Fears mount around ‘catastrophic’ abortion pills case as decision nears

Abortion rights advocates delivered a stark warning to the Biden administration’s top health official in a private meeting last week: It’s time to take seriously “fringe” threats that could wind up blocking abortion access across the country.

Driving their anxiety is a Texas lawsuit brought by conservative groups seeking to revoke the decades-old government approval of a key abortion drug.

The suit has been widely ridiculed by legal experts as rooted in baseless and debunked arguments. But in recent weeks, abortion rights advocates and some in the Biden administration have grown increasingly concerned that the case is likely to be decided entirely by conservative judges who might be eager for a chance to restrict abortion access even in Democrat-led states, where the procedure has remained legal since the fall of Roe v. Wade.

“It’s hard to really comprehend the full and terrible impact if what the plaintiffs have asked for in that case is actually granted,” Liz Wagner, senior federal policy counsel at the Center for Reproductive Rights, told Health and Human Services Secretary Xavier Becerra during the meeting at a Virginia abortion clinic. “It would be catastrophic.”

The case was filed in Amarillo, where U.S. District Court Judge Matthew Kacsmaryk, nominated by President Donald Trump and known for his conservative views on issues like same-sex marriage and abortion, could rule as early as this week. An appeal would land in the right-leaning Fifth Circuit Court of Appeals, ultimately presenting the Supreme Court with another major abortion case less than a year after its conservative majority retracted the constitutional right to abortion.

“Obviously we have people who are not fans of the administrative state on that court and also obviously people who are not fans of abortion,” Jenny Ma, senior counsel for the Center for Reproductive Rights, told Becerra. “It’s a perfect storm.”

The suit aims to undo the U.S. Food and Drug Administration’s 2000 approval of mifepristone, one of two drugs used in a medication abortion. The regimen, which includes a dose of another drug called misoprostol, now accounts for more than 50 percent of abortions nationwide. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.

Alliance Defending Freedom, a conservative legal group that has been involved in antiabortion litigation, filed the suit in November on behalf of four antiabortion medical organizations and four doctors who say they have treated patients with the drug.

The FDA has repeatedly deemed the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions. But the conservative group’s 113-page lawsuit argues that the FDA chose politics over science when it approved “chemical abortion drugs,” purposely ignoring what the plaintiffs claim are potentially harmful side effects.

“We think that when the court will look at the law and the facts of what the FDA has done that it will agree that FDA has failed in its job to protect America’s women and girls,” said Julie Marie Blake, senior counsel at Alliance Defending Freedom.

Wagner said in an interview that she and her colleagues have struggled to get people to take the case seriously. In a recent briefing on Capitol Hill with congressional staff, Wagner said, some attendees had a hard time understanding how abortion access could be under threat in states like New York and California.

“We were getting comments like, ‘But these states protect the right to have an abortion,’” said Wagner, adding that she and Ma had to repeatedly explain that the right to abortion was not a right to a specific method of abortion.

At the Alexandria, Va., Whole Woman’s Health clinic last week, Becerra pointed the lawyers to the Justice Department, which he said was “paying close attention” to the Texas case. His staff declined to comment further.

Inside the Justice Department, a reproductive rights task force established in July by Attorney General Merrick Garland has been searching for legal avenues to protect access to abortion pills.

The department issued a legal opinion in January saying that the U.S. Postal Service may deliver abortion pills to people in states that have sharply restricted the procedure, arguing that federal law allows the mailing of the pills because the sender cannot know for sure whether the recipient would use them illegally.

Now, officials say, the task force has its eyes on the case in Texas.

“We are vigorously defending the FDA in unprecedented litigation that is seeking to withdraw mifepristone from the marketplace — an action that would work severe harm to all who rely on the medication,” Associate Attorney General Vanita Gupta, who chairs the reproductive task force, said at a public event in January.

The Justice Department has conceded in its legal arguments that the Supreme Court’s opinion striking down Roe stands as the reigning federal law. The crux of the department’s opposition in the Texas case is that Congress empowered the FDA to approve the use of new drugs — not states. Allowing abortion pill opponents to undercut the FDA’s judgment with “cursory and baseless allegations of harm” could spark challenges to other approved drugs and fuel public distrust of the process, Justice Department lawyers argued in a filing in the case.

Despite a widespread belief among abortion rights advocates that the lawsuit’s claims are baseless, providers have been preparing for their worst-case scenario, with many ready to implement new protocols if they can no longer distribute mifepristone.

“I don’t think it’s a stretch at all,” said Amy Hagstrom Miller, chief executive of Whole Woman’s Health, a network of abortion clinics with locations across several states, including Texas before the Supreme Court ruling triggered a law banning almost all abortions there. “I have a lot of experience with these crazy legal theories that sound radical in Texas actually becoming reality.”

In a two-step medication abortion, a patient first takes one pill of mifepristone, which terminates the pregnancy. Approximately 24 hours later, they typically take a four-pill dose of misoprostol, a drug introduced in 1973 to treat stomach ulcers, to soften the cervix and prompt contractions that expel the fetus.

If the Texas case results in taking mifepristone off the market, Hagstrom Miller said, her clinics would likely default to a misoprostol-only protocol for medication abortion, prescribing just misoprostol pills instead of the standard regimen of mifepristone and misoprostol together.

While she has discussed this plan with several members of her staff, she said, she still needs to discuss it with the clinic’s lawyers.

Many Planned Parenthood clinics also have a misoprostol-only protocol in place, Ma said, ready to be implemented if needed.

“We want to provide patients with the safest and most effective regimen,” said Deborah Nucatola, a chief medical officer with Planned Parenthood, who has facilitated both types of medication abortion since she started practicing more than two decades ago. “That is mifepristone and misoprostol.”

The Justice Department warned in its legal filing opposing the lawsuit that banning abortion pills would lead to overcrowding and delays at clinics that provide surgical abortions, putting a burden on health-care systems.

Inside her clinics, Hagstrom Miller fears that a mifepristone ban would trigger “a huge amount of congestion and waiting.” Because a misoprostol-only regimen would likely take some time to implement, she said, far more patients would need to have surgical procedures — which generally require more time and staff resources than medication abortion.

She anticipates converting every possible room into a space that can be used for surgical abortions.

While she is trying to prepare her clinics as much as possible, Hagstrom Miller said, there is only so much energy she can devote to this hypothetical.

Especially since the June Supreme Court ruling, she said, “we already have so much we’re trying to navigate.”