0:00

We will hear argument this morning.

0:02

And Case twenty three to thirty

0:04

five: The Food and Drug Administration

0:06

Forces Alliance for Hippocratic Medicine and

0:08

The Consolidated Case Journal. Predator. Mister

0:11

Chief Justice and may it please

0:13

the court F D A Approved

0:15

Meth A Christian based on the

0:17

agency scientific judgment that the drug

0:19

is safe and effective if maintain

0:21

that judgment across five presidential administrations

0:23

and millions of Americans have used

0:25

with a press down to safely

0:27

in their pregnancies. Respondents may not

0:29

agree with that choice, but that

0:31

doesn't give them article Three standing

0:33

or a legal basis up and

0:35

the regulatory scheme at the outset.

0:37

Respondents lacks the ending. The now

0:39

concedes they can't. Rely on a statistical

0:42

theory of injury like the lower court

0:44

dead I said they have to identify

0:46

a specific doctor who faces imminent harm.

0:48

But. There are theories rests on a

0:50

long chain of remote contingencies. Only.

0:53

An exceptionally small number of women suffer

0:55

the kind of serious complications that could

0:57

trigger any need for emergency treatment is

0:59

speculative that any of those women with

1:01

seat care from the to specific doctors

1:04

who assorted conscience injuries and even if

1:06

that happened, federal contracts protections would guard

1:08

against the injury the doctor space and

1:10

there's no basis to conclude that any

1:12

of that would be traceable to the

1:14

incremental changes that ft a maid and

1:17

twenty six team and twenty twenty one

1:19

as opposed to the availability of myth,

1:21

press down and general respondents' theories. Are

1:23

to attenuated as a matter of law. The court

1:25

should say so and put an end to this

1:27

case. If. The court reaches

1:29

the merits ft a his actions

1:31

were lawful. The agency relied on dozens

1:34

of studies involving tens of thousands

1:36

of women. Respondents don't identify any evidence

1:38

that the agency overlooked. they just

1:40

disagree with the agency's analysis of the

1:42

data before it. But that doesn't provide

1:45

a license to authorize judicial second

1:47

guessing of the agency's expert judgments. Finally,

1:50

On a remedy the relief entered

1:52

below with severely disrupt the federal

1:54

system for developing and approving drugs

1:56

harming the agency and the pharmaceutical

1:58

industry. The also inflict

2:01

grave harm on women approximation.

2:03

Rolling. Back Sch changes would unnecessarily

2:06

restrict access to miss a press

2:08

down with no cc justification. Some.

2:10

Woman could be forced to undergo more

2:13

invasive surgical abortions, others might not be

2:15

able to access the drug at all.

2:17

And all of this would happen at

2:19

the request of plaintiffs who have no

2:21

certain injury of their own. The court

2:23

should reject that profoundly and equitable results.

2:26

Are welcome the courts

2:28

Questions general if we

2:30

agree with you on

2:32

standard could you give

2:34

us an example of

2:36

whom would have been

2:39

determined to ride on

2:41

salaries Visa experiences. As

2:43

a general matter, we've seen lawsuits in

2:45

the past that are brought by for

2:47

example prescribing physician or patients who wants

2:49

later access to a drugs and sometimes

2:52

we've seen series of competitor standings were

2:54

competing drug manufacturer might sue and claim

2:56

that Esses approval of a drug free

2:58

it's a competitive farmer and or injury

3:00

in that sense. I guess it's Hamas.

3:02

I think that guess the question is

3:04

whether there would be individuals who generally

3:07

oppose abortion who would have standing and

3:09

want to challenge at the is accents.

3:11

The answer to that is no. But

3:13

the reason is because those people aren't

3:15

regulated in any relevant way under Sch

3:17

decisions. hear your take these respond and

3:19

doctors they don't prescribe with a press

3:21

down. they don't take my for so

3:23

obviously as he is not requiring them

3:25

to do or refrain from doing anything,

3:27

they are required to treat women who

3:29

thickness of her sounds as he is

3:31

not directing the women who take the

3:33

drugs to go, seek out carefully specific

3:35

doctors and so they stand at a

3:37

far distance from the upstream regulatory action

3:39

they're challenging and the court said in

3:41

in many cases that. In a situation like

3:44

that when you are not the direct opposite

3:46

of the agency's regulation can be substantially. More

3:48

difficult to establish the I mean. But

3:51

isn't that sort of or

3:53

criticism of some of our

3:56

association know or stand increases

3:58

and organizational stuff? I

4:01

don't think it is for a couple

4:03

of different reasons that respect to associational

4:05

standing. This court has said time and

4:07

again that the association needs to identify

4:09

a specific member who is suffering a

4:11

concrete harm, a cog, nice little injury

4:13

that's not speculate. have and I don't

4:15

hit respondents now to take issue with

4:17

that, That's who they are agreeing that

4:19

it would be necessary to come forward

4:21

and identify specific doctor the problem with

4:23

their association. Of the ending series. Is

4:25

that the rest on this chain of remote

4:28

possibility? So many different steps in the process

4:30

that would have to occur, each one layering

4:32

one speculative remote odds of a chance of

4:34

injury on top of another to get to

4:36

the ultimate form. They're claiming on behalf

4:39

of these doctors was you. I'm

4:41

emphasize to remove nature of these

4:43

with a small number of adverse

4:46

effects the likelihood of deliver the

4:48

physicians who go to emergency room

4:50

So is there a number of

4:53

which your own argument would would

4:55

change the significant number of consequences

4:57

a higher likelihood of an emergency

5:00

room visit. To

5:02

the doctors who fired from spend more

5:05

time in the emergency room as have

5:07

had. Some points as this analysis we

5:09

to the other result. Is hard

5:11

for me to amass and that it clyde

5:13

and and there are a couple of different

5:15

reasons for that. I take the point that

5:17

you might pick out different links and the

5:19

chain and success is there are ways to

5:21

wildly the person the facts here and suggest

5:23

maybe as a statistical matter one or two

5:25

of those events. Could be probabilistic me

5:27

more likely to occur. But we

5:29

have an obsession here to the underlying serious

5:32

a legal matter because it rests on so

5:34

many different things that would have to happen

5:36

of one on top of another and that

5:38

turn on independent decisions made by third parties.

5:40

Who are strangers to this litigation? Who are not part of

5:42

the city? So we think that brings

5:44

the case within those like Clapper Four

5:47

Summers for this court has recognized that

5:49

when the theory of injury really turns

5:51

on so many different intervening events separated

5:53

by independent decision, it can mean that

5:55

there is this an insurmountable hurdle to

5:57

establish expanding. could

5:59

you put it a more specific answer

6:02

to the first question that Justice Thomas

6:04

asked you, is there

6:06

anybody who could challenge

6:08

in court the lawfulness of what

6:10

the FDA did here? In this

6:12

particular case, I think the answer

6:14

is no. Well, that wasn't my

6:16

question. Is there anybody who can

6:18

do that? Let's start with the

6:20

states that intervened below. Will

6:24

you say in that

6:26

litigation, fine, you can challenge it

6:28

and let's get to

6:30

the merits of this issue, the lawfulness of

6:32

what the FDA did. No.

6:35

We think the states lack standing. There are

6:37

certain indirect injuries that would, if it

6:39

provided a basis for standing, mean that

6:41

states could always sue the federal government. And the

6:43

court cautioned against that result in United States versus

6:45

Texas, footnote three of that decision. Okay.

6:47

How about a doctor who

6:49

opposes abortion? So she's on duty

6:52

in an emergency room when a

6:54

woman comes in with complications from

6:57

having taken metoprestone and

7:00

the doctor's the only one there on

7:03

duty who can attend to this woman's problem.

7:05

And as a result, in order to save

7:07

her life, the doctor has to

7:09

abort a viable fetus. Now, would

7:12

that doctor then have standing to seek

7:14

injunctive relief? Or would you say that's

7:16

too speculative? This was like being struck

7:18

by lightning and there's no, it's

7:21

not sufficiently likely that this is going to happen

7:23

to this doctor again. We would agree that

7:25

that would represent past harm. So we're

7:28

not disputing that that kind of conscience violation,

7:30

providing care and violation of one's conscience, would

7:32

be cognizable. But yes, we think that

7:34

that situation has never come to pass. Respondents

7:36

haven't identified any incident in more than

7:39

20 years that metoprestone has been available

7:41

on the market that resembles that kind

7:43

of hypothetical situation. And so, yes,

7:45

our view would be it's unduly speculative. And you have

7:47

to think about all of the events that would have

7:49

to transpire to get to that moment. I understand the

7:51

argument. Now, How

7:53

about a woman who suffers adverse consequences

7:56

from having taken Metoprestone? Would She be

7:58

able to sue for damages? Where

8:00

you would say that Sparred my son of

8:02

a community I exits. That we would have

8:04

sovereign immunity arguments and that kind of casing

8:06

the I recognize that expects with respect to

8:08

trace ability that's a harder. Argument for

8:10

us? Okay, is there anybody

8:13

who can. Sue

8:15

and get a judicial rulings on whether

8:17

what as the I did was lawful

8:19

and maybe what they did was perfectly

8:21

lawful. But since somebody be able to

8:24

challenge them in court who interview who

8:26

would have standing to bring message I

8:28

think that was respected. These regulatory changes

8:30

It's hard to identify anyone who was

8:32

standing to sue, but the court has

8:35

said time and again that the fact

8:37

that no one would have standing doesn't

8:39

provide a basis that from Article Three

8:41

principles it's a day Rains in Richardson

8:43

and Valley Forward. And and clapper and some.

8:45

I think it's clear that even if there is

8:48

no alternative person here who could still, that

8:50

doesn't mean that the courts to dispense with that

8:52

indispensable. Requirements. Of article or okay

8:54

I understand that an article for is

8:56

important for your argument is that doesn't

8:58

matter if as the a flagrantly violated

9:01

the law didn't do what it should

9:03

have done are endangered the health and

9:05

women As says, too bad nobody can

9:07

suing for certainly Moon sitters no remedy

9:09

the American people have no remedy for

9:12

that's. Will I pissing that? It would be

9:14

wrong to suggest that it's as the I had made

9:16

a mistake and. As ruff were actually producing cc

9:18

consequences as it would be nothing to be

9:20

done. I I don't think that these respondents

9:22

said insult article three to six and to

9:24

have. The courts that then that Se

9:26

A takes very seriously as responsibility to

9:28

ensure the safety of frogs. It

9:31

conducts ongoing surveillance. And can make

9:33

adjustments to the regulatory regime. A Think these

9:35

situations emerged. the Drug. Sponsors themselves the

9:37

mean responsible at all. Times We have

9:39

a court system in this country and. Back

9:41

and help ensure that is darcy problems that come

9:44

to pass. The sponsors will take action and reaction.

9:46

To that was the premise here. is

9:48

that unsafe shrugs to somehow remain on

9:50

the market? I think that's that's incorrect.

9:53

when for your argument here is an

9:55

offensive i have great respect for article

9:57

free we all do we have to

9:59

come with it, but your argument here

10:01

is that even if

10:03

the FDA acted unlawfully,

10:07

nobody can challenge that in court. And that's

10:09

basically the argument you made last week, right?

10:11

In the Murthy case, we shouldn't get to

10:14

the question whether the White House and others

10:16

violated the right to freedom of speech. We

10:18

should just say, well, these plaintiffs can't bring

10:20

suit, right? We are looking

10:22

at the specific respondents in this case

10:24

and their theories of standing. We don't

10:27

think they come within 100 miles of

10:29

the kind of circumstances this court has

10:31

previously identified of non-speculative harm that can

10:33

create the kind of cognizable injury for

10:35

forward-looking relief. Jennifer? I

10:37

am assuming that if there were

10:40

an un- if this had been

10:42

unsafe in a grossly

10:45

visible way, you know, 40

10:47

percent more increased hospitalizations, that

10:49

some doctor who was prescribing

10:51

it would have challenged the

10:53

lack of an in-person. Well,

10:56

no doctor is required, Justice Sotomayor, to

10:59

dispense other- No, but if a doctor

11:01

wants to, just like in a doctor who wants

11:03

to do abortion, we have said if

11:06

there's regulations that stop them from doing

11:08

it, I guess that doctor

11:10

could come in and say, this

11:13

is unsafe. I can't. By

11:16

not having people visit me beforehand,

11:20

we're not warning them, et cetera, et cetera.

11:23

Certainly, I think if those kinds of distinct

11:25

safety concerns emerge, there would be steps

11:27

taken at the agency level. There's

11:30

nothing like that here. There's no contrary evidence to

11:32

test it. I'm pondering a hypothetical. But I

11:34

do want to be clear that

11:36

FDA's regulations here don't require doctors

11:39

to not grant an

11:41

in-person visit because they think that that is the

11:43

best way to provide a standard of care here.

11:45

So they are not directly required to dispense with

11:47

a PRIST-DONE through any particular arrangement.

11:50

Counsel, can I ask you a question about the

11:52

conscience injury? So that's one

11:54

of the roadblocks you identify in the

11:56

specular chain because you say a doctor

11:58

could invoke federal conscience protection. to

12:00

refuse to complete an

12:03

abortion that was when the embryo or

12:05

fetus was still alive. So

12:08

I just want to be clear. The federal government's position

12:10

is that their doctor would have

12:12

conscience objections. I'm thinking about the

12:14

EMTALA litigation, and the Fifth Circuit

12:16

criticized the government's inconsistent positions. But

12:18

it is your position that such doctors

12:21

would have recourse to the conscience protections

12:23

of federal law. Yes, absolutely. And let me

12:25

be clear about this, because I think the

12:27

Fifth Circuit did fundamentally misunderstand our

12:30

arguments, and respondents have repeated that

12:32

misunderstanding here. The federal government has

12:34

never taken the position that EMTALA

12:36

would override an individual doctor's conscience

12:38

objections. We said exactly the

12:40

opposite. If you go and look at our

12:42

Fifth Circuit reply brief in the Texas litigation, we

12:44

disclaimed that understanding of EMTALA and made clear that

12:47

we understand the conscience protections to continue to

12:49

apply and shield the doctor who doesn't want to

12:51

provide care in violation of those protections. Would

12:53

that be true in a health care desert as

12:55

well? Yes. So we don't

12:57

think that EMTALA would override conscience protections

12:59

for the individual doctor. It, of course,

13:01

imposes obligations on hospitals. And hospitals have

13:03

all kinds of plans in place to address

13:05

these types of contingencies. You know, they have staffing

13:08

plans. I understand it's a matter of best practices. They

13:11

often ask for doctors to articulate their

13:13

conscience objections in advance, so they can

13:15

take account of that in staffing. They

13:17

have cross-staffing agreements with other hospitals. And

13:19

in the government's experience enforcing EMTALA, this

13:21

is almost four decades of experience, we

13:23

are not aware of any situation where

13:25

there has been that kind of direct

13:27

conflict between EMTALA and conscience protection. Okay.

13:29

And just one last question. This is

13:31

about the association's standing. So its own

13:33

standing and its own, right? I'm talking about not its

13:35

standing. That is based on an injury to one of its

13:37

members. So the injuries

13:40

of the association is arguing

13:42

sound in the Haven's Realty associational standing,

13:44

and they're the kinds of allegations we

13:47

see by immigration advocacy groups. The

13:49

diversion of resources, increased expenses

13:53

that result from the complications of having to

13:55

address and explain the new

13:57

changes. And I'm not talking about the expenses of

13:59

filing. Now I'm

14:01

talking about let's decide whether to. Version of resources can.

14:04

You distinguish that from Havens. we'll see. Yes,

14:06

so I think Seasons itself was

14:08

trying to distinguish between two types

14:10

of potential organizational injuries. and with

14:12

haven sad is that in that

14:14

case, the organization had come forward

14:16

with the rest and concrete demonstrable

14:18

injury to it's south and bear.

14:21

that organization had a contract to

14:23

provide. Low income housing or or asserts

14:25

to secure it for clients and said

14:27

racial searing practices directly interfered with that

14:29

made it more difficult for the organization

14:31

to carry out a contractual obligations. That

14:33

Havens itself said that it was not

14:35

blessing a theory of sand Things that

14:38

would allow an organization to assert a

14:40

setback to it's abstract social interest. So

14:42

I think that reflects the court trying

14:44

to distinguish between more concrete, direct, demonstrable

14:46

harms on the one hand and that

14:48

kind of upset set back on the

14:50

other hand. And I recognize and you're

14:52

you're pushing touches on it as a

14:54

spirit that some lower courts in particular

14:56

has seems red meat havens to to

14:59

endorse far broader theories of standing including

15:01

and the immigration contacts the government has

15:03

been routinely. Resisting standing because we think

15:05

that that would essentially means that the

15:07

Me advocacy organization could say it opposes

15:09

what the Federal government is doing and

15:11

so therefore have to devote resources to

15:13

our opposition. If that were enough than

15:15

every organization would have standing and it

15:17

would be a vast expansion. Of ordinary

15:20

article Three, Principal so we would

15:22

welcome an eventual clarification from the scored

15:24

on organizational standing. But here I think

15:26

that the organization's assertion of injury falls

15:28

in the bucket of the abstract. Sat

15:30

back and doesn't come. Close to the

15:32

kind of demonstrable harm that was an

15:35

issue in Haven with it. So Under

15:37

the does have that settle for clarification

15:39

of like those similar surface they do.

15:43

With respect to individuals, some.

15:46

Of the I've heard I've heard

15:48

and messenger human where the Bruce

15:50

and I think I understand it

15:53

would. How does it fit your

15:55

mind with offended observer standing under

15:57

the establishment clause were. injuries

16:01

about them. I access a park and I

16:03

like to look at it in a certain

16:05

way and those kinds

16:07

of injuries that the court has

16:10

sometimes recognized and other times cast

16:12

out on. So it's true

16:14

I think that there are different strands of this

16:16

court's precedent and I would put

16:18

the Establishment Clause precedent and First

16:20

Amendment precedent generally in its own

16:23

bucket because the court has sometimes recognized

16:25

different theories in the First Amendment context. Back

16:27

on that a little bit because standing is

16:29

standing. It's Article 3 that we're

16:31

interpreting here. And so I think it's

16:33

got to, we're going to spot somebody to stitch it all

16:35

together and I'm looking for guidance from you.

16:38

So I think the way to approach this

16:40

is to, if you're going to recognize some

16:43

kind of offense or distress type of injury,

16:46

to recognize that there are... Could we? Well... I

16:48

guess it's a political... No, I mean I represent the

16:50

government so I think that that kind of

16:52

theory of injury would likely go far, far

16:54

too much in the direction of allowing Article

16:56

3 courts to weigh in based

16:58

on generalized grievances. But I

17:00

guess what I would say is to distinguish

17:02

the cases where this court has sometimes found

17:05

that type of injury cognizable. Generally it's in

17:07

a situation where there is a kind of

17:09

direct governmental action producing that type of injury.

17:11

And here our argument is that the FDA's

17:14

actions in approving misopristone, specifically in 2016

17:16

and 2021, and if you're looking at that

17:18

which was an incremental change, is

17:21

so far upstream of the downstream assertion

17:23

of harm or distress that the respondents

17:25

are asserting that there is just as

17:27

a matter of law an attenuated link

17:29

here that cannot suffice for Article 3

17:31

jurisdiction. Thank you. Thank you, counsel. Justice

17:33

Thomas, any further? Justice Alito?

17:37

You say that the Fifth Circuit didn't

17:39

give any reason to think that the

17:41

three changes made in

17:43

2016 would be more dangerous

17:46

in combination than they were

17:48

individually. But isn't that obvious

17:50

that three things

17:53

that may be innocuous

17:55

or not excessively dangerous

17:58

If engaged in. By themselves

18:01

may be some very dangerous

18:03

when they're all been together.

18:06

For why shouldn't be? As the A

18:08

have addressed that I think the only

18:11

ways that that would be three would

18:13

be is to three change as are

18:15

interconnected and mutually reinforcing, guarding against the

18:17

same kind of safety risk. So

18:19

I agree that it's the reason to

18:21

think that that the reason why Mr.

18:23

Persona save up to ten weeks gestation

18:25

is because it's been prescribed by doctor

18:27

As instead of nurse practitioners for example.

18:30

Than those changes have been significant because

18:32

he mentions. Would effectively be the since enough

18:34

for another. But there was nothing like

18:36

that in this record. The study is that

18:38

Se A examines and said demonstrated to the

18:40

be seen says i'm fit and with an

18:42

exhaustive examinations or safe Not because there were

18:45

other different safeguards in place to guard against

18:47

risks but rather because if you go up

18:49

to ten weeks of gestation there is no

18:51

observable increase and serious adverse events no matter

18:53

who's prescribing. So when the absence of that

18:55

kind of for with his effect of the

18:57

cheeses I don't think you can fault the

19:00

agency's for not giving even more explicit attention

19:02

to this issue and is it is cited

19:04

multiple studies. That combines multiple seems as precisely

19:06

because the standard of care had evolved

19:08

over the fifteen years if a person

19:10

had been approved and many of the

19:12

changes were already been deployed together safely.

19:15

Shouldn't be of the I have

19:17

at we considered the application of

19:19

eating. You see Fourteen Sixty One.

19:22

So I think that the Comstock.

19:24

Provisions don't fall within as the a

19:27

slave. Sta Under the Fcc, I

19:29

can only maintain restrictions under the Rams

19:31

program is necessary to ensure safe use

19:33

and Twenty Twenty One what Se determined

19:35

is you don't need and person dispensing

19:37

for safe use so the Fcc A

19:39

did not independently require that months. This

19:41

restriction, an emphatic couldn't be imposed months

19:43

as he had me that the twenty

19:45

cents and that doesn't affect other sources

19:47

of law as the A was not

19:49

affirmatively approving mailings and violation of com

19:51

Zoc even if you interpret it as

19:53

that way and we don't think it

19:56

means what respondents suggests, that means. But it's

19:58

a very least I don't think that it with. Responsibility

20:00

to consider that nor could it have permitted

20:02

like consider that under the statute throw isn't

20:04

say any of that. It didn't say anything

20:06

about it, and this is a prominent. Of

20:09

provision as smart as some obscure

20:11

subsection of a complicated, obscure law

20:13

them they knew about and everybody

20:16

in this field knew about it.

20:18

Shouldn't they have at least address

20:20

that? you have answers to the

20:22

arguments that are made on the

20:24

other side? Sydney, as the I

20:26

have at least said, we'd consider

20:28

those and provide some kind of

20:30

an explanation of. Let. Me give to

20:33

respond says one is that I don't think

20:35

it would have even been permissible for as

20:37

the A to consider maintaining this restriction because

20:39

of comstock. If you look at the relevant

20:41

statutory section here at three Fifty Five-one is

20:44

he for this is reproduced a paid six

20:46

say of the appendix to our brief. It's.

20:48

Very clear that the only thing as the I can

20:50

take into account. For restrictions or safety.

20:52

And efficacy concerns in deciding whether to

20:55

maintain Rams. Program. But the other thing I

20:57

would say Justice Alito is that the agency

20:59

did have a memorandum on com Sarcosuchus a

21:01

size thirty five. That is the advice that

21:03

Se. A receive from a well conveying

21:06

the interpretation of from Zoc. They got

21:08

the advice from our free but it

21:10

didn't refer to that. See.

21:12

In the two Thousand and Twenty One decision,

21:14

know that their benefits and modified and Twenty

21:16

Twenty Three and the support of the administrative

21:18

record for that. Ah,

21:21

Ok, when when was questioned the

21:23

plane of say that the studies

21:25

have you have to rely on

21:27

for the twenty twenty One amendment

21:29

says it: Mail order to suppress

21:31

them suggests more frequent trips to

21:33

the emergency room. Now this is

21:35

what I see as the of

21:37

response to that food. Although the

21:39

literature suggests there may be for

21:41

more frequent emergency room service, it's

21:43

related to use of the suppress

21:45

them when dispense by mail from

21:47

the clinic. There are no apparent

21:49

increases in other serious. Adverse events

21:51

related to Mister President use

21:54

doesn't really count as a

21:56

reasoned explanation. To

21:59

thus. The estimate the data shows

22:01

they're gonna be more emergency room

22:03

visits. This is that they increase

22:06

emergency room visits is just have

22:08

no consequences. Doesn't even merit some

22:10

com some comment. That is a

22:12

reason explanation what as the A was observing,

22:14

and that passage is that although would acknowledge

22:17

the fact that some other studies reported additional

22:19

emergency room visits that didn't equate to additional

22:21

serious adverse events and of that one of

22:23

the studies, half of the women who went

22:26

to the emergency room didn't get any treatment

22:28

at all, and many women might go because

22:30

they're experiencing. Heavy bleeding which mimics a miscarriage

22:32

and they majesty to know. Whether or not

22:34

they're having a complications but and that kind of

22:36

circumstance the woman is not having a as a

22:39

serious adverse event from if a person's and so

22:41

it doesn't call. Into question the sixty determinations

22:43

regarding the drug dealing with the end of

22:45

the day as the a carefully. Part to

22:47

those studies, it made specific determinations about the

22:49

results to be gleaned with respect to safety

22:52

and efficacy of fully explain his decision making

22:54

and I think a false well within the.

22:56

Zone of reasonableness under arbitrary person for

22:58

the sake of. The

23:01

sooner. On that last question,

23:03

because this is troubling. For

23:05

the reality is, even if there

23:07

is. Some increase in emergency

23:10

room visits. The question

23:12

of when that rises

23:14

to for sufficient. Safety

23:16

risk is of to the as

23:19

the current. That's right, an issue

23:21

as the A acknowledge that so it's not

23:23

like it overlooks this aspect of the studies.

23:25

I also want to emphasize Sessa said i'm

23:28

I or that the studies were far from

23:30

the only evidence as the a consultant at

23:32

the time and after than twenty twenty one

23:34

and had real world experience during the covered

23:36

nineteen pandemic a period of time when the

23:39

and plus into something requirement was not and

23:41

forth and Se started by looking at as

23:43

a comparative analysis the two periods of time

23:45

when you had imprisoned dispensing and when you

23:48

didn't and saw that there was no relevant

23:50

increases. Serious adverse events or difference between us

23:52

to timeframe So that further supported the say.

23:54

Took a problem with all drugs is

23:56

there are complications of virtually all of

23:58

them yet as. What level

24:01

The cost benefit analysis tells you

24:03

The stop prescribing something is a

24:05

very difficult question. his of it.

24:08

And that's a question that Congress has

24:10

entrusted to Fts. But putting that

24:13

aside here, whatever. the statistical

24:15

increase was as as the

24:17

A determined under the Rams,

24:19

Sanders said it was insufficient.

24:22

To. Create a risk

24:24

that counterbalance disease for

24:26

access, Correct. Correct because at the

24:28

As instructed to take into account burdens on

24:30

the health care delivery system as well and

24:33

it looked at a variety of sources of

24:35

the that's it concludes that on balance the

24:37

burdens were I was suggested that it was

24:39

not necessary. To keep this recession and place

24:42

to ensure safety of sense of. The

24:45

screen some. Tunnels I could take you

24:47

back to. The discussion that you were having was just.

24:49

Disparate about the conference objections and just

24:51

ask you. I'm sure that you've read

24:53

the declarations carefully, and I'm sure Miss

24:55

Holly will have things to say about

24:58

this too. But

25:00

as you read those preparations. What

25:03

is the conscience objection? What.

25:06

What are the doctors objecting

25:08

to? exactly? I think

25:10

the declarations are specific. On this point,

25:13

there are only seven doctor who regularly

25:15

practice and submitted evidence, and that declarations

25:17

are relatively. Short, this isn't say eight,

25:19

one fifty to two hundred. I encourage

25:21

reading them because there are only two

25:23

doctors out of the seven who even

25:25

provide any information about their specific content

25:28

subsections so's to or who those are,

25:30

Doctor Stop and Doctor Francis the relevant

25:32

language for another five. Don't refer to

25:34

conscience objectives. They don't. Refer to their

25:36

own conscience objections, or provide any specific

25:38

detail about exactly what can the families

25:40

upon sense? Doctor Francis is at j

25:43

one fifty five Doctor Scott messaging. a

25:45

one sixty seven both described the injury in

25:47

the same terms they object to ending the

25:49

life of a human being in the womb

25:52

and fear that they might have to complete

25:54

an abortion for a woman who has an

25:56

ongoing pregnancy so as you understand those declarations

25:58

they do not object to

26:01

providing whatever care is necessary

26:03

to a person who may

26:05

have complications from taking mephapristone.

26:07

In other words, for example,

26:09

suppose somebody has pled

26:11

significantly, needs a transfusion

26:14

or any of a number of other

26:16

things that might happen. As you understand

26:18

the declarations, there's not an objection to that.

26:21

I think that the fair reading of the declarations

26:23

is they are not objecting to that. Now I

26:25

acknowledge that respondents in their red brief have suggested

26:28

there's a broader conscience injury in play here and

26:30

that there might be other doctors who have a

26:32

broader concern about providing any care, even

26:35

if that broader conscience injury had been in

26:37

this declaration we think still is a matter

26:39

of law that could not demonstrate that they

26:41

have a non-speculative injury, in part because of

26:43

all of the upstream things that would have

26:45

to happen in terms of a woman having

26:47

the serious event, going to these specific doctors,

26:49

but also the fact that federal conscience protections

26:51

are specifically designed to deal with this issue

26:53

and they would cover the range of conscience

26:56

objections that exist in this context. Right.

26:58

There are obviously conscience objections of all

27:00

kinds. I was just asking about the

27:02

particular declarations of these

27:04

particular members of the organization. Yes,

27:06

and I think on these declarations they have

27:08

not asserted a broader injury, but even if

27:11

they could conceivably come forward with other doctors

27:13

or try to adjust their declarations in

27:15

some way, still that would not suffice. Okay.

27:17

Can I just ask a quick question about

27:19

the merits? You open

27:21

your brief with a somewhat arresting

27:24

statement, but it starts with

27:26

to the government's knowledge, and this was written

27:28

a few months ago, and since then I'm

27:30

sure that you've had lots

27:32

of time to think about this case and

27:34

to get all background information on it. So

27:36

I'll just read you this sentence

27:38

and ask you whether it's still true

27:41

to the government's knowledge. To the

27:43

government's knowledge, this case marks the first time,

27:45

and I'm going to say, is it the first

27:47

time? Is it the only time? Any

27:50

court has restricted access to an

27:53

FDA-approved drug by second-guessing FDA's expert

27:55

judgment about the conditions required to

27:57

assure that drug's safe use. Is

28:00

it still the only time that is still to

28:02

our knowledge? The only. Time a court has done

28:04

that and we have. Seen a disturbing trend

28:06

of course sometimes also overriding as the such

28:09

meant to try to grant greater access to

28:11

drugs when that over rights as the eighth

28:13

or Jasmine about what's necessary to ensure safe

28:15

use and no matter which direction you com

28:17

at it from we on behalf of Se

28:20

A since the courts have no business making

28:22

those judgments in the absence of the kinds

28:24

as arbitrary and capricious error that would satisfy.

28:26

The A P I think if. The

28:30

sources to school systems

28:32

farm our on issue

28:34

under federal law know

28:36

doctors can be. Force

28:40

against their consciences to perform

28:42

or assists in an abortion?

28:45

Correct? Yes. We think that federal

28:47

Constance protections provided broad coverage here. Just

28:49

to be super precise, there are some

28:51

triggering. Requirements of receiving federal funding and

28:53

so forth. We sided the relevant provisions

28:55

at Peace five. Of our reply brief

28:57

that Hurts Amendments have the most comprehensive perceptions

29:00

the earth and we think that those amendments

29:02

guard against to the kind of injury that

29:04

respondents are asserting. Their also state. Law protections

29:07

that often applied in this context. To

29:10

suspect was asking is true even

29:13

if the declarations were interpreted as

29:15

respondents due to say that save

29:17

regard. Any participation, even ten.

29:19

Seasons or D and sees. After

29:21

the person is otherwise completely has to, she

29:23

needs to be removed. Yes, I think that

29:26

would be true so that most relevant for

29:28

some Mm provision is forty two U S.

29:30

E Three hundred A-seven

29:32

V. And it's language says

29:34

that adopters on not be required to

29:36

perform or as four assists in any

29:38

part of the health care program that

29:40

would violate the doctors. Religious or moral

29:42

beliefs, so it's tied to the nature of

29:45

the doctors beliefs rather than particular procedures. And.

29:47

One other question in this goes to the merits.

29:50

as i understand that the

29:52

serious adverse consequences that have

29:54

to be reported or that

29:56

as the a considers risks

29:58

hard death and chances but

30:00

not say, I mean, it seems

30:02

to me, and I think the data bears this out, that

30:05

the elimination of the in-person dispensing

30:09

requirement or, you know, the in-person visit

30:11

at the outset would lead to mistakes

30:15

in gestational aging, which

30:17

could increase the

30:19

need for a DNC or the amount of

30:21

bleeding, et cetera. But that does not count,

30:24

correct, as an adverse event? So, I want

30:26

to be careful because there's a list of

30:28

serious adverse events, and I'm not sure that

30:30

I have all of them down to be

30:32

able to recite them to you, although they're in

30:34

the record. But I do think the premise of

30:36

the question is wrong, this idea that the change

30:39

to in-person dispensing would necessarily increase

30:41

the risk of those events. That was not

30:43

reflected in the data that FDA consulted. And I would

30:45

point you to J.A. 383 to 384 in particular,

30:48

where FDA explains that even in

30:51

person, you're not necessarily getting an

30:53

ultrasound that's never been required. And

30:55

so, the relevant question might be,

30:57

is your provider going to

30:59

ask you a series of screening questions, like

31:01

when was your last menstrual period, in person

31:03

or via telemedicine? And there's no evident reason

31:05

why that difference would actually lead to different

31:07

safety outcomes. So, there was not even a

31:09

– I thought there was a

31:11

small percentage increase in the tracking.

31:14

I'm wrong about that, which I may well be.

31:16

You know the J.A. way better than I thought.

31:18

Yeah, so I think that with respect to the

31:20

ER visits, there was some evidence that there were

31:22

increased ER visits, although as I explained to

31:24

Justice Alito, that wasn't actually correlated with an

31:27

increase in serious adverse events. You know, I

31:29

don't want to represent all of the different

31:31

findings of the different studies because they varied

31:33

a little bit. But FDA's ultimate conclusion was

31:35

that mifacristone could successfully be dispensed without in-person

31:38

visits. It had voluminous evidence, I think, to

31:40

support that conclusion in 2021. And there's been

31:43

no contrary evidence that's been introduced.

31:45

So, there was no requirement of

31:47

either an ultrasound or detecting

31:50

a fetal heartbeat or anything like that, even

31:52

before the doctor could just go based on

31:55

the woman's recounting when her last menstrual period

31:57

was. That's right. And that dates all the way back to

31:59

the initial – approval of this drug in

32:01

2000. It has never been a required

32:03

condition of use to have an ultrasound. FDA

32:06

has always left that up to medical judgment.

32:08

Now, it is, of course, necessary for providers

32:10

to be able to diagnose ectopic pregnancy and

32:12

to date gestational age. That remains true under

32:15

the REMS now. Prescribers still have to have

32:17

that capability, and they have to deploy whatever

32:19

mechanisms they believe would accurately allow them to

32:21

identify contraindications for use of misopristone. But it's

32:24

wrong to suggest that if the court reverses 2021

32:26

changes, then every woman

32:28

is going to get an ultrasound. That's never

32:30

been the state of play in how this

32:32

drug has been administered. How, even under the

32:35

pre-2021 REMS, was it possible to

32:37

detect an ectopic pregnancy without an

32:39

ultrasound unless the woman was presenting

32:41

with pain? So there's a

32:43

set of screening questions that are often deployed.

32:45

You can ask things like, do you have

32:47

unilateral pelvic pain? Did you become pregnant while

32:49

you had an IUD in or after a

32:51

tubal ligation? Are you experiencing unusual

32:54

bleeding? You could ask whether the woman has

32:56

had a prior ectopic pregnancy. And if the

32:58

woman has those kinds of risk factors, then

33:00

imaging may be necessary. But that remains true

33:03

under the 2021 REMS as well. The prescriber

33:05

has to be confident that it has excluded

33:07

those kinds of conditions before prescribing this drug.

33:10

And the standard of care around the world,

33:12

most medication abortion occurs without

33:14

an ultrasound. Thanks. Justice

33:16

Jackson? Good morning, General. So

33:20

I'm worried that there is

33:22

a significant mismatch in

33:24

this case between the claimed

33:27

injury and the

33:30

remedy that's being sought, and

33:32

that that might or should matter

33:34

for standing purposes. I don't know

33:36

that our doctrines capture this,

33:39

but I guess I

33:41

see it that the injuries that

33:43

the respondents allege, as you've articulated

33:45

them, are a conscience injury,

33:47

that they are being forced to

33:50

participate in a medical procedure that they object

33:52

to. And so the obvious

33:54

common sense remedy would be to provide

33:56

them with an exemption that they don't

33:59

have to participate. Image

34:01

Procedure and you say and he

34:03

said here several times a federal

34:05

law already teasing them next. So

34:07

I guess then what they're asking

34:09

for in this lawsuit is is

34:11

more than they're saying because we

34:13

object to having to be forced

34:15

to participate in this procedure. were

34:17

seeking an order preventing anyone from

34:19

having access to these drugs at

34:21

all, and I guess I'm just

34:23

trying to understand how they could

34:25

possibly be entitled to that given

34:27

the injury that they have alleged.

34:30

I agree to have sex and and I

34:32

do think it's relevant to stand in Stark

34:34

or Profiles and mismatch here between the same

34:36

century and the remedy they were seeking and.

34:38

Either you can almost think of this as

34:41

a type of and zone of interest kind

34:43

of analysis. You know if the doctors had

34:45

a constant century there's a specific that is

34:47

designed to deal with that to specifically tailor

34:49

made guard against the risk. Of that inslee

34:52

occurring and instead of their reaching out and

34:54

seeking to invoke rights under a different statues,

34:56

the Fcc. A said doesn't regulate them at

34:58

all the doesn't make them feel or not

35:01

he when he sang and that abed belief

35:03

that their sittings would dramatically alter the improve

35:05

conditions of use from if a person and

35:07

effect when an all around than a sense

35:09

because of Wisconsin century that's already directly addressed

35:12

by other provided. If it wasn't all is

35:14

it wasn't as rest and we would see

35:16

this lawsuit and the remedy would be to

35:18

some some crazy and yes and I think

35:21

that one is a hard things about trying

35:23

to tailor relief here is that they're asserting

35:25

such as a few serious injuries that. It's

35:27

almost as though the only option was to grants

35:29

nationwide remedy of the climbed the lower courts issued

35:32

and that runs counter to ordinary Article Three principles

35:34

of party specific relief. But I just think it

35:36

shows that there's something wrong with the theory of

35:38

injury and the first place because it so. Attenuated

35:41

and because they claim they would need so

35:43

much release. All over the country. Me

35:45

ask you another question I'm in addition

35:47

to the challenges that we have, your.

35:49

the respondents below challenge the as

35:51

these initial decision to prove mr

35:54

preston into in the year two

35:56

thousand and of course that occurred

35:59

very long The fifth

36:01

circuit found that that challenge wasn't timely because

36:04

of the statute of limitations. As you're

36:06

aware in the context of another case

36:09

we heard this term, the court is

36:11

currently considering the statute of limitations issue.

36:13

So setting aside standing,

36:15

have you thought about how a ruling

36:18

from this court on the statute of

36:20

limitations in either direction might impact what

36:22

happens in these kinds of

36:24

cases with these kinds of challenges? Yes,

36:26

I think that it just reflects the

36:28

stakes of the corner post case and

36:30

provides a vivid example of the way

36:32

that it might be possible if this

36:34

court were to approve the request for a

36:37

broader theory of the statute of limitations in that

36:39

case. The way it could open the door to

36:41

plaintiffs coming in and saying, well, I only became

36:43

a doctor later, or I only started working in

36:45

an emergency room later and would try to

36:47

unsettle longstanding agency actions that

36:49

maybe occurred decades previously. I do want to

36:52

say that I understand the corner post petitioner

36:54

to have suggested maybe there would be equitable

36:56

defenses that the government could raise in those

36:58

kinds of cases. We would certainly want to

37:00

raise that type of defense with respect to

37:03

the approval of myth of Christone, which I

37:05

think has generated tremendous reliance interests and proven

37:07

to be safe and effective over decades of

37:09

use. Thank you. Thank you,

37:11

counsel. Ms. Ellsworth.

37:14

Mr. Chief Justice, and may it please the court. In

37:18

2016 and 2021, FDA

37:20

made certain changes to the labeling

37:22

and use restrictions for Danko's drug,

37:24

Meffa-Prix. The decision

37:26

below stops Danko from selling Meffa-Prix in

37:29

line with that scientific judgment based

37:31

on a highly attenuated claim that an

37:34

unknown doctor could be called someday to

37:36

an unknown emergency room after a series

37:38

of decisions by third parties. No

37:41

facts causally link that possible future encounter

37:44

to a specific change FDA made in

37:46

2016 or 2021. Respondents

37:50

view of the Food, Drug, and

37:52

Cosmetic Act is so inflexible it

37:55

would upend not just Meffa-Prix, but

37:57

virtually every drug approval and REMS

37:59

modification. FDA has made for decades.

38:02

Reversal is required for two reasons. First,

38:05

Article III standing is not

38:07

an academic exercise in what's

38:09

conceivable. Respondents lack standing

38:11

under every prong of the analysis.

38:14

Second, on the merits, FDA exhaustively

38:16

considered the evidence and reasonably explained

38:18

its conclusions, which is what is

38:20

required to do. I welcome the

38:22

Court's questions. The

38:25

government, the Solicitor

38:28

General points out, would

38:30

not be susceptible to

38:33

a Comstock Act problem.

38:37

But in your case, you would be.

38:40

So how

38:42

do you respond to an

38:45

argument that mailing

38:47

your product and

38:50

advertising it would violate the Comstock

38:52

Act? Justice Thomas,

38:54

we agree very much with the government

38:56

that FDA's charge under the Food, Drug,

38:59

and Cosmetic Act is limited to looking

39:01

at safety and FSP considerations. That's true

39:03

for new drug approvals. It's also true

39:06

for RUM's modifications. FDA routinely

39:08

approves drugs whose manufacture and

39:10

distribution is restricted by other

39:12

laws, like the Controlled Substances

39:14

Act, environmental laws, customs laws,

39:16

and so on. I

39:18

think this Court should think hard about the mischief

39:20

it would invite if it

39:22

allowed agencies to start taking

39:25

action based on statutory responsibilities that

39:27

Congress has assigned to other agencies.

39:30

On the merits, this issue was not presented below,

39:32

excuse me, it was not ruled on below. And

39:35

in any event, I would also point out that in 2021, FDA's

39:39

decision allows use

39:41

of brick and mortar pharmacies in addition

39:43

to mail order pharmacies. Well,

39:47

my problem is that

39:49

you're private. The

39:51

government, I understand the government's argument,

39:55

but you're private and the statute

39:57

doesn't have this

39:59

sort of... safe harbor that you're

40:03

suggesting, and

40:05

it's fairly broad, and it

40:07

specifically covers drugs such

40:09

as yours. Your

40:12

Honor, we disagree that that's the correct

40:14

interpretation of the statute, but we think

40:16

that in order to

40:18

address the correct interpretation, there would need

40:20

to be a situation in which that

40:22

issue was actually teed up. This statute

40:24

has not been enforced for nearly 100

40:27

years, and I don't

40:30

believe that this case presents an opportunity for this

40:32

Court to opine on the reach of the statute.

40:35

Counsel, I'd like to ask you

40:38

the same questions I was posing to the Solicitor

40:40

General. Our precedents Clapper and Susan

40:43

B. Anthony List talk about requiring

40:45

a substantial risk that harm will

40:47

recur, and you argue that's not

40:49

present here. How are we supposed

40:51

to find the spot at which

40:53

the risk becomes substantial?

40:57

Your Honor, I think this Court has always thought

40:59

about these standing inquiries as really a

41:01

question of degree, and you're trying to

41:04

evaluate whether something is actual

41:06

and imminent or whether it's

41:08

conjectural and hypothetical. These

41:10

terms, substantial risk, certainly impending, which

41:12

has been used dating all the

41:14

way back to

41:16

1923, get at where a claim falls

41:18

in this spectrum. Right, I

41:20

mean we toss around a lot of adjectives,

41:22

but I'm just trying as a practical matter,

41:25

how do you figure out? I mean, what

41:27

percentage of adverse consequences would be enough?

41:30

What percentage of emergency room visits would

41:32

be enough? I think that's

41:34

way Clapper thought at that question, and

41:36

you can see this in footnote five

41:38

of the opinion, is to really think

41:40

about whether there is an attenuated chain

41:43

of contingencies that have to happen. And

41:45

in situations where there is this kind

41:47

of attenuated chain of circumstances involving third

41:49

party decisions that have to play out

41:51

in a particular way, and here that

41:53

chain is quite long, that that squarely

41:56

puts a plaintiff's theory on the side

41:58

of the conjectural or hypothetical and not

42:00

the certainly impending injury. How

42:02

is your company aggrieved by

42:06

the challenge that is

42:08

brought in this case? I gather this

42:10

is, your version of Mipha

42:12

Preston is the only product you are

42:15

currently marketing, is that right? That's correct,

42:17

yes. And the

42:19

Fifth Circuit decision does not

42:21

prohibit you from continuing

42:24

to produce and sell that product,

42:26

right? That is

42:28

correct. And so

42:30

I gather your injury is

42:32

that you think you're gonna sell more if

42:35

the restrictions that previously were in place

42:37

were lifted. Yes.

42:40

So you're gonna make more money. The injury is

42:42

that we are prevented from selling our

42:45

product in line with FDA's scientific judgment

42:47

about the safe and efficacious use of

42:49

the drugs. And you're gonna be harmed

42:51

because you're gonna sell more. I

42:54

think that certainly a company's ability to

42:56

market its product is a part of

42:58

how it considers the regulatory scheme that

43:01

governs its conduct. During

43:03

the questioning of the Solicitor General,

43:07

this statement was made that no

43:09

court has ever previously second

43:13

guessed the FDA's judgment

43:16

about access to

43:19

a drug, right? It's never

43:22

second guessed that. That's

43:25

correct. Do you think the FDA is

43:27

infallible? No, your honor. We

43:29

don't think that at all. And we don't think that

43:31

question is really teed up in any way in

43:33

this case. Has the FDA ever approved a

43:35

drug and then pulled it

43:37

after experience, showed that it had

43:39

a lot of really serious adverse

43:41

consequences? It has certainly

43:44

done that. And your honor, I

43:46

think that underscores why the adverse event

43:48

reporting, the post-market surveillance

43:50

that FDA does, the ability that

43:52

these plaintiffs have, even if

43:55

they don't have standing, certainly if

43:57

they are seeing patients who are

43:59

presenting with adverse events, if they

44:01

are doing studies that show there

44:03

is some unknown safety component that

44:05

FDA should acknowledge, they can take

44:07

significant steps to bring that to

44:10

the agency's attention, to bring that

44:12

to Dango's intention. But don't you

44:14

think the FDA should have continued to

44:16

require reporting of non-fatal consequences? Your Honor,

44:20

the FDA decided not to continue that

44:22

reporting requirement in 2016 based on more

44:25

than 15 years of a

44:28

well-established safety profile when that

44:30

reporting was required. There

44:32

is no drug on the market today

44:34

under any runs that requires the kind

44:36

of reporting that the plaintiffs are saying

44:39

should be reimposed here. So why

44:41

would that be a bad thing? Wouldn't your company, I

44:43

mean you don't want to sell a product that

44:45

causes very serious harm

44:48

to the people who take your

44:50

product, relying on your

44:52

tests and the FDA's tests. Wouldn't you

44:55

want that data? Your

44:57

Honor, that data is certainly something that

45:00

we are looking for all the time.

45:02

It is part of the reporting obligations

45:04

for a manufacturer to be aware of

45:06

any data that is becoming available through

45:08

any means. We have a 1-800 number

45:10

on our website. There is a 1-800

45:13

number on the labeling. I think your

45:15

Honor's question though gets at concern I

45:17

heard and some of the earlier questioning

45:19

about who would have standing if

45:21

these plaintiffs don't have standing. And one of

45:23

the things I want to note is that

45:25

drug manufacturers are very frequently subject

45:27

to tort litigation. Product

45:30

liability suits, failure to warn

45:32

suits, deceptive advertising suits when

45:35

someone is claiming harm from

45:37

a pharmaceutical manufacturer's planet. What

45:39

is so I think revolutionary

45:41

really about the arguments here both on

45:43

standing and the merits are the way

45:45

that they attempt by individuals

45:48

who do not use this product, do

45:50

not prescribe this product and have a

45:52

conscience right not to treat anyone who

45:54

has taken this product. Those

45:56

individuals want to prevent anyone else

45:58

from using it in line. with FDA's

46:01

considered scientific judgment. Does your company,

46:03

just one more point along the same,

46:05

sort of along the same lines, does

46:08

your company think that

46:10

what the FDA has done preempts

46:12

state laws that prohibit

46:15

the dispensation of mythopress stone

46:17

within their borders? We

46:19

have not taken a position on that issue and it has

46:22

not been teed up in this case. What

46:24

is your company's position on it? You

46:26

haven't even thought about it. One of

46:28

your competitors made that argument, right? That's

46:31

right. There are some lawsuits that have been

46:33

brought by the generic company that do make

46:35

that argument and I think that is for

46:37

later courts to sort out. Our

46:40

position in this case has been that

46:42

this is about FDA's scientific judgments reached

46:45

in 2016 and 2021. You

46:48

don't wanna answer that question. I

46:50

don't think we have a position that's on

46:52

that that I'm prepared to say today. Could

46:54

you go back to Justice Alito's questions

46:56

about adverse event reporting and you said

46:59

you were subject, your product, to

47:01

higher standards and now

47:05

we're being brought down to the sort of regular, could

47:08

you talk about that a little

47:10

bit? What are the normal standards

47:12

for adverse event reporting? As you understand

47:14

them, why are they there? What

47:16

instead were you subject to in the

47:18

past? May I answer the question? Justice

47:22

Kagan, what changed was not Danko's

47:24

adverse event reporting responsibility. Danko's adverse

47:27

event reporting responsibility has been the

47:29

same throughout this period. What changed

47:31

was that from 2000 until 2016,

47:36

prescribers were obligated to report adverse

47:38

events to Danko and then Danko

47:41

then had its separate reporting obligation

47:43

to FDA. So in

47:47

2016, the REMS for

47:49

Mipherstone were aligned to be more

47:51

consistent with the reporting requirement

47:53

that applies to all 20,000

47:55

plus FDA approved drugs. There

47:57

are only today seven REMS.

48:00

that continue to have even

48:02

the limited higher adverse

48:04

event reporting for deaths that apply to Mipha

48:06

Pristone. So it is only one of seven

48:08

that have that. Thank

48:11

you. Justice Thomas? Justice

48:13

Alito? Need further? Justice Sotomayor? Justice

48:16

Kavanaugh? Justice Barrett? Justice Jackson? I

48:18

just have one quick question. So

48:21

you were asked if the agency is infallible.

48:23

I guess I'm wondering about the flip

48:26

side, which is do you

48:28

think that courts have specialized

48:31

scientific knowledge with respect to

48:33

pharmaceuticals? And as a company

48:36

that has pharmaceuticals, do you

48:38

have concerns about judges parsing

48:41

medical and scientific studies? Yes,

48:44

Your Honor. I think we have

48:46

significant concerns about that. And there

48:48

are two amicus briefs from the

48:51

pharmaceutical industry that expand on why

48:53

exactly that's so concerning for

48:55

pharmaceutical companies who do

48:57

depend on FDA's gold standard review

48:59

process to approve their drugs and then

49:01

to be able to sell their product

49:04

in line with that considered judgment. Can

49:06

you say a little bit about what they say? I'm

49:10

happy to. I think the reality

49:13

is, and this court is, this decision

49:15

below is a good example of

49:18

it. You have a district court

49:20

that, among other things, relied on

49:22

one study that was an analysis

49:25

of anonymous blog posts. You

49:27

have another set of studies that he

49:29

relied on that were not in the

49:32

administrative record and would never be because

49:34

they post-date the FDA decisions here. They

49:36

have since been retracted for lack of

49:38

scientific rigor and for misleading presentations

49:40

of data. Those

49:42

sorts of errors can infect

49:44

judicial analyses precisely because judges

49:47

are not experts

49:49

in statistics. They are not experts

49:52

in the methodology used for scientific

49:54

studies for clinical trials. That

49:56

is why FDA has made

49:59

a difference. hundreds of pages

50:01

of analysis in the record of

50:03

what the scientific data showed, and

50:06

courts are just not in a position to parse

50:08

through and second-guess that. Thank you. Thank

50:11

you, counsel. Ms.

50:13

Hawley. Mr. Chief Justice, and may it

50:16

please the court. FDA approved

50:18

abortion by mail based on data

50:20

it admitted was quote not adequate.

50:23

That violates the APA. The

50:25

lower courts decision merely restored

50:28

long-standing and crucial protections under

50:30

which millions of women use abortion drugs. We

50:33

part a lot this morning about standing.

50:36

Article 3 is satisfied here because

50:38

one, the FDA relies on OB

50:40

hospitalists to care for women harmed

50:42

by abortion drugs. Two, the

50:44

FDA concedes that between 2.9 and 4.6 percent

50:47

of women will end up in the emergency

50:49

room. And three, the FDA

50:52

acknowledges that women are even more

50:54

likely to need surgical intervention and

50:56

other medical care without an in-person

50:58

visit. According to Guttmacher,

51:01

nearly 650,000 women take mifrapristone every single

51:03

year. It's no surprise that respondents

51:08

have experienced an increase in emergency

51:10

room visits and indeed treated

51:12

women suffering from abortion drug harms

51:15

tens of thousands of times. Excuse

51:17

me, dozens of times. Women have

51:19

suffered tens of thousands of times.

51:21

That respondent doctors will

51:24

be forced to manage abortion drug harm is

51:26

not a bug in FDA system but part of

51:28

its very design. Ruling against

51:30

respondents on standing here would allow

51:33

federal agencies to conscript non-regulated parties

51:36

into violating their consciences and suffering

51:38

other harm without judicial recourse. Article

51:41

3 neither demands nor permits this.

51:44

FDA's outsourcing of abortion drug harm

51:46

to respondent doctors forces them to

51:48

choose between helping a woman with

51:51

a life-threatening condition and violating

51:53

their conscience. This HOPSA's

51:55

choice is intolerable. On

51:57

the merits, FDA failed to comply with

52:00

with basic APA requirements. In

52:02

2021, it eliminated the

52:04

initial in-person visit based on

52:06

data it says elsewhere is

52:08

unreliable. And in 2016,

52:10

it failed to consider or explain

52:12

the cumulative effects of its wholesale

52:14

removal of safeguard. These

52:17

actions, though far short of what the

52:19

AP requires, this court should

52:21

affirm. I welcome the court's question.

52:24

Counsel, you assert an

52:27

injury on the part of the

52:29

alliance of

52:31

diverted time and resources. Isn't

52:35

that just the cost of litigating,

52:39

of pursuing this litigation? I

52:42

don't think so, Your Honor, for a couple of reasons.

52:44

First, what respondent doctors have done here

52:46

is chosen their particular practice, as well

52:48

as structure that medical practice to bring

52:50

life into the world. When they are

52:52

called from their labor and delivery floor

52:54

down to the operating room to treat

52:57

a woman suffering from abortion and drug harm,

52:59

that is diametrically opposed to why

53:01

they entered the medical profession. It

53:03

comes along with emotional

53:06

harm. Dr. Scott

53:08

talks about these being heartbreaking situations

53:10

and some of the most stressful work she's had to deal

53:12

with, Your Honor. Well, I

53:15

understand that, but I'm talking about

53:17

the injury of having to divert

53:19

resources to litigate this. With

53:23

respect to the organizational safety. The alliance. Absolutely,

53:26

Your Honor. So we think Haven's Realty is

53:28

on all fours with this case. The best

53:30

evidence of that, I believe, is the FDA's

53:32

reply brief. The government resorts to the

53:34

underlying briefs in the case to say that there was

53:37

a contract and an economic harm. But

53:39

this court's case specifically said that

53:41

the nature of the harm was,

53:43

quote, non-economic,

53:46

did not prevent the court from finding an injury.

53:49

In Haven's, the court looked to two things. One,

53:52

whether there was an impairment of the

53:54

organization's mission. And second, whether

53:56

there was an expenditure of resources.

53:58

Both things are satisfied. here. If

54:01

you look at how our organizations

54:03

have been harmed, they've been forced

54:05

to divert resources from speaking

54:07

and advocating for their pro-life

54:09

mission generally to explaining the

54:11

dangers of the harm from

54:13

abortion drugs. One of the

54:15

primary reasons that that's required

54:18

is because in 2016, FDA

54:20

took away the requirement that

54:23

abortion providers report adverse events.

54:25

Well, but that would

54:27

be anyone who is aggressive

54:31

or vigilant

54:33

about bringing lawsuits. Just

54:37

simply by using resources

54:39

to advocate their position

54:41

in court, you say

54:43

now causes an injury.

54:45

It seems easily, easy

54:47

to manufacture. So I

54:49

don't think that's true in this case,

54:51

Justice Thomas. I acknowledge that the lower

54:53

courts have cabin havens to say where

54:55

you have sort of prelude to litigation

54:57

types of activities. In those sorts of

54:59

cases, those resource justifications don't count. In

55:02

this case, if you look at respondents declarations,

55:04

they note that they have performed studies. They've

55:07

analyzed studies. Several of those are in the

55:09

record and they're not short. They comb

55:11

through Medicaid data. They comb through FAERS data

55:13

to get at the true nature of adverse

55:16

events. And all those sorts of things are

55:18

neither prelude to litigation,

55:21

nor would they have occurred, but for

55:23

FDA's unlawful conduct in this case. Counsel,

55:25

in the line you quoted about economic

55:28

harm, that had to

55:30

do with the fact that they

55:32

didn't intend through their testers to

55:34

rent an apartment. And

55:36

so there was no economic loss to them

55:38

or gain to them from renting the apartment.

55:41

But what was, I think the SG

55:43

is pointing to is

55:46

that they provided services on

55:49

their own. It wasn't just

55:51

the members' services that they were

55:53

relying upon. They were providing services

55:55

to people to help them rent

55:58

departments. So

56:00

that's a very important distinction from here,

56:03

separate from the individual

56:05

defendant's claims

56:08

of standing based on

56:11

wasted resources, their resources.

56:14

The organizations are not losing anything. Their

56:18

job is to do exactly what you're talking

56:20

about and they're doing it. They're investigating

56:25

certain problems, but

56:28

that's not an injury

56:30

that's redressable by vacating

56:34

this rule. So a

56:36

couple of things, Your Honor. This Court's opinion

56:38

in Havens did not rely on the economic

56:40

nature at all. Again, I'd point, Your Honor,

56:43

to the line in Havens where the Court

56:45

says a non-economic nature of respondents' interest in

56:47

housing. They were speaking broadly. Again,

56:50

you have to dig to the underlying briefs

56:52

to find that economic interest that this Court

56:54

did not rely on. With respect to our

56:57

own injury, it's absolutely redressable. For

56:59

example, if the

57:01

regulations are put back

57:03

in place, the protections whereby individual

57:07

abortion providers need to provide

57:09

information about adverse events, that

57:12

would provide our funded organizations with

57:14

more accurate information about the harms

57:16

from abortion drugs. Counsel, can

57:19

I ask you about the remedy

57:21

in sort of the way that

57:23

I was talking with the SG?

57:25

I mean, it makes perfect sense for

57:27

the individual doctors to seek an exemption,

57:30

but as I understand it, they already have that. And

57:34

so what they're asking for here is

57:36

that in order to prevent

57:38

them from possibly ever having to

57:41

do these kinds of procedures, everyone

57:43

else should be prevented from

57:45

getting access to this medication. So

57:47

why isn't that plainly

57:50

overbroad scope of

57:52

the remedy the end of this case? So

57:55

with respect to the premise of that question,

57:58

Justice Jackson, I don't think our doctor... necessarily

58:02

are able to object for two reasons. One

58:05

of this is the emergency nature of

58:07

these procedures. As the FDA

58:09

acknowledges, many women do go to the emergency

58:11

room, and if we just think about what

58:13

that might look like, take Dr. Francis. She's

58:16

on the labor and delivery floor supervising... I'm

58:19

sorry, I don't want to hypothesize. Tell

58:21

me in her declaration where she talks

58:23

about not being able to object or

58:26

pose a conscientious objection. She

58:29

talks about, Your Honor, being an... Can

58:32

you point me to any place in

58:34

the declarations where a declarant states that

58:36

they attempted to object but were unable

58:39

to? No, Your Honor, for two reasons.

58:41

One, these are emergency situations. Respondent

58:43

doctors don't necessarily know until they scrub

58:45

into that operating room whether

58:47

this may or may not be abortion drug harm. It

58:49

could be a miscarriage, it could be an ectopic pregnancy,

58:52

or it could be an elective abortion, Your Honor. In

58:55

addition, the government simply cannot give its story

58:57

straight on intella. If you

58:59

look at the district court brief in that case, we

59:01

just heard that the church amendment applies, and

59:04

while we would love for this court to adopt

59:06

that position, they told the district court the very opposite.

59:08

All right, let me ask you this.

59:10

If we were to

59:12

find that there are conscientious

59:15

objections that, say,

59:17

hospitals take them into account and these doctors do have

59:19

a way to not do

59:21

these kinds of procedures, should

59:24

we, in this case, on that basis? No,

59:26

Your Honor, we would welcome that holding, but

59:29

it's not broad enough to remedy our doctors' harm. Why?

59:32

Because these are emergency situations, they

59:34

can't waste precious moments scrubbing in and

59:36

scrubbing out. No, no, I'm saying assuming

59:38

we have a world in

59:40

which they can actually lodge the

59:43

objections that you say that they have. My

59:46

question is, isn't that enough to remedy

59:48

their issue? Do we

59:50

have to also entertain your argument that no

59:52

one else in the world can

59:55

have this drug, or no one else in America

59:57

should have this drug, in order to protect your

59:59

clients? So again, Your

1:00:01

Honor, it's not possible, given the

1:00:04

emergency nature of these situations. Counsel,

1:00:06

let me interrupt there. I'm

1:00:08

sorry. I think Justice Jackson

1:00:10

is saying, let's spot you all that, okay,

1:00:13

with respect to your clients.

1:00:17

Normally in Article 3, traditional

1:00:20

equitable remedies, we

1:00:22

issue and we say over and over again, provide

1:00:24

a remedy sufficient to address the

1:00:27

plaintiff's asserted injuries and go

1:00:29

no further. We

1:00:31

have before us a handful of

1:00:33

individuals who have asserted a conscience

1:00:36

objection. Normally

1:00:39

we would allow equitable relief

1:00:41

to address them. Recently,

1:00:43

I think what Justice Jackson's alluding to,

1:00:46

we've had one might call it a

1:00:48

rash of universal

1:00:50

injunctions or vacatures. In

1:00:53

this case, seems like a

1:00:56

prime example of turning what could be

1:00:58

a small lawsuit into

1:01:00

a nationwide legislative

1:01:03

assembly on an

1:01:06

FDA rule or any other

1:01:08

federal government action. Thoughts? Yes,

1:01:11

Your Honor. Again, I have to say

1:01:13

that I think it's impracticable to raise

1:01:16

a conscience objection, but even spotting that,

1:01:18

I think the district court remedy here

1:01:20

was perfectly appropriate under Section 705. Section

1:01:24

705 grants the reviewing courts the

1:01:26

authority to issue all necessary and

1:01:29

appropriate relief. As the

1:01:31

government acknowledged an oral argument in

1:01:33

Corner Post, when the parties before

1:01:35

the court are non-regulated parties, the

1:01:37

only avenue in which they can

1:01:39

possibly get relief, and of course that sort

1:01:42

of thing went on of equitable relief, is that the parties

1:01:44

before the court get it. That's

1:01:46

for, as in this case, a state

1:01:48

issue or another case is a vacature.

1:01:51

That's because without that sort of relief, the very

1:01:53

parties before the court won't get it. I

1:01:56

think so, sir. Why can't the court specify

1:01:58

that this relief runs? to precisely the

1:02:01

parties before the court as

1:02:03

opposed to looking to the agency

1:02:07

in general and saying agency you can't do

1:02:10

this anywhere. So

1:02:13

I think, Your Honor, that might be impracticable.

1:02:15

If we're thinking again about the emergency room

1:02:17

situation, would Dr. Francis

1:02:19

again have to know when she's in the

1:02:21

emergency room whether this is a miscarriage, an

1:02:23

ectopic pregnancy or an elective abortion,

1:02:25

this is what she does day in

1:02:27

and day out. And so it seems

1:02:30

like to say that these would run

1:02:32

two particular plaintiffs would

1:02:34

be missing that the FDA regulations

1:02:36

would still be in place and

1:02:39

permit things like mail order abortions. They

1:02:42

would have removed the reporting requirements.

1:02:45

And if we look at the merits of what FDA did

1:02:47

in 2021, FDA relied on two things. They

1:02:51

relied first on the FAERS data. Counsel, before

1:02:53

you pivot back to the merits, and

1:02:55

I can understand your impulse there.

1:02:58

But I went back and looked and

1:03:01

there are exactly zero universal injunctions

1:03:03

that were issued during Franklin Delano

1:03:05

Roosevelt's 12 years in

1:03:07

office, pretty consequential

1:03:09

ones. And over

1:03:11

the last four years or so, the number is

1:03:14

something like 60 and

1:03:16

maybe more than that. And

1:03:19

they're relatively new thing. And

1:03:21

you're asking us to extend and

1:03:24

pursue this relatively new remedial course,

1:03:26

which this court has never adopted

1:03:29

itself. Lower courts kind

1:03:31

of run with this. And

1:03:33

I just want to give you one more shot at that. Sure,

1:03:36

Your Honor. So again, the APA

1:03:38

of course encapsulates equitable remedies. And

1:03:41

as Pomeroy and others have said from

1:03:44

the beginning of the 19th century, equity

1:03:46

requires that the parties before the court

1:03:49

get relief. In this

1:03:51

instance, again, as the government pointed out in

1:03:53

corner posts where you have non-regulated parties, those

1:03:55

parties could be farmers, they could be ranchers,

1:03:57

and they could be the seed farms in

1:03:59

Gertz. But their only

1:04:01

availability for relief is if the

1:04:04

court does something to

1:04:06

the FDA order or regulation at

1:04:08

issue. Otherwise, those parties are simply

1:04:10

out of luck, and that's inconsistent with equity.

1:04:12

May I ask Ms. Hawley about

1:04:15

your basic theory of standing, and just

1:04:17

this is a clarification question as much

1:04:19

as it's anything. When you did your

1:04:21

one, two, three in your opening

1:04:23

statement, it sounded very probabilistic to

1:04:26

me. I don't remember exactly

1:04:28

what the one, two, three are, but let's

1:04:30

say it's something along the lines of

1:04:32

we represent a lot of doctors, and there

1:04:34

are a lot of women out there taking

1:04:37

methopristone, and some fraction of them are

1:04:39

going to have adverse events, and some

1:04:41

fraction of those are going to come

1:04:44

to the emergency room, and so

1:04:48

there's some probability or likelihood

1:04:50

that one of our doctors who

1:04:52

has a conscience objection is going

1:04:54

to come face-to-face with one of

1:04:56

these women who has an adverse

1:04:58

event. Is that your theory? No,

1:05:01

Your Honor. What we think

1:05:03

really shows that respondents have standing here

1:05:06

is FDA's own acknowledgments. I would point

1:05:08

you to JA 384, and

1:05:11

in regulating methopristone, FDA

1:05:13

has continually said that

1:05:15

emergency room doctors and OBGYN hospitalists are

1:05:17

critical to the safe use of drugs.

1:05:19

Well, I think then it is your

1:05:21

theory. I mean, you're just

1:05:24

saying even FDA

1:05:26

admits that there are going to

1:05:28

be some adverse events, people

1:05:30

are going to show up in emergency rooms,

1:05:32

people are going to come face-to-face with one

1:05:36

of our doctors who objects to

1:05:39

some aspect of the treatment. That's the theory,

1:05:41

yes? Well, we certainly think

1:05:43

all of that is true, but we don't

1:05:46

think it's a problem with probabilistic standing, as

1:05:48

was the case under Summers for three reasons.

1:05:51

One, Summers involved unidentified

1:05:53

members. Here we have

1:05:55

seven named plaintiffs. In addition, no

1:05:57

one in Summers, at least, is still part of it.

1:06:00

So does your theory really depend on

1:06:02

your having at least one person? Because

1:06:05

I take summers to be saying

1:06:07

these probability theories, they sound very nice, they

1:06:09

have nothing to do with our Article 3

1:06:12

requirements, you need a person. You need a

1:06:14

person to be able to come in and

1:06:16

meet the Court's regular standing requirements. So you

1:06:19

agree with that, yes? I think that's correct,

1:06:21

Your Honor, yes. Okay, so who's your person?

1:06:23

I know you have seven of them. But

1:06:26

if you had to pick one and

1:06:28

say, go read that declaration, and

1:06:30

that declaration is going to tell

1:06:32

you why we're entitled to be

1:06:34

up here. Who's

1:06:37

the person? I have to pick two,

1:06:39

Your Honor, but Dr. Francis and Dr. Scott.

1:06:41

Okay, and what about those

1:06:44

two doctors gives

1:06:46

you the kind of imminent

1:06:48

injury, let alone the traceability

1:06:50

that we've typically required? So

1:06:53

to speak to Dr. Francis at

1:06:55

the beginning, there's been some confusion, I think, about

1:06:58

the precise nature of the conscience harm. But

1:07:00

if you look at J.A. 155, paragraph

1:07:03

15, she talks about her and other

1:07:05

APLOG members who object not only to

1:07:07

taking the life of an unborn child

1:07:10

during an elective abortion, but also to,

1:07:12

quote, completing that process. That

1:07:14

echoes the CMDA Declaration at 142 and

1:07:17

143. It's

1:07:19

also consistent with- Has she ever been,

1:07:22

because I read that declaration

1:07:24

pretty carefully, has, what

1:07:26

actual emergency

1:07:28

treatment has she participated in

1:07:31

that she objects to and that

1:07:34

she has stated an objection to?

1:07:37

So the prior page, Your Honor, J.A. 154 talks

1:07:40

about a DNC, which she

1:07:42

was required to perform due to a

1:07:44

life-threatening emergency. She herself performed

1:07:46

that. That is correct. And

1:07:49

did she have an opportunity to

1:07:51

object? Did she object? No, Your

1:07:53

Honor. Again, these are life-threatening situations

1:07:55

in which the choice for a

1:07:57

doctor is either to scrub out-

1:08:00

and try to find someone else or to

1:08:02

treat the woman who's- Usually conscience

1:08:04

objections, the way people with

1:08:07

conscience objections do this is

1:08:09

they make those objections known. And

1:08:12

that may be harder, it may

1:08:14

be easier in a particular context,

1:08:17

but most hospitals have

1:08:19

mechanisms in place, routines in place

1:08:21

to ensure that doctors who are

1:08:23

allowed to do this in advance,

1:08:26

right? And are allowed

1:08:28

to do it at the moment. They

1:08:31

say so. And when

1:08:34

I looked at Dr. Francis's

1:08:36

and Dr. Stopp's, there's just

1:08:38

nothing that you have there that's a justin- This

1:08:40

is like there are other requirements

1:08:43

that you need, but at the very least

1:08:45

to be able to say, well, this happens

1:08:47

to them in the past. I

1:08:49

don't think you have it for either one of

1:08:51

those doctors. So I

1:08:53

think we do, Your Honor, given the

1:08:56

emergency nature, it's simply impractical to have

1:08:58

a objection lodged prior to

1:09:00

understanding what's going on in that operating

1:09:02

room. And again, I'd point your honor

1:09:04

to the district court Fifth Circuit brief

1:09:06

in Impala, where the government says that

1:09:08

neither the church nor any of the

1:09:11

other sponsors of those federal conscience protections

1:09:13

intended them to apply in emergency situations.

1:09:15

So it's a lot to ask our

1:09:17

respondent doctors to go up to the

1:09:19

top floor and litigate this with a

1:09:21

general counsel when the federal government is telling

1:09:23

them they don't have a conscience protection. Is

1:09:27

it true that our standing

1:09:29

decisions have not relied on

1:09:32

probabilistic determinations like

1:09:34

the Department of Commerce case? Court

1:09:37

said there was standing because if

1:09:40

a question about citizenship was

1:09:42

included on the questionnaire,

1:09:44

a certain percentage, an unknown

1:09:46

percentage of residents would

1:09:48

then not fill out the census

1:09:51

at all. And therefore it was

1:09:53

probable that there was some risk

1:09:55

that New York state would risk

1:09:58

losing a representative. in

1:10:00

the House of Representatives or would

1:10:02

risk losing money under some federal

1:10:05

program and you put together this

1:10:07

chain of probabilities and that was

1:10:09

sufficient to establish standing. Absolutely.

1:10:12

We agree with that, Justice

1:10:15

Alito. In particular, you can look at

1:10:17

the Gertson Seed Farms case, which also

1:10:19

involved non-regulated parties, and this court looked

1:10:21

at the distance that bees might fly

1:10:23

in order to pollinate seed farms. So

1:10:25

it's certainly true that data is

1:10:28

appropriate to consider in determining whether

1:10:30

there's a substantial risk under SBA

1:10:32

list. Here, the FDA

1:10:34

admits, this is at 533, that

1:10:36

between 2.9 and 4.6 percent

1:10:39

of women will go to the emergency

1:10:41

room. It acknowledges, this is at

1:10:43

542, that up to 7 percent of women

1:10:46

will need surgical intervention. And

1:10:48

when the FDA talks about there being

1:10:51

no increase in adverse events from the

1:10:53

increased gestational age, the only way they

1:10:55

can say that is by ignoring

1:10:58

surgical interventions. And that's

1:11:00

because at JA207, the FDA... Counsel,

1:11:03

what do we do with the fact that these

1:11:05

two people that you rely

1:11:08

on, Francis and

1:11:10

Scope, that Indiana

1:11:12

and Texas have abolished

1:11:16

abortions and abolished them

1:11:18

by pills or otherwise? Now,

1:11:21

we can get into whether other people

1:11:23

are illegally breaking the law and supplying

1:11:25

it, contrary to law. But

1:11:28

what does that do to your probability? Which

1:11:31

is, it's already infinitesimally small

1:11:33

because there are thousands of

1:11:35

hospitals in the

1:11:38

country. Fifty states, I don't know how

1:11:40

many territories, thousands and thousands

1:11:42

of places

1:11:46

where pregnant women go who may

1:11:48

be suffering from a miscarriage

1:11:50

or otherwise, to

1:11:53

know or to even imagine

1:11:55

how one doctor is

1:11:58

going to ever actually see it. the A patient

1:12:00

that it's going to be, that he or

1:12:03

she is going to be forced to intervene

1:12:06

on their behalf, but then

1:12:08

add to it that this

1:12:10

is illegal in these states. So

1:12:13

I think that the best answer, Justice

1:12:15

Sotomayor, is that pass this prologue. In

1:12:17

our declarations, we have three doctors who

1:12:19

have treated harms from abortion drugs at

1:12:21

least a dozen times. We have two

1:12:23

examples when women went out of state.

1:12:26

And if you go out of state, there's a higher likelihood

1:12:28

you're not going to have a follow up visit. What

1:12:31

the FDA's regime has done is turn

1:12:33

ER rooms into those follow up visits.

1:12:36

We've had that happen with both Dr. Jester, where a

1:12:38

woman went to New Mexico and returned to Texas, as

1:12:40

well as Dr. Johnson, where a woman went to Illinois

1:12:43

and returned to Indiana. Indeed,

1:12:45

according to Guttmacher, one in five

1:12:47

abortions take place out of state in

1:12:50

search states like New Mexico, like

1:12:52

Illinois, the border states in

1:12:54

which our doctors reside. Ms. Holly, can I

1:12:56

take you back to the affidavits and some

1:12:58

of Justice Kagan's questions? You

1:13:01

were talking about Dr. Francis. And

1:13:04

as I read her allegations, or

1:13:06

as her affidavit reads, she

1:13:09

said that her partner was forced

1:13:11

to perform a DNC when there

1:13:13

was a living fetus. And she

1:13:16

said she performed a DNC on a woman

1:13:18

who was suffering serious complications. But the fact

1:13:20

that she performed a DNC does not necessarily

1:13:22

mean that there was a living embryo or a fetus. Because

1:13:24

you can have a DNC after a

1:13:26

miscarriage. So

1:13:29

if that's right, I mean, I think

1:13:31

the difficulty here is that, at least

1:13:33

to me, these affidavits do read more.

1:13:35

Like the conscience objection is strictly to

1:13:38

actually participating in the abortion to end

1:13:40

the life of the embryo

1:13:43

or fetus. And

1:13:45

I don't read either Scott or Francis to say

1:13:47

that they ever participated in that. So

1:13:50

do you want to address that? Sure. I

1:13:53

think Dr. Francis, combined with

1:13:56

CMDA, can be read for the broader conscience

1:13:58

harm. Again, that's how the District Court understood

1:14:00

that I point you to pages 7 and 8,

1:14:02

that's how both the State Panel and the Fifth

1:14:04

Circuit understood respondents' conscience harms

1:14:07

to extend beyond simply

1:14:10

requiring the ending of an unborn life.

1:14:13

And with respect to even the more

1:14:15

narrow conscience harms, whether a doctor may

1:14:17

need to end a life, we think

1:14:19

there's still a substantial risk of that

1:14:21

occurring. If you look at

1:14:24

the numbers of the increase from 7

1:14:26

to 10 weeks in gestational age, that

1:14:28

means that 3.1 percent of

1:14:30

pregnancies will be ongoing. Requiring

1:14:33

a DNC, we know at ROA 870 that 55 percent

1:14:35

of those DNC's occur in the emergency room.

1:14:42

This is a substantial number of women suffering

1:14:44

abortion drug harm. Again, Gootmacher says

1:14:46

650,000 women took the drug in 2013. But

1:14:50

not all those DNC's will involve a

1:14:52

pregnancy that would otherwise be viable or

1:14:55

an embryo or fetus that would otherwise be

1:14:57

living, because you can have complications or excessive

1:14:59

bleeding even after the abortion

1:15:01

is complete in that respect, but there's pregnancy

1:15:03

tissue remaining. So, with

1:15:05

the 3.1, your honor, is ongoing

1:15:08

pregnancy. Is ongoing pregnancy. Yes. And

1:15:11

FDA says at JA 542 that up to

1:15:13

7 percent will need surgeries

1:15:15

to stop either bleeding or ongoing

1:15:17

pregnancies or failures. How many members

1:15:20

of your organization? You have a broad number of,

1:15:22

you know, doctors that are in your organization. I

1:15:24

gather dentists, some doctors who are

1:15:26

retired. How many members of your

1:15:29

organization are OBGYNs who practice in

1:15:31

hospitals who might be called into these

1:15:33

ERs? There are hundreds of them,

1:15:35

your honor, but I think, may I finish? I

1:15:38

think in particular that the named plaintiffs

1:15:40

are OBGYN hospitalists who spend most of

1:15:42

their time on the labor and delivery

1:15:44

floors, but also are called to the

1:15:46

OR to treat these sorts of emergencies.

1:15:48

Can you clarify the broader

1:15:51

conscience harm from the narrow one? Because

1:15:53

I had understood the conscience harm as

1:15:56

just as Barrett does, but you suggest

1:15:58

that there's a broader conscience. So what

1:16:00

is that? Yes, Your Honor. I'd

1:16:03

point you to pages 7 and 8 of

1:16:05

the district court opinion. The district court understands

1:16:08

the conscious harm to be either taking

1:16:10

the life of an unborn child, which

1:16:12

would sometimes be required, Dr. Francis testifies to

1:16:14

a partner who is required to do that

1:16:17

because of emergency situations. That's what

1:16:19

I understood the narrow one to be, right? I'm

1:16:22

participating in a procedure that is

1:16:24

ending the life. Yes. That's

1:16:27

there. Okay. So what's

1:16:29

the broader one? It's being complicit

1:16:31

in the process that unnecessarily takes

1:16:34

an unborn life, such as performing a DNC

1:16:37

and abortion. And it's really not that hard

1:16:39

to see. No, wait. I'm

1:16:41

sorry. Complicit like I worked in the

1:16:43

emergency room and this is going on.

1:16:46

I'm handing them a water bottle.

1:16:49

What do you mean complicit in

1:16:51

the process? So this court,

1:16:53

of course, takes religious beliefs and

1:16:55

conscious beliefs as it finds them.

1:16:57

Yes. honor,

1:17:01

is being involved in completing in

1:17:03

the terms of our declaration and

1:17:05

elective abortion. And it's really

1:17:07

not that hard to see why that might be

1:17:09

a conscious harm. If you think about what's involved

1:17:11

in it, you just said again, it's being involved

1:17:13

in completing an elective abortion.

1:17:16

So I took that to be

1:17:18

the conscious objection. I think what

1:17:20

Justice Jackson is asking or what

1:17:22

I asked before or what Justice

1:17:24

Barrett is, is there any broader

1:17:26

conscious objection that appears? I'm

1:17:29

not sure I care all that much about the district court,

1:17:31

but that appears in the declarations. Yes,

1:17:34

your honor. And in this sense, completing

1:17:36

an elective abortion means removing an embryo

1:17:38

fetus, whether or not they're alive, as

1:17:41

well as placental tissue. Again, Dr. Francis

1:17:43

talks about being required to perform a

1:17:45

DNC. This is at 154 and remove

1:17:48

placental tissue. Whether or not

1:17:50

there's any live tissue. Yes,

1:17:53

your honor. And again, this makes sense. And where are we

1:17:56

looking for that? So I would point your honor to J155,

1:17:58

paragraph 55. where

1:18:00

again she talks about completing an abortion. The

1:18:03

CMDA Declaration at pages 142 and 143 also

1:18:07

described this sort of complicity harm

1:18:10

from being involved in an elective abortion,

1:18:12

Your Honor. And again, these doctors performing

1:18:14

a D&C must

1:18:16

scrape out a woman's uterus of

1:18:19

a child, the embryo, the fetus, or placental tissue.

1:18:22

And this court has recognized harms like that in

1:18:24

cases like Little Sisters of the Poor, as

1:18:27

well as Hobby Lobby. It

1:18:29

matters. No, go ahead. Sorry.

1:18:33

It's my understanding that sometimes the

1:18:36

completion, it doesn't involve surgical intervention. Do

1:18:38

you have a sense of how often?

1:18:40

I mean, we may get all the

1:18:42

way down the chain to

1:18:44

the doctor there, the person is having an

1:18:46

emergency procedure. My understanding is with some of

1:18:48

these chemical

1:18:51

abortion scenarios, the completion

1:18:53

occurs by prescribing additional

1:18:55

medication. Do you have

1:18:57

a sense of how many times the completion

1:19:00

is that route and could be done by

1:19:02

another physician as opposed to

1:19:04

your clients in doing a medical procedure?

1:19:07

So that second dose, Your Honor, of mesoprostol

1:19:09

has been part of the regimen since 2016, really

1:19:12

I think all the way back to 2001, but

1:19:14

it's been approved by FDA since 2016. So

1:19:18

the best numbers we have from FDA are

1:19:20

still consistent with that. And that means that

1:19:22

3.1% of pregnancies at 10 weeks will

1:19:25

be ongoing. I'd encourage

1:19:28

you to look at JA405 through 407. And

1:19:31

this explains that these risks go up without an

1:19:33

in-person visit. Yeah, no, I guess I'm just trying to

1:19:35

get at, I'm still working

1:19:38

on how many circumstances or how

1:19:40

often it would be that your

1:19:42

clients actually have to complete the

1:19:46

procedure in the way that

1:19:48

you are describing. So Dr. Scott

1:19:50

talks about doing this at least a dozen

1:19:52

of times, either a DNC or a suction

1:19:54

aspiration abortion to remove again,

1:19:57

embryos, fetuses, or placental tissue. your

1:20:00

honor, if you think about the numbers, again, it says 3.1%

1:20:02

at 10 weeks, and this has

1:20:07

only gone up. In 2020, FDA

1:20:10

told this Court that the

1:20:12

in-person visit was both, quote,

1:20:14

necessary and minimally burdensome, and

1:20:17

necessary to preserve women's health, precisely

1:20:19

so these sorts of situations occur

1:20:21

less frequently. Thank

1:20:23

you, counsel. Justice Thomas? Ms.

1:20:26

Hawley, I'm sure you've heard

1:20:28

the answers of the Solicitor

1:20:31

General and the Counsel for

1:20:33

Danko with respect to the

1:20:36

Comstock Act.

1:20:39

I'd like you to comment on their

1:20:41

answers. Sure, Justice

1:20:43

Thomas. We don't think that there's any case of

1:20:45

this Court that empowers

1:20:47

FDA to ignore other

1:20:49

federal law. With

1:20:52

respect, the Comstock Act is relevant

1:20:54

here. The Comstock Act says

1:20:56

that drugs should not be mailed

1:20:58

either through the mail or through common

1:21:01

carriers. So we think that the plain text of

1:21:03

that, your honor, is pretty clear. When

1:21:06

did you first raise the

1:21:09

Comstock Act? So I believe

1:21:11

the Comstock Act was first raised at

1:21:13

the district court, your honor, but we

1:21:16

think that exhaustion does not apply for

1:21:18

two reasons. First, it would

1:21:20

be plainly futile, as FDA's adoption

1:21:22

of the OLC memorandum goes. In

1:21:25

addition, this is a whole other kettle of fish, but

1:21:27

if you look at Section 704,

1:21:30

exhaustion is only required in two

1:21:32

instances, either when required by a

1:21:34

statute or by an agency

1:21:36

rule when that agency rule is stayed

1:21:39

pending litigation. This is consistent with this

1:21:41

Court's case in Derby. The lower courts have

1:21:43

taken conflicting opinions, but we think the

1:21:45

better reading of Section 704 is

1:21:47

that there's no exhaustion required unless either

1:21:50

a statute or agency rule stays

1:21:53

the proceeding during judicial review. May

1:22:01

I ask about your view of traceability? And,

1:22:03

you know, on one understanding, and

1:22:05

I want you to tell me if you agree with this, that

1:22:09

even beyond proving whatever injury you're trying

1:22:11

to prove, that you have to

1:22:13

show that that injury is traceable to the 2016 and

1:22:16

2021 FDA actions that you're challenging. And,

1:22:22

of course, that means showing

1:22:24

that these incidents that you're

1:22:26

talking about in the emergency room are

1:22:30

caused by whatever incremental increase

1:22:32

in risk there is as a result

1:22:34

of those 2016 and 2021 actions. And

1:22:38

I guess my first question is, do you agree with

1:22:40

that statement of what you need to show? And

1:22:43

if you do, how

1:22:45

do you satisfy that?

1:22:47

Why do you satisfy that? So

1:22:50

we believe, Justice Kagan, under the case law, that we

1:22:52

need to show that each the 2016 action and

1:22:55

the 2021 action increase the risk of

1:22:57

harm. And we think the way... But

1:22:59

then I guess what I'm saying is that you have to

1:23:01

link whatever injury your

1:23:04

members have to that increased risk.

1:23:06

Do you agree with that? We

1:23:08

do, and we think we can do that for a

1:23:11

couple of reasons. First of all, traceability, of course, is

1:23:13

de facto. We're not in the Paul's graph sort of

1:23:15

world of tort causation. And when you look

1:23:17

at the 2021 action, we

1:23:19

think traceability is satisfied by FDA's

1:23:21

own words. It says at JA405

1:23:23

that without the in-person visit, this

1:23:25

is the anger study, without

1:23:28

that in-person visit, ER and

1:23:30

other medical care is likely to increase,

1:23:32

as well as surgical interventions. And

1:23:35

these are the very same surgical interventions that harm

1:23:37

respondent clients. So there

1:23:39

might be some disputes between the two

1:23:41

of you, as to exactly how bid the

1:23:43

increased risk is. But let's even

1:23:45

take your view that there is, you

1:23:48

know, some measurable increased

1:23:50

risk. How do you

1:23:52

connect that risk to

1:23:54

particular actions that

1:23:56

your members have

1:23:58

to particular? or injuries that

1:24:01

your members have undergone or

1:24:03

imminently will undergo. I

1:24:05

mean, it could be, you know, the

1:24:08

original risk. So I

1:24:10

think the declarations are actually quite clear on

1:24:12

this. If you look at Dr. Francis' declaration,

1:24:14

she says that when the in-person visit was

1:24:16

enjoined in 2020 by a federal district court,

1:24:19

that she saw an increase in emergency

1:24:21

room visits from abortion drug harm. Dr.

1:24:23

Johnson, Dr. Scott see the same thing.

1:24:26

And again, this is entirely consistent with

1:24:28

FDA's own numbers. Again, in

1:24:30

2020, FDA told this court that

1:24:32

the in-person visit was necessary to

1:24:35

preserve women's health because an in-person

1:24:37

visit is the best opportunity to

1:24:39

examine for things like ectopic pregnancy

1:24:41

and accurately assess gestational age. Thank you.

1:24:45

Justice Gorsuch. This

1:24:47

is Kim. This is Barrett. So

1:24:50

General Prelager said that that initial

1:24:53

in-person visit had no requirement of

1:24:55

an ultrasound or, you know, any

1:24:57

effort to detect fetal heartbeat. So

1:24:59

it wouldn't necessarily give an accurate

1:25:01

read on gestational age or detect

1:25:04

an ectopic pregnancy. So why

1:25:06

would that necessarily be eliminate? Why would

1:25:08

the elimination of the visit necessarily increase

1:25:10

the risk? So I

1:25:12

think, Your Honor, FDA's own data shows that

1:25:14

those risks did go up. If

1:25:17

you look at the Caressi study, it

1:25:20

shows a nearly threefold increase in the

1:25:22

emergency room visits when you have the

1:25:24

in-person visit and when you removed it.

1:25:26

There was 5.8% with an in-person visit

1:25:29

and it was also in about 2.1 without. Is

1:25:32

that because doctors were just kind of voluntarily saying, hey,

1:25:34

it would be a good idea to give you an

1:25:36

ultrasound or try to detect a fetal heartbeat or what?

1:25:39

So when FDA removed the in-person visit,

1:25:41

Your Honor, it took away the opportunity

1:25:43

to do that. I think ACOG, I

1:25:45

think medical organizations agree that that is

1:25:48

best practice. So if a

1:25:50

woman comes into a doctor's office, she's likely

1:25:52

to get an ultrasound to accurately assess both

1:25:55

ectopic pregnancies, diagnose or

1:25:57

assess gestational age. But

1:25:59

what? allowed under FDA's

1:26:01

rules currently is to

1:26:03

be able to order these online with a couple

1:26:06

of screening questions. And I don't think that's nearly

1:26:08

as good as an in-person exam. Let me just

1:26:10

pivot to the organizational standing question. So

1:26:13

let's say that I'm just going to carve

1:26:15

out and put aside the costs of filing

1:26:17

a petition or litigation as

1:26:19

harms to your organization itself. Explain

1:26:23

to me what additional costs you might

1:26:25

have incurred or how your resources were

1:26:27

diverted in a way that would satisfy

1:26:29

havens. Absolutely, Your Honor.

1:26:31

So putting to one side the citizen

1:26:33

petition, the APLOG Declaration is clear that

1:26:35

respondent organizations conducted studies and analyzed studies.

1:26:37

This included going through the Medicaid data.

1:26:40

It included going through the FAERS data

1:26:42

to the extent it was available. Is

1:26:44

that it? Well, those

1:26:46

studies, Your Honor, I would point to one of them, ROA

1:26:48

870 and before and after. And

1:26:54

those are pretty comprehensive studies, Your Honor. Are they

1:26:56

to the end of the litigation and the citizen

1:26:58

petition or what are they to the end of?

1:27:01

To accurately assess the harm from

1:27:03

abortion drugs, Your Honor. So

1:27:05

I think it's absolutely separate from the litigation.

1:27:08

And one thing to note with the citizen petition is

1:27:11

that is the only way in

1:27:13

which anyone can raise

1:27:15

a concern to the FDA.

1:27:18

These proceedings go on between DANCO and

1:27:20

the FDA behind closed doors. This is

1:27:22

not a notice and comment process. The

1:27:24

first time anyone can raise these objections

1:27:26

is a citizen petition. Justice

1:27:29

Jackson? So what

1:27:32

deference, if any, do

1:27:34

courts owe the opinion of the

1:27:36

expert agency concerning the safety and

1:27:39

efficacy of drugs? So

1:27:41

under this court's administrative procedure precedents, Your

1:27:43

Honor, APA review, of course, is not

1:27:46

toothless. Instead, in

1:27:48

this case, we're not asking that

1:27:50

the court second-guess the agency determinations

1:27:52

at all, but rather look at

1:27:54

what FDA said. Again, in

1:27:56

2021, when FDA took away the in-person

1:27:58

visit, it did So based on FAERS

1:28:01

data, it says elsewhere cannot be used to

1:28:03

calculate the instance of an adverse event, as

1:28:05

well as studies that said that JA 407

1:28:07

are, quote, not adequate. I guess

1:28:09

I don't understand how that scope

1:28:12

of review is not second-guessing the

1:28:14

agency. I mean, they're looking at

1:28:16

studies, and you're saying that the

1:28:19

court can look at studies, maybe

1:28:21

different studies, maybe the same studies,

1:28:24

and critique their conclusions about them.

1:28:27

So what deference do we owe

1:28:29

them at all with respect to

1:28:31

their assessment that these studies establish

1:28:33

what it is that they say

1:28:35

they do about safety and efficacy? I

1:28:38

don't think that's an accurate portrayal of the

1:28:41

APA claimant issue here, Your Honor. And the

1:28:43

reason being, again, is we're just asking this

1:28:45

court to look at what FDA said. The

1:28:48

FCCA says you have to have adequate tests and

1:28:50

test results, as well as sufficient information.

1:28:52

I understand, but didn't the lower courts go beyond

1:28:54

that? I mean, representations were made here today that

1:28:56

the lower courts actually relied on studies that

1:28:59

have since been found discredited

1:29:01

and removed. So they were obviously

1:29:03

looking at not just what the

1:29:06

FDA was looking at in order to make

1:29:08

their assessment. So are you asking us to

1:29:10

just look at the FDA and not anything

1:29:12

else? So, yes, that claim

1:29:14

is not even before this court. But

1:29:17

with respect to the two claims that are before the court, the 2016 and

1:29:19

the 2021, we think

1:29:22

the FDA's own statements here are

1:29:25

arbitrary. In

1:29:27

2016, what the FDA said was

1:29:29

we're going to look at individual

1:29:31

studies, and then even though we

1:29:33

say they're interrelated at J298, we're

1:29:37

going to take all of the protections away

1:29:39

at once. That was arbitrary

1:29:41

in State Farm. It would be arbitrary here

1:29:43

as well. Thank you. Thank

1:29:45

you, counsel. rebuttal, General Preloger.

1:29:49

Thank you. In the organizational standing, Mr.

1:29:51

Chief Justice, you asked where do you cross the line

1:29:53

to get to a certainly impending injury? One

1:29:56

thing the court has looked at is whether that

1:29:58

harm has materialized. in the past and

1:30:01

how often. Now, it doesn't always guarantee there

1:30:03

will be a future injury, but it can

1:30:05

be a source of information. And here what

1:30:07

is so telling is that respondents don't have

1:30:09

a specific example of any doctor ever having

1:30:11

to violate this care in violation of

1:30:13

their conscience. Instead, respondents have pointed to

1:30:16

generalized assertions in the declarations

1:30:18

that never come out and specifically say by

1:30:20

one of their identified members, here's

1:30:22

the care I provided, here's how it violated my

1:30:24

conscience, and here's why conscience protections

1:30:26

were unavailable to me. The fact that they don't

1:30:28

have a doctor who's willing to

1:30:30

submit that kind of sworn declaration in court I think

1:30:32

demonstrates that the past harm hasn't

1:30:35

happened, and the reason for that is because it is

1:30:37

so speculative and turns on so many links

1:30:40

in the chain that would have to occur

1:30:42

and at the end would be backstopped by

1:30:44

having the federal conscience protections in play. On

1:30:47

organizational standing, my friend has pointed to

1:30:49

the fact that they invested time in

1:30:51

preparing their citizen petition. She says they

1:30:53

voluntarily conducted studies and then generally refers

1:30:56

to diversion of resources. If

1:30:58

that is enough, then every organization in

1:31:00

this country has standing to challenge any

1:31:02

federal policy they dislike. Haven's

1:31:04

Realty cannot possibly mean that. The court

1:31:06

should say so and clarify. It is

1:31:08

at the outer bounds and respondents don't

1:31:11

qualify under that standard. On

1:31:13

remedy, Justice Gorsuch, Justice Jackson, you pointed

1:31:15

out the striking anomaly here of the

1:31:18

nationwide nature of this remedy. Justice Jackson,

1:31:20

you suggested maybe a more tailored remedy

1:31:22

to the parties protecting their conscience protections

1:31:24

should have been entered. The problem here

1:31:27

is they sued the FDA. FDA

1:31:29

has nothing to do with enforcement of

1:31:31

the conscience protections. That's all happening far

1:31:33

downstream at the hospital level, and the

1:31:36

only way to provide a remedy based

1:31:38

on this theory of injury, therefore, was

1:31:40

to grant this kind of nationwide relief

1:31:42

that is so far removed from

1:31:45

FDA's regulatory authority that it's ultimately requiring

1:31:47

all women everywhere to change the conditions

1:31:49

of use of this drug. I

1:31:52

think it's worth stepping back finally and thinking about the profound

1:31:55

mismatch between that theory of

1:31:58

injury and the remedy that

1:32:00

was respondents obtained. They have

1:32:02

said that they fear that there might

1:32:04

be some emergency room doctor somewhere, someday,

1:32:06

who might be presented with some woman

1:32:08

who is suffering an incredibly rare complication

1:32:10

and that the doctor might have to

1:32:13

provide treatment notwithstanding the conscience protections. We

1:32:15

don't think that harm is materialized, but

1:32:17

what the court did to guard against

1:32:19

that very remote risk is enter sweeping

1:32:21

nationwide relief that restricts access to misoprised

1:32:24

stones for every single woman in this

1:32:26

country, and that causes profound harm. It

1:32:28

harms the agency which

1:32:30

had the Federal courts come in and

1:32:32

displace the agency's scientific judgments. It harms

1:32:35

the pharmaceutical industry, which is sounding alarm

1:32:37

bells in this case and saying that

1:32:39

this would destabilize the system for approving

1:32:41

and regulating drugs, and it

1:32:43

harms women who need access to medication

1:32:46

abortion under the conditions that FDA determined

1:32:48

were safe and effective. The

1:32:50

court should reverse and remand with instructions

1:32:52

to dismiss to conclusively in this litigation.

1:32:55

Thank you, counsel. The case is submitted.