Due court cases can rule on the legality of mifepristone

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

In Washington state, US District Judge Thomas Rice is considering whether to scrap federal regulations on mifepristone that make access difficult even when abortion is legal. He’s also considering issuing an injunction that would prevent the Food and Drug Administration from taking action to take the pill off the market or reduce its availability.

In Texas, US District Judge Matthew Kacsmaryk is considering ordering the FDA to withdraw mifepristone from the US market. Medical groups, which oppose abortion, sued the FDA in November to overturn the drug’s more than 20-year-old approval.

Rice heard arguments Tuesday in Spokane from the FDA and the legal team representing a coalition of Democratic attorneys general who filed the lawsuit against the agency. The entire hearing lasted less than 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.

“When we made our complaint, we were obviously well aware of what was going on in Texas. That’s just the legal world we live in,” said Washington State Attorney General Bob Ferguson, who is leading the lawsuit to keep mifepristone on the market and expand access to the drug.

The US is now braced for the possibility that two federal district courts could issue conflicting rulings on the abortion pill, potentially adding further confusion to an already complex web of state regulations on mifepristone.

The cases also suggest that the Supreme Court could eventually become embroiled in the escalating legal battle over the most commonly used method of abortion in the United States

“If we get two diametrically opposed rulings on what the FDA should do, it will almost certainly go to the US Supreme Court,” wrote Glenn Cohen, a former attorney with the Civil Division of the Justice Department and a Harvard Law School professor, in an email. Cohen signed a brief in the Texas case supporting FDA approval of mifepristone.

Ferguson said the Washington case urges the judge to expand and protect access to mifepristone, particularly in the 17 states plus the District of Columbia that are parties to the lawsuit. In the Texas case, anti-abortion medical associations are asking the judge to remove the abortion pill from the US market statewide.

If the Texas judge rules first and orders the FDA to take mifepristone off the market, the Washington judge could still issue an order that at least preserves access in the 17 states and DC, Ferguson said.

“The federal judge in Washington will rule on Washington, and that would preserve it in Washington State and the plaintiff states,” Ferguson said. “But you would have competing court orders, and sometimes that’s resolved on appeal.”

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

The FDA has placed restrictions on mifepristone under a government surveillance program since it approved the pill in 2000, but the agency has gradually eased those restrictions over the years. In January, the requirement for patients to receive the pill in person was finally ended, allowing mifepristone to be mailed. The FDA also allowed retail pharmacies to begin dispensing the pill for the first time.

But the agency has retained some caveats. Patients must sign a form outlining the risks of mifepristone, and they must obtain a prescription from a health care provider certified under the federal surveillance program. Pharmacies must also be certified under this program in order to dispense the drug to the patient.

Ferguson and the other attorneys general are asking the Washington state judge to lift those restrictions. The 17 states include Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and Washington.

“It only serves to make mifepristone harder for physicians to prescribe, harder for pharmacies to fill, harder for patients to access, and harder for plaintiff states and their healthcare providers to distribute,” the attorney general told the judge in their complaint.

Cohen said the lawsuit in Washington raises questions about whether the Biden administration would appeal a decision ordering the FDA to drop mifepristone restrictions.

The White House may not want to explain why it defends barriers to medical abortion, even though the FDA likely wants to protect its regulator, Cohen said. It’s possible that the Biden administration would not appeal if they lost in Washington state and simply dropped remaining restrictions on the abortion pill, he added.

However, Ferguson noted that on Tuesday the government decided to defend the restrictions in court: “It was not like they said, ‘Ferguson is right, we shouldn’t have these restrictions.’ They fight it, they defend it. So what they would do if we prevailed, I don’t know.”

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

When district court cases in Washington and Texas are challenged in the 9th Circuit and 5th Circuit Courts of Appeals, respectively, and those circuit courts return conflicting judgments, “then those are issues that take precedence for the Supreme Court,” Rebouche said.

A narrow majority of the 9th Circuit Court justices were nominated by Democratic presidents, while an overwhelming majority of the 5th Circuit Court justices were nominated by Republican presidents.

Oregon Attorney General Ellen Rosenblum, who co-chaired the lawsuit in Washington with Ferguson, said she was concerned that the case would fall after the court’s decision last year to uphold abortion rights under Roe v. Wade would end up in the Supreme Court.

“We don’t necessarily want to make this a US Supreme Court case,” Rosenblum said.