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 Wednesday. The wide-ranging hearing included a discussion about whether anti-abortion plaintiffs had the legal standing to sue the government and what kind of ruling it had the power to issue.
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 well aware of the unprecedented nature of the case, establishing through questioning that a court had never ordered the federal government to withdraw 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 doctors and anti-abortion groups, if they expected “the court itself could order a withdrawal or stay.” When the attorney, Erik Baptist, said yes, the judge responded, “What gives the court that authority?”
At another point in the session, the judge asked a Justice Department attorney representing the defendant in the case, the Food and Drug Administration, whether the fact that 22 conservative states had written a brief supporting the case of the plaintiffs demonstrated that repealing the abortion pill would be beneficial to public policy. The lawyer, Julie Straus Harris, responded: “An injunction here would interfere with every state in the country” and could make it more difficult to access abortion even in cases of non-viable pregnancies and rape.
That seemed to impress the judge, who noted, “This is not a case where we’re comparing 22 versus 28 states, but 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 those that try to restrict it. Medication is the method used in more than half of all abortions in the United States, and since last year’s Supreme Court ruling that struck down the nation’s right to abortion, pills have increasingly become the focus of political and legal battles.
The lawsuit against the FDA was brought by the Alliance for Hippocratic Medicine, a coalition of anti-abortion groups and four anti-abortion doctors. It seeks to undo the approval nearly 23 years ago of mifepristone, the first pill in the two-drug medical abortion regimen, and prevent the second drug in the regimen, misoprostol, which is used for several medical conditions, from being used for the abortion. .
The focus of the hearing was a request by the plaintiffs that Judge Kacsmaryk grant a preliminary injunction ordering the FDA to suspend approval of mifepristone or withdraw it entirely while the case progresses through trial.
As the hearing unfolded, a handful of abortion rights advocates chose the courthouse, some taunting 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 of Roe v. Wade, who previously worked for a conservative Christian legal organization, calmly asked all the lawyers detailed questions. He made occasional banter with the lawyers for both sides and at the end of the hearing praised both legal teams, saying “this was just a smorgasbord of excellent appellate grade work.”
More about abortion problems in the United States
The hearing covered a variety of topics, including:
Whether the plaintiffs have legal capacity to file the lawsuit.
Standing to sue requires plaintiffs to show that the approval of mifepristone has harmed them in some way. Lawyers for the plaintiffs argued that anti-abortion doctors have been negatively affected because they have treated some patients who took abortion pills and sought help for side effects such as bleeding.
Erin Morrow Hawley, a lawyer with 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 sometimes they had to act against their moral views and perform a surgical procedure after an incomplete medical abortion.
Lawyers representing the FDA and a manufacturer of mifepristone, Danco Laboratories, argued that the plaintiffs had no standing because the harm they claimed was several steps short of mifepristone’s approval.
Jessica Ellsworth, an attorney 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 a very small number of patients with complications” and I look for help. of one of the plaintiffs instead of the doctor who provided the medicine.
“No court has found that a doctor has standing based on a patient having a side effect from a drug another doctor prescribed,” he said.
If mifepristone is not safe
Lawyers for the plaintiffs argued that what they called a “chemical abortion” causes “cramps, profuse bleeding, and severe pain” and that the FDA had never adequately evaluated the scientific evidence of safety.
“How many women must die or be close to dying before the FDA removes mifepristone from the market?” said Mr. Baptist, who is also with Alliance Defending Freedom.
Lawyers for the FDA and Danco said bleeding and cramping were normal consequences of the pregnancy termination process, a sign that the pregnancy tissue was being expelled. They cited years of scientific studies showing that serious complications are rare and that patients require hospitalization less than 1 percent of the time.
Ms. Straus Harris added that the FDA approval “did not require anyone to prescribe or take mifepristone” and said that it “simply said that we are giving our seal that mifepristone is safe and effective.”
The lawyers also pointed out that mifepristone has been much more strictly regulated and studied more intensely than most other drugs because for years it has been under a framework of additional restrictions called Risk Assessment and Mitigation Strategyor REMS, which has been used to only about 300 other drugs.
Whether the FDA erred in approving mifepristone under the regulation it used
The hearing spent a significant amount of time discussing the regulation under which mifepristone was initially approved. Called Subpart H, it allowed the approval of drugs “that have been studied for their safety and effectiveness in the treatment of serious or life-threatening conditions.”
“Pregnancy is not a disease,” Mr. Baptist said. A Justice Department attorney, Daniel Schwei, said pregnancy “may be life-threatening” for some patients and that the term “disease” was considered to apply broadly to both diseases and conditions at the time. He also said that in subsequent years, when the approval of mifepristone was transferred to the REMS program, the regulatory language explicitly included the term “condition.”
Mr. Baptist also said that because the studies the FDA used for approval involved doctors examining patients with ultrasound before prescribing mifepristone, the agency should have required an ultrasound to determine if the patients were early enough in pregnancy to use the drug and rule out an ectopic pregnancy. pregnancy, a dangerous condition in which the embryo grows outside the uterus and cannot result in a live birth. Mr. Schwei responded that the FDA had required doctors to stage the pregnancy and rule out ectopic pregnancies, but allowed doctors to use various methods, including ultrasound.
Whether the FDA’s decision in 2021 to allow abortion pills to be mailed violates a law called the Comstock Act.
Lawyers for the plaintiffs said 19th-century law prevented the mailing of abortion medications. he Justice Department He said in a recent memo that the law only prohibits sending 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.
If one of the parties made errors in the handling of two petitions that some of the same anti-abortion organizations filed with the FDA
Both citizen petitions, filed in 2002 and 2019, were rejected by the FDA as unfounded. The plaintiffs said that because the FDA did not make a final decision on the 2002 petition until 2016, the delay helps justify the lawsuit because it suggests the agency did not take the plaintiffs’ concerns seriously.
The FDA said the way the plaintiffs handled the petitions undermines their lawsuit because the plaintiffs never complained about the delay at the time and the 2019 petition did not request that mifepristone’s approval be revoked.
Whether the judge should issue a preliminary injunction or take no action until after the full trial
Injunctions are generally used to preserve the status quo while a law or official action is being challenged. The preliminary injunction sought by the plaintiffs in this case would do the opposite: hold on to long-standing government approval of a drug before a full challenge can be heard in court.
The judge said he might consider short steps to immediately order the drug recall, such as ruling in favor of one or two of the plaintiffs’ claims.
Government lawyers said an injunction would harm patients, health care providers and the public. Ms Ellsworth said it would also cause “serious and irreparable damage” to Danco, a small company that 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 more than two decades.
lucinda holt contributed reporting from Amarillo.