U.S. District Judge Matthew Kacsmaryk’s decision to suspend the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone has cast doubt on future access to medical abortion across the country and set the grounds for a high-stakes battle in the Supreme Court.
The ruling, issued on Friday, will take effect at the end of this week unless a higher court intervenes. The Justice Department asked an appeals court to block it on Monday.
In interviews, several legal and medical experts said Kacsmaryk’s decision was unprecedented and clearly ideological. His language and reasoning, they said, faithfully reflected the arguments and concepts put forward by the anti-abortion movement, at the expense of scientific consensus in some cases.
The experts pointed to several key examples of the extreme nature of Kacsmaryk’s 67-page ruling, including his use of politicized terminology and his apparent endorsement of the controversial «fetal personality» idea. These are the parts the experts ruled were the most eye-catching.
Charged terminology: ‘chemical abortion’ and ‘human unborn’
Kacsmaryk, a Trump appointee, earlier in his career represented a conservative Christian legal group that sued the federal government challenging the part of the Affordable Care Act that required employers to provide free health-control insurance coverage. birth.
In his ruling on Friday, Kacsmaryk used several terms closely associated with the anti-abortion movement, according to the experts interviewed. In particular, Kacsmaryk referred to the two-pill regimen that is the most common way to terminate a pregnancy in the US as «chemical abortion,» rather than «medical abortion.» The plaintiffs in the lawsuit, a group called the Alliance for Hippocratic Medicine, use the same term in their presentations and messages.
«‘Chemical abortion’ is not a scientific or medical term at all. It’s something that has been used and propagated by those who want to ban or restrict abortion,» said Dr. Jenni Villavicencio, an OB/GYN leader at the American College of Obstetricians. and Gynecologists for the transformation of equity.
Villavicencio characterized «chemical abortion» as an «emotional» term intended to inspire fear about the risks of terminating a pregnancy.
He also noted Kacsmaryk’s references to a fetus as an «unborn human» or an «unborn child».
Kacsmaryk wrote that mifepristone «blocks the hormone progesterone, stops nutrition, and ultimately causes the unborn human to starve.»
Many pregnant women use the phrase «unborn child» to describe their experiences, Villavicencio said, but «it’s certainly not a scientific term, and it’s not a term that should be used when talking about science and medicine.»
Kacsmaryk’s language implies a belief about when life begins, a question that continues to trouble American society. Medical experts generally recognize around 24 weeks of gestation as the point at which a fetus can survive outside the womb.
The notion of ‘fetal personality’
Kacsmaryk’s references to an «unborn child» align with other parts of his decision in which he suggests that any potential «side effects» or «significant complications» caused by mifepristone should apply to both the pregnant woman and «the unborn human beings extinguished by mifepristone». .»
Such wording, the experts said, refers to the concept of «fetal personality»: the idea promoted by the anti-abortion movement that a fetus should be recognized as a person with constitutional rights from the moment of conception. Under that theory, which is opposed by many legal analysts and abortion rights advocates, an abortion would be considered murder.
“You won’t find any embryo terminology in the federal Constitution,” said Michele Goodwin, a law professor at the University of California, Irvine, adding: “You won’t find the term ‘fetus.’ You won’t find the term ‘unborn child’.»
‘Pregnancy is not a disease,’ plaintiffs say
The FDA approved mifepristone in 2000 under a regulatory provision called Subpart H, which allows for accelerated approval of drugs that studies have shown to be safe and effective for treating serious diseases. The provision was not used to expedite drug approval, the Kaiser Family Foundation recently reported, but to regulate who could dispense the pills and where. (At that time, mifepristone could only be administered by or under the supervision of a qualified physician.)
In her ruling, Kacsmaryk argued that Subpart H should not have applied to mifepristone because pregnancy is a «normal physiological state that most women experience one or more times.»
The plaintiffs made the same point in a post-decision statement.
«Pregnancy is not a disease, and chemical abortion drugs provide no therapeutic benefit… The FDA never had the authority to approve these dangerous drugs,» said Erik Baptist, a senior counsel at Alliance Defending Freedom, which represents claimants. .
But Mary Ziegler, a law professor at the University of California, Davis, and a historian who has studied the abortion debate in the US, rejected that premise.
«Obviously, people experience complications and deaths from pregnancy, especially in the United States, which has by far the highest maternal mortality rate in the developed world,» Ziegler said. (A National Center for Health Statistics report last month found that the US maternal mortality rate increased significantly in 2021 compared to the previous two years).
Villavicencio said that pregnancy can be thought of both as a natural state for women to experience and as a medical condition that requires specialized care.
«There’s a reason insurance covers it. There’s a reason you have doctors who train half their lives to treat people who are pregnant, because it’s absolutely a different condition than not being pregnant.» he said, and added. , «I think it really goes against the facts and understanding to suggest that it’s not a potentially dangerous condition.»
One key question: Do those challenging the FDA have the legal standing to sue?
In defending the FDA, Justice Department lawyers have questioned whether the group that filed the lawsuit has the ability to do so. To bring a lawsuit, a party must be able to show that they have suffered an injury.
Attorney Erin Morrow Hawley argued on behalf of the plaintiffs at a hearing last month that the approval of mifepristone hurt some doctors because it forces them, «against their deepest ethical, medical and religious convictions, to participate in and terminate abortions.» electives». «
Kacsmaryk agreed, concluding that «adverse events from chemical abortion medications can overwhelm the medical system and place ‘enormous pressure and stress’ on physicians during emergencies and complications.»
But Ziegler disputed that reasoning. Usually, at least one plaintiff needs a «specific injury to get on his feet,» she said, but in his opinion, «it doesn’t seem like we have one here.»
Then there’s the question of whether it’s too late to challenge the FDA’s approval 22 years later. Kacsmaryk said the plaintiffs can still sue because the FDA changed its rules on mifepristone in 2016 and 2021, thus reopening its approval to challenges.
It’s unusual legal reasoning, Ziegler said: «The judge basically had to go through a lot of hoops to get there.»