AMARILLO, Texas — The judge in a closely watched lawsuit seeking to overturn federal approval of a widely used abortion pill questioned lawyers publicly for the first time on Wednesday. The wide-ranging hearing included discussion about whether the anti-abortion plaintiffs had the legal standing to sue the government and what type of ruling he had the power to issue.
The judge, Matthew J. Kacsmaryk of the Northern District of Texas, said he would decide as soon as possible whether to issue a preliminary injunction that could, at least temporarily, take the pill, mifepristone, off the market. He seemed acutely aware of the unprecedented nature of the case, establishing through his questions that a court had never ordered the federal government to withdraw the approval of a drug that had been legally available for years.
Toward the end of the court hearing, which lasted more than four hours, Judge Kacsmaryk asked a lawyer for the plaintiffs, a coalition of anti-abortion groups and doctors, if they expected that “the court itself can order a withdrawal or suspension.” When the lawyer, Erik Baptist, said yes, the judge replied, “What gives the court that authority?”
At another point in the session, the judge asked a Justice Department lawyer representing the defendant in the case, the Food and Drug Administration, if the fact that 22 conservative states had written a brief supporting the plaintiffs’ case showed that revoking the abortion pill would be beneficial for public policy. The lawyer, Julie Straus Harris, replied, “An injunction here would interfere with every state in the country” and could make abortion access difficult even in cases of nonviable pregnancies and rape.
That seemed to make an impression on the judge, who noted, “This isn’t a case where we’re comparing 22 versus 28 states, but rather, all 50 states, especially in some of those other circumstances, right?”
The hearing was the first public session in a case that could have far-reaching consequences for states where abortion is still legal, not just for those trying to restrict it. Medication is the method used in more than half of abortions in the United States, and since last year’s Supreme Court ruling overturning the national right to abortion, the pills have increasingly become the focus of political and legal battles.
The lawsuit was filed against the F.D.A. by the Alliance for Hippocratic Medicine, a coalition of anti-abortion groups, and four anti-abortion doctors. It seeks to overturn the approval nearly 23 years ago of mifepristone — the first pill in the two-drug medication abortion regimen — and to prevent the second drug in the regimen, misoprostol, which is used for several medical conditions, from being used for abortion.
The focus of the hearing was a request by the plaintiffs for Judge Kacsmaryk to grant a preliminary injunction ordering the F.D.A. either to suspend the approval of mifepristone or to withdraw it completely while the case proceeds through trial.
While the hearing was underway, a smattering of abortion rights supporters picketed the courthouse, some mocking the judge by wearing clown wigs and a kangaroo suit. A group of women supporting the lawsuit prayed on the steps of a building across the street. No large crowds materialized.
Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade and who previously worked for a Christian conservative legal organization, calmly asked all of the lawyers detailed questions. He made occasional jokes with lawyers from both sides and at the end of the hearing praised both legal teams, saying that “this was just a smorgasbord of excellent appellate-grade work.”
More on Abortion Issues in America
The hearing covered a range of issues, including:
Whether the plaintiffs have legal standing to bring the lawsuit
Standing to sue requires the plaintiffs to show that the approval of mifepristone has injured them in some way. The plaintiffs’ lawyers argued that the anti-abortion doctors have been adversely affected because they have treated some patients who took abortion pills and sought help for side effects like bleeding.
Erin Morrow Hawley, a lawyer for the Alliance Defending Freedom, a conservative Christian organization representing the plaintiffs, said the doctors had “suffered concrete harm” because treating the women required them to divert medical resources they would have used for other patients and they sometimes had to act against their moral views and perform a surgical procedure after an incomplete medication abortion.
Lawyers representing the F.D.A. and a manufacturer of mifepristone, Danco Laboratories, argued that the plaintiffs did not have standing because the harm they claimed was several steps removed from the approval of mifepristone.
Jessica Ellsworth, a lawyer for Danco, said the claim required a scenario in which a “hypothetical patient” who chose to take abortion pills received them from an abortion provider, was “one of the very small number of patients with complications” and sought help from one of the plaintiffs instead of from the doctor who provided the medication.
“No court has found a doctor has standing based on a patient having a side effect from a drug another doctor has prescribed,” she said.
Whether mifepristone is unsafe
The plaintiffs’ lawyers contended that what they called “chemical abortion” causes “cramping, heavy bleeding and severe pain” and that the F.D.A. had never adequately evaluated the scientific evidence for safety.
“How many women must die or come close to death before the F.D.A. takes mifepristone off the market?” said Mr. Baptist, who is also with the Alliance Defending Freedom.
Lawyers for the F.D.A. and Danco said that bleeding and cramping were normal consequences of the process of terminating a pregnancy, a sign that the pregnancy tissue was being expelled. They cited years of scientific studies that show that serious complications are rare and that patients need hospitalization less than 1 percent of the time.
Ms. Straus Harris added that the F.D.A.’s approval “did not require anyone to prescribe or take mifepristone” and said that “it simply said we are giving our stamp that mifepristone is safe and effective.”
The lawyers also noted that mifepristone had been regulated much more strictly and studied more intensively than most other drugs because for years it has been under a framework of additional restrictions called a Risk Evaluation and Mitigation Strategy, or REMS, that has been used for only about 300 other drugs.
Whether the F.D.A. erred in approving mifepristone under the regulation it used
The hearing devoted a significant amount of time to discussing the regulation mifepristone was initially approved under. Called Subpart H, it allowed for approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses.”
“Pregnancy is not an illness,” Mr. Baptist said. A Justice Department lawyer, Daniel Schwei, said that pregnancy “can be life-threatening” for some patients and that the term “illness” was considered at the time to apply broadly to both diseases and conditions. He also said that in subsequent years, when mifepristone’s approval was transferred into the REMS program, the regulatory language explicitly included the term “condition.”
Mr. Baptist also said that because studies the F.D.A. used for the approval had involved doctors’ examining patients with ultrasound before prescribing mifepristone, the agency should have required ultrasound to determine whether patients were early enough in pregnancy to use the drug and to rule out ectopic pregnancies, a dangerous condition in which the embryo grows outside the uterus and cannot result in a live birth. Mr. Schwei countered that the F.D.A. had required that doctors determine pregnancy stage and rule out ectopic pregnancies but allowed doctors to use various methods, including ultrasound.
Whether the F.D.A.’s decision in 2021 to allow abortion pills to be mailed violates a law called the Comstock Act.
The plaintiffs lawyers said the 19th century law prevents the mailing of drugs used for abortions. The Justice Department said in a recent memorandum that the act only prohibits mailing the pills if the sender knows they will be used for an illegal abortion, not if the patient is in a state where abortion is legal.
Whether one side or the other made mistakes in the handling of two petitions that some of the same anti-abortion organizations filed with the F.D.A.
Both citizen petitions, filed in 2002 and 2019, were rejected by the F.D.A. as unfounded. The plaintiffs said that because the F.D.A. did not make a final decision on the 2002 petition until 2016, the delay helps justify the lawsuit because it suggests that the agency failed to take plaintiffs’ concerns seriously.
The F.D.A. said that the way the plaintiffs handled the petitions undercuts their lawsuit because the plaintiffs never complained about the delay at the time and the 2019 petition did not ask for mifepristone’s approval to be overturned.
Whether the judge should issue a preliminary injunction or take no action until after the full trial
Injunctions are typically used to preserve the status quo while a law or official action is being challenged. The preliminary injunction the plaintiffs seek in this case would do the opposite: upend longstanding government approval of a drug before the full challenge can be heard in court.
The judge signaled he might consider steps short of immediately ordering a withdrawal of the drug, such as ruling in favor of one or two of the plaintiffs’ claims.
The government lawyers said an injunction would hurt patients, health care providers and the public. Ms. Ellsworth said it would also cause “serious irreparable harm” to Danco, a small company which has no other product. She added that the plaintiffs have not shown the urgency of an injunction, given that the drug has been the standard of care for abortions for over two decades.
Lucinda Holt contributed reporting from Amarillo.