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The U.S. government as well as Danco Laboratories, the maker of a pill used in medication abortions, plan to appeal a Texas federal judge’s decision blocking the drug’s distribution nationwide.
The ruling by U.S. District Judge Matthew Kacsmaryk, an Amarillo-based appointee of former president Donald Trump, “rewrites the facts and the law to tell its preferred narrative – which is a storyline that conflicts with established legal principles” as well as mifepristone’s “well-established safety profile,” said Jessica Ellsworth, the Hogan Lovells partner serving as Danco’s lead counsel.
Kacsmaryk, who stayed the FDA’s September 2000 approval of the drug as well as its later modifications, allowed seven days for appeal before the decision takes effect.
While Kacsmaryk’s ruling has been widely criticized, the conservative-leaning 5th U.S. Circuit Court of Appeals, which would review the decision, upheld sharp restrictions on abortion even before the U.S. Supreme Court reversed Roe v. Wade, the 1973 decision that had guaranteed abortion rights nationwide.
Kacsmaryk’s decision came nearly concurrently with a ruling from the U.S. District Judge Thomas Rice of the Eastern District of Washington ordering the FDA not to alter the status quo regarding its approval of mifepristone pending the outcome of a lawsuit in Spokane. That ruling applied in 17 states and the District of Columbia.
The conflicting decisions set up a likely pathway to the U.S. Supreme Court, whose conservative justices – three of them appointed by Trump – just last year overturned Roe .
At that time, Justice Samuel Alito, writing for the majority in Dobbs v. Jackson, said decisions about the legality of abortion would be left to individual states.
“But now, Judge Kacsmaryk has made that decision for all us – you and me, for our mothers, daughters, sisters, aunts and friends, regardless of medical necessity or our personal religious and moral beliefs,” Joyce Vance, a University of Alabama Law professor and former federal prosecutor, wrote in a blog post.
“Soon we’ll find out if the court meant it when it said abortion would be up to the states,” she wrote, or if a single judge in Texas can “terminate people’s rights across America.”
Rice, the federal judge who issued the injunction preserving access to mifepristone, declined to apply his order outside the 18 jurisdictions that requested it.
A nationwide injunction would be inappropriate, he wrote, since abortion restrictions vary state by state and the “potential for competing litigation” is another bar.
Rice’s decision applies in Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota and Pennsylvania as well as the District of Columbia.
Along with seeking protection for mifepristone access, the states also asked Rice to broaden access by eliminating FDA restrictions that limit who can prescribe and dispense the drug and require documentation of patients’ use of it for abortions.
Keeping the necessary paper trail “puts both patients and providers in danger of violence, harassment and threats of liability amid the growing criminalization and outlawing of abortion in other states,” said the 18 attorneys general, among them many elected as Democrats.
‘No Basis in Medical Science’
“In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk,” Washington Attorney General Bob Ferguson said when the suit was filed in late February. “The FDA’s excessive restrictions on this important drug have no basis in medical science.”
Government attorneys representing the FDA touched on similar themes in a March hearing in the Amarillo, Texas, case.
“The public interest here would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” Julie Straus Harris, a trial lawyer with the U.S. Department of Justice, said in the hearing, a transcript of which CNBC posted on its website.
Introduced under the brand name Mifeprex, mifepristone is one of two drugs prescribed together in nonsurgical abortions and commonly referred to as the abortion pill. Mifepristone blocks progesterone, a hormone required for a pregnancy to grow. The second drug in the procedure, misoprostol, causes contractions that force the fetus from a pregnant woman’s uterus.
The Texas plaintiffs argued that an injunction taking mifepristone off pharmacy shelves is necessary because it was improperly approved by the FDA and poses significant health risks to women who use it.
“Mifepristone actually does not provide a medical benefit,” Erik Baptist, an attorney representing the Alliance for Hippocratic Medicine, argued in the hearing. “It is not a medication that treats any illness or disease.”
Instead, he claimed, its supporters “best” characterization of it is that it prevents complications in pregnancies “because it ends the life of an unborn baby before those complications present themselves.”
Since other medications and surgical procedures exist to address such complications, making mifepristone inaccessible wouldn’t cause any harm, said Baptist, senior counsel for the Scottsdale, Ariz.-based Alliance Defending Freedom.
‘Innocent Human Life’
As for women unable to obtain an abortion because they live too far from surgical providers, they shouldn’t take mifepristone in the first place because they would also be unable to get medical help for any complications that followed, he said.
Kacsmaryk’s ruling echoed many of those arguments.
“Considering FDA’s 2021 decision to permit ‘mail-in’ chemical abortion, many women and girls will consume mifepristone without physician supervision,” he wrote. “And in maternity-care ‘deserts,’ women may not have ready access to emergency care. In sum, there are fewer safety restrictions for women and girls today than ever before.”
While Kacsmaryk said the FDA’s failure to include more restrictions on mifepristone’s use has “resulted in many deaths and many more severe or life-threatening adverse reactions,” he declined to go as far in his order as plaintiffs sought. They had requested he “withdraw or suspend the approval of chemical abortion drugs” and remove them from the list of approved drugs, he noted.
Prior to the ruling, critics had accused the alliance and abortion-rights opponents of judge-shopping in the case by filing it in Amarillo, one of seven divisions of the Northern District of Texas, in which Kacsmaryk is the only jurist.
The former deputy general counsel for the First Liberty Institute, a Christian conservative legal group that takes on religious liberty cases, the judge used language favored by abortion-rights opponents to describe mifepristone in his ruling.
It’s a drug that “ultimately starves the unborn human until death,” he wrote. “Because mifepristone alone will not always complete the abortion, FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb.”
As a freshman in college, Kacsmaryk penned a 1996 letter to the editor of his school newspaper that described abortion as “federally sanctioned eradication of innocent human life.” The letter, earlier reported by The Washington Post, said the Democratic Party had “facilitated the demise of America’s Christian heritage.”
On Friday, President Biden characterized Kacsmaryk’s ruling as “the next step toward an abortion ban that Republican elected officials vowed to make law” and said it risked politicizing a variety of medications.
“The court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden wrote on Twitter. “That means if this ruling were to stand, there would be virtually no prescription approved by the FDA safe from this kind of attack.”
Fundamental freedoms ‘stripped away’
The American Medical Association, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine, the professional group for obstetricians specially trained in high-risk pregnancies, argued before Kacsmaryk’s ruling that the plaintiffs' position was ideological rather than scientific.
Mifepristone “is one of the most studied medications prescribed in the U.S. and has a safety profile comparable to ibuprofen,” the active ingredient in over-the-counter painkillers such as Motrin and Advil, they wrote in an amicus curiae brief.
“Serious side effects occur in less than 1% of patients and major adverse events – significant infection, blood loss or hospitalization – occur in less than 0.3% of patients,” the groups wrote. “The risk of death is almost non-existent.”
New York Gov. Kathy Hochul, who said she was alarmed by the decision, underscored Biden’s concerns about the potential public health impact.
“This unprecedented ruling not only overrides the FDA's evidence-based scientific approval process, it also alarmingly opens a new door to politicizing medicine,” she said. “Regardless of today's ruling, abortion access and care is still available in New York. For anyone who needs care, our state will welcome you with open arms.”
Neither New York nor California, whose governor also pledged to continue supporting abortion access, are covered under the decision in the Washington case.
“Abortion is still legal and accessible here in California,” Gov. Gavin Newsom said in a statement. “We won’t stand by as fundamental freedoms are stripped away.”