On Good Friday, a federal judge in Texas handed down a potentially historic abortion ruling.
The case at hand revolves around the Food and Drug Administration’s approval of the abortion pill mifepristone. In 2000, the FDA approved the use of mifepristone to be used along with the drug misoprostol to terminate a pregnancy. But some medical experts have argued the FDA’s approval was rushed and unlawful.
In 2022, a group of pro-life medical professionals and an organization represented by Alliance Defending Freedom, a Christian legal organization, filed a lawsuit against the FDA arguing that it had improperly approved the abortion pill, and federal Judge Matthew Kacsmaryk for the Northern District of Texas agreed.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in his ruling. “But here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions.”
Denise Harle, Alliance Defending Freedom senior counsel, joins the show today to discuss what the ruling means and the likelihood of the case ultimately rising to the Supreme Court. Harle also breaks down a ruling the same day by a judge in Washington state in favor of continued access to the abortion pill.
Listen to the podcast below or read the lightly edited transcript:
Virginia Allen: We are joined today by Denise Harle. Denise serves as senior counsel with Alliance Defending Freedom where she is the director of the Center for Life and leads her team’s litigation and advocacy efforts to defend pro-life laws around the nation. Denise, thank you so much for your time today.
Denise Harle: Thanks, Virginia.
Allen: I want to start by backing up a little bit and going back to last year and talking about some of the background to what we have just seen happen in the courts. There was a lot of news that came on Friday, on Good Friday, about rulings related to the abortion pill mifepristone. Before we dive too far into those rulings, can you explain the background of the case that challenged the abortion pill and that Alliance Defending Freedom has really been on the forefront of?
Harle: Happy to do that. It’s really a shocking story when you go to the beginning of what happened with mifepristone, this dangerous chemical abortion drug.
Back in 2000, under pressure from the Clinton administration, the [Food and Drug Administration] recklessly, unlawfully approved this chemical abortion regimen by ignoring its own regulations. It actually used a special approval process that’s supposed to be reserved only for lifesaving drugs.
It did so by categorizing pregnancy as an illness, which, of course, it’s not—it’s just a natural process that most women experience—and by claiming that mifepristone, this abortion drug, provides a therapeutic benefit.
From the very beginning, the approval was unlawful just on that front alone. In addition to that, the FDA never did the required safety testing.
It does not have one single research study reflecting the real-world conditions of these drugs that it let onto the market. In other words, all of the safeguards that were done in any testing on these drugs are not required now and these drugs are being given out widely, even mail-order abortions, to teen girls and women around the United States.
After nearly 20 years of the FDA stonewalling our clients, we finally brought an action in federal court and we are thrilled to say that the court agreed with us and in a very thorough ruling painstakingly walked through all the failures of the FDA in this case and stayed the approval. Meaning when the order goes into effect, FDA approval will be rescinded effectively for this dangerous drug.
Allen: The judge in Texas has ruled in favor of the individuals, the pro-life doctors, the pro-life organizations who you-all at Alliance Defending Freedom have been representing. What was really the heart behind or the reasoning for those pro-life doctors and organizations to say, “OK, we’re going to challenge the FDA’s approval of the abortion pill”? These are busy people. They have a lot of things that they could be doing. Why did they challenge the FDA’s rule?
Harle: Two pieces of that. Two pieces in response to your question. One is our clients in this lawsuit today are the same doctors who back right after the approval in 2000 waived the flag, submitted an extensive citizen’s petition as what the FDA requires explaining the science and the medicine and the danger of these drugs. These are expert OB-GYNs and the FDA completely ignored that. Instead of responding within 180 days, they sat on that first petition for 14 years. This is nothing new in terms of the dangers.
Another part of the answer to your question is that what we’ve seen in terms of escalating harms to women and girls, chemical abortions now account for something like 60%, maybe even more, of the abortions in the United States. In addition, the escalation of FDA’s recklessness with these drugs is really shocking.
In 2021, the FDA said that these drugs could just be mailed and that a woman would never even need to see a medical professional in person to have an examination or an ultrasound to rule out ectopic pregnancy, which can be absolutely deadly if given chemical abortion drugs, or to even check the gestational age. These drugs are only supposed to be used up to 10 weeks of pregnancy and massive complications happen when that’s not followed.
What our doctors and plaintiffs in this case have seen is the prevalence and spread of chemical abortions now available by telemed are leading to an exponential rise in emergency room visits.
Our plaintiff doctors have treated women, multiple women, that have come in, gotten these drugs off the internet or by mail, and are hemorrhaging. They have retained fetal parts. They are undergoing emergency surgeries and blood transfusions. The dangers are just getting more and more apparent. We are so relieved that the federal court is finally putting a stop to this.
Allen: To complicate things, though, on Friday, shortly after the judge in Texas made his ruling, then we saw a ruling come out from a judge in Washington state. He issued a ruling directing the FDA to continue allowing many Americans the ability to access the abortion drug. Explain what exactly the judge in Washington ruled and this other case, what are the similarities? What are the differences? And how does this complicate things moving forward?
Harle: The Washington case is so bizarre. I’ll try to get to the essence and then I’ll explain some of the peculiarities that you might find a little bit interesting.
The Washington case only deals with one FDA action. That’s the January 2023 Biden administration FDA change in the safeguards, again, lifting a safeguard and now saying that any retail pharmacy or online pharmacy can apply to dispense the chemical abortion drugs, whereas before prescribers had to at least be physicians. Now it can be pharmacists and picked up from retail pharmacies. That’s the only action at issue in that case.
That action is not an issue in our case. We actually filed before the Biden administration even did that. Our case deals with the unlawful 2000 approval and all of the subsequent actions where the FDA failed to follow its safety regulations in 2016, 2019, 2021. In a sense, they’re ships passing in the night.
The Washington case says that tentatively the 2023 action can remain in place, but our federal district judge, after reviewing all of the underlying facts, said the initial approval in the first place was wrong. That pulls the rug out from under whatever happened in 2023. Effectively, it’s as if that initial approval never happened in the first place.
The Washington case is also a little bit odd because what you’re seeing is these very pro-abortion state [attorneys general] are suing the FDA. Yet, they’re on the same side on this because they both want this expansive view of chemical abortion and want these drugs on the market.
I think it was an attempt to try to undo our very valid lawsuit, which they knew had some merit to it, and they were trying to come up with a way to undermine it, but it’s not going to work. I’m very confident that ours is going to have priority over that order.
Allen: How is the Biden administration responding?
Harle: In our case, the Biden administration filed an emergency motion for stay. In other words, it’s trying to get the appellate federal court, the 5th Circuit Court of Appeals, to stay the order we got. It would actually be a stay of a stay. Meaning that our judge’s order would be on pause until the merits are resolved and mifepristone could continue to be marketed and sold.
Allen: Is that normal to have a stay on a stay? Is that common in the legal world?
Harle: It’s not uncommon in a high-stakes, high-profile case. It’s just funny because you have to think through it like a double negative, which is a little weird.
In Washington, on the other hand, actually, DOJ, which is FDA—Department of Justice is actually FDA’s law firm because they represent the administration.
What they did in the Washington case was they filed a notice for expedited clarification, basically asking the Washington court to try to explain its order again because it doesn’t make a lot of sense where the Washington court order says, “I am ordering the FDA not to take any action to disrupt the status quo as to the 2023 [Risk Evaluation and Mitigation Strategy].”
In light of the Texas order, which came out only 20 minutes before that, it doesn’t make a lot of sense and isn’t really possible. I think they’re trying to get a clear answer there just so they know whether they want to appeal or not or whether it would even be futile.
Allen: Wow. What happens next? There’s a lot of activity happening here and it sounds a little bit like a legal maze.
Harle: Yes. I mean, it’s fun for those of us who live in this world. What happens now is in the 5th Circuit things are moving very quickly. We are filing our brief today by midnight per order from the 5th Circuit and we definitely expect the 5th Circuit will rule on whether it’s going to stay the underlying order before it goes into effect.
Our district court judge put a seven-day delay on the effectiveness of the order just so that this process could play its way out, recognizing the significance of this case. We’re very confident, though, that as we continue on the merits of the 5th Circuit, regardless of what happens in the stay, our record is very strong.
Our legal arguments are extremely strong and the district court did a really good job of detailing those in his decision, just walking through failure after failure, violation after violation of the FDA, and all the ways that this has put women and girls at risk as well as the actual real-world data showing that that’s the case. In response, there’s a lot of concessions by the FDA, I would say.
They’ve conceded that pregnancy is not an illness, which was actually required. It was a prerequisite for them to ever get this drug approved in the way that it was done. They’ve conceded that they don’t have tests that actually match the real-world conditions under which women and teen girls are taking these drugs.
It almost reminds me of when we had the Dobbs [v. Jackson Women’s Health Organization] case and the Supreme Court was considering whether to overturn Roe [v. Wade] and [Planned Parenthood v.] Casey.
Instead of defending Roe and Casey on the merits, what you heard from the pro-abortion side was really more like, “Yeah, but women are relying on this. We’ve been doing this for a long time.”
In this case, this is all about the health and safety of women and girls. The FDA has one job, which is to protect Americans from dangerous drugs, which it did not do here. That should be the issue, not this vague idea that, “Oh, well, we’ve been taking these dangerous drugs for a long time so don’t take them away now.” I don’t see that standing up in court.
Allen: I know one of the arguments that we do hear from those on the pro-abortion side is if this drug can’t be sold in pharmacies or if individuals can’t get it from their doctor, then women are going to order the pills online. They’ll order them from other countries. It might even create a black market for them. What’s your response to that?
Harle: One of the most concerning aspects of this whole thing is how the abortion industry and pro-abortion government officials are openly calling on illegal back-alley abortions.
Now, you may have seen that the state of California has stocked up 2 million doses of misoprostol, which is not even approved for abortion in the first place. It’s not even illegally approved and has an extremely high failure and complication rate. It’s used off-label in Third-World countries.
The idea that Planned Parenthood would continue to try to sell illegal, dangerous drugs to me just highlights the fact that so much of this is about selling abortions for profit at the expense of women’s and girls’ health.
Why not direct your state resources to helping support women who are facing difficult circumstances in their pregnancy, maybe an unexpected pregnancy? Why not redirect some support to pregnancy help networks or pregnancy centers to make sure these women can confidently choose to welcome their baby into the world or to supporting foster and adoption care?
Instead, we’re seeing doctors openly say that illegal, dangerous drugs should continue to be taken without medical supervision by women in their own homes, turning their own bathrooms into abortion clinics. It’s absolutely horrific. I just am praying and hoping we look back on this and are so grieved by the way we treated our women in this nation.
Allen: A lot of individuals are anticipating that this case may rise to the level of the Supreme Court. What’s the likelihood of that happening and what would the path be moving forward? How long would that likely take if the Supreme Court weighs in?
Harle: I mean, that’s quite the speculation because although it is a major case in terms of the impact and the significance of what this would do in terms of restoring the FDA to its proper role, the reality is the issues, like I said, they’re not in conflict with any other court ruling. They’re certainly not in direct conflict with any court ruling.
The Supreme Court is pretty slow to weigh into cases where there’s not a conflict in how courts are acting around the nation or a direct split between different federal circuits.
We always look to different factors that make something a good vehicle for the Supreme Court to take and the court doesn’t just reach out and grab cases just to get involved. In fact, the Supreme Court hears less than 1% of the cases it’s asked to take each year.
Especially on the heels of the Dobbs decision, which was a major abortion ruling, I wouldn’t expect a lot of interest from the justices to reach out and get involved in something if it can be resolved by the 5th Circuit or potentially the 5th Circuit en banc. I would hope that we are going to get a resolution there in the 5th Circuit and that will be the end of the case.
Allen: If that is the case, the 5th Circuit hears it, what’s the timeline we’re looking at there? How quickly is the 5th Circuit going to hear the case? Do we know? And then, how quickly would we get that final ruling from them?
Harle: Walking through the steps, obviously, the defendant is DOJ and then of course the manufacturer of mifepristone is this Cayman Islands company that only makes this abortion drug. That’s their whole livelihood. They’re trying to move things along very quickly. I think the consideration of the stay will be done within a matter of a few weeks at most, whether the order is paused, but also whether the order is tentatively overturned.
There’s multiple steps. One, do you immediately pause the order? Then, two, do you reverse the order itself after a little more time considering the merits? Then, the district court still hasn’t done a full trial on the merits. What would probably happen here is a bench trial where not only would the court be looking at the record, but potentially would hear witnesses and go into more depth into a full merits hearing.
I would expect if the parties can move things along quickly, it would be by the end of the summer that we would have a merits ruling from the district court and then potentially an appeal or, excuse me, inevitably an appeal to the 5th Circuit. That, again, I think would be moved very quickly. Hopefully, we would know by the end of the year, no later than that.
Allen: What, in your mind, is the likely outcome and maybe for you-all, in your mind, what’s best-case scenario? What’s worst-case scenario?
Harle: Best-case scenario for us is that the 5th Circuit hears this on the merits, agrees with the lower court. I mean, we know that there are going to be these interlocutory appeals and then a final appeal. Then, that’s the end of the story and then the Supreme Court declines to weigh in.
I feel very confident. I would actually encourage anyone who’s interested in this case to read through the court’s opinion. It’s a very easy read. It’s very clear and it’s so compelling to just go through the timeline and all of the places that the FDA violated its own rules without any excuse.
I mean, it’s a clear text of things that are required for the FDA to do and it just didn’t do them, in addition to the fact that federal law bans the mailing or shipping of abortion drugs.
In 2021, the FDA just said, “Oh, you know what? We’re going to recommend that everyone can just go ahead and mail these,” without Congress rescinding that law or repealing it or any change on that front.
Time after time, the FDA has just bent the rules on this and it’s just more of the same abortion distortion that we’ve seen in a lot of ways, I think, since Roe v. Wade.
On the merits, I feel very confident about our appeal and I would just really love a quick resolution because every day that goes by is more women and girls that are harmed and ending up in emergency rooms every single day. Enough is enough.
Allen: For anyone who wants to learn more, I encourage you both to check out ADFLegal.org, lots of great information there. Also, The Heritage Foundation website, Heritage.org. Great resources. They are breaking this down further. Denise, thank you so much for your time today and for your legal expertise and explaining this so well.
Harle: Thanks, Virginia. I appreciate you sharing the story.
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