AMARILLO, Texas (KAMR/KCIT) – As the abortion-pill-related lawsuit continues through Amarillo Federal Court, United States District Judge Matthew J. Kacsmaryk ruled on Tuesday that the injunction hearing and the trial will be separate in this case.
This comes as the plaintiffs involved in the lawsuit, including the Alliance for Hippocratic Medicine, asked Kacsmaryk in documents filed on Feb. 10 in the United States District Court for the Northern District of Texas Amarillo Division, to consolidate the preliminary injunction hearing with a trial, arguing that combining the two would “promote judicial efficiency by avoiding briefing the same legal issues” multiple times before the court.
The defendants, including the United States Food and Drug Administration, argued in documents also filed on Feb. 10 that it would be “generally inappropriate” to accelerate the trial to be consolidated with the preliminary injunction hearing and would “substantially prejudice” the defendants.
The responses come after Kacsmaryk asked on Feb. 3 for both sides to submit briefs on whether or not the court should “consolidate the injunction hearing and the trial,” citing the Federal Rule of Civil Procedure. According to the rule, the court can make a decision on whether or not a trial on the merits of a case can be combined with the injunction hearing.
“Even when consolidation is not ordered,” the Federal Rule of Civil Procedure states, “evidence that is received on the motion and that would be admissible at trial becomes part of the trial record and need not be repeated at trial.”
How have we gotten to this point?
According to previous reports by MyHighPlains.com, the Alliance for Hippocratic Medicine, an Amarillo nonprofit, filed a lawsuit in Amarillo Federal Court with a group of doctors and associations, against the U.S. FDA surrounding the approval and use of Mifepristone, or Mifeprex, and Misoprostol for chemical abortions.
On the FDA’s website, officials described the treatment as a way to end an “intrauterine pregnancy through ten weeks gestation,” after first approving the drug in 2000. Mifeprex tablets are created by Danco Laboratories LLC, an entity that became part of this lawsuit in mid-January.
Ultimately, the plaintiffs are asking for Kacsmaryk to suspend the approved use of these drugs and/or put back safeguards surrounding the use of this treatment they allege were taken away, including changes in dosage and changes to the people who could prescribe and administer the treatment. The plaintiffs also claim that the FDA did not have the authority in 2000 to approve the sale of this treatment.
The defendants responded by stating that the FDA concluded that the treatments are safe and effective, something that was determined in 2000, and that the subsequent changes were approved by the FDA “after careful review of clinical and other data…” that the treatment “…would continue to be safe and effective under the revised conditions.”
The plaintiffs in the case, which includes Shaun Jester, a doctor in the Dumas area who is listed in the lawsuit as the medical director of the Moore County OB/GYN, filed a motion for a preliminary injunction, asking Kacsmaryk to rule that the FDA should withdraw or suspend the approval of the treatment, taking it off the market as the lawsuit proceeds in Amarillo Federal Court.
Since that motion was made, Kacsmaryk made the request for both sides to submit briefs on whether or not the court should “consolidate the injunction hearing and the trial”
How did each side argue on the consolidation of the injunction and the trial?
The plaintiffs’ main argument in favor of consolidating the injunction hearing and the trial was to avoid repetitive rounds of briefing, ultimately promoting a prompt resolution to the case, which they stressed was in everyone’s interest.
Through that, the plaintiffs also asked the court to direct the FDA to “immediately produce” its administrative record related to the treatment involved in the case, and not “significantly extend the time that the FDA’s actions continue to harm” the medical associations and the doctors involved in the lawsuit, along with patients.
The documents state that the administrative record consists of the complete, unredacted, documents surrounding the FDA’s decision-making about the treatment. The plaintiffs claim that the publicly released documents, along with the ones provided in response to Freedom of Information Act requests, have been significantly redacted.
“To avoid unnecessary delay of the trial, it should be made clear at the outset that the FDA must immediately collect (and presumptively must produce) an unredacted and complete version of the administrative record for this case,” the plaintiffs said in its argument.
In the defendants’ response, they argued that accelerating a trial under the cited portion of the Federal Rule of Civil Procedure would be “generally inappropriate,” as they claimed has been ruled by numerous courts, including the Supreme Court. They also stated that the plaintiffs have failed to demonstrate harm from the treatment to continue to be on the market, as it has been on the market since 2000.
The defendants also claimed that accelerating a process like this would prejudice the defendants, with the plaintiffs not presenting a complete picture of the agency’s decisions and the evidence on which it was based. They said many allegations would be disputed after a full review of the administrative records.
Consolidation in this case, in the defendants’ view, would not let them have an opportunity to present a “more-fulsome briefing” on the issues included in the records. What has been made available to the court is only excerpts of that whole record.
Ultimately, the order read that Kacsmaryk sided with the defendants, citing the same case law the defendants used, “Univ. of Tex. v. Camenisch,” which explains that it is “generally inappropriate for a federal court at the preliminary injunction stage to give a final judgment on the merits” of a case.
According to previous reports, Kacsmaryk previously ruled that replies surrounding the preliminary injunction can be made through Friday when the briefing will then be closed. Kacsmaryk has not yet ruled on the preliminary injunction and is expected to make a decision surrounding the motion in the case.