Abortion Drug Rule Case Moves Forward in Hawaii Federal Court

The US failed to convince a federal court in Hawaii to put off a case challenging heightened regulations for the abortion-inducing drug mifepristone until after two other federal lawsuits involving the same drug have ended.

Litigation in Texas, which has already made one trip to the US Supreme Court, likely won’t be finally decided until 2025, and there’s little likelihood that the Hawaii-based lawsuit and the Washington litigation will end inconsistently, Judge Jill A. Otake said Tuesday. Delaying the Hawaii litigation based on either of those suits would be unreasonable, she said.

The Food and Drug Administration originally approved mifepristone in 2000 as part of a regimen used to end pregnancies through 10 weeks gestation. The agency later added regulations for its use through the Risk Evaluation and Mitigation Strategy program.

Physician Graham Chelius, the Society of Family Planning, and California Academy of Family Physicians sued the US Health and Human Services secretary, the FDA Commissioner, and the agencies in 2017. They alleged that heightened regulations exceeded the agencies’ authority because the drug’s risks didn’t justify the burden.

In April, the plaintiffs amended the complaint to challenge new REMS regulations issued by the FDA in January. The defendants moved to stay the litigation pending the outcome in the Texas and Washington cases, which were filed after this suit.

Doctors in the Texas litigation sought to invalidate FDA’s 2000 approval of mifepristone. The trial court granted them a preliminary injunction, but the Fifth Circuit partially stayed it because the challenge likely was time-barred. The Supreme Court then stayed the entire injunction and sent the case back to the Fifth Circuit, where an appeal is pending, Otake said.

Whatever the Fifth Circuit holds, the case likely will go back to the Supreme Court, Otake said. Staying the Hawaii case “is simply not worth the wait,” especially because the top court’s ruling could turn on an issue not relevant to this case, such as the Texas doctors’ standing or lack of irreparable harm, she said.

The Washington litigation presented issues identical to those in the Hawaii case, and the district court there blocked the FDA from enforcing the 2023 REMS or taking any action to reduce mifepristone’s availability in the plaintiff states, the court said. But the defendants didn’t show that forcing them to defend cases in Washington and Hawaii at the same time would cause a “clear case of hardship,” she said.

The American Civil Liberties Union Foundation, ACLU of Hawaii, and Arnold & Porter Kaye Scholer LLP represent the plaintiffs. The US Justice Department represents the defendants.

The case is Chelius v. Wright, D. Haw., No. 17-cv-493, 8/8/23.