Federal appeals court says government’s defense of abortion pill ‘puzzling’

The 5th U.S. Circuit Court of Appeals heard arguments Wednesday from pro-life doctors over banning the abortion pill after the Supreme Court refused to impose limitations on its use — for now.

The three-judge panel, composed of all Republican appointees, appeared skeptical of the Justice Department’s argument that the pro-life doctors don’t have legal standing — or have not suffered sufficient injury — to challenge the Food and Drug Administration’s approval of mifepristone, a drug used to end pregnancies.

Judge Jennifer Walker Elrod, a Bush appointee, asked the federal government about one of the plaintiffs, a physician, who said she was forced to perform emergency surgery after a failed chemical abortion.

“She doesn’t ever say she was compelled to do that against her religious beliefs,” said Sarah Elaine Harrington, a lawyer representing the Justice Department and the FDA. “It’s pure speculation.”

She said hospitals could find other physicians who don’t have religious objections to abortions to help women in emergency situations.

Judge Elrod, though, called the government’s argument “puzzling.”

Judge James Ho, a Trump appointee, noted that doctors have historically been able to sue on behalf of patients. The plaintiffs, Alliance for Hippocratic Medicine, are a group of pro-life doctors who say they’ve seen women face health problems following the taking of mifepristone.

“Third-party standing is still a thing,” he said.

Ms. Harrington, meanwhile, also argued the challenge to the FDA’s approval of mifepristone is an attack on science.

But Judge Ho shot that down, noting challenges to the FDA aren’t unprecedented.

“I don’t understand this theme, the FDA can do no wrong,” he said.

Judge Cory T. Wilson, also a Trump appointee, was part of the three-judge panel reviewing the case.

Erin Hawley, senior counsel with the Alliance Defending Freedom which represents the pro-life doctors, said the physicians have conscious objections to being involved in abortions and emergency situations caused by the abortion pill. They’ve challenged the federal authorization of the drug.

“There is no question there is a substantial risk of harm,” she said. “Plaintiff-doctors have been forced to participate in and perform abortions.”

“The actions are directly traceable to the FDA’s unlawful actions in regulation … of mifepristone,” she said.

The 5th Circuit heard arguments for about two hours on Wednesday, less than a month after the Supreme Court issued an order keeping federal rules in place for using the abortion drug mifepristone while the legal battle moves through the court system.

The high court decided to lift restrictions on April 21 that had been ordered by lower courts as the case against mifepristone is weighed by the appeals court.

Although the case was heard Wednesday by the 5th Circuit, a decision was not immediately reached. It could be issued anytime by the panel.

Any ruling, though, is likely to be appealed again to the Supreme Court by either side.

The 5th Circuit had initially issued an emergency order limiting the use of the drug.

The Supreme Court’s move last month, though, erased limitations that included banning the drug from being mailed and only allowing it to be used up to seven weeks into pregnancy, instead of the FDA-approved 10 weeks.

The previous move by the 5th Circuit was less severe than the district court’s initial order.

District Judge Matthew Kacsmaryk, a Trump appointee, had first issued an order in the case, saying that the abortion pill can no longer be distributed because it was unlawfully authorized by the Food and Drug Administration.

He said the FDA could not continue to approve the pill in a case brought by pro-life advocates and physicians who argued that women have had grave health consequences from using the pill.

Judge Kacsmaryk said in his decision that the court “does not second-guess FDA’s decision-making lightly.”

“But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions,” he said.

The issue was then appealed all the way to the Supreme Court over the total ban and subsequent limitations — and the justices’ lifted them, which was seen as a temporary win for pro-choice activists.

Both the Justice Department and a producer of mifepristone, Danco Laboratories, have been fighting the lower court’s restrictions.

Jessica Lynn Ellsworth, who represented Danco Laboratories, said there’s no link between the plaintiff-doctors to any failed use of the abortion drug, suggesting — like the federal government — that they don’t have sufficient legal injury to bring the challenge to the FDA’s approval of the product.

“They have not identified in any way in which the stakes for them have changed,” she said.

“It got safer,” Ms. Ellsworth said of mifepristone.

“We view this case as essentially existential to our existence,” she said.

The drug was originally approved in 2000 for up to seven weeks of pregnancy. But it was not sent through the mail. Getting the drug required three steps: first a visit with a doctor to receive the mifepristone and then another one to get the drug misoprostol. A third visit with a doctor was required to address complications.

Later guidelines from the FDA said the drug could be used further into pregnancy and delivered to patients by mail, without doctor supervision.

The Biden administration says prohibiting the pill undermines science and is creating chaos in the courts. Officials have noted a separate district court in Washington approved the FDA’s regulation of mifepristone the same day that Judge Kacsmaryk blocked it.  

The Eastern District of Washington, in contrast to the Texas court, issued an order in a different lawsuit saying the FDA’s authorization of mifepristone was legal, approving the abortion pill’s production and distribution.