Tag: matthew kacsmaryk

Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics

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.”

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April 7, 2023
19th century chastity law endangers 21st century abortion medicine | CNN Politics
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CNN
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The Wild West of the post-Roe v. Wade legal landscape is focused on a lone federal judge in Amarillo, Texas, who could use a 19th century law to limit access to abortion medication for every American woman.

The judge, 45-year-old Matthew Kacsmaryk, held a hearing Wednesday about whether he should impose a preliminary injunction that would require the US Food and Drug Administration to withdraw or suspend its approval of the drug, mifepristone, while a larger case progresses.

Mifepristone is taken along with another drug, misoprostol, as part of the two-step medication abortion process. Misoprostol can be prescribed on its own, but it is considered less effective.

Kacsmaryk, who sounded open to the idea of restricting access to mifepristone, will have to agree with some or all of these general points raised if he decides to issue an injunction:
That doctors who don’t perform abortions and live in Texas, where abortions are already banned, are harmed by abortions conducted elsewhere.
That an FDA approval conducted over the course of four years and finalized 23 years ago was so flawed that it should be rescinded.

That a single federal judge in Amarillo should do what no federal judge has ever done and unilaterally rescind an FDA approval.
That a drug, which studies suggest is on par with ibuprofen in terms of safety, is actually so harmful it should be reconsidered by the FDA.
CNN’s Tierney Sneed wrote a longer list of takeaways from the hearing, where anti-abortion rights doctors and activist groups teed up their lawsuit in Kacsmaryk’s courtroom to further limit access to abortion care in the US.

It’s important to note that no matter what Kacsmaryk does, it will be appealed up through the 5th US Circuit Court of Appeals and potentially to the Supreme Court.

But perhaps the most incredible question Kacsmaryk faces is whether an 1870s chastity law named for an anti-vice crusader, Anthony Comstock, should be resuscitated and applied to the medicine that now accounts for a majority of US abortions.

Comstock operated the New York Society for the Suppression of Vice and was a special agent of the US Postal Service. He was known for seizing contraband like contraceptives and condoms in the name of rooting out obscenity, according to the New York Historical Society.

Mary Ziegler, a law professor at the University of California, Davis who has written about the Comstock Act for CNN Opinion, described Comstock as being “obsessed by what he saw as the decaying morals of a country preoccupied with sex.”

Ziegler writes:

The law he inspired barred not just the mailing of “obscene books” but also birth control and abortion drugs and devices. In the 19th and early 20th centuries, the Comstock Act was used to prohibit the mailing of many literary classics, from Geoffrey Chaucer’s “The Canterbury Tales” to works by James Joyce and Walt Whitman.

Comstock himself proudly carried a gun and scoured the mail for cases involving information about abortion or contraception, even if a doctor provided it. By Comstock’s standard, the law was a great success: he claimed to have destroyed 15 tons of books, arrested more than 4,000 people and driven at least 15 people to suicide.

While Congress has acted to relax elements of the Comstock Act, including to allow the mailing of contraceptives, it is still technically on the books with regard to the mailing of anything that could be used for an abortion.

During the Covid-19 pandemic, the FDA dropped its requirement that a person obtain mifepristone in person. A prescription is still required.

In December, the Department of Justice notified the US Postal Service that the Comstock Act did not apply as long as “the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

The FDA permanently removed the in-person requirement in January, hoping to guarantee more access to the medication after the Supreme Court ended Roe v. Wade last June.

The group that brought the Texas lawsuit, the Alliance for Hippocratic Medicine, wants to reapply the Comstock Act and restrict the mailing of abortion medication.

The FDA’s already exhaustive and detailed drug approval process was especially scrutinized for mifepristone, which was more commonly known as part of the RU-486 regimen when it became available to American women at the turn of the century.

It had been available in Europe for a dozen years before that. Here’s CNN’s report from September 2000.

That the drug works safely as a means of abortion is not really up for dispute as a medical matter after all that time, according to CNN’s Jen Christensen, who explains more about the medication in this article about mifepristone.

Another CNN data analysis suggests mifepristone is safer than penicillin and Viagra.

Mifepristone has a death rate of 0.0005% – five deaths for every 1 million people in the US who used it. Penicillin’s death rate is four times greater. Viagra’s is 10 times greater, according to the analysis by CNN’s Annette Choi and Will Mullery.

Kacsmaryk had a long history of challenging laws providing greater access to reproductive rights before he became a federal judge. While he has promised to be an impartial judge, every Democrat and one Republican, Sen. Susan Collins of Maine, opposed his nomination in 2019.

Now Kacsmaryk is the only federal judge at the courthouse in Amarillo, which almost guarantees he hears cases filed there.

So it may be no coincidence that the group challenging use of mifepristone set up an outpost months before filing its lawsuit. The group is based in Tennessee, but one of the doctors named as a plaintiff in the lawsuit practices near Amarillo.

However one feels about judicial shopping and whether that happened in this case, the word appears to be out that a conservative judge is alone in Amarillo and open for business.

According to a CNN profile, Kacsmaryk has also put on hold Biden administration policies related to immigration and overseen cases related to vaccine requirements and gender identity. Last December, he halted a federal program in Texas that allowed minors to get birth control without their parents’ consent.

That suit regarding the birth control program established in 1970 was brought by a Texas father “raising each of his daughters in accordance with Christian teaching on matters of sexuality,” which he said forbids premarital sex.

Kacsmaryk agreed, even citing the Catechism of the Catholic Church in his decision to say “contraception (just like abortion) violates traditional tenets of many faiths, including the Christian faith Plaintiff practices.”

His sister described him to The Washington Post as an anti-abortion rights activist and detailed her own decision to give a child up for adoption rather than seek an abortion.

“He’s very passionate about the fact that you can’t preach pro-life and do nothing,” Jennifer Griffith told the Post. “We both hold the stance of you have to do something. You can’t not.”
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March 16, 2023
Takeaways from the Texas hearing on medication abortion drugs | CNN Politics

Amarillo, Texas
CNN
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Over the course of about four hours of arguments, a federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of a medication abortion drug and the agency’s moves to relax the rules around its use.

But the judge, US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also indicated he was thinking through scenarios in which he could keep the drug’s 2000 approval intact while blocking other FDA rules.

Anti-abortion doctors and medical associations are seeking a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, and that would block the agency’s more recent regulatory changes making the pills more accessible.

Here are takeaways from the hearing:

Kacsmaryk showed a particular interest in the arguments by the abortion opponents that the FDA approved mifepristone in an unlawful way.

He zeroed in on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being treated with the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

Kacsmaryk returned to that “apples to oranges” argument several times throughout the hearing.

Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine what studies are adequate for approving a drug’s safety. He also said the challengers’ claims were factually flawed, because the FDA also was looking at studies where the patients did not receive an ultrasound.

Kacsmaryk was similarly focused on a claim by the plaintiffs that the FDA violated the law in the special, accelerated process that it used to approve mifepristone in 2000.

At one point the judge revealed in the hearing that he had downloaded a list of the other drugs the FDA had approved through the process. He ticked through the list of drugs, which were made up mostly of treatments for HIV and cancer, and he asked the Justice Department for its “best argument” for why mifepristone fit into the list.

One of the sharpest questions from the judge was whether the anti-abortion activists could point to another analogous case when a court intervened in the way he is being asked to intervene here.

Baptist conceded there was none and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, Baptist raised other times the FDA had suspended or withdrawn drugs based on court cases in other contexts, arguing those cases showed that Kascmaryk had the authority to grant the plaintiffs’ request.

Attorneys for the defendants – which include both the FDA and a drug company that manufactures mifepristone and intervened in the case – pushed back on those examples. They said that the plaintiffs were relying on patent cases, where the dispute was between a brand name drug and a generic counterpart, and those examples were not analogous here.

The medication abortion lawsuit targets actions the FDA took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it and suggested it could have an impact on his thinking about the case.

He brought up Dobbs early on in the hearing and raised it specifically in connection with a friend of the court brief filed by 22 GOP-led states supporting the challengers.

The judge noted that the red states’ brief argued that the FDA’s actions were infringing on their state laws concerning abortion pills.

He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy.

Hawley agreed, calling it a “sea change.”

If Kacsmaryk has any sore feelings over the blow up around his efforts to keep Wednesday’s hearing plans quiet, he didn’t show them at the proceedings.

When questioning both sides of the case, Kacsmaryk had a restrained, straight-forward tone. He had occasional follow-up questions for the plaintiffs, but did not aggressively push back on their arguments. The substance of his questions for the FDA’s defenders was more skeptical, but he kept with the measured approach in his questioning, and avoided any pushiness when grilling the government and the drug company about the approval process.

At the end of the hearing, he thanked the parties, as well as those who filed dozens of friend of the courts briefs, for their “superb” briefing. He also acknowledged the logistical hurdles the lawyers at the hearing went through to get to his courthouse in Amarillo, which is a several hours’ drive from Texas’ biggest cities.

Left unmentioned by the judge was the fact that he tried to delay the announcement of the hearing until the evening before, which would have made it difficult for members of the public and the media to attend Wednesday’s proceedings. When there was blowback to The Washington Post reporting about his plan – laid out in a private teleconference with attorneys where he pointed to death threats and harassment that had been directed to the courthouse staff – he announced the hearing on Monday.

The courtroom was open to the public, but only with limited seating: 19 seats for reporters and 19 for members of the public. By 6 a.m. CT Wednesday there were already lines outside the courtroom to claim those seats. Those attendees were not allowed to bring electronics in with them, and if they left the courthouse, they were not allowed back in.

Kacsmaryk warned at the beginning of the hearing that anyone who disrupted the proceedings would be immediately removed without warning. But there were no such disruptions.

Kacsmaryk wrapped up the hearing without any explicit timeline for when he’ll rule, telling the parties he would issue an order and opinion “as soon as possible.”

While he was arguing, Schwei, the DOJ attorney, requested that the judge – if he were to rule against the FDA – to immediately put that ruling on pause so it could be appealed. The judge stopped short of promising an automatic stay in the event of an adverse ruling, but he acknowledged he understood what DOJ was asking for.

An appeal would first go to a panel of three judges of the 5th US Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision could then be appealed either to the full 5th Circuit or the US Supreme Court.

Beyond these procedural questions, Kacsmaryk seemed to be grappling with the practical impact of a ruling in favor of the plaintiffs. He asked plaintiffs’ attorneys, the DOJ lawyers and the attorneys for the drug company Danco whether it would be possible for him to block some but not all of the FDA actions the challengers were targeting. He returned to the question again when the plaintiffs were back up for the rebuttal.

He also pressed Baptist, the attorney for the abortion opponents, on whether the plaintiffs were seeking an order that the FDA begin the withdrawal of the drug – a process that would take months – or if they thought the judge could directly take if off the market.

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March 16, 2023
Appeals court can rule at any time in dispute over suspending FDA approval of medication abortion drug | CNN Politics

CNN
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The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.

Now that the filings have been submitted, the US 5th Circuit Court of Appeals Court could rule at any time on whether to put a hold on the order from US District Judge Matthew Kacsmaryk.

Kacsmaryk on Friday night said he was halting the FDA’s approval of the drug mifepristone but that he was delaying the order by seven days to give the pill’s defenders time to appeal the case. The Justice Department has asked the appeals court to act by 12 p.m. CT Thursday on its request that Kacsmaryk’s ruling be paused, to give the government time to seek a Supreme Court intervention if need be. The 5th Circuit is not obligated to meet that deadline.

The Justice Department wrote in its new filing that Kacsmaryk purported “to be acting in a restrained manner … but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug.”

“Effectively requiring Danco Laboratories and GenBioPro to cease distribution of mifepristone after more than two decades would upend the status quo, severely harming women, healthcare systems, and the public,” the Justice Department said, referring to the two US manufacturers of mifepristone.

The Justice Department filing pushed back on the assertions by the challengers, made in their filing overnight in the emergency dispute, that the 5th Circuit did not have the authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department also called out Kacsmaryk and the challengers for relying on anonymous blog posts to claim mifepristone is unsafe.

Danco Labroratories, which intervened in the case to defend mifepristone’s approval, wrote in its new filing with the appeals court that if the ruling is not frozen, “women across the nation will face serious, unnecessary health risks from the elimination of access to a drug FDA has repeatedly deemed safe and effective and that is the standard of care.”

In an overnight filing, the anti-abortion doctors who sued to ban medication abortion drugs told a federal appeals court that it should leave in place the ruling that will halt the drug’s FDA approval.

The anti-abortion doctors defended Kacsmaryk’s ruling called it a “meticulously considered” ruling that “paints an alarming picture of decades-long agency lawlessness – all to the detriment of the women and girls FDA is charged to protect.”

Mifepristone has been approved by the FDA for terminating pregnancies for nearly 23 years. Leading medical associations have rebuked the claims by the approval’s legal challengers and by the judge that the drug is unsafe.

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April 12, 2021
Justice Department asks Supreme Court to intervene in abortion drug ruling | CNN Politics

CNN
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The Justice Department asked the Supreme Court Friday to intervene in an emergency dispute over a Texas judge’s medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal to formally play out at the federal appellate level.

The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the US Food and Drug Administration’s authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.

Solicitor General Elizabeth Prelogar said in the filing that it “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”

She said that if the ruling were allowed to stand it would “inflict grave harm on women, the medical system, the agency, and the public.”

Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will “irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide.”

“The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers,” the attonrey, Jessica L. Ellsworth, told the justices.

The clock is ticking. If the Supreme Court does not step in, the district court’s ruling, as amended by a subsequent appeals court opinion, will go into effect at midnight CT, and access to the drug, Mifepristone, will be restricted while the appeals process plays out.

Both the government and Danco are asking the court to freeze the lower court opinion, or alternatively, agree to take up the case themselves and hear arguments before the summer recess, a very expedited time frame.

The controversy began when US District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA’s 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.

Late Wednesday, the 5th US Circuit Court of Appeals froze part of the ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.

The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.

The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It’s possible however that even with the ruling in effect, some providers could go “off-label” and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.

Prelogar, the solicitor general, argued in her filing to the Supreme Court that the FDA’s expert judgment should not be challenged.

“FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” she wrote, reminding the justices that currently, “more than half of women in this country who choose to terminate their pregnancies rely on mifrepristone to do so.”

She highlighted a key threshold issue in the case, arguing that the doctors opposed to abortion who are behind the suit do not have the legal right to be in court. That is because, she said, they neither “take nor prescribe” the drug, and the FDA’s approval “does not require them to do or refrain from doing anything.”

CNN Supreme Court analyst Steve Vladeck, who is a professor at the University of Texas School of Law, said the 5th Circuit’s ruling “froze the craziest, most harmful parts of Kacsmaryk’s ruling,” but that access to mifepristone is still significantly limited.

“The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling,” he wrote on Twitter. “But it *didn’t* freeze Kacsmaryk’s block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail.”

Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.

In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

A split 5th Circuit panel said in its order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill’s defenders had not shown that they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s more recent regulatory actions toward mifepristone.

The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it’s been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug’s supposed risks.

This story has been updated with additional developments.

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April 12, 2021
Judge who suspended abortion pill failed to disclose interviews that discussed social issues | CNN Politics

CNN
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The federal district judge who first suspended the US Food and Drug Administration’s approval of the so-called abortion pill mifepristone failed to disclose during his Senate confirmation process two interviews on Christian talk radio where he discussed social issues such as contraception and gay rights.

In undisclosed radio interviews, Matthew Kacsmaryk referred to being gay as “a lifestyle” and expressed concerns that new norms for “people who experience same-sex attraction” would lead to clashes with religious institutions, calling it the latest in a change in sexual norms that began with “no-fault divorce” and “permissive policies on contraception.”

Kacsmaryk, a Trump-appointed federal district judge, made the unreported comments in two appearances in 2014 on Chosen Generation, a radio show that offers “a biblical constitutional worldview.” At the time, Kacsmaryk was deputy general counsel at First Liberty Institute, a nonprofit religious liberty advocacy group known before 2016 as the Liberty Institute, and was brought on to the radio show to discuss “the homosexual agenda” to silence churches and religious liberty, according to the show’s host.

Federal judicial nominees are required to submit detailed paperwork to the Senate Judiciary Committee ahead of their confirmation process, including copies of nearly everything they have ever written or said in public, in order for the committee to evaluate a nominee’s qualifications and personal opinions. Neither interview is listed in the paperwork Kacsmaryk provided to the Senate during his judicial nomination process, which first began in 2017.

The radio interviews were not included in the 22 media works Kacsmaryk disclosed, which included three radio appearances and 19 written pieces.

A spokesperson for Democratic Sen. Dick Durbin, the chair of the Senate Judiciary Committee, told CNN the interviews weren’t in their archived files from Kacsmaryk’s confirmation, which included all paperwork submitted for his nomination.

In a statement sent to CNN, Kacsmaryk said he did not locate the interview when searching for media to disclose and he did not recall the interview.

“I used the DOJ-OLP manual to run searches for all media but did not locate this interview and did not recall this event, which involved a call-in to a local radio show,” he told CNN. “After listening to the audio file supplied by CNN, I agree that the content is equivalent to the legal analysis appearing throughout my SJQ and discussed extensively during my Senate confirmation hearing. Additionally, the transcript supplied by CNN appears to track with the audio and accurately recounts my responses during the phone call—when quoted in full.”

The Washington Post reported last week that Kacsmaryk removed his name in 2017 from a pending law review article criticizing protections for transgender people and those seeking abortions during his judicial nomination process, a highly unusual move for a judicial nominee.

Kacsmaryk did not respond to the Post’s request for comment, but a spokesperson for his old employer First Liberty claimed Kacsmaryk’s name had been a “placeholder” on the article and that Kacsmaryk had not provided a “substantive contribution,” despite the final version being almost identical to the one submitted under Kacsmaryk’s name according to the Post.

Kacsmaryk later submitted supplemental material in 2019 to the committee to reflect interviews and events he participated since in 2017, but neither of the 2014 radio interviews were included.

Democratic senators grilled Kacsmaryk on his positions on abortion and LGBTQ rights during both his nomination hearing and in written questions in 2017.

While Kacsmaryk worked at First Liberty, one of his colleagues, general counsel Jeff Mateer, was also nominated for a federal judgeship. But Mateer came under scrutiny in 2017 for comments unearthed during his confirmation process in which he once compared the US to Nazi Germany on Chosen Generation – the same radio program Kacsmaryk appeared on and whose interviews he did not disclose.

Mateer’s nomination was later rescinded; Kacsmaryk was later confirmed in 2019.

The interviews were shared by Kacsmaryk’s employer, the Liberty Institute, at the time on social media. A guest from First Liberty appeared once a week, according to the show’s radio host in the broadcast and archives available online.

In one interview from February 2014, in response to a question on the “homosexual agenda,” Kacsmaryk expressed concerns that new social norms surrounding “same-sex marriage” and “people who experience same-sex attraction” would lead to clashes with religious institutions.

“I just want to make very clear, people who experience a same-sex attraction are not responsible individually or solely for the atmosphere of the sexual revolution,” Kacsmaryk said. “You know it. It’s a long time coming. It came after no-fault divorce. It came after we implemented very permissive policies on contraception. The sexual revolution has gone through several phases. We just happen to be at the phase now where same sex marriages is at the fore.”

“But through that progression or regression, I think you can see five areas where there will be a clash of absolutes between the traditional Judeo-Christian understanding of marriage and the revisionist, redefined vision of marriage that you saw in last term’s Supreme Court opinions,” he said before outlining those areas as over tax exempt statuses, adoption services, federal government programs, and discrimination at universities.

He appeared on the program to discuss the federal government’s view of same-sex marriage and opponents of it following the court ruling striking down the Defense of Marriage Act. The host suggested opponents of same-sex marriage could be viewed as “hostile” enemies of the government in line with al-Qaeda, which Kacsmaryk agreed with.

“Yeah, and I can speak from immediate firsthand experience,” he said, citing his work formerly in the Justice Department. “That is very much in vogue now in the federal government to characterize opposition to same sex marriage and related issues as irrational prejudice at best and a potential hate crime at worse,” he continued.

“It really has infused the entire federal service top to bottom as the administration has declared that they will join this culture war, that there’s one side that is destined to win and that you’re on the wrong side of history in the federal government if you are on an opposing side,” he added.

Kacsmaryk also appeared on the program in July 2014 to discuss an executive order signed by then-President Barack Obama that banned federal contractors from discriminating against employees on the basis of sexual orientation or gender identity which did not exempt faith-based groups.

Kacsmaryk linked changes in Democrats’ views on the issue of religious freedom to the “emergence of this very powerful constituency in the LGBT community,” which he said the Obama administration made campaign promises to fulfill. Kacsmaryk said religious organizations entering into contracts with the federal government would have risk under the executive order and face a “real burden” for dissenting from “the new sexual orthodoxy” on gay rights.

The new rules, Kacsmaryk suggested, were poorly written and didn’t differentiate between gay people who lived “celibate” lives and those who made being gay “a lifestyle,” in a discussion of how religious groups would comply with the new rules.

“If you look at the letter that was issued by the United States Conference of Catholic Bishops, they point out that the category sexual orientation is problematic because it’s not defined,” he said. “Most Abrahamic faith traditions will draw a distinction between someone who experiences the same sex attraction but is willing to live celibate and somebody who experiences the same sex attraction and makes it a lifestyle and seeks to sexualize that lifestyle. Those are two different categories that most Abrahamic faith traditions recognize.”

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April 12, 2021