Antiabortion group says appeals court lacks authority to block Texas abortion pill ruling

The antiabortion group at the center of a legal fight over the abortion pill mifepristone told a U.S. appeals court that it does not have jurisdiction to block the Texas ruling which suspended the Food and Drug Administration's approval of the drug.

The Alliance Defending Freedom's lead attorney, Erik Baptist, argued in a new filing to the U.S. 5th Circuit Court of Appeals late Tuesday that the court lacks authority to grant the Justice Department's request to block the decision. The lawyer for the plaintiffs argued the court does not have jurisdiction because U.S. District Judge Matthew Kacsmaryk did not issue an injunction ordering the FDA to withdraw mifepristone.

Instead, Kacsmaryk unilaterally suspended the FDA's Sept. 28, 2000, approval of mifepristone pending further litigation. His decision is set to take effect a 12 a.m. central time on Saturday if the 5th Circuit does not block it. At that point, mifepristone would no longer be an approved drug in the U.S., which means it can't be distributed for abortions.

Baptist made a technical argument that Kacsmaryk's decision to suspend the approval date cannot be appealed to the 5th Circuit under federal law, in contrast to an injunction or a final court decision. He argued the case should continue to play out in the U.S. District Court for the Northern District of Texas.

"Accordingly, this Court should dismiss Defendants' appeal for lack of jurisdiction," Baptist argued.

The Justice Department, in its response Wednesday, said the Alliance Defending Freedom has cited no case holding that the type of order issued by Kacsmaryk cannot be appealed. The government's lawyers argued that Kacsmaryk's decision is equivalent to an injunction. They called on the 5th Circuit to immediately block the judge's order from going into effect early Saturday.

"The district court purported to be acting in a restrained manner; but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug," the Justice Department said. "If allowed to take effect, the court's order will cause irreparable harm across the country".

Danco Laboratories, the company that distributes mifepristone, said the Alliance Defending Freedom is using a "last-ditch argument" to keep Kacsmaryk's order in place. The group's claims reveal the weaknesses in the judge's order and in its own arguments against the drug's approval, Danco argued.

"A district court cannot shield its order from appellate review by using the word 'stay,'" wrote Danco's attorney Jessica Ellsworth in a filing to the 5th Circuit on Wednesday. "Nor did the court here try to. It understood the order was appealable and gave the parties seven days to seek emergency relief from this Court."

The Justice Department and Danco said in their motion to the 5th Circuit on Monday that they will ask the Supreme Court to intervene in the case if necessary.

The Alliance Defending Freedom sued the FDA in the U.S. Northern District of Texas in November, arguing the agency did not use the proper process to approve mifepristone in 2000. It also contended the medication is unsafe. Kacsmaryk embraced those claims in his ruling last week.

The FDA, at least 23 states, hundreds of members of Congress, leading medical associations, and drug law experts all strongly dispute the group's claims. They argue that the FDA approved mifepristone using its authority delegated by Congress, and that the evidence overwhelmingly demonstrates the medication is a safe and effective way to terminate an early pregnancy.

"There is no basis in science or fact for plaintiffs' repeated claims that mifepristone is unsafe when used in the manner approved by FDA," Justice Department lawyers wrote in their brief Wednesday. "Nor is there any basis in administrative law for the district court's unprecedented overriding of FDA's considered scientific judgment."

In addition to the Justice Department, nearly half the states in the U.S. have called on the 5th Circuit to block Kacsmaryk's ruling, warning the judge's order threatens abortion even in states that have protected access to the procedure in the wake of the Supreme Court's decision to overturn Roe v. Wade last summer.

Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions, according to the Centers for Disease Control and Prevention.

The Alliance Defending Freedom worked with Mississippi lawmakers to draft the law at the center of Dobbs v. Jackson Women's Health Organization. That case ultimately resulted in the Supreme Court overturning Roe v. Wade, the 1973 ruling that guaranteed abortion rights nationwide.

The Alliance Defending Freedom represents a group of physicians who oppose abortion called the Alliance for Hippocratic Medicine in the case against the FDA.