WASHINGTON (CN) — A group of anti-abortion doctors wants the Supreme Court to curb access to the most common form of abortion — via the drug mifepristone — because the doctors might have to treat patients who suffer rare complications from the pill.
The Alliance for Defending Freedom brings the court the biggest abortion battle since Dobbs v. Jackson Women’s Health Organization, asking the justices to disregard the Food and Drug Administration’s peer-reviewed studies citing their own contradictory evidence.
The case — like several others brought by ADF — has been criticized for lacking an essential component: an actual injury.
Last term, the group won a First Amendment case involving a Christian wedding website designer who did not want to make websites for gay couples. Lorie Smith based her lawsuit on an inquiry form submitted by a gay couple — Stewart and Mike. Except one of the names on the form did not belong to a gay man.
Stewart hadn’t even heard of Lorie’s website until a reporter called him asking about the case before the court. At the time the form was supposedly filed, he was married to a woman.
The anti-abortion doctors' suit ADF also stands on shaky ground — its validity is a key question before the justices.
The Alliance for Hippocratic Medicine, the organization these doctors belong to, claims its members are harmed by the side effects of mifepristone — one of two drugs used in pill abortions. These doctors do not prescribe the pill but instead claim to treat patients who come into emergency rooms with complications after taking the medicine.
Mifepristone is used alongside misoprostol — an ulcer medication — to end early-stage pregnancies. The two-drug regimen blocks the hormones necessary to support the pregnancy and the contents of the uterus are expelled. This can result in cramping and bleeding similar to a miscarriage.
Mifepristone’s safety record compares to common medications like penicillin or Viagra. The medication is also 14 times safer than childbirth. But despite that record, the anti-abortion doctors claim the pill has serious complications not seen in any of the FDA’s studies.
The doctors claim the FDA rushed the approval of mifepristone and removed guardrails to its availability, leaving emergency room doctors to deal with the fallout.
“In removing crucial safeguards for the use of abortion drugs, FDA expressly counted on OB/GYN hospitalists and emergency-room doctors … to manage abortion-drug complications,” wrote Erin Hawley, an attorney with the ADF.
The Biden administration said this theory is speculative and points to the lack of evidence that this scenario has played out in reality.
“Respondents claim that their members include ‘thousands of doctors and hundreds of OB/Gyns and emergency-room doctors,’” U.S. Solicitor General Elizabeth Prelogar wrote in the government’s brief. “Yet neither respondents nor the Fifth Circuit have pointed to even a single instance in which a member of a respondent organization was required to terminate an ongoing pregnancy.”
Mifepristone was first approved by the FDA in 2000. Under that approval, patients had to make three clinic visits: one to take mifepristone, one to take misoprostol and a follow-up appointment two weeks later.
However, in the decades since its approval, the FDA has made access to mifepristone easier, citing its safety record. In 2016, the agency extended the pill's use up to 10 weeks gestation instead of the seven weeks in the 2000 approval. Patients would also only have to visit a clinic once to receive the pill. The FDA widened the aperture on who could prescribe mifepristone, allowing licensed non-physician health care providers like nurse practitioners to offer the medication.
In 2021, the Covid-19 pandemic led to the approval of mifepristone through telehealth. Virtual prescription of the pill has broken down barriers to access and freed up already overburdened clinics.
The anti-abortion doctors challenged mifepristone’s 2000, 2016 and 2021 approvals, asking a federal judge to order the FDA to suspend mifepristone’s use for safety concerns. U.S. District Judge Matthew Kacsmaryk, a Trump appointee in Texas, agreed to do so.
Kacsmaryk rejected the FDA’s peer-reviewed research and used the anti-abortion doctors’ evidence to find that mifepristone could have harmful side effects that have been ignored by the government.
The conservative Fifth Circuit Court of Appeals upheld parts of Kacsmaryk’s ruling, putting limitations on mifepristone’s prescription and distribution. The Supreme Court put the ruling on pause to review the case.
The FDA says the evidence used by the lower courts is as unreliable as the doctors’ injuries.
“To the government’s knowledge, this case marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use,” Prelogar wrote. “The Fifth Circuit reached that unprecedented result through a series of errors that contradict this court’s precedents and violate black-letter Article III and administrative-law principles.”
Much of the doctors’ claims rely on the lack of information. Mifepristone’s 2016 approval loosened reporting requirements on adverse reactions to the drug, no longer requiring doctors to report non-fatal complications.
The doctors claim the elimination of this requirement left manufacturers far removed from the on-the-ground impact of their drug. The doctors claim the FDA relied on this incomplete data to remove guardrails to the medication while at the same time using that data to prove its safety.
According to the FDA, adverse reactions are not determinative of a drug’s safety. The doctors use this argument against the agency, questioning how it could claim the pill was safe because complications were rare while discounting the importance of the data collection on the reactions.
“FDA unlawfully and without adequate explanation removed safeguards it had once deemed necessary to protect women who use abortion drugs,” Hawley wrote.
If the Supreme Court upholds the Fifth Circuit’s ruling, mifepristone will be limited to its 2000 approval. Patients will only be able to use the pill through seven weeks of pregnancy. They will also have to attend multiple in-office visits to receive the medication and only physicians would be able to prescribe the pill.
Manufacturers and distributors would be forced to relabel mifepristone before shipping the product and have warned that this process could result in supply chain disruptions.
The Supreme Court will hear arguments on March 26.
Follow @KelseyReichmann
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