Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022. Walgreens said Thursday, March 2, 2023, that it will not start selling mifepristone, an abortion pill, in 20 states that had warned of legal consequences if it did that.
Amarillo, Texas CNN  — 

A federal judge in Texas will consider at a high-stakes hearing on Wednesday whether he should block the US government’s approval of the drug used for medication abortions.

The case, brought by anti-abortion doctors and medical associations, is arguably the most significant legal dispute concerning abortion since the Supreme Court ended nationwide abortion protections with its overturning of Roe v. Wade last summer.

Depending on how US District Judge Matthew Kacsmaryk handles the medication abortion lawsuit, access could be cut off nationwide to the most common method of abortion in the United States.

The Justice Department and outside legal experts say that it would be “unprecedented” for a US district court to order that the US Food and Drug Administration rescind its approval of the drug, as the plaintiffs are asking Kacsmaryk to do. The drug – mifepristone – was approved by the FDA more than two decades ago, and the plaintiffs are also challenging more recent moves by the FDA that made abortion pills easier to obtain.

Before Kacsmaryk on Wednesday is the challengers’ request for a preliminary injunction that would force the FDA to withdraw or suspend the approval while the lawsuit plays out.

The hearing will start at 9 a.m. CT and is expected to last several hours. While it will be open to the public, the hearing will not be livestreamed.

Here is what to watch for in Wednesday’s hearing:

What the judge thinks of the merits of the lawsuit

The challengers, who are being represented by a prominent anti-abortion legal organization, are arguing that the FDA violated administrative law in how it went about approving mifepristone and in how it relaxed the rules around the drug’s use over the years.

“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.

Critics of the lawsuit, which include many mainstream medical organizations that filed amicus briefs supporting the FDA, say that the plaintiffs use misleading and cherry-picked evidence to argue mifepristone is unsafe.

“The scientific evidence supporting mifepristone’s safety and efficacy is overwhelming. Mifepristone is one of the most studied medications prescribed in the United States and has a safety profile comparable to ibuprofen,” a group of leading medical and public health societies wrote to the court in one such brief.

Mifepristone is the first drug in the two-pill regimen for terminating a pregnancy. If it is no longer available, wait times at brick-and-mortar clinics in states where abortion is legal will likely increase significantly. The capacity of those clinics has already been stretched thin by the flood of patients from states where abortion is illegal, Democratic attorneys general said in a brief.

Before joining the bench, Kacsmaryk engaged in work that suggested an opposition to abortion and he was a lawyer for a conservative legal firm specializing in religious liberty cases.

The case before him, however, is not just about abortion, but about administrative law and to what extent the FDA’s approach can be second guessed in court. Even some conservative legal scholars have indicated skepticism to the plaintiffs’ arguments.

Kacsmaryk had considered holding a full trial on the merits of the lawsuit before deciding the preliminary injunction, but ultimately forewent that route, which will limit the evidence that will be before him Wednesday.

Does the judge think he has the power to block FDA’s approval?

Before Kacsmaryk gets to the merits of the challengers’ arguments, he’ll have to weigh several procedural questions that might constrain his ability to intervene in the dispute.

In his instructions to the lawyers ahead of the hearing, Kacsmaryk told them to be prepared to answer several questions about whether the challengers have established that they are being harmed by the FDA’s actions in a way that makes it appropriate for a court to get involved. Additionally, there have been questions raised about whether the judge, as a practical matter, can unilaterally pull the drug off the market.

There are specific legal procedures for how and when the FDA withdraws a drug, and it’s not clear whether the FDA would have to go through those steps – which could take several weeks or even months – if the court orders the approval withdrawn.

There’s also the question of what effect an order from Kacsmaryk would have on the actions of providers to prescribe mifepristone and on those of manufacturers and distributors, who are not party to the case. (One drug company that manufactures and distributes mifepristone has intervened as a defendant, but the other main manufacturer has not.)

Kacsmaryk has asked the lawyers to be prepared to argue what the remedy would look like if he were to rule in favor of the plaintiffs.

How the arguments will play out

Among those listed in the case as attorneys with the Alliance Defending Freedom, the legal advocacy group representing the plaintiffs, is Erin Morrow Hawley, the wife of Republican Sen. Josh Hawley. However, the lead signatory on many of ADF’s briefs has been another attorney at the organization, Erik Baptist.

Kacsmaryk has given both sides two hours each to argue the case. Some of the Justice Department’s time might be shared with lawyers for Danco, the drug company that has intervened. The challengers’ attorneys will be up first, and they’ll be allowed to reserve some of their two hours for rebuttal after the defendants have their chance to present to the judge.

Will the judge hint at the timing of a decision

It is always possible that Kacsmaryk will rule on the preliminary injunction from the bench during hearing. But that is unlikely, given the high-profile nature of the case and the breadth of topics the judge has asked the lawyers to be prepared to argue on.

When he does issue his ruling, if it is an order in favor of the challengers, he could proactively put the order on pause to give the DOJ time to appeal it to the conservative-leaning 5th US Circuit Court of Appeals. If not, the department is expected to ask him, as well as the appellate court, to do so.

If Kacsmaryk rejects the plaintiffs’ request for a preliminary injunction, they will also have the opportunity to seek the immediate intervention of a higher court.

Addressing death threats

It will also be worth watching whether Kacsmaryk addresses the death threats his courthouse has received and his botched attempt to minimize publicity around Wednesday’s hearing.

Kacsmaryk called a private teleconference with the case’s attorneys Friday to discuss scheduling the hearing and the logistics for it. The teleconference, however, was not announced at the time on the public docket, and during the call, Kacsmaryk said he would hold off announcing Wednesday’s hearing publicly “to minimize some of the unnecessary death threats and voicemails and harassment that this division has received from the start of the case.”

He asked the attorneys not to publicize it themselves, but the hearing – and Kacsmaryk’s request that the plan for it be kept quiet – was reported by The Washington Post Saturday.

As legal experts and media organizations criticized his secretive approach as undermining the principles of judicial transparency, Kacsmaryk announced the hearing on Monday. But his order did not address why he had sought to keep it under wraps and it is unclear whether the fracas will come be mentioned during Wednesday’s proceedings.

Kacsmaryk said, according to a transcript of the Friday status conference obtained by CNN, that the courthouse had received a “barrage of death threats” and harassing phone calls.