What to know about the lawsuit aiming to ban medication abortion drug mifepristone

By Devan Cole, CNN

A federal judge in Texas is considering a lawsuit seeking to block the use of medication abortion nationwide, in the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year.

The lawsuit, filed in November by anti-abortion advocates against the US Food and Drug Administration, targets the agency’s two-decade-old approval of mifepristone, the first drug in the medication abortion process.

Medication abortion, which now makes up a majority of abortions obtained in the US, has become a particularly acute flashpoint in the fallout from the Supreme Court’s decision last year overturning Roe v. Wade.

US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, has scheduled a hearing for Wednesday on the issue.

Any decision that blocks access to medication abortion — even temporarily — will significantly disrupt abortion cases nationwide.

Reproductive rights advocates say that if Kacsmaryk ultimately sides with the plaintiffs, “it would eliminate the most commonly used method of abortion care,” according to NARAL Pro-Choice America.

Here’s what to know about the lawsuit:

What the lawsuit is seeking

The lawsuit, filed last year by a coalition of anti-abortion national medical associations under the umbrella of the “Alliance for Hippocratic Medicine” and several doctors, is seeking a number of actions by the court, chief among them a preliminary and permanent injunction ordering the FDA “to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw defendants’ actions to deregulate these chemical abortion drugs.”

“After two decades of engaging the FDA to no avail, plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” the complaint reads.

The challengers are also targeting the FDA’s recent moves to make the pills more accessible, which include removing the requirement that the pills be picked up in person from an abortion provider.

What the FDA says

The FDA responded to the lawsuit in January by asking the judge to deny a motion for a preliminary injunction, arguing that issuing one in the matter “would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”

The agency also says a ruling against it would set a dangerous precedent.

“More generally, if longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the FDA wrote.

“A preliminary injunction would interfere with Congress’s decision to entrust FDA with responsibility to ensure the safety and efficacy of drugs. In discharging this role, FDA applies its technical expertise to make complex scientific determinations about drugs’ safety and efficacy, and these determinations are entitled to substantial deference.”

What the drug company says

Danco, which makes mifepristone, also made a request similar to the FDA’s in a court filing, stressing that the lawsuit could decimate the company’s business.

The drug company has been allowed to intervene in the case, as the anti-abortion activists are also asking the court to halt the FDA’s 2016 approval of its version of the medication abortion drug.

“Danco is a small pharmaceutical company. It sells one drug: Mifeprex,” lawyers for the company wrote in court papers. “Entering the mandatory preliminary injunction plaintiffs seek would force FDA to withdraw approval for Danco’s only product, effectively shuttering Danco’s business.”

“Congress entrusts decision-making like this with the FDA. And they’re coming in trying to overrule that, saying this medication is unsafe because women bleed. Well, that’s part of having an abortion. It’s also part of having a pregnancy,” said Ryan Brown, an attorney representing Danco in the case. “The bottom line being that they just want to do away with abortion across the board and for any reason.”

Who is the judge in the case?

Kacsmaryk was appointed to the court in 2017 by then-President Trump and was confirmed by a 52-46 vote in 2019.

Since then, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, presiding over 95% of the civil cases brought in Amarillo, Texas.

In December, Kacsmaryk put on hold the Biden administration’s most recent attempt to end the so-called “Remain in Mexico” immigration program. And he has overseen Texas cases challenging vaccine mandates, the gender identity guidance issued by the US Equal Employment Opportunity Commission and the administration’s limits on the use of Covid-19 relief funds for tax cuts.

Before joining the court, Kacsmaryk served as deputy general counsel at the First Liberty Institute, a nonprofit religious liberty legal group, where he worked mainly on “religious liberty litigation in federal courts and amicus briefs in the US Supreme Court,” according to his White House biography.

Red and blue states weigh in

The abortion drug case is being closely watched by a number of interested parties, including Republican and Democratic state attorneys general. In February, two different multi-state coalitions filed amicus briefs with the court urging them to act one way or another in the matter.

A coalition of 22 Democratic attorneys general urged Kacsmaryk to deny the motion for a preliminary injunction, writing in court papers that “annulling — or even merely limiting — any of the FDA’s actions relating to medication abortion would result in an even more drastic reduction in abortion access across the entire nation, worsening already dire outcomes, deepening entrenched disparities in access to health care, and placing a potentially unbearable strain on the health care system as a whole.”

They noted that “the availability of mifepristone has been particularly critical in providing access to abortion in low-income, underserved, and rural communities where procedural abortion may be unavailable,” adding that since the drug is used more during the first trimester of pregnancy, “eliminating access to this method will result in more abortions taking place later in pregnancy, further increasing costs and medical risks.”

The Democratic attorneys general noted that abortion clinics in their states have already seen a surge in patients because of traffic from residents of states where extreme abortion restrictions are in effect. Cutting off access to medication abortion would further overburden those clinics, the blue states argued, as surgical abortion would be the only available method.

A coalition of 22 Republican attorneys general, meanwhile, asked the court to issue the preliminary injunction, arguing the FDA exceeded its authority when it approved the medication.

“State laws on chemical abortion thus account for the public interests at issue — and they do so with the benefit of democratic legitimacy (and legal authority). The FDA’s actions can make no such claim. By obstructing the judgments of elected representatives, the agency has undermined the public interest,” they wrote.

What abortion-rights advocates are saying

Abortion rights advocates have sounded the alarm on the case, stressing that a ruling by Kacsmaryk in favor of the plaintiffs would affect every corner of the country since the lawsuit is targeting a federal agency.

“If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight,” NARAL said in a statement in February, pointing to internal research.

“This research reveals the high stakes of this lawsuit, and we can only expect the worst from this Trump-appointed federal judge. Americans want access to abortion, but anti-choice bad actors are dead set on restricting reproductive freedom by any means possible,” said Angela Vasquez-Giroux, the group’s vice president of communications and research.

And activists quickly mobilized in Texas around the issue, with the Women’s March holding a rally at the federal courthouse in Amarillo in February to protest the suit.

“We’ve said it before: the fight for reproductive rights now lies in the states, and legal challenges like these are just the latest example of how our fight is bigger than Roe,” said Rachel Carmona, the executive director of Women’s March.

Judge decides against fast-tracking trial

Kacsmaryk had been considering whether to consolidate a potential hearing on the preliminary injunction request with a trial on the merits of the lawsuit, a move that would have fast-tracked the entire case.

He asked the parties to weigh in, with both the plaintiffs and Danco voicing support for the consolidation. The FDA, however, urged the judge not to fast-track the trial, saying in a brief that because of the plaintiffs’ “extreme delay in filing suit to challenge FDA’s approval of the drug, there is no reason to decide this case on an emergency basis.”

Kacsmaryk ultimately decided against fast-tracking the trial, writing in a February 21 order: “Having considered the briefing and relevant law, the court determines that consolidation would not be appropriate in this case.”

When will Kacsmaryk rule?

Wednesday’s hearing will give both sides an opportunity to present their arguments to the judge and address a number of issues he has outlined.

The judge’s decision to notify the public of the hearing came days after he held a private call with the case’s lawyers to schedule the hearing, according to The Washington Post. The call was not publicly reflected on the case’s docket for several days, nor did the judge immediately issue a public order announcing that a hearing had been scheduled. The case is not under seal.

Because he has decided against fast-tracking the trial in the case, his first ruling will be only on the preliminary injunction request, which, if granted in full, would temporarily pull the abortion drug from the market.

Potential Supreme Court showdown

A day before the plaintiffs had submitted their brief, 12 states led by liberal attorneys general sued the FDA, saying its limits on mifepristone are too strict.

The suit creates the possibility of circuit courts offering conflicting takes about the safety of abortion medication and how accessible the drug should be, something that would increase the likelihood of the Supreme Court weighing in.

The lawsuit was filed in federal court in the Eastern District of Washington state. The states in the lawsuit are: Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.

This story has been updated with additional developments.

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CNN’s Tierney Sneed and Kara Scannell contributed to this report.