By Brendan Pierson
(Reuters) – U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas on Friday suspended approval of the abortion pill mifepristone, which will essentially make sales of the pill illegal in the U.S., while a legal challenge proceeds.
The legal battle over medication abortion is only beginning and could wend its way through multiple levels of appeals courts over a period of months or years before it is resolved. Here is what you need to know about the case as it further unfolds:
WHAT IS MEDICATION ABORTION?
Medication abortion is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate a pregnancy within the first 10 weeks. It accounts for more than half of U.S. abortions.
WHAT HAS HAPPENED SO FAR?
Anti-abortion groups led by the Texas-based Alliance for Hippocratic Medicine sued the U.S. Food and Drug Administration last year, claiming that it approved mifepristone for abortion in 2000 using an unlawful process and did not adequately consider the drug’s safety. They asked Kacsmaryk to revoke the drug’s approval.
Kacsmaryk’s order is not a final ruling on the merits of the case but rather a preliminary injunction, meaning that it bans the drug while the case proceeds. Like all federal judges, Kacsmaryk can issue injunctions with nationwide effect, even though he is assigned to one district in Texas.
WHAT WILL THE BIDEN ADMINISTRATION DO FIRST?
The Biden administration is seeking an emergency stay of Kacsmaryk’s order from the New Orleans-based 5th U.S. Circuit Court of Appeals. Such a stay would stop the order from taking effect until that court hears a full appeal.
Kacsmaryk has already put his own order on hold for seven days in order to give the administration time to seek the emergency stay.
The 5th Circuit has a conservative reputation, with 12 of its 16 active judges appointed by Republican presidents. A three-judge panel will decide whether to grant the stay, and its decision will depend partly on whether it believes the agency is likely to succeed on the merits of the case.
WHAT IF THE 5TH CIRCUIT DOES NOT GRANT A STAY?
The FDA could then petition the U.S. Supreme Court for an emergency stay. Emergency petitions from the 5th Circuit initially go to Justice Samuel Alito, one of the court’s most conservative justices and the author of last year’s ruling overturning Roe v. Wade, which had guaranteed abortion rights nationwide.
Individual justices typically refer emergency petitions to the full court, though they can also decide them on their own. Such petitions are usually decided without argument and with minimal explanation; for that reason, they are often known collectively as the court’s “shadow docket.”
WHAT DOES A STAY MEAN FOR MIFEPRISTONE?
If the FDA wins a stay blocking the injunction, mifepristone will remain an FDA-approved drug for as long as the stay remains in place. If it does not, then the agency can be ordered to rescind the approval and it will be illegal to sell the drug in the United States. Whether the FDA would take any enforcement action to stop continued use of the drug is not immediately clear.
WILL THAT END THE APPEAL?
No. Regardless of whether it wins an emergency stay of the injunction, the FDA will continue its appeal of Kacsmaryk’s preliminary injunction. The agency and the anti-abortion groups will both have a chance to file briefs with their legal arguments in the 5th Circuit, and a three-judge panel may or may not decide to hold an oral argument.
The 5th Circuit will not be considering the full merits of the case, but only whether Kacsmaryk was right to issue a preliminary injunction. That depends on whether the plaintiffs challenging mifepristone’s approval have shown a likelihood that they will win on the merits, and that they would be irreparably harmed without an injunction.
That appeal process could last months. Whichever way the panel rules, the losing party could petition for rehearing with all judges of the 5th Circuit, known as en banc rehearing, and ultimately petition the Supreme Court. However, most such petitions are denied.
WHAT NEXT?
Once all the appeals over the preliminary injunction are over, the case can proceed to trial on the merits, giving both sides a chance to present factual evidence.
The FDA will need to produce evidence about the process leading to mifepristone’s original approval in 2000, as well as several later actions modifying the approval and rules around the drug.
The anti-abortion groups will have to offer evidence to support their claim that the process was improper, and that mifepristone is dangerous. The two sides will exchange evidence in a process known as discovery.
Kacsmaryk could then decide the case without trial, known as summary judgment, or hold a trial including witness testimony.
A final resolution could be months or years away. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
(Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill Berkrot)
