The U.S. Fifth Circuit Court of Appeals heard oral argument on Wednesday about the abortion drug mifepristone.
The case against the U.S. Food and Drug Administration, brought by a conservative group called the Alliance for Hippocratic Medicine, was first heard in Texas by Amarillo-based District Judge Matthew Kacsmaryk earlier this spring. Kacsmaryk ruled in favor of the plaintiffs, a group of doctors who say they have had to treat women in emergency room settings when a medication abortion has led to complications. The doctors say they have conscientious objections to caring for abortion patients. The group, who have been accused of “judge shopping” since they have no known relationship to Amarillo but filed suit there, claim the FDA’s approval process of mifepristone in 2000 was rushed to market too soon and that the FDA did so by calling pregnancy “an illness.” They want to see the drug removed from the market and restudied.
The U.S. Department of Justice, which argued the case on Wednesday, said the plaintiffs lack standing and that the case is time barred because the approval process took place 23 years ago.
The three judges who heard the FDA’s appeal on Wednesday, Judges Jennifer Walker Elrod, James Ho and Cory T. Wilson, have records of ruling against abortion groups in the past. Ho, a former Solicitor General for Texas, has been known for his inflammatory remarks about abortion care. President George W. Bush appointed Walker Elrod. President Donald Trump appointed both Ho and Wilson.
Legal and medical experts have called the case “unprecedented” because of over 100 studies that have shown mifepristone to be extremely safe, with less than 1 percent of complications. But Ho began by questioning the DOJ lawyer, Sarah Harrington, where she referred to the case as “unprecedented” in her legal briefing.
“I don’t understand the statement that the FDA can do no wrong,” Ho said.
Wilson brought up a concern that a provider in one state where abortion is legal could prescribe mifepristone to a patient in another state where abortion is not.
“The FDA didn’t consider an important part of the problem. It’s up to us to consider when they decide capriciously,” Wilson said.
Danco, the sole U.S. manufacturer of the mifepristone brand label, has joined the case in the FDA’s appeal. Danco’s lawyer, Jessica Ellsworth, argued that the company sees the suit as “an existential threat” to the company. Mifepristone is the only drug the company manufactures.
Walker Ellrod asked if Danco couldn’t, during the months of waiting for the court to make its decision, “pivot” its business to “something already approved” so that it would “not really be affected.”
Ellsworth said that would still require a process of seeking approval through the FDA and that “is not a light switch.”
When Kacsmaryk made his ruling in April, he put a stay on his own decision to give the FDA time to appeal to the Fifth Circuit Court of Appeals. The FDA did so and the Fifth Circuit initially made a midnight ruling that disagreed, in part, with Kacsmaryk’s decision to force the FDA to take the drug off the market. The Fifth Circuit, instead, initially ruled that the FDA had to take the drug back to its 2016 regulations.
The FDA then appealed to the U.S. Supreme Court which put a stay on the Fifth Circuit’s early decision. Jennifer Dalven, a reproductive rights attorney with the American Civil Liberties Union, said during a press conference on Monday that the Supreme Court’s stay will continue even if the Fifth Circuit rules after hearing oral argument in favor of the plaintiffs.
Dalven said the legal whiplash in April was “incredibly chaotic for patients and providers” but because of the Supreme Court’s stay “we should not be in that position we were in a few weeks ago,” if the Fifth Circuit rules in favor of the plaintiffs.
Currently, mifepristone, the first of the two-drug regimen for medication abortion, remains legal and available in New Mexico. New Mexico is one of 18 jurisdictions that were part of a separate lawsuit, filed in eastern Washington earlier this year. That lawsuit, decided by Washington District Court Judge Thomas Rice, protects New Mexico and the other jurisdictions from the vicissitudes of the Texas case still being decided. President Barack Obama appointed Rice.
But the Supreme Court is expected to weigh in on the divisive issue, although it may not take up the case until next fall, Dalven said. If that is the case, it may not announce its ruling until next summer, six months before the presidential election, she said.Some legal and medical experts worry about the various effects of the case, including that it could affect the manufacturing of the drug, while some experts have said that mifepristone will remain legal in New Mexico. One abortion provider told NM Political Report last month that fewer patients were requesting medication abortion.
