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Maryland Officials Speak after Bridge Collapse; SCOTUS Hearing Arguments on Abortion Drug. Aired 10-11a ET

Aired March 26, 2024 - 10:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

[10:00:00]

(JOINED IN PROGRESS)

PAUL WIEDEFELD, MARYLAND TRANSPORTATION SECRETARY: -- repairing potholes, just so you understand that had nothing to do with a structural issue at

all in the facility.

At this time, one person has been rescued insofar and our continuing -- efforts continue in terms of that.

Engineers are on site right now, determining both some of the structural issues, obviously, some of the debris field and we'll start to work that

but we work hand-in-hand with the NTSB before we take any further action in that area.

With that, I did want to introduce the FBI for a few comments as well.

WILLIAM DELBAGNO, FBI SPECIAL AGENT IN CHARGE: Hello, my name is Bill DelBagno. I'm the special agent in charge of the Baltimore Field Office.

First and foremost, so I want say that our hearts go out to everyone that is impacted by this tragedy especially the victims and their families.

On behalf of the FBI, I would like to say that we are with you we're with Baltimore and we, with the partners, every step of the way.

The FBI, on very first, looking at and assessing this matter from an investigative standpoint, I want to be clear that there is no specific or

credible information to suggest that there are ties to terrorism in this incident.

The FBI has been part of this response from the beginning. We came within one hour to the command post and quickly latched up with our very strong

partners all along the way. We will bring whatever resources that the FBI has to bear.

We've already brought our crisis response, our victim services and just recently our underwater search evidence recovery teams are on site and we

will continue to provide all those resources as long as it takes.

And as the investigation goes on we will take it to its logical conclusion along with our partners. To the people of Baltimore, to the public, I ask

you to be patient as we go through this and as information becomes available to us.

And, lastly, I want to say thank you. Thank you to our partners. Thank you to everyone who -- in the FBI and counts on the FBI, we will always bring

what we need to the people of Baltimore and we are with you.

Next, I'd like to introduce the Coast Guard.

UNIDENTIFIED MALE: Good morning. The Coast Guard is still actively searching at this time. We are using response boat crews from two of our

local Coast guard stations one of our helo crews at Air Station Atlantic City and also one of the cutter crews on one our 87- foot patrol boats.

We will continue to work with our local, state and federal partners during this tragedy. Thank you.

QUESTION: As far as you are aware, was the collapse of that bridge inevitable as that ship hit that part of the bridge?

GOV. WES MOORE (D-MD): No. We're still in the process of investigating exactly what happened. So we don't have any further details about whether

or not it was inevitable or not.

QUESTION: No structural issue with the bridge?

MOORE: No. In fact, the bridge was actually fully up to code. So we have no further information about what happened.

QUESTION: Governor, is all shipping in and out of the port now stopped completely?

And do you have any estimate very early on as to how long it will be before shipping can resume to the port?

MOORE: Yes. We don't have any estimates on timeline, because, right now, our exclusive focus is on saving lives. Our exclusive focus is on search

and rescue.

QUESTION: Can you give us a better sense for the number?

Because we've heard -- I know Mr. Wiedefeld said one at the rescue but earlier from Baltimore, we heard that two have been rescued. Can you tell

us the total numbers we're talking about that may be -- that you're searching for and how many have had been rescue?

MOORE: Well, there are eight individuals, six are being searched for right now. One was taken to the hospital and one is right in the hospital that

we're speaking to.

QUESTION: So six unaccounted for?

MOORE: Yes.

QUESTION: And does that involve individuals that may have been in vehicles that were underwater?

(INAUDIBLE)?

MOORE: We believe it's a construction crew.

QUESTION: So you don't think there's any (INAUDIBLE)?

MOORE: No, we do not believe so.

QUESTION: Governor, two questions quick. How quickly did you find out about what happened here?

And what was your reaction when you heard the scale of what just occurred at that bridge earlier today?

MOORE: Well, I mean, I -- it was -- I think it was probably within minutes of everything.

[10:05:03]

Less than an hour when I know that my phone first rang on and, you know, first from the mayor of Baltimore and also from our chief of staff.

And it was -- we know the Key Bridge. I've ridden over the Key Bridge countless times. So many of us know the Key Bridge because it is our normal

commute. This is a place that is a normal commute route for over 30,000 Marylanders every single day.

And so to hear the words that the Key Bridge has collapsed, it's shocking and heartbreaking. And immediately are the first thought and the first

ideas go back to what happened to the people, where we -- what was the impact on human life.

But for every single one of us who are Marylanders, the words that the Key Bridge is gone. It still shakes us, because for over -- for 47 years,

that's all we've known. And so this is not just not just unprecedented from what we're seeing and what we're looking at today, it's heartbreaking.

QUESTION: Governor, can you confirm that the crew on the ship alerted authorities that it had lost propulsion?

MOORE: We can confirm that the crew notified authorities of a power issue.

QUESTION: And that they had lost power on the ship?

MOORE: Yes.

QUESTION: Was there any effort to shut down the bridge?

QUESTION: (INAUDIBLE)?

WIEDEFELD: A total of eight -- excuse me, a total of eight, one rescued, in a hospital, one not in a hospital but it is, so we have communicated

with that person and then six that we are searching for.

QUESTION: (INAUDIBLE)?

WIEDEFELD: Yes, they were all related to the construction program, yes.

QUESTION: So we heard that multiple vehicles went into the water. Any word on how many vehicles went into the water and the condition of those people

that were in the vehicle?

WIEDEFELD: Not a at this time.

QUESTION: Was there any way to shut down the bridge?

Was there enough time for that distress call to trigger something like that?

MOORE: Now the thing that we know is that, you know, even as the boat was coming in, you know, we had a ship that was coming in at eight knots, so

coming in at a very rapid speed.

We do know that the investigation is currently going on. But I have to say, I'm thankful for the folks who -- once the warning came up and once

notification came up, that there was a mayday, who, literally, by being able to stop cars from coming over the bridge, these people are heroes.

They saved lives last night.

QUESTION: (INAUDIBLE). But looking forward, is there any vision for how long it could possibly take to move the wreckage to rebuild and how it

could possibly be done?

Can you look into the future at all at this point?

MOORE: This is going to be a long-term build. It's going to be a build that's going to require every facet and every aspect of our society. It is

something that I can tell you we are going to get this done.

We are going to make sure that this is not just rebuilt but that we are going to rebuild in a way that remembers the people who this tragedy has

impacted and also do it in a way that honors the community that it serves.

But right now, I could not give you any form of investment on timing or cost. Right now, my and all of our exclusive focus is we're just trying to

save lives.

QUESTION: (INAUDIBLE), please?

MAYOR BRANDON SCOTT (D-MD), BALTIMORE: Yes, thank you. Listen, we know the governor issued a state of emergency but we at the local level felt the

need to do that, too.

Because there may be some things that we have to encumber with fire department and other agencies that will be able to pull down support for as

we all work together again, as we're focused right now on saving lives and working through this unspeakable tragedy.

QUESTION: In the interim, I know that there's obviously the focus is on the rescue and the recovery. But this is such an important thoroughfare

here in all the more for drivers, people trying to get around. How are they going to manage while that is also going on?

MOORE: Yes. So we've also already been in touch with people about alternative routes and ways people can navigate now that this tragedy has

happened. And I don't know, Secretary, if you want to speak to that as well.

WIEDEFELD: Just give you a sense of scale, roughly about 35,000 people a day use that facility.

About double that use the Harbor Tunnel and double that, again, use the Fort McHenry Tunnel.

[10:10:00]

So basically, we have those two other options.

We'll make sure that we have as much personnel out there to deal with any incidents, because, as you know, that can cause the backups very quickly

and we will basically put out a lot of communication on different alternatives. We're also looking at transit alternatives as well.

QUESTION: Governor, (INAUDIBLE) in this response?

What role will the legislature play in this response?

Are there any policies, any (INAUDIBLE)?

MOORE: Yes, no. So we are in fact, you know, we have our Senate president here. We have members of the legislature here. The legislature is going to

have a role in all this, as will our local elected officials, as will state officials, as will the federal government. You know, everybody is going to

have a role in terms of how we think about the rebuild.

QUESTION: Governor, how long do you expect shipping to be closed down in the port?

Do we have any estimate in terms of the port here?

MOORE: We don't at this point. We don't at this point.

QUESTION: (INAUDIBLE)?

MOORE: Correct, yes. And we don't have an estimate on timeline as of yet. Our focus really is right now and just make sure we're saving lives.

QUESTION: (INAUDIBLE), are they able to get (INAUDIBLE)?

MOORE: I'm sorry, say it again.

QUESTION: (INAUDIBLE)?

MOORE: You know, with the one that's captured under the -- is that what --

UNIDENTIFIED MALE: (INAUDIBLE).

MOORE: Oh, yes. That one, that one is still at port, yes.

QUESTION: One last question. Was the ship being guided out by tugs, firstly?

And, secondly, did you just say that it issued a mayday in enough time that you were able to stop all traffic from entering both sides so that the only

casualties we expect were other workers on the bridge?

MOORE: Yes, ma'am. So the investigation is still going on. So we're going to have all the full details and also all the full details about the

timeline and the tick tock that took place.

But we're thankful that between the mayday and the collapse that that we had officials who were able to begin to stop the flow of traffic so more

cars were not up on the bridge. And I can --

QUESTION: (INAUDIBLE) on the bridge or not?

Were there any --

MOORE: During the collapse?

QUESTION: Yes. Were there some on the bridge?

There have been reports that have been sonar that have detected vehicles at the bottom of the water. So as well as the eight people, there could still

be people trapped inside or potentially have died in vehicles, is that correct?

WIEDEFELD: I think, well, the investigation is still going on to find out exactly how many people in what situation. But the thing that we do know is

that many of the vehicles were stopped before they got onto the bridge, which saved lives in a very, very heroic way.

UNIDENTIFIED MALE: Thank you all very much. Thank you. We'll have another update later. Thank you.

(CROSSTALK)

UNIDENTIFIED MALE: Press speaking (ph).

(OFF MIKE COMMENTS)

[10:12:46]

ELENI GIOKOS, CNN ANCHOR AND CORRESPONDENT: All right. That was Maryland governor Wes Moore with a press conference with other authorities on the

ground. President Holland (ph) also spoke. We heard from the FBI special agent in charge for the team on the ground, as well as Brandon Scott, the

Baltimore mayor.

Important information coming through. Remember, this is a dynamic situation and more trickling through as the day goes on, perhaps the most significant

than what we've heard is that the vessel did alert a mayday signal.

So between the alert of mayday as well as the collapse, there was a small window where they were able to stop the flow of traffic. He reiterated that

the investigation is still ongoing, that details are still very sketchy but importantly that the vessel had put out a mayday signal.

In terms of the numbers that we're looking at right now, what the latest numbers are telling us, six, that they're searching for, six potential

people that are trapped in the water. They have rescued two; one is in hospital and one uninjured.

Those numbers, of course, against in terms of what we've been seeing preliminary and they reiterated that things could change.

I want to bring in CNN transportation analyst, Mary Schiavo, who is also listening into that press conference.

Mary, no surprise that we are starting to get a little bit more information but I think importantly that they've said, things could change. And, of

course, the investigation is still ongoing.

But for the first time we heard that the vessel had put out a mayday signal and they were able to stop some of the traffic before the collision.

MARY SCHIAVO, CNN TRANSPORTATION ANALYST: Yes, that was a very important and encouraging development because in the history of the U.S. and bridge

collapses, a ship or barge hitting the bridge has been the cause of many a bridge collapse in the United States.

The second highest cause is probably construction on bridges but by putting out that mayday call and if it's correct, that they were able to stop

people on both ends of the bridge, now.

[10:15:00]

Calculating the speed limit, the length of the bridge -- most speed limits in the United States are 55 miles an hour -- it is possible that people who

were already on the bridge had transversed the bridge and were off.

But undoubtedly that mayday call from the ship saved countless lives. So I mean, there have been collapses of bridges in the United States where there

wasn't a mayday call and obviously many vehicles went into the water.

So that was a really important development. And also, we heard earlier in the day that there was a fully qualified harbor pilot, who knows the

channels, knows that harbor very well.

And clearly there was a problem with the ship because a harbor pilot trained in that harbor -- by the way, they have a background check, too --

would not have steered from the channel going under the bridge. That would have been hugely dangerous.

And so that was an interesting development, too, so there is hope now with that mayday call that there may not be a lot of vehicles under the water,

other than the work crew on the bridge

GIOKOS: Yes. Look, what is important to end the priority and authorities have reiterated this as a search and rescue operation that is currently

underway. Initially, we were hearing about at least seven people that could be trapped. We didn't know whether they were in vehicles, workers.

We've got a little bit more clarity on that. That number is now sitting at six. They're saying two people have been rescued. Information we've had

from the morning.

But this is sort of again a lot of information that we still require.

Is this going to do with vehicles that are still underwater?

That question was posed to the governor. He wasn't able to give a definitive answer.

We're relying on the sonar technology for a little bit of hope as time passes.

And time is of the essence.

SCHIAVO: Right, and they had used solar -- sonar technology to locate the underwater vehicles. But it does take divers to go down, examine the

situation, get any of the people out. And to do that, that additional step.

So while the sonar was very important to find them and to help the divers with the water conditions, it's cold. There's currents. I mean, this is not

a calm pool of water like a lake, with the currents coming and going. The divers have their work cut out for them.

With the assistance of the sonar, they will have a good idea of where to look. Now persons who are not in vehicles with these currents, they could

be looking over a wide area to find them.

GIOKOS: All right, Mary Schiavo, great to have you with us. Thank you so much for your analysis.

And just ahead we will take you back to Baltimore as Washington's top transportation investigators sent their go team to that massive bridge

collapse. Back right after this, stay with CNN.

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GIOKOS: Welcome to the second hour of CONNECT THE WORLD. I'm Eleni Giokos in Abu Dhabi and you've been watching special coverage of breaking news out

of Baltimore here on CNN. We will have much more on the collapsed bridge throughout the next hour.

AMARA WALKER, CNN ANCHOR AND CORRESPONDENT: Eleni, good to be with you. I'm Amara Walker in Atlanta with the other breaking news we are watching

this hour, a pivotal moment in the U.S. Supreme Court. Reproductive rights are back on the docket nearly two years after the landmark ruling, Roe v.

Wade, was overturned.

Justices are hearing oral arguments right now on a blockbuster case that could limit access to the widely used abortion drug, mifepristone, even in

states where abortion is legal.

Now the court has to decide if the FDA overstepped its authority by making it easier for women to get access to the pill, which is one of the two

drugs in a regimen for medication abortion.

Now just last year, research shows it was used in 63 percent of all abortions across the U.S. CNN's Justice correspondent Jessica Schneider is

live in Washington.

And as we said, Jessica, the oral arguments are now underway. Walk us through this case.

JESSICA SCHNEIDER, CNN JUSTICE CORRESPONDENT: Yes, this case has actually been ongoing for two years now since 2022. And that's when this group of

doctors sued -- and they argued that the FDA did not follow proper procedures when it approved this abortion pill in the year 2000.

They also say that they didn't follow -- the FDA didn't follow proper procedures when they relaxed certain requirements to obtain the pill in

both 2016 and 2021. And those doctors actually won in the courts below.

But all of those rulings have been put on hold until the Supreme Court here makes its decision, which we're expecting by the end of June, the arguments

are ongoing this morning. So for now, the abortion pill, it remains widely available.

But the question will be, will it continue to remain available?

And will maybe those restrictions go back into place that were relaxed by the FDA in recent years?

Some of the restrictions that were relaxed include women can now take the pill up to 10 weeks of pregnancy. That's up from seven originally. Also the

number of required doctors' visits were lessened from three to one.

And crucially, women can now get this pill via the mail, which, for many women, has proved crucial in the years since Roe v. Wade was overturned

because, if you're in a state that outlaws abortion, you can still get this abortion pill by mail up to 10 weeks of pregnancy.

So there was a lot at stake in this decision especially because, as you said, half -- more than half of all abortions are performed using this

medication. So the Supreme Court is yet again weighing into this abortion issue just two years after saying it was for the states to decide.

So the question now is to the power of the FDA to have even approved this pill in the first place. And it would be, Amara, monumental if the Supreme

Court suddenly questions the FDA's power in that capacity.

It's really something a court, especially the Supreme Court, has never done. So there was a lot at stake here, especially because, like we said,

more than half of all abortions are now performed using this medication, mifepristone.

So the arguments are ongoing now. We're about 20 minutes in. Right now there's a lot of question as to whether this doctors group that initially

brought this lawsuit, whether they even have the power to bring it, a concept known as standing.

Those have been the arguments so far but there's a lot more to come this morning, Amara.

(CROSSTALK)

WALKER: -- that this is extremely high stakes. The impacts are -- could be monumental, especially on women's rights but also on the FDA's authority to

approve drugs. Jessica Schneider, thank you so much.

The arguments are underway. Let's listen in.

JUSTICE SAMUEL ALITO, SCOTUS: 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 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?

ELIZABETH PRELOGAR, SOLICITOR GENERAL: 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.

[10:25:05]

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 been in deployed together safely.

ALITO: Shouldn't the FDA have at least considered the application of 18 USC 1461?

PRELOGAR: So I think that the Comstock provisions don't fall within FDA's lane. FDA, under the FECA, 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 FECA 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 respondents 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 permissibly considered that under the

statute.

ALITO: 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 it?

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?

PRELOGAR: 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 (g)(4). 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 (j)(a535) (ph). That was the advice that

FDA received from OLC (ph) conveying the interpretation of Comstock.

ALITO: They've got the advice from OLC (ph) but it didn't refer to that, did it?

PRELOGAR: In the 2021 decision, no. But the REMS was then modified in 2023 and this was part of the administrative record for that.

ALITO: OK. One -- 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, quote, "Although the literature suggests there may be more frequent emergency room care visits

related to the use of mifepristone 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 there are going to be more emergency room visits?

This is -- the -- the increase in emergency room visits is just of no consequence?

It doesn't even merit some -- some comment?

PRELOGAR: 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, you know, 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.

ALITO: All right. Thank you.

ROBERTS: Justice Sotomayor?

SOTOMAYOR: 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?

PRELOGAR: That's right. And, you know, 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 a difference between those two timeframes.

[10:30:04]

So that further supported the safety conclusion.

SOTOMAYOR: The problem with all drugs is there are complications in virtually all of them.

PRELOGAR: Yes, virtually all.

SOTOMAYOR: And at what level the cost/benefit analysis tells you to stop prescribing something is a very difficult question, isn't it?

PRELOGAR: And that's a question that Congress has entrusted to FDA.

SOTOMAYOR: 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?

PRELOGAR: 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 were -- suggested that it was not necessary to keep this restriction in place to ensure safe

use.

SOTOMAYOR: Thank you.

ROBERTS: Justice Kagan?

KAGAN: 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 -- what are the doctors objecting to exactly?

PRELOGAR: 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.

KAGAN: Those two are who?

PRELOGAR: Those are Dr. Skop and Dr. Francis. The relevant language for the other five don't refer to conscience objections.

PRELOGAR: 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 at 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.

KAGAN: So, 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, you know, any of a number of other things that might

happen.

As you understand the declarations, there's not an objection to that?

PRELOGAR: 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 the 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.

KAGAN: Right, there are obviously conscience objections of all kinds. I was just asking --

(CROSSTALK)

PRELOGAR: Yes.

KAGAN: -- about the particular declarations of these particular members of the organizations.

PRELOGAR: 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.

KAGAN: OK. Can I just ask a quick question about the merits?

You -- you opened 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.

So 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 -- 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?

PRELOGAR: That is still to our knowledge the only time a court has done that. We have seen a disturbing trend of courts 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.

And 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.

KAGAN: Thank you.

ROBERTS: Justice Gorsuch?

Justice Kavanaugh?

KAVANAUGH: 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?

PRELOGAR: Yes. We think that federal conscience protections provide broad coverage here.

[10:35:00]

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 5 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.

KAVANAUGH: Thank you.

ROBERTS: Justice Barrett?

BARRETT: 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?

PRELOGAR: Yes, I think that would be true. So the most relevant church amendment provision is 42 U.S.C. 300a-7(d) and its language says that

doctors shall not be required to perform or -- or assist in any part of the healthcare program that would violate the doctor's religious or moral

beliefs.

So it's tied to the nature of the doctor's beliefs rather than particular procedures.

BARRETT: And 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 in transfusion.

But not, say -- I mean, it -- it seems to me and I think the data bears this out, that the elimination of the in-person dispensing requirement or,

you know, the in-person visit at the outset would lead to mistakes in gestational aging, which could increase the need for a D&C or the amount of

bleeding, et cetera.

But that does not count, correct, as an adverse event?

PRELOGAR: So 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 and I would point you to JA 383 to 384 in particular --

(CROSSTALK)

BARRETT: OK.

PRELOGAR: -- where FDA explained that even in person you're not necessarily getting an ultrasound. That's never been required.

And so the relevant question might be is your -- your provider going to ask you a series of screening questions, like when was your last menstrual

period, in person or via telemedicine and there's no evident reason why that difference would actually lead to different safety outcomes.

BARRETT: So there was not even a -- I thought --

WALKER: You are listening to live oral arguments taking place at the Supreme Court of the United States. The most important abortion case since

Roe v. Wade was overturned in 2022.

You heard a lot of questioning there from the Supreme Court justices to the U.S. solicitor general about under what grounds the FDA expanded access to

this medication abortion called mifepristone and how it was determined safe to do so.

We will continue to follow these live oral arguments. We'll take a quick break and come right back.

(MUSIC PLAYING)

(COMMERCIAL BREAK)

[10:40:00]

(MUSIC PLAYING)

WALKER: Welcome back, everyone. I'm Amara Walker in Atlanta. Right now, the U.S. Supreme Court is hearing arguments in a case that could limit

access to one of two drugs used in medical abortion -- medication abortion -- even in states where abortion is legal.

It all centers around this drug, mifepristone. It was approved by the FDA more than 20 years ago and it's been shown to be both safe and effective.

However, anti-abortion advocates say the FDA didn't study it enough before approving it. And now the Supreme Court is hearing arguments to decide

whether to restrict access.

Arguments are underway right now. Let's listen in.

-- injury that's already directly addressed by other pertaining --

(CROSSTALK)

JUSTICE KETANJI BROWN JACKSON, U.S. SUPREME COURT: Right. And if it wasn't --

PRELOGAR: -- protections under federal law.

JACKSON: -- if it wasn't addressed, then we would see this lawsuit and the remedy would be to exempt them, right?

PRELOGAR: Yes. I mean, I think that --

JACKSON: Yeah.

PRELOGAR: -- 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 3 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.

JACKSON: 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 -- 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.

So 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?

PRELOGAR: 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 maybe 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.

JACKSON: Thank you.

ROBERTS: Thank you, counsel.

Ms. Ellsworth.

JESSICA ELLSWORTH, ATTORNEY FOR DANCO LABORATORIES: 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, Mifeprex. The decision below stops Danco from selling Mifeprex in line with that scientific

judgment based on a highly attenuated claim.

And an unknown doctor could be called someday 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.

Respondents' view of the Food, Drug and Cosmetic Act is so inflexible, it would upend not just Mifeprex but virtually every drug approval and REMS

modification FDA has made for decades.

Reversal is required for two reasons. First, Article 3 standing is not an academic exercise in what's conceivable. Respondents lacked 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.

ASSOCIATE JUSTICE CLARENCE THOMAS, SCOTUS: The government, the solicitor general points out, would not be susceptible to a Comstock Act problem. But

you, in your case, you would be.

So how do you respond to an argument that mailing your product and advertising it would violate the Comstock Act?

[10:45:10]

ELLSWORTH: 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 FSB 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 -- excuse me -- was not ruled on below and, 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.

THOMAS: 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 the sort of safe harbor that you're suggesting. And it's fairly broad and it specifically covers drugs such as yours.

ELLSWORTH: 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 was actually teed up.

This statute has not been enforced for nearly 100 years and I don't believe that this case presents an opportunity for this court to opine on the reach

of the statute.

ROBERTS: 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

(ph), 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?

ELLSWORTH: Your honor, I think this court has always thought about these standing inquiries as really a question of degree. And 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.

ROBERTS: Right, I mean, we tossed 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?

ELLSWORTH: I think that the way Clapper got at that question -- and you can see this in footnote 5 of the opinion -- is to really think about

whether there is an attenuated chain of contingencies that have to happen.

And 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.

ALITO: How was 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?

ELLSWORTH: That's correct, Justice Alito.

ALITO: And the Fifth Circuit decision does not prohibit you from continuing to produce and sell that product, right?

ELLSWORTH: That is correct.

ALITO: All right. And so I gather your injury is that you think you're going to sell more if the restrictions that previously were in place were

lifted.

ELLSWORTH: Yes.

ALITO: You're going to make more money.

ELLSWORTH: 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.

ALITO: And you're going to be harmed because you're going to sell more.

ELLSWORTH: 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.

ALITO: 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.

ELLSWORTH: That's correct.

ALITO: Do you think the FDA is infallible?

ELLSWORTH: No, your honor. We don't think that'll -- and we don't think that question is really teed up in any way in this case.

ALITO: Has the FDA ever approved a drug and then pulled it after experience showed that it had a lot of really serious adverse consequences?

[10:50:05]

ELLSWORTH: 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 there are -- 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 attention.

ALITO: But don't you think the FDA should have continued to require reporting of non-fatal consequences?

ELLSWORTH: 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.

ALITO: So why would that be a bad thing?

Wouldn't your company -- I mean, you don't want to sell product that causes very serious harm to the people who take your product, relying on your

tests, the FDA's tests.

Wouldn't you want that data?

ELLSWORTH: 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 concern I heard in

some of the earlier questioning about who would have standing if these plaintiffs don't have standing.

And one of the things I want to note is that drug manufacturers are very frequently subject to tort litigation, a 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 (ph).

(CROSSTALK)

ALITO: -- does your company -- just one more point along the same -- 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?

ELLSWORTH: We have not taken a position on that issue and it has not been teed up in this case.

ALITO: Well, what is your -- what is your company's position on it?

You haven't even thought about it?

One of your competitors made that argument, right?

ELLSWORTH: 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.

ALITO: So you don't want to answer that question?

ELLSWORTH: I don't think we have a position that's on that that I'm prepared to say today.

KAGAN: 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 we're 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?

ELLSWORTH: 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 report adverse events to Danco.

And then Danco then had its separate reporting obligation to FDA. So what - - 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.

KAGAN: Thank you.

ROBERTS: Justice Thomas?

Justice Alito, any further?

Justice Sotomayor?

Justice Kavanaugh?

(INAUDIBLE).

Justice Jackson, do you --

JACKSON: May I just have one quick question?

So you were asked if the agency's infallible. And I'm -- 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?

[10:55:05]

ELLSWORTH: 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.

JACKSON: Can you say a little bit about what they say?

ELLSWORTH: I'm happy to. I think the reality is -- and this court is that 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 postdate 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 are not -- 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.

JACKSON: Thank you

ROBERTS: Thank you, Counsel.

ELLSWORTH: Thank you.

ROBERTS: Ms. Hawley.

ERIN HAWLEY, ATTORNEY FOR AFD: Mr. Chief Justice and may it please the court, FDA approved abortion by mail based on data, it admitted, was,

quote, "not adequate." That violates the APA (ph). 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 3 is satisfied here because, one, the FDA relies on OB hospitalists (ph) to care for women

harmed by abortion drugs.

Two, the FDA concedes that between 2.9 percent and 4.6 percent 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.

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. The respondent doctors will be forced to manage abortion drug harm is not a bug in FDA's 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 3 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 (ph) 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

AP (ph) requires this court should affirm. I welcome of course questions.

THOMAS: Counsel, you assert that an injury on the part of the alliance diverted time and resources.

Isn't that just the cost of litigating, of pursuing this litigation?

HAWLEY: 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 structured 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. Skop talks about these being heartbreaking situations and some of the most stressful work she's had to

deal with, your honor.

THOMAS: Well, I understand that but I'm talking about the injury of having to divert resources to litigate this.

HAWLEY: Oh, for respect to the organizational --

(CROSSTALK)

THOMAS: -- and the alliance.

HAWLEY: Absolutely, your honor. So we think Havens Realty (ph) 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 in an economic harm.

But this court's case specifically said that the fact that the --

[11:00:00]

END