Front Burner - U.S. abortion pill access threatened by Texas lawsuit

Episode Date: March 20, 2023

It’s been less than a year since the U.S. Supreme Court overturned Roe v. Wade and now abortions are banned in 13 states. And in several other states, abortion is prohibited after a certain length of pregnancy. But now the new frontier in the legal fight is all about the abortion pill as a Texas judge weighs arguments from anti-abortion groups who are suing the U.S. Food and Drug Administration (FDA). These groups want the judge to order the FDA to withdraw its two decades-long approval of a drug called mifepristone that’s used in abortion pills. If this happens, it could curtail access to abortion pills across the entire country. Mary Ziegler, a professor at the University of California’s Davis School of Law, shares her thoughts on this case and other efforts that are contributing to the uncertain legal landscape for the abortion pill in the United States. For transcripts of this series, please visit: https://www.cbc.ca/radio/frontburner/transcripts

In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization, empowering Canada's entrepreneurs through angel investment and industry connections. This is a CBC Podcast. Hi, I'm Jamie Poisson. It's been less than a year since the U.S. Supreme Court overturned Roe v. Wade. Most abortions are now banned in 13 states, and in several others, abortion is prohibited after a certain length of pregnancy.

But now the new frontier in the fight is all about the abortion pill. Last week, demonstrators gathered outside a federal courthouse in Amarillo, Texas, as a judge heard arguments from anti-abortion groups who are suing the Food and Drug Administration. They want him to order the FDA to withdraw its two decades long approval of an abortion pill, specifically a drug called Mephepristone. If he does this, it could curtail access to abortion pills across the entire country. It appears that the process has been politicized since the beginning. When it was approved in the year 2000, the FDA broke several of its own rules in order to approve it. This is all a part of a continued effort by anti-abortion extremists who want to use this arcane law to impose a backdoor ban on abortion.

Medication abortion is the safest and most accessible option now for millions of women across the country, not just in Texas. So it's very scary to know that women are going to be pushed into even a more difficult position when they need or want to terminate a pregnancy. It feels very discouraging. It feels like we have gone back in history. Today on Front Burner, I'm talking to Mary Ziegler. She's a professor at the University of California's Davis School of Law. She'll take us through this case and other efforts that are contributing to the uncertain legal landscape for the abortion pill in the U.S. and what it all says about life after Rome. Hi, Mary. Thanks so much for being here. Thanks for having me. So we're talking about the legal fight over the abortion pill today.

But first, I wonder if you could just clarify what this abortion pill, Mifepristone, is and how it's used. So in the United States, more than half of abortions now take place via pill. And the standard of care is to use two pills, Mifepristone and misoprostol, to complete a medication abortion. This is, you know, not just in the United States. This is around the world, a very common and safe abortion method. They're very, very low complication rates. But I think because it's becoming most common, and it's also worth emphasizing, mifepristone is used primarily early in pregnancy, right? So this is used primarily in the first 10 weeks of pregnancy. Again, kind of a reminder that most abort of abortion for the anti-abortion movement and kind of, I think, a window into the broader abortion conflict in the United States. Yeah. And before we get into who has brought this case, this hearing in Texas,

it follows a lawsuit that was filed last year that would overturn federal approval of mefapristone. And what are the arguments that the plaintiffs are making here? Plaintiffs are making two arguments. The first involves the FDA's approval. So they're essentially arguing that the initial approval of mefapristone by the Food and Drug Administration was illegal. The lawsuit was filed by an anti-abortion group, represented by Denise Harley of the Christian Legal Advocacy Group, Alliance Defending Freedom. The FDA has one job, which is just to protect Americans from dangerous drugs.

It's caused great harm to women and girls. It's extremely dangerous. And we're asking the court to remove that chemical drug regimen until and unless the FDA actually goes through the proper testing that it's required to do. They argued that the FDA used the wrong and basically didn't have the authority under part of the law that it used to approve mifepristone, that it never really studied the safety of mifepristone, and that at various other points, it removed what this group is calling kind of necessary safeguards by loosening the hurdles to accessing Mephepristone.

The second argument involves a statute called the Comstock Act, which is a law that was passed in 1873. It was originally kind of a much broader law that dealt with, you know, obscene books like Think Anything from the Canterbury Tales to Lady Chatterley's Lover. It also prohibited mailing any device intended or adapted for birth control or abortion. The group bringing this suit is arguing that the Comstock Act also essentially means no mailing of Mifepristone, which would sort of be tantamount to no Mifepristone at all, because no one in abortion clinics in the United States or doctor's offices or hospitals is making their own Mifepristone on site, right? They're all getting

it from drug manufacturers. So there are two kind of independent claims that the judge is considering. So they're using this very old law basically to make an argument for today. What is the FDA saying about this? They're the ones being sued. And like, how are they responding to claims that, you know, the drug was rushed, that it's unsafe? The FDA is, I mean, there are lots of things that are weird about this lawsuit. I mean, it's not clear that people bringing the lawsuit have standing. It's not clear that they is even harmed by what the FDA is doing when they're essentially kind of, you know, an anti-abortion advocacy group. And then on the merits, I think the FDA is saying that there's no evidence that this drug is safe or ineffective and that most of the scientific arguments raised by the plaintiffs have been given a full airing by the FDA in previous decades and rejected. On the Comstock Act argument, the FDA is borrowing from arguments raised by the U.S. Justice Department earlier, which essentially says that the Comstock Act hasn't been interpreted broadly or as broadly as the plaintiffs wanted to be by the federal courts. The federal courts have limited it to scenarios

where there's a sort of intent to break the law. So in other words, someone who has criminal intent, not a doctor filling a bona fide prescription. And then there's a whole sort of separate set of questions of even if the judge agrees with some of the plaintiffs on these points, what authority does the judge actually have to remove a drug from the market? Because we've never actually in the United States been in a position where a judge has tried to do that. Right. So I agree. What authority, like what happens if the judge agrees with them? This is sort of unprecedented, too. Do we have any sense of what might happen if the judge agrees with them?

I guess maybe you don't know because there's no precedent. Yeah, I mean, there are a couple of different possibilities that we could see. The judge, I think, could say essentially, hey, you know, this drug wasn't properly authorized and he can't take it off the market. That's not really up to him. That's essentially would be up to the FDA. There's a pretty specific protocol that Congress laid out for the FDA to withdraw drug approval. So basically, the judge could say, hey, you know, the FDA needs to start this withdrawal process, but it's not clear the ultimate authority to actually do that would remain in the FDA's hands. The other thing that the judge could do essentially is to say, Mifepristone was unlawfully approved, so then it would be an unapproved drug.

But then, you know, the question would be, well, okay, well, what does that actually mean in concrete terms? And the FDA is the agency that enforces whether drugs are unlawfully approved or not. So then the question would be, well, what does the FDA do? The FDA could say, we agree this is an unlawfully approved drug and we're going to use all of our resources to come after people who are distributing it. That's not very likely under the Biden administration. after people who are distributing it. That's not very likely under the Biden administration. They could issue what's called an enforcement discretion letter and say, you know, we think Mifepristone is safe. And so while the judge said what they said, we're not going to spend a lot of time trying to go after people who are doing this. We're going to just, you know, keep a hands-off position. If the FDA does that, you could imagine that doctors may continue to prescribe mifepristone. Companies that are manufacturing it may continue to manufacture it, but, you know, that would create a lot of uncertainty, I think.

Yeah, I want to get into that a little bit more with you in a minute. There's also a possibility that access to the drug could be put on hold, right? While proceedings move forward. Am I right about that? I think that the complicated thing is, you know, how much authority does the judge have? And then I think the secondary question is, even if the judge doesn't have the authority to kind of freeze access to the drug, are people going to want to test that, right? So, I mean, there's going to be really complicated questions here about what the judge can make the FDA do and what the FDA is actually going to want to do in response to the judge. And then what other parties who aren't even involved in the case, like doctors or other drug companies, are going to do. Like, how are they going to react to a decision by the judge? Because it's not clear he has the power to do any of this stuff. But what we've already seen in the United States is sometimes that doesn't matter because people are afraid of legal consequences. Right. So if there's any uncertainty, the access to the drug might be cut off nationwide while this suit moves up through the courts. Yeah. And of course, that would have real world consequences, some of which we're going to get into soon. But you've

alluded to this group that's behind this lawsuit. I just wonder if you could tell me a bit more about them. This Texas-based group, Alliance for Hippocratic Medicine, this is one of the groups bringing the lawsuit. And just who are they and what are their ultimate goals here? Well, the Alliance for Hippocratic Medicine is one of several groups that represent doctors who are opposed to abortion. And they're being represented by the Alliance Defending Freedom, which I think is just as important a part of this lawsuit as the actual Alliance for Hippocratic Medicine. The Alliance Defending Freedom is probably one of the largest, richest conservative Christian litigation shops in the United States. They bring cases not just on abortion, but on a variety of LGBTQ issues,

too. They have a case pending for the U.S. Supreme Court now about religious businesses withholding services to same-sex couples, for example. While the Alliance for Hippocratic Medicine is part of this kind of ecosystem of anti-abortion medical organizations, this suit is also part of this much bigger conservative Christian litigation effort that goes, you know, beyond even just the abortion issue. And it tells you a lot that there's been, you know, like I said, this very wealthy, very sophisticated conservative Christian litigation group leading the charge here. charge here. And the judge who's hearing the case, Matthew Kazmarek, is a federal judge appointed by Trump when he was still president. And much has been said about this judge as well. And so what

else do we know about his background? Well, Judge Kaczmarek has direct ties to the anti-abortion movement. Kaczmarek has ties to the conservative Federalist Society that date back to his law school years when he attended meetings. Between 2015 and last month, Kaczmarek spoke at 10 Federalist Society events. When he was a college student at Abilene Christian University, he wrote a column for his school paper endorsing a Republican Party platform that would support fetal personhood. He has done work with anti-abortion organizations and homes for women who are having children

outside of marriage. His sister has said, you know, to the media that she believes he was sort of put in the position he's in for a reason. Judge Kaczmarek's sister told The Washington Post his beliefs are strongly held and there's no reason to doubt that. Quote, he's very passionate about the fact that you can't preach for life and do nothing. Before he was nominated to the federal bench by Donald Trump, he had a history of working with conservative Christian litigation groups, not directly with the Alliance Defending Freedom, but with organizations like it. And what's significant is that it's not just some silly, funny coincidence that this case came before Judge Kaczmarek. The way Texas divides

up its district courts, there are some scenarios where, for example, if they filed the suit in Dallas, there would be several different district judges who might hear the case. But if they filed the case in Amarillo, where Judge Kaczmarek presides, the only judge who could hear it would be Judge Kaczmarek. It's not an accident that that's what happened because people believe that, you know, these claims were kind of a stretch. Right. And if given a favorable hearing by anybody, it would be by Judge Kaczmarek. Right. And I guess that would also explain some of the protesters outside the court in Amarillo last week. They were dressed as kangaroos and clowns calling the hearings a kangaroo court. During the four hour hearing on Wednesday, what did we hear from the judge that might give us a sense of where he's leaning? he's leaning? Well, the judge, I think, seemed a little bit, to the extent there were hard questions for the lawyers, for the Alliance Defending Freedom, they were essentially the judge recognizing that nobody, you know, had ever done this. The judge did not, I think,

kind of remarkably seem really concerned about the plaintiff's standing, even though I think that that would have been, for most judges, a concern. He seemed open to the idea that the FDA had not had the authority to approve Mifepristone and that the Comstock Act may apply. But again, there were some questions he asked about subsequent steps taken by the FDA, not just the initial 2000 approval, but some of the subsequent shifts, you know, for example, the move to making pills available through the mail or available through brick and mortar pharmacies. He was also asking questions about that, which raises the possibility that he may try perhaps not to remove mifepristone from the market altogether. Again, I don't know if he has the authority to do that, but he may not even try.

He may try to sort of attack one of the more recent decisions by the FDA regarding Mifepristone. But, you know, it's really hard to tell. One of the things that comes through pretty loud and clear in the hearing is that this is a complicated case. So, yeah, we may not get a decision as quickly as we initially were thinking. Judge Kaczmarek is famous for kind of issuing decisions at lightning speed, but he rarely deals with things that are this dense. And I'm guessing, I know we don't really know what will happen if he rules in favor of the plaintiffs, like what the FDA will do, but I'm assuming this will get appealed through higher courts too, right?

It will, and I mean, I think one of the reasons, again, ADF brought this suit in Texas is that it'll go up to the Fifth Circuit, which is widely viewed in the United States as the most conservative intermediate appellate federal court. And then from there, potentially to the U.S. Supreme Court, which, of course, has a conservative supermajority as well. You know, having said that, just because the Supreme Court has a conservative supermajority doesn't mean that any single argument raised by a conservative group will succeed, right? I mean, that's not a given. But I think, you know, ADF likes its chances as it moves up through the appellate process as well.

In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization, empowering Canada's entrepreneurs through angel investment and industry connections. Hi, it's Ramit Sethi here. You may have seen my money show on Netflix. empowering Canada's entrepreneurs through angel investment and industry connections. know their own household income. That's not a typo. 50%. That's because money is confusing. In my new book and podcast, Money for Couples, I help you and your partner create a financial vision together. To listen to this podcast, just search for Money for Couples. Mary, you said earlier that all the uncertainty creates like real life consequences, right? People are worried about possibly the possibility of being prosecuted.

And so can you flesh that out for me? Like, how could it play out? How is it already playing out this uncertainty? So the consequences in the United States of getting it wrong, if you will, of interpreting the law wrong can be really harsh, right? So if you're a physician, depending on the state you're in, if you're in Texas, just to take one example, you can go to prison for up to 99 years for doing an abortion the state considers to be unjustified. as well as civil lawsuit liability to people who help other people get abortions too. So just this week there was a lawsuit, or I am not sure if it was this week, but recently filed a wrongful death lawsuit on behalf of a man who is suing his ex-wife's friends for helping her get abortion pills for over a million dollars each and kind of implicitly accusing them of murder, suggesting

that criminal charges would be appropriate against them as well. So I think it's not clear, again, that these things will work, right? It's not clear that these people will have to pay millions of dollars or be prosecuted for murder. It's not clear if doctors invoke exceptions, for example, to save a patient's life, that they would get in trouble. But any kind of uncertainty when the wrong answer could land you in prison for 99 years or be forced to pay millions of dollars, a lot of people are not going to want to come close to that line. And I think the same kind of uncertainty could follow with the Smith-Pristone decision. If the FDA essentially issues a letter saying, hey, you know, we were told this is an unlawful drug, we don't entirely agree, so we're not going to use our enforcement

authority to come after people who are manufacturing or distributing it. I don't know if doctors or manufacturers are going to want to test that, right? I mean, they might be afraid that that won't hold or that a Republican will get elected in 2024 or the FDA will pivot or some prosecutor will do something else. Like I think when a climate of uncertainty, people don't want to test their luck. And that tends to harm patients at the end of the day. And in parallel to what's happening with this federal lawsuit in this attempt to ban the drugs through the FDA, states are taking a run at this pill as well, right? Like in Wyoming, they just became the

first U.S. state to ban the abortion pill. I believe that comes into effect in July. And can you paint me a picture of what's going on there? I mean, so a lot of states have, in effect, already banned the abortion pill by banning abortion, period. Yeah, I was a bit confused about that. The Wyoming law is the first state law to ban abortion pills by themselves. Wyoming is also simultaneously pushing through a ban that would ban all abortions, including abortion pills. So this is sort of, I think, a representative in the sense that states are banning abortion more than once with multiple laws that can also add to this chilling effect to doctors, right? Because the laws are not always perfectly harmonious. So their exceptions don't say different things. But yeah, states, I think, are targeting abortion pills. One interesting question is, you know, if states already have bans that apply to all abortions, including abortion pills, why also pass laws that focus

on the pills? I think the answer is kind of twofold. One, some of the laws are just written more broadly. And so sometimes you may see these laws passed, you know, to target a bigger group of folks. Maybe it's more people who are helping. Maybe it's women themselves or other pregnant folks. Another possibility, which I think is just important, is messaging, right? Anti-abortion groups recognize that a lot of Americans are having abortions by pill and find that that whole procedure to be less intimidating earlier in pregnancy than a surgical abortion may be. So I think sometimes these bills are designed to send the message that abortion medication is unsafe or abortion medication is polluting the environment or any number of the other messages you see coming out of anti-abortion organizations in the States. Just to loop back to some of the side effects that we were talking about today, I think it's worth us mentioning that when they talk about the side effects of this pill,

they talk about excessive bleeding and cramping, these anti-abortion groups, but these are also just symptoms of miscarriages, right? Usually the strategy, right, is you take there's something with a grain of truth. So it's true that abortion pills cause a lot of bleeding like that. That is true, usually. And they'll say abortion pills lead to more emergency room visits than surgical abortions, which is also completely unsurprising because a lot of abortion pill abortions happen at home. They don't happen in an abortion clinic or a hospital. So if you have complications after a surgical abortion, you're already going to be somewhere where you receive medical attention, where if you're having a telehealth abortion, you're not. But then they

kind of make big leaps from there to say, you know, how many more women need to die as if people have been dying? You know, pregnant miscarriage and even, you know, childbirth tend to lead to a lot of bleeding. And that doesn't necessarily mean people are dying as hell. Although I will, of course, say that people are dying of pregnancy in the United States, which has an unusually for the developed world high maternal mortality rate. Especially among women of color. So, of course, as you've mentioned, these pills are, you know, widely, widely, widely considered safe. I think it's worth us mentioning, since we're talking about the consequences of uncertainty

here, what has happened in the States with Walgreens, because that feels like another very real life tangible example. Walgreens, America's second largest pharmacy chain, has told 21 Republican attorney generals they will not be distributing mefepristone in their states. And this includes states, I understand, where it's currently legal to have an abortion. So I wonder if you could expand on what's been happening. Yeah, absolutely. So there's been kind of escalating corporate culture wars in the United States, not just on abortion, but on a variety of other issues from racial justice to climate justice. But abortion's obviously been front and center, even before the

Dobbs decision reversed Roe v. Wade. What's changed recently, of course, the FDA in January announced that it would allow brick andand-mortar pharmacies to seek certification to prescribe mifepristone. A group of pharmacies, including Walgreens, then announced they were planning to seek certification. Then a bunch of different things happened. So first, Walgreens distributor, their exclusive distributor of mifepristone, said they were not willing to distribute the drug to 31 states where they thought it would be illegal to do so. It's mysterious exactly where they got the 31 number from, because that's way more than the number of states that criminalize abortion. Walgreens itself then received a letter from the attorneys general of 21 conservative states threatening a variety of legal action against

Walgreens if they proceeded, it's worth emphasizing, again, it's not clear if any of these legal strategies would actually work. A lot of them were stretches. But Walgreens then backpedaled and said they were not going to dispense in any of the states represented by these attorneys general. And that included a handful of states that have state constitutional protections for abortion. So, for example, you know, Alaska, Montana, Kansas, and these also include places like Kansas, where voters explicitly recently signed off on the idea that they wanted to preserve abortion rights.

So not just, you know, judges saying this, but voters as well. And Walgreens still took the position that they were not going to dispense in those states. So it's a sign, again, that these kind of threats of action in the conservative federal courts are really effective, even sometimes when people think the arguments behind the threats are weak. Yeah, yet another chill. Mary, thank you so much for this. It's always a pleasure to have you on the show. Thank you so much for coming by. Yeah, of course. Thanks for having me. for having me. All right, that's all for today. I'm Jamie Poisson. Thanks so much for listening. We'll talk to you tomorrow.