UPDATE: Thursday, Apr 13, 2023 · 4:10:19 PM +00:00 · Joan McCarter
Attorney General Merrick Garland just issued this statement: “The Justice Department strongly disagrees with the Fifth Circuit’s decision […] to deny in part our request for a stay pending appeal. We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgement and protect Americans’ access to safe and effective reproductive care.”
A three-judge panel on a federal appeals court ruled late Wednesday to lift a ban on the abortion pill mifepristone, but reinstated outdated and medically unnecessary restrictions on its use and access. It would limit the use of the drug to the seventh week of pregnancy and bar it from being distributed by mail.
That’s a partial stay of the district court ruling from extremist judge Matthew Kacsmaryk that would have reversed the Food and Drug Administration’s 20-year-old approval of the drug. The panel of two Trump judges and one George W. Bush appointee made clear that they were only reversing Kacsmaryk on a technicality. “At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.”
Then they played doctor and overruled the FDA, imposing their own restrictions on the drug. In 2016, the FDA allowed for the drug to be used up to 10 weeks gestation and for it to be prescribed by some providers other than doctors. During the COVID-19 pandemic, the FDA temporarily allowed the drug to be available by mail, then made that permanent this year.
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The judges agreed with Kacsmayk that the 1873 Comstock Act, an “anti-vice” law that has been dormant since the Supreme Court’s Griswold decision in the 1960s, applied here. That 19th-century law prohibited the distribution of contraceptives, “lewd” writings, and any “instrument, substance, drug, medicine or thing” that could be used in an abortion.
“To the extent the Comstock Act introduces uncertainty into the ultimate merits of the case, that uncertainty favors the plaintiffs,” the court said, writing that “merely by knowingly making use of the mail for a prohibited abortion item” violates the outdated law.
An 18th-century law thus overrides the 21st-century determinations of the FDA. The appeals court’s application of this law is also flawed in imposing the ban on states where abortion is legal. As the Department of Justice argued in a recent memo, the act prohibits mailing the pills only if the sender knows they would be used for an illegal abortion, not a legal one in states where abortion is legal.
The judges made very clear that they are with forced birth extremist Kacsmaryk and the anti-abortion plaintiffs, echoing the totally unscientific language of abortion opponents in calling medication abortion “chemical abortion” and referring to an embryo as “an unborn child.” The judges agreed with the plaintiffs' assertion that the drug is unsafe, causing “cramping, heavy bleeding and severe pain,” and said that the FDA “cannot deny that serious complications from mifepristone” are possible, raising the question of whether they know what happens in pregnancy and childbirth.
They also took issue with the FDA’s argument that they drug is comparable in safety to ibuprofen. “FDA’s own documents show that mifepristone bears no resemblance to ibuprofen,” the court said, which was not the point the FDA made in that comparison. Because no one would take ibuprofen for an abortion or mifepristone for a headache.
The judges also swept aside the Department of Justice's argument on whether the plaintiffs had any business bringing the suit in the first place by lying about it. They said that “as a result of FDA’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects. This harm is sufficiently concrete.” They added that the plaintiffs “also face an injury from the irreconcilable choice between performing their jobs and abiding by their consciences.”
But the doctors bringing the suit, the DOJ pointed out, didn’t prescribe the drug and were arguing that the harm was that they might someday be faced with treating a patient having dangerous side effects from it. The DOJ argued in their brief to the appellate court that that’s pure speculation “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.”
Which, by the way, is a doctor’s job. To treat patients no matter what causes their symptoms.
The Biden administration will certainly appeal the decision to the U.S. Supreme Court. The issue is complicated by another conflicting ruling from Judge Thomas O. Rice in the Eastern District of Washington issued the same day as Kacsmaryk’s decision.
Rice ruled for 17 Democratic state attorneys general who challenged FDA restrictions that they say are onerous on the drug. Those restrictions include forcing providers to receive a special certification to prescribe the drug and requiring an extensive paper trail that exposes both patients and providers to privacy and security risks.
The Department of Justice asked Rice to clarify his ruling in light of the Kacsmaryk, and now 5th Circuit, decisions saying that there “appears to be in significant tension” with the opinion of the Texas judge.
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