Petition for Writ of Certiorari — Aila Curtis, et al., Petitioners v. Jay Inslee, former Governor of Washington, et al.

No. ____________

In the Supreme Court of the United States

____________ ____________

AILA CURTIS, et al.,

Petitioners,

v.

JAY ROBERT INSLEE,

GOVERNOR OF WASHINGTON,

in his individual capacity, et al.,

Respondents.

.

____________ ____________

On Petition for a Writ of Certiorari

to the United States Court of Appeals

for the Ninth Circuit

____________ ____________

PETITION FOR A WRIT OF CERTIORARI

____________ ____________

DAVID J. SCHEXNAYDRE

SCHEXNAYDRE LAW FIRM, LLC

2895 Hwy 190, Ste. 212

Mandeville, LA 70471

(985) 292-2020

david@schexnaydre.com

Counsel for Petitioners

–i–

QUESTIONS PRESENTED

The Ninth Circuit held that Petitioners’

substantive due process claims were foreclosed by

Jacobson v. Massachusetts, 197 U.S. 11 (1905) and

Health Freedom Defense Fund, Inc. v. Carvalho, 148

F.4th 1020 (9th Cir. 2025).

Because Carvalho, pending as No. 25-765,* cites

the present case as an example of the detrimental

effects of the Carvalho ruling, the Court may wish to

consider this case in conjunction with Carvalho.

Additionally, Sweeney v. University of Colorado

Hospital Authority, No. 25-1055, involves a

materially similar factual and legal backdrop and

identical procedural errors by both the district and

circuit courts as those detailed herein. The Court

may wish to consider these petitions in tandem to

address the recurring issues of party presentation

and premature merits adjudication at the pleading

stage.

Question 1:

Does Jacobson v. Massachusetts, 197 U.S. 11

(1905) limit a court’s review of governmentmandated investigational medical treatments to

whether the mandate is rationally related to a

legitimate government objective, or does Jacobson

first require the court to determine if the scope and

means of the mandate constitute a legitimate

exercise of the police power of the state that does not

infringe upon the federal domain?

* This Court issued a call for response on February 5, 2026.

– ii –

Question 2:

Did the Ninth Circuit violate the principle of

party presentation by sua sponte deciding a major

constitutional question — whether Jacobson forecloses any substantive due process right to refuse an

investigational drug — based on facts neither raised,

briefed, nor argued by any party, to affirm dismissal

under Federal Rule of Civil Procedure 12(b)(6)?

– iii –

LIST OF PARTIES TO THE PROCEEDING

Petitioners

are

former

employees

of

PeaceHealth: Aila Curtis, Shannon Lee Adams, Ciera

Agee, Nelli Antonov, Alison Archer, Rebecca

Barcenas, David Bennett, Kathy Bordeaux, Daniel

Brickert, Britney Brown, Christine Amber Bruce,

Susan Buchanan, Kirsten Clarke, Diane Clemans,

Jeff Coffey, The Estate of Cherie Coiner, Sheila

Craig, Rae Lynn Crocker, Lisa Daluz, Christina

Dawson, Margarita Demchenko, Monica Dickinson,

Hayley Dixon, Jason Dong, Kristin Ellison, Katerina

Erokhina, Shanta Gervickas, The Estate of Caleb

Gervickas, Eduard Goncharuk, Staci Gray, Amy

Haserot, Betheny Hayden, Rhonda Holmes, Mikayla

Holsinger, Amy James, Josey Kolbo, Whitney

Konrady, Tamara Kopp, Sumiko Kuba, Lindsey

Lamb, Nadezhda Litvinenko, Liliya Lopatin, Misty

Lyons, Sheila Lyons, Irina Maksimenko, Lyubov

Melnychuk, Ashley Mendoza, Monica Miller, Cheryl

Mitchell, Damaris Mocan, Kathryn Morgan, Nick

Morzhov, Dwain Nash, Lysander Nerida, Yelena

Onofrey, Kathryn Ortega, Yvonne Quashie, Leslie

Quintana, Emma Ranson, Shannon Ringnalda,

Angela Ripp, Violetta Roberts, Mallory Schlang, Igor

Shapoval, Melissa Smithdeal, Lori Souders, Amy

Tallbut, Brooke Tanner, Amber Taylor, Tracie

Thomas, Dena Thorp, Jennifer Torres, Lyubov

Tshuprin, Olga Tsytsyna, Linda Veatch, Roxana

Volynets, Hannah Wagar, Vera Yadlovskiy, Alla

Kutsar Zabolotska, Dina Zabolotska, Nelya

Zabolotska, and Kristine Zamudio.

Respondents are Jay Robert Inslee, Governor of

the State of Washington, in his individual capacity,

and PeaceHealth, a not-for-profit healthcare system

headquartered in Clark County, Washington; Liz

– iv –

Dunne, President and Chief Executive Officer of

PeaceHealth, in her official and individual capacities;

and Doug Koekkoek, Chief Physician and Clinical

Executive of PeaceHealth, in his official and

individual capacities.*

CORPORATE DISCLOSURE STATEMENT

Petitioners have no information to disclose under

Rule 29.6.

LIST OF DIRECTLY RELATED CASES

Curtis, et al. v. Inslee, et al., No. 24-1869, U.S. Court

of Appeals for the Ninth Circuit. Judgment

entered October 6, 2025.

Curtis, et al. v. Inslee, et al., No. 3:23-cv-05741-RJB,

U.S. District Court for the Western District of

Washington. Judgments on motions to dismiss

entered December 21, 2023 and January 23,

2024; Judgment denying leave to amend entered

February 27, 2024.

* The Ninth Circuit caption (at App. 1a–2a) contains the

following errors: Derek Coiner and Hannah Bernhardt are

listed as parties in error; The Estate of Caleb Gervickas is a

party but was omitted; The Estate of Cherie Coiner is a party

but was omitted; the correct first name of Yelena Onofrey is

Yelena, not Whitney; the correct first name of Rebecca Barcenas

is Rebecca, not Becky; the correct first name of Rae Lynn

Crocker is Rae Lynn, not Rae Ly; the correct first name of

Betheny Hayden is Betheny, not Bethen; the correct last name

of Hannah Wagar is Wagar, not Wager; and the correct middle

name of Alla Kutsar Zabolotska, is Kutsar not Kutsa.

–v–

TABLE OF CONTENTS

Questions Presented ................................................... i

List of Parties to the Proceeding .............................. iii

Corporate Disclosure Statement .............................. iv

List of Directly Related Cases .................................. iv

Table of Contents....................................................... v

Table of Authorities .................................................. ix

Petition for a Writ of Certiorari ................................ 1

Opinions Below .......................................................... 1

Jurisdiction ................................................................ 1

Constitutional and Statutory

Provisions Involved .................................................. 2

Introduction ............................................................... 2

Statement of the Case ............................................... 4

Reasons for Granting the Writ.................................. 8

I.

The Ninth Circuit misconstrued

Jacobson and inverted the

Supremacy Clause. ...................................... 9

II.

Respondents’ mandates were not

a legitimate exercise of state police

power. .......................................................... 14

– vi –

TABLE OF CONTENTS

(continued)

A. The Federal Food, Drug, and

Cosmetic Act preempts mandates

of investigational drugs ..........................15

B. The Public Readiness and

Emergency Preparedness Act

expressly preempts EUA

mandates .................................................21

C. Federalwide Assurance and

legally effective informed consent

prohibits involuntary use of

investigational drugs. .............................23

D. Public and private entities cannot

assign a medical indication to an

investigational drug. ...............................25

III.

Jacobson does not foreclose an

individual’s right to refuse an

investigational new drug. ........................28

A. Individuals possess a fundamental

right to bodily integrity ..........................28

B. The PREP Act implicates the Due

Process Clause ........................................31

IV.

The Ninth Circuit violated the

principle of party presentation. .............33

V.

Dismissal with prejudice was an

abuse of discretion.....................................35

– vii –

TABLE OF CONTENTS

(continued)

Conclusion ................................................................ 36

APPENDIX A

Ninth Circuit Court of Appeals’ Opinion

(October 6, 2025) ............................................... 1a

APPENDIX B

District Court for the Western District of

Washington Order Denying Plaintiffs’

Various Motions and Dismissing

Remaining State Law Claims Without

Prejudice (February 27, 2024) ........................ 30a

APPENDIX C

District Court for the Western District

of Washington Order on PeaceHealth

Defendants’ Motion to Dismiss

(January 23, 2024) .......................................... 52a

APPENDIX D

District Court for the Western District

of Washington Order Granting

Defendant Inslee’s Motion to Dismiss

(December 21, 2023) ....................................... 76a

APPENDIX E

Constitutional and Statutory

Provisions ................................................... 96a

Fourteenth Amendment, Section 1 ................ 96a

U.S. Constitution, Art. VI, Cl. 2 ..................... 96a

42 U.S.C. § 1983 .............................................. 97a

21 U.S.C. § 355 ................................................ 97a

21 U.S.C. § 360bbb .......................................... 98a

– viii –

TABLE OF CONTENTS

(continued)

21 U.S.C. § 360bbb-3 .......................................99a

42 U.S.C. § 247d-6d(b)(8) ..............................101a

42 U.S.C. § 247d-6e(c) ...................................102a

42 U.S.C. § 289 ..............................................102a

– ix –

TABLE OF AUTHORITIES

CASES

Abigail Alliance for Better Access to

Developmental Drugs v. von Eschenbach,

495 F.3d 695 (D.C. Cir. 2007) .................. 18, 20, 30

Albright v. Oliver,

510 U.S. 266 (1994) .............................................. 29

Arizona v. United States,

567 U.S. 387 (2012) .................................. 12–13, 19

Ashcroft v. Iqbal,

556 U.S. 662 (2009) .............................................. 15

Bailey v. Alabama,

219 U.S. 219 (1911) .............................................. 32

Barrett v. United States,

689 F.2d 324 (2d Cir. 1982).................................. 32

Bell Atlantic Corp. v. Twombly,

550 U.S. 544 (2007) .............................................. 15

Berghuis v. Thompkins,

560 U.S. 370 (2010) ........................................ 30, 32

Biden v. Missouri,

595 U.S. 87 (2022) ................................................ 13

Board of Regents v. Roth,

408 U.S. 564 (1972) .............................................. 31

–x–

TABLE OF AUTHORITIES

(continued)

Buckman Co. v. Plaintiffs’ Legal Comm.,

531 U.S. 341 (2001) .............................................. 18

Clark v. Sweeney,

607 U.S. 7 (2025) .................................................. 33

City of Cleburne v. Cleburne Living Center,

Inc., 473 U.S. 432 (1985) ...................................... 11

Cruzan v. Director, Missouri Dep’t of Health,

497 U.S. 261 (1990) ........................................ 29, 31

Foman v. Davis,

371 U.S. 178 (1962) .............................................. 35

Greenlaw v. United States,

554 U. S. 237 (2008) ............................................. 33

Health & Hospital Corp. v. Talevski,

599 U.S. 166 (2023) .............................................. 31

Health Freedom Defense Fund, Inc. v. Carvalho,

148 F.4th 1020 (9th Cir. 2025) ........................... i, 9

Hishon v. King & Spalding

467 U.S. 69 (1984) ................................................ 15

Jacobson v. Massachusetts ,

197 U.S. 11 (1905) ........... i, ii, 2, 3, 4, 7, 8, 9, 10, 11

.............................. 12, 13, 14, 20, 21, 28, 29, 33, 34

Logan v. Zimmerman Brush Co.,

455 U.S. 422 (1982) .............................................. 31

– xi –

TABLE OF AUTHORITIES

(continued)

Lomax v. Ortiz-Marquez,

590 U. S. 595 (2020) ............................................. 33

Miranda v. Arizona,

384 U.S. 436 (1966) .............................................. 30

Mullane v. Central Hanover Bank & Trust Co.,

339 U.S. 306(1988) ............................................... 32

Perry v. Sindermann,

408 U.S. 593 (1972) .............................................. 31

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) .............................................. 18

Pritchard v. Norton,

106 U.S. 124 (1882) ........................................ 31–32

Railroad Company v. Husen,

95 U.S. 465 (1877) ...........................................10-11

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008) .............................................. 18

Speiser v. Randall,

357 U.S. 513 (1958) .............................................. 32

Stormans, Inc. v. Wiesman,

794 F.3d 1064 (9th Cir. 2015) .............................. 28

United States v. Oakland Cannabis Buyers’

Cooperative, 532 U.S. 483 (2001) ................... 20–21

– xii –

TABLE OF AUTHORITIES

(continued)

United States v. Rutherford,

442 U.S. 544 (1979) .............................. 3, 18–19, 30

United States v. Sineneng-Smith,

590 U.S. 371 (2020) .................................... 3, 33, 34

Washington v. Glucksberg,

521 U.S. 702 (1997) ........................................ 13, 29

Wroblewski v. City of Washburn,

965 F.2d 452 (7th Cir. 1992) ................................ 15

CONSTITUTIONAL PROVISIONS

Article VI, Clause 2 ....................... 2, 3, 8, 9, 10, 12, 22

Fourteenth Amendment ........................ 4, 8, 13, 31, 32

FEDERAL STATUTES

FDCA, 52 Stat. 1040 (1938) ...... 3, 7, 12, 13, 16–17, 18

.......................................... 19, 20, 22, 25–26, 27, 30, 33

NRA, 88 Stat. 342 (1974) .......................................... 23

PREP Act, 119 Stat. 2818 (2005) ............ 21, 31, 32, 33

21 U.S.C. § 331 .................................................... 25, 26

21 U.S.C. § 352 .................................................... 25, 26

– xiii –

TABLE OF AUTHORITIES

(continued)

21 U.S.C. § 355 ........................ 3, 16, 17, 18, 19, 20, 34

21 U.S.C. § 360bbb .............................................. 16–17

21 U.S.C. § 360bbb-3 ..................................... 16, 17, 24

28 U.S.C. § 1254(1) ...................................................... 1

42 U.S.C. § 247d-6d ............................................. 21–22

42 U.S.C. § 247d-6e ................................................... 21

42 U.S.C. § 262 .......................................................... 27

42 U.S.C. § 289 .................................. 23, 29, 30–31, 34

42 U.S.C. § 1983 ........................................ 4, 22, 23, 31

FEDERAL REGULATIONS

21 C.F.R. § 312.7........................................................ 25

45 C.F.R. § 46.101...................................................... 24

45 C.F.R. § 46.116................................................ 23, 24

45 C.F.R. § 46.122...................................................... 24

45 C.F.R. Part 46 ................................................. 24, 29

– xiv –

TABLE OF AUTHORITIES

(continued)

FEDERAL RULES

Fed. Rule Civ. Proc. 12(b)(6) ..... ii, 5, 14, 15, 29, 34, 35

Fed. Rule Civ. Proc. 15(a)(2) ..................................... 35

Fed. Rule Civ. Proc. 59(e) ............................................ 7

Supreme Court Rule 10(c) ........................................... 8

–1–

PETITION FOR A WRIT OF CERTIORARI

Petitioners Aila Curtis, et al. respectfully seek a

writ of certiorari to review the judgment of the

United States Court of Appeals for the Ninth Circuit,

which affirmed orders granting Respondents’ Rule

12(b)(6) motions to dismiss and denying Petitioners’

motion for leave to amend.

OPINIONS BELOW

The Ninth Circuit’s opinion is published at

Curtis v. Inslee, 154 F.4th 678 (9th Cir. 2025), and

reproduced at Appendix A.

The U.S. District Court for the Western District

of Washington’s decision dismissing Respondent

Inslee is published at Curtis v. Inslee, 709 F.Supp.3d

1257 (W.D. Wash. 2023), and is reproduced at

Appendix D. The District Court’s decision dismissing

Respondent PeaceHealth is found at Curtis v.

PeaceHealth, 2024 WL 248719; the District Court’s

denial of leave to amend is found at Curtis v. Inslee,

2024 WL 810503; these decisions are reproduced at

Appendix C and B, respectively.

JURISDICTION

The Ninth Circuit issued its opinion on October

6, 2025. Petitioners requested an extension of time in

which to file the instant petition for a writ of

certiorari, and were granted an extension by Justice

Kagan until March 5, 2026, No. 25A703. This Court

has jurisdiction under 28 U.S.C. § 1254(1).

–2–

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

The Constitutional provisions

included at Appendix E, App. 96a:

involved

are

U.S. Constitution, Art. VI, Cl. 2

Fourteenth Amendment, Section 1.

The relevant statutory provisions are included at

Appendix E, App. 97a–102a:

42 U.S.C. § 1983

21 U.S.C. § 355

21 U.S.C. § 360bbb

21 U.S.C. § 360bbb-3

42 U.S.C. § 247d-6e(c)

42 U.S.C. § 247d-6d(b)(8)

42 U.S.C. § 289.

INTRODUCTION

This Petition presents a constitutional crisis of

national importance that urgently requires this

Court’s immediate intervention: whether a state may

impose mandatory investigational medical treatment

in direct defiance of federal law, or whether federal

law remains supreme as the Constitution commands.

Under the Supremacy Clause and more than two

centuries of this Court’s unbroken precedents, the

answer is axiomatic — federal law prevails. Yet the

Ninth Circuit radically inverted that foundational

order. It misconstrued Jacobson v. Massachusetts,

197 U.S. 11 (1905), to require courts to examine only

the state’s asserted public-health objective, while

–3–

rendering wholly irrelevant whether the means

chosen constitute a legitimate exercise of police

power or brazenly intrude upon the field Congress

has exclusively occupied for itself under the

Supremacy Clause.

The Ninth Circuit’s errors are both profound and

multifaceted. It sua sponte resolved a sweeping

constitutional question — whether Jacobson

categorically forecloses any substantive due process

right to refuse an investigational drug — based on

facts that no party had raised, briefed, or argued,

violating the principle of party presentation. See

United States v. Sineneng-Smith, 590 U.S. 371

(2020). It also engaged in blatant appellate factfinding by dismissing mandatory federal statutes,

regulations, and binding agreements as mere

“suggestions” and by inventing a novel “clinically

identical” doctrine that effectively rewrites the

Federal Food, Drug, and Cosmetic Act of 1938

(FDCA), 21 U.S.C. § 301 et seq., insofar as it permits

public and private entities to treat unapproved drugs

as if they are approved when they are “clinically

identical.” Most concerning is that such a

precedential ruling serves as a blank check for

wrongdoers because the court did not define

“clinically identical,” leaving it to society to prescribe

its own meaning. The Ninth Circuit judicially

manufactured a fourth, implied exception to 21

U.S.C. § 355(a) — one Congress has never enacted —

thereby authorizing the involuntary use of

unapproved

investigational

drugs

in

direct

contravention of the FDCA and this Court’s holding

in United States v. Rutherford, 442 U.S. 544 (1979),

that lower courts may not create exceptions to FDCA

that Congress itself has not authorized.

–4–

What began as a straightforward claim for

monetary damages under 42 U.S.C. § 1983 for the

deprivation of Petitioners’ Fourteenth Amendment

rights was transformed by the Ninth Circuit into a

sweeping declaration of state supremacy over federal

drug regulation, labeling, and administration. The

opinion is not merely erroneous; it is an

unprecedented abuse of judicial power. Certiorari is

essential to restore the constitutional hierarchy,

reaffirm the supremacy of federal law in drug

regulation, and prevent the Ninth Circuit’s ruling

from becoming a dangerous nationwide precedent

that eviscerates Congress’ strict regulation of

investigational drugs and covered countermeasures.

Compelling healthy citizens to inject investigational

drugs into their bodies while simultaneously

depriving them of any right to judicial redress if

injured — all as a condition of retaining stateconferred privileges such as employment within the

healthcare industry — is an abusive and oppressive

exercise of governmental power. The Ninth Circuit’s

novel extension of Jacobson to sanction such a result

cannot be reconciled with the Due Process Clause of

the Fourteenth Amendment.

STATEMENT OF THE CASE

The underlying action challenged mandatory

policies promulgated and enforced by Respondents.

Governor Inslee issued Proclamation 21-14-1,1 which

prohibited state-licensed healthcare facilities from

employing licensed healthcare providers who had not

been injected with an investigational COVID-19

1 ECF No. 8 ¶¶ 25–26

–5–

vaccine not licensed for any indication2 by October

18, 2021. PeaceHealth cited the Proclamation as the

basis for implementing its mandatory policy3

requiring

full

“vaccination”

with

available

investigational drugs by October 15, 2021.4

Petitioners alleged that PeaceHealth engaged in a

scorched-earth policy,5 including requiring publicly

displayed vaccination badges to disclose Petitioners’

private health information and leaving binders in

public hallways containing Petitioners’ full name,

employee ID, and vaccination status. Petitioners also

alleged that they were openly harassed, ridiculed,

mocked, and intimidated as a result,6 and that staff

managers continually invaded their privacy by

asking publicly if and when they would be injected

with one of the drugs and why they would not use

the product.

Starting on October 15, 2021, and continuing

through 2022, on the state’s behalf, PeaceHealth,

through

employment

termination,

punished

Petitioners who refused to accept one of the available

COVID-19 investigational drugs.7 On August 18,

2023, Petitioners filed their Complaint.8 On August

28, 2023, the court, sua sponte, required Petitioners

to reduce their page count.9 On August 31, 2023,

Petitioners filed an Amended Complaint.10 Governor

Inslee filed his Rule 12(b)(6) motion to dismiss on

2 Id. ¶¶ 30–32

3 Id. ¶ 123

4 Id. ¶ 137

5 Id. ¶ 156

6 Id. ¶ 162

7 Id. ¶ 27

8 ECF No. 1

9 ECF No. 7

10 ECF No. 8

–6–

October 30, 2023,11 and PeaceHealth filed its motion

to dismiss on November 30, 2023.12

Governor Inslee’s primary defense rested on his

assertion that the drugs made available for

compliance were not investigational drugs.13

PeaceHealth alleged that “[b]y the time Plaintiffs

were required to receive a COVID vaccine under

PeaceHealth’s policy, an FDA-approved vaccine was

available.”14 Both Respondents alleged that

Petitioners cited to no authority that provided a

private right of action. Petitioners filed oppositions

relying upon the FDA’s EUA (Emergency Use

Authorization) letters that described the available

drugs as “an investigational vaccine not licensed for

any indication.”15 Petitioners informed the court that

the presence of an EUA means that an approved

drug is not available for use and alleged, with

supporting judicially noticeable documentation, that

“the FDA and Pfizer informed the public that

although Comirnaty was licensed for commercial use,

the drug was never available in the U.S.”16

On December 21, 2023, the district court granted

Governor Inslee’s motion to dismiss,17 and factually

concluded, based on no evidence, that because the

FDA approved Comirnaty, it was available for policy

compliance. The district court thus found that the

mandates were lawful because the available drugs

were FDA-approved drugs rather than investiga11 ECF No. 18

12 ECF No. 30

13 ECF No. 18 at 19, “i”

14 ECF No. 30 at 15, 11-12

15 ECF No. 8, ¶¶ 30-32

16 ECF No. 29 at 18-19

17 ECF No. 32

–7–

tional.18 On January 18, 2024, Petitioners filed a

Rule 59(e) Motion to Alter or Amend, or in the

Alternative, Motion for Leave to File Second

Amended Complaint,19 and attached a proposed

Second Amended Complaint with judicially

noticeable documents as exhibits.20 While the Motion

to Alter or Amend was pending, on January 23, 2024,

the district court granted PeaceHealth’s motion to

dismiss on the same basis that it granted Gov.

Inslee’s.21 On February 27, 2024, the district court

denied Petitioners’ Motion to Alter or Amend/Motion

for Leave to File Second Amended Complaint.22

On March 26, 2024, Petitioners filed a timely

appeal to the Ninth Circuit.23 The Ninth Circuit held

that any error of the lower court relating to whether

the drug was investigational was “harmless.” App.

5a. The Court affirmed the district court’s dismissals

by (a) issuing a novel ruling that Jacobson precludes

any argument of a constitutional right to refuse

investigational drugs, (b) dismissing mandatory

federal

statutes,

regulations,

and

binding

agreements as mere “suggestions,” and (c) inventing

a novel “clinically identical” doctrine that effectively

rewrites the Federal Food, Drug, and Cosmetic Act of

1938 (FDCA), 21 U.S.C. § 301 et seq.

18 Id.

19 ECF No. 38

20 ECF Nos. 38-2 through 38-10

21 ECF No. 41

22 ECF No. 54

23 ECF No. 56

–8–

REASONS FOR GRANTING THE WRIT

The Court should grant the petition because it

presents important and recurring questions of

federal procedure, Supremacy Clause preemption,

and substantive due process that only this Court can

authoritatively resolve. Review is necessary to

protect the comprehensive federal framework

Congress has carefully constructed over more than

eight decades to safeguard public health, drug safety,

and the fundamental liberty interests in informed

consent and bodily integrity.

This Court may grant certiorari when “a United

States court of appeals has decided an important

question of federal law that has not been, but should

be, settled by this Court, or has decided an important

federal question in a way that conflicts with relevant

decisions of this Court.” Sup. Ct. R. 10(c). Both

criteria are squarely met. The Ninth Circuit’s entire

opinion rests on its recasting of Jacobson, supported

only by improper fact-finding at the pleading stage.

Only this Court can correct the lower court’s

inversion of the Supremacy Clause, restore the

proper analysis of Jacobson, and safeguard the

liberty interest that Congress has strictly enforced

through its legislative efforts for the protection of the

American people.

Although PeaceHealth is a private entity,

Petitioners alleged that it was acting on behalf of

official state policy when it deprived them of their

Fourteenth Amendment rights — a contention the

Ninth Circuit expressly acknowledged. App. 6a. The

panel made clear that it was not addressing whether

PeaceHealth qualified as a state actor or whether

qualified immunity applied to any Respondent.

Additionally, the panel referred to Petitioners as “at-

–9–

will employees.” That characterization has no

bearing on this case. PeaceHealth did not invoke the

State of Washington’s at-will employment doctrine to

terminate Petitioners’ employment; it relied on

Governor Inslee’s proclamation — the very official

state policy the petitioners are challenging. Finally,

the court’s repeated use of the term “employees” to

refer to Petitioners is misleading. They were citizens

who were denied meaningful use of their state-issued

healthcare licenses because a state policy barred

them from entering healthcare facilities unless they

participated in the CDC’s COVID-19 Vaccination

Program on the terms set forth in the Governor’s

proclamation.

I.

The Ninth Circuit misconstrued Jacobson

and inverted the Supremacy Clause.

The Ninth Circuit held that “Jacobson and

Carvalho foreclose Employees’ substantive due

process claim regarding the purported ‘right to refuse

an investigational drug without penalty or pressure’”

because they “have failed to plausibly allege that the

state action in this case was an exercise of ‘arbitrary

power’ rather than merely ‘that broad discretion

required for the protection of the public health.’” App.

19a.

This holding rests on a fundamental mischaracterization of Jacobson’s two-prong analysis. Jacobson

first requires a court to determine whether the

challenged policy is a legitimate exercise of the

state’s police power — including whether its scope

and means intrude upon the federal domain occupied

by Congress under the Supremacy Clause. Only if

the policy survives that threshold inquiry does the

court then ask whether the regulation is reasonable

– 10 –

and not arbitrary, oppressive, or beyond what is

necessary for the protection of the public health. The

Ninth Circuit determined that Petitioners failed to

plausibly allege the state action was not arbitrary

because it ignored Jacobson’s required inquiry of

whether the scope and extent of the mandates were a

legitimate exercise of the state’s police powers. In

doing so, the panel erroneously implied that federal

law governing investigational drug use is irrelevant

to the legitimacy of the state’s conduct. This is a clear

constitutional error. By reading Jacobson to insulate

state mandates from federal statutory limits and the

Supremacy Clause, the Ninth Circuit inverted the

constitutional hierarchy and eviscerated the very

limits this Court has long imposed on state police

power.

Jacobson is clear that the first inquiry is whether

the scope and extent of the statute constitute a

legitimate exercise of the state’s police powers.

A local enactment or regulation, even if based on

the acknowledged police powers of a State, must

always yield in case of conflict with the exercise by

the General Government24 of any power it possesses

under the Constitution, or with any right that

instrument gives or secures. Jacobson, supra at 25.

In Railroad Company v. Husen, 95 U.S. 465

(1877), a case where the state’s legitimate interest

extended to slowing the spread of the Texas or

Spanish flu, the Court acknowledged states’ rights to

enact sanitary laws for the protection of life, liberty,

health, or property. Yet, this Court struck down the

public health policy because it “went beyond the

In historical and constitutional contexts, particularly in

opinions like Jacobson, the term “general government” refers to

the federal (or national) government of the United States, as

distinguished from individual state governments.

24

– 11 –

necessity of the case and under the guise of exerting

a police power invaded the domain of Federal

authority, and violated rights secured by the

Constitution.” Jacobson, 197 U.S. at 25 (citing

Husen, 95 U.S. at 471–73); see also Husen, 95 U.S. at

469 (“It seems hardly necessary to argue at length

that unless the statute can be justified as a

legitimate exercise of the police power of the state, it

is a usurpation of the power vested exclusively in

Congress.”) Only after inquiring whether the scope

and extent of the statute rests within “the authority

of the State to enact th[e] statute,” Jacobson at 25,

did the court move to the second prong of inquiry of

whether the means prescribed by the state for the

“protection of the public health and the public safety”

furthered a legitimate interest of the state that was

not arbitrary, oppressive, or an unreasonable

exercise of the state’s police powers. Id. at 31.

The Ninth Circuit now establishes new precedent

that “our only inquiry is whether Employees’

treatment is rationally related to the State’s

objective.”25 That approach directly contradicts this

Court’s opinion in City of Cleburne v. Cleburne Living

Center, Inc., 473 U.S. 432, 441 (1985), that when

reviewing an equal protection claim, rational-basis

review applies only to “interests the State has the

authority to implement.”

Because Petitioners alleged that the challenged

mandates are preempted by federal law, the Ninth

Circuit, as a matter of law, cannot supply any

legitimate state interest at the pleading stage. A

policy that violates federal law is not a legitimate

exercise of police power; it is void under the

25 App. 23a (internal quotation marks omitted) (emphasis

added).

– 12 –

Supremacy Clause. The Ninth Circuit’s inverted

framework — treating federal preemption as

irrelevant once a state invokes “public health” —

cannot be reconciled with Jacobson, Cleburne, or the

Supremacy Clause.

The panel acknowledged Petitioners’ allegations

that the challenged mandates might plausibly violate

federal law, stating: “even if these regulations

applied to the conduct at issue here,” App. 12a;

“[e]ven assuming this language applies to

Defendants and their conduct, Congress has limited

the enforcement of the FDCA to public actions,” App.

9a; and “[e]ven if the FWA created such a duty, and

such a duty applied to Defendants,” App. 13a. Still,

the panel would not defer to the authority of its

coequal constitutional partners to even consider

whether

the

state

policy

infringed

upon

Congressional authority.

The panel’s opinion casts the state as sovereign

and the federal government as the stepstool, turning

Jacobson on its head, effectively ruling that once a

state invokes “public health,” federal statutes,

regulations, and binding agreements governing the

administration of investigational drugs become

irrelevant, and a court’s only inquiry is limited to

whether the mandate is rationally related to a

legitimate state objective.

The Supremacy Clause commands the opposite

result. It declares that “the Laws of the United

States … shall be the supreme Law of the Land.”

U.S. Const. art. VI, cl. 2. As this Court has

repeatedly held, “States are precluded from

regulating conduct in a field that Congress, acting

within its proper authority, has determined must be

regulated by its exclusive governance,” and “[t]he

State may not pursue policies that undermine federal

– 13 –

law.” Arizona v. United States, 567 U.S. 387, 399, 416

(2012). For more than eighty-five years, since the

FDCA’s enactment in 1938, Congress has occupied

the entire field of unapproved drug regulation, under

its power to regulate interstate commerce, leaving no

room for state intrusion.

The Ninth Circuit’s precedential holding reduces

every Fourteenth Amendment challenge of a state

public health policy to the single, deferential

question: whether the “mandate … has a real or

substantial relation to the protection of public

health,”26 while pointedly refusing to inquire whether

the policy is a legitimate exercise of the state’s police

power. App. 19a. The panel thereby places

Petitioners in an impossible position: to claim that

the right to refuse an investigational drug is a

fundamental right they must prove as both “deeply

rooted in this Nation’s history and tradition” and

“implicit in the concept of ordered liberty,” such that

“neither liberty nor justice would exist if [it] were

sacrificed,” Washington v. Glucksberg, 521 U.S. 702,

721 (1997). Yet the Ninth Circuit voids all such

arguments the instant Respondents utter the words

“public health.”

This ruling directly contradicts the federal

government’s determination that protecting public

health requires preserving the unfettered right to

refuse investigational medical treatments without

incurring a penalty or losing an otherwise-entitled

benefit. The Ninth Circuit’s refusal to apply the

Jacobson framework rests not on law, but on its own

policy preferences.

26 The Ninth Circuit referenced this Court’s opinion in Biden v.

Missouri, 595 U.S. 87, 93 (2022) to imply that this Court has

affirmed the right of states to mandate investigational medical

treatments, despite no such facts presented in that case. App. 24a.

– 14 –

II. Respondents’ mandates were not a

legitimate exercise of state police power.

Petitioners expressly alleged that “[n]o person

has the legal authority to require another person to

inject an unlicensed investigational drug into their

body as a condition to earn, receive, or enjoy a

privilege of the State or conduct commerce, including

employment.”27 Respondents never disputed this

allegation at any stage of the litigation, and the

district court never rejected it. Only the Ninth

Circuit, acting sua sponte and without any prompting

from the parties, invented a defense on the

Respondents’ behalf, effectively ruling that it has

been definitively resolved under Jacobson that

governments can require Americans to accept the

administration of investigational drugs under threat

of penalty.

The Ninth Circuit engaged in improper factfinding and premature merits adjudication at the

Rule 12(b)(6) stage. The panel dismissed Petitioners’

allegations concerning federal statutes, regulations,

and binding agreements by recharacterizing them as

imposing only “merely precatory obligation[s] on the

government” that “do not create enforceable rights.”

App. 8a. In so doing, the court ignored the expressly

mandatory language — “must,” “ensure,” “shall,”

“obtain,” and “require” — that appears throughout

Petitioners’ cited authorities. Such language imposes

ministerial, nondiscretionary obligations, not mere

hortatory suggestions, that can lead to claims of

entitlement upon full discovery.

By reframing these expressly mandatory federal

mandates as mere precatory suggestions, the Ninth

27 ECF No. 8 ¶ 28

– 15 –

Circuit committed a separation-of-powers violation

by judicially implying that such sources of authority

are not binding federal mandates but rather mere

suggestions for Respondents to consider. The panel

compounded the violation by affirmatively holding —

without any discovery or factual development — that

those sources of federal authority create no private

right of action, despite not having an informed

understanding of the matters of first impression that

would arise from discovery. At the pleading stage,

the court was constitutionally required to accept

Petitioners’ factual allegations as true and draw all

reasonable inferences in their favor. Instead, it

resolved contested questions of statutory and

contractual interpretation against Petitioners and

effectively found facts outside the pleadings —

precisely the type of improper appellate fact-finding

and premature merits adjudication that violates Rule

12(b)(6) and this Court’s precedents under Bell

Atlantic Corp. v. Twombly (2007) and Ashcroft v.

Iqbal, 556 U.S. 662 (2009). See also Wroblewski v.

City of Washburn, 965 F.2d 452 (7th Cir. 1992)

(“[t]he rational basis standard … cannot defeat the

plaintiff’s benefit of the broad Rule 12(b)(6) standard.

The latter standard is procedural, and simply allows

the plaintiff to progress beyond the pleadings and

obtain discovery, while the rational basis standard is

the substantive burden that the plaintiff will

ultimately have to meet to prevail on [a

constitutional] claim.”) (quoting Hishon v. King &

Spalding, 467 U.S. 69, 73 (1984)).

– 16 –

A. The Federal Food, Drug and Cosmetic

Act preempts mandates of investigational

drugs.

The Ninth Circuit’s ruling — that Respondents

may mandate administration of an investigational

drug whenever they subjectively believe it would

protect public health — contains no requirement that

the drug first be authorized by the Secretary of

Health and Human Services (Secretary) under any of

the FDCA’s three statutory exemptions discussed

below. The decision therefore expands to include the

investigational drug classification in general, not

merely those granted Emergency Use Authorization

under 21 U.S.C. § 360bbb-3.

The foundational prohibition of the FDCA states

that “[n]o person shall introduce or deliver for

introduction into interstate commerce any new drug”

unless the Secretary has approved a new-drug

application. 21 U.S.C. § 355(a). Through this

provision and its subsequent amendments, Congress

has exercised its Commerce Clause authority to

occupy the field of regulating the introduction of

unapproved drugs into interstate commerce. States

are therefore precluded from creating exceptions to

this federal ban or intruding upon the Secretary’s

exclusive authority to determine the conditions

under which such drugs may be used.

Congress has created only three narrow,

expressly conditioned exemptions to § 355(a):

(1) The Investigational New Drug pathway, 21

U.S.C. § 355(i), which conditions the exemption

on the sponsor “obtain[ing] … consent” from the

participant (§ 355(i)(4));

(2) Expanded-access (compassionate-use) provisions, § 360bbb, which condition use upon a

– 17 –

licensed physician’s compliance with the

informed-consent requirements of § 355(i)(4), see

§ 360bbb(b)(4) (a “clinical protocol consistent

with the provisions of section” § 355(i)(4) must be

submitted); and

(3) Emergency Use Authorization (EUA), § 360bbb3, which authorizes temporary population-wide

access only when the Secretary “shall ensure”

that potential recipients are informed “of the

option to accept or refuse administration of the

product” § 360bbb-3(e)(1)(A)(ii)(III).

Congress expressly withheld from the Secretary

any power to mandate that an individual participate

in the authorized activity of accepting the

administration of an EUA drug. See § 360bbb-3(l)

(“Nothing in this section provides the Secretary any

authority to require any person to carry out any

activity that becomes lawful pursuant to an

authorization under this section, and no person is

required to inform the Secretary that the person will

not be carrying out such activity”). The Secretary

must, by statute, incorporate the conditions of

voluntary participation and the right to refuse — as

expressly stated in each EUA letter of authorization

— as mandatory terms governing the manufacturer’s

authorization to introduce the investigational drug

into interstate commerce. Respondents possess no

authority to override, interfere with, or nullify those

binding federal conditions.

First, the phrase “obtains … consent” in §

355(i)(4) is mandatory, not precatory; it is an express

condition precedent to lawful use of the drug. Failure

to satisfy that condition renders the administration

unlawful. The same mandatory informed-consent

requirement governs expanded access and EUA

products. These are ministerial, nondiscretionary

– 18 –

duties imposed by Congress, not discretionary

suggestions.

Second, no federal statute, regulation, or

executive agreement authorizes any state official

(including Respondents) to mandate involuntary

administration of a product exempted from § 355(a),

to amend the Secretary’s conditions of authorization,

or to nullify the statutory right of refusal through

penalties or loss of employment. It is firmly

established that, since 1938, Congress has exercised

comprehensive and exclusive authority over the

regulation of drugs in interstate commerce,

preempting conflicting state action. See, e.g.,

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S.

341, 348 (2001); Riegel v. Medtronic, Inc., 552 U.S.

312, 330 (2008); PLIVA, Inc. v. Mensing, 564 U.S.

604, 624 (2011); Abigail Alliance for Better Access to

Developmental Drugs v. von Eschenbach, 495 F.3d

695, 713 (D.C. Cir. 2007) (en banc), cert. denied, 552

U.S. 1159 (2008) (affirming no constitutional right to

unapproved drugs outside the FDCA framework, as

“the FDCA’s comprehensive scheme” occupies the

field).

The Ninth Circuit committed an error of law

when it held that the Governor’s and PeaceHealth’s

subjective belief that the investigational drugs

“would protect public health” authorized their

mandatory administration. App. 18a. By so ruling,

the panel judicially created a fourth, implied

exception to § 355(a) — one Congress has never

enacted — thereby permitting the introduction of

unapproved drugs into interstate commerce for

involuntary use. This is a classic violation of the

separation of powers doctrine. In Rutherford, supra,

this Court expressly rejected the Tenth Circuit’s

attempt to imply an additional exception for terminal

– 19 –

patients, holding “that the ACT makes explicit

provision for carefully regulated use of certain drugs

not yet demonstrated safe and effective reinforces

our conclusion that no exception for terminal

patients may be judicially implied. Whether, as a

policy matter, an exemption should be created is a

question for legislative judgment, not judicial

inference.” Id. at 559. The Court issued a warning

that “federal courts do not sit as councils of revision,

empowered to rewrite legislation in accord with their

own conceptions of prudent public policy.” Id. at 555.

The same principle applies here. States “are

precluded from regulating conduct in a field that

Congress, acting within its proper authority, has

determined must be regulated by its exclusive

governance.” Arizona v. United States, supra, at 399.

Under the FDCA, states cannot enact public health

policies that piggyback on 21 U.S.C. § 355(a)

exemptions to require what Congress explicitly

prohibits — namely, involuntary use of unapproved

medical treatments, nor can they condition the

option to refuse on whether an individual submits a

medical or religious exemption request to exercise

such option. They are completely preempted from

establishing a legal requirement that conflicts with

the FDCA’s voluntary requirement of investigational

drug use, irrespective of the method of exemption

Congress has prescribed.

To circumvent Congress, the Ninth Circuit

inserted a necessity defense on Respondents’ behalf,

stating that “a community has the right to protect

itself against an epidemic of disease which threatens

the safety of its members, [so] a vaccine mandate

that has a real or substantial relation to the

protection of public health is not in palpable conflict

with the Constitution.” App. 18–19a. (quoting

– 20 –

Jacobson, supra, at 27, discussing the necessity

defense). This Court foreclosed precisely that

argument in United States v. Oakland Cannabis

Buyers’ Cooperative, 532 U.S. 483 (2001). There,

patients seeking access to marijuana for medical

purposes contended that “medical necessity” should

be read into the Controlled Substances Act because

necessity was a common-law defense. The Court

rejected the claim outright, explaining that “[u]nder

any conception of legal necessity, one principle is

clear: The defense cannot succeed when the

legislature itself has made a determination of

values.” Id. at 491.

The FDCA embodies exactly such a legislative

value judgment. In Abigail Alliance, the D.C. Circuit

explained the meaning of Oakland Cannabis:

Congress may limit or even eliminate a

necessity defense that might otherwise be

available. That is precisely what the FDCA

has done. Congress has prohibited general

access to experimental drugs, see 21 U.S.C. §

355(a), and has prescribed in detail how

experimental drugs may be studied and used

by the scientific and medical communities,

see id. § 355(i). Given the Supreme Court’s

conclusion that the common law defense of

necessity remains controversial and cannot

override

a

value

judgment

already

determined by the legislature, the common

law doctrine of necessity provides little

support to the Alliance’s proposed right.

Abigail Alliance at 713.

By judicially creating a necessity-based exception

to the FDCA’s mandatory informed-consent and

– 21 –

voluntary-use requirements, the Ninth Circuit

directly contravened this Court’s holding in Oakland

Cannabis and impermissibly elevated its own policy

preferences over Congress’ explicit value-based

judgments.

B. The Public Readiness and Emergency

Preparedness Act expressly preempts

EUA mandates.

The

Public

Readiness

and

Emergency

Preparedness (PREP) Act was enacted as Division C

of the Defense Appropriations Act for Fiscal Year

2006, Pub. L. No. 109-148, 119 Stat. 2818 (Dec. 30,

2005). It amends the Public Health Service Act by

inserting sections 319F-3 and 319F-4, codified at 42

U.S.C. §§ 247d-6d and 247d-6e. The Act erects a

product liability shield, designed to immunize

covered persons from suits and liability for claims

arising from the manufacture, distribution,

administration, or use of designated countermeasures during a declared public health emergency.

Congress vests exclusive authority in the Secretary

to issue declarations specifying the covered

countermeasures, qualified persons, geographic

areas, effective periods, and other conditions

triggering such immunity. See 42 U.S.C. § 247d6d(b).

For purposes of this action, the PREP Act’s

express preemption clause clarifies the proper

application of the Jacobson doctrine, under which

state police powers must yield to federal supremacy.

The clause informs that:

During the effective period of a declaration

under subsection (b) … no State or political

– 22 –

subdivision of a State may establish, enforce,

or continue in effect with respect to a covered

countermeasure any provision of law or legal

requirement that — (A) is different from, or

is in conflict with, any requirement

applicable under this section; and (B) relates

to the…administration by qualified persons

of the covered countermeasure, or to any

matter included in a requirement applicable

to the covered countermeasure under this

section or any other provision of this chapter,

or under the Federal Food, Drug, and

Cosmetic Act [21 U.S.C. 301 et seq.]

42 U.S.C. § 247d-6d(b)(8).

The Secretary’s ministerial duty to ensure that

potential participants are informed of their option to

refuse administration — and to refrain from

mandating use — establishes statutory conditions

applicable to a covered countermeasure that is

introduced into interstate commerce under the

FDCA. Respondents are therefore expressly

preempted from imposing a legal requirement that

conflicts with the FDCA’s option to refuse, which

their respective mandates violate. Therefore, the

scope and extent of the mandates were not legitimate

exercises of police power because they directly

conflicted

with

the

Secretary’s

ministerial

obligations. The Ninth Circuit sidestepped this

allegation by stating that “[t]he Supremacy Clause

itself ‘is not a source of any federal rights’

enforceable under Section 1983.” App. 16a. While

that observation is technically accurate, it is

materially misleading in this context. The

Supremacy Clause establishes that the mandates

were invalid from the outset as preempted exercises

– 23 –

of police power. Because those unlawful mandates

arbitrarily deprived Petitioners of protected property

and liberty interests, the resulting emotional and

economic damages are actionable under 42 U.S.C. §

1983. The panel’s reasoning conflates the source of

the underlying federal prohibition with the separate

constitutional violation redressable through § 1983.

C. Federalwide Assurance and legally

effective informed consent prohibits

involuntary use of investigational drugs.

To safeguard the nation’s due process rights and

fundamental protections for individuals involved in

investigational

medical

treatments,

Congress

enacted the National Research Act (NRA) of 1974,

Pub. L. No. 93-348, 88 Stat. 342 (codified as amended

in scattered sections of 42 U.S.C.). The NRA

amended the Public Health Service Act, including 42

U.S.C. § 289, to require the Executive Branch to

“protect the rights” of individuals offered an

opportunity to use an investigational new drug

through the establishment of Institutional Review

Boards to provide lawful oversight. The right, as

established by the Secretary under Congressional

mandate, is known as legally effective informed

consent. See 45 C.F.R. 46.116(a)(1). Informed consent

is legally effective only when it is voluntary and free

of coercion, undue influence, or unjustifiable pressure

that might compromise the subject’s autonomy.

To ensure compliance with its obligations under

42 U.S.C. § 289(a) to protect the rights of the public,

the Executive Branch established the Federalwide

Assurance (FWA) program requiring any entity

desiring to conduct business with the federal

– 24 –

government to provide written assurance28 to the

Health and Human Services agency that they will, at

minimum, obtain legally effective informed consent

when involving humans with federally funded

investigational

drugs,

including

“cooperative”

agreements, such as the CDC COVID-19 Vaccination

Program. Petitioners alleged that the State of

Washington was under FWA0000032729 and

PeaceHealth operated under FWA00003906,30

binding them to the legally effective informed

consent requirement, even when offering individuals

an opportunity to use an investigational drug

authorized under 21 U.S.C. § 360bbb-3.

The duty to obtain legally effective informed

consent is mandatory, not precatory. It is spelled out

in exacting detail in 45 C.F.R. § 46.116 and

constitutes a condition of performance that expressly

conditions the expenditure of federal funds. See 45

C.F.R. § 46.122. The FWA program likewise requires

strict adherence to the Belmont Report’s core

principle of voluntariness — a requirement to which

the Executive Branch has bound both exempt and

non-exempt activities. See 45 C.F.R. § 46.101(c) and

(i). Thus, the Executive Branch, through the FWA

and 45 C.F.R. Part 46, has given the Belmont

Report’s voluntariness requirement the full force of

federal regulation.

28 See 45 CFR 46.103(a) (entities “shall provide written

assurance satisfactory to the department or agency head that it

will comply with the requirements of this policy.”)

29 ECF No. 8 ¶ 79

30 ECF No. 8 ¶ 138

– 25 –

D. Public and private entities cannot assign

a medical indication to an investigational

drug.

The Ninth Circuit erred when it held that “the

absence of a legal indication does not negate the

obvious inference that the available COVID-19

[investigational] vaccine would be rationally related

to the protection of public health.” App. 25a. The

panel’s opinion rests on impermissible appellate factfinding at the pleading stage.

Under the FDCA, a sponsor (or any person acting

on its behalf) “shall not represent in a promotional

context that an investigational new drug is safe or

effective for the purposes for which it is under

investigation or otherwise promote the drug.” 21

C.F.R. § 312.7(a). Promotion of an unapproved use of

a licensed drug likewise constitutes misbranding

under 21 U.S.C. §§ 331(a), 352(a) and (f). The federal

government has long enforced this prohibition. See,

e.g., Justice Department Announces Largest Health

Care Fraud Settlement in Its History (DOJ Press

Release Number: 09-900, Sept. 2, 2009):31

Under the provisions of the Food, Drug, and

Cosmetic Act, a company must specify the

intended uses of a product in its new drug

application to the FDA. Once approved, the

drug may not be marketed or promoted for

so-called “off-label” uses — i.e., any use not

specified in an application and approved by

FDA.

31

https://www.justice.gov/archives/opa/pr/justice-departmentannounces-largest-health-care-fraud-settlement-its-history (last

visited March 4, 2025)

– 26 –

Secretary Becerra, acting under congressional

mandate, required Respondents under each EUA to

“conspicuously” state that the products have “not

been approved or licensed by the FDA.”32 This

resulted from the FDA informing Respondents that

the subject drug “is an investigational vaccine not

licensed for any indication.”33

Under the FDCA, states are preempted from

promoting a drug, biologic, or device for any use not

authorized by its approved labeling. See 21 U.S.C. §

352. Recipients of EUA products must be informed of

the product’s known and potential risks and benefits

based solely on the Secretary’s determinations

resulting from incomplete clinical trials. Such determinations do not provide a state any authority to

claim that the drug “will,” “would,” or “can” prevent

disease transmission. Because the FDCA expressly

forbids promotion of unapproved uses, a state’s subtive belief that an investigational product will protect

public health cannot supply a legitimate state

interest for rational-basis review, because such

promotion infringes upon the FDA’s exclusive

authority to make such determinations and constitutes the criminal act of misbranding. See 21

U.S.C. § 331.

Most troubling is the panel’s additional act of

improper appellate fact-finding based on phrases

with unknown meanings, which created a binding

precedent that, because the investigational drugs

share the same “medical formulation” (unknown

meaning) as an FDA-approved vaccine, “there is no

material distinction” between the refusal of a

licensed vaccine and Petitioners’ refusal of an

32 ECF No. 8-4, FDA EUA letter to Pfizer, Inc., Dec. 11, 2020.

33 ECF No.8 ¶¶ 30–32

– 27 –

investigational drug that is “clinically identical”

(unknown meaning) to one. App. 18a. The panel’s

assertion is nonsensical, as the entire litigation is

about the material legal differences between

investigational and approved drugs. The panel

nowhere defines “clinically identical,” cites no

authority for the assertion, and fails to explain how

this extra-record “fact” overrides the FDCA’s labeling

and status-based regulatory scheme.

Federal rights and obligations under the FDCA

are governed exclusively by a product’s labeling and

regulatory classification — not its molecular

composition. The FDA regulates approximately

19,000 approved drugs in the U.S. marketplace,

many of which are manufactured, labeled, and

administered for investigational purposes under

distinct statutory regimes. A biologic is licensed only

when it meets the conditions prescribed under 42

U.S.C. § 262. The Ninth Circuit judicially implied an

exception from 42 U.S.C. § 262(a)(1) to permit public

and private entities to treat unapproved biologics as

if they are approved when they are supposedly

“clinically identical.” Further, a manufacturer is not

required to maintain its approved formulation under

an investigational drug label, since its purpose is

experimental. Factually, Pfizer informed the CDC

that it never manufactured any vials of its original

licensed formulation.34

The panel created binding precedent for the

Ninth Circuit, that investigational drugs deemed

“clinically identical” in formulation to an FDAapproved product are legally identical for all

regulatory purposes under the FDCA — and that this

34

See https://www.cdc.gov/vaccines/programs/iis/downloads/Pre

view-Posting-of-COVID-19-Vaccine-Codes-and-Crosswalk-20230

228.xlsx

– 28 –

equivalence supplies states with a legitimate exercise

of police power to mandate their administration,

even when such mandates directly contradict the

product’s approved labeling and federal prohibitions.

This unprecedented judicial legislation injects

profound uncertainty into the multi-trillion-dollar

pharmaceutical industry and operates as a green

light for public and private persons to misbrand

pharmaceutical products (a federal crime).

III. Jacobson does not foreclose an individual’s

right to refuse an investigational new drug.

A.

Individuals possess a fundamental

right to bodily integrity.

It was irrational for the Ninth Circuit,

confronting matters of first impression, to foreclose

Petitioners’ claims by relying on Jacobson — a

decision rendered 120 years earlier that could not

possibly have considered the federal statutes,

regulations, and binding agreements on which those

claims rest, none of which had yet been enacted by

Congress.

The Ninth Circuit held that when claiming a

right is fundamental, Petitioners “must therefore

articulate a ‘careful description’ of a fundamental

right,” citing Stormans, Inc. v. Wiesman, 794 F.3d

1064, 1085 (9th Cir. 2015). App. 17a. However, the

Wiesman court dismissed plaintiff’s claims because

the plaintiffs’ asserted right not to take life was too

broad. This is not the case here, as the court correctly

identified Petitioners’ narrow and specific claim that

they allege a “substantive due process right ‘to refuse

unwanted investigational drugs.’” App. 17a.

Furthermore, Petitioners supplied a half-century of

– 29 –

federal acts prohibiting the use of investigational

drugs, aptly demonstrating at the pleading stage

sufficient “probative weight” to survive a Rule

12(b)(6) dismissal.

Space in this petition does not permit a full

exposition of how deeply rooted in this Nation’s

history and tradition — and implicit in the concept of

ordered liberty — the right to refuse investigational

medical treatments has become since Jacobson, such

that “neither liberty nor justice would exist if [it]

were sacrificed.” Washington v. Glucksberg, supra.

Nevertheless, because the federal government

exclusively determines the conditions under which

investigational drugs may be used prior to FDA

approval, and because Congress has expressly

mandated the protection of individual rights in such

use under 42 U.S.C. § 289 — a mandate the

Executive Branch has implemented through 45

C.F.R. Part 46 and made contractually binding via

the Federalwide Assurance — the right to refuse

stands on exceptionally strong constitutional footing.

It is difficult to conceive how the right could be

more deeply rooted to qualify as fundamental under

the Due Process Clause. This right should be

developed through discovery and full adversarial

briefing, not be categorically foreclosed at the

pleading stage by a 120-year-old decision that

predates the modern federal framework.

This Court has repeatedly recognized that the

right to bodily integrity and the right to refuse

unwanted medical treatment lie at the core of

substantive due process. See Cruzan v. Director,

Missouri Dep’t of Health, 497 U.S. 261, 273 (1990);

Washington v. Glucksberg, supra; Albright v. Oliver,

510 U.S. 266, 272 (1994). It is untenable to hold, on

the one hand, that individuals have no constitutional

– 30 –

right to access investigational drugs outside the

FDCA framework because it might harm them

(Rutherford, supra; Abigail Alliance, supra), while

holding, on the other, that healthy individuals may

be compelled to receive investigational drugs that

might result in irreparable harm — with no right to

judicial redress if injured. Such a rule, if allowed to

become binding precedent, would eviscerate the

FDCA’s protective regime and render the right to

bodily integrity illusory.

The regulatory framework described hereto,

authorizing the use of investigational drugs, all of

which require voluntary use, together establish a

uniform congressional command that no investigational drug may ever be administered except on a

fully informed and voluntary basis. The language is

classically rights-creating: it uses mandatory “shall”

directives and speaks directly to the benefit conferred

on identified individuals (“each individual,” “the

person,” “individuals to whom the product is

administered,” “any person”), creating a concrete

entitlement — the option to refuse — that no

governmental actor may override. Congress’s

command functions as a statutory Miranda warning

for investigational drugs. Just as Miranda v.

Arizona, 384 U.S. 436 (1966), requires law

enforcement to inform a suspect of the right to

remain silent and ensures that any waiver is “the

product of a free and deliberate choice rather than

intimidation, coercion, or deception,” Berghuis v.

Thompkins, 560 U.S. 370, 382–83 (2010), the FDCA

requires the government to inform every potential

recipient of the right to refuse an investigational

drug and prohibits coercive pressure that would

destroy the meaningful exercise of that right.

Under 42 U.S.C. § 289, Congress imposes a

– 31 –

ministerial obligation on the Executive Branch to

ensure the public’s rights are protected, and the

Executive Branch enforces that mandate through its

FWA program. The duty to obtain “legally effective

informed consent” confers upon the potential

recipient the right not to be pressured or punished

for refusing, which duty establishes a “legitimate

claim of entitlement” to grant or withhold consent —

a property interest protected by the Due Process

Clause. See Cruzan at 270 (“the logical corollary of

the doctrine of informed consent is that the patient

generally possesses the right not to consent, that is,

to refuse treatment.”); Board of Regents v. Roth, 408

U.S. 564, 577 (1972); Perry v. Sindermann, 408 U.S.

593, 601 (1972). When Respondents conditioned

Petitioners’ employment and licensure on surrender

of that statutorily guaranteed option, they deprived

Petitioners of a right secured by federal law, which

42 U.S.C. § 1983 provides a private right of action to

redress. Health & Hospital Corp. v. Talevski, 599

U.S. 166, 183–84 (2023).

B. The PREP Act implicates the Due

Process Clause.

This Court has long held that “the hallmark [of]

property ... is an individual entitlement grounded in

state law, which cannot be removed except for cause.”

Logan v. Zimmerman Brush Co., 455 U.S. 422, 430

(1982). See also Board of Regents v. Roth at 577.

Specifically, this Court has recognized that a cause of

action is a species of property protected by the

Fourteenth Amendment’s Due Process Clause. See

Logan at 428. In fact, this Court, as far back as 1882,

held that a “vested right of action is properly in the

same sense in which tangible things are property,

– 32 –

and is equally protected from arbitrary interference.”

Pritchard v. Norton, 106 U.S. 124, 132 (1882).

Because a cause of action is a species of property

protected by the Fourteenth Amendment, any state

action that substantially interferes with an

individual’s claims or precludes his or her

opportunity to be heard violates procedural due

process. Mullane v. Central Hanover Bank & Trust

Co., 339 U.S. 306, 314 (1988); Barrett v. United

States, 689 F.2d 324, 322 (2d Cir. 1982).

Petitioners expressly alleged a Constitutional

right to refuse covered countermeasures under the

PREP Act because the Act’s grant of immunity from

tort liability necessarily forces individuals to

prospectively waive their constitutional right to seek

judicial remedies for any injury caused by the

countermeasure, its administration, or any causally

connected activity. The Ninth Circuit sidestepped

this allegation entirely by raising and resolving an

issue no party had presented: the supposed “limit on

the Congressional power to grant immunity.” App.

20a.

To mandate the use of a PREP Act-covered

countermeasure is, by definition, to compel a

prospective waiver of due-process rights. A waiver

must be “the product of a free and deliberate choice

rather than intimidation, coercion, or deception.”

Berghuis v. Thompkins, at 382–83. The state may not

accomplish indirectly what it is constitutionally

forbidden to do directly. See Speiser v. Randall, 357

U.S. 513 (1958); Bailey v. Alabama, 219 U.S. 219

(1911). When a complaint plausibly alleges the

infringement of a fundamental right, the court must

apply strict scrutiny even at the pleading stage. The

mandate at issue is precisely such an infringement:

it conditions Petitioners’ effective use of a state-

– 33 –

issued medical license and other state-conferred

benefits under the CDC Program on the surrender of

a fundamental right inherent to the use of PREP Act

countermeasures. Because this allegation alone is

dispositive, the panel’s refusal to address it

constitutes reversible error.

IV. The Ninth Circuit violated the principle

of party presentation.

“In our adversarial system of adjudication, we

follow the principle of party presentation.” United

States v. Sineneng-Smith, 590 U. S. 371, 375 (2020).

The parties “‘frame the issues for decision,’” while the

court serves as “‘neutral arbiter of matters the

parties present.’” Ibid. (quoting Greenlaw v. United

States, 554 U. S. 237, 243 (2008)). As this Court put

it in Clark v. Sweeney, 607 U.S. 7, 9 (2025), “courts

‘call balls and strikes’; they don’t get a turn at bat.”

(quoting Lomax v. Ortiz-Marquez, 590 U. S. 595, 599

(2020)).

Petitioners expressly alleged a constitutional

right to work within the state’s licensed healthcare

industry without that right being conditioned on the

administration of investigational drugs or the

coerced waiver of due-process protections when

confronted with a PREP Act-covered countermeasure. Respondents did not dispute this

allegation, nor did the district court dismiss the case

on the ground that Petitioners did not hold such a

right. On appeal, the Ninth Circuit transformed the

case and sua sponte invoked Jacobson — a decision

issued decades before the modern FDCA framework

— to declare that no fundamental right to refuse

investigational drugs exists and to argue a necessity

defense on Respondents’ behalf, to which the Court

– 34 –

did not provide Petitioners an opportunity to

respond. Neither party had briefed or argued that

Jacobson categorically forecloses such a right.

Respondents had never contested the right, never

claimed authority to override it, and never asserted

that investigational drug mandates would advance a

legitimate state interest sufficient to defeat it. By

resolving this sweeping constitutional question on its

own initiative, the Ninth Circuit violated the party

presentation principle.

Compounding the error, the panel announced a

novel, “clinically identical” doctrine that Congress

never enacted. The Ninth Circuit’s combination of

sua sponte constitutional innovation and premature

merits adjudication under Rule 12(b)(6) is precisely

the sort of “drastic[]” departure from proper judicial

procedure that this Court has condemned. SinenengSmith, supra, at 379. By judicially creating a fourth,

implied exception to 21 U.S.C. § 355(a) that Congress

never enacted, and by rendering the Executive

Branch powerless to enforce its congressional

mandates under 42 U.S.C. § 289, the panel engaged

in legislative, not adjudicative, action. The Ninth

Circuit’s use of its own sua sponte legal theory was a

violation of Petitioners’ Due Process rights.

The following ten cases, involving hundreds of

plaintiffs represented by undersigned counsel, are

poised to petition this Court or are working their way

through the Ninth Circuit. They all involve nearly

identical legal issues as those identified herein, and

have or will be impacted by, the Ninth Circuit’s

ruling in this case:

•

Horsley v. Kaiser Found. Hosps., Inc., No. 245812 (9th Cir. Nov. 17, 2025). See No. 25A880.

– 35 –

•

•

•

•

•

•

•

•

•

Boysen v. PeaceHealth, No. 24-5204 (9th Cir. Dec.

3, 2025). See No. 25A910.

Roberts v. Inslee, No. 24-1949 (9th Cir, Dec. 10,

2025). See No. 25A911.

Brock v. City of Bellingham, No. 25-1070 (9th

Cir, pending oral argument).

Martinez v. Eastside Fire & Rescue, No. 25-5982

(9th Cir., briefing in progress).

Schroeder v. LAUSD, No. 2:23-CV-10307 (C.D.

Cal., awaiting ruling on motion to dismiss).

Abrigo v. Kaiser Foundation Hospitals, No. 252154 (9th Cir, stayed pending instant Curtis v.

Inslee petition).

Wilson v. Kaiser Foundation, No. 2:24-cv-2142

(W.D. Wash., stayed pending instant Curtis v.

Inslee petition).

McMahon v. City of Los Angeles, No. 25-6872

(9th Cir, stayed pending instant Curtis v. Inslee

petition).

Edwards v. County of Los Angeles, No. 2:24-cv1736 (C.D. Cal., stayed pending instant Curtis v.

Inslee petition).

V. Dismissal with prejudice was an abuse

of discretion.

Federal Rule of Civil Procedure 15(a)(2) directs

that “the court should freely give leave [to amend]

when justice so requires.” This Court has repeatedly

emphasized that this mandate reflects the

fundamental principle that pleading is not “a game of

skill” in which a single misstep should decide the

outcome, but rather a means “to facilitate a proper

decision on the merits.” Foman v. Davis, 371 U.S.

178, 181–82 (1962). Accordingly, dismissal with

prejudice on the first Rule 12(b)(6) motion — without

– 36 –

granting at least one opportunity to amend35 — is

strongly disfavored and ordinarily constitutes an

abuse of discretion unless the complaint is incurably

defective and amendment would be futile. Id. at 182.

Here, the district court abused its discretion by

resolving the central factual dispute — whether

FDA-approved COVID-19 drugs were available in the

marketplace — at the pleading stage, notwithstanding judicially noticeable documents from the

Executive Branch and Pfizer, Inc. confirming that no

such approved products existed. The Ninth Circuit

compounded this error by affirming the dismissal

with prejudice, not on the grounds presented to the

district court, but on a novel legal theory the panel

itself advanced sua sponte. The outright denial of any

opportunity to amend, particularly in light of the

lower courts’ errors, constitutes an abuse of

discretion that violates this Court’s settled

precedents favoring liberal amendment to reach the

merits.

CONCLUSION

Petitioners respectfully request that the Court

grant the petition for a writ of certiorari.

35 The first Amended Complaint was filed at the court’s

direction, not at Petitioners’ request.

– 37 –

Respectfully submitted,

DAVID J. SCHEXNAYDRE

SCHEXNAYDRE LAW FIRM, LLC

2895 Hwy 190, Ste. 212

Mandeville, LA 70471

(985) 292-2020

david@schexnaydre.com

Counsel for Petitioners