Judge appears open to blocking medication abortion drug after hearing in Texas

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 medication abortion drugs and the agency’s moves to relax the rules around its use. 

But the judge, US District Judge Matthew Kacsmaryk, also indicated he was thinking through scenarios in which he could keep the drug's approval intact while blocking the FDA's more recent moves to make abortion pills easier to obtain.

Wednesday's hearing concerned a request by the challengers for a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, as well as the more agency’s recent regulatory changes regarding abortion pills.

Kacsmaryk's line of questioning for defenders of the FDA's approval of mifepristone hinted that he sympathized with the legal arguments from challengers who argued the approval was unlawful. 

Kacsmaryk also had many questions for the lawyers for the plaintiffs, anti-abortion doctors and medical associations, and showed some skepticism towards granting an order that was as aggressive as what they were seeking.

A federal judge in Amarillo, Texas, concluded a high-stakes hearing without announcing whether he plans to grant a preliminary injunction that would suspend or withdraw approval of a medication abortion drug that's been available for more than 20 years.

US District Judge Matthew Kacsmaryk said he would issue an order and an opinion "as soon as possible" in the case challenging the US Food and Drug Administration's approval of the drug. 

A preliminary injunction would temporarily cut off access to the most common method of abortion in the United States, and the dispute marks the most significant legal battle concerning abortion since the Supreme Court ended nationwide abortion protections with its overturning of Roe v. Wade last summer.

The drug mifepristone was approved by the FDA in 2000, and the plaintiffs — a coalition of anti-abortion medical associations and doctors — are also challenging more recent moves by the FDA that made abortion pills easier to obtain.

Kacsmaryk's decision came after hearing arguments from both the government defending the medication as well as challengers of the drug in a federal courtroom on Wednesday. 

A federal judge in Texas is considering a lawsuit seeking to block the use of medication abortion nationwide. The lawsuit targets the agency’s 2000 approval of mifepristone, one of the two drugs used for medication abortion.

Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks' gestation, which is “70 days or less since the first day of the last menstrual period,” according to the US Food and Drug Administration.

In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

“Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” Grossman said. “A growing body of research indicates that self-managed abortion is safe and effective.”

What happens during a medication abortion? To find out, CNN spoke with Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

Read the conversation here.

The federal judge overseeing the high-profile challenge to the FDA’s two-decade-old approval of certain drugs used to terminate a pregnancy is a deeply conservative jurist with a proclivity for siding with plaintiffs looking to roll back reproductive and LGBTQ rights or block key Biden administration policies.

US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, was confirmed by a 52-46 Senate vote in 2019.

The FDA case, the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year, has drawn considerable criticism from abortion rights advocates. But Kacsmaryk himself has also drawn scrutiny for the way he’s handled the matter, with critics taking issue with some highly unusual steps he took to delay making the public aware that a hearing was scheduled in the case for Wednesday.

Since Kacsmaryk took the bench in 2019, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, largely due to the fact that Texas’ rules for how federal cases are assigned in the state have allowed conservatives to file there strategically, almost guaranteeing their complaints will be before sympathetic judges. Kacsmaryk is assigned every case filed in his division.

In recent comments to The Washington Post, Kacsmaryk’s sister, Jennifer Griffith, detailed her brother’s long history of being anti-abortion and how she believes fate brought the abortion case before him.

“I feel like he was made for this,” Griffith said. “He is exactly where he needs to be.”

The group that brought the medication abortion lawsuit, the Alliance for Hippocratic Medicine, incorporated in Amarillo a few months before they filed the suit, according to documents from the Texas secretary of state’s office.

Kacsmaryk is the only federal district judge seated in the Amarillo division of the US District of Northern Texas.

Read more about Kacsmaryk here.

US District Judge Matthew Kacsmaryk asked the challengers to the US Food and Drug Administration's approval of a medication abortion drug to walk him through their arguments for why and how he could reverse that approval from more than 20 years ago.

The federal judge asked the plaintiffs – a group of anti-abortion medical associations and doctors – how they overcome certain procedural thresholds in the case and about the legal approach he should take in analyzing their arguments. 

While the judge did not appear skeptical of the plaintiffs’ arguments, one of the sharpest questions from the judge was whether the challengers could point to another analogous case when a court intervened in the way he is being asked to intervene here. 

Erik Baptist – one of the lawyers for the plaintiffs – conceded they could not point to a similar case and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, however, he pointed to other times the FDA had suspended or withdrawn drugs based on court cases, suggesting the court has authority in such matters.

Other key moments: Baptist also took issue with how the FDA used certain protocols during studies conducted before approving the drug – like requiring ultrasounds – but did not issue those same requirements when approving the drug for the public. He described that as a reckless act, calling it an "apples and oranges" approach.  

For remedies, the judge asked the plaintiffs whether they suggest he order a suspension or withdrawal of the medication. Baptist said the better approach would be withdrawal but that suspension would be an alternative action. 

Whatever relief the judge may grant, Baptist argued, must be swift and complete, saying the harms of these drugs "know no bounds" and "time cannot be lost." 

The defenders of the FDA's moves have not argued yet, so it's not clear if they will face more skepticism or if Kacsmaryk will strike a similar tone with them as he did with the challengers.

Baptist and Erin Morrow Hawley argued for the challengers. Both are lawyers at the Alliance Defending Freedom.  

While Baptist argued the drug is causing irreparable harm for the plaintiffs and putting the public at risk, Hawley focused on standing, saying the plaintiffs have had to divert resources to care for women who've dealt with complications from the drug, which she described as "dangerous." 

The challengers have reserved 30 minutes for rebuttal after the defenders of the drug go next. The hearing is still ongoing.

Electronics and video are not allowed in the courtroom, but CNN's reporters are inside and will continue to provide updates as the hearing unfolds.

Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

The growing popularity of medication abortion is largely because of its accessibility, said Abigail Aiken, associate professor at the University of Texas at Austin who leads a research group on medication abortion.

It is also a safer option than both procedural abortion or childbirth. The rate of major complications — like hemorrhages or infections — for medication abortions is about one-third of a percent, according to a 2015 study conducted by Upadhyay. That means out of more than 11,000 cases, 35 experienced any major complications.

The likelihood of serious complications via procedural abortion — performed second-trimester or later — is slightly higher than medication abortion at 0.41%, according to the same study. And childbirth by far comes with the highest risk, at 1.3%.

If access to mifepristone is cut off, abortion clinics and telehealth organizations could pivot to misoprostol-only abortions, Aiken told CNN. Although misoprostol-only abortions are used around the world, they are less effective, associated with a higher risk of serious complications and often more painful than the mifepristone and misoprostol combination, she said.

In the latest study of self-managed misoprostol-only medication abortions in the US, Johnson found misoprostol-only abortions to be a safe alternative, though less safe than using both pills. The study, published in February, analyzed data from online telehealth medication abortion provider Aid Access from 2020. Nearly 90% of 568 users reported completed abortions and 2% experienced serious complications using only misoprostol.

Mifepristone and misoprostol together is still considered the gold standard, Aiken told CNN. People who used the two-pill combination were less likely to experience serious complications than those who went with the misoprostol-only regimen.

Because misoprostol is used to treat multiple ailments including stomach ulcers, it’s readily stocked in pharmacies and unlikely to be taken off the market anytime soon, Johnson told CNN.

Read more here.

As a federal judge in Texas hears a lawsuit on a medication abortion case, the Women’s March is holding a protest outside the courthouse in Amarillo.

Protesters were slowly arriving this morning, as well as a handful of police officers in bikes.

A small group of protesters hold signs that say, “Defend Medication Abortion” and “Not your Uterus not your decision.” 

“Abortion is health care. I’m a registered nurse and I believe very strongly in everyone’s right to access medication abortion as they see fit,” Lindsay London, a protester from Amarillo, said.

Some of the protesters are dressed in costume. One man is wearing a plush kangaroo judge outfit, and two other people are dressed in clown costumes.

“His court is a joke,” said Felix Robertson, donning a clown wig.

Lyons and Robertson said they decided to dress up like clowns because of what US District Judge Matthew Kacsmaryk said during a status conference call last week. During the call, Kacsmaryk asked that the attorneys "not further advertise or tweet any of the details of this hearing so that all parties can be heard and we don't have any unnecessary circus-like atmosphere of what should be more of an appellate-style proceeding."

“We’ll bring the circus then,” Robertson said.

“We’re reminding him that he created the circus,” Lyons said. “We're here to show him that he doesn't have support in Amarillo, that we don't agree with his decision, and we're going to continue to be outspoken against this joke circus of a courtroom.” 

Lyons and Robertson said that they expect a small number of protesters to show up today because of the secrecy around the announcement of the hearing, which didn’t give people much time to plan to attend. 

As a hearing on the case challenging the federal government’s approval of a medication abortion drug takes place today, here's a look at the latest polling on Americans' views on the topic.

Data analyzed by CNN shows mifepristone — the first drug in the medication abortion process — is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.

There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.

Comparatively, the risk of death by penicillin — a common antibiotic used to treat bacterial infections like pneumonia — is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra — used to treat erectile dysfunction — is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.

“[Mifepristone] has been used for over 20 years by over five million people with the capacity to become pregnant,” said Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco. “Its safety is very well established.”

Read more here.