Amarillo, Texas (Trends Wide) — A federal judge in Texas will determine this Wednesday in a high-level hearing whether to block the US government’s authorization of mifepristone, which is used for medical abortions.
The case, brought by doctors and medical associations opposed to abortion, is arguably the most important legal battle related to abortion since the Supreme Court ended this reproductive protection across the country by striking down Roe v. Wade last summer.
Depending on how U.S. District Judge Matthew Kacsmaryk rules on the drug lawsuit, access to the most common abortion method in the United States could be restricted across the country.
The Justice Department and outside legal experts say it would be “unheard of” for a US district court to order the US Food and Drug Administration (FDA) to rescind the authorization of the drug, as the plaintiffs request from Kacsmaryk.
The drug mifepristone was approved by the FDA more than two decades ago, and the plaintiffs are also challenging more recent FDA actions that have made it easier to obtain abortion pills.
This Wednesday, Kacsmaryk is considering the plaintiffs’ request for an injunction that would force the FDA to withdraw or suspend the approval while the legal dispute is resolved.
The hearing began at 9 a.m. and is expected to last several hours. Although it will be open to the public, it will not be broadcast live.
Here’s what to expect from the audience:
The opinion of the judge on the merits of the claim
The plaintiffs, represented by a leading anti-abortion law organization, contend that the FDA violated administrative law by approving mifepristone and relaxing rules on its use over the years.
“After two decades of fighting the FDA to no avail, the plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by outlawing, nullifying, and nullifying the FDA’s actions to approve chemical abortion drugs and remove crucial safeguards for those who undergo this dangerous drug regimen,” the lawsuit says.
Opponents of the lawsuit, including many mainstream medical organizations that have filed amicus briefs in support of the FDA, claim that the plaintiffs use misleading and randomly chosen 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 medications prescribed in the United States and has a safety profile comparable to that of ibuprofen,” a group of leading medical and public health societies in one of those writings.
Mifepristone is the first drug in the two-pill regimen to terminate a pregnancy. If it is no longer available, wait times at clinics in states where abortion is legal are likely to increase significantly. The capacity of those clinics has already been strained by the flood of patients from states where abortion is illegal, the Democratic attorneys general said in a brief.
Before sitting on the bench, Kacsmaryk did work suggesting opposition to abortion and was a lawyer for a conservative law firm specializing in religious liberty cases.
However, the case before him is not just about abortion, but about administrative law and the extent to which the FDA’s approach can be upheld in court. Even some conservative legal scholars have been skeptical of the plaintiffs’ arguments.
Kacsmaryk had considered the possibility of holding a full trial on the merits of the lawsuit before deciding on the injunction, but finally gave up that route, which will limit the evidence before him on Wednesday.
Does the judge think he has the power to block FDA approval?
Before going into the substance of the plaintiffs’ arguments, Kacsmaryk will have to weigh several procedural issues that could limit his ability to intervene in the litigation.
In his instructions to the lawyers before the hearing, Kacsmaryk asked them to be prepared to answer several questions about whether the plaintiffs have shown that the FDA’s actions harm them in such a way that it is appropriate for a court to intervene. In addition, questions have been raised about whether the judge can, in practice, 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 follow those steps — which could take several weeks or even months — if the court orders to withdraw approval.
There is also the question of what effect a Kacsmaryk order would have on the actions of providers to prescribe mifepristone and on those of manufacturers and distributors, who are not parties to the case. (A pharmaceutical company that manufactures and distributes mifepristone has intervened as a defendant, but the other major manufacturer has not.)
Kacsmaryk has asked lawyers to be prepared to argue what the settlement would look like if it ruled in favor of the plaintiffs.
How the arguments will develop
Among the lawyers for Alliance Defending Freedom (ADF), the legal defense group representing the plaintiffs, is Erin Morrow Hawley, wife of Republican Senator Josh Hawley. However, the main signatory to many of the ADF’s writings is another lawyer for the organization, Erik Baptist.
Kacsmaryk has given both sides two hours each to argue the case. Some of the Justice Department’s time could be shared with lawyers for Danco, the pharmaceutical company that has intervened. The plaintiffs’ lawyers will be the first to speak, and will be allowed to reserve part of their two hours for rebuttal after the defendants have had their chance to present their arguments before the judge.
Will the judge hint when he will make a decision?
It is always possible for Kacsmaryk to rule on the injunction from the bench during the hearing. But it’s unlikely, given the high profile of the case and the breadth of issues the judge has asked lawyers to be prepared to argue on.
When you render your ruling, if it favors the plaintiffs, you could proactively put it on hold to give the Justice Department time to appeal it to the conservative-leaning US Court of Appeals for the 5th Circuit. If not, the Justice Department is expected to ask him and the appellate court to do so.
If Kacsmaryk rejects the plaintiffs’ request for injunctive relief, they will also have the opportunity to request immediate intervention by a higher court.
Address death threats
It will also remain to be seen if Kacsmaryk addresses the death threats his court has received and his failed attempt to minimize publicity surrounding Wednesday’s hearing.
Kacsmaryk convened a private teleconference with lawyers on the case Friday to discuss the hearing’s scheduling and logistics. The conference call, however, was not announced at the time on the public record, and during the call, Kacsmaryk said he would not publicly announce Wednesday’s hearing “in order to minimize some of the unnecessary death threats, voicemails and harassment that this division has received since the beginning of the case”.
He asked lawyers not to make it public, but the hearing and Kacsmaryk’s request that the plan for it be kept secret was reported by The Washington Post on Saturday.
While legal experts and the media criticized his secrecy on the grounds that it undermined the principles of judicial transparency, Kacsmaryk announced on Monday that the hearing would be held. But his order did not explain why he had tried to keep it a secret and it is not clear if the reasons will be mentioned during Wednesday’s proceedings.
Kacsmaryk said, according to a transcript of the conference Friday obtained by Trends Wide, that the court had received a “mountain of death threats” and harassing phone calls.
