A Texas judge's abortion pill ruling was 'extraordinary' because it let doctors ban a drug they neither use nor prescribe, the DOJ said in a bid to reverse the decision

• The Justice Department filed an emergency motion seeking a stay on last week's abortion pill ruling.
• The department says the order banning mifepristone is "extraordinary" and legally flawed.

An "extraordinary and unprecedented" ruling last week that would allow a single judge to take an FDA-approved abortion drug off the market should be placed on hold while the Biden administration appeals the decision, lawyers for the Department of Justice argued in an emergency motion Monday.

Last Friday, a federal judge in Texas sided with anti-abortion activists and ruled that the Food & Drug Administration erred when it approved mifepristone more than two decades ago. Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, cited adverse side effects, including death, to argue that the drug is simply too dangerous to remain on the market — a conclusion opposed by all leading medical organizations, which have noted that mifepristone is safer than ibuprofen, Viagra, and pregnancy itself.

Kacsmaryk gave federal authorities a week to comply with his decision. The ruling came the same day as a separate decision from a Washington federal court that barred the FDA from taking "any action" that would limit access to mifepristone. The dueling rulings provoked uncertainty about the legal status of the drug.

In their 49-page response on Monday, DOJ lawyers asked the Court of Appeals for the Fifth Circuit to put Kacsmaryk's ruling on hold indefinitely during the appeals process, arguing that the case should never have been allowed to move forward in the first place.

"The district court erred in holding that plaintiffs have standing," the DOJ motion states. The plaintiffs in the lawsuit are a group of anti-abortion activists, including medical professionals, called the Alliance for Hippocratic Medicine. In order to bring their case forward, they needed to show they have been or could be personally harmed by the FDA's approval of mifepristone.

But anti-abortion doctors are neither in a position to use nor prescribe mifepristone, the DOJ said. Their argument, instead, relies on speculation — and absurdity: "that other doctors will prescribe mifepristone; that those doctors' patients will experience exceedingly rare serious adverse events; that those patients will then seek out plaintiffs — doctors who oppose mifepristone and abortion — for care; and that they will do so in sufficient numbers to burden plaintiffs' medical practice."

DOJ lawyers also said the case should be tossed because the activists waited far too long to bring their suit, since the FDA approved mifepristone in 2000.

Feds criticize anti-abortion study

In their filing, Justice Department lawyers also took aim at the sources Judge Kacsmaryk cited to justify his decision. In last Friday's ruling, Kacsmaryk disregarded the statements of the American Medical Association and other medical organizations — that mifepristone is generally safe when taken as directed. He instead cited what he described as "one study" that purportedly found 14% of those who took the drug reported they had "received insufficient information" about its side effects, including "potential negative emotional reactions like fear, uncertainty, sadness, regret, and pain."

But as Insider noted the day of the ruling, that study was in fact a textual analysis of online posts that purported to use "relational dialectics theory" to interpret the language choices of women writing about their experiences with medical abortions. The Justice Department, in turn, described the source as "an article" that was "based entirely on fewer than 100 anonymous blog posts submitted to a website titled 'Abortion Changes You.'"

The study was also a product of the anti-abortion movement. Its coauthor was listed as a staff researcher at the Charlotte Lozier Institute, a group based in Arlington, Virginia, that "advises and leads the pro-life movement," according to its website. The study's acknowledgments section begins by thanking the institute's president, among others, for providing "support and assistance throughout the entire research process."

In calling for a stay on the Texas decision, Justice Department lawyers argued there is no reason for the ruling to take immediate effect and "upend a decades-long status quo and inflict grave harm on women, the medical system, and the public."

Responding to the government's filing, a lawyer for the plaintiffs, Erin Hawley, issued a statement saying the Texas court correctly decided the case. "The FDA put women in harm's way, and the agency should be held accountable for its reckless actions," she wrote.

Have a news tip? Email this reporter: cdavis@insider.com