From the start of the high-stakes oral arguments, the judges quickly and repeatedly pressed lawyers for the US government and Danco Laboratories, which sells the drug under the brand name Mifeprex.
The attorneys were pressed to explain their view that the doctors and organisations could not pursue the lawsuit because they have not been harmed by the drug, which was approved by the US Food and Drug Administration more than two decades ago.
The federal government is urging a three-judge panel of the 5th US Circuit Court of Appeals in New Orleans to overturn last month’s unprecedented ruling by US district judge Matthew Kacsmaryk in Amarillo, Texas suspending mifepristone’s approval.
The administration of President Joe Biden is defending mifepristone in the face of mounting abortion bans and restrictions enacted by Republican-led states since the US Supreme Court in June overturned the landmark 1973 Roe v Wade decision that had legalised the procedure nationwide.
Anti-abortion groups and doctors, led by the recently formed Alliance for Hippocratic Medicine, defended Kacsmaryk’s order during Wednesday’s argument. They claimed in their lawsuit last year that mifepristone is unsafe and that the FDA’s 2000 approval of it was illegal.
Sarah Harrington, an attorney for the federal government, was repeatedly interrupted by all three judges when asked to explain why the government thought the doctors lacked standing to sue.
The emergency room doctors said in court filings they were being forced to complete surgical abortions, which was against their conscience, for women who took the pill but failed to complete a medical abortion.
“It just strikes me that what the FDA has done in making this more available,” said circuit judge Cory Wilson, “is you’ve made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors are a member.”
The oral arguments concluded after about two hours, with most of the questions from the judges focused on whether the plaintiffs could bring their case and whether they had allowed too much time to pass before suing.
By filing their case in Amarillo, the plaintiffs assured it would go before Kacsmaryk, a conservative and former Christian activist, and that any appeal would go the conservative 5th Circuit. Twelve of the circuit’s 16 active judges were appointed by Republican presidents.
All three judges on Wednesday’s panel are staunchly conservative, with a history of opposing abortion rights. Circuit judges James Ho and Wilson were appointed by Donald Trump. The third judge, Jennifer Walker Elrod, was appointed by George W Bush.
Kacsmaryk’s ruling last month alarmed the pharmaceutical industry and hundreds of drugmakers banded together to urge the decision be reversed because it undermined the authority of the FDA.
Walker Elrod told Danco’s attorney she was concerned about “unusual remarks” in the company’s briefs, which described the Kacsmaryk ruling as an “unprecedented judicial assault” on the regulatory process.
Those sort of remarks directed at a lower court “we normally don’t see from learned counsel,” Walker Elrod said.
“I don’t think that those remarks, any of them, were intended as any sort of personal attack,” Danco attorney Jessica Ellsworth replied. She said the language might have been softened if the case wasn’t rushed when questioned about it again.
Safe and effective
Mifepristone remains available for now, following an emergency order from the US Supreme Court putting Kacsmaryk’s order on hold during the appeal.
Mifepristone is part of a two-drug regimen with misoprostol used for medication abortions, which account for more than half of US abortions. It is approved for use in the first 10 weeks of pregnancy.
Numerous medical studies have concluded that the drug is safe and effective.
Major medical associations, including the American College of Obstetricians and Gynecologists (Acog) and the American Medical Association (Ama), have said in court filings that pulling mifepristone off the market would harm patients by forcing them to undergo more invasive surgical abortions.
The Ama, Acog and Democratic lawmakers have also weighed in to support the administration, while anti-abortion groups and Republicans have backed the plaintiffs.
Whichever way the 5th Circuit panel rules, the decision is sure to be appealed, first to the full court and then to the US Supreme Court.