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Fifth Circuit hears arguments in abortion pill case

Three conservative judges with a history of rulings restricting abortion access signaled they will side with a group of doctors challenging the approval of an abortion drug.

(CN) — The Biden administration and counsel for anti-abortion doctors aiming to get mifepristone off the market cited conflicting statistics about the drug's safety in a two-hour hearing Wednesday before the Fifth Circuit.

The parties sparred over a key fact issue. Counsel for the government said the rate of serious complications for women taking mifepristone is less than 1%.

But the plaintiffs’ attorney said it was unclear where they got that number. She observed that the current FDA medication guide for the drug, updated in January, states that between 2.6% and 4.9% of women will present to an emergency room.

Mifepristone causes miscarriages by blocking a hormone called progesterone that readies the uterus to carry an embryo. In the U.S., it is typically prescribed in tandem with misoprostol.

Misoprostol, which can induce abortions but is not as effective as the two-pill regimen, is taken 24 to 48 hours after mifepristone and causes contractions that clear the uterus.

According to Danco Laboratories LLC, the maker of mifepristone which has intervened as a defendant in the case, and the government, mifepristone is safer than most drugs and pregnancy itself with only five deaths for every 1 million uses.

By comparison, the U.S. Centers for Disease Control and Prevention says the maternal mortality rate in the United States for 2021 was 39.2 deaths per 100,000 live births. 

The method has become preferred over surgeries in recent years. In 2020, 53% of the more than 900,000 abortions in the U.S. were done by pill, rising from 39% in 2017.

Sarah Harrington, a Justice Department attorney representing the Food and Drug Administration and its commissioners, opened her arguments by calling U.S. District Judge Matthew Kacsmaryk’s April 7 order rejecting the FDA’s approval in 2000 of mifepristone an “unprecedented and unjustified attack on the FDA’s scientific expertise.”

U.S. Circuit Judge James Ho, a Donald Trump appointee and former clerk for Supreme Court Justice Clarence Thomas, challenged that statement.

He noted that just last month the FDA had withdrawn approval of a drug meant to reduce to risk of preterm birth for women with a history of going into labor before their babies reach full-term.

“The FDA can make that determination based on exercising its own scientific expertise,” Harrington replied. “But it’s not a court’s role to come in and second-guess that expertise and no court has ever done that.”

Ho urged Harrington to focus on the facts of the case “rather than have this sort of FDA-can-do-no-wrong theme.”

The plaintiffs are anti-abortion doctors and national medical associations. They filed the lawsuit in November 2022 in Amarillo federal court, claiming the FDA had violated the Administrative Procedure Act with its initial approval of mifepristone and by easing access to the drug in 2016, 2019 and 2021.

Throughout the two-hour hearing, the three judges on the panel and attorneys focused on whether Kacsmaryk had improperly determined plaintiffs have standing to challenge the FDA.

Harrington stressed that in declarations submitted for the case plaintiff doctors never said that over their religious or conscience objections they had been forced to do emergency abortions on women who needed procedures after taking mifepristone.

"And it would be surprising if they could allege that because they have robust conscience protections in federal and state law," she added.

U.S. Circuit Judge Jennifer Walker Elrod, a George W. Bush appointee, pointed to a declaration in which a physician stated she had performed surgery on at least 12 women after a failed chemical abortion, sometimes including removing the embryo or fetus. "Is that not akin enough, removing the embryo or fetus in a surgical proceeding?" Elrod asked.

"It doesn’t ever say she was compelled to do that against her religious beliefs," Harrington said.


U.S. Circuit Judge Cory Wilson, another Trump appointee, focused on changes the FDA has made to standards for prescribing the drug.

In 2016, the agency changed the window it could be prescribed from 7 to 10 weeks of gestation, got rid of the requirement for an in-person follow-up exam, allowed nondoctors to prescribe so long as they had prescription authority in their home states, nixed the mandate that misoprostol be administered in person and changed the dosages of both drugs.

The FDA approved a generic version of mifepristone in 2019, a move Kacsmaryk also deemed unlawful.

In 2021, spurred by the pandemic, the FDA allowed mifepristone to be dispensed via mail. Kacsmaryk took particular issue with the mailing of mifepristone. He determined the Comstock Act of 1873 bars the mailing of abortion drugs.

And just this year, the FDA revoked a rule against retail pharmacies filling mifepristone prescriptions.

Wilson said it seems to him the FDA has "made it much more likely that the patients are going to go to an emergency room or a medical clinic where one of these [plaintiff] doctors" is on the staff.

"I don’t think any of that is right," Harrison said.

She noted even if a woman gets her prescription from a retail pharmacy their doctor is still available to provide them follow-up care. And, she went on, when the drugs don't end a pregnancy in the first 14 days after the woman takes them they take a second dose of misoprostol that "works in something like in 95% of those cases."

In the rare instance when a woman needs follow-up surgery, Harrington continued, if their physician is not qualified to do it, they are required by the FDA to have a plan in place before writing the prescription, identifying a doctor who can do the surgery.

Representing Danco, Jessica Ellsworth with the Washington office of Hogan Lovells, also attacked the plaintiffs' standing.

She said the declarations submitted by the plaintiff doctors purporting to show they have treated patients suffering complications from mifepristone are vague, they don't say the physician personally provided the care or when the event occurred.

"In the few cases they give detail it’s care that someone else provided," Ellsworth stated. "It is drugs that came from India, those are not FDA approved drugs. And it is patients who had contraindications. That again is not traceable in any way to FDA."

She said only two declarants identified specific care they gave to a patient who had taken FDA-approved mifepristone in accord with the agency's guidance and they practice in Texas and Indiana.

After the Supreme Court's June 2022 ruling in Dobbs v. Jackson Women's Health Organization striking down a constitutional right to abortion, Texas barred abortions except for when the mother's life is at stake.

In Indiana, medication abortion pills must be dispensed in person and taken on site.

"So even if they alleged one patient they actually cared for at some time in the past," Ellsworth said, "we now live in a world where the availability of abortion in Texas and Indiana is quite different than it was prior to Dobbs. That matters when what this court is tasked with is determining whether there is a certainly impending injury."

Judge Elrod offered Ellsworth a chance to apologize. Elrod said she was surprised at statements she perceived as personal attacks on Judge Kacsmaryk in Danco's brief for Wednesday's expedited hearing.

"There are comments 'the district court defied longstanding precedent,' 'the court's injunction was an unprecedented judicial assault,' ‘the court’s relentless one-sided narrative,’ . . . ‘bending every settled rule,'" Elrod said.

"I was wondering if you hadn’t been given more time and not been under a rush and probably exhausted from this whole process, would those statements have been included in your brief? Or do you want to say anything about that?" she asked.

Ellsworth replied the remarks were not intended as a personal attack on Kacsmaryk but on his analysis. "I certainly think with more time we may have ratcheted down some of that…this is a case that has been litigated at breakneck speed," she said.

Kacsmaryk is a former federal prosecutor and general counsel of First Liberty Institute, a Christian conservative legal organization that advocates for religious liberty.

Following his order, the Biden administration and Danco sought a stay from the Fifth Circuit pending appeal.

A three-judge panel of the court stayed his injunction against the FDA’s initial approval of the pill, agreeing with the Biden administration that after 23 years it was too late to challenge it.

But they let the injunction stand against the FDA’s decisions to broaden its use from 7 to 10 weeks into a pregnancy and allow it to be distributed by mail.

Danco and the government secured a stay of the lower courts' orders from the Supreme Court on April 21, returning the drug’s availability to the status quo as it was before Kacsmaryk’s injunction.

The plaintiffs' counsel, Erin Hawley of the Alliance Defending Freedom, argued Wednesday the FDA had put politics over women's health when it approved mifepristone, and got it approved by mislabeling pregnancy an "illness."

Mifepristone was approved under Subpart H — an accelerated process for drugs for serious or life-threatening illnesses. The challengers claim pregnancy should not qualify. 

Hawley argued the FDA erred with its green-lighting of mifepristone in 2000 and changes to the drug's prescription standards in 2016 because it relied on studies that had "crucial safeguards like ultrasounds and 14-day follow-up visits" only to turn around and approve the drug without those necessary safeguards.

Judge Elrod asked Hawley to explain why the plaintiffs have standing.

Hawley ticked off several factors. She argued they have established it by being forced to be complicit in abortions, resulting emotional harms and the "heartbreaking toll" of treating women with grief complications.

She also claimed the plaintiff doctors associations had been forced to divert resources. "If not for the FDA's approval of mifepristone, they would be engaged in other activities . . . protecting life at every stage and advocating for an end to abortion," she said.

The judges gave no timeline for a ruling. Experts say whoever they rule against will likely appeal to the Supreme Court and its all but guaranteed the case will go back before the high court.

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