AMARILLO, Texas — The judge in a closely watched lawsuit aimed at overturning federal approval of a widely used abortion pill publicly questioned attorneys for the first time Wednesday. The wide-ranging hearing included a discussion of whether anti-abortion activists had legal authority to sue the government and what kind of judgment he could issue.
The judge, Matthew J. Kacsmaryk of the Northern District of Texas, said he would decide as soon as possible whether to issue an injunction that could at least temporarily take the pill mifepristone off the market. He seemed aware of the unprecedented nature of the case and, through his questions, found that no court had ever ordered the federal government to revoke a drug that had been legally available for years.
Toward the end of the more than four-hour court session, Judge Kacsmaryk asked a lawyer for the plaintiffs, a coalition of anti-abortion doctors and doctors, whether they expected “the court itself to be able to order a resignation or a suspension.” When attorney Erik Baptist said yes, the judge replied, “What gives the court this 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 in support of the plaintiffs’ case showed that revocation of the abortion pill would be beneficial to public policy. Attorney Julie Straus Harris replied, “An injunction here would upset every state in the country” and could make access to abortion more difficult even in cases of nonviable pregnancy and rape.
That seemed to impress the judge, who noted, “This isn’t a case where we’re comparing 22 states to 28 states, it’s all 50 states, especially in some of these other circumstances, isn’t it?”
The hearing was the first public hearing in a case that could have far-reaching ramifications for states where abortion is still legal, not just those trying to restrict it. Drugs are the method used in more than half of abortions in the United States, and since the Supreme Court’s ruling last year overturning the national right to abortions, the pills have increasingly become the focus of political and human rights legal disputes.
The lawsuit was filed against the FDA by the Alliance for Hippocratic Medicine, a coalition of anti-abortion groups and four anti-abortion doctors. It is trying to de-authorize mifepristone nearly 23 years ago – the first pill in the two-drug abortion regimen – and prevent the second drug in the regimen, misoprostol, which is used for several conditions, from being used for abortion.
The hearing focused on plaintiffs’ request for an injunction from Judge Kacsmaryk ordering the FDA to either stay or withdraw approval of mifepristone outright while the case is still at trial.
While the hearing was underway, a few pro-choice advocates demonstrated outside the courthouse, some mocking the judge by wearing clown wigs and kangaroo suits. A group of women supporting the lawsuit prayed on the steps of a building across the street. There were no large gatherings of people.
Judge Kacsmaryk, a Trump agent critical of Roe v. Wade, who previously worked for a Christian conservative legal organization, calmly asked detailed questions to all of the attorneys. He occasionally joked with attorneys on both sides and at the end of the hearing commended both legal teams, saying that “this was just a hodgepodge of excellent work at the appeal level.”
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The hearing covered a range of topics including:
Whether the plaintiffs have legal authority to bring the action
In order to sue, plaintiffs must show that the approval of mifepristone hurt them in some way. The plaintiffs’ attorneys argued that the anti-abortion doctors were adversely affected because they had treated some patients who had been taking abortion pills and sought help for side effects such as bleeding.
Erin Morrow Hawley, an attorney for Alliance Defending Freedom, a conservative Christian organization representing the plaintiffs, said the doctors “suffered tangible harm” because the women’s treatment required them to divert medical resources they used for others patients would have used and they sometimes had to act against their moral standards and perform surgery after an incomplete medical abortion.
Attorneys representing the FDA and a manufacturer of mifepristone, Danco Laboratories, argued that the plaintiffs had no standing to sue because the harm they allege was several steps away from 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 the very few patients with complications” and Help sought from one of the plaintiffs rather than the doctor who provided the drug.
“No court has found that a doctor has a claim based on an adverse reaction to a drug prescribed by another doctor,” she said.
Whether mifepristone is unsafe
Plaintiffs’ attorneys claimed that what they called a “chemical abortion” caused “convulsions, profuse bleeding, and severe pain” and that the FDA had never adequately assessed the scientific evidence of safety.
“How many women have to die or be near death before the FDA takes mifepristone off the market?” said Mr. Baptist, who is also with the Alliance Defending Freedom.
Attorneys for the FDA and Danco said bleeding and cramping are normal consequences of the abortion process, a sign that pregnancy tissue is being expelled. They cited years of scientific studies showing that serious complications are rare and 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,” saying that “it simply says that we are putting our stamp on mifepristone as being safe and effective.”
The attorneys also noted that mifepristone has been much more tightly regulated and studied than most other drugs because it has been under a framework of additional restrictions called the Risk Evaluation and Mitigation Strategy (REMS) for years, and has only been used for approximate purposes 300 other drugs.
Whether the FDA made a mistake in approving mifepristone under the regulation they used
The hearing devoted considerable time to discussing the regulation under which mifepristone was originally approved. Called Subpart H, it allowed the approval of medicines “that had been evaluated for their safety and efficacy in the treatment of serious or life-threatening diseases.”
“Pregnancy is not a disease,” Baptist said. A Justice Department attorney, Daniel Schwei, said that pregnancy “can be life-threatening” for some patients and that the term “disease” at the time applied to diseases and conditions in general. 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 the agency should have requested ultrasounds to determine if the patients were early enough in pregnancy to use the drug and to rule out tubal disease because of the studies the FDA used for approval , patients had had ultrasounds before prescribing mifepristone Pregnancies, a dangerous condition in which the embryo grows outside the uterus and cannot result in a live birth. Mr. Schwei countered that the FDA required doctors to stage the pregnancy and rule out ectopic pregnancies, but allowed doctors to use various methods, including ultrasounds.
Whether the FDA’s decision in 2021 to allow abortion pills to be shipped violates a law called the Comstock Act.
Lawyers for the plaintiffs said the 19th-century law banned the shipping of drugs used for abortions. The Justice Department said in a recent memorandum that the law prohibits the pills from being mailed unless 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 handling two petitions filed with the FDA by some of the same anti-abortion organizations
Both citizen applications, filed in 2002 and 2019, were rejected by the FDA as baseless. The plaintiffs said that because the FDA did not make a final decision on the 2002 petition by 2016, the delay helps vindicate the lawsuit as 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 at the time, the plaintiffs never complained about the delay and the 2019 petition did not ask for mifepristone’s approval to be overturned.
Whether the judge should issue an injunction or only act after the full trial
Injunctions are typically used to maintain the status quo while a law or regulatory action is challenged. The injunction the plaintiffs are seeking in this case would do the opposite: overturn a drug’s long-standing state approval before the full challenge can be heard in court.
The judge signaled that he might consider other steps to not immediately order withdrawal of the drug, such as ruling in favor of one or two of the plaintiffs’ claims.
Government lawyers said an injunction would harm patients, healthcare providers and the public. Ms Ellsworth said it would also cause “serious irreparable damage” to Danco, a small company that has no other product. She added that the plaintiffs have not shown the urgency of a restraining order because the drug has been the standard of care for abortions for over two decades.
Lucinda Holt provided reporting from Amarillo.
Pam Belluck and Allison McCann