Mifepristone, the primary medication in a medical abortion, is ready for a patient at Alamo Women’s Clinic in Carbondale, Illinois, April 20, 2023.
Evelyn Hockstein | Reuters
A federal appeals court will hear arguments Wednesday afternoon in a closely watched lawsuit that seeks to tug the abortion pill mifepristone from the U.S. market.
The hearing on the U.S. fifth Circuit Court of Appeals in Latest Orleans comes 11 months after the Supreme Court ruled there was not a federal constitutional right to abortion.
Lawyers from the Department of Justice, who’re representing the Food and Drug Administration, and attorneys for a bunch of anti-abortion doctors called the Alliance for Hippocratic Medicine each can have 40 minutes to present their case before the three-judge panel.
The end result of the hearing, set to start at 2 p.m. ET, could determine whether women will proceed to have access to what has turn out to be the common method to terminate a pregnancy within the U.S.
Mifepristone, used together with one other drug, misoprostol, accounts for about half of all abortions domestically.
The judges who will hear the arguments all were nominated by Republican presidents.
Judges James Ho and Cory Wilson were appointed by Donald Trump. Judge Jennifer Elrod was appointed by George W. Bush.
The panel’s ruling could come at any time after the arguments. But no matter what that ruling says, the losing side is definite to ask the high court to listen to an appeal of the choice.
If the Supreme Court accepts the case for appeal, mifepristone will remain widely available until the high court issues a final decision within the case.
But when it refuses to listen to an appeal, the fifth Circuit decision will probably be the ultimate word on the drug’s fate.
Challenge to mifepristone
The Alliance for Hippocratic Medicine in November sued the FDA in U.S. District Court for the Northern District of Texas, difficult the agency’s authorization of mifepristone, which occurred in 2000.
The group argued the agency didn’t use the proper process to approve mifepristone, claimed the medication is unsafe, and asked a judge to order the drug withdrawn from the market.
Those claims were strongly disputed by the FDA, leading medical associations, nearly half the U.S. states, and greater than 200 members of Congress.
Those entities argued in court filings that the FDA properly approved mifepristone and that the approval was based on extensive data that supported the medication’s safety and effectiveness.
But U.S. Judge Matthew Kacsmaryk ruled in favor of the anti-abortion group’s claims and suspended the FDA approval of mifepristone. His order would have halted sales of the medication nationwide pending appeal.
Days later, the DOJ appealed Kacsmaryk’s decision to the fifth Circuit, which handles cases arising from the Northern District of Texas.
In April, a three-judge panel on the circuit said that FDA’s approval of mifepristone would remain in place pending the end result of the DOJ’s appeal.
That panel said the challenge to the approval likely is barred by federal statute of limitations, although the judges made clear that their determination was based on an “abbreviated review.”
But that panel also blocked mail delivery of the drug and imposed tight restrictions on how the medication is used.
Soon afterward, the high court, acting on the request of the Biden administration, ordered mifepristone to stay in the marketplace without restrictions while the legal battle played out within the fifth Circuit.
If the anti-abortion group wins
The Alliance Defending Freedom, an anti-abortion legal organization representing the doctors’ group, is asking the three judges who will hear Wednesday’s arguments to uphold Kacsmaryk’s order in full, halting sales of mifepristone nationwide.
The trio of judges is different than the fifth Circuit panel that last month issued the order that imposed some restrictions on the supply of mifepristone while keeping the drug in the marketplace.
Glenn Cohen, a former DOJ lawyer, said the present three-judge panel shouldn’t be certain by the prior panel’s decision in April.
The brand new panel could issue an order that goes further or less far than the restrictions imposed in April, said Cohen, who’s now a professor at Harvard Law School. Or the panel could go in a special direction altogether, he said.
Cohen filed a transient on the fifth Circuit with other drug law experts in support of the FDA’s position.
He said the Supreme Court will likely comply with take the case if the fifth Circuit panel decides to tug mifepristone from the U.S. market.
Cohen argued the high court justices would take that position because a majority of them had approved the DOJ’s request to maintain mifepristone available without restrictions as lower-court litigation played out.
If the FDA wins
The DOJ is asking the fifth Circuit to reverse Kacsmaryk’s sweeping order and keep mifepristone available under the FDA’s current regulations. The FDA now allows women to acquire mifepristone without visiting a health care provider in person and may receive the prescription drug through the mail.
The prior fifth Circuit panel in April had blocked mail delivery of mifepristone, reimposed a requirement that ladies visit doctors to be prescribed the pill, and shortened the time period when women can take the drug from the tenth week of pregnancy to the seventh week.
That panel in its ruling last month said the FDA’s prior decision to loosen its regulations on mifepristone would end in more women looking for emergency care as a consequence of serious complications from the medication.
The Justice Department, in its appeal, said the panel misunderstood data that shows that the medication is protected.
DOJ lawyers noted in a court filing that sepsis and hemorrhage occurs in only 0.2% of patients who take the drug, and the rates of blood transfusion or hospitalization are 0.7% or less.
“And study after study has shown that when mifepristone is taken consistent with its approved conditions of use, serious opposed events are ‘exceedingly rare,'” the DOJ said in its transient to the panel that may hear Wednesday’s arguments.
“As well as, pregnancy itself entails a significantly higher risk of great opposed events, including a death rate 14 times higher than that related to legal abortion,” the DOJ said.
Cohen believes the Supreme Court is less more likely to take the case if the federal government wins on the fifth Circuit and the anti-abortion group appeals the ruling.
He said the undeniable fact that a majority of justices selected to maintain mifepristone available while lower-court litigation plays out suggests they will not be particularly sympathetic to the anti-abortion doctors’ case.
And while the lawsuit raises issues the Supreme Court could be desirous about sooner or later, he said the case against the FDA is a technical one which the justices might prefer to pass on reviewing.