Tag: obstetrics and gynecology

CNN
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A pair of conflicting federal court rulings on Friday created arguably the most contentious and chaotic legal flashpoint over abortion access since the Supreme Court’s ruling last summer that overturned Roe v. Wade and ended the right to an abortion nationwide.

Within less than an hour, two major rulings came down in separate, closely watched cases concerning medication abortion – in lawsuits that are completely at odds with each other.

In one case, filed by anti-abortion activists in Texas, a judge said the FDA’s 2000 approval of mifepristone – one of the drugs used to terminate a pregnancy – should be halted. But the court paused its ruling for a week so that it can be appealed, and that appeal is already under way.

In the second case, where Democratic-led states had sued in Washington to expand access to abortion pills, a judge ordered the federal government to keep the drug available in the 17 states, plus the District of Columbia, that brought the lawsuit.

On their face, both cases deal with the administrative law that controls how the US Food and Drug Administration goes about regulating mifepristone. The disputes did not rely directly on the question of whether there is a right to an abortion – the question that was at the center of the Supreme Court’s ruling last June. But tucked in the Texas ruling, by US District Judge Matthew Kacsmaryk, was the idea that embryos could have individual rights that courts can consider in their rulings.

Both cases emerge from a political environment that was unleashed by the Supreme Court’s Roe v. Wade reversal and a willingness to push the legal envelope that the Supreme Court ruling created. The abortion issue is now on a path back to the Supreme Court, as higher courts are asked to sort out the contradictory commands of Friday night’s decisions.

Because the Texas judge has paused his ruling, it has no immediate impact on the availability of medication abortion drugs. But the next several days stand to be a dramatic and combustible legal fight over the order – a fight ratcheted up by the rival ruling in Washington.

Besides pausing his ruling for one week, Kacsmaryk – an appointee of former President Donald Trump who sits in Amarillo, Texas – seemed to hold nothing back as he ripped apart the FDA’s approval of mifepristone and embraced wholeheartedly the challengers’ arguments the drug’s risks weren’t adequately considered.

Kacsmaryk, whose anti-abortion advocacy before joining the federal bench was documented by a recent Washington Post profile, showed a striking hostility to medication abortion, which is the method used in a majority of the abortions in the United States.

Leading medical organizations have already condemned his opinion and pushed back at the judge’s analysis of the safety of medication abortion.

The judge said that the FDA failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion,” in what was a repeated invocation of “chemical abortion,” the term preferred by abortion opponents. Kacsmaryk suggested that the FDA’s data was downplaying the frequency with which the drug being mistakenly administered to someone who had an ectopic pregnancy, i.e. a pregnancy outside the cavity of the uterus. He repeated the challengers’ accusations that the FDA’s approval process had been the subject of improper political pressure.

He said the FDA’s refusal to impose certain restrictions on the drug’s use “resulted in many deaths and many more severe or life-threatening adverse reactions.”

“Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety,” he said.

Jack Resneck Jr., the president of the American Medical Association, said in a statement that Kacsmaryk’s ruling “flies in the face of science and evidence and threatens to upend access to a safe and effective drug.”

“The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” the AMA president said.

Kacsmaryk’s opinion paid no heed to the argument made by the FDA’s defenders that cutting off access to medication abortion would put the health of pregnant people at risk and that it would force abortion seekers to terminate their pregnancies through a surgical procedure instead.

Instead, the judge wrote that a ruling in the challengers’ favor would ensure “that women and girls are protected from unnecessary harm and that Defendants do not disregard federal law.”

As he explained why the preliminary injunction – which was being handed down before the case could proceed to a trial – was justified, he said that embryos had their own rights that could be part of the analysis. That assertion goes farther than what the Supreme Court said in its June ruling, known as Dobbs v. Jackson Women’s Health.

“Parenthetically, said ‘individual justice’ and ‘irreparable injury’ analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era,” Kacsmaryk said Friday.

Whereas Kacsmaryk had been asked by the challengers in Texas to block medication abortion, US District Judge Thomas Owen Rice, who sits in Spokane, Washington, was considering whether abortion pills should be easier to obtain.

Rice, an Obama appointee, granted the Democratic attorneys general who brought the lawsuit a partial win.

They had asked Rice to remove certain restrictions – known as REMS or Risk Evaluation and Mitigation Strategy – the FDA has imposed on mifepristone, with the blue states arguing the drug was safe and effective enough to make those restrictions unnecessary.

While Rice is rejecting that bid for now, he granted a request the states also made that the FDA be ordered to keep the drugs on the market. But Rice’s ruling only applies in the 17 plaintiff states and the District of Columbia.

His decision maintains the status quo for the availability of abortion pills in those places and he specifically is blocking the agency from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy.”

Rice’s opinion was a striking split screen to Kacmsaryk’s. While the Texas judge said the FDA did not adequately take into account the drug risks, Rice showed sympathy to the arguments that the rules for mifepristone’s use were too strict and that the agency should be taking a more lenient approach to how the abortion pill is regulated.

Ultimately, he said he would not grant the Democratic states’ request that he remove some of the drug restrictions at this preliminary stage in the proceedings, because that would go well beyond maintaining the status quo while the case advances. He noted that if he had granted that request, it would also undo a new FDA rule that allows pharmacies to dispense abortion pills. That would reduce its availability and would run “directly counter to Plaintiffs’ request.”

If Kacsmaryk’s ruling halting mifepristone’s approval is allowed to go into effect, it will run headlong into Rice’s order that mifepristone remain available in several states. Kacsmaryk’s ruling is a nationwide injunction.

The Justice Department and Danco, a mifepristone manufacturer that intervened in the case to defend the approval, both filed notices of appeal. Both Attorney General Merrick Garland and Danco said in statements that in addition to the appeals, they will seek “stays” of the ruling, meaning emergency requests that the decision is frozen while the appeal moves forward.

They’re appealing to the US 5th Circuit Court of Appeals, which is sometimes said to be the country’s most conservative appeals court. Yet some legal scholars were skeptical that the 5th Circuit, as conservative as it is, would let Kacmsaryk’s order take effect.

Washington, where the blue states’ lawsuit was filed, is covered under the 9th Circuit, a liberal appellate court. But it’s unclear if the ruling from Rice will be appealed. Garland said the Justice Department was still reviewing the decision out of Washington. A so-called circuit split would increase the odds that the Supreme Court would intervene. But given how the practical impact of the two district court rulings contradict each other, the Supreme Court may have no choice but to get involved.

The lawyer for the challengers in the Texas case, anti-abortion medication associations and doctors, said Friday evening that he had not reviewed the Washington decision, so he could not weigh in on how it impacted Kacsmaryk’s order that the drug’s approval be halted.

“I’m not sure whether there’s a direct conflict yet and with the Washington state decision just because I haven’t read it yet, but there may not be a direct conflict,” Erik Baptist, who is an attorney with Alliance Defending Freedom, said. “But if there is a direct conflict then there may be – it may be inevitably going to the Supreme Court, but I’m not convinced that it’s necessary at this point to make that conclusion.”