A federal judge in Texas will consider in a high-stakes hearing Wednesday whether to block the US government’s approval of the drug used for medical abortions.
The case, brought by anti-abortion doctors and medical associations, is arguably the most significant abortion litigation since the Supreme Court ended national abortion protections by overturning Roe v. Wade last summer.
Depending on how U.S. District Judge Matthew Kacsmaryk handles the medication abortion lawsuit, access could be cut nationwide to the most common abortion method in the United States.
The Justice Department and outside legal experts say it would be “unprecedented” for a U.S. district court to order the U.S. Food and Drug Administration to revoke its approval of the drug, as the Kacsmaryk plaintiffs are asking. The drug — mifepristone — was approved by the FDA more than two decades ago, and the plaintiffs are also challenging more recent FDA moves 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 is pending.
The hearing will begin at 9 a.m. CT and is expected to last several hours. While open to the public, the hearing will not be streamed live.
Here’s what to look out for in Wednesday’s hearing:
The challengers, who are represented by a prominent anti-abortion legal group, argue that the FDA violated administrative law in how it approved mifepristone and how it relaxed rules on the drug’s use with years.
“After two decades of futile FDA engagement, the plaintiffs are now asking this court to do what the FDA was and is legally required to do: protect women and girls by holding illegal, setting aside and invalidating the FDA’s actions to the approval of chemical abortion. drugs and gut critical safeguards for those undergoing this dangerous medication regimen,” the complaint states.
Critics of the lawsuit, which include several medical organizations that filed amicus briefs supporting the FDA, say the plaintiffs are using misleading and cherry-picked evidence to argue that mifepristone is unsafe.
“The scientific evidence supporting the safety and efficacy of mifepristone is overwhelming. Mifepristone is one of the most studied prescription drugs in the United States and has a safety profile comparable to ibuprofen,” a group of leading medical and public health companies wrote in court.
Mifepristone is the first drug in a two-pill form to terminate pregnancy. If it is no longer available, wait times at clinics in states where abortion is legal will likely increase significantly. The capacity of these clinics has already been reduced by a flood of patients from states where abortion is illegal, the Democratic attorneys general said in a brief.
Before joining the bench, Kacsmaryk was involved in anti-abortion work and was an attorney for a conservative law firm specializing in religious liberty cases.
The case before him, however, is not just about abortion, but about administrative law and whether the FDA’s approach can be second-guessed in court. Even some conservative legal scholars have shown skepticism of the plaintiffs’ arguments.
Kacsmaryk had considered holding a full trial on the merits of the suit before deciding on the preliminary injunction, but ultimately went that route, which will limit the evidence before him on Wednesday.
Before Kacsmaryk gets to the heart of the challengers’ arguments, he will have to weigh several procedural questions that may limit his ability to intervene in the controversy.
In his instructions to the lawyers before the hearing, Kacsmaryk told them to be prepared to answer several questions about whether the challengers have shown they are harmed by the FDA’s actions in a way that makes it appropriate for a court to get involved. In addition, questions have been raised about whether the judge, as a practical matter, can unilaterally withdraw the drug from the market.
There are specific legal procedures for how and when the FDA withdraws a drug, and it’s unclear whether the FDA would have to go through those steps — which can take several weeks or even months — if a court orders the approval withdrawn.
There is 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 involved in the case. (A pharmaceutical company that makes and distributes mifepristone has intervened as a defendant, but the other major manufacturer has not.)
Kacsmaryk asked lawyers to be prepared to argue what the remedy would look like if it were to rule in favor of the plaintiffs.
Among those named in the case as attorneys for the Alliance Defending Freedom, the legal defense group representing the plaintiffs, is Erin Morrow Hawley, wife of Republican Sen. Josh Hawley. However, the main signatory to many of ADF’s briefs was another lawyer for the organization, Erik Baptist.
Kacsmaryk gave both sides two hours each to argue. Some of the Justice Department’s time may be shared with lawyers for Danco, the drug company that intervened. The disputants’ lawyers will be first and allowed to reserve some of their two hours for rebuttal after the defendants have had a chance to present it to the judge.
It is always possible that Kacsmaryk will decide on the preliminary injunction from the bench during the hearing. But that’s unlikely, given the high-profile nature of the case and the range of issues the judge asked lawyers to be prepared to argue.
When he does issue his decision, if it is an order in favor of the challengers, he could preemptively put the order on hold to give the DOJ time to appeal it to the conservative 5th US Circuit Court of Appeals. Otherwise, the department, as well as the appellate court, is expected to ask him.
If Kacsmaryk rejects the plaintiffs’ request for a preliminary injunction, they will also have the option of seeking immediate higher court intervention.
Also worth watching is whether Kaczmaric deals with the death threats his court has received and his failed attempt to minimize the publicity surrounding Wednesday’s hearing.
Kacsmaryk called a private conference call with lawyers in the case on Friday to discuss scheduling the hearing and logistics for it. The conference call, however, was not publicly announced at the time, and during the call, Kacsmaryk said he would delay publicly announcing Wednesday’s hearing “to minimize some of the unnecessary death threats and voicemails and harassment.” which this department has received since the beginning of the case.’
He asked the lawyers not to make it public themselves, but the hearing — and Kacsmaryk’s request that the plan for her be kept quiet — was reported by the Washington Post on Saturday.
As legal experts and media organizations criticized his secretive approach as undermining the principles of judicial transparency, Kaczmaric announced the hearing on Monday. However, his order did not address why he had tried to keep it a secret, and it is unclear whether the victims will be named during Wednesday’s proceedings.
Kaczmaric said, according to a transcript of Friday’s status conference obtained by CNN, that the courthouse had received a “boil of death threats” and harassing phone calls.