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1st hearing set in abortion pill case
Judge took steps to delay public notice, some sources allege
The federal judge in a closely watched lawsuit that seeks to overturn federal approval of a widely used abortion pill has scheduled the first hearing in the case for this week, but he planned to delay making the public aware of it, according to people familiar with the case.
Judge Matthew Kacsmaryk, of the Northern District in Texas, told lawyers in the case Friday that he was scheduling the hearing for Wednesday morning. However, he asked them not to disclose that information and said he would not enter it into the public court record until late Tuesday evening.
One person familiar with the case, which is being heard in federal court in Amarillo, Texas, said such steps were “very irregular,” especially for a case of intense public interest.
Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade and previously worked for a Christian conservative legal organization, told lawyers in a conference call Friday that he did not want the hearing to be “disrupted,” and that he wanted all parties involved to share their points in an orderly fashion, according to people familiar with the discussion.
The judge also said that court staff had faced security issues, including death threats, and that the measure was intended to keep the court proceedings safe.
The lawsuit, filed in November against the Food and Drug Administration by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of medications for abortion.
The plaintiffs, led by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members, have asked the judge to issue a preliminary injunction ordering the FDA to withdraw its long-standing approval of mifepristone, the first pill in the two-drug medication abortion regimen.
At the hearing, lawyers representing the plaintiffs, the FDA and a manufacturer of mifepristone will present arguments for and against an injunction. It is unclear if the judge will decide whether to issue an order that day or sometime later.
Such an order would be unprecedented, legal experts say, and — if higher courts were to allow an injunction to stand — would make it harder for patients to get abortions in states where abortion is legal, not just in those trying to restrict it.
Medication abortion is used in more than half of abortions in the United States. That proportion has been increasing as conservative states impose abortion bans or sweeping restrictions in the wake of the Supreme Court’s decision to overturn the national right to abortion last June.
The Washington Post earlier reported on the Friday call and upcoming hearing.
In asking the lawyers to keep quiet about the hearing, the judge did not issue a gag order, which would bar the participants on the call from sharing the information. Rather, he asked them to keep the information secret “as a courtesy.”
He said that the court would provide seating for the public and the press, but his plan to provide little advance notice seemed likely to have the practical effect of minimizing the number of people who would attend, according to people familiar with the discussion. Amarillo, in the Texas Panhandle, is several hours’ drive from other major Texas cities, and only a couple of those cities provide direct flights.
On Friday, the public court record showed subtle signs that something unusual had occurred. That morning, the first new entry in 10 days was added to the case’s docket: a notice of appearance for a Justice Department lawyer, a standard document usually added to a case in advance of an upcoming proceeding, but the docket did not show any proceeding.
In addition, there was a gap in the numerical listing of documents in the docket — Document 124 was missing — suggesting that a recent entry had been sealed. People familiar with the case said the sealed document referred to the Friday meeting between the judge and the lawyers.
The lawsuit claims that the FDA did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.
The lead plaintiff, the Alliance for Hippocratic Medicine, was incorporated in August in Amarillo, shortly after the Supreme Court overturned Roe v. Wade. Kacsmaryk is the only federal judge covering the Amarillo division in the court’s Northern District.
The FDA and the Department of Justice have strongly disputed the lawsuit’s claims and said the FDA’s rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve the drug, which blocks a hormone that allows a pregnancy to develop. In a court filing, the FDA said that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”
If the judge issues a preliminary order to bar access to mifepristone, the federal government is expected to immediately appeal and to seek a stay of the injunction while the trial proceeds.
Legal experts said that even if the preliminary injunction remained in place, there were several legal options that could allow the manufacturers of mifepristone to continue supplying the drug and providers to continue prescribing it to patients.
If legal access to mifepristone is blocked, some abortion providers plan to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries. Misoprostol, which is approved for other medical uses, causes contractions similar to a miscarriage and is considered slightly less effective on its own than in combination with mifepristone and more prone to cause side effects such as nausea.
In the lawsuit, the plaintiffs also seek to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Many patients would also likely still be able to order both mifepristone and misoprostol from telemedicine abortion services based in other countries.
Still, such a ruling would create confusion and difficulty for patients and providers nationwide. Legal experts said that it would also be the first time that a court had acted to order that a drug be removed from the market over the objection of the FDA and that if such a ruling stood, it could have repercussions for federal authority to regulate other types of drugs.