Supreme Court hears arguments on abortion pill

Justice Roberts (00:00):

… versus Alliance for Hippocratic Medicine and the consolidated case. General Prelogar.

General Prelogar (00:05):

Mr. Chief Justice, and may it please the court. FDA approved mifepristone based on the Agency’s scientific judgment that the drug is safe and effective. It’s maintained that judgment across five presidential administrations and millions of Americans have used mifepristone to safely end their pregnancies. Respondents may not agree with that choice, but that doesn’t give them Article III standing or a legal basis to upend the regulatory scheme.

(00:31)
At the outset, respondents lack standing. They now concede they can’t rely on a statistical theory of injury, like the lower courts did. Instead, they have to identify a specific doctor who faces imminent harm. But their theories rest on a long chain of remote contingencies. Only an exceptionally small number of women suffer the kind of serious complications that could trigger any need for emergency treatment. It’s speculative that any of those women would seek care from the two specific doctors who asserted conscience injuries. And even if that happened, federal conscience protections would guard against the injury the doctor’s face. And there’s no basis to conclude that any of that would be traceable to the incremental changes that FDA made in 2016 and 2021 as opposed to the availability of mifepristone in general.

Respondent’s theories are too attenuated. As a matter of law, the court should say so and put an end to this case. If the court reaches the merits FDA’s actions were lawful. The Agency relied on dozens of studies involving tens of thousands of women. Respondents don’t identify any evidence that the Agency overlooked. They just disagree with the Agency’s analysis of the data before it. But that doesn’t provide a license to authorize judicial second guessing of the Agency’s expert judgments.

(01:44)
Finally on remedy. The relief entered below would severely disrupt the federal system for developing and approving drugs, harming the Agency and the pharmaceutical industry. It would also inflict grave harm on women across the nation. Rolling back FDA’s changes would unnecessarily restrict access to mifepristone with no safety justification. Some women could be forced to undergo more invasive surgical abortions. Others might not be able to access the drug at all. And all of this would happen at the request of plaintiffs who have no certain injury of their own. The court should reject that profoundly inequitable result. I welcome the court’s questions.

Justice Thomas (02:23):General, if we agree with you on standing, could you give us an example of who would have standing to challenge these FDA actions?


As a general matter, we’ve seen lawsuits in the past that are brought by, for example, prescribing physicians or patients who want greater access to a drug. Sometimes we’ve seen theories of competitor standing where a competing drug manufacturer might sue and claim that FDA’s approval of a drug creates a competitive harm or injury in that sense.
Justice Thomas, I think that if the question is whether there would be individuals who generally oppose abortion who would have standing and want to challenge FDA’s actions, the answer to that is no. But the reason is because those people aren’t regulated in any relevant way under FDA’s decisions here. Take these respondent doctors. They don’t prescribe mifepristone. They don’t take mifepristone, obviously. FDA is not requiring them to do or refrain from doing anything. They aren’t required to treat women who take mifepristone. FDA is not directing the women who take the drug to go seek out care from these specific doctors. And so they stand at a far distance from the upstream regulatory action they’re challenging. And the court has said in many cases that in a situation like that, when you are not the direct object of the Agency’s regulation, it can be substantially more difficult to establish standing.

Justice Thomas (03:47):But isn’t that sort of a criticism of some of our association standing cases and organizational standing cases?


I don’t think it is for a couple of different reasons. With respect to associational standing, this court has said time and again that the association needs to identify a specific member who is suffering a concrete harm, a cognizable injury that’s non-speculative. And I don’t take respondents now to take issue with that fact. They’re agreeing that it would be necessary to come forward and identify a specific doctor. The problem with their associational standing theories is that they rest on this chain of remote possibilities. So many different steps in the process that would have to occur, each one layering one speculative remote odds of a chance of injury on top of another to get to the ultimate harm they’re claiming on behalf of these doctors.

Justice Roberts (04:36):

Well, you emphasized the remote nature of the injury, the small number of adverse effects, the likelihood that the patients will go to the emergency room and so on. Is there a number at which your argument would change? The significant number of consequences? A higher likelihood of an emergency room visit? Doctors who spend more time in the emergency room? At some point does this analysis lead to the other result?


It’s hard for me to imagine that it could, and there are a couple of different reasons for that. I take the point that you might pick out different links in the chain and suggest that there are ways to wildly depart from the facts here and suggest maybe as a statistical matter, one or two of those events could be probabilistically more likely to occur. But we have an objection here to the underlying theory as a legal matter because it rests on so many different things that would have to happen one on top of another and that turn on independent decisions made by third parties who are strangers to this litigation who are not part of the suit.
So we think that brings the case within those like Clapper or Summers where this court has recognized that when the theory of injury really turns on so many different intervening events separated by independent decisions, it can mean that there is just an insurmountable hurdle to establishing standing.

Justice Alito (05:56):Could you provide a more specific answer to the first question that Justice Thomas asked you? Is there anybody who could challenge in court the lawfulness of what the FDA did here?

General Prelogar (06:09):In this particular case I think the answer is no.

Justice Alito (06:11):

Well, that wasn’t my question. Is there anybody who can do that? Let’s start with the states that intervened below. Will you say in that litigation, fine, you can challenge it and let’s get to the merits of this issue, the lawfulness of what the FDA did?


No, we think the states lack standing. They’re asserting indirect injuries that would, if it provided a basis for standing, mean that states could always sue the federal government and the court cautioned against that result in United States versus Texas, footnote three of that decision.


Okay. How about a doctor who opposes abortion? So she’s on duty in an emergency room when a woman comes in with complications from having taken misoprostol, and the doctor’s the only one there on duty who can attend to this woman’s problem. And as a result, in order to save her life, the doctor has to abort a viable fetus. Now, would that doctor then have standing to seek injunctive relief? Or would you say that’s too speculative, this was like being struck by lightning and it’s not sufficiently likely that this is going to happen to this doctor again?


We would agree that that would represent past harm. So we’re not disputing that that kind of conscience violation providing care in violation of one’s conscience would be cognizable. But yes, we think that that situation has never come to pass. Respondents haven’t identified any incident in more than 20 years that mifepristone has been available on the market that resembles that kind of hypothetical situation. And so yes, our view would be it’s unduly speculative and you have to think about all of the events that would have to transpire to get to that moment in time.

Justice Alito (07:48):Sure. No, I understand the argument. Now, how about a woman who suffers adverse consequences from having taken misoprostol? Would she be able to sue for damages? Or you would say that’s barred by sovereign immunity?

General Prelogar (07:59):I expect that we would have sovereign immunity arguments in that kind of case. I recognize that with respect to traceability, that’s a harder argument for us.


Okay. Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court? Who? In your view, who would have standing to bring that suit?


I think that with respect to these regulatory changes it’s hard to identify anyone who would have standing to sue. But the court has said time and again that the fact that no one would have standing doesn’t provide a basis to depart from Article III principles. It said that in Raines, in Richardson, in Valley Ford and in Clapper. And so I think it’s clear that even if there is no alternative person here who could sue, that doesn’t mean that the court should dispense with the indispensable requirements of Article III.


Okay, I understand that. And Article III is important. So your argument is that it matter if FDA flagrantly violated the law, didn’t do what it should have done, endangered the health of women, it’s just too bad nobody can sue in court.

General Prelogar (09:05):Certainly we think that these-

Justice Alito (09:06):There’s no remedy. The American people have no remedy for that.


Well, I think that it would be wrong to suggest that if FDA had made a mistake and a drug were actually producing safety consequences that there would be nothing to be done. I don’t think that these respondents could invoke Article III jurisdiction to have the court step in. But FDA takes very seriously its responsibility to ensure the safety of drugs. It conducts ongoing surveillance and can make adjustments to the regulatory regime of safety situations emerge. The drug sponsors themselves remain responsible at all times. We have a tort system in this country and that can help ensure that if there are safety problems that come to pass, the sponsors will take action in reaction to that. So if the premise here is that unsafe drugs could somehow remain on the market, I think that that’s incorrect.


Your argument here is… And as I said, I have great respect for Article III. We all do. We have to comply with it. But your argument here is that even if the FDA acted unlawfully, nobody can challenge that in court. And that’s basically the argument you made last week, in the case Murthy. We shouldn’t get to the question whether the White House and others violated the right to freedom of speech. We should just say, well, these plaintiffs can’t bring suit, right?


We are looking at the specific respondents in this case and their theories of standing. We don’t think they come within 100 miles of the kind of circumstances this court has previously identified of non-speculative harm that can create the kind of cognizable injury for forward-looking relief.

Justice Sotomayor (10:34):General, I’m assuming that if this had been unsafe in a grossly visible way, 40% more increased hospitalizations that some doctor who was prescribing it would’ve challenged the lack of an in-person?

General Prelogar (10:53):Well, no doctor is required, Justice Sotomayor, to dispense other than [inaudible 00:10:58] sense that they would have-

Justice Sotomayor (10:57):

No, but a doctor who wants to. Just like in a doctor who wants to do abortion, we have said if there’s regulations that stop them from doing it, I guess that doctor could come in and say this is unsafe, by not having people visit me beforehand, we’re not warning them, et cetera, et cetera.

General Prelogar (11:19):Certainly I think of those kinds of distinct safety concerns emerge. There would be steps taken at the Agency level. There’s nothing like that here. There’s no contrary evidence to suggest it-

Justice Sotomayor (11:29):No. I’m pondering a hypothetical.


But I do want to be clear that FDA’s regulations here don’t require doctors to not grant an in-person visit if they think that that is the best way to provide a standard of care here. So they are not directly required to dispense mifepristone through any particular arrangement.

Justice Barrett (11:46):

Counsel, can I ask you a question about the conscience injury? So that’s one of the roadblocks you identify in the speculative chain because you say a doctor could invoke federal conscience protections to refuse to complete an abortion when the embryo or fetus was still alive. So I just want to be clear, the federal government’s position is that their doctor would have conscience objections. I’m thinking about the EMTALA litigation and the Fifth Circuit criticized the government’s inconsistent positions, but it is your position that such doctors would have recourse to the conscience protections of federal law?


Yes, absolutely. And let me be clear about this because I think the Fifth Circuit did fundamentally misunderstand our arguments and respondents have repeated that misunderstanding here. The federal government has never taken the position that EMTALA would override an individual doctor’s conscience objections. We said exactly the opposite. If you go and look at our Fifth Circuit reply brief in the Texas litigation, we disclaimed that understanding of EMTALA and made clear that we understand that conscience protections to continue to apply and shield the doctor who doesn’t want to provide care in violation of those protections.

Justice Barrett (12:50):Would that be true in a healthcare desert as well?


Yes. So we don’t think that EMTALA would override conscience protections for the individual doctor. It of course imposes obligations on hospitals and hospitals have all kinds of plans in place to address these types of contingencies. They have staffing plans. I understand as a matter of best practices they often ask for doctors to articulate their conscience objections in advance so they can take account of that in staffing. They have cross staffing agreements with other hospitals. And in the government’s experience enforcing EMTALA, this is almost four decades of experience, we are not aware of any situation where there has been that kind of direct conflict between EMTALA and conscience protection.


Okay. And just one last question, this is about the association standing. So its own standing in its own right, I’m talking about not its standing that is based on an injury to one of its members. So the injuries that the association is arguing sound in the Havens Realty associational standing, and they’re the kinds of allegations we see by immigration advocacy groups, diversion of resources, increased expenses that result from the complications of having to address and explain the new changes. And I’m not talking about the expenses of filing the petition, that’s not what I’m talking about. Let’s just talk about the diversion of resources. Can you distinguish that from Havens Realty?


Yes. So I think Havens itself was trying to distinguish between two types of potential organizational injuries. And what Havens said is that in that case, the organization had come forward with direct and concrete demonstrable injury to itself, and there the organization had a contract to provide low income housing or a search to secure it for clients. And the racial steering practices directly interfered with that made it more difficult for the organization to carry out its contractual obligations. But Havens itself said that it was not blessing a theory of standing that would allow an organization to assert a setback to its abstract social interests. So I think that reflects the court trying to distinguish between more concrete, direct demonstrable harms on the one hand and that kind of abstract setback on the other hand. And I recognize and your question touches on it Justice Barrett, that some lower courts in particular have seemed to read havens to endorse far broader theories of standing, including in the immigration context.
The government has been routinely resisting standing because we think that that would essentially mean that any advocacy organization could say it opposes what the federal government is doing and so therefore has to devote resources to that opposition. If that were enough, then every organization would have standing and it would be a vast expansion of ordinary Article III principles. So we would welcome an eventual clarification from this court on organizational standing. But here I think that the organization’s assertion of injury falls in the bucket of the abstract setback and doesn’t come close to the kind of demonstrable harm that was at issue in Havens.

Speaker 1 (15:31):That’s… I’m sorry.

Justice Barrett (15:31):I’m done.

Speaker 1 (15:34):

Okay. That’s a helpful clarification. I’d like a similar, thank you, with respect to individuals. I’ve heard and listened to your argument and read the briefs, and I think I understand it. But how does it fit in your mind with offended observer standing under the Establishment Clause or some injuries about I access a park and I like to look at it in a certain way and those kinds of injuries that the court has sometimes recognized and other times cast out on.


So it’s true. I think that there are different strands of this court’s precedent and I would put the Establishment Clause precedent and First Amendment precedent generally in its own bucket because the court has sometimes recognized different theories in the First Amendment context-

Speaker 1 (16:24):Let me push back on that a little bit because standing is standing, it’s Article III, that we’re interpreting here. And so I think we’ve got to find some way to stitch it all together. And I’m looking for guidance from you.

General Prelogar (16:35):So I think the way to approach this is to, if you’re going to recognize some kind of offense or distress type of injury that to recognize that there has-

Speaker 1 (16:43):Should we… I guess is a political-


No. I mean I represent the government so I think that that kind of theory of injury would likely go far too much in the direction of allowing Article III courts to weigh in based on generalized grievances. But I guess what I would say is to distinguish the cases where this court has sometimes found that type of injury cognizable, generally it’s in a situation where there is a direct governmental action producing that type of injury. And here our argument is that the FDA’s actions in approving mifepristone specifically in 2016 and 2021, and if you’re looking at that which was an incremental change, is so far upstream of the downstream assertion of harm or distress that the respondents are asserting that there is just as a matter of law, an attenuated link here that cannot suffice for Article III jurisdiction.

Speaker 1 (17:28):Thank you.

Justice Roberts (17:29):Thank you Counsel Justice Thomas, anything further? Justice Alito?


You say that the Fifth Circuit didn’t give any reason to think that the three changes made in 2016 would be more dangerous in combination than they were individually. But isn’t that obvious that three things that may be innocuous or not excessively dangerous if engaged in by themselves may become very dangerous when they’re all done together? And why shouldn’t the FDA have addressed that?


I think the only way that that would be true would be if the three changes are interconnected and mutually reinforcing guarding against the same kind of safety risk. So I agree that if there were a reason to think that the reason why mifepristone is safe up to 10 weeks gestation is because it’s being prescribed by doctors instead of nurse practitioners for example, then those changes would be interconnected because one change would effectively be the safety net for another. But there was nothing like that in this record.

The studies that FDA examined instead demonstrated that these changes, and it was an exhaustive examination, were safe, not because there were other different safeguards in place to guard against risks, but rather because if you go up to 10 weeks of gestation, there is no observable increase in serious adverse events no matter who’s prescribing. So in the absence of that kind of correlative effect of the changes, I don’t think you can fault the Agency for not giving even more explicit attention to this issue. And it did, it cited multiple studies that combined multiple changes precisely because the standard of care had evolved over the 15 years mifepristone had been approved and many of the changes were already being deployed together safely.

Justice Alito (19:12):Shouldn’t the FDA have at least considered the application of 18 USC 1461?


So I think that the Comstock provisions don’t fall within FDA’s lane. FDA under the FDCA can only maintain restrictions under the REMS program if it’s necessary to ensure safe use. In 2021 what FDA determined is you don’t need in-person dispensing for safe use. So the FDCA did not independently require that REMS restriction. And in fact, it couldn’t be imposed once FDA had made that determination. Now that doesn’t affect other sources of law. FDA was not affirmatively approving mailing in violation of Comstock even if you interpreted it that way, and we don’t think it means what respondent suggest it means. But at the very least I don’t think that it was FDA’s responsibility to consider that. Nor could it have permissively considered that under the statute.


Well, it didn’t say any of that. It didn’t say anything about it. And this is a prominent provision, it’s not some obscure subsection of a complicated obscure law. They knew about it. Everybody in this field knew about it. Shouldn’t they have at least addressed that? You have answers to the arguments that are made on the other side, shouldn’t the FDA have at least said we’ve considered those and provide some kind of an explanation?


Well, let me give two responses. One is that I don’t think it would have even been permissible for FDA to consider maintaining this restriction because of Comstock. If you look at the relevant statutory section here, it’s 355-1-G4 this is reproduced at page 6A of the appendix to our brief, it’s very clear that the only thing FDA can take into account for restrictions are safety and efficacy concerns in deciding whether to maintain a REMS program.
But the other thing I would say, Justice Alito is that the Agency did have a memorandum on Comstock, it’s at JA535. That was the advice that FDA received from OLC conveying the interpretation of Comstock.

Justice Alito (21:05):But it got the advice from LLC, but it didn’t refer to that, did it?

General Prelogar (21:08):In the 2021 decision, no. But the REMS was then modified in 2023 and this was part of the administrative record for that.


Okay, one last question. The plaintiffs say that the studies that the FDA relied on for the 2021 amendments say that mail order mifepristone suggests more frequent trips to the emergency room. Now this is what I see as the FDA’s response to that.
“Although the literature suggests there may be more frequent emergency room care visits related to the use of mifepristone on when dispensed by mail from the clinic, there are no apparent increases in other serious adverse events related to mifepristone use.”
Does that really count as a reasoned explanation to the suggestion that the data shows they’re going to be more emergency room visits? The increase in emergency room visits is just of no consequence, it doesn’t even merit some comment?


That is a reasoned explanation. What FDA was observing in that passage is that although it acknowledged the fact that some of the studies reported additional emergency room visits, that didn’t equate to additional serious adverse events. And in fact one of the studies, half of the women who went to the emergency room didn’t get any treatment at all. Many women might go because they’re experiencing heavy bleeding which mimics a miscarriage and they might just need to know whether or not they’re having a complication. But in that kind of circumstance, the woman is not having a serious adverse event from mifepristone. And so it doesn’t call into question the safety determinations regarding the drug.
And at the end of the day, FDA carefully parsed those studies. It made specific determinations about the results to be gleaned with respect to safety and efficacy. It fully explained its decision making and I think it falls well within the zone of reasonableness under arbitrary and capricious review.

Justice Alito (22:56):All right. Thank you.

Justice Roberts (22:57):Justice Sotomayor.

Justice Sotomayor (22:58):

On that last question, because that did trouble me. But the reality is even if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the FDA, correct?


That’s right. And FDA acknowledged it, so it’s not like it overlooked this aspect of the studies. I also want to emphasize, Justice Sotomayor, that the studies were far from the only evidence FDA consulted. At the time it acted in 2021 it had real world experience during the COVID-19 pandemic, a period of time when the in-person dispensing requirement was not enforced. And FDA started by looking at, as a comparative analysis, the two periods of time when you had in-person dispensing and when you didn’t and saw that there was no relevant increase in serious adverse events or difference between those two timeframes. So that further supported the safety condition.

Justice Sotomayor (23:51):The problem with all drugs is there are complications in virtually all of them.

General Prelogar (23:56):Yes, virtually all.

Justice Sotomayor (23:56):And at what level the cost benefit analysis tells you to stop prescribing something is a very difficult question, isn’t it?

General Prelogar (24:05):That’s a question that Congress has entrusted to FDA.

Justice Sotomayor (24:08):But putting that aside here, whatever the statistical increase was, FDA determined under the REMS standard that it wasn’t sufficient to create a risk that counterbalanced the need for access. Correct?


Correct, because FDA is instructed to take into account burdens on the healthcare delivery system as well and it looked at a variety of sources of data to conclude that on balance the burdens suggested that it was not necessary to keep this restriction in place to ensure safe use.

Justice Sotomayor (24:39):Thank you.

Justice Roberts (24:41):Justice Kagan.

Justice Kagan (24:42):

General, if I could take you back to the discussion that you were having with Justice Barrett about the conscience objection and just ask you, I’m sure that you’ve read the declarations carefully and I’m sure Ms. Hawley will have things to say about this too, but as you read those declarations, what is the conscience objection? What are the doctors objecting to exactly?


I think the declarations are specific on this point. There are only seven doctors who regularly practice and submitted evidence and the declarations are relatively short. This is at JA 150 to 200. I encourage reading them because there are only two doctors out of the seven who even provide any information about their specific conscience objections.

Justice Kagan (25:25):Those two are who?

General Prelogar (25:26):Those are, Dr. Skop and Dr. Francis. The relevant language for D-

Justice Kagan (25:29):The other five don’t refer to conscience objections?


They don’t refer to their own conscience objections or provide any specific detail about exactly what care would violate their conscience. Dr. Francis is at JA 155, Dr. Skop is a JA 167. Both describe the injury in the same terms. They object to ending the life of a human being in the womb and fear that they might have to complete an abortion for a woman who has an ongoing pregnancy.


As you understand those declarations, they do not object to providing whatever care is necessary to a person who may have complications from taking Mifepristone? In other words, for example, suppose somebody has bled significantly, needs a transfusion or any of a number of other things that might happen. As you understand the declarations, there’s not an objection to that?


I think that the fairest reading of the declarations is they are not objecting to that. Now, I acknowledge that respondents in their red brief have suggested there’s a broader conscience injury in play here and that there might be other doctors who have a broader concern about providing any care. Even if that broader conscience injury had been in this declaration, we think still as a matter of law, they could not demonstrate that they have a non-speculative injury in part because of all of the upstream things that would have to happen in terms of a woman having the serious event going to these specific doctors, but also the fact that federal conscience protections are specifically designed to deal with this issue and they would cover the range of conscience objections that exist in this context.

Justice Kagan (26:54):Right. There are obviously conscience objections of all kinds. I was just asking about the particular declarations of these particular members of the organizations.


Yes, and I think on these declarations they have not asserted a broader injury. But even if they could conceivably come forward with other doctors or try to adjust their declarations in some way, still that would not suffice.


Okay. Can I just ask a quick question about the merits? You open your brief with a somewhat arresting statement, but it starts with “To the government’s knowledge,” and this was written a few months ago and since then I’m sure that you’ve had lots of time to think about this case and to get all background information on it. I’ll just read you this sentence and ask you whether it’s still true to the government’s knowledge. “To the government’s knowledge this case marks the first time,” and I’m going to say is it the first time? Is it the only time? “Any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.” Is it still the only time?


That is still, to our knowledge, the only time a court has done that. We have seen a disturbing trend of court sometimes also overriding FDA’s judgment to try to grant greater access to drugs when that overrides FDA’s expert judgment about what’s necessary to ensure safe use. No matter which direction you come at it from, we on behalf of FDA think that courts have no business making those judgments in the absence of the kind of arbitrary and capricious error that would satisfy the APA.

Justice Kagan (28:24):Thank you.

Justice Roberts (28:26):Justice Gorsuch? Justice Kavanaugh?

Justice Kavanaugh (28:28):Just to confirm on the standing issue, under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?


Yes. We think that federal conscience protections provide broad coverage here. Just to be super precise, there are some triggering requirements of receiving federal funding and so forth. We’ve cited the relevant provisions at page five of our reply brief. The church amendments have the most comprehensive protection here and we think that those amendments guard against the kind of injury that respondents are asserting. There are also state law protections that often apply in this context.

Justice Kavanaugh (29:05):Thank you.

Justice Roberts (29:07):Justice Barrett.

Justice Barrett (29:08):Would that be true even if the declarations were interpreted as respondents do to say that they regard any participation, even transfusions or DNCs after the abortion is otherwise complete because tissue needs to be removed?


Yes, I think that would be true. The most relevant church amendment provision is 42 USC 300A-7D, and its language says that a doctor shall not be required to perform or assist in any part of the healthcare program that would violate the doctor’s religious or moral beliefs. It’s tied to the nature of the doctor’s beliefs rather than particular procedures.


One other question, and this goes to the merits. As I understand it, the serious adverse consequences that have to be reported or that FDA considers risks are death and transfusion, but not say, I mean it seems to me and I think the data bears this out, that the elimination of the in-person dispensing requirement or the in-person visit at the outset would lead to mistakes in gestational aging, which could increase the need for a DNC or the amount of bleeding, et cetera. But that does not count, correct, as an adverse event?


I want to be careful because there’s a list of serious adverse events and I’m not sure that I have all of them down to be able to recite them to you, although they’re in the record. But I do think the premise of the question is wrong. This idea that the change to in-person dispensing would necessarily increase the risk of those events, that was not reflected in the data that FDA consulted. I would point you to JA 383 to 384 in particular, where FDA explained that even in person, you’re not necessarily getting an ultrasound. That’s never been required. The relevant question might be, is your provider going to ask you a series of screening questions like when was your last menstrual period in person or via telemedicine? There’s no evident reason why that difference would actually lead to different safety outcomes.

Justice Barrett (31:07):I thought that there was a small percentage increase in the tracking. I’m wrong about that? Which I may well be. You know the JA way better than I do, so…


Yeah, so I think that with respect to the ER visits, there was some evidence that there were increased ER visits, although as I explained to Justice Alito, that wasn’t actually correlated with an increase in serious adverse events. I don’t want to represent all of the different findings of the different studies because they varied a little bit, but FDA’s ultimate conclusion was that Mifepristone could safely be dispensed without in-person visits. It had voluminous evidence, I think, to support that conclusion in 2021 and there’s been no contrary evidence that’s been introduced.

Justice Barrett (31:42):There was no requirement of either an ultrasound or detecting a fetal heartbeat or anything like that even before the doctor could just go based on the woman’s recounting when her last menstrual period was?


That’s right, and that dates all the way back to the initial approval of this drug in 2000. It has never been a required condition of use to have an ultrasound. FDA has always left that up to medical judgment. Now, it is of course necessary for providers to be able to diagnose ectopic pregnancy and to date gestational age, that remains true under the REMS now. Prescribers still have to have that capability and they have to deploy whatever mechanisms they believe would accurately allow them to identify contraindications for use of mifepristone. But it’s wrong to suggest that if the Court reverses 2021 changes, then every woman’s going to get an ultrasound. That’s never been the state of play in how this drug has been administered.

Justice Barrett (32:29):How even under the pre-2021 REMS, was it possible to detect an ectopic pregnancy without an ultrasound unless the woman was presenting with pain?


There’s a set of screening questions that are often deployed. You can ask things like, “Do you have unilateral pelvic pain?”, “Did you become pregnant while you had an IUD in or after a tubal ligation?,” “Are you experiencing unusual bleeding?”. You could ask whether the woman has had a prior ectopic pregnancy. If the woman has those kinds of risk factors, then imaging may be necessary. But that remains true under the 2021 REMS as well. The prescriber has to be confident that it has excluded those kinds of conditions before prescribing this drug. The standard of care around the world, most medication abortion occurs without an ultrasound.

Justice Barrett (33:12):Thanks.

Justice Roberts (33:13):Justice Jackson.

Justice Jackson (33:14):

Good Morning, General. I’m worried that there is a significant mismatch in this case between the claimed injury and the remedy that’s being sought and that that might or should matter for standing purposes. I don’t know that our doctrines sort of capture this. But I guess I see it that the injuries that the respondents allege, as you’ve articulated them, are a conscience injury, that they are being forced to participate in a medical procedure that they object to and so the obvious common-sense remedy would be to provide them with an exemption, that they don’t have to participate in this procedure. You say, and you’ve said here several times, that federal law already gives them that. I guess then what they’re asking for in this lawsuit is more than that. They’re saying, “Because we object to be forced to participate in this procedure, we are seeking an order preventing anyone from having access to these drugs at all.” I guess I’m just trying to understand how they could possibly be entitled to that given the injury that they have alleged.


I agree, Justice Jackson, and I do think it’s relevant to standing. There’s a profound mismatch here between the claimed injury and the remedy they were seeking. You can almost think of this as a type of zone of interest kind of analysis. If the doctors have a conscience injury, there’s a specific statute designed to deal with it, to specifically tailor-made guard against the risk of that injury occurring. Instead, they’re reaching out and seeking to invoke rights under a different statute, the FDCA, that doesn’t regulate them at all, that doesn’t make them do or not do anything, and the relief that they’re seeking would dramatically alter the approved conditions of use for Mifepristone and affect women all around the nation simply because of this conscience injury that’s already directly addressed by other protections in federal law.

Justice Jackson (35:11):Right. If it wasn’t addressed, then we would see this lawsuit and the remedy would be to exempt them, right?


Yes. I mean, I think that one of the hard things about trying to tailor relief here is that they’re asserting such a diffuse theory of injury that it’s almost as though the only option was to grant a nationwide remedy of the kind the lower courts issued, and that runs counter to ordinary Article III principles of party-specific relief. But I just think it shows that there’s something wrong with the theory of injury in the first place because it’s so attenuated and because they claim they would need so much relief all over the country.

Justice Jackson (35:41):

Let me ask you another question. In addition to the challenges that we have here, the respondents below challenged the FDA’s initial decision to approve Mifepristone in the year 2000. Of course that occurred a very long time ago, the Fifth Circuit found that that challenge wasn’t timely because of the statute of limitations. As you’re aware in the context of another case we heard this term, the Court is currently considering the statute of limitations issue. Setting aside standing, have you thought about how a ruling from this court on the statute of limitations in either direction might impact what happens in these kinds of cases with these kinds of challenges?


Yes, I think that it just reflects the stakes of the Corner Post case and provides a vivid example of the way that it might be possible if this court were to approve the request for a broader theory of the statute of limitations in that case, the way it could open the door to plaintiffs coming in and saying, “Well, I only became a doctor later,” or “I only started working in an emergency room later,” and would try to unsettle longstanding agency actions that may be occurred decades previously.
I do want to say that I understand the Corner Post petitioner to have suggested maybe there would be equitable defenses that the government could raise in those kinds of cases. We would certainly want to raise that type of defense with respect to the approval of Mifepristone, which I think has generated tremendous reliance interests and proven to be safe and effective over decades of use.

Justice Jackson (37:06):Thank you.

Justice Roberts (37:08):Thank you, counsel. Ms. Ellsworth?

Jessica Ellsworth (37:17):

Mr. Chief Justice, and may it please the Court, in 2016 and 2021, FDA made certain changes to the labeling and use restrictions for Danco’s drug Mifeprix. The decision below stops Danco from selling Mifeprix in line with that scientific judgment based on a highly attenuated claim that an unknown doctor could be called some day to an unknown emergency room after a series of decisions by third parties. No facts causally link that possible future encounter to a specific change FDA made in 2016 or 2021. Respondent’s view of the Food Drug and Cosmetic Act is so inflexible it would upend not just Mifeprix but virtually every drug approval and REMS modification FDA has made for decades.
Reversal is required for two reasons. First, Article III standing is not an academic exercise in what’s conceivable. Respondents lack standing under every prong of the analysis. Second, on the merits, FDA exhaustively considered the evidence and reasonably explained its conclusions, which is what is required to do.
I welcome the Court’s questions.

Justice Thomas (38:27):The government, the Solicitor General points out, would not be susceptible to a Comstock Act problem, but in your case you would be. How do you respond to an argument that mailing your product and advertising it would violate the Comstock Act?


Justice Thomas, we agree very much with the government that FDA’s charge under the Food Drug and Cosmetic Act is limited to looking at safety and FSV considerations. That’s true for new drug approvals, it’s also true for REMS modifications. FDA routinely approves drugs whose manufacture and distribution is restricted by other laws like the Controlled Substances Act, environmental laws, customs laws and so on.
I think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies. On the merits, this issue was not presented below, excuse me, it was not ruled on below. In any event, I would also point out that in 2021, FDA’s decision allows use of brick-and-mortar pharmacies in addition to mail-order pharmacies.

Justice Thomas (39:48):

Well, my problem is that you’re private. The government, I understand the government’s argument. But you’re private and the statute doesn’t have this sort of safe harbor that you are suggesting, and it’s fairly broad and it specifically covers drugs such as yours.


Your Honor, we disagree that that’s the correct interpretation of the statute, but we think that in order to address the correct interpretation there would need to be a situation in which that issue is actually teed up. This statute has not been enforced for nearly a hundred years, and I don’t believe that this case presents an opportunity for this court to opine on the reach of the statute.


Counsel, I’d like to ask you the same questions I was posing to the Solicitor General. Our precedents, Clapper and Susan B. Anthony list, talk about requiring a substantial risk that harm will recur, and you argue that’s not present here. How are we supposed to find the spot at which the risk becomes substantial?


Your Honor, I think this court has always thought about these standing inquiries as really a question of degree. You’re trying to evaluate whether something is actual and imminent or whether it’s conjectural and hypothetical and these terms substantial risk, certainly impending, which has been used dating all the way back to 1923, get at where a claim falls in this spectrum.


Right. I mean, we toss around a lot of adjectives, but I’m just trying as a practical matter, how do you figure out? I mean, what percentage of adverse consequences would be enough? What percentage of emergency room visits would be enough?


I think the way Clapper got at that question, and you can see this in Footnote Five of the opinion, is to really think about whether there is an attenuated chain of contingencies that have to happen. In situations where there is this kind of attenuated chain of circumstances involving third-party decisions that have to play out in a particular way, and here that chain is quite long, that that squarely puts a plaintiff’s theory on the side of the conjectural or hypothetical and not the certainly impending injury.

Justice Alito (42:08):How is your company aggrieved by the challenge that is brought in this case? I gather this is, your version of Mifepristone is the only product you are currently marketing. Is that right?

Jessica Ellsworth (42:23):That’s correct, Justice Alito.

Justice Alito (42:25):The Fifth Circuit decision does not prohibit you from continuing to produce and sell that product, right?

Jessica Ellsworth (42:33):That is correct.

Justice Alito (42:35):All right. I gather your injury is that you think you’re going to sell more if the restrictions that previously were in place were lifted?

Jessica Ellsworth (42:46):Yes.

Justice Alito (42:46):You’re going to make more money?

Jessica Ellsworth (42:48):The injury is that we are prevented from selling our product in line with FDA’s scientific judgment about the safe and efficacious use of the drug.

Justice Alito (42:57):And you’re going to be harmed because you’re going to sell more?

Jessica Ellsworth (43:00):I think that certainly a company’s ability to market its product is a part of how it considers the regulatory scheme that governs its conduct.

Justice Alito (43:09):During the questioning of the Solicitor General, the statement was made that no court has ever previously second-guessed the FDA’s judgment about access to a drug, right? It’s never second-guessed that?

Jessica Ellsworth (43:31):That’s correct.

Justice Alito (43:32):Do you think the FDA is infallible?

Jessica Ellsworth (43:34):No, Your Honor. We don’t think that at all, and we don’t think that question is really teed up in any way in this case.

Justice Alito (43:40):Has the FDA ever approved a drug and then pulled it after experience showed that it had a lot of really serious adverse consequences?


It has certainly done that, and Your Honor, I think that underscores why the adverse event reporting, the post-market surveillance that FDA does, the ability that these plaintiffs have, even if they don’t have standing, certainly if they are seeing patients who are presenting with adverse events, if they are doing studies that show there is some unknown safety component that FDA should acknowledge, they can take significant steps to bring that to the agency’s attention, to bring that to Danco’s intention.

Justice Alito (44:19):But don’t you think the FDA should have continued to require reporting of non-fatal consequences?


Your Honor, the FDA decided not to continue that reporting requirement in 2016 based on more than 15 years of a well-established safety profile when that reporting was required. There is no drug on the market today under any REMS that requires the kind of reporting that the plaintiffs are saying should be reimposed here.


Why would that be a bad thing? You don’t want to sell a product that causes very serious harm to the people who take your product, relying on your tests and the FDA’s tests. Wouldn’t you want that data?


Your Honor, that data is certainly something that we are looking for all the time. It is part of the reporting obligations for a manufacturer to be aware of any data that’s becoming available through any means. We have a 1-800 number on our website, there’s a 1-800 number on the labeling.
I think Your Honor’s question though gets at a concern I heard in some of the earlier questioning about who would have standing if these plaintiffs don’t have standing. One of the things I want to note is that drug manufacturers are very frequently subject to tort litigation, product liability suit, failure to warn suits, deceptive advertising suits when someone is claiming harm from a pharmaceutical manufacturer’s product. What is so I think revolutionary really about the arguments here both on standing and the merits are the way that they attempt by individuals who do not use this product, do not prescribe this product and have a conscience right not to treat anyone who has taken this product, those individuals want to prevent anyone else from using it in line with FDA’s considered scientific judgment.

Justice Kagan (46:08):Could you go-

Justice Alito (46:10):Just one more point sort of along the same lines, does your company think that what the FDA has done preempts state laws that prohibit the dispensation of Mifepristone within their borders?

Jessica Ellsworth (46:26):We have not taken a position on that issue and it has not been teed up in this case.

Justice Alito (46:29):Well, what is your company’s position on it? You haven’t even thought about it? One of your competitors made that argument, right?


That’s right. There are some lawsuits that have been brought by the generic company that do make that argument, and I think that is for later courts to sort out. Our position in this case has been that this is about FDA’s scientific judgments reached in 2016 and 2021.

Justice Alito (46:54):You don’t want to answer that question?

Jessica Ellsworth (46:56):I don’t think we have a position that’s on that that I’m prepared to say today.


Could you go back to Justice Alito’s questions about adverse event reporting and you said you were subject, your product, to higher standards and now were being brought down to the sort of regular? Could you talk about that a little bit? What are the normal standards for adverse event reporting, as you understand them? Why are they there? What instead were you subject to in the past?


May I answer the question? Justice Kagan, what changed was not Danco’s adverse event reporting responsibility. Danco’s adverse event reporting responsibility has been the same throughout this period. What changed was that from 2000 until 2016, prescribers were obligated to adverse events to Danco and then Danco then had its separate reporting obligation to FDA.
In 2016, the REMS for Mifepristone were aligned to be more consistent with the reporting requirement that applies to all 20,000 plus FDA-approved drugs. There are only today seven REMs that continue to have even the limited higher adverse event reporting for deaths that apply to mifepristone. So it is only one of seven that have that.

Speaker 2 (48:16):Thank you

Supreme Court hears arguments on abortion pill

Supreme Court hears arguments on abortion pill access