Justice Roberts (48:19):Justice Thomas, Justice Alito, anything further? Justice Sotomayor? Justice Kavanaugh, Justice Barrett, Justice Jackson, anything further?
Justice Jackson (48:27):
I just have one quick question. So you were asked if the agency is infallible, and I guess I’m wondering about the flip side, which is, do you think that courts have specialized scientific knowledge with respect to pharmaceuticals, and as a company that has pharmaceuticals, do you have concerns about judges parsing medical and scientific studies?
Jessica Ellsworth (48:51):
Yes, Your Honor. I think we have significant concerns about that. And there are two amicus briefs from the pharmaceutical industry that expand on why exactly that’s so concerning for pharmaceutical companies who do depend on FDA’s Gold Standard review process to approve their drugs and then to be able to sell their products in line with that considered judgment.
Justice Jackson (49:14):Can you say a little bit about what they say?
Jessica Ellsworth (49:17):
I’m happy to. I think the reality is, and this decision below is a good example of it, you have a district court that, among other things, relied on one study that was an analysis of anonymous blog posts. You have another set of studies that he relied on that were not in the administrative record and would never be because they post-date the FDA decisions here. They have since been retracted for lack of scientific rigor and for misleading presentations of data. Those sorts of errors can infect judicial analyses precisely because judges, they are not experts in statistics, they are not experts in the methodology used for scientific studies, for clinical trials. That is why FDA has many hundreds of pages of analysis in the record of what the scientific data showed, and courts are just not in a position to parse through and second guess that.
Justice Jackson (50:18):Thank you.
Justice Roberts (50:19):Thank you, counsel.
Jessica Ellsworth (50:20):Thank you.
Justice Roberts (50:26):Ms. Hawley.
Ms. Hawley (50:27):
Mr. Chief Justice, and may it please the court, FDA-approved abortion by mail based on data admitted was, quote, not adequate. That violates the APA. The lower court’s decision merely restored longstanding and crucial protections under which millions of women used abortion drugs. We’ve heard a lot this morning about standing. Article three is satisfied here because, one, the FDA relies on OB hospitalists to care for women harmed by abortion drugs, two, the FDA concedes that between 2.9% and 4.6% of women will end up in the emergency room, and three, the FDA acknowledges that women are even more likely to need surgical intervention and other medical care without an in-person visit.
(51:12)
According to Guttmacher, nearly 650,000 women take mifepristone every single year. It’s no surprise that respondents have experienced an increase in emergency room visits, and indeed, treated women suffering from abortion drug harms tens of thousands of times, excuse me, dozens of times, women have suffered tens of thousands of times. That respondent doctors will be forced to manage abortion harm is not a bug in FDA system, but part of its very design. Ruling against respondents on standing here would allow federal agencies to conscript non-regulated parties into violating their consciences and suffering other harm without judicial recourse. Article three neither demands nor permits this.
FDA’s outsourcing of abortion drug harm to respondent doctors forces them to choose between helping a woman with a life-threatening condition and violating their conscience. This Hobson’s choice is intolerable. On the merits, FDA failed to comply with basic APA requirements. In 2021, it eliminated the initial in-person visit based on data it says elsewhere is unreliable, and in 2016, it failed to consider or explain the cumulative effects of its wholesale removal of safeguards. These actions fall far short of what the APA requires this court should affirm. I welcome the court’s questions.
Justice Thomas (52:37):Counsel, you assert an injury on the part of the alliance of diverted time and resources. Isn’t that just the cost of litigating, of pursuing this litigation?
Ms. Hawley (52:54):
I don’t think so, Your Honor, for a couple of reasons. First, what respondent doctors have done here is chosen their particular practice, as well as structure that medical practice to bring life into the world. When they are called from their labor and delivery floor down to the operating room to treat a woman suffering from abortion drug harm, that is diametrically opposed to why they entered the medical profession. It comes along with emotional harm. Dr. Scott talks about these being heartbreaking situations and some of the most stressful work she’s had to deal with, Your Honor.
Justice Thomas (53:26):Well, I understand that, but I’m talking about the injury of having to divert resources to litigate this.
Ms. Hawley (53:35):Oh, with respect to the organizational standing.
Justice Thomas (53:37):The alliance.
Ms. Hawley (53:38):
Absolutely, Your Honor. So we think Havens Realty is on all fours with this case. The best evidence of that, I believe, is the FDA’s reply brief. The government resorts to the underlying briefs in the case to say that there was a contract and an economic harm, but this court’s case specifically said that the fact that the nature of the harm was, quote, non-economic did not prevent the court from finding an injury. In Havens, the court looked to two things, whether there was an impairment of the organization’s mission, and second, whether there was an expenditure of resources. Both things are satisfied here. If you look at how our organizations have been harmed, they’ve been forced to divert resources from speaking and advocating for their pro-life mission generally to explaining the dangers of the harm from abortion drugs. One of the primary reasons that that’s required is because, in 2016, FDA took away the requirement that abortion providers report adverse events, aside from death.
Justice Thomas (54:39):But that would be anyone who is aggressive or vigilant about bringing lawsuits. Just simply by using resources to advocate their position in court, you say now causes an injury that seems easy to manufacture.
Ms. Hawley (55:01):
So I don’t think that’s true in this case, Justice Thomas. I acknowledge that the lower courts have cabined Havens to say where you have prelude to litigation types of activities. In those sorts of cases, those resource justifications don’t count. In this case, if you look at respondents’ declarations, they note that they have performed studies, they’ve analyzed studies. Several of those are in the record and they’re not short. They comb through Medicaid data, they comb through FAERS data, so they get at the true nature of adverse events, and all those sorts of things are neither a prelude to litigation nor would they have occurred but for FDA’s unlawful conduct in this case.
Justice Sotomayor (55:38):
Counsel, in the line you quoted about economic harm, that had to do with the fact that they didn’t intend through their testers to rent an apartment, and so there was no economic loss to them or gain to them from renting the apartment, but what I think the SG is pointing to is that they provided services on their own. It wasn’t just the member services that they were relying upon, they were providing services to people to help them rent apartments. And so that’s a very important distinction from here, separate from the individual defendant’s claims of standing based on wasted resources, their resources. The organizations are not losing anything. Their job is to do exactly what you’re talking about, and they’re doing it. They’re investigating certain problems, but that’s not an injury that’s redressable by vacating this rule.
Ms. Hawley (56:48):
A couple of things, Your Honor. This court’s opinion in Havens did not rely on the economic nature at all. Again, I’d point Your Honor to the line in Havens where the court says the non-economic nature of respondents’ interest in housing, they were speaking broadly. Again, you have to dig to the underlying briefs to find the economic interest that this court did not rely on. With respect to our own injury, it’s absolutely redressable. For example, if the regulations are put back in place, the protections whereby individual abortion providers need to provide information about adverse events, that would provide our respondent organizations with more accurate information about the harms from abortion drugs.
Justice Jackson (57:30):
Counsel, can I ask you about the remedy and the way that I was talking with the SG? It makes perfect sense for the individual doctors to seek an exemption, but as I understand it, they already had that. And so what they’re asking for here is that, in order to prevent them from possibly ever having to do these kinds of procedures, everyone else should be prevented from getting access to this medication. So why isn’t that plainly over-broad scope of the remedy the end of this case?
Ms. Hawley (58:08):
With respect to the premise of that question, justice Jackson, I don’t think our doctors necessarily are able to object for two reasons. One of this is the emergency nature of these procedures. As the FDA acknowledges, many women do go to the emergency room, and if we just think about what that might look like, take Dr. Francis, she’s on the labor and delivery floor supervising-
Justice Jackson (58:31):I’m sorry, I don’t want to hypothesize. Tell me in her declaration where she talks about not being able to object or pose a conscientious objection.
Ms. Hawley (58:41):She talks about, Your Honor, being in a-
Justice Jackson (58:45):Can you point me to any place in the declarations where a declarant states that they attempted to object, but were unable to?
Ms. Hawley (58:52):
No, Your Honor, for two reasons. One is these are emergency situations. Respondent doctors don’t necessarily know until they scrub into that operating room whether this may or may not be abortion drug harm. It could be a miscarriage, it could be an ectopic pregnancy, or it could be an elective abortion, Your Honor. In addition, the government simply cannot get its story straight on EMTALA. If you look at the district court brief in that case, we just heard that the church amendment applies, and while we would love for this court to adopt that position, they told the district court the very opposite.
Justice Jackson (59:21):All right. Let me ask you this. If we were to find that there are conscientious objections that, say hospitals take them into account and these doctors do have a way to not do these kinds of procedures, should we in this case on that basis?
Ms. Hawley (59:39):No, Your Honor. We would welcome that holding, but it’s not broad enough to remedy our doctors’ harm.
Justice Jackson (59:43):Why?
Ms. Hawley (59:44):
Because these are emergency situations, they can’t waste precious moments scrubbing in, scrubbing out.
Justice Jackson (59:49):
No, no, no. I’m saying, assuming we have a world in which they can actually lodge the objections that you say that they have, my question is, isn’t that enough to remedy their issue? Do we have to also entertain your argument that no one else in the world can have this drug or no one else in America should have this drug in order to protect your clients?
Ms. Hawley (01:00:13):Again, Your Honor, it’s not possible. Given the emergency nature of these situations-
Speaker 1 (01:00:18):
Counsel, let me interrupt there. I’m sorry. I think Justice Jackson’s saying, let’s [inaudible 01:00:25] all that with respect to your clients, normally, in article three, traditional equitable remedies, we issue and we say over and over again, provide a remedy sufficient to address the plaintiff’s asserted injuries and go no further. We have before us a handful of individuals who have asserted a conscience objection. Normally, we would allow equitable relief to address them. Recently, I think what Justice Jackson’s alluding to, we’ve had, one might call it, a rash of universal injunctions or vacatures. And this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action. Thoughts.
Ms. Hawley (01:01:24):
Yes, Your Honor. Again, I have to say that I think it’s impracticable to raise a conscience objection, but even spotting that, I think that the district court remedy here was perfectly appropriate under Section 705. Section 705 grants the reviewing courts the authority to issue all necessary and appropriate relief. And as the government acknowledged an oral argument in Corner Post, when the parties before the court are non-regulated parties, the only avenue in which they can possibly get relief, and of course, that’s the sine qua non of equitable relief, is that the parties before the court get it. And that’s for, as in this case, a state issue, or another case, is a vacature. And that’s because, without that sort of relief, the very parties before the court won’t get it.
Speaker 1 (01:02:08):I think something-
Justice Roberts (01:02:09):Why can’t the court specify that this relief runs to precisely the parties before the court as opposed to looking to the agency in general and saying, “Agency, you can’t do this anywhere?”
Ms. Hawley (01:02:25):
I think, Your Honor, that might be impracticable. If we’re thinking again about the emergency room situation, would Dr. Francis, again, have to know when she’s in the emergency room whether this is a miscarriage, an ectopic pregnancy, or an elective abortion, this is what she does day in and day out. And so it seems like to say that these would run two particular plaintiffs would be missing that the FDA regulations would still be in place and permit things like mail order abortions, they would have removed the reporting requirements, and if we look at the merits of what FDA did in 2021, FDA relied on two things. They relied first on the FAERS data.
Speaker 1 (01:03:05):
Counsel, before you pivot back to the merits, and I can understand your impulse there, but I went back and looked and there are exactly zero universal injunctions that were issued during Franklin Delano Roosevelt’s 12 years in office, pretty consequential ones. And over the last four years or so, the number is something like 60, and maybe more than that. And they’re a relatively new thing, and you’re asking us to extend and pursue this relatively new remedial course, which this court has never adopted itself. Lower courts have run with this. And I just want to give you one more shot at that.
Ms. Hawley (01:03:48):
Sure, Your Honor. So again, the APA, of course, encapsulates equitable remedies, and as Pomeroy and others have said from the beginning of the 19th century, equity requires that the parties before the court get relief. In this instance, again, as the government pointed out in Corner Post, where you have non-regulated parties, those parties could be farmers, they could be ranchers, they could be the seed farms in Geertson, but their only availability for relief is if the court does something to the FDA order or regulation at issue. Otherwise, those parties are simply out of luck, and that’s inconsistent with equity.
Justice Kagan (01:04:25):
May I ask, Ms. Hawley, about your basic theory of standing? And just this is a clarification question as much as it’s anything. When you did your one, two, three in your opening statement, it sounded very probabilistic to me. I don’t remember exactly what the one, two, three are, but let’s say it’s something along the lines of, “We represent a lot of doctors and there are a lot of women out there taking mifepristone, and some fraction of them are going to have adverse events, and some fraction of those are going to come to the emergency room, and so there’s some probability or likelihood that one of our doctors who has a conscience objection is going to come face-to-face with one of these women who has an adverse event.” Is that your theory?
Ms. Hawley (01:05:14):
No, Your Honor. What we think really shows that respondents have standing here is FDA’s own acknowledgements. I would point you to JA384. And in regulating mifepristone, FDA has continually said that emergency room doctors and OBGYN hospitalists are critical to the safe use of drug.
Justice Kagan (01:05:33):
Well, I think, then, it is your theory. You’re just saying even FDA admits that there are going to be some adverse events, people are going to show up in emergency rooms, people are going to come face-to-face with one of our doctors who objects to some aspect of the treatment. That’s the theory, yes?
Ms. Hawley (01:05:55):
Well, we certainly think all of that is true, but we don’t think it’s a problem with probabilistic standing, as was the case under Summers for three reasons. First, Summers involved unidentified members. Here, we have seven named plaintiffs. In addition, no one in Summers at least was still part of the case at-
Justice Kagan (01:06:13):
Yeah. So does your theory really depend on your having at least one person? Because I take Summers to be saying these probability theories, they sound very nice, they have nothing to do with our article three requirements. You need a person. You need a person to be able to come in and meet the court’s regular standing requirements. So you agree with that, yes?
Ms. Hawley (01:06:34):I think that’s correct, Your Honor. Yes.
Justice Kagan (01:06:35):
Okay. So who’s your person? I know you have seven of them, but if you had to pick one and say, “Go read that declaration,” and that declaration is going to tell you why we’re entitled to be up here, who’s the person? So I have
Ms. Hawley (01:06:50):I have to pick two, Your Honor, but Dr. Francis and Dr. Scott.
Justice Kagan (01:06:53):Okay. And what about those two doctors gives you the kind of imminent injury, let alone the traceability that we’ve typically required?
Ms. Hawley (01:07:06):
To speak to Dr. Francis, at the beginning, there’s been some confusion, I think, about the precise nature of the conscience harm, but if you look at JA155, paragraph 15, she talks about her and other AAPLOG members who object not only to taking the life of an unborn child during an elective abortion, but also to, quote, completing that process. That echoes the CMDA declaration at 142 and 143. It’s also consistent with-
Justice Kagan (01:07:34):
Because I read that declaration pretty carefully, what actual emergency treatment has she participated in that she objects to and that she has stated an objection to?
Ms. Hawley (01:07:50):The prior page, Your Honor, JA154, talks about a DNC which she was required to perform due to a life-threatening emergency.
Justice Kagan (01:07:58):She, herself, performed that.
Ms. Hawley (01:08:00):That is correct, Your Honor.
Justice Kagan (01:08:01):And did she have an opportunity to object? Did she object?
Ms. Hawley (01:08:05):No, Your Honor. Again, these are life-threatening situations in which the choice for a doctor is either to scrub out and try to find someone else or to treat the woman who’s hemorrhaging on the [inaudible 01:08:17].
Justice Kagan (01:08:16):
Usually, the way people with conscience objections do this is they make those objections known. And that may be harder, it may be easier in a particular context, but most hospitals have mechanisms in place, routines in place to ensure that doctors who are allowed to do this in advance and are allowed to do it at the moment, they say so. And when I looked at Dr. Francis’s and Dr. Scott’s, there’s just nothing that you have there that suggests … There are other requirements that you need, but at the very least to be able to say, “Well, this happened to them in the past,” I don’t think you have it for either one of those doctors.
Ms. Hawley (01:09:05):
I think we do, Your Honor. Given the emergency nature, it’s simply impracticable to have an objection lodged prior to understanding what’s going on in that operating room. And again, I’d point Your Honor to the district court Fifth Circuit brief in EMTALA where the government says that neither the church nor any of the other sponsors of those federal conscience protections intended them to apply in emergency situations. So it’s a lot to ask our respondent doctors to go up to the top floor and litigate this with a general counsel when the federal government’s telling them they don’t have a conscience protection.
Justice Alito (01:09:38):
Is it true that our standing decisions have not relied on probabilistic determinations, like the Department of Commerce case? The court said there was standing because, if a question about citizenship was included on the questionnaire, a certain percentage, an unknown percentage of residents would then not fill out the census at all, and therefore, it was probable that there was some risk that New York State would risk losing a representative in the House of Representatives or would risk losing money under some federal program, and you put together this chain of probabilities, and that was sufficient to establish standing.
Ms. Hawley (01:10:24):
Absolutely. We agree with that, Justice Alito. In particular, you can look at the Geertson Seed Farms case, which also involved non-regulated parties, and this court looked at the distance that bees might fly in order to pollinate seed farms. So it’s certainly true that data is appropriate to consider in determining whether there’s a substantial risk under SBA list. Here, the FDA admits, this is at 533, that between 2.9% and 4.6% of women will go to the emergency room. It acknowledges, this is at 542, that up to 7% of women will need surgical intervention. And when the FDA talks about there being no increase in adverse events from the increased gestational age, the only way they can say that is by ignoring surgical interventions, and that’s because, at JA207, the FDA_
Justice Sotomayor (01:11:15):
Counsel, what do we do with the fact that these two people that you rely on, Francis and Scope, that Indiana and Texas have abolished abortions and abolished them by pills or otherwise? Now, we can get into whether other people are illegally breaking the law and supplying it contrary to law, but what does that do to your probability, which is, it’s already infinitesimally small because there are thousands of hospitals in the country, 50 states, I don’t know how many territories, thousands and thousands of places where pregnant women go who may be suffering from miscarriages or otherwise, to know or to even imagine how one doctor is going to ever actually see a patient, that he or she is going to be forced to intervene on their behalf, but then add to it that this is illegal in these states.
Ms. Hawley (01:12:25):
So, I think that the best answer, Justice Sotomayor, is that past is prologue.
In our declarations, we have three doctors who have treated harms from abortion drugs at least a dozen times. We have two examples when women went out of state, and if you go out of state, there’s a higher likelihood you are not going to have a follow-up visit.
What the FDA’s regime has done is turn ER rooms into those follow-up visits. We’ve had that happen with both Dr. Jester, where a woman went to New Mexico and returned to Texas, as well as Dr. Johnson, where a woman went to Illinois and returned to Indiana.
Indeed, according to Guttmacher, one in five abortions take place out of state, in surge states like New Mexico, like Illinois, the border states in which our doctors reside.
Justice Barrett (01:13:08):
Ms. Holly, can I take you back to the affidavits and some of Justice Kagan’s questions? You were talking about Dr. Francis, and as I read her allegations, or as her affidavit reads, she said that her partner was forced to perform a D&C when there was a living fetus. And she said she performed a D& C on a woman who was suffering serious complications. But the fact that she performed a D&C does not necessarily mean that there was a living embryo or fetus, because you can have a D&C after a miscarriage.
So, if that’s right, I mean, I think that the difficulty here is that, at least to me, these affidavits do read more like the conscience objection is strictly to actually participating in the abortion to end the life of the embryo or fetus. And I don’t read either Skop or Francis to say that they ever participated in that. So, do you want to address that?
Ms. Hawley (01:14:04):
Sure. So first, Justice Barrett, I think Dr. Francis’ combined with CMDA can be read for the broader conscience harm. Again, that’s how the district court understood that. I’d point you to pages seven and eight. That’s how both the state panel and the Fifth Circuit understood respondents’ conscience harms to extend beyond simply requiring that the ending of an unborn life.
And with respect to even the more narrow conscience harm, to whether a doctor may need to end a life, we think there’s still a substantial risk of that occurring. If you look at the numbers of the increase from seven to 10 weeks in gestational age, that means that 3.1% of pregnancies will be ongoing, requiring a D&C. We know a ROA.870, that 55% of those D&Cs occur in the emergency room. This is a substantial number of women suffering abortion drug harm. Again, Guttmacher says 650, 000 women took the drug in 2003.
Justice Barrett (01:15:03):
But not all those D&Cs will involve a pregnancy that would otherwise be viable or an embryo or fetus that would otherwise be living, because you can have complications or excessive bleeding even after the abortion is complete in that respect, but there’s pregnancy tissue remaining.
Ms. Hawley (01:15:18):So, with the 3.1, your Honor, is ongoing pregnancies.
Justice Barrett (01:15:21):Is ongoing pregnancies?
Ms. Hawley (01:15:22):Yes. And FDA says at J.A. 542, that up to 7% will need surgeries to stop either bleeding or ongoing pregnancies or failures.
Justice Barrett (01:15:33):You have a broad number of doctors that are in your organization, I gather dentists, some doctors who have retired, how many members of your organization are OB-GYNs who practice in hospitals who might be called into these ERs?
Ms. Hawley (01:15:46):There are hundreds of them, your Honor, but I think… May I finish?
Justice Roberts (01:15:50):Sure.
Ms. Hawley (01:15:50):
I think in particular that the named plaintiffs are OB-GYN hospitalists who spend most of their time on the labor and delivery floors, but also are called to the OR to treat these sorts of emergencies.
Justice Jackson (01:16:00):Ms. Holly, can you clarify the broader conscience harm from the narrow one? Because I had understood the conscience harm as Justice Barrett does, but you suggest that there’s a broader one. So, what is that?
Ms. Hawley (01:16:15):Yes, your Honor. I’d point you to pages seven and eight of the district court opinion, and the district court understands the conscience harm to be either taking the life of an unborn child, which would sometimes be required. Dr. Francis testifies to a partner who was required to do that because of emergency situations.
Justice Jackson (01:16:31):That’s what I understood the narrow one to be, right? I’m participating in a procedure that is ending the life. That’s-
Ms. Hawley (01:16:39):Yes, I think that’s correct.
Justice Jackson (01:16:39):Okay. So, what’s the broader one?
Ms. Hawley (01:16:41):
So, the broader one, your Honor, is being complicit in the process that unnecessarily takes an unborn lives, such as performing a D&C and abortion. And it’s really not that hard to see-
Justice Jackson (01:16:52):No, wait. I’m sorry. Complicit, like I work in the emergency room and this is going on? I’m handing them a water bottle? What do you mean complicit in the process?
Ms. Hawley (01:17:04):
So, this court, of course takes religious beliefs and conscience beliefs as it finds them. But what harms our doctors, your Honor, is being involved in completing, in the terms of our declaration, an elective abortion. And it’s really not that hard to see why that might be a conscience harm if you think about what’s involved in a D&C.
Justice Kagan (01:17:24):
But you just said again, it’s being involved in completing an elective abortion. So, I took that to be the conscience objection. I think what Justice Jackson is asking or what I asked before, or what Justice Barrett, is there any broader conscience objection that appears… I’m not sure I care all that much about the district court, but that appears in the declarations?
Ms. Hawley (01:17:46):
Yes, your Honor. And in this sense, completing an elective abortion means removing an embryo fetus, whether or not they’re alive, as well as placental tissue. Again, Dr. Francis talks about being required to perform a D&C, this is at 154, and remove placental tissue.
Justice Kagan (01:18:02):Whether or not there’s any live tissue?
Ms. Hawley (01:18:06):Yes, your Honor. And again, this makes sense-
Justice Kagan (01:18:08):And where are we looking for that?
Ms. Hawley (01:18:09):
So, I would point Your Honor to J.A. 155, paragraph 15, where again, she talks about completing an abortion. The CMDA declaration at pages 142 and 143 also describe the sort of complicity harm from being involved in an elective abortion, your Honor. And again, these doctors performing a D&C must scrape out a woman’s uterus, of a child, of the embryo, the fetus, or placental tissue. And this court has recognized harms like that in cases like Little Sisters of the Poor, as well as Hobby Lobby.
Speaker 4 (01:18:42):Ms.-
Justice Kagan (01:18:42):No, go ahead.
Justice Jackson (01:18:43):It’s-
Ms. Hawley (01:18:44):Sorry.
Justice Jackson (01:18:46):
It’s my understanding that sometimes the completion, it doesn’t involve surgical intervention. Do you have a sense of how often? I mean, we may get all the way down the chain to the doctors there, the person is having an emergency procedure, my understanding is with some of these chemical abortion scenarios, the completion occurs by prescribing additional medication. Do you have a sense of how many times the completion is that route and could be done by another physician as opposed to your clients and doing a medical procedure?
Ms. Hawley (01:19:19):
So, that second dose, your Honor, of misoprostol has been part of the regimen since 2016. Really, I think all the way back to 2001. But it’s been approved by FDA since 2016. So, the best numbers we have from FDA are still consistent with that, and that means that 3.1% of pregnancies at 10 weeks will be ongoing. I’d encourage you to look at J.A. 405 through 407, and this explains that these risks go up without an in-person visit.
Justice Jackson (01:19:49):I’m still working on how many circumstances or how often it would be that your clients actually have to complete the procedure in the way that you are describing.
Ms. Hawley (01:20:02):
So, Dr. Scott talks about doing this at least a dozen of times, either a D&C or a suction aspiration abortion to remove, again, embryos, fetuses, or placental tissue.
In addition, your Honor, if you think about the numbers. Again, it says 3.1% at 10 weeks. And this has only gone up. In 2020, FDA told this court that the in-person visit was both, “Necessary and minimally burdensome,” and necessary to preserve women’s health, precisely so these sorts of situations occur less frequently.
Justice Roberts (01:20:35):Thank you, counsel. Justice Thomas?
Justice Thomas (01:20:38):Ms. Holly, I am sure you heard the answers of the solicitor general and the Council for Danco with respect to the Comstock Act. I’d like you to comment on their answers.
Ms. Hawley (01:20:55):
Sure, Justice Thomas. We don’t think that there’s any case of this court that empowers FDA to ignore other federal law. With respect to the Comstock Act, is relevant here. The Comstock Act says that drugs should not be mailed either through the mail or through common carriers. So, we think that the plain text of that, your Honor, is pretty clear.
Justice Thomas (01:21:19):When did you first raise the Comstock Act?
Ms. Hawley (01:21:23):
So, I believe the Comstock Act was first raised at the district court, your Honor, but we think that exhaustion does not apply for two reasons.
First, it would be plainly futile, as FDA’s adoption of the OLC memorandum goes. In addition, this is a whole nother kettle of fish.
But if you look at Section 704, exhaustion is only required in two instances; either when required by a statute or by an agency rule, when that agency rule is stayed pending litigation.
This is consistent with this court’s case in Darby. The lower courts have taken conflicting opinions, but we think the better reading of Section 704 is that there’s no exhaustion required unless either a statute or agency rule stays the proceeding during judicial review.
Justice Roberts (01:22:08):Justice Alito? Justice Sotomayor? Justice Kagan?
Justice Kagan (01:22:13):
May I ask about your view of traceability? And on one understanding, and I want you to tell me if you agree with this, that even beyond proving whatever injury you’re trying to prove, that you have to show that that injury is traceable to the 2016 and 2021 FDA actions that you are challenging. And of course, that means showing that these incidents that you’re talking about in the emergency room are caused by whatever incremental increase in risk there is as a result of those 2016 and 2021 actions.
And I guess, my first question is do you agree with that statement, of what you need to show? And if you do, how do you satisfy that? Why do you satisfy that?
Ms. Hawley (01:23:02):So, we believe, Justice Kagan, under the case law, that we need to show that each of the 2016 action and the 2021 action increased the risk of harm. And we think the way-
Justice Kagan (01:23:12):But then, I guess, what I’m saying is that you have to link whatever injury your members have to that increased risk. Do you agree with that?
Ms. Hawley (01:23:21):
We do, and we think we can do that for a couple of reasons. First of all, traceability of course is defacto, we’re not in the Palsgraf sort of world of tort causation. And when you look at the 2021 action, we think traceability is satisfied by FDA’s own words. It says at J.A. 405, that without the in-person visit, this is the Anger study, without that in-person visits, ER and other medical care is likely to increase, as well as surgical interventions. And these are the very same surgical interventions that harm respondent clients.
Justice Kagan (01:23:51):
So, there might be some dispute between the two of you as to exactly how big the increased risk is, but let’s even take your view that there is some measurable increased risk. How do you connect that risk to particular injuries that your members have undergone or imminently will undergo? I mean, it could be the original risk.
Ms. Hawley (01:24:22):
So, I think the declarations are actually quite clear on this. If you look at Dr. Francis’ declaration, she says that when the in-person visit was enjoined in 2020 by a federal district court, that she saw an increase in emergency room visits from abortion drug harm. Dr. Johnson, Dr. Skop say the same thing.
And again, this is entirely consistent with FDA’s own numbers. Again, in 2020, FDA told this court that the in-person visit was necessary to preserve women’s health because an in-person visit is the best opportunity to examine for things like ectopic pregnancy and accurately assess gestational age.
Justice Kagan (01:24:56):Thank you.
Justice Roberts (01:24:57):Justice Gorsuch? Justice Kim? Justice Barrett?
Justice Barrett (01:25:02):
So, General Prelogar said that that initial in-person visit had no requirement of an ultrasound or any effort to detect fetal heartbeat. So, it wouldn’t necessarily give an accurate read on gestational age or detect an ectopic pregnancy. So, why would the elimination of the visit necessarily increase the risks?
Ms. Hawley (01:25:24):
So, I think, your Honor, FDA’s own data shows that those risks did go up. If you look at the Coresti study, it shows a nearly threefold increase in emergency room visits when you have the in-person visit and when you removed it. There was 5.8% with an in-person visit. And it was also about 2.1 without.
Justice Barrett (01:25:44):Is that because doctors were just kind of voluntarily saying, “Hey, it would be a good idea to give you an ultrasound or try to detect a fetal heartbeat,” or what?
Ms. Hawley (01:25:52):
So, when FDA removed the in-person visit, your Honor, it took away the opportunity to do that. I think ACOG, I think medical organizations agree that that is best practice. So, if a woman comes into a doctor’s office, she’s likely to get an ultrasound to accurately assess both ectopic pregnancies, diagnose or assess gestational age. But what’s allowed under FDA’s rules currently is to be able to order these online with a couple of screening questions, and I don’t think that’s nearly as good as an in-person exam.
Justice Barrett (01:26:22):
Let me just pivot to the organizational standing question. So, let’s say that, I’m just going to carve out and put aside the costs of filing a petition or litigation as harms to your organization itself, explain to me what additional costs you might have incurred or how your resources were diverted in a way that would satisfy Havens.
Ms. Hawley (01:26:42):
Absolutely, your Honor. So, putting to one side the citizen petition, the ACOG declaration is clear, that respondent organizations conducted studies and analyzed studies. This included going through the Medicaid data, it included going through the FAERS data to the extent it was available.
Justice Barrett (01:26:57):Is that it?
Ms. Hawley (01:26:58):Well, those studies, your Honor, I would point… One of them is a ROA.870, and before and after. And those are pretty comprehensive studies, your Honor.
Justice Barrett (01:27:08):And are they to the end of the litigation and the citizen petition, or what are they to the end of?
Ms. Hawley (01:27:14):To accurately assess the harm from abortion drugs, your Honor. So, I think it’s absolutely separate from the litigation.
And one thing to note with the citizen petition is that is the only way in which anyone can raise a concern to the FDA. These proceedings go on between Danco and the FDA behind closed doors. This is not a notice and comment process. The first time anyone can raise these objections is a citizen petition.
Justice Roberts (01:27:42):Justice Jackson?
Justice Jackson (01:27:43):So what deference, if any, do courts owe the opinion of the expert agency concerning the safety and efficacy of drugs?
Ms. Hawley (01:27:53):
So, under this court’s administrative procedure precedence, your Honor, APA review, of course, is not toothless. Instead, in this case, we’re not asking that the court second guess the agency determinations at all. But rather, look at what FDA said.
Again, in 2021, when FDA took away the in-person visit, it did so based on FAERS data. It says elsewhere cannot be used to calculate the incidents of an adverse event, as well as studies that says that J.A. 407 are, “Not adequate.”
Justice Jackson (01:28:22):
I guess, I don’t understand how that scope of review is not second guessing the agency. I mean, they’re looking at studies, and you’re saying that the court can look at studies, maybe different studies, maybe the same studies, and critique their conclusions about them. So, what deference do we owe them at all with respect to their assessment that these studies establish what it is that they say they do about safety and efficacy?
Ms. Hawley (01:28:50):
I don’t think that’s an accurate portrayal of the APA claimant issue here, your Honor. And the reason being, again, is we’re just asking this court to look at what FDA said. The FTCA says you have to have adequate tests and test results, as well as sufficient information-
Justice Jackson (01:29:05):
I understand, but didn’t the lower courts go beyond that? I mean, representations were made here today that the lower courts actually relied on studies that have since been found discredited and removed. So, they were obviously looking at not just what the FDA was looking at in order to make their assessment. So, are you asking us to just look at the FDA and not anything else?
Ms. Hawley (01:29:26):
So, yes, that claim is not even before this court. But with respect to the two claims that are before the court, the 2016 and the 2021, we think the FDA’s own statements here are arbitrary. In 2016, what the FDA said was, “We’re going to look at individual studies. And then, even though we say they’re interrelated at J.A. 298, we’re going to take all of the protections away at once.” That was arbitrary in State Farm. It would be arbitrary here as well.
Justice Jackson (01:29:57):Thank you.
Justice Roberts (01:29:58):Thank you, counsel. Rebuttal, General Prelogar?
General Prelogar (01:30:01):
Thank you. On associational standing, Mr. Chief Justice, you asked, “Where do you cross the line to get to a certainly impending injury?” One thing the court has looked at is whether that harm has materialized in the past and how often. Now, it doesn’t always guarantee there will be a future injury, but it can be a source of information.
And here, what is so telling is that respondents don’t have a specific example of any doctor ever having to violate this care in violation of their conscience. Instead, respondents have pointed to generalized assertions in the declarations that never come out and specifically say by one of their identified members, “Here’s the care I provided, here’s how it violated my conscience, and here’s why conscience protections were unavailable to me.” The fact that they don’t have a doctor who’s willing to submit that kind of sworn declaration in court, I think demonstrates that the past harm hasn’t happened. And the reason for that is because it is so speculative and turns on so many links in the chain that would have to occur. And at the end, would be backstopped by having the federal conscience protections in play.
(01:30:59)
On organizational standing, my friend has pointed to the fact that they invested time in preparing their citizen petition. She says they voluntarily conducted studies and then generally refers to diversion of resources. If that is enough, then every organization in this country has standing to challenge any federal policy they dislike. Havens Realty cannot possibly mean that, the court should say so and clarify. It is at the outer bounds and respondents don’t qualify under that standard.
On remedy, Justice Gorsuch, Justice Jackson, you pointed out the striking anomaly here of the nationwide nature of this remedy. Justice Jackson, you suggested maybe a more tailored remedy to the parties, protecting their conscience protections, should have been entered. The problem here is they sued the FDA. FDA has nothing to do with enforcement of the conscience protections. That’s all happening far downstream at the hospital level. And the only way to provide a remedy based on this theory of injury, therefore, was to grant this kind of nationwide relief that is so far removed from FDA’s regulatory authority that it’s ultimately requiring all women, everywhere to change the conditions of use of this drug.
(01:32:04)
And I think it’s worth stepping back, finally, and thinking about the profound mismatch between that theory of injury and the remedy that respondents obtained. They have said that they fear that there might be some emergency room doctor somewhere, someday who might be presented with some woman who is suffering an incredibly rare complication and that the doctor might have to provide treatment not withstanding the conscience protections. We don’t think that harm is materialized. But what the court did to guard against that very remote risk is enter sweeping nationwide relief that restricts access to mifepristone for every single woman in this country. And that causes profound harm. It harms the agency which had the federal courts come in and displace the agency’s scientific judgements. It harms the pharmaceutical industry, which is sounding alarm bells in this case and saying that this would destabilize the system for approving and regulating drugs. And it harms women who need access to medication abortion under the conditions that FDA determined were safe and effective.
The court should reverse and remand with instructions to dismiss to conclusively end this litigation.
Justice Roberts (01:33:08):Thank you, counsel. The case is submitted.
Speaker 3 (01:33:12):The honorable court is now adjourned until tomorrow at 10 o’clock.