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Dueling court cases could determine legality of mifepristone

Dueling court cases could determine legality of mifepristone
Dueling court cases could determine legality of mifepristone


Two federal judges are poised to issue rulings soon in dueling cases that could dramatically impact access to the abortion pill mifepristone.

In Washington state, U.S. Judge Thomas Rice is weighing whether to scrap federal regulations on mifepristone that complicate access even where abortion is legal. He is also considering whether to issue an order that would block the Food and Drug Administration from taking any action to pull the pill from the market or reduce its availability.

In Texas, U.S. Judge Matthew Kacsmaryk is considering whether to order the FDA to pull the mifepristone from the U.S. market. Medical associations that oppose abortion sued the FDA in November to overturn its approval of the medication, which dates back more than 20 years.

Rice heard arguments Tuesday in Spokane from the FDA and the legal team representing the Democratic attorneys general who filed the lawsuit challenging the agency. The entire hearing lasted under an hour.

Kacsmaryk heard arguments in the Texas case earlier this month and said he would issue an order as soon as possible. Kacsmaryk was appointed by former President Donald Trump and Rice was appointed by former President Barack Obama.

“By the time we filed our complaint, we were obviously very much aware of what’s going on in Texas. That’s just the legal world we’re living in,” said Washington state Attorney General Bob Ferguson, who is leading the lawsuit seeking to keep mifepristone on the market and expand access to the medication. 

The U.S. is now set up for the possibility that two federal district courts could issue rulings on the abortion pill that conflict with each other, potentially adding further confusion to an already complex web of state-by-state regulations on mifepristone.

The cases also raise the prospect that the Supreme Court might ultimately become involved in the escalating litigation over the most common method to terminate a pregnancy in the U.S.

“If we get two diametrically opposite rulings on what FDA should do that’s almost certain to go to the U.S. Supreme Court,” wrote Glenn Cohen, a former lawyer with the Justice Department’s civil division and a professor at Harvard Law School, in an email. Cohen signed a brief in the Texas case supporting the FDA approval of mifepristone. 

Ferguson said the case in Washington state is asking the judge to expand and protect mifepristone access, specifically in the 17 states and D.C. that are parties to the lawsuit. In the case of Texas, medical associations that oppose abortion are asking the judge to pull the abortion pill from the U.S. market nationwide.

If the Texas judge rules first and orders the FDA to pull mifepristone from the market, the federal judge in Washington state could still issue an order that at least preserves access in the 17 states and D.C. that are parties to the lawsuit, Ferguson said.

“The federal judge in Washington will be finding on Washington and that would preserve it in Washington state and the plaintiff states, but you’d have competing judicial orders and sometimes that gets worked out on appeal,” Ferguson said.

“You could have a situation where in some states it’s not available and in some states it is available. Any of those things are possible. A lot though depends on how these judges write these rulings,” Ferguson said.

The FDA has subject mifepristone to restrictions under a federal monitoring program since it approved the pill in 2000, but the agency has gradually eased those restrictions over the years. It permanently ended a requirement in January that patients obtain the pill in-person, which allowed delivery of mifepristone by mail. The FDA also allowed retail pharmacies to start dispensing the pill for the first time.

But the agency has kept some restrictions in place. Patients have to sign a form that lays out the risks of mifepristone and they have to obtain a prescription from a health-care provider that is certified under the federal monitoring program. Pharmacies also have to be certified under that program to dispense the medication to the patient.

Ferguson and the 17 other attorneys general are asking the judge in Washington state to drop these restrictions. The states include Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and Washington State. D.C. is also a party to the lawsuit.

“It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense,” the Democratic attorneys general told the judge in their complaint.

Cohen said the Washington state lawsuit raises the question of whether the Biden administration would appeal a decision that orders the FDA to drop mifepristone restrictions.

The White House may not want to explain why they are defending obstacles to medication abortion, even though the FDA probably wants to protect its regulatory authority, Cohen said. It’s possible the Biden administration wouldn’t appeal if they lose in Washington state and just let the remaining restrictions on the abortion pill fall, he added.

But Ferguson noted the Biden administration chose to defend the restrictions in court on Tuesday: “It wasn’t like they said Ferguson’s right, we shouldn’t have these restrictions. They’re fighting it, they’re defending it. So what they would do if we prevail, I don’t know,” he said.

Rachel Rebouche, an expert on reproductive health law at Temple University, said the cases in Washington state and Texas raise the prospect of Supreme Court involvement. Rebouche signed a brief in the Texas case that defended the FDA’s approval of mifepristone.

If the district court cases in Washington and Texas get appealed to the 9th Circuit and 5th Circuit Court of Appeals respectively and those circuit courts issue contradictory rulings, “those are then questions that are prime for the Supreme Court,” Rebouche said.

A slight majority of the judges in the 9th Circuit were nominated by Democratic presidents, while an overwhelming majority of the judges on the 5th Circuit were nominated by Republican presidents.

Oregon Attorney General Ellen Rosenblum, who co-led the lawsuit in Washington state with Ferguson, said she would have concerns about the case ending up in the Supreme Court after its decision last year to end Roe. “We don’t particularly want to make this into a U.S. Supreme Court case,” Rosenblum said.

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