Courthouse Steps Decision: FDA v. AHM

Chayila Kleist: Hello and welcome to this FedSoc Forum webinar call, today, June 24th, 2024. We're delighted to host a Courthouse Steps Decision program on The Food and Drug Administration v. The Alliance for Hippocratic Medicine, which was decided recently by the court. My name is Chayila Kleist and I'm an Associate Director of Practice Groups here at the Federalist Society. As always, please note that all expressions of opinion are those of the experts on today's program as the Federalist Society takes no position on particular legal or public policy issues. Now, in the interest of time, I'll keep my introduction of our guests today brief, but if you'd like to know more about any of our speakers, you can access their impressive full bios at FedSoc.org. Today we are fortunate to have with us Adam Unikowsky, who is a partner in General Block LLP's Appellate and Supreme Court Practice Group, where his areas of focus include life sciences, appellate and Supreme Court litigation, Communications, Internet and Technology, Native American Law, and Aerospace and Defense Law, among others.

 

Prior to joining General Block in 2011, Mr. Unikowsky served as judicial law clerk to former Justice Antonin Scalia. He also previously clerked for Judge Douglas Ginsburg on the US Courts of Appeals for the DC Circuit. Also, joining us today is Megan Wold, who is a partner at Cooper and Kirk LLP. Ms. Wold previously served as the Simon Karas Fellow and Deputy Solicitor General in the Ohio Attorney General's office. She also previously practiced as an associate at Bancroft PLLC, and as a partner in the Washington DC office of Kirkland and Ellis LLP. Ms. Wold served as a law clerk to Justice Samuel Alito of the US Supreme Court, and to Judge Jeffrey Sutton of the US Court of Appeals for the Sixth Circuit. Finally, joining us today is our moderator for today's conversation is Professor Teresa Collett, who is a professor of Law and Director of the Pro-Life Center at the University of St. Thomas School of Law. 

 

She's an elected member of the American Law Institute and testified before committees of the US Senate and House of Representatives as well as before legislative committees of several states. She also served formerly as a Special Attorney General for the states of Oklahoma and Kansas, and prior to joining St. Thomas in 2003, Professor Collett taught at South Texas College of Law. She established the nation's first annual symposium on legal ethics, and I'll leave it there. One last note and then I'll get off your screens. If you have any questions, please submit them by the question and answer feature found at the bottom of the Zoom screen so it'll be accessible when we get to that portion of today's webinar. With that, thank you all for joining us today. Ms. Colett, the floor is yours.

 

Teresa Stanton Collett: Thank you very much. I'm delighted to be a part of this program and excited to hear what our panelists have to say. We are discussing a case that I believe has been widely in some ways misreported in the press, in part because it turns on what some have been calling a legal technicality. And so rather than take up time with my comments on it, I will turn to our panelists who have some opening statements to sort of explain how they read the case itself. Adam?

 

Adam Unikowsky: Thank you for that introduction. So I'll probably just talk for a couple of minutes. I'll begin by summarizing what the case was, what the Supreme Court held, and what the implications of the ruling are. And then I'll very briefly editorialize a little bit about what I think about the ruling, which is maybe the more interesting part. So most of you know what the case is about, but for those who don't, the plaintiffs are organizations of pro-life doctors, as well as a few individual pro-life doctors. They filed a lawsuit in the Northern District of Texas alleging that the FDA had acted illegally in approving mifepristone - which is a drug that causes abortions - in 2000, and alternatively arguing that the FDA acted illegally in loosening certain conditions of use through a series of orders in 2016, 19 and 21. And the plaintiffs, of course, to establish their entitlement to any relief at all, must have Article 3 standing.

 

And so the plaintiffs are doctors that do not prescribe mifepristone themselves. They're not required to, and they never alleged that they did in fact prescribe it. Their theory of standing was a little bit different. Essentially their theory of standing turned on injuries that would result if other doctors prescribed mifepristone. The theory was that if other doctors would do that, then patients would have complications and then come to emergency rooms and encounter the plaintiff doctors, whereupon the plaintiff doctors either would experience a conscience violation or would simply be expending resources on caring for the patients that they'd rather expend in a different way, and the plaintiff organizations also alleged that they had to spend time and money essentially educating people as to the harms of mifepristone, which they wouldn't have had to do if mifepristone hadn't been approved. So Federal District Court in Texas agreed with the plaintiff's arguments on both standing and the merits and held that the FDA had acted illegally in approving mifepristone back in 2000, and essentially granted complete victory to the plaintiffs. After some flurry of filings, both in the Fifth Circuit and in the Supreme Court, that order was stayed in its entirety, so it never actually went into effect as a result of the Supreme Court's order.

 

Ultimately, the Fifth Circuit partially affirmed the District Court as relevant to the Supreme Court's ruling the court held that the plaintiffs did have standing, which is what opened up the door for them to obtain relief on other issues. And the Fifth Circuit ultimately concluded that the district court was correct to hold that the FDA acted illegally with respect to certain decisions in 2016 and 2021 loosening conditions of use, but the Fifth Circuit disagreed with the district court's assessments with regard to the initial approval in 2000. So in the Supreme Court, the parties litigated both the standing issue, which the plaintiffs had prevailed on in the Fifth Circuit, as well as the merits issue that the plaintiffs had prevailed on. The Supreme Court declined to hear the plaintiff's cross challenge to the issues on what the plaintiffs lost on in the Fifth Circuit, and the Supreme Court ultimately ruled that the plaintiffs did not have Article 3 standing in a unanimous decision by Justice Kavanaugh.

 

So the court walked through the three theories of standing that the plaintiff had proffered and concluded that each of them was inadequate. First of all, the plaintiffs alleged a conscience violation that they might experience, either if they had to perform an abortion or perhaps provide medical care to someone who had complications from a mifepristone abortion, and the Supreme Court rejected this argument both as a matter of law and fact. As a matter of law, the court held that there were conscience protections which ensure that the doctors wouldn't personally have to face this situation in the future. As a matter of fact, the court walked through the doctor's declarations and concluded that they didn't have any examples of situations in the past when they faced these experiences, and so they hadn't shown a sufficient likelihood that they'd have to face these situations in the future. The plaintiffs also argued that there was a conscience violation that they'd experienced if they essentially were aware of other doctors performing abortions prescribing mifepristone, complaining about complications. The court held that this type of conscience injury didn't give rise to standing. In other words, it's one thing to say "It's an injury to my conscience if I have to provide medical care", but it's another to say "My conscience is injured if I just witness other people doing things that I don't agree with." That's not enough for standing, the court held. The second theory of standing was simply that there was a risk that the plaintiffs would just have to take care of these patients in the future. And if they did that they would spend time on that, and they'd rather spend time on other things, and that was an injury. 

 

And the court held both as a matter of fact and law that this didn't establish standing. As a matter of fact, it was too speculative. There was no real evidence that this was going to happen.

And as a matter of law, I would really open the courthouse door for doctors to be able to challenge essentially any rule eliminating safety restrictions. So if a rule on gun safety were relaxed or a speed limit were increased, doctors could sue and say, well, "There's going to be more people in the emergency room. We'll have to see them, so we're going to spend time on that." And the court basically wasn't willing to open up courthouse doors in quite that way.

 

And the final theory of standing that the plaintiffs proffered was organizational standing - essentially saying that the organization themselves would be injured basically because they'd have to spend time educating people or combating the rule or advocating against it. And that would expend resources, and if the rule didn't exist, they wouldn't have to do that. As the court pointed out, that would basically obliterate all limits on standing because anytime any agency passes a rule on anything, an organization can say, "Well, we're spending money advocating against it, and so that's an injury and we'd rather spend the money on other things."

And that limitless principle would essentially allow, as I said, any organization to sue any agency over anything, and the court decided that expanded standing too far. So I'll just say one word about my views on the decision. I agree that - I view it as a victory for the separation of powers and judicial restraint. The plaintiff's theories of standing would really broaden the category of agency actions that would be challenged by private plaintiffs. I think that the premise of Article 3 is that the role of the courts is to address legitimate grievances by people who have rules that personally affect them, but when plaintiffs basically disagree as citizens as opposed to individual litigants, the correct remedy is the political process and not litigation, and that I think is the principle that was indicated by the court in this case. And so I'll turn it over to my colleague now.

 

Teresa Stanton Collett: Megan, please respond or give us your views of the case.

 

Megan M. Wold: Thank you. I appreciate that, and I appreciate Adam's discussion of what the opinion said. I don't really intend to add to that, he's ably covered everything that it was addressing. In this case. I filed an amicus brief on behalf of the Catholic Association along with a doctor, Dr. Grazie Pozo Christie, who is a practicing physician in diagnostic radiology, so she reads ultrasounds, which would be the most direct relevance to this case. And I wanted to say a little bit more about the purpose of that amicus brief and the information that it was conveying, in part because I think it is going to continue to be relevant in potentially the further litigation of this case, but also another case that exists in the lower courts in the Ninth Circuit, in which states are challenging these same mifepristone regulations, and that obviously changes the standing calculation - something we can talk a little bit more about.

 

But, for purposes of our amicus brief, the goal of the brief was to convey two different things, some additional factual background that was echoing and supportive of what the plaintiffs in this case were arguing. And the first was the medical background about how the deregulation of mifepristone, could lead to - not could, but does - lead to more emergency room visits from women who have taken the drug and are experiencing incomplete abortions. So mifepristone is a drug that a woman takes usually in a two drug cocktail - it's a little bit more complicated than that, but for simplicity's sake - a woman takes the drug and it causes the body to expel a pregnancy. And that process becomes increasingly risky as a pregnancy progresses. So mifepristone is supposed to be taken before 70 days of gestation, so when a woman's been pregnant for roughly two months, and the best way to date a pregnancy, in fact, the only effective and accurate way to know the date of a pregnancy - to know how far along a woman is - is through an in-person ultrasound, but the FDA's deregulation of mifepristone did away with the requirement of an in-person visit before mifepristone could be administered.

 

And so the result of that is a greatly increased risk - that women are self-assessing their pregnancies incorrectly, or with the help of a doctor, their pregnancies are being assessed incorrectly and improperly dated, causing them to take mifepristone much later than 70 days gestation - at which point the risks increase quite significantly, the risk being that the abortion might be initiated but it wouldn't be completed, and that would necessarily require treatment in an emergency room. And in fact, FDA's package insert on mifepristone says that emergency room care is the backstop for when these drugs fail to complete the abortion, which is expected in a certain percentage of cases. It's also important to note that women do experience ectopic pregnancies, which are non-viable pregnancies located in the fallopian tube rather than the uterus, and those can only be diagnosed through an in-person ultrasound as well. There are no questions you can ask a woman.

 

There are no home pregnancy tests that can tell you whether a pregnancy is ectopic and taking mifepristone in the case of an ectopic pregnancy can be very risky as well and result in the necessity of emergency room care and other complications. So for this reason, our brief was trying to elucidate further some of the factual circumstances at issue here that the FDA's deregulation of mifepristone by doing away with the requirement of an in-person diagnostic visit would increase the number of emergency room visits and complications that women face. Then the second portion of the brief is really focused on Catholic hospitals. First of all, the very high percentage of hospitals in the United States that are Catholic hospitals and some of the historical background for why that is. And these hospitals do have conscience concerns when it comes to treating women in these emergency circumstances. To be clear, Catholic hospitals will always treat women who present in an emergency regardless of whether they've taken mifepristone, regardless of how they come to be in that emergency medical situation.

 

The concern of Catholic hospitals is that there can be very fraught moral circumstances at issue. For example, a woman may come in wanting to complete the abortion but with a living unborn child, and this would create a serious moral complication for Catholic hospitals and also in the heat of an emergency some of these details may not be clear. So this was the second portion of the brief that was elucidating some of the conscience problems that would arise for Catholic hospitals. Now, there were no Catholic hospitals as named plaintiffs in the case, and as with all amicus briefs, we're not able to actually supplement the factual record. This was just some additional information. I don't read the court's opinion, and I think they're pretty explicit in not addressing these kinds of medical evidence or weighing that evidence in the case, which makes perfect sense.

 

You don't have a plaintiff with standing, so of course you wouldn't engage in the merits of the dispute, but what the court's opinion focused on was the connection between these plaintiffs and these alleged injuries, and I think it did a number of important things. I think affirming that the federal law provides conscience protections and that doctors can invoke them simply by refusing to perform medical care that violates their conscience is a helpful elaboration by the court. It wasn't entirely clear how those conscience protections would apply or how EMTALA - another statute at issue in another case before the court right now - would affect conscience protections. And so the court did elaborate on those things, and I think very helpfully for people who have conscience objections to performing abortions. But for that reason, these plaintiffs couldn't assert those conscience objections because they were already protected by federal law.

 

And then I think the focus of the court's opinion was on the attenuation and the speculative nature of these injuries, some of which I was just discussing about the increase in emergency room visits, the attenuation between that connection and these plaintiffs, that they were unable to substantiate that they had been seeing these increased numbers or that they had been required to perform these additional procedures in an emergency, so I don't think that the court's decision is altogether surprising. I think it is an application of existing standing doctrines, and the court was confronted with some very difficult questions that if these plaintiffs had standing, it would be like giving a blanket, doctor-created standing to challenge any public health regulation, for example. And that's this type of generalized grievance that the court does not recognize as conveying standing. And instead that the Constitution provides political avenues for complaints like those of the plaintiffs so that they can petition Congress and the President to legislatively change things. They can petition the FDA through the appropriate channels to reregulate or otherwise change its regulation of mifepristone or challenge it in the first instance. And those are the types of relief that these plaintiffs have not through the courts and through Article 3 standing. I'm happy to talk more about that in the questions or to talk about the possibility that there would be continued litigation on this issue brought by a plaintiff with standing, but for now, I'll leave it there.

 

Teresa Stanton Collett: Megan, is it also true though that, at least in one of the declarations filed by one of the physicians, while she herself had not encountered a woman coming into the emergency room who still had a live pregnancy, one of her partners had where the child, they detected the heartbeat and the doctor felt in order to stop the hemorrhaging that was caused by the mifepristone, that the only way to do that successfully was to terminate the pregnancy? Could you explain to the listeners why that wasn't adequate given the nature of your brief?

 

Megan M. Wold: That's right. I believe that was Dr. Francis who did have in her declaration a description of what she had witnessed or was aware of happening to a partner exactly as you describe it. And I think had that circumstance happened to Dr. Francis, the court may have reached a different decision or Dr. Francis herself may have had standing, but because that hadn't happened to her, it almost in some ways confirmed the fact that in many hospital settings, there are other doctors who can and are willing to perform these procedures. And so if one doctor has a conscience objection, there's someone else who can take over. Or perhaps if these things happened so infrequently that it wasn't likely that this would happen again, it had never happened to Dr. Francis previously, I think that attenuation analysis is what caused that aspect of Dr. Francis' declaration to not be enough to confer standing.

 

Teresa Stanton Collett: And Adam, I had a friend ask me a question when I was telling them about this program and encouraging them to watch it. And the question was, how is it that we have this plethora of cases where doctors providing abortion have been granted standing - third-party standing - based on allegations of their patients, and these particular doctors don't have third-party standing? Why didn't these doctors fall into a similar exception to the general rule of third-party standing?

 

Adam Unikowsky: Well, I think the difference is that when - so it's true that many laws, abortion laws essentially say that if a doctor performs an abortion, the doctor will face certain criminal or civil consequences - and so, in those cases, the doctors are directly harmed by the state action in the sense that their actions are regulated. So the classic situation in which a plaintiff has standing is when there's a regulation that's targeting them, like "You do something, you go to jail. So obviously going to jail is an injury that affects the person that's caused by the government, if it's the criminal law that's putting them in jail. And so they have standing to challenge it. They say "I don't want to go to jail, and so I'm harmed by your law. That would put me there." Now, the third-party standing in those cases stems from the fact that the Constitutional violation is really experienced by the women.

 

In other words, the argument is, “I don't want to go to jail”, and my merits claim is that the constitutional rights of the woman who would be getting the abortion would be violated, but standing is just premised on the direct injury of those who are facing a criminal trial. The doctors in this case were not targeted by the regulation. The FDA wasn't saying, "Hey doctors, you're going to go to jail unless you do something you don't want to do." The doctors were really complaining about the collateral effects of other doctors doing things that were legal under the FDA's rules. And so that's the difference between those two due fact patterns.

 

Teresa Stanton Collett: And I think Justice Gorsuch in writing the - I'm sorry, Justice Kavanaugh - in writing the opinion, addressed that directly by saying that they were not compelled to do anything, although as Megan noted the Idaho case that will be decided this term also, raises the question about what sorts of treatments might be required. Do you have any predictions on that, either of you, Megan?

 

Megan M. Wold: It's famously difficult to read the tea leaves and predict what the court is going to do in any particular case. I am on the briefs in that case, so I'm following it very closely. And it obviously makes sense that it's going to go down to one of the last days of the term. It was a very important and significant case argued in the last week of arguments at the court. So in that sense, I'm not surprised that we're still waiting, and I think it's just difficult to say. It's really difficult to predict. I'm optimistic that the court will say that EMTALA doesn't preempt Idaho's laws, but because this case was also arising in sort of an emergency posture, there will be more factual development in the lower courts, and so I also think there might be some factual issues that the court allows the lower courts to contend with. So that's another one of these problems with predicting the outcome of decisions is not only is it difficult to predict which way the decision goes, but because of all the different ways it can be written and the complicating factors, sometimes there aren't clear wins and losses. So I think based on oral argument, I am optimistic that Idaho's law will not be preempted by EMTALA, but I also think that there might be more life to the case, and so there's going to be continued litigation about it, but again, famously difficult to predict and I don't want to be out on a limb doing that. Maybe Adam feels otherwise

 

 Adam Unikowsky: I don't feel otherwise. And it's going to come out this week, probably Wednesday or Thursday anyway, so any prediction will quickly become moot. I don't really have a prediction with any educated - I mean there's some - at oral argument, I think there was some back and forth about exactly what it is that Idaho's banned, that EMTALA would be legal. There was some confusion in the record of exactly what the gap was between EMTALA and Idaho law and maybe that's going to be worked out in the opinions. I don't know. But no, I don't really have any educated guesses.

 

Teresa Stanton Collett: You don't think Justice Kavanaugh gave us any hints in the FDA opinion?

 

Adam Unikowsky: I mean, one can infer from that anything. I dunno. He did quote the oral argument transcript in that case, but I find it very hard to - those tea leaves are pretty vague in my opinion.

 

Megan M. Wold: Yeah, I think just as Kavanaugh noted that EMTALA would only apply to hospitals, so not individual doctors, and I think that was a point that he could make without conveying what the likely outcome of the EMTALA case is. So I agree, I don't think it really gives us any better grounds for predicting than we had before this decision came out.

 

Teresa Stanton Collett: So looking at the questions that are coming in, our listeners are particularly interested in the organizational standing and the associational standing. One of the listeners asked, "Does this opinion provide any clarification on the difference between organizational and associational standing? And if so, will we see a preference for using one or the other after this case?" Do you all have an opinion on that? Let's start with Adam perhaps.

 

Adam Unikowsky: Sure. Yeah. So I think the court does cabin the doctrine of organizational standing quite a bit. So previously the doctrine had been rooted in this case called Haven's Realty, in which an organization that essentially tried to help African-American people find places to live, was held to have standing to challenge defendants who lied about the availability of housing for African-American people, essentially saying that it made it harder for them to find housing if people were lying, and so it harmed the organization irrespective of the members of the organization. And the court was essentially limited to its facts. It just has this language like "Havens Realty is a very unusual case" or something, which is kind of a signal of, "Okay, there but no further" kind of thing. And the court said that - as I interpret the decision - if you're just an organization, and all you're saying is "We don't like a rule, and so we're spending money to try to get rid of it or to try to combat it", that's not going to be enough for standing. And exactly where Haven's Realty ends and this case begins is sort of unclear, but I feel like the (unintelligible) in the opinion aren't great for plaintiffs asserting associational standing - organizational standing in the future. One word about associational standing. So Justice Thomas has a separate opinion, he wants to abolish the doctrine. Interesting opinion, characteristically thoughtful and well-written, but it got only one vote, so I don't really see a world in which that doctrine will actually go away. Maybe it'll be trimmed a little bit going forward, but I think that as of right now, people are going to still feel free to bring - organizations will still feel free to bring suits on behalf of their members.

 

Teresa Stanton Collett: Reading Justice Thomas's concurrence, I had the same feelings that I had when I read his Dobbs concurrence where he took a predictive stance on certain doctrines that no one had joined him on, and yet the media seemed to feature it as if it were almost the majority opinion regularly right after that. Megan, do you think Havens has any continuing viability now given the opinion?

 

Megan M. Wold: I really agree with Adam. It's sort of that coded language of this is an unusual case, it's a way of telegraphing to litigants that you should be careful before relying on it because it sort of stands alone, it would be difficult to replicate or here drawing this clear distinction that there were things about that case that were different than what's presented here. So I would be reluctant to rely on it, but, of course, the court is also very clear that the prerogative of overruling its own opinions belongs to it. And so I don't think we are to treat that opinion as bad law because the court quite explicitly doesn't overrule it and kind of describes why it came out the way that it did, but also why that is unusual and doesn't apply here or why the same outcome doesn't happen here. So yeah, I think it definitely is being sort of shelved a little bit and it's allowed to stay, but be careful about invoking it or assuming that your circumstances are the same. I think I'd be very, very inclined to argue that my case was exactly like that case if I wanted to rely on it.

 

Teresa Stanton Collett: So resource diversion should be an alternative theory of standing for those who are bringing suit now and not the sole theory of standing.

 

Megan M. Wold: Yeah, and I guess I would say that the part of that that makes a lot of sense is that if you are an advocacy organization, you really get to decide what you spend your money on. And I think the court says the type of advocacy theory that was being put forward here that the organizations were saying we had to conduct research to understand the effects of the mifepristone deregulation, and then we had to engage in advocacy to try to change this rule or try to argue about why the old regulation was better, why it was necessary to protect women's health. That is really an interest that just depends on the intensity of how much you care about something because anybody who really cares about a particular public issue can choose to spend money and resources on it and can even say, I'm compelled to do that by my convictions.

This is an area that I've cared about for a long time. We're a prominent organization and we need to be speaking our mind on this issue and trying to change the direction of the public conversation. That is all true. It just doesn't convey Article 3 standing and allow you access to the court. That's exactly the kind of political advocacy that belongs in the other branches of government, but it doesn't convey standing because you don't have an injury other than one of your own making, right? The choice to pay money and to advocate in this way. So I think that's the way in which it makes sense that it's not to cast doubt at all on the conviction of these organizations, just that their choice to spend money advocating on these issues can't manufacture standing to get into an Article 3 court.

 

Teresa Stanton Collett: Certainly, that's what Justice Kavanaugh said, but Adam, as I read the complaint and read the declarations regarding the organizations, their claim was - at least the organizations that represent groups of doctors only - as I read their argument, it was more that because doctors have a duty of providing sufficient information for the client to make an informed decision, and because they were concerned about the mail order abortions in particular where there's no physical exam, that they had an obligation to determine whether or not there were indeed increased visits to the emergency room, were there indeed these adverse consequences that should be part of the information provided to a woman prior to her making the decision of using mifepristone. Why wasn't that enough to give them standing? That seems to me a little different than the Pro-Life Center choosing to devote their resources to advocating in a particular case. I don't have a legal obligation, but doctors do have a legal obligation for informed consent.

 

 Adam Unikowsky: Yeah, so the Supreme Court's opinion did address that argument somewhat briefly, but there's a paragraph about it. The court says, first of all, that the associations didn't claim an informational injury. I don't know whether that's true. You may have read the complaint differently, but this is what the court said, and then the court said, in any event, federal law doesn't require the FDA to disseminate this sort of information, so it doesn't create a legal duty to disclose information and therefore the absence of information couldn't violate any legal right that the organization had. I just say one other thing about that, I mean there's a little bit of a mismatch I think between the relief that was requested and the asserted informational injury. I mean, it's true that the organizations were saying something like, well, "We need more information about the effects of these drugs in order to do these studies."

 

There's an argument, oral argument, that they were doing studies about it, but I mean they were seeking to ban mifepristone altogether or at least ban certain uses. So I mean obviously you couldn't get that information for the purpose of the studies if it was illegal anyways. So it wasn't as though the relief they were asking the court to grant them would've expanded access to information, and would've reduced the availability of information because it would've made it illegal to even do it. So I think that was - if they were just asking if they had filed a FOIA request or something or asked for some kind of rule that would expand the availability of information about complications, then maybe the litigation would've proceeded differently.

 

Teresa Stanton Collett: So given that answer in particular, we have a hypothetical pose by one of our listeners and he writes - he or she writes - "Suppose the FDA approves an antipsychotic drug that as it turns out later, increases the risk that a patient taking the drug will violently lash out at anyone nearby, including pedestrians, fellow apartment dwellers, or the like. Could a member of the public bring suit against the FDA to have the approval rescinded? Any thoughts on that?"

 

Adam Unikowsky: I don't want to - (chuckles) Go ahead.

 

Teresa Stanton Collett: Don't want to touch it? (chuckles)

 

Adam Unikowsky: I'll say one word, and then I'll turn it over. I think the court's decisions foreclose that theory, in fact, that's almost an easier case for no standing than this case, because the theory would be that anyone in the entire world could sue because anyone might hypothetically encounter someone. And that's sort of almost the paradigmatic generalized grievance. So yeah, I think, no, I think that the court basically said that you have to be harmed in a particularized way beyond the sort of increased risk that you and everyone else in the world faces.

 

Teresa Stanton Collett: Megan, do you agree with that analysis?

 

Megan M. Wold: Yeah, I think I agree with that, and I think you could kind of consider this to apply to the entire realm of public health regulations. And those can take all kinds of forms. They can be pollution and air quality, water quality, medical restrictions, medical devices, FDA approval of drugs, all of these things are going to have consequences to the public, and there's a way that we assess those consequences, their risks, and the reasonability of those risks that happens through agency determination and through the administrative processes. But again, as Adam says, I think unless there's some other special circumstance, you're very close to just generalized grievance territory where the injury that any particular member of the public experiences is the same and undifferentiated as to every other member of the public and so insufficient to create standing.

 

Teresa Stanton Collett: I think we are fortunate, as I recall, the FDA was one of the few national drug regulatory bodies that did not approve the use of thalidomide for nausea in early pregnancy several decades ago, and therefore we didn't have the large number of birth defects and disabilities that were caused by the drug that England and other countries had. So they do have a role to play in protecting the public health, but how then does - when they fail to adequately investigate in the approval process, I know that at least one of the organizations had filed a complaint about that through the agency. We don't see any discussion of exhaustion of remedies in the Supreme Court opinion. Are there any other ways when the FDA fails to adequately investigate in the approval process?

 

Megan M. Wold:

Yeah, I guess one thing I'd say is that the court obviously does not take a position on whether FDA acted appropriately and followed all of the requirements of the Administrative Procedure Act when engaging in these decisions that it made about mifepristone that do go to the merits of the case and the court did not reach the merits, so we don't have any assessment of where the court would land on that. So it's very possible that these are real problems that the plaintiffs were raising and that mifepristone was inappropriately or unlawfully deregulated at various points in the process. I think when that happens, you may have some other party with standing.

Now, the court addresses this argument of "If not us who?" and says that really never works. So if a particular plaintiff arrives at the courthouse and says, "Look, my standing might be a little shaky, but if I can't bring this case, who's going to do it? There's nobody else with standing." 

 

That's not enough to give you standing. There's no presumption that every problem that we see, every legal flaw that happens in an agency's analysis for example, is remediable in the courts, that there's something we can do about that, that a plaintiff necessarily exists. However, here, there are states that are challenging these same regulations initially in a separate case, but then the states of Missouri and Idaho, and I think maybe Kansas, I'm not sure I have the list exactly right, but a few states moved to intervene in the district court and were granted intervention. So the initial preliminary injunction, which has been stayed, does now I believe apply to those states as well or it's enforceable by those states. And the states have a different basis for standing in the case, they operate state-run hospitals, they provide Medicaid funding and other sources of funding that would be affected by the increase in emergency room visits.

 

And so at least in the state's telling, they say that the government effectively conceded that they have standing in the proceedings below. So this issue could - not just could - I would say it's very likely to come up again and it will matter how it percolates through the lower courts. For example, if the Ninth Circuit says that the state's claims even though they have standing, they fail on their merits, then you don't have any injunction applying to the prescription of mifepristone, then it's easier for the court to deny review in that circumstance if it simply doesn't want to take up the issue. But if now the intervention in the Fifth Circuit leads there to be two cases in the creation of a circuit split, well then it's more likely that you could see this case come before the court in the future. So I just think there's more to this and the issue being litigated isn't going to go away even though these plaintiffs aren't in a position to continue litigating it.

 

Teresa Stanton Collett:

And Adam, I think your explanation of why, in certain circumstances, doctors who perform abortions might be able to have third-party standing in a way that doctors who declined to actually perform the abortion and therefore are only dealing with consequences of the medication going awry or not completing the termination of the pregnancy would not have standing in that instance. But part of the concern, and you noted that the trial court originally would've enjoined the 2000 approval of mifepristone to be used in this way, and the Fifth Circuit reversed on that point, and so we don't have the Supreme Court, it was not necessary for them to address that, but there was an unusual procedure used to approve the use of mifepristone for abortion in 2000. They approved it as an emergency drug. Is the same point that you made about the remedy true for that problem also, to the extent that the FDA didn't have adequate information because of the fast-tracking they did that's been cured by the intervening years? Is that part of the reasoning you think of why it's different?

 

Adam Unikowsky: So there's a lot of things packed in there. Let me try to get all of them, but if I misunderstood your question or I'm not complete, please, please tell me.

 

Teresa Stanton Collett: Well, it wasn't very clear so - (chuckles)

 

Adam Unikowsky: No it's - so in regard to the 2000 decision, the Fifth Circuit actually didn't address whether the 2000 decision was arbitrary and capricious or not. I think the core of the holding was that the challenge to the 2000 order was time-barred, or at least it was an exhausted time-barred. Basically, 2000 is a long time ago. And the plaintiffs argued essentially that the 2016 decision by the agency had the effect of reopening the 2000 approval. And essentially the court said that's not really the case, the court. And there's some sense of that in 2016, I mean the agency didn't really consider its original decision. Sort of the premise of the 2016 decision loosening the restrictions was that the drug was safe, right? They wouldn't have loosened the restrictions unless it sort of was agreeing with its own prior determination that it was safe. So it wasn't really reconsidering, it was expanding that.

 

And so basically the court said that the 2016 order didn't really reopen the 2000 order and any challenge to the 2000 order itself was probably going to be time-barred, unexhausted and various other administrative law problems. And of course, the 2000 decision was also under a somewhat different regulatory regime. There's been various changes to the statute since then. So I think those sort of procedural barriers probably would make it difficult for other plaintiffs to bring those claims as well because I don't think that there's any plaintiff who wouldn't have a similar problem in terms of a time bar and exhaustion and things like that. And so I think that's the issue with the 2000 decision. Of course, the FDA can reconsider things on their own and those would be litigated as well. So I dunno, that was your question about that. Was there another question on the table? I'm sorry I may have lost -

 

Teresa Stanton Collett: No, I think that - your comment that you've got the remedy they were seeking in this particular case would've precluded any additional research. Here, the FDA had 16 years of experience with the drug being actively used when they made the determination to go from a more limited time period where it should be used to the 10 weeks, the different changes they've made at that point, reducing the three doctor visits down to one, those changes in 2016 reflected the lived experience with those drugs, which -

 

 Adam Unikowsky: That's right. I guess it would be a little odd to sort of reverse the 2000 decision and force the agency to reconsider it on the evidentiary record before the agency in 2000 without regard to the subsequent information. I think that would be a little bit of an artificial way of addressing the problem. And the same thing happened. It's interesting. One of the arguments that was made, which was not actually reached because of the standing holding, was that the agency acted arbitrarily and capriciously in declining and basically reducing the number of reporting obligations in 2016. That's one of the things that the agencies did that was challenged. Fifth Circuit said that was arbitrary and capricious, and then the Supreme Court didn't address that because of its ruling on standing. It would be sort of odd to say, "Well, the agency can't consider information between 2016 and today because, on the 2016 record, they didn't have enough. And so we have to sort of roll it back like that." I guess it gets questions of remedies, but it's a little odd to sort of "freeze the world" at the time that the agency made its decisions and sort of ignored all subsequent developments. That would be an unusual way of going about an administrative review.

 

Teresa Stanton Collett: So Megan, will the record - you say the record will be more developed with the state case - so that there will be a greater potential perhaps to establish not only standing but to answer some of the factual questions that appeared in this record here we've got doctors whose declarations were very clear that they were seeing an increased number of patients. Why wasn't that sufficient to establish that for purposes of standing?

 

Megan M. Wold: I think that one aspect of what's happening in the case is that doctors treat patients. That's what they do anyway. And so I am not sure that the court perceived that to be an injury - that you would continue treating patients. Maybe the circumstances of that treatment is different. More people coming in in an emergency posture than you had seen before, or more - a different percentage coming in because of having taken mifepristone as opposed to other types of pregnancy complications, changing the balance of your practice. But I don't think that was sufficient to be an injury or to be a particularized injury as to these doctors. And it does come back to this, the point the court makes about public health regulations and that the court interpreted the type of standing being requested to almost be like a specific doctor type of standing that doctors would always have standing to challenge a public health regulation if it would affect their practice in some way. And of course, doctors are working at the boundary of public health. They're encountering members of the public, and that just wasn't sufficient to convey standing for a particular individual.

 

Teresa Stanton Collett: And so, the EMTALA case is sufficiently different both in the nature of who the plaintiffs are as well as the nature of the complaint that's being made that you don't anticipate similar sort of standing objections. Is that fair?

 

Megan M. Wold: That's right. The EMTALA case arises in an entirely different posture. That case comes from the United States, the government, the Department of Justice suing the state of Idaho over its state law, commonly known as the Defense of Life Act that prohibits most abortions from happening in the state. And the federal government's argument is that the federal EMTALA statute - which is the Emergency Medical Treatment and Labor Act that requires emergency rooms that accept certain federal funding to treat all comers, whether they have insurance or not, they're required to be treated in the emergency room - and the Department of Justice's position is that Idaho's law forbids treatments - forbids performing abortions in certain emergencies where the government views it as the standard of care when that is what EMTALA requires - so it's a federal preemption argument that you have a federal law - EMTALA - that's requiring something, a state law that is forbidding the same thing, and that's an intractable problem for hospitals. They can't comply with both things simultaneously and by virtue of the Supremacy Clause, the federal law controls, that's the government's argument. And so there's no standing problem here in the same way that we have in this case, right? In this case, these were doctors challenging federal regulatory action and they needed to make a connection to that injury. Here it's the Department of, sorry - not here - In the EMTALA case, it's the Department of Justice challenging a state law because the Department of Justice believes it's preempted by a federal one.

 

Teresa Stanton Collett: Well, and as Adam noted, one of the very first things that Justice Kavanaugh disposes of is there's no action required by the doctors or the organizations in the FDA case. And here there is an action or requirement, and so it falls neatly into what Justice Kavanaugh and all the justices say is required for standing. So it seems that it's a non-issue there. I think it's also important to note that EMTALA really only requires stabilization. It doesn't require long-term care that a hospital or doctor provide, nor as I read it, one of our listeners has asked where the doctor has a professional opinion that the procedure is contraindicated or should not be performed, my understanding of EMTALA is that in fact, you would be obligated to follow your professional opinion. It doesn't require negligence, it doesn't require misconduct, rather it requires you to stabilize the patient in accordance with your best medical judgment. Is that your understanding of EMTALA also?

 

Megan M. Wold: I think in that case there are a lot of discussions back and forth between the parties about exactly what EMTALA requires and doesn't require. And so I think the kinds of things you're saying are exactly the kinds of things that the court is likely to cover in its opinion. Yes, EMTALA applies to stabilizing care. There's a dispute among the parties about whether an abortion is ever stabilizing care. Is that ever the required medical care when confronted with an emergency? So there are just a lot of questions swirling about exactly what EMTALA means and also what EMTALA's purpose is. There is another provision of EMTALA that specifically requires hospitals in an emergency setting to treat not only the presenting pregnant woman but also her unborn child. And so there's a very strong argument that EMTALA itself says that there are two patients. And so how can you also have a circumstance where it's required to harm one to save another, as is simply beyond what EMTALA is addressing. So again, there's a lot of disputes about the exact meaning of the statute, and I think those are - at least some of those - are going to be things the court is likely to cover in its opinion.

 

Teresa Stanton Collett: Adam, you have a lot of appellate experience, and Megan's answer just sort of builds upon the question that the listener asks. What is the role of these sort of professional medical associations organizations like the American College of Obstetricians and Gynecology - sorry, I think they've changed their name now - the American Congress of Obstetricians and Gynecologists, or even the Catholic Medical Association or the American Association of Pro-Life Obstetricians and Gynecologists. Do they have any sort of unique role in deciding how the law should apply or deciding what the conduct is?

 

Adam Unikowsky: I think so. I mean, setting aside Justice Thomas's separate opinion, the doctrine of associational standing is still alive and well. And so under existing law, they're free to assert the interests of their members in litigation. Assuming the other requirements for organizational standing, excuse me, are met and associational standing is very important, because many times individual doctors don't want to be plaintiffs in litigation. Maybe they don't want to be deposed, they don't want their name on the lawsuit. There's lots of reasons why individuals don't want to sue. And also sometimes individuals sort of come and go and problems with individual standings arise. And so it's much easier sometimes to pursue a lawsuit through an organization. And so organizations like that certainly can pursue lawsuits as long as their individual members can show standing. So if there's direct regulation, so if a state or something has a law that would require people to offer care contrary to their consciences or would have some other direct regulatory impact on them, maybe a state would ban them from prescribing a particular drug, ban them from particular types of counseling or treatment - I mean, a direct regulation of the doctor could be challenged via associational standing by the association - so the courthouse doors are wide open to them just like any other organization.

 

Teresa Stanton Collett: So we saw today, in fact, that the Supreme Court has granted cert in one of the gender transition cases. And one of our listeners has asked, 'Could you speak to the court statement about the broad conscience protections that federal and state law provide and possible implications for the doctors with conscientious objections to gender transition treatments?" And let me add to that, conscience objections to the denial of the opportunity to provide gender transition, because ou've got both sorts of lawsuits all over the country. Adam? Yes. I'm giving you the hard one.

 

Adam Unikowsky: Okay, sure. Yeah. So the particular case that was granted today was actually a lawsuit. It was a petition for cert by the United States, a little bit like the Idaho case, not exactly, but it sort of pitted the United States against a specific state. And in that case, the United States intervened in the lawsuit taking the position that Tennessee's law was unconstitutional and the plaintiffs in that case were individuals and the families of individuals who wanted to get the treatments but weren't able to because the state law rendered it illegal.

 

So that's a good example of a case where standing is rather obvious. I mean the state is banning something that you want to do that always gives standing. In terms of conscience objections. So there is this interesting separate line of cases about whether the state can ban something that the doctor feels like they have a conscience objection to do. There's this lawsuit in Indiana right now involving doctors who say that they have a right under the Religious Freedom Restoration Act to provide abortions even though the state would ban that. And that claim actually prevailed in an intermediate appellate court in Indiana. I think it's now going to the highest court of Indiana. That is a new frontier of litigation, which has never been endorsed by the Supreme Court or a state Supreme Court as far as I know, but those lawsuits are being filed. And so I guess I can just say I'm watching them closely.

 

Teresa Stanton Collett: And they think lawyers aren't creative. Megan, what do you think, how will the gender case will EMTALA give us any clues given that it's the federal government - that they've taken this gender transition case? What do you think?

 

Megan M. Wold: I think the issues in the two cases are different, so I would maybe want to give that some more thought. I don't know that we'll really be able to make a better prediction than we could today after that EMTALA decision comes out, but on the conscience protections, I think the first step to a doctor invoking them would need to be some kind of conflict with the law in a way in which a doctor would otherwise be obligated to treat a certain patient, and the doctor finds that that violates their conscience. And I'm no expert on the Church Amendments, but just based off the opinion in this case, there's an aspect of the Church Amendments that is abortion-specific - that doctors can refuse based on their conscience to assist or perform an abortion. But then there is also a broader protection for doctors violating their conscience.

 

And then Justice Kavanaugh says most if not all states have very similar protections as well, and the court is pretty clear. One of the arguments the plaintiffs had made is that even if we have conscience protections and we're allowed to object to particular procedures when it's an emergency context, for example, I'm the only physician on duty, things are moving very quickly, I may not be able to invoke those protections. And Justice Kavanaugh said, there really isn't anything special required for you to invoke them. You can just refuse because you are protected if you have refused on the basis of a conscientious objection. I guess I can't say for sure that that's breaking new ground, but I think that might be a clarification that was not previously made. And so that's sort of really enforcing a robust understanding of what the conscience protections are that an individual can just invoke them. Now, that would apply to the Church Amendments, but again, some aspects of those are specific to abortion, so might not apply if there was a doctor objecting to a medical transition of a minor, for example. And then to the extent that these are protections created by state law, of course they vary from all 50 states and it's possible that some states would require more than simple refusal, but there is this aspect of the opinion that says it's really not burdensome for a doctor to invoke a conscience objection. They can simply refuse to perform a medical procedure on the basis of their conscience.

 

Teresa Stanton Collett: So we want to be mindful of both your time as participants - we're grateful for that - as well as our listeners. Do you have any closing comments you'd like to make? Adam, let's start with you.

 

Adam Unikowsky: Well, first I just want to thank you for participating, and I guess I just wanted to say that I agree that the litigation on these issues is not going to end. The court said something like, "It's not clear whether other people would have standing to sue", which can mean anything. I'm aware that the states are litigating the case in the Northern District of Texas. There's some question as to whether that can continue if the original plaintiffs didn't have standing, that's one issue that will surely be litigated there. Even if they can, the states are certainly free to file lawsuits in their home districts and litigation will occur there. And legal creativity is boundless as I think all of us have learned over the years. And so I assume that people will attempt to walk through the door that the court may have left the jar. I guess so, yes, I suspect more mifepristone litigation will continue and maybe we'll have another one of these discussions next year or in a couple of years.

 

Teresa Stanton Collett: Megan, closing thoughts?

 

Megan M. Wold: No, I echo what Adam said. I think he's exactly right that these issues aren't over and we'll continue to see litigation about them and it'll be something that I am watching closely, as I am sure many of our listeners will be as well. Thank you very much for hosting and for moderating today. I think it's been a really lovely panel and I appreciate the chance to participate.

 

Teresa Stanton Collett: It's been terrific. Chayila, final directions?

 

Chayila Kleist: Absolutely, I'll take it away. Thank you so much, I'll echo the thanks already extended. I really appreciate you carving out this section of your days to share your expertise and insight. Thanks also to our audience for joining and participating. You're welcome to post your feedback by email at [email protected]. And as always, keep an eye on our website and your emails for announcements about other upcoming virtual events. With that, thank you all for joining us today. We are adjourned.