NEW ORLEANS — Federal appeal court judges in New Orleans heard arguments May 17 in a case to end the abortion pill mifepristone in the United States.

Erin Hawley, attorney for a group of anti-abortion doctors called the Alliance for Hippocratic Medicine Alliance, said the case “Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (and Danco Laboratories)” is not about ending abortion.

“It’s about ending a particularly dangerous type of abortion,” Hawley said. “I think the availability of other abortion procedures would mitigate much of that harm that we’re talking about.”

Hawley argued before conservative judges Jennifer Elrod, James Ho and Cory Wilson in the U.S. 5th Circuit Court of Appeals that the use of mifepristone has resulted in safety issues and sometimes results in the need for emergency room visits.

Elrod questioned if Hawley’s referenced data included actual emergencies and life-threatening situations or if those who have gone to to emergency rooms “just because they don’t know what to do or they’re confused.”

Hawley said her clients have testified in previous cases that the FDA’s deregulatory efforts of the pills, such as allowing mailed abortion pills, have increased the number of women they’re seeing. She argued that the FDA didn’t perform studies showing that the deregulation is safe, and that allowing mail-order abortion pills despite states’ rights to regulate abortion allows her clients to act in court.

Attorney Sarah Harrington, of the Department of Justice on behalf of the FDA, attested to the safety of mifepristone, stating that only 1% of cases involving mifepristone use result in emergencies requiring surgical follow-up. The drug is the most common form of abortion for up to 10 weeks of pregnancy.  

“Congress charged the FDA with considering whether a drug is safe and whether it’s effective. … I think FDA is charged with determining what is relevant for safety and efficacy, and it’s certainly not up to lawyers and judges,” Harrington said.  

Jessica Ellsworth, attorney for Danco Laboratories, which manufactures mifepristone, argued that none of the doctors’ statements or records evidenced the use of mifepristone in the patients they referenced.

“There was not a single statement in any of the declarations before you that identifies a declarant who treated a patient after that patient received FDA-approved mifepristone through a telemedicine appointment,” Ellsworth said. “There is not a single declarant who identifies a patient they treated because they had to because it was a rural patient who had no other option other than to go to an ER, so it all comes back to what’s in these declarations. The court needs to read them carefully and when it does, I think it will conclude that there is no standing.”  

Ho said defendants appeared to have a “recurring theme” that the FDA does not make errors. He cited recent litigation that resulted in the removal Makena, a drug the FDA approved more than a decade ago to treat preterm birth. He also noted blame the FDA has endured for the opioid crisis.  

“I don’t understand this theme the FDA can do no wrong. … Nobody should ever question the FDA. … This is unprecedented,” Ho said. “We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts.”

Throughout the two-hour hearing, Ho frequently referenced claims that the FDA incorrectly classified mifepristone in 2000 under Subpart H, which applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful, therapeutic benefit to patients over existing treatments, according to the Code of Federal Regulations.

But Harrington said plaintiffs’ argument against Subpart H is untimely, and that Subpart H is also applicable to serious conditions like pregnancy, and drugs for pain management and blood pressure issues are also under Subpart H.

Ultimately, Hawley said doctors face emotional harm by being forced to “clean up the aftermath of the abortion pill gone wrong’ despite their consciouses; however, Harrington argued that the doctors have not indicated in court documents that they have performed procedures in contravention or objection to their consciences at the time of the procedures.

“I believe being forced to be complicit in completing an elective chemical abortion would be an irreparable harm,” Hawley said. “… The doctors talk about the heartbreaking toll that treating post-abortive women suffering grief and complication causes. There’s a lot of evidence in the record about the harm to their medical practice. They talk about emergency and chaos in the emergency room.”

Hawley said doctors feel compelled to treat women, and the nature of a conscious objection would not require them to say it.

“Dr. Francis says that plaintiff doctors with ethical, medical and conscious objections to abortion will, ‘… be forced to participate in completing unfinished elected and chemical abortions.’ … They allege that they feel complicit in an elective abortion by being forced to complete that procedure,” she said.

Wilson suggested that doctors with conscious objections could pass off the patient to another doctor who doesn’t have the same objection.

“The approval of any drug that triggers a conscience concern in the part of a doctor gives that doctor standing to bring a suit and challenge the approval,” Wilson said.

Elrod implied that there is harm for all involved in deciding on the case, including Danco Laboratories, which could loose business if mifepristone is banned.

“I don’t want to minimize their situation, but people who are in sexually abusive relationships and they file briefs on both sides of this. There’s one group who says, ‘Well, if you can’t see the doctor you’re not going to get away from the being abused or human trafficked.’ And there’s the other group who says, ‘If you don’t give them the pill by mail then they will never get away because they will be trapped by the abuser.’ … And these are serious societal issues. … Do we take that into consent consideration at all in deciding the balance of equities here, and how do we decide that?”

Elrod also questioned Hawley’s public comments about a Texas district court’s ruling to ban mifepristone, saying that the now pending decision “defied long standing precedent” and the court’s injunction was an “unprecedented judicial assault.” 

“That’s an unusual remark,” Elrod said. “This is much more kind of remarks towards the district court that we normally don’t see from learned counsel.”