On this episode of Life Matters, Brendan interviews Carry Severino regarding the case against the FDA brought by the Alliance For Hippocratic Medicine.
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Life Matters
The following commentary does not necessarily reflect the views of the staff and management of WBCA or the Boston Neighborhood Network. If you would like to express another opinion, you can address your comments to Boston Neighborhood Network, 302-5 Washington Street, Boston, Massachusetts, 02119. To arrange a time for your own commentary, you can call WBCA at 617-708-3215 or email radio at BNNMedia.org. Welcome to Life Matters, I'm your host, Brendan O'Connell. We had this guest on about 15, maybe 20 years ago, and she hasn't aged a bit since I last interviewed her, and she's now got a very lofty position with the judicial network in Washington, D.C., looking out on the conservative side of issues, whether it's judges or decisions and that sort of thing. We welcome Carrie Campbell Severino. Well, it's great to be here. Thanks. This was my first TV interview, now part of a long career going on TV to talk about legal issues, so I appreciate you giving me that first big breath. You're welcome. I wanted to talk to you today about the federal, the Food and Drug Administration versus the Alliance for Hippocratic Medicine, and this was a 9 to nothing decision on June 13, 2024. What do you make of that decision? I feel as if standing was used to not even get to the issues of what was really important as far as medicinally for women that are pregnant. Yeah, well, I'm sure your viewers are familiar with the case, but just to remind everyone, this is the case that was challenging, actually, the original case was challenging even more broadly, the approval of Mythopristone, RU-4E6 in the first place, because there were a lot of kind of regulatory shenanigans, shall we say, that went into getting this approved, using an emergency approval mechanism that short-cutted some of the normal procedures, et cetera, but then also challenging some later 2016 changes to the regulations that made it much more easy for women to get access to the abortion pill. And was that? It did things like increase it from making the cap at seven weeks to moving it up to ten weeks of pregnancy, making it so that doctors weren't the only ones who could prescribe the pill, that now it can be other health care providers as well. And then also making it so that doctors didn't have to even, or whoever's prescribing, didn't have to even see the women in person, which is important for so many reasons they can be screening for sexual assault, and we know that abortion is a way that a lot of people try to cover up crimes, other crimes and trafficking and things that are going on, but also screening for important health issues, like are they really below the seven-week or the ten-week guideline, or is this someone who's trying to get a quicker and easier abortion, but actually is beyond the age where it's safe for the woman, obviously, that's never safe for the child involved, right? But then also for screening for ectopic pregnancy, this would be a condition that would make it very dangerous to receive these drugs and receive an abortion through that mechanism and needs to be addressed in other way. And then finally, they also removed the monitoring that was put in place because they had used this shortcut procedure, emergency procedure to get the abortion drugs approved initially. They were supposed to be following up and checking on the adverse effects and the complications that were going on. And what the FDA did in 2016, kind of on its way out the door at the end of the Obama administration, was said, "Actually, don't even bother reporting adverse events unless someone actually dies." And that's something that is amazing in the context of a drug, that the FDA itself, the FDA who said that this is not really that dangerous and we can remove all these safeguards, it says that one in 22 women who take these drugs end up in the emergency room. And by taking away the fact that doctors were screening on the front end and then following up with their patients, it's just further increasing that burden on the emergency rooms. And that was the basis for standing in this case. So standing is this technical legal jargon, but basically what it means is, are you the right person to bring this lawsuit? We can't just go to court and say, "I don't think this law is fair or," and so I'm just going to sue because I think the law should be changed. Courts only constitutionally are federal courts, only constitutionally have the authority to hear cases and controversies. And so the standing doctrine is kind of an articulation of what makes something a real case. If you're the person who has standing, that means you are actually harmed by what's going on here, it can't just be someone off the street, it's not a real case if I just walk up and say, "This guy violated this law or broke this other guy's contract." They have to be the ones to bring the lawsuit. So what the court was looking at here is, are these the right people to even bring this lawsuit? The people that were suing in the case were a group of emergency room physicians who talked about a few different ways that they were harmed because of the expanded access to these abortion drugs and the decreased protections that FDA allowed. And one of them was just simply, these are ER doctors who have very serious things they need to deal with in the emergency room, lots of patients coming in who are in life threatening scenarios and by dramatically increasing the number of women that are coming in with these type of complications, they're taking time away from the other patients who also need emergency medical treatment. So you're increasing their burden of emergency room patients because there are so many women who are having serious hemorrhaging and other complications that go along with these drugs. And then they also talked about the potential of being brought in in violation of their own consciences to complete an abortion. Say some woman has started to take this pill, but the abortion wasn't complete. And then they're being bragooned into a violation of their own consciences being brought in to finish an abortion when that's something that they would not feel that they could in good conscience do. What the court ultimately decided in this case was that these doctors could not, were not actually the right people to bring this lawsuit. And that is a decision that was unanimous. So that means all six originalists, all three of the liberals agreed. This isn't the right, these aren't the right people to bring with the case. I think the fact that you had an unanimous, unanimous decision in the case suggests to me that, you know, while a lot of people feel frustrated, maybe this is the court just kicking the can down the road. We know there's a lot of members of the court, Justice Thomas, for example, who I clerked for. He doesn't make decisions because he's worried about, you know, poking the hornet's nest. He's perfectly willing to walk up and say, if he thinks this is the right legal decision, he's going to say it. And in this case, even Justice Thomas said, you know what? There's not standing in this case. And what that result is something that for those conservative justices is actually very consistent. The conservative justices have for a long time been very careful to make sure the court is protecting standing, fundamentally because it comes from their constitution. There are additional limits on the judicial role. Every branch has limits from the constitution. And only being able to hear cases and controversies is the limit on the judicial branch. And the conservative justices have been policing it. And in many ways, they're also often policing it from some kind of hair brain and crazy litigation strategies that come out of the left. Now, the liberal justices, I think, were not particularly consistent in their decision in this case, because just a few years ago, in a kind of flip of this case, the June medical case, which is another abortion-related case, those justices were perfectly happy to grant standing to doctors who were similarly challenging a law, but they weren't just like in this case, the doctors weren't the ones directly affected. It's the women who are seeking abortions who were affected. In that case, it was abortionist challenging, and this was, if you guys may recall, it was a case having to do with making sure that outpatient procedures had a certain high threshold of medical protections, and if you were going to do these kind of procedures, you had to have a lot of different things, making sure there was proper access to if there was an emergency and a woman needed to be evacuated, for example, different things like that. The abortions didn't want to have to meet those safety standards, so they sued, even though their patients presumably would want the safest experience possible, so any of the court allowed them to sue on behalf of their patients. I would say this was a decision that was very consistent for the conservatives who said, "You know what, abortionists don't get standing, but neither do pro-life ER doctors," whereas the liberals said, it seems like they were a lot more flexible on allowing standing when it came to an abortionist than when it comes to a pro-life doctor. The U.S. Supreme Court held plaintiffs with standing with Article 3. Can you talk a little bit about Article 3 and also about the Havens Realty versus Coleman case? I don't know if you know that one at all. There's many cases. Hey, yeah, there are. Article 3 is the article of the Constitution. We have the first article that talks about the Congress, the second article talks about President and the President and the executive branch, and the third article talks about the judicial branch. When we talk about Article 3, that's really just the fundamental, what does the Constitution say about how the judicial branch is organized. Article 3 is what sets up the Supreme Court, it's what says that the Congress can create other inferior courts that they see fit, it tells you what the jurisdiction of the Supreme Court is, and it tells you that they serve well and good behavior effectively, giving them life tenure, how they get appointed, et cetera. It's also the place, as I mentioned, that they have the limit saying they are empowered to hear cases and controversies. They only can hear cases that are actually live cases, so if a case is moot, it's already been decided or it's already too late, whatever has happened, whatever has happened and the court can't do anything else about it, the court can't hear those types of cases. If it's a case where they're just seeking an advisory rule, someone isn't really affected, they just start saying, "Hey, I'd like to know if this law is constitutional or not constitutional." The court doesn't hear those cases either because it's not a case yet until someone is really affected by it, you cannot bring the lawsuit. That's what Article III has to do. The Havens Realty case was a fundamental case dealing with standing doctrine. It had to do with the Fair Housing Act and racial steering, so the realtors were trying to steer certain races into different neighborhoods, et cetera. They might tell a black applicant that there weren't vacancies available, but telling the white applicant that there were vacancies available, so they're trying to effectively create discrimination and segregation by that. In that case, the Supreme Court did say the plaintiffs could sue, and it's interesting because they were just testers. They were testing the law. They weren't even necessarily someone who was going to move to this particular location. They just wanted to see if the law was going to be properly carried out. They also said they weren't able to say, "Hey, we aren't able to have the benefit of living in an integrated community. That's enough of a harm for them." That's just a historical case that talks also about the standing doctrine as well. It's an example of some of the complicated ways that standing can play in because you do sometimes have standing cases where you have to decide what is the adequate level of harm against the individuals involved that would give them standing. In this case, I feel like the court unanimously agreed this wasn't sufficient harm. That's not to say it was an open and shut case. I think it was understandable given how complicated the court's standing doctrine is, that the Fifth Circuit below thought they did have standing. Just recently, just within the last decade, the court said that abortionists have standing. I think what really happened here is, at first, the makeup of the court has changed. We have more originalists who are more protective of making sure the court stays within its constitutional limits. You have the liberals who it looks like turned on a dime to suddenly flip from saying we should have broader standing, we're not going to have broad standing rights when it comes to pro-life litigation. Can I ask the FDA's actions violated the Administrative Procedure Act? That was what the, I think, the app log and their group, what are the Alliance for Hippocratic Medicine, I should say? What is the Administrative Procedure Act and why would the Alliance for Hippocratic Medicine bring that topic up saying that FDA violated it? So the Administrative Procedures Act is a law that was enacted to help regulate this whole administrative state we have. We talked about Article 1, 2, and 3 of the Constitution. We've got the 3 branches, but we have this extra growth on our government that has expanded over the last century, and that's really the Administrative State. It's all of these agencies, some of which officially are located in the Executive Branch, some of which are kind of in awkward places in between some of the other branches, but the FDA is one of them. It's the Department of Health and Human Services, and they oversee a lot of different laws, including some of our drug laws. The Administrative Procedure Act says, it just outlines the procedures that are required by these agencies to put out regulations or to take regulatory action like, for example, approving a drug for sale, and one of the things it says is that agencies have to, in certain circumstances, they have to provide notice and comment so that people have, if they're going to have a new regulation, which effectively has the force of law, but it's not being passed by Congress, so the APA is a little bit there as a backstop to try to make sure there's some accountability. It's pretty minimal on regulatory agencies, but making sure there's something to say, "Okay, people have notice of what the government's going to do. They have the opportunity to comment, and then the agency has to at least respond to these comments." If they don't, or if they don't take into account obvious factual issues, then they can be sued under the APA, and one of the grounds for which they could be sued is that they are acting arbitrarily or capriciously, that they didn't have sufficient evidence for what they were doing, and so that's one of the things the Alliance for Hippocratic Medicine was saying, is they didn't comply with APA procedures because how could you remove all of these protections that the FDA had initially put in place for the use of mipapristone without having adequate evidence, and they were saying, "Oh, well, we were going along just fine." Well, yeah, but you were part of the reason that the complications were even as low as they were, and as I said, they still were. There were stills a very high number of complications, and there have been dozens of women who died from these drugs. Even with that number of complications, it was partly kept that low because of these protections that then FDA went back and said, "Actually, on second thought, we don't need these anymore. We don't need a doctor to see the woman beforehand, and we don't need him to check out on her afterwards, and we don't need to be a doctor, and we can just distribute this versus telemed." And then, of course, during COVID, they even were starting to mail it across state lines, et cetera. And they eliminated... The argument is, this has now gone far beyond being a reasoned decision, because now you're just throwing a wide open the doors without adequate evidence to support the idea that it's going to continue to be reasonably safe for women to use. And did they use AMTALA for this decision, because I know in the Idaho decision, and maybe we can talk about the Idaho decision, they were banding that about an Alito dissented significantly. Do you know about that? Yeah, the AMTALA... Yeah, that was the other major abortion case that was considered this term. And this was... This case came out of Idaho. Idaho had a very good pro-life law that was very protective of life. I believe it was a six-week ban on abortions after six weeks. And immediately, obviously, after the Dobbs decision, after Roe versus Wade was overturned, the Biden administration decided they were going to do everything they could to still find ways to get as many women having abortions as possible. So they've talked about a lot of things, whether it's having abortions from military places, whether it's any way they can backdoor fund this in prisons, but also they're using AMTALA. Now, AMTALA is a law... I'm trying to remember the specifics, the emergency... Medical. Medical labor. Anyway, the design of this law is to make sure that people going to an emergency room, who maybe don't have adequate health care, emergency room can't just turn you away. If you are an emergency room and you're receiving federal funding, which I probably almost all medical emergency rooms in the country are, right, then you have to abide by this law, which says if someone comes, you have to at least stabilize them. And what's so interesting about this law is when it was passed, they actually had pregnant women, particularly in mind, because that's an area in which a lot of people who might not have insurance, nonetheless, are going to need to deliver their baby at some point, right? And it's something that the hospital doesn't make a lot of money on, and yet this woman could be here for hours. I mean, my first child worth 28 hours, right? They don't want to take up all this space, all this money on someone who's not... They know isn't going to be able to pay. So there was an incentive before AMTALA to just kick pregnant women down, go walk down, go down the street to the next hospital, and then you've got this woman in labor being kind of ping ponged around different hospitals. So they specifically said that you have to take pregnant women and that when you have a pregnant woman, you have to not just stabilize her, because they could say, "Oh, she's stable. She's fine." But you have to also stabilize the unborn child. So what's so perverse about what the Biden administration is doing here is they were taking a law, one of the laws in our country that specifically recognizes the life of the unborn child and says you have to treat them as a patient and stabilize them. And they were trying to use that as a way to force Idaho to perform abortions. The way they did this is they said some women who are coming to the emergency room are the only way to stabilize them to prevent serious harm or potentially maternal death is to provide the abortion. Now, Idaho's law does provide for maternal life, a maternal life exception. And I think a lot of people from a moral standpoint, obviously there's a big difference between trying ending a pregnancy if the woman's life is in danger, but you're trying to do what you can to save the child and actually performing an abortion. But setting that aside for the purposes of the statute, this would not be, if the woman's life is in danger, that would not be covered by the Idaho ban. So you'd be allowed to do it. But the government was saying is no, there are cases where a woman, her life isn't really yet in danger, but she needs the abortion now. And if they allowed her to continue in labor or in this pregnancy, she could potentially say lose her fertility. I think one of the examples they gave was a pre, a early rupture of membranes where preclamps. That was one of them. And so you need to get, deliver the baby quickly. And if you, if it's early enough in the pregnancy, then unfortunately the child is almost no chance of survival either way, but if, but you could say, well, the woman isn't, her life isn't at risk, but maybe if you don't, if you don't do the delivery quickly enough, her, she may lose her uterus, she may lose her ability to bear a future child. So that was the wedge they were trying to drive and say, well, Idaho's law doesn't cover this. But, and Tala does, so in these circumstances, in these very narrow circumstances, you do need to perform an abortion, and therefore federal law trumps. And so you have to be able to, to do this, and then the case, yes, go on, well, that federal law, Trump in other states, well, in other words, go kind of, well, yeah, well, I mean, they're going to argue that in any state that that that law is going to Trump. I think in every state, though, the details might be slightly different because, and this is one of the, one of the things that sort of doomed this case, a, a, a, the law was a little bit of a moving target during the litigation, it was that they actually revised the law a couple of times. And the government and, and Idaho, in such a, to some extent, seem to be changing their positions throughout. So one of the things the government did when they came to the Supreme Court is they, they actually, in a, in a, because of they had to do so defensively, they actually argued there was a very strong argument for conscience protections because that was another, another area that the, that people were, were saying, hey, there's doctors that if MTALA is really this strong, you're going to be forcing doctors against their consciences then to perform abortions if their hospitals aren't to lose Medicaid funding. And that's, that's pretty dramatic. And the government said, oh, no, no, no, we have all these wonderful conscience protections, we absolutely are going to respect. So that was one of the areas that the government conceded or at least, you know, said in the course of litigation, they're going to concede, I, I, I, not super optimistic they're going to do it in real life because they haven't actually been protective. The federal government, the federal government. The federal government. Yeah. This is the federal government suing Idaho. So Idaho is defending its law. The federal government wants Idaho to also allow a significant number of, or what they say is a very small number of other abortions, but I think what, what they want to do is just create a wedge and then hopefully they'll be, their goal is to, is to get as many women in there as possible. But the court ultimately did is they said, look, we took this case, it went, it was argued, it went all the way up to almost the end of the term, but they ultimately did what they call dismissed as improvidently granted. And that means the court was saying, what's actually, we probably shouldn't have taken this case in the first place, why don't you go back to the lower courts? Because when the court took the case, it actually hadn't gone through the whole normal process. Normally you have the trial court, you have the appellate court, and then you have the Supreme court, they jumped in before they were able to finish the normal court, that normal course. So the court didn't really have all of the factual development that they would normally have and all of the legal development that they would normally have at that point. I'll pull that with some of the changing positions in the case, the government's changing statements about its protection of conscience rights. And the majority in the court said, look, we're not even sure how much of a conflict there is anymore between Idaho's law and the federal government's position. Let's send this back, we probably shouldn't have taken this. Justice Alito, as you said, had a very powerful dissent in that case. And he said, look, maybe we shouldn't have taken this case, but at this point, we have had all the arguments. Let's decide the case and move forward rather than just, maybe it was our bad in the first place, but we need to decide this issue because it's really pressing and it's very significant. And he particularly took issue with, which I think was the most egregious part of the case. The fact the court changed the injunction. Originally, I think the Ninth Circuit had put an injunction in place on the Idaho law, saying Idaho can't enforce its ban on abortions. Then the Supreme Court jumped in and said, actually, we're going to stay that for now. And we're not going, we're going to say Idaho can continue to enforce its law and continue to protect fetal life while the case goes on. What the Supreme Court did is moved it back so that Idaho now cannot enforce its law or at least cannot enforce it as to these women who might fall into the federal government's EMTALA definition. And that I think was not the right legal decision at all. They basically said, well, Idaho, it's not a huge number of abortions. We first thought it was a huge number of abortions that was going to happen now based on what the federal government's saying, it's not that many. And so it's not what they would call, this is a significant enough harm to the government. The government's interests here are in protecting fetal life. And I think the court incorrectly concluded, you know, there's not a lot of additional fetal life being lost here. So that's not irreparable damage to Idaho. I would say, of course it is. They're trying to protect fetal life and you can't, obviously you can't undo an abortion, right? This is something that they can't go back and protect their citizens the way that they, their legislature and their citizens have determined they want to. And so there certainly is irreparable harm to Idaho. If you don't have to have something that virtually nullifies the law for it to be preempting the law in a way that's irreparable harm. So I was very disappointed the court didn't leave the injunction at least in place. But, you know, silver lining, the decision because it was made, it wasn't really presidential in any way. It's now going to continue to go back to the procedures in the lower courts and eventually may make it back. We, you know, we may be next year talking about the same case, but with the benefit of further briefing and further elaboration of the lower courts. Well, Carrie Severino, thank you so much for explaining that to us. And I think it's important for people to follow these cases and what it really means for the pro-life baby movement and for, for having children being born alive. So thanks so much again, Carrie. And folks, we hope you found today's show to be unique and formative content rich, truthful and thought-provoking. Thanks for watching and listening. My name is Brendan O'Connell. You're a friend for life. The proceeding commentary does not necessarily reflect the views of the staff and management of WBCA or the Boston Neighborhood Network. If you would like to express another opinion, you can address your comments to Boston Neighborhood Network, 302-5 Washington Street, Boston, Massachusetts, 02119. To arrange a time for your own commentary, you can call WBCA at 617-708-3215 or email radio@bnandmedia.org. [BLANK_AUDIO]