uterus after a chemical abortion. These medical emergencies can require surgeries, blood transfusions, and hysterectomies. If hysterectomy must be performed, our doctors have had to look these women in the eye and tell them they have no chance of having any future pregnancies,” Dr. Harrison said.

AAPLOG CEO Dr. Christina Francis described what she has been hearing from doctors on the ground. “I was sitting and talking with a couple of the emergency room physicians, and they were telling me how frustrated they were because weekly, women were coming into our emergency room with complications related to chemical abortions,” she noted. “What I’ve seen over the last few years is the frequency of complications related to chemical abortion drugs is increasing significantly.”

“I personally, along with many of my colleagues, have seen women and girls come through our emergency rooms with severe complications from these drugs, “Dr. Francis said in a recent interview. “Complications like heavy bleeding and hemorrhage, the need for emergency surgery, the need for admission to the hospital for blood transfusions and infections. And even, one of our members took care of a woman who likely will not be able to have children in the future because of major complications that required two major surgeries to correct these complications due to these chemical abortion drugs.

 

Emergency department doctors recently presented the case of a woman who took the abortion pill and was later treated in the emergency room for an undiagnosed ectopic pregnancy. But disturbingly, rather than put the onus on the abortion industry for failing to appropriately identify the potentially deadly complication beforehand, the group of medical doctors warned ER doctors to be on alert as abortion clients present to emergency departments for ectopic pregnancies after taking the abortion pill.

Today, bad actors inside the abortion industry frequently tell women to lie and have suggested that ER doctors falsify documents, to hide abortion pill complications.

DIY abortions are traumatic

Baptist pointed out in a recent interview that “Any girl of any age, 13-year-old girl, 15-year-old girl, can obtain these drugs without parental consent. Without seeing a doctor or medical professional… without any medical supervision.”

“This essentially induces labor and delivery, and women are being advised by the abortion industry to do this in your own bathroom, in a hotel room, in your dorm room, without any medical supervision. Sometimes without any support. And inducing labor and delivery of a baby upwards of 10 weeks, sometimes even longer, is highly dangerous and it’s also just traumatic in many ways for the woman to go through as well,” Baptist stated.

Live Action News has previously detailed gripping accounts from women delivering their aborted children alone in their bathrooms.

Baptist previously called the abortion pill (mifepristone or Mifeprex) a “very loosely regulated drug” and he pointed out that “a pregnant woman or girl can obtain mifepristone without ever visiting a doctor in person… And the FDA no longer requires a doctor to be the one to prescribe this drug.”

“So, a woman never has to visit a doctor… she doesn’t have to be screened for any type of complications such as an ectopic pregnancy,” he stated. “And, as of January 2023, your local CVS or Walgreens can start dispensing this drug.”

Dr. Harrison noted in her statement to media this week, “There are no safe abortions, and while chemical abortions are increasingly becoming more popular, the rate of complications from chemical abortions is four times higher than surgical abortions. Our doctors frequently treat the women and girls victimized by the FDA’s negligence.”

She added, “As the FDA has removed safeguards around the drugs, women and girls have been left more vulnerable than ever. These women most often have to face the trauma of passing a dead child and risk bleeding out and dealing with deadly infections alone, with no doctor either present or even involved to get her the attention she needs.”

ADF’s Baptist emphasized, “After years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls. We hope the court will agree the FDA never had the authority to approve these dangerous drugs and reject the rolled-back protections and distribution of them.”

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