Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. Alliance for Hippocratic Medicine, et al.

Supreme Court briefFeb 29, 2024

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Nos. 23-235, 23-236

In the

Supreme Court of the United States

U.S. FOOD AND DRUG ADMINISTRATION, et al.,

Petitioners,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

DANCO LABORATORIES, L.L.C,

Petitioner,

v.

ALLIANCE FOR HIPPOCRATIC MEDICINE, et al.,

Respondents.

On Writs of Certiorari to the

U.S. Court of Appeals for the Fifth Circuit

Brief of Missouri, Idaho, & Kansas in support

of Alliance for Hippocratic Medicine, et al.

KRIS W. KOBACH

Kansas Attorney General

120 SW 10th Ave., 2nd Fl

Topeka, KS 66612

ANDREW BAILEY

Missouri Attorney General

JOSHUA M. DIVINE

Solicitor General

Counsel of Record

RAÚL R. LABRADOR

207 West High St.

Idaho Attorney General

Jefferson City, MO 65101

700 W. Jefferson St., # 210 (573) 751-8870

Boise, ID 8372

Josh.Divine@ago.mo.gov

Counsel for Amici States

Additional counsel in signature block

February 29, 2024

i

TABLE OF CONTENTS

Table of Authorities.................................................... ii

Interest of Amici States ..............................................1

Summary of Argument................................................1

Argument .....................................................................4

I. Because the States are parties to the

preliminary injunction, but are not parties

before this Court, FDA cannot challenge the

standing of all plaintiffs to the preliminary

injunction, so the injunction cannot be

vacated on standing grounds. ............................4

II. If the Court does not reach the merits, FDA

will no doubt have to quickly return to this

Court and seek further relief because it will

not prevail in its attempt in the district court

to vacate the injunction on jurisdictional

grounds. ..............................................................6

A. The States have standing. ............................6

1. The States have suffered traditional

economic injuries from FDA’s unlawful

actions. .....................................................6

2. The States have suffered sovereign

injuries from FDA’s unlawful actions. . 11

3. The States have suffered quasisovereign

injuries

from

FDA’s

unlawful actions, and while this Court

has consistently barred third-party

parens patriae actions, it has

consistently

permitted

first-party

parens patriae actions to proceed. ........ 15

B. FDA’s arguments about venue lack merit. 24

Conclusion ................................................................. 26

ii

TABLE OF AUTHORITIES

Page(s)

Cases

Abrams v. Heckler,

582 F. Supp. 1155 (S.D.N.Y. 1984) ........................ 20

Alfred L. Snapp & Son, Inc. v. Puerto Rico, ex rel.,

Barez,

458 U.S. 592 (1982) ........................ 11, 14, 16, 20, 23

Aziz v. Trump,

231 F. Supp. 3d 23 (E.D. Va. 2017) ....................... 19

Biden v. Nebraska,

143 S. Ct. 2355 (2023) ...................................... 2, 5, 6

Challenge v. Moniz,

218 F. Supp. 3d 1171 (E.D. Wash. 2016)............... 19

City of New York v. Heckler,

578 F. Supp. 1109 (E.D.N.Y. 1984) ....................... 20

Clearing House Assn., L.L.C. v. Cuomo,

510 F.3d 105 (CA2 2007)........................................ 19

Crow Indian Tribe v. United States,

965 F.3d 662 (CA9 2020)........................................ 14

Czyzewski v. Jevic Holding Corp.,

580 U.S. 451 (2017) ................................................ 10

Department of Commerce v. New York,

139 S. Ct. 2551 (2019) .............................. 8, 9, 13, 14

iii

Dobbs v. Jackson Women’s Health Org.,

597 U.S. 215 (2022) ..................................................3

GenBioPro, Inc. v. Sorsaia,

No. CV 3:23-0058, 2023 WL 5490179 (S.D.W. Va.,

Aug. 24, 2023)......................................................... 12

Haaland v. Brackeen,

599 U.S. 255 (2023) .................................... 15, 16, 17

Hippocratic Med. v. U.S. Food & Drug Admin.,

78 F.4th 210 (CA5 2023) .......................... 5, 7, 10, 21

Holder v. Humanitarian L. Project,

561 U.S. 1 (2010) .................................................... 12

Kansas v. United States,

748 F. Supp. 797 (D. Kan. 1990) ........................... 20

Kentucky v. Biden,

23 F.4th 585 (CA6 2022) .................................. 16, 17

Lujan v. Defenders of Wildlife,

504 U.S. 555 (1992) ................................................ 24

Maine v. Taylor,

477 U.S. 131 (1986) ................................................ 11

Massachusetts v. EPA,

549 U.S. 497 (2007) .................................... 17, 19, 20

Massachusetts v. Mellon,

262 U.S. 447 (1923) .................................... 15, 16, 17

Miller v. Alamo,

975 F.2d 547 (CA8 1992)..........................................1

Missouri v. Biden,

No. 3:22-CV-01213, 2023 WL 4335270 ................. 19

iv

Nebraska v. Wyoming,

515 U.S. 1 (1995) .................................................... 17

Puerto Rico Pub. Hous. Admin. v. U.S. Dep’t of Hous.

& Urban Dev.,

59 F. Supp. 2d 310 (D.P.R. 1999) .......................... 20

South Carolina v. Katzenbach,

383 U.S. 301 (1966) ................................................ 18

State of Ala. ex rel. Baxley v. Tennessee Valley Auth.,

467 F. Supp. 791 (N.D. Ala. 1979) ......................... 20

Susan B. Anthony List v. Driehaus,

573 U.S. 149 (2014) ..................................................8

Texas v. United States,

809 F.3d 134 (CA5 2015)........................................ 11

TransUnion LLC v. Ramirez,

594 U.S. 413 (2021) ........................................ 6, 7, 10

Turkiye Halk Bankasi A.S. v. United States,

143 S. Ct. 940 (2023) .............................................. 16

United States v. Texas,

599 U.S. 670 (2023) ............................................ 9, 10

Wisconsin Dep’t of Health and Fam. Services v.

Blumer,

534 U.S. 473 (2002) ..................................................9

Statutes

18 U.S.C. § 1461 .................................................. 13, 19

28 U.S.C. § 1406(b) .................................................... 25

Mo. Rev. Stat. § 188.017.2 .................................. 11, 23

v

Mo. Rev. Stat. § 188.021.1 .................................. 11, 23

Mo. Rev. Stat. § 188.027 ..................................... 22, 23

Mo. Rev. Stat. § 566.209 ..................................... 22, 23

Other Authorities

C. Wright & A. Miller, Federal Practice and

Procedure § 1920 ................................................ 1, 25

Roubein, ‘Shield’ Laws Make it Easier to Send

Abortion Pills to Banned States, Wash. Post (July

20, 2023) ................................................................. 13

The Federalist No. 51, at 320 (Clinton Rossiter ed.,

Signet Classic 2003) (1788).................................... 18

1

INTEREST OF AMICI STATES

Missouri, Idaho, and Kansas have an exceptionally

strong interest in the outcome of this case because the

States are parties to the preliminary injunction this

Court is reviewing. As explained in more detail in

the States’ intervention motion in this Court, the

States moved to intervene in the district court in early

November, before this Court granted certiorari. The

district court granted intervention in early January

(after certiorari). When the district court did so, the

States automatically became “bound by all prior

orders and adjudications of fact and law as though

[they] had been a party from the commencement of the

suit.” C. Wright & A. Miller, Federal Practice and

Procedure § 1920 n.8 (citation omitted). That

includes the preliminary injunction order. E.g.,

Miller v. Alamo, 975 F.2d 547, 551 (CA8 1992)

(“[T]here is no principled justification for binding

intervenors to unfavorable prior decisions while at the

same time denying intervenors the benefits of

favorable prior decisions.”).

The States agree with the amicus brief led by

Mississippi but file this separate amicus brief because

of Missouri, Idaho, and Kansas’s unique interest as

parties to the injunction being reviewed. In

particular, the States explain herein that because the

States are parties before the district court but not

before this Court, FDA cannot obtain vacatur of the

preliminary injunction through FDA’s standing

argument.

SUMMARY OF ARGUMENT

FDA principally argues that the private plaintiffs

lack standing. That is wrong. To fail to find

2

standing for the private plaintiffs here would blow a

hole in this Court’s standing jurisprudence, allowing

federal agencies to conscript third parties without

judicial recourse.

FDA’s standing argument doubly fails because

even if this Court agreed with it, that would not

entitle FDA to relief from the preliminary injunction.

That is because the private plaintiffs are not the only

plaintiffs who are party to the preliminary injunction

order. The States are parties to the same order, and

it is well settled that only “one plaintiff” needs

standing to maintain a preliminary injunction.

Biden v. Nebraska, 143 S. Ct. 2355, 2365 (2023).

FDA cannot obtain vacatur merely by arguing that

some of the plaintiffs to the preliminary injunction

lack standing. To vacate the order, FDA bears the

burden of proving that all the plaintiffs to the

preliminary injunction lack standing. It cannot do so

before this Court because FDA successfully opposed

the States becoming parties before this Court. Thus,

if this Court accepts FDA’s standing argument about

the private plaintiffs, the only remedy FDA could

receive is remand to the district court without

vacatur.

If that happens, FDA will no doubt have to petition

this Court again for relief quite soon because FDA will

not be able to succeed in obtaining vacatur in the

district court. FDA has primarily contended that the

States lack standing. Not so. The States have

standing for several independent reasons: (1) the

States have suffered traditional economic injuries; (2)

the States have suffered injuries to their sovereign

interests; and (3) the States have suffered quasisovereign injuries. Indeed, FDA in effect conceded at

3

oral argument before the Fifth Circuit that States

would have standing to challenge FDA’s actions.

The Federal Government conceded States can sue

when they experience population-level effects from

federal actions that cause economic harm. The

States have shown exactly that. FDA does not

dispute that a known proportion—up to about 5

percent—of women obtaining chemical abortions

must seek emergency medical services, and that this

number is much higher than with surgical abortions.

By promoting chemical abortions over surgical

abortions and removing longstanding safety

precautions for chemical abortions, FDA has imposed

increased costs to state-funded medical insurance and

public hospitals. FDA’s unlawful actions have also

imposed sovereign harms that radically interfere with

the ability of the States to set policy on what this

Court recently described as one of the most “profound”

issues of public policy. Dobbs v. Jackson Women’s

Health Org., 597 U.S. 215, 223 (2022). In particular,

FDA’s decision to illegally permit mailing of abortion

pills nationwide frustrates the ability of States to

enforce their laws.

Other arguments raised by FDA likewise fail.

FDA asserts that it will be able to vacate the

preliminary injunction order with respect to the

States because FDA believes the States lack venue.

But when a party successfully intervenes in a case,

that party’s case may proceed even if the original

plaintiffs are dismissed and even if the intervening

party could not independently establish venue.

The Court should speedily reach the merits and

affirm for the reasons argued by the private plaintiffs.

But if this Court accepts FDA’s argument that the

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private plaintiffs lack standing, then remand to the

district court without vacatur is the only remedy

appropriate. The States are party to the preliminary

injunction order, and so FDA cannot obtain relief from

that order until the case returns to the district court.

ARGUMENT

I.

Because the States are parties to the

preliminary injunction, but are not parties

before this Court, FDA cannot challenge the

standing of all plaintiffs to the preliminary

injunction, so the injunction cannot be

vacated on standing grounds.

The private plaintiffs possess standing. FDA has

long told women harmed by abortion drugs to seek

emergency care from the private plaintiffs. Resp. Br.

25 (quoting FDA Approval Memorandum, J.A. 229

(“direct[ing] patients to hospitals” for “emergency

services”)). That women take FDA at its word and

seek emergency care from the private plaintiffs is not

speculative; it is predictable. Nor can FDA deny that

the private plaintiffs sincerely object to being

complicit in elective abortion. Their conscience and

other injuries are both concrete and imminent. To

hold otherwise, would create an exception to standing

for third parties harmed by agency action—even when

the agency expressly conscripts those third parties.

That is not the law.

That rule would also make a mockery of this

Court’s standing jurisprudence. For example, if

persons have standing to assert aesthetic injuries in

plants (as courts have concluded), certainly the

private plaintiff physicians have standing to sue over

their much more serious conscience injuries. All. for

5

Hippocratic Med. v. U.S. Food & Drug Admin., 78

F.4th 210, 259–60 (CA5 2023) (Ho, J., concurring in

part).

But if this Court accepts FDA’s standing

argument, the proper remedy is to remand to the

district court for further proceedings without vacatur.

It is well settled that a preliminary injunction can be

vacated for lack of jurisdiction only if none of the

plaintiffs have standing to maintain it. Biden v.

Nebraska, 143 S. Ct., at 2365. But because FDA

successfully opposed the States participating as

parties before this Court, FDA presently can

challenge the standing of only some of the parties to

the preliminary injunction. FDA will not be able to

challenge the standing of all plaintiffs unless and

until the case returns to the district court.

In its briefing opposing the States’ motion to

intervene before this Court, FDA argued that the

States also are not entitled to the preliminary

injunction. They argue that the States lack standing

and venue. But because FDA opposed the States

from participating before this Court, FDA’s

arguments are premature. Only if this Court accepts

FDA’s flawed standing argument about the private

plaintiffs and remands to the district court will FDA

be able to press its arguments for vacating the

preliminary injunction on jurisdiction grounds.

6

II. If the Court does not reach the merits, FDA

will no doubt have to quickly return to this

Court and seek further relief because it will

not prevail in its attempt in the district

court to vacate the injunction on

jurisdictional grounds.

If this Court remands to the district court, FDA

will no doubt be back at this Court seeking relief very

soon. In its opposition to the intervention motion,

FDA asserts that the States lack standing and venue,

and so FDA will be able to vacate the injunction if this

Court returns the case to the district court. Not so.

The States plainly have standing and need not

independently establish venue. Indeed, State

standing is so clear that FDA in effect conceded it last

May in oral argument before the Fifth Circuit. FDA

changed its position only after the States intervened.

A. The States have standing.

1.

The States have suffered traditional

economic injuries from FDA’s

unlawful actions.

The States have standing because they have

suffered traditional economic injury. See Biden v.

Nebraska, 143 S. Ct., at 2366 (“financial harm is an

injury in fact”); TransUnion LLC v. Ramirez, 594 U.S.

413, 425 (2021) (“[C]ertain harms readily qualify as

concrete injuries under Article III. The most obvious

are traditional tangible harms, such as physical

harms and monetary harms.”).

The States allege and present evidence of many

economic harms caused by Defendants, including (1)

increased public insurance costs for emergency

7

medical procedures and mental health support for

women who experience complications from chemical

abortions; and (2) diversion of resources by public

hospitals to care for those who experience

complications. Compl., ECF 176, at 68–78.

FDA does “not dispute that a significant

percentage of women who take mifepristone

experience adverse effects,” with close to 5 percent

requiring emergency room care. All. for Hippocratic

Med., 78 F.4th, at 229. Nor can there be dispute that

these costs, at the population level, are borne by the

States through Medicaid and similar programs.

ECF 176, ¶¶ 257–315. The States also submitted

evidence that these tragedies impose costs on States

for mental health support, id., ¶¶ 307–315, and staterun hospitals, id., ¶¶ 301–306. These “monetary

harms,” under established precedent, “readily qualify

as concrete injuries under Article III.” TransUnion,

594 U.S., at 425.

To give a concrete example, Missouri submitted

evidence that 1,718 Missourians obtained chemical

abortions in 2022 by traveling to just one of Missouri’s

eight neighboring States (four of which permitted

elective abortions). ECF 176, ¶ 281. That means

up to 86 Missourians (5% of 1,718) in 2022 who

traveled to just one neighboring State were forced to

go to the emergency room because of serious

complications from mifepristone. About 400,000

women and girls in Missouri ages 14 through 45 are

eligible for Medicaid, id. ¶ 291—about one-third of all

women and girls of that age range in the State. That

means Missouri, through Medicaid, directly pays for

the cost of emergency care for at least dozens of

women each year who travel to just one of the four

neighboring States that perform elective abortions.

8

The States need only establish a “‘substantial risk’

that the harm will occur.” Susan B. Anthony List v.

Driehaus, 573 U.S. 149, 158 (2014) (citation omitted).

Missouri has established, by near-certain statistical

evidence, that FDA’s actions harm the States.

This is exactly the kind of argument FDA

previously conceded is sufficient to establish standing.

At oral argument before the Fifth Circuit, the Federal

Government was asked why the private plaintiffs lack

standing given this Court’s unanimous ruling that

plaintiffs in Department of Commerce v. New York,

139 S. Ct. 2551 (2019), had standing. The Federal

Government responded that, in Department of

Commerce, “the plaintiffs were states,” meaning “the

effects [of challenged federal action] on them

happened at the population level,” and the States

could thus “rely on population-wide statistics and

probabilities.” Oral Arg. Rec. at 17:16–17:42 (May

17, 2023), All. for Hippocratic Med., No. 23-10362.1

In other words, the States need not identify specific

women for whom they have paid and will pay for

emergency medical care caused by FDA’s policies—

just like the States in Department of Commerce were

not obliged to identify specific people who would

refuse to fill out the Census correctly. It is enough to

note that FDA acknowledges that close to 5 percent of

women are forced to seek emergency medical services

and then rely on those “population-wide statistics and

probabilities” to show that the States bear the cost of

emergency care for dozens of women each year

1

https://www.ca5.uscourts.gov/OralArgRecordings/23/2310362_5-17-2023.mp3

9

because of FDA’s policies. It is of course true that

the States experience loss only after private parties

engage in certain actions. But it the “predictable

effect of Government action,” Dept. of Com., 139 S. Ct.,

at 2566, that women harmed by mifepristone because

of FDA’s actions will seek emergency services paid for

by the States.

Take another concrete example: Idaho identified

that $12,658.05 of its 2022 expenditures covered

medical costs of botched abortions. ECF 176, ¶ 296.

Most of these costs come from chemical abortions

because the complication rate for chemical abortions

is “much higher than … for women receiving surgical

abortions.” Id., ¶ 268 (citing affidavit). That

number also understates the true cost because the

substantial majority of chemical abortions are

miscoded as natural miscarriages and thus not

correctly captured in databases as abortion costs.

Id., ¶ 298 (citing affidavit).

These connections between FDA’s actions and loss

of revenue (including Medicaid revenue) is much

closer than in Department of Commerce. “Medicaid

… is designed to advance cooperative federalism.”

Wisconsin Dep’t of Health and Fam. Services v.

Blumer, 534 U.S. 473, 495 (2002). And yet FDA’s

actions increase the number of women who must seek

emergency medical care, including care paid for by

Medicaid. At the same time that the States have

agreed to operate a cooperative-federalism program to

cover emergency medical costs, FDA has taken action

to drain state resources that go into that program.

In their opposition to the States’ motion to

intervene, Defendants were unable to dispute that the

States have clear economic injuries, so they instead

argued that United States v. Texas, 599 U.S. 670

10

(2023), overturned what this Court described as a

“traditional” basis for standing just two years before,

TransUnion, 594 U.S., at 425. But Texas is no sea

change. To the contrary, this Court stressed that the

Texas decision “is narrow and simply maintains the

longstanding jurisprudential status quo.” 599 U.S.,

at 686. Standing was improper in that case, which

concerned “both a highly unusual provision of federal

law and a highly unusual lawsuit,” id., at 684, because

the States’ challenge there would have required the

executive to “make more arrests or bring more

prosecutions,” id., at 680.

With Texas inapplicable, Defendants questioned in

their response to the States’ motion to intervene

whether the States can muster “factual” proof for their

allegations, arguing that the States have only

established “isolated instances” of harm. But, as is

oft-repeated, “[f]or standing purposes, a loss of even a

small amount of money is ordinarily an ‘injury.’”

Czyzewski v. Jevic Holding Corp., 580 U.S. 451, 464

(2017).

Moreover, in addition to affidavits detailing

specific instances of fiscal harm, the States presented

expert evidence that financial harm is pervasive.

While “FDA’s own data shows that a definite

percentage of women who take mifepristone will

require emergency-room care,” All. for Hippocratic

Med., 78 F.4th, at 233, the States have shown by

expert evidence that the true figure is much higher

because emergency room staff systemically miscode

abortion complications as natural miscarriages.

E.g., ECF 176-1, App. 588–89 (Ex. 36). “[B]etween

one-third and two-thirds of women who obtained

chemical abortions paid for by Medicaid and then had

an abortion-related ER visit were improperly coded by

11

ER staff as having had a natural miscarriage instead

of an abortion.” ECF 176, ¶ 275 (citing expert

affidavit).

2.

The States have suffered sovereign

injuries from FDA’s unlawful

actions.

FDA’s actions also harm the States’ “sovereign

interests” in “the power to create and enforce a legal

code.” Alfred L. Snapp & Son, Inc. v. Puerto Rico, ex

rel., Barez, 458 U.S. 592, 601 (1982). “[F]ederal

preemption of state law” and “federal interference

with the enforcement of state law” both create

standing. Texas v. United States, 809 F.3d 134, 153

(CA5 2015). That is because “a State clearly has a

legitimate interest in the continued enforceability of

its own statutes.” Maine v. Taylor, 477 U.S. 131, 137

(1986).

A number of Missouri laws are threatened by

FDA’s unlawful actions. These include (1) Missouri’s

prohibition on abortions “except in cases of medical

emergency,” Mo. Rev. Stat. § 188.017.2; (2) Missouri’s

prohibition on providers administering chemical

abortion drugs without first submitting a sufficient

plan to address complications from chemical

abortions, id. § 188.021.2; (3) Missouri’s regulations

passed under § 188.021.2 requiring physicians who

perform abortions to prearrange for backup

physicians to address complications if needed, 19

C.S.R. 10-15.050; and (4) Missouri’s requirement that

chemical abortion drugs be dispensed in-person, not

through the mail, Mo. Rev. Stat. § 188.021.1. FDA’s

actions directly interfere with Missouri’s ability to

create and enforce a legal code—both through a

substantial risk of federal preemption and federal

12

interference with enforcement of state law.

176, ¶¶ 316–60.

ECF

First, consider preemption. The States have

sovereign injuries because FDA’s actions impose a

serious threat of preemption to state laws. Indeed,

just two weeks before Petitioners filed for certiorari, a

federal court held that FDA’s actions preempt West

Virginia law, which is similar to, for example,

Missouri law. GenBioPro, Inc. v. Sorsaia, No. CV

3:23-0058, 2023 WL 5490179, at *10 (S.D.W. Va., Aug.

24, 2023).2 To be sure, the States are not presently

defending lawsuits by private parties asserting

preemption. But FDA’s actions still place the States’

laws at substantial risk, and the States are not

“required to await and undergo a … prosecution” by

some other party. Holder v. Humanitarian L.

Project, 561 U.S. 1, 15 (2010) (internal quotation

marks omitted). States can assert their own rights

offensively, not just defensively. Indeed, given the

statute of limitations, States often must bring

offensive suits against agencies where those agencies

engage in actions that risk preempting state law.

The GenBioPro decision makes clear that FDA’s

unlawful decisions create a substantial risk of injury

to the States in the form of interference with their

ability to create and enforce a legal code.

2

Although the plaintiff later voluntarily dismissed its

(successful) preemption claim, it appears the plaintiff did so

because it needed to drop the one count that was not dismissed

so that the district court’s ruling dismissing all other counts

would become a final judgment that could be appealed. See

GenBioPro, ECF 78 (filing a notice of appeal three days after

dropping its successful preemption argument).

13

Next, consider that FDA, through its unlawful

actions, has encouraged and enabled private parties

to evade the States’ laws. For example, FDA’s

decision—in flagrant violation of 18 U.S.C. § 1461—to

endorse private parties distributing chemical abortion

pills through the mail has created a robust industry

designed to evade the States’ laws. Beginning in

summer 2023, organizations started shipping

abortion drugs into all 50 States in large quantities in

an attempt to evade state laws. These organizations

expressly relied on what they called “an FDAapproved pipeline” created by the FDA actions

challenged here. ECF 152, at 3–5; ECF 172, at 7–8

(citing sources). According to just one report, in less

than a month, seven U.S. based providers mailed

3,500 doses of mifepristone to States that have banned

the use of chemical abortions or have prohibited

distribution of those chemical by mail. Roubein,

‘Shield’ Laws Make it Easier to Send Abortion Pills to

3

Banned States, Wash. Post (July 20, 2023). Their

capacity has only grown since then.

In its response to the motion to intervene, FDA

asserted that this harm “is too attenuated to support

standing.” But just a few years ago, this Court

unanimously held that States establish standing

when they raise claims based not on “mere

speculation” but “instead on the predictable effect of

Government action on the decisions of third parties.”

Dept. of Com., 139 S. Ct., at 2566. When FDA

unlawfully removed its prohibition against mailing

3

https://www.washingtonpost.com/politics/2023/07/20/shieldlaws-make-it-easier-send-abortion-pills-banned-states

14

abortion pills, it was “predictable” that private parties

would start mailing those pills. There is nothing

“attenuated” about people doing exactly what FDA

expressly encourages them to do.

Indeed, the link here is much more direct than in

Department of Commerce. There, this Court

unanimously determined that States could sue under

the theory that a citizenship question would cause

private parties to “unlawfully” decline to fill out the

Census, causing an undercount in various States.

139 S. Ct., at 2566. Here, FDA expressly (and

wrongly) told the world it is lawful to mail abortion

pills into all 50 States. The actions of private parties

in Department of Commerce were a “predictable” but

unintended effect of the agency. Here, mailing

abortions into all 50 States is the intended effect of

FDA’s actions.

FDA’s decisions have similarly deprived Plaintiff

States of their sovereign “benefits that are to flow

from participation in the federal system.” Snapp,

458 U.S., at 608. One such benefit is the uniform

application of federal law and the ability of States to

rely on the backdrop of federal law when enacting

their own regulations. See ibid.; Crow Indian Tribe

v. United States, 965 F.3d 662, 676–77 (CA9 2020).

FDA’s actions have the direct effect of enabling and

encouraging third parties to provide, through the

mail, mifepristone to citizens of Plaintiff States for the

purpose of inducing risky abortions that are expressly

contrary to the policies expressed in many of those

States’ statutes.

15

3.

The States have suffered quasisovereign injuries from FDA’s

unlawful actions, and while this

Court has consistently barred thirdparty parens patriae actions, it has

consistently permitted first-party

parens patriae actions to proceed.

The States have also suffered quasi-sovereign

injuries due to FDA’s unlawful actions.

a.

The Court’s precedents consistently

prohibit one kind of parens patriae

suit

against

the

Federal

Government but consistently permit

the second kind.

A century ago, this Court ruled that

Massachusetts could not bring its parens patriae

action

against

the

Federal

Government.

Massachusetts v. Mellon, 262 U.S. 447, 485–486

(1923). The rule announced in that decision has

become known as the “Mellon bar” and was recently

stated in Haaland v. Brackeen, 599 U.S. 255, 295 n.11

(2023).

But there are several kinds of parens patriae

actions, and this Court has treated them differently.

Under this Court’s precedents, the Mellon bar applies

only when two circumstances are present: (1) a State

is suing solely on behalf of a private party, rather than

asserting any interests of its own (such as “quasisovereign” interests); and (2) the State is challenging

the constitutionality of a federal statute. Outside

those circumstances, this Court has always permitted

parens patriae suits to proceed.

16

It is thus no use simply to appeal to broad and outof-context statements like the one found in Brackeen

where this Court, quoting dictum from a case that did

not involve the Federal Government, said “a State

does not have standing as parens patriae to bring an

action against the Federal Government.” Brackeen,

599 U.S., at 295 (brackets accepted) (quoting Snapp,

458 U.S., at 610 n.16). As this Court has repeatedly

cautioned, “‘general language in judicial opinions’

should be read ‘as referring in context to

circumstances similar to the circumstances then

before the Court and not referring to quite different

circumstances that the Court was not then

considering.’” Turkiye Halk Bankasi A.S. v. United

States, 143 S. Ct. 940, 950 (2023) (citation omitted)).

Brackeen involved only one kind of parens patriae

case, and so the Court had no occasion to opine on the

other kind. But every time the Court has faced the

second kind of parens patriae action, the Court has

permitted the suit to proceed against the Federal

Government.

State parens patriae suits “encompass[ ] two

distinct concepts”: (1) purely “third-party” suits where

the State is only a “nominal party”; and (2) a “second,

more modern conception” where a State “assert[s]

some injury to [its] own interests”—for example,

“quasi-sovereign interests.” Kentucky v. Biden, 23

F.4th 585, 596–97 (CA6 2022) (emphasis in original).

Only the first kind of parens patriae action against

the Federal Government is barred. In every case

where this Court has announced a bar on parens

patriae suits against the government, the Court noted

that the State failed to assert its own interests.

Mellon, 262 U.S., at 484–85 (“[W]e are called upon to

adjudicate, not rights of person or property, not rights

17

of dominion over physical domain, not quasi sovereign

rights actually invaded or threatened, but abstract

questions of political power, of sovereignty, of

government.”) (emphasis added); Brackeen, 599 U.S.,

at 295 n.11 (faulting Texas for failing to assert a

“concrete injury to the State” and instead asserting

only the equal-protection rights of a tiny segment of

its population).

In contrast, every time a State has asserted a

quasi-sovereign interest, which is an “injury to the

state itself,” Biden, 23 F.4th, at 596–601 (emphasis in

original), this Court has permitted a parens patriae

suit against the Federal Government to proceed.

Nebraska v. Wyoming, 515 U.S. 1, 20 (1995)

(permitting a parens patriae suit to proceed because it

was not “‘in reality for the benefit of particular

individuals’”); Massachusetts v. EPA, 549 U.S. 497,

520 & n.17 (2007) (permitting a parens patriae suit to

proceed where the State asserted a “stake in

protecting its quasi-sovereign interests” rather than

purely

third-party

interests). Mellon

itself

previewed that this development would occur. While

rejecting a parens patriae suit in that case, the Court

said, “We need not go so far as to say that a state may

never intervene” against the Federal Government

through a parens patriae suit, and it suggested States

could do so if they asserted “quasi sovereign rights.”

Mellon, 262 U.S., at 484–85.

This Court’s precedents thus create a sharp

dividing line. Third-party parens patriae suits—

where a State fails to assert any of its own interests—

are barred against the Federal Government. But

first-party parens patriae suits—where a State does

assert an interest of its own—are permitted against

the Federal Government.

18

That rule makes sense given the ordinary

jurisdictional requirement that a party assert an

interest of its own. Purely third-party parens patriae

actions are barred because the Federal Government is

“the ultimate parens patriae of every American

citizen.” South Carolina v. Katzenbach, 383 U.S.

301, 324 (1966). When a State asserts a third-party

parens patriae suit, it asserts only an interest already

shared by the Federal Government. It is like an aunt

suing a mother on behalf of the mother’s daughter.

But that logic does not apply, and a suit is not barred,

when a State asserts its own interest, because the

Federal Government is not the “ultimate parens

patriae” of the States. When a State asserts its own

interest, that interest is not shared by the Federal

Government, so the State can press it in a parens

patriae action.

In fact, it would be exceptionally strange if States

were not permitted to sue the Federal Government

when the States identify their own interest. That

rule would be a stark exception to the ordinary rules

of standing. And it would thwart the original

federalism design explained by Madison, where “[t]he

different governments will control each other” to

create “a double security.” The Federalist No. 51, at

320 (Clinton Rossiter ed., Signet Classic 2003) (1788).

The Founders envisioned that the States would

“guard one part of the society against the injustice of

the other part.” Ibid. A rule that treated States

with special disfavor by not permitting them to bring

suit when they undisputedly have asserted their own

interests—separate and apart from the Federal

Government’s—would gut the ability of States to keep

the Federal Government in check.

19

In addition, the Mellon bar applies only when a

State challenges the validity of a federal statute. As

this Court put it in Massachusetts v. EPA, “there is a

critical difference between allowing a State ‘to protect

her citizens from the operation of federal statutes’

(which is what Mellon prohibits) and allowing a State

to assert its rights under federal law (which it has

standing to do). Massachusetts does not here

dispute that the Clean Air Act applies to its citizens;

it rather seeks to assert its rights under the Act.”

Massachusetts v. EPA, 549 U.S., at 520 n.17

(emphasis in original). Like Massachusetts, the

States here are not challenging the validity of a

statute; the States are instead seeking to vindicate 18

U.S.C. § 1461 and their rights under the

Administrative Procedure Act. Indeed, because the

APA gives any “aggrieved” party a right to bring an

action, that language “reflect[s] ‘Congressional intent

to permit states to enforce the rights protected by

federal statutes through parens patriae actions.’”

Clearing House Assn., L.L.C. v. Cuomo, 510 F.3d 105,

125 (CA2 2007) (applying the same logic to the Fair

Housing Act), aff’d in part, rev’d in part on other

grounds, 557 U.S. 519 (2009).

Multiple courts after Massachusetts v. EPA have

recognized that the Mellon bar applies only to

challenges to the validity of federal statutes.

Missouri v. Biden, No. 3:22-CV-01213, 2023 WL

4335270, at *57–58; Aziz v. Trump, 231 F. Supp. 3d

23, 31 (E.D. Va. 2017) (collecting cases) (“[R]eading

Mellon as a complete ban on parens patriae actions by

states against the federal government would

contradict Massachusetts v. EPA.”); see also Challenge

v. Moniz, 218 F. Supp. 3d 1171, 1178 (E.D. Wash.

2016) (“[T]he Court cannot ignore the Supreme

20

Court’s 2007 decision in Massachusetts v. E.P.A.,

wherein the majority acknowledged a state’s ability to

sue the federal government under a federal statute in

seeking to protect its quasi-sovereign interests

concerning greenhouse gas emissions.”).4

b.

The States have quasi-sovereign

injuries because FDA’s actions put

countless women and girls in these

States at risk.

Here, the States do not bring third-party parens

patriae suits; they instead assert quasi-sovereign

injuries to the States themselves. When “a

sufficiently substantial segment of [a State’s]

population” is injured, that harm becomes an injury to

the State itself. Snapp, 458 U.S., at 599, 607 (quasisovereign injury to Puerto Rico when “787” people

were affected). An injury to a substantial population

in a State becomes an injury to the State itself and

“suffices to give the State[s] standing to sue” because

that injury to the population “is one that the State, if

it could, would likely attempt to address through its

4

Cases before Massachusetts v. EPA likewise recognized that

Mellon bars only some parens patriae suits. E.g., Puerto Rico

Pub. Hous. Admin. v. U.S. Dep’t of Hous. & Urban Dev., 59 F.

Supp. 2d 310, 326 (D.P.R. 1999); Kansas v. United States, 748 F.

Supp. 797, 802 (D. Kan. 1990); Abrams v. Heckler, 582 F. Supp.

1155, 1159 (S.D.N.Y. 1984); City of New York v. Heckler, 578 F.

Supp. 1109, 1122–25 (E.D.N.Y. 1984); State of Ala. ex rel. Baxley

v. Tennessee Valley Auth., 467 F. Supp. 791, 793–94 (N.D. Ala.

1979) (holding that Mellon did not apply because the State “seeks

only to vindicate the will of the people as it has been expressed

by their duly elected representatives in the national

legislature”).

21

sovereign lawmaking powers.” Id., at 607. FDA’s

actions have imposed harm on a large number of

individuals in each State, and the States have

exercised their sovereign lawmaking powers to try to

address those harms.

1. FDA cannot reasonably dispute that its actions

impose harm on a substantial number of individuals

in each State. In Missouri alone, 1,718 residents

obtained chemical abortions in 2022 in just one of

Missouri’s eight neighboring States (four of which

permitted elective abortions). ECF 176, ¶ 281. By

removing longstanding safety protocols for chemical

abortion drugs, FDA’s actions have made chemical

abortions riskier. Worse, given FDA’s concession

that about 5 percent of these women required

emergency room care, All. for Hippocratic Med., 78

F.4th, at 229, FDA’s challenged actions are directly

responsible for sending up to 86 women from Missouri

to the emergency room in 2022. And that is just

women in Missouri who obtained abortions in one year

from one of Missouri’s four neighboring States that

permit elective abortion.

FDA’s unlawful actions make chemical abortions

riskier in a number of ways. For example, FDA’s

removal of previous requirements of physician

supervision, patient follow-up, reporting of adverse

outcomes, and in-person distribution of drugs expose

individuals in the States to increased risk of suffering

complications from chemical abortion and requiring

emergency medical care. ECF 176, ¶¶ 203, 255–56,

262–274, 349. Indeed, because FDA does not require

any physician supervision, women and girls typically

experience the most painful and complicated parts of

the chemical abortion drug regimen at home—away

from any medical assistance. And because the

22

person providing the drug is almost always absent

when complications arise—and very often unqualified

to treat those complications—thousands of women a

year are denied continuity of care and forced to go to

emergency rooms. ECF 176, ¶¶ 167, 271, 282, 350.

FDA also has eliminated all procedural safeguards

that would rule out ectopic pregnancies, verify

gestational age, identify any contraindications to

prescribing mifepristone, or identify potential

complications until the patient is at a critical time or

it is too late to help her. As a result, patients are

more likely to suffer unexpected episodes of heavy

bleeding or severe pain and must rush to the

emergency room of the nearest hospital. ECF 176,

¶¶ 203, 255–56, 262–274, 351.

All these harms occur on top of the distress and

regret individuals often suffer after undergoing

chemical abortion. ECF 176-1, App. 601–03 (Ex. 37).

Unlike with surgical abortions, an individual

obtaining a chemical abortion often sees the body of

the lifeless child after taking chemical abortion drugs.

Ibid.

FDA’s actions also make coerced abortion much

easier and contribute to human trafficking. ECF

176-1, App. 285, 608–10 (Ex. 14, 37). With no

physician supervision required, and with individuals

able to easily obtain chemical abortion drugs through

the mail, a coerced abortion is now as easy as slipping

a pill into a girlfriend’s or trafficking victim’s drink or

food. Human trafficking and coerced abortion have

of course long been illegal in the Plaintiff States.

E.g., Mo. Rev. Stat. §§ 188.027, 566.209. But FDA’s

actions make human trafficking and coerced abortion

worse.

23

2. Nor can FDA dispute that these are the kinds of

harms a “State, if it could, would likely attempt to

address through its sovereign lawmaking powers.”

Snapp, 458 U.S., at 607. The States have passed

laws to guard against these harms. For instance,

Missouri has outlawed elective abortions except in

cases of medical emergency. Mo. Rev. Stat.

§ 188.017.2. Missouri has also put in place

safeguards for women and girls who undergo chemical

abortions, such as requiring that abortion drugs be

dispensed in-person and requiring that physicians

who perform abortions provide a plan for and care for

complications that arise. Mo. Rev. Stat. § 188.021.1–

.2; 19 C.S.R. 10-15-050. And Missouri has long

banned human trafficking and coerced abortions.

Mo. Rev. Stat. §§ 188.027, 566.209. These laws exist

to protect women and girls, but FDA frustrates them

by aggravating all these harms. Having exhausted

its sovereign capabilities—the States, of course,

cannot regulate FDA—the States have no remaining

option other than to sue.

c.

The States have quasi-sovereign

injuries because FDA’s actions harm

doctors in the States.

Likewise,

certain Missouri

statutes and

regulations were designed to prevent injuries to

doctors and hospitals, but they are being undermined

by FDA’s unlawful actions. Missouri statutes and

regulations require physicians to plan for and provide

care for abortion complications so that persons

receiving abortions are not forced to go to emergency

rooms. See Mo. Rev. Stat. § 188.021.1–.2; 19 C.S.R.

10-15-050. But FDA’s challenged actions cause

doctors who live and work in Plaintiff States to treat

24

more women and girls who have suffered

complications from chemical abortion drugs because

physicians are not providing follow-up care when

individuals experience complications. ECF 176,

¶¶ 363–68. Increased

complications

consume

limited medical resources, such as physician time and

attention, space in hospitals, blood for transfusions,

and other equipment and medicines—in both public

and private hospitals. ECF 176, ¶¶ 301–06, 369–76.

The Plaintiff States have an interest in preventing

these harms and have passed laws to prevent them.

FDA’s unlawful actions have hindered their efforts,

harming the States. Again, unable to use their

sovereign authority to regulate FDA, the States are

forced to sue.

B. FDA’s arguments about

merit.

venue

lack

No better is FDA’s confident assertion that if this

Court remands to the district court, FDA will be able

to vacate the preliminary injunction by arguing that

the States lack venue.

FDA’s argument—expressed in their opposition to

the intervention motion—rests on the fundamentally

flawed premise that a determination by this Court on

standing favorable to FDA would automatically

dismiss the private plaintiffs from this suit. FDA

never filed, and the district court never ruled on, a

motion to dismiss. FDA instead appeals a

preliminary injunction. But establishing standing

for a preliminary injunction requires a “degree of

evidence” different from surviving a motion to

dismiss. Lujan v. Defenders of Wildlife, 504 U.S.

555, 561 (1992). A holding by this Court that the

private plaintiffs failed to submit sufficient evidence

25

to establish standing for a preliminary injunction

would not require dismissal. FDA would have to

wait until the case returned to the district court before

moving to dismiss.

But even if the private plaintiffs were dismissed, it

is well established that the district court may “treat

the intervenor’s claim as if it were a separate suit” and

permit it to continue—with all previous orders still in

effect. Wright & Miller, supra, § 1918. Venue is not

jurisdictional, 28 U.S.C. § 1406(b), and a plaintiff who

successfully intervenes in a case where venue was

satisfied by the original party need not independently

satisfy venue after dismissal of the original action “if

a particular claim or party is so closely related to the

original action that it can be considered ancillary,”

Wright & Miller, supra, § 1918. Here, every FDA

action the States challenge is also challenged by the

private plaintiffs, so the States’ challenge satisfies the

“closely related” test.

26

CONCLUSION

The Court should affirm the preliminary

injunction, but if this Court accepts FDA’s flawed

argument that the private plaintiffs lack standing, the

only proper remedy is a remand to the district court

without vacatur.

Respectfully submitted,

KRIS W. KOBACH

Kansas Attorney General

ANTHONY J. POWELL

Solicitor General

ERIN B. GAIDE

Assistant Att’y General

120 SW 10th Ave., 2d Fl

Topeka, KS 66612

(785) 368-8539

RAÚL R. LABRADOR

Idaho Attorney General

ALAN M. HURST,

Solicitor General

JOSHUA N. TURNER,

Chief of Constitutional

Litigation and Policy

JAMES E.M. CRAIG,

Acting Division Chief

700 W. Jefferson St., # 210

Boise, ID 83720

(208) 334-2400

ANDREW BAILEY

Missouri Attorney General

JOSHUA M. DIVINE

Solicitor General

Counsel of Record

MARIA A. LANAHAN

SAMUEL C. FREEDLUND

Deputy Solicitors General

Supreme Court Building

207 West High Street

Jefferson City, MO 65102

(573) 751-8870

Josh.Divine@ago.mo.gov

Counsel for Missouri, Idaho, and Kansas

February 29, 2024

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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