Health Law

One mifepristone decision 'runs roughshod’ over procedural issues, the other 'is no better,' law profs say

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Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama, on March 16, 2022. The drug was approved by the Food and Drug Administration in 2000. Photo by Allen G. Breed/The Associated Press.

At least one law professor has said the competing abortion pill decisions issued Friday suffer from the same defect: The plaintiffs lack standing.

Writing at the Volokh Conspiracy, Jonathan H. Adler, a professor at the Case Western Reserve University School of Law, noted the “amazing coincidence” of two decisions on mifepristone being released on the same day.

The Washington Post and the New York Times covered the decisions Friday.

In Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, U.S. District Judge Matthew J. Kacsmaryk of the Northern District of Texas stayed the FDA’s 2000 approval of the drug but said his opinion won’t take effect for seven days to allow the government to seek emergency relief. Kacsmaryk is an appointee of former President Donald Trump.

“The court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “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. There is also evidence indicating FDA faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”

In State of Washington v. U.S. Food and Drug Administration, U.S. District Judge Thomas Rice of the Eastern District of Washington enjoined the FDA from changing the status quo regarding the availability of mifepristone in the 18 jurisdictions that sued: 17 states and the District of Columbia. Rice is an appointee of former President Barack Obama.

Experts who see standing problems with Kacsmaryk’s decision include Adler; Steve Vladeck, a professor at the University of Texas School of Law; and Adam Unikowsky, a lawyer at Jenner & Block.

“The ruling runs roughshod over an array of procedural obstacles,” Vladeck wrote at his One First newsletter, “including the plaintiffs’ lack of standing and some fairly serious statute-of-limitations problems.”

According to Adler, the standing analysis “rests on outlier decisions,” while the opinion’s “embrace of an expansive conception of equitable tolling and refusal to enforce the administrative exhaustion requirement rest on the most gossamer of threads.”

The plaintiffs in Kacsmaryk’s case are organizations of anti-abortion doctors. To establish standing, Unikowsky wrote at Adam’s Legal Newsletter, they must show that they personally face an imminent risk of concrete and particularized injury.

“Vague speculation that someday, somewhere, some unspecified doctor will be ‘overwhelmed’ by an onslaught of patients coming to the ER” doesn’t satisfy that standard, he said.

Kacsmaryk also relied on allegations that doctors may have to be made “complicit” in an “elective chemical abortion” by forcing them into a situation in which they “need to remove a baby with a beating heart or pregnancy tissue as the only means to save the life of the woman or girl.” According to Unikowsky, “it’s absurd to suggest that this is a ‘certainly impending’ outcome for these doctors.”

Kacsmaryk also cited a study to establish that the physician-patient relationship is harmed because the physicians can’t receive informed consent from the women they treat. According to Kacsmaryk, the study showed that 14% of women and girls report having received insufficient information about the side effects of mifepristone, the severity of cramping and bleeding that they will experience, and their potential negative emotional reactions.

Unikowsky countered that the study is actually “an analysis of anonymous blog posts on a pro-life website.”

Kacsmaryk also said the medical association plaintiffs have associational standing from their members’ third-party standing to sue on behalf of their patients. But third-party standing, Unikowsky said, “is something that plaintiffs sometimes have to show in addition to—not instead of—Article III standing,” which requires a concrete and particularized injury caused by the defendants that can be redressed with the requested relief.

Rice’s decision in the suit by the 17 states and the District of Columbia “is no better,” Adler said.

The plaintiffs “face equivalent jurisdictional hurdles in demonstrating standing and exhaustion, particularly insofar as they were suing to maintain the status quo (as opposed to challenging the FDA’s existing mifepristone rules as too restrictive). The Washington district court barely engages these arguments, waiving them away with conclusory statements unaccompanied by any meaningful analysis.

“It is enough to make a cynical observer think that the opinion was rushed for release, perhaps explaining the coincidental timing,” Adler wrote.

See also: “Can court ban abortion pill? Federal judge considers authority, plaintiffs’ standing”

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