Amicus Curiae Brief — Eli Lilly and Company, Petitioner v. United States, et al., ex. rel., Ronald J. Streck

No. 25-1126

In the

Supreme Court of the United States

ELI LILLY AND COMPANY,

Petitioner,

v.

UNITED STATES, et al., ex rel. RONALD J. STRECK,

Respondent.

On Petition for Writ of Certiorari to the U.S.

Court of Appeals for the Seventh Circuit

BRIEF OF AMICUS CURIAE THE CHAMBER OF

COMMERCE OF THE UNITED STATES OF

AMERICA IN SUPPORT OF PETITIONER

MICHAEL H. MCGINLEY

BRIAN A. KULP

DECHERT LLP

Cira Centre

2929 Arch Street

Philadelphia, PA 19104

ANDREW R. VARCOE

MARIEL A. BROOKINS

U.S. CHAMBER

LITIGATION CENTER

1615 H Street, NW

Washington, DC 20062

STEVEN A. ENGEL

Counsel of Record

DECHERT LLP

1900 K Street, NW

Washington, DC 20006

(202) 261-3369

steven.engel@dechert.com

Counsel for Amicus Curiae

April 27, 2026

i

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ...................................... iii

INTEREST OF AMICUS CURIAE ............................ 1

INTRODUCTION

AND

SUMMARY

OF

ARGUMENT ............................................................ 2

ARGUMENT ............................................................... 4

I. This Court Should Grant Certiorari to Settle

the Constitutionality of the False Claims Act’s

Qui Tam Provisions .............................................. 4

A. The Qui Tam Provisions Violate Article II’s

Vesting Clause ................................................. 5

B. The Qui Tam Provisions Violate the

Appointments Clause ...................................... 7

C. The Qui Tam Provisions Violate the Take

Care Clause .................................................... 11

D. History Cannot Salvage the Qui Tam

Provisions’ Affront to Article II...................... 13

1. Abuses in Early English Qui Tam

Practice Led to its Decline ....................... 14

2. Early Congressional Laws Do Not

Support Qui Tam’s Constitutionality ...... 15

3. The False Claims Act Revived an

Unconstitutional Practice ........................ 17

II. The Seventh Circuit’s Distorted Scienter

Standard Also Warrants Review ........................ 19

A. A Rigorous Scienter Standard is Critical for

Cabining Punitive Liability ........................... 19

ii

B. A Rigorous Scienter Standard is Critical for

Ensuring Fair Notice ..................................... 22

CONCLUSION ......................................................... 25

iii

TABLE OF AUTHORITIES

Page(s)

Cases

Buckley v. Valeo,

424 U.S. 1 (1976) ............................................... 7-9

Cheek v. United States,

498 U.S. 192 (1991) ............................................ 21

Confiscation Cases,

74 U.S. 454 (1869) ................................................ 7

Dep’t of Transp. v. Ass’n of Am. R.R.,

575 U.S. 43 (2015) .......................................... 9, 11

Edmond v. United States,

520 U.S. 651 (1997) .............................................. 9

FCC v. Fox TV Stations, Inc.,

567 U.S. 239 (2012) ............................................ 22

Free Enter. Fund v. PCAOB,

561 U.S. 477 (2010) .................................. 2, 10, 24

Freytag v. Commissioner,

501 U.S. 868 (1991) .......................................... 3, 9

Heckler v. Chaney,

470 U.S. 821 (1985) ............................................ 13

In re Aiken County,

725 F.3d 255 (D.C. Cir. 2013) ............................. 12

King v. Burnell,

Carth. 478 (K.B. 1700) ......................................... 8

Kisor v. Wilkie,

588 U.S. 558 (2019) ............................................ 23

iv

Marsh v. Chambers,

463 U.S. 783 (1983) ............................................ 16

Martin v. Hunter’s Lessee,

14 U.S. 304 (1816) ................................................ 6

Morrison v. Olson,

487 U.S. 654 (1988). ........................................... 11

N.Y. State Rifle & Pistol Ass’n v. Bruen,

597 U.S. 1 (2022) ...................................... 3, 13, 16

Printz v. United States,

521 U.S. 898 (1997) ............................................ 12

Rehab. Ass’n of Va., Inc. v. Kozlowski,

42 F.3d 1444 (4th Cir. 1994)............................... 20

Riley v. St. Luke’s Episcopal Hosp.,

252 F.3d 749 (5th Cir. 2001)......................... 10, 15

Robertson v. United States ex rel. Watson,

560 U.S. 272 (2010) .............................................. 5

Seila Law LLC v. CFPB,

591 U.S. 197 (2020) .................................. 6, 10, 17

Springer v. Gov. of Philippine Islands,

277 U.S. 189 (1928) ............................................ 10

TransUnion LLC v. Ramirez,

594 U.S. 413 (2021) ............................................ 12

United States ex rel. Farmer v. City of Houston,

523 F.3d 333 (5th Cir. 2008)............................... 20

United States ex rel. Hunt v.

Cochise Consultancy, Inc.,

887 F.3d 1081 (11th Cir. 2018) ............................. 6

United States ex rel. Kelly v. Boeing Co.,

9 F.3d 743 (9th Cir. 1993)..................................... 6

v

United States ex rel. Milam v.

Univ. of Tex. M.D. Anderson Cancer Ctr.,

961 F.2d 46 (4th Cir. 1992)............................. 3, 18

United States ex rel. Owens v. First Kuwaiti

Gen. Trading & Contracting Co.,

612 F.3d 724 (4th Cir. 2010)............................... 20

United States ex rel. Polansky v.

Exec. Health Res., Inc.,

599 U.S. 419 (2023) .............................. 2, 3, 15, 17

United States ex rel. Purcell v. MWI Corp.,

807 F.3d 281 (D.C. Cir. 2015) ............................. 23

United States ex rel. Schutte v. SuperValu Inc.,

598 U.S. 739 (2023) ................................. 19-21, 24

United States ex rel. Streck v. Allergan, Inc.,

746 F. App’x 101 (3d Cir. 2018) .......................... 23

United States ex rel. Zafirov v.

Fla. Med. Assocs., LLC,

751 F. Supp. 3d 1293

(M.D. Fla. 2024) ............................... 10, 11, 16, 18

United States v. Comstock,

560 U.S. 126 (2010) ............................................ 15

United States v. Germaine,

99 U.S. 508 (1878) .............................................. 10

United States v. McNinch,

356 U.S. 595 (1958) ............................................ 17

United States v. Nixon,

418 U.S. 683 (1974) .............................................. 7

United States v. Prigmore,

243 F.3d 1 (1st Cir. 2001) ................................... 21

vi

United States v. Texas,

599 U.S. 670 (2023) ............................................ 13

Universal Health Servs., Inc. v.

United States ex rel. Escobar,

579 U.S. 176 (2016) ........................................ 4, 20

Vt. Agency of Nat. Res. v.

United States ex rel. Stevens,

529 U.S. 765 (2000). ......................... 10, 14, 15, 19

Walz v. Tax Comm’n of City of New York,

397 U.S. 664 (1970) ............................................ 13

Constitutional Provisions

U.S. Const. art. II, § 1, cl. 1 .................................... 2, 6

U.S. Const. art. II, § 2, cl. 2 .................................... 3, 7

U.S. Const. art. II, § 3 .......................................... 2, 13

Statutes

31 U.S.C. § 3729(a)(1) ................................................. 8

31 U.S.C. § 3729(a)(1)(A) .......................................... 19

31 U.S.C. § 3729(b)(1)(A) .......................................... 19

31 U.S.C. § 3730 ....................................................... 11

31 U.S.C. § 3730(b)(1) ................................................. 8

31 U.S.C. § 3730(c)(1) ............................................... 10

42 U.S.C. § 1396r-8(k)(1)(A) ..................................... 23

Act of Apr. 30, 1790, ch. 9, §§ 16-17,

1 Stat. 112........................................................... 17

Act of Mar. 2, 1863, ch. 67, § 4, 12 Stat. 696 ........... 18

vii

Other Authorities

J. Randy Beck, The False Claims Act and

the English Eradication of Qui Tam

Legislation, 78 N.C. L. Rev. 539 (2000) ....... 14, 15

John T. Bentivoglio et al., False Claims Act

Investigations: Time for a New Approach?,

3 Fin. Fraud L. Rep. 801 (2011) ......................... 22

1 William Blackstone, Commentaries on the

Laws of England (1765) ................................... 6, 7

3 William Blackstone, Commentaries on the

Laws of England (1768) ....................................... 6

4 William Blackstone, Commentaries on the

Laws of England (1769) ....................................... 5

James T. Blanch, The Constitutionality of the

False Claims Act’s Qui Tam Provision, 16

Harv. J.L. & Pub. Pol’y 701 (1993) ...................... 9

Todd J. Canni, Who’s Making False Claims,

the Qui Tam Plaintiff or the Government

Contractor?, 37 Pub. Cont. L.J. 1 (2007) ........... 22

3 Sir Edward Coke, Institutes of the Laws of

England (4th ed. 1797) ...................................... 15

Cong. Globe, 37th Cong., 3d Sess. 956 (1863) ......... 18

Constitutionality of the Qui Tam Provisions of

the False Claims Act, 13 Op. O.L.C. 207

(1989) ........................................ 2, 3, 13, 14, 16, 18

Edward S. Corwin, The President: Office and

Powers 1787-1957 (4th ed. 1957) ......................... 8

2 Timothy Cunningham, A New and Complete

Law-dictionary (1765) .......................................... 8

viii

Sean Elameto, Guarding the Guardians:

Accountability in Qui Tam Litigation

Under the Civil False Claims Act,

41 Pub. Contract L.J. 813 (2012) ....................... 22

4 William S. Holdsworth, A History of English

Law (1924) .................................................... 14, 15

Harold J. Krent, Executive Control over

Criminal Law Enforcement: Some Lessons

from History, 38 Am. U. L. Rev. 275

(1989) .................................................................. 17

8 Legal Observer No. 204 (1834).............................. 14

Letter from James Madison to President

Monroe (Dec. 27, 1817), in 3 Letters and

Other Writings of James Madison 54 (J.B.

Lippincott & Co. 1867) ....................................... 17

John Locke, Two Treatises on Civil

Government (George Routledge & Sons

ed., 1884) .......................................................... 5, 6

Floyd R. Mechem, A Treatise on the Law of

Public Offices and Officers (1890) ....................... 9

Zachary S. Price, Enforcement Discretion and

Executive Duty, 67 Vand. L. Rev. 671

(2014) .................................................................. 12

S. Rep. No. 99-345 (1986) ......................................... 18

The Federalist No. 29 (Alexander Hamilton)

(Clinton Rossiter ed., 2003) ................................. 9

The Federalist No. 47 (James Madison)

(Clinton Rossiter ed., 2003) ............................... 11

ix

The Federalist No. 72 (Alexander Hamilton)

(Clinton Rossiter ed., 2003) ................................. 9

U.S. Dep’t of Justice, Fraud Statistics—Overview

(Jan. 16, 2026), bit.ly/3LNm8yE........................ 18

2 Noah Webster, American Dictionary of the

English Language (1828) ..................................... 8

Ann Woolhandler & Caleb Nelson, Does

History Defeat Standing Doctrine?, 102

Mich. L. Rev. 689 (2004)..................................... 16

1

INTEREST OF AMICUS CURIAE1

The Chamber of Commerce of the United States of

America (“Chamber”) is the world’s largest business

federation.

It represents approximately 300,000

members and indirectly represents the interests of

more than three million companies and professional

organizations of every size, in every industry sector,

and from every region of the country. An important

function of the Chamber is to represent the interests

of its members in matters before Congress, the

Executive Branch, and the courts. To that end, the

Chamber regularly files amicus curiae briefs in cases,

like this one, that raise issues of concern to the

nation’s business community.

In recent years, profit-driven relators have abused

the False Claims Act’s (“FCA”) qui tam mechanism.

That abuse has exacted a substantial economic toll on

businesses nationwide, and the Chamber has a

significant interest in preventing such harm to its

members. It thus submits this brief to explain how qui

tam litigation violates Article II—and to show why the

Court of Appeals’ distortion of the FCA’s scienter

standard, which warrants this Court’s review in its

own right, magnifies those constitutional concerns.

No counsel for any party authored this brief in whole or in part

and no entity or person, aside from amicus curiae, its members,

or its counsel, made any monetary contribution intended to fund

this brief ’s preparation or submission. Counsel for all parties

received timely notice of the intention to file this brief.

1

2

INTRODUCTION AND

SUMMARY OF ARGUMENT

This case is a prime candidate for review. Three

Members of this Court have already recognized there

are “substantial arguments that the qui tam device is

inconsistent with Article II.” United States ex rel.

Polansky v. Exec. Health Res., Inc., 599 U.S. 419, 449

(2023) (Thomas, J., dissenting); see id. at 442

(Kavanaugh, J., joined by Barrett, J., concurring).

And this profoundly important question has now

percolated for nearly 40 years. Shortly after the 1986

FCA amendments “resuscitat[ed] the dormant qui tam

device,” the Department of Justice’s Office of Legal

Counsel concluded that this private enforcement

scheme

is

“patently

unconstitutional.”

Constitutionality of the Qui Tam Provisions of the

False Claims Act, 13 Op. O.L.C. 207, 209, 238 (1989)

(William Barr, Ass’t A.G.) (hereafter, “Barr Memo”).

Since then, lower court judges have exhaustively aired

out the arguments on both sides.

This Court should settle the issue and hold qui tam

litigation unconstitutional. Article II’s text leaves no

doubt on this score. It vests all “executive Power” in

one elected President, who is singularly charged with

“tak[ing] Care that the Laws be faithfully executed.”

U.S. Const. art. II, §§ 1, 3. The Framers adopted that

unitary structure to promote accountability and

ensure that “a President chosen by the entire Nation”

would “oversee the execution of the laws.” Free Enter.

Fund v. PCAOB, 561 U.S. 477, 499 (2010). In addition,

they “carefully husband[ed] the appointment power”

to hold the President responsible for the “‘Officers of

the United States’” who wield executive Power in his

3

name. Freytag v. Commissioner, 501 U.S. 868, 881-84

(1991) (quoting U.S. Const. art. II, § 2, cl. 2).

The FCA runs roughshod over these safeguards. It

vests unaccountable bounty hunters with substantial

executive Power to litigate for the United States. And

it enables these “relators” to bypass the Appointments

Clause and “self-appoint[]” themselves into a “private

attorney general” role. United States ex rel. Milam v.

Univ. of Tex. M.D. Anderson Cancer Ctr., 961 F.2d 46,

48-49 (4th Cir. 1992).

Article II forbids such

privatization of the President’s Take Care charge.

The “primary counterargument” for upholding the

FCA’s qui tam provisions emphasizes qui tam’s

“historical pedigree.” Polansky, 599 U.S. at 450

(Thomas, J., dissenting).

But the “adoption or

acceptance of laws that are inconsistent with the

original meaning of the constitutional text”—even

laws passed near the Founding—“cannot overcome or

alter that text.” N.Y. State Rifle & Pistol Ass’n v.

Bruen, 597 U.S. 1, 36 (2022) (citation omitted). And

qui tam’s historical roots are limited at best. The

practice “rapidly fell into disfavor” with the

establishment of the Executive Branch. Barr Memo

235. Then, when the Civil War Congress revived qui

tam decades later with the original FCA, the practice

quickly fell into desuetude once again. Such scattered

historical episodes cannot excuse the manifest conflict

between the modern FCA’s qui tam provisions and

Article II’s text.

Settling qui tam’s constitutionality is reason

enough to grant certiorari. Yet this case illustrates

just how badly relator-driven enforcement has jumped

the tracks. The government told Petitioner Eli Lilly

4

and Company (“Lilly”) to make “reasonable

assumptions” about how to interpret a byzantine set

of Medicaid regulations.

Lilly followed those

commands, repeatedly disclosed its assumptions, and

the government never questioned them. But a serial

relator, motivated by profit, took matters into his own

hands. He sought to recover massive penalties on the

government’s behalf—for fraud no less—based on

Lilly’s following the government’s instructions. And

the Seventh Circuit watered down the FCA’s

“rigorous” scienter requirement to reward that effort.

Universal Health Servs., Inc. v. United States ex rel.

Escobar, 579 U.S. 176, 192 (2016). That ruling flouts

our legal system’s commitment to fair notice and due

process, and allowing it to persist will only encourage

further qui tam overreach.

This Court should grant certiorari to review both

questions presented.

ARGUMENT

I. This Court Should Grant Certiorari to Settle

the Constitutionality of the False Claims

Act’s Qui Tam Provisions.

The FCA’s qui tam provisions violate Article II

several times over. They empower self-appointed

private persons to litigate on behalf of the United

States, in violation of Article II’s Vesting Clause and

the Appointments Clause. And they usurp both the

President’s prosecutorial discretion and control over

FCA actions, in violation of the Take Care Clause.

5

A. The Qui Tam Provisions Violate Article

II’s Vesting Clause.

Congress may not authorize private bounty

hunters to litigate for the United States. Rather, the

Framers understood that “[a] basic step in organizing

a civilized society” was to take the “sword” of lawenforcement actions “out of private hands and turn it

over to an organized government, acting on behalf of

all the people.” Robertson v. United States ex rel.

Watson, 560 U.S. 272, 282-83 (2010) (Roberts, C.J.,

dissenting from dismissal of writ of certiorari as

improvidently granted). To that end, the Constitution

established a unitary and accountable Executive who

alone was responsible for enforcing federal law.

This conception of centralized executive authority

finds roots in the political theory of John Locke. As he

explained, “in the state of Nature[,] every one has the

executive power of the law of Nature.” John Locke,

Two Treatises on Civil Government 197 (George

Routledge & Sons ed., 1884) (“Locke”). But “when they

enter into society,” individuals “give up” the “executive

power they had in the state of Nature into the hands

of the society.” Id. at 258. That is, the people delegate

their executive authority to public officials, whose

power is “to be directed to no other end but the peace,

safety, and public good of the people.” Id. at 259.

Blackstone’s Commentaries reflect a similar

understanding. “In a state of society,” he reasoned, the

right “to put [the law] in execution” is “transferred

from individuals to the sovereign power,” who “alone”

bears “the sword of justice by the consent of the whole

community.” 4 William Blackstone, Commentaries on

the Laws of England 7-8 (1769) (“Blackstone”). And

6

when the public “delegate[s] all its power and rights,

with regard to the execution of the laws, to one visible

magistrate,” that officer is “the proper person to

prosecute for all public offences.” 1 Blackstone 25859.

Of course, the common law recognized that one

who personally “suffered the damage” from a public

infraction might have a concomitant right to demand

redress “in his own name.” Locke 196. But that would

not permit him to pursue relief on behalf of the public

writ large. “[N]o person” other than the official

entrusted with the executive authority “can have an

action for a public nuisance, or punish it,” unless that

“private person suffers some extraordinary damage.”

3 Blackstone 219-20. Because individuals give up the

executive power by entering society, “the law gives no

private remedy for any thing but a private wrong.” Id.

at 219.

The Framers enshrined this basic understanding

in Article II’s text, vesting all “executive Power” in a

single “President.” U.S. Const. art. II, § 1, cl. 1; see

Seila Law LLC v. CFPB, 591 U.S. 197, 213 (2020). It

would therefore be “utterly inadmissible” for Congress

to vest executive authority “in any other person.”

Martin v. Hunter’s Lessee, 14 U.S. 304, 330 (1816).

That, however, is precisely what Congress did with

the FCA’s qui tam provisions. It “sought to disperse

some quantum of executive authority amongst the

general public.” United States ex rel. Kelly v. Boeing

Co., 9 F.3d 743, 750 (9th Cir. 1993). That dispersion

cannot be justified as remedying private wrongs, for

the alleged harm, by definition, was “suffered by the

United States.” United States ex rel. Hunt v. Cochise

7

Consultancy, Inc., 887 F.3d 1081, 1091 (11th Cir.

2018), aff’d, 587 U.S. 262 (2019). Such “public

offences” may be prosecuted only by those acting on

behalf of the President, in whom the people have

vested all executive Power. 1 Blackstone 259.

This Court’s precedent confirms the point. The

executive Power includes the “exclusive authority and

absolute discretion to decide whether to prosecute a

case” on the United States’ behalf. United States v.

Nixon, 418 U.S. 683, 693 (1974). And the “[s]ettled

rule” has long been that courts cannot entertain “any

suit, civil or criminal, as regularly before them, if

prosecuted in the name and for the benefit of the

United States,” unless the government is represented

by the Executive. Confiscation Cases, 74 U.S. 454, 457

(1869). The FCA’s qui tam provisions contravene

Article II’s Vesting Clause by outsourcing that

responsibility to private parties.

B. The Qui Tam Provisions Violate the

Appointments Clause.

Qui tam suits also conflict with the Appointments

Clause, which works in tandem with the Vesting

Clause to ensure that “executive Power” is exercised

only by appointed “Officers of the United States.” U.S.

Const. art. II, § 2, cl. 2.

The key test for an “Officer” is whether the person

“exercis[es] significant authority pursuant to the laws

of the United States.” Buckley v. Valeo, 424 U.S. 1,

126 (1976). Such authority includes the power to

“conduct[] civil litigation in the courts of the United

States for vindicating public rights.” Id. at 140. And

that describes the power of an FCA relator to a tee:

The relator may sue “for the United States” and “in

8

the name of the Government” for “penalt[ies]” and

“damages which the Government [has] sustain[ed].”

31 U.S.C. §§ 3729(a)(1), 3730(b)(1).

Buckley forbids such a diffusion of executive Power.

There, the Court struck down the FEC’s original

structure, which permitted congressional leaders to

appoint commissioners. See 424 U.S. at 113. That

violated the Appointments Clause, because the

commissioners performed executive “functions” by

wielding “enforcement power” to “seek judicial relief”

for violations of law. Id. at 138-40. Such executive

“functions may be discharged only by persons who are

‘Officers of the United States’ within the language” of

the Appointments Clause. Id. at 140 (emphasis

added).

In considering whether one exercises an executive

“function,” Buckley reflects the original public

meaning of “Officer.” “Etymologically, an ‘office’ is an

officium, a duty; and an ‘officer’ was simply one whom

the King had charged with a duty.” Edward S. Corwin,

The President: Office and Powers 1787-1957, at 70 (4th

ed. 1957). In keeping with that understanding, the

Crown argued prior to the Founding that “every Man

is a publick officer who hath any duty concerning the

publick.” King v. Burnell, Carth. 478, 479 (K.B. 1700).

Later dictionaries reflected the same understanding.

See Officer, 2 Timothy Cunningham, A New and

Complete Law-dictionary (1765) (recounting Burnell

formulation); Officer, 2 Noah Webster, American

Dictionary of the English Language (1828) (“A person

commissioned or authorized to perform any public

duty.”).

9

The Framers likewise regarded an “Officer” as one

“invested with some portion of the sovereign functions

of the government.” Floyd R. Mechem, A Treatise on

the Law of Public Offices and Officers 2 (1890). In

Hamilton’s words, persons to whose “management”

the “executive details” of government “are committed

ought to be considered as the [President’s] assistants

or deputies” and “ought to derive their offices from his

appointment.” The Federalist No. 72, at 435-36

(Alexander Hamilton) (Clinton Rossiter ed., 2003).

Those executive appointees alone are “the officers who

may be [e]ntrusted with the execution of [the] laws.”

The Federalist No. 29, at 183 (Alexander Hamilton).

This

understanding

explains

why

the

Appointments Clause was no mere matter of

“etiquette or protocol.” Buckley, 424 U.S. at 125. It

was instead regarded among the “significant

structural safeguards of the constitutional scheme.”

Edmond v. United States, 520 U.S. 651, 659 (1997).

“The Appointments Clause prevents Congress from

dispensing power too freely” to those who might wield

it improperly. Freytag, 501 U.S. at 880. And it

simultaneously “ensures that those who exercise the

power of the United States are accountable to the

President, who himself is accountable to the people.”

Dep’t of Transp. v. Ass’n of Am. R.R., 575 U.S. 43, 63

(2015) (Alito, J., concurring).

The FCA’s qui tam provisions upend these

safeguards. Indeed, Congress could hardly have

dispensed executive Power more freely, “effectively

permit[ting] all private persons in the entire world to

appoint themselves special fraud prosecutors in the

name of the United States.” James T. Blanch, The

10

Constitutionality of the False Claims Act’s Qui Tam

Provision, 16 Harv. J.L. & Pub. Pol’y 701, 742 (1993).

Congress also shielded relators from removal—and

thus presidential supervision—by providing them a

“right to continue as a party” even after duly

appointed officials intervene. 31 U.S.C. § 3730(c)(1).

The result is a relator “that is not accountable to the

President, and a President who is not responsible for

the [relator].” Free Enter. Fund, 561 U.S. at 495. That

violates Article II.

It makes no difference that relators lack a

“continuing

and

formalized

relationship

of

employment with the United States.” Riley v. St.

Luke’s Episcopal Hosp., 252 F.3d 749, 757-58 (5th Cir.

2001) (en banc). They still unquestionably wield “core

executive power.” United States ex rel. Zafirov v. Fla.

Med. Assocs., LLC, 751 F. Supp. 3d 1293, 1300 (M.D.

Fla. 2024). So, whether or not “public officers in a

strict sense,” relators may not be “charged with the

exercise of executive functions” unless appointed

through the method Article II commands. Springer v.

Gov. of Philippine Islands, 277 U.S. 189, 203 (1928).

Certainly, they cannot exercise the core executive

function of prosecuting claims on the public’s behalf

for penalties that are “essentially punitive in nature.”

Vt. Agency of Nat. Res. v. United States ex rel. Stevens,

529 U.S. 765, 784 (2000). This “power to seek

daunting monetary penalties against private parties”

is a “quintessentially executive power.” Seila Law,

591 U.S. at 219.

The employment argument also reads “Officer” too

narrowly. While the word often “embraces the ideas of

tenure, duration, emolument, and duties,” United

11

States v. Germaine, 99 U.S. 508, 511 (1878), this Court

has never held all such indicia to be necessary. To the

contrary, Morrison v. Olson held that an independent

counsel—a temporary prosecutor appointed for a

single investigation—was “clear[ly]” an “‘officer’ of the

United States.” 487 U.S. 654, 671 & n.12 (1988).

As in Morrison, a qui tam relator functions as a

single-case officer empowered to sue on the

government’s behalf. See 31 U.S.C. § 3730. While the

“office is limited in tenure” and “‘temporary’ in the

sense that [relators are] appointed essentially to

accomplish a single task,” those limits do not foreclose

officer status “in the constitutional sense.” Morrison,

487 U.S. at 671-72 & n.12. Rather, “the office of an

FCA relator is continuous” by operation of law, “even

if it is not continually filled.” Zafirov, 751 F. Supp. 3d

at 1314. The FCA empowers individuals to appoint

themselves to that office—in which they represent the

United States in complex, high-stakes litigation for

years.

At bottom, “there is not even a fig leaf of

constitutional justification” for empowering “private

entities” to prosecute alleged FCA offenders on the

government’s behalf. Ass’n of Am. R.R., 575 U.S. at 62

(Alito, J., concurring). As independent and selfappointed bounty hunters, qui tam relators operate

well outside Article II’s carefully crafted scheme.

C. The Qui Tam Provisions Violate the Take

Care Clause.

Qui tam litigation violates the Take Care Clause

too. The Framers knew that there “can be no liberty”

if a single body “should enact tyrannical laws,” to have

them then “execute[d]” “in a tyrannical manner.” The

12

Federalist No. 47, at 303 (James Madison) (emphasis

and citation omitted). So they divided the Nation’s

lawmaking and law-enforcement powers.

That

“separation of legislative and executive functions

helps prevent tyranny precisely because a

discretionary decision by executive officers intervenes

between the enactment of the prohibition and its

application to any particular individual.” Zachary S.

Price, Enforcement Discretion and Executive Duty, 67

Vand. L. Rev. 671, 702 (2014).

At the same time, “[t]he Constitution does not

leave to speculation who is to administer the laws

enacted by Congress”—and exercise discretion in their

execution. Printz v. United States, 521 U.S. 898, 922

(1997). “[T]he President, it says, ‘shall take Care that

the Laws be faithfully executed.’”

Id. (citation

omitted). Included within that charge “is the power to

protect individual liberty by essentially underenforcing federal statutes regulating private

behavior.” In re Aiken County, 725 F.3d 255, 264 (D.C.

Cir. 2013) (opinion of Kavanaugh, J.). For that reason,

“the choice of how to prioritize and how aggressively

to pursue legal actions against defendants who violate

the law falls within the discretion of the Executive

Branch, not within the purview of private plaintiffs

(and their attorneys).” TransUnion LLC v. Ramirez,

594 U.S. 413, 429 (2021).

The FCA’s qui tam provisions cannot be squared

with these principles either. They permit unharmed

private parties to commandeer the Executive’s

enforcement discretion and decide whether, where,

when, and how to sue alleged violators. This “allows

Congress to circumvent the Executive’s check and to

13

have its laws enforced directly by its own private

bounty hunters.” Barr Memo 211. Such reallocation

of power not only threatens individual liberty, but also

undermines the Executive’s power to set “overall

policies.” Heckler v. Chaney, 470 U.S. 821, 831 (1985).

That is why the Framers entrusted these sorts of

enforcement decisions to one, publicly accountable

President. “[O]nly a unitary executive properly can

balance the competing interests at stake, including

law enforcement, foreign affairs, national security,

and the overriding interest in just administration of

the laws.” Barr Memo 232. That is, only the President

can “take Care that the Laws be faithfully executed,”

U.S. Const. art. II, § 3, so as to best serve the “publicwelfare needs of the American people,” United States

v. Texas, 599 U.S. 670, 680 (2023).

D. History Cannot Salvage the Qui Tam

Provisions’ Affront to Article II.

History cannot wash away these constitutional

shortcomings. After all, “[t]he Constitution, not

history, is the supreme law.” Barr Memo 233; see

Bruen, 597 U.S. at 36. Historical practice thus cannot

cure constitutional infirmities even when it “covers

our entire national existence and indeed predates it.”

Walz v. Tax Comm’n of City of New York, 397 U.S. 664,

678 (1970).

At any rate, qui tam suffers from a checkered

history. It did not become ubiquitous until Congress

amended the FCA in 1986—two centuries after the

Founding. Those modern amendments, of course, are

the very provisions at issue.

14

1. Abuses in Early English Qui Tam

Practice Led to its Decline.

Qui tam actions originated in medieval times,

“when private individuals who had suffered injury

began bringing actions in the royal courts on both

their own and the Crown’s behalf.” Stevens, 529 U.S.

at 774. This practice was originally aimed at getting

“private claims into the respected royal courts, which

generally entertained only matters involving the

Crown’s interests.” Id. But as the “royal courts began

to extend jurisdiction to suits involving wholly private

wrongs” in the 14th century, “the common-law qui tam

action gradually fell into disuse.” Id. at 775.

Around that time, Parliament was “[f]aced with

limited public enforcement resources and the

difficulty of implementing national policies” over an

expansive region. J. Randy Beck, The False Claims

Act and the English Eradication of Qui Tam

Legislation, 78 N.C. L. Rev. 539, 567 (2000). It

therefore began experimenting with statutory qui tam

litigation. See id. at 567-73.

Over the next two centuries, however, qui tam

“proved a vexatious device that ultimately could not

be reconciled with the institutions of free and

responsible government.” Barr Memo 235. Informers

“occupied in this branch of executive jurisprudence”

did not “give impartial efficiency to the laws,” but

acted instead as “instrument[s] of individual

extortion, caprice, and tyranny.” 8 Legal Observer No.

204, at 20 (1834) (citation omitted). They unearthed

old and forgotten statutes “as means to gratify illwill.” 4 William S. Holdsworth, A History of English

Law 356 (1924). They threatened enforcement suits

15

to “levy[] blackmail” against others. Id. And they

stirred up litigation simply in the hopes of recovering

money. Id.

These abuses led to considerable outrage—

prompting Lord Coke to denounce the informers as

“viperous vermin” who “vex and depauperize the

subject” for “malice or private ends, and never for love

of justice.” 3 Sir Edward Coke, Institutes of the Laws

of England 194 (4th ed. 1797). Parliament responded

by curbing qui tam abuses. See Beck, supra, at 57489. And, by the Jacobean era, “many of the old

enactments were repealed” entirely. Stevens, 529 U.S.

at 775.

Some English qui tam statutes did remain in effect

up through the Founding. But even those lend little

support to the constitutionality of qui tam litigation.

After all, “the Constitution’s creation of a separate

Executive Branch coequal to the Legislature was a

structural departure from the English system of

parliamentary supremacy, from which many legal

practices like qui tam were inherited.” Polansky, 599

U.S. at 450 (Thomas, J., dissenting) (citation omitted).

The English history only underscores the hazards

posed by legislative transfers of executive power to

private hands. Article II eliminated those hazards.

2. Early Congressional Laws Do Not

Support Qui Tam’s Constitutionality.

Some courts counter that “the First Congress

enacted a number of statutes authorizing qui tam

actions.” Riley, 252 F.3d at 752. But even “a

longstanding history of related federal action does not

demonstrate a statute’s constitutionality.” United

States v. Comstock, 560 U.S. 126, 137 (2010). And

16

early congressional practice provides

precedent for the modern-day FCA.

a

weak

For starters, many early qui tam enactments are

not “relevantly similar.” Bruen, 597 U.S. at 29. They

operated differently from the current FCA, which

places unharmed plaintiffs in the government’s shoes

to litigate on its behalf. Many of the early statutes

instead offered only a reward to informers for bringing

a matter to the government, without providing a cause

of action; others sought to redress private injuries,

with the government receiving only incidental

recoveries. See Zafirov, 751 F. Supp. 3d at 1319-20.

These two categories differ in kind from the modern

FCA and thus have little bearing on the inquiry. See

Bruen, 597 U.S. at 29-30, 46-50.

As to the few enactments that allowed informers to

pursue the sovereign’s claims, these “were essentially

stop-gap measures, confined to narrow circumstances”

to assist the fledging Executive. Barr Memo 213. And

the “transitory and aberrational” qui tam device

“never gained a secure foothold within our

constitutional structure.” Id. It produced “little actual

litigation” and was curtailed by Congress in short

order. Ann Woolhandler & Caleb Nelson, Does History

Defeat Standing Doctrine?, 102 Mich. L. Rev. 689, 728

(2004); see Barr Memo 235-36.

Moreover, there is “no evidence” that Congress ever

“considered the constitutional status of qui tam.” Barr

Memo 214. The early qui tam statutes instead have

all the hallmarks of action “taken thoughtlessly, by

force of long tradition” from an archaic English device,

“and without regard to the problems” presented to the

new constitutional order. Marsh v. Chambers, 463

17

U.S. 783, 791 (1983). The Framers themselves

recognized that early congressional practice should

receive little weight where, as here, “the question of

Constitutionality was but slightly, if at all, examined.”

Letter from James Madison to President Monroe (Dec.

27, 1817), in 3 Letters and Other Writings of James

Madison 54, 55-56 (J.B. Lippincott & Co. 1867).

Reliance on congressional practice also proves too

much. For many “qui tam provisions authoriz[ed]

individuals to sue under criminal statutes to help

enforce the law.” Harold J. Krent, Executive Control

over Criminal Law Enforcement: Some Lessons from

History, 38 Am. U. L. Rev. 275, 296-97 & n.104 (1989)

(emphasis added). An early larceny statute, for

example, gave half the fine “to the informer and

prosecutor,” and provided that, “on conviction,” the

offender would “be publicly whipped.” Act of Apr. 30,

1790, ch. 9, §§ 16-17, 1 Stat. 112, 116. There can be no

doubt that outsourcing such “core executive power” to

the plaintiffs’ bar would violate Article II. Seila Law,

591 U.S. at 219.

3. The False Claims Act Revived an

Unconstitutional Practice.

The early qui tam provisions fell into disuse before

the antebellum period. During the Civil War, however,

the country’s resources were stretched to the breaking

point, and Congress revived the concept by enacting

the original FCA. See United States v. McNinch, 356

U.S. 595, 599 (1958).

Congress viewed aggressive enforcement as critical

to funding the wartime emergency. So, it turned to the

“unusual” practice of “authorizing private parties” to

sue “on the Government’s behalf.” Polansky, 599 U.S.

18

at 423. In the legislature’s view, allowing “any person”

to sue “for the United States” and share in the

proceeds, see Act of Mar. 2, 1863, ch. 67, § 4, 12 Stat.

696, 698, was the “most expeditious way” of enforcing

the law, Cong. Globe, 37th Cong., 3d Sess. 956 (1863)

(Sen. Howard). Congress therefore “let loose a posse

of ad hoc deputies to uncover and prosecute frauds

against the government.” Milam, 961 F.2d at 49.

After the Civil War crisis receded, qui tam once

again “fell into relative desuetude.” Barr Memo 209.

By 1986, though, Congress became “dissatisfied with

the way the executive branch was enforcing

government procurement laws.” Id. And it sought to

“check” the Executive’s enforcement discretion with

amendments designed to “encourage more private

enforcement suits.” S. Rep. No. 99-345, at 23-24, 26

(1986). This ushered in a new era of litigation, with

qui tam actions surging more than a hundredfold.

Compare U.S. Dep’t of Justice, Fraud Statistics—

Overview (Jan. 16, 2026), bit.ly/3LNm8yE, with

Zafirov, 751 F. Supp. 3d at 1302 (citing pre-1986

statistics). Indeed, in every year since 1995, private

relators have surpassed the Executive Branch as the

primary executors of the statute. See Fraud Statistics,

supra. The imbalance is now stark; relators brought

over 75% of FCA cases this past year. See id.

This Court should grant certiorari to bury that

unlawful and abusive practice for good. The sooner it

does so the better. But if the Court concludes that a

better vehicle for resolving this issue waits in the

wings, see BIO.20-21, then it should at least hold this

case for that resolution.

19

II. The Seventh Circuit’s Distorted Scienter

Standard Also Warrants Review.

The Court of Appeals also watered down the FCA’s

scienter standard in a way that will fuel further qui

tam overreach. That statutory distortion separately

warrants review. And it underscores the need for this

Court’s immediate intervention.

A. A Rigorous Scienter Standard is Critical

for Cabining Punitive Liability.

Profit-driven relators naturally push the bounds of

the FCA’s “essentially punitive” regime. Stevens, 529

U.S. at 784. In recent years, they have increasingly

brought claims challenging good-faith interpretations

of complex regulations as fraud. The Seventh Circuit

indulged that effort here. And allowing its decision to

stand will arm qui tam relators with a new weapon for

punishing all sorts of honest regulatory mistakes with

crippling penalties.

The FCA forbids that expansive authority.

Congress imposed liability only for “knowingly”

submitting false claims to the government. 31 U.S.C.

§ 3729(a)(1)(A). And it carefully defined “knowingly,”

in turn, to mean that the defendant “(i) has actual

knowledge of the information; (ii) acts in deliberate

ignorance of the truth or falsity of the information; or

(iii) acts in reckless disregard of the truth or falsity of

the information.” Id. § 3729(b)(1)(A). “That threepart test largely tracks the traditional common-law

scienter requirement for claims of fraud.” United

States ex rel. Schutte v. SuperValu Inc., 598 U.S. 739,

750 (2023).

20

This test requires a “culpable state of mind.” Id. at

752 (citation omitted). That is, the FCA focuses on

what the defendant “thought and believed.” Id. at 751.

And that subjective focus applies across all three parts

of Congress’s definition. “Actual knowledge” requires

“aware[ness]” of a claim’s falsity.

Id. (citation

omitted). “Deliberate ignorance” means that a person

is “aware of a substantial risk that [his] statements

are false, but intentionally avoid[s] taking steps to

confirm” his suspicions. Id. And “reckless disregard”

similarly “captures defendants who are conscious of a

substantial and unjustifiable risk that their claims are

false, but submit the claims anyway.” Id.

Those requirements are rightly “rigorous.”

Escobar, 579 U.S. at 192. Congress demanded “strict

enforcement” of the FCA’s scienter element to avoid

“open-ended liability” for regulatory infractions. Id.

(quotation marks omitted). After all, “billing parties

are often subject to thousands of complex statutory

and regulatory provisions.” Id. And the provisions for

Medicare and Medicaid, in particular, are “among the

most completely impenetrable texts within human

experience.” Rehab. Ass’n of Va., Inc. v. Kozlowski, 42

F.3d 1444, 1450 (4th Cir. 1994). Congress thus knew

that perfect compliance would be impossible. So it

“made plain ‘its intention that the [FCA] not punish

honest mistakes or incorrect claims submitted

through mere negligence.’” United States ex rel.

Owens v. First Kuwaiti Gen. Trading & Contracting

Co., 612 F.3d 724, 728 (4th Cir. 2010) (citation

omitted). Not even “gross negligence” will suffice.

United States ex rel. Farmer v. City of Houston, 523

F.3d 333, 338 (5th Cir. 2008). Congress sought only to

punish fraud with treble damages and civil penalties.

21

The Court of Appeals lost sight of Congress’s

charge. Its scienter analysis was driven, not by Lilly’s

state of mind, but by the court’s own interpretation of

the “legal framework.”

Pet.App.20.

And its

interpretive

endeavor

was

anything

but

straightforward. Over nearly a dozen pages, the court

sifted through the text of “interlac[ed]” statutory,

regulatory, and contractual provisions, imposed its

view of what “makes sense,” rejected Lilly’s contrary

interpretation based on “the statute’s clear purpose,”

and noted the court’s interpretive “divergence” from a

unanimous Third Circuit panel. Pet.App.20-30. Then,

the court held that “Lilly’s objectively unreasonable

interpretation” was “highly probative” of scienter—

and that the jury could weigh the legal

“unreasonableness of that view in finding scienter.”

Pet.App.38-39.

That was mistaken. The “objective reasonableness

of [a] defendant’s view of the law is a legal question”

that is “not [for] the jury” to decide. United States v.

Prigmore, 243 F.3d 1, 18 (1st Cir. 2001) (citing Cheek

v. United States, 498 U.S. 192, 203 (1991)). Nor does

anything in the FCA task juries with divining how a

court might later construe the law. Post hoc judicial

pronouncements of what the law objectively required

thus cannot substitute for a defendant’s “subjective

beliefs” and “thought[s] when submitting the false

claim.” Schutte, 598 U.S. at 749, 752. To hold

otherwise—as the Seventh Circuit did—would allow

relators to punish businesses absent the “culpable

state of mind” that Congress demanded. Id. at 752

(citation omitted).

22

The consequences of this position are dire.

Relators are keenly aware that their mere allegations,

regardless of merit, can “be used to extract

settlements,” Sean Elameto, Guarding the Guardians:

Accountability in Qui Tam Litigation Under the Civil

False Claims Act, 41 Pub. Contract L.J. 813, 824

(2012), because simply defending an FCA case

requires a “tremendous expenditure of time and

energy” and money, Todd J. Canni, Who’s Making

False Claims, the Qui Tam Plaintiff or the Government

Contractor?, 37 Pub. Cont. L.J. 1, 11 & n.66 (2007).

Indeed, companies in the “[p]harmaceutical, medical

devices, and health care” industries alone “spend

billions each year” dealing with FCA investigations.

John T. Bentivoglio et al., False Claims Act

Investigations: Time for a New Approach?, 3 Fin.

Fraud L. Rep. 801, 801 (2011). And the Seventh

Circuit’s contortion of the FCA’s scienter standard will

only fan the flames in today’s overbearing regulatory

environment. Thousands of businesses, non-profits,

and individuals now face protracted litigation—and

potentially ruinous liability—any time a relator coins

a theory that their interpretation of a complicated

regulation or statute is better than the one the

defendant embraced. That is not what Congress

endorsed when it crafted the FCA.

B. A Rigorous Scienter Standard is Critical

for Ensuring Fair Notice.

The problems with the Seventh Circuit’s position

go further still. “A fundamental principle in our legal

system is that laws which regulate persons or entities

must give fair notice of conduct that is forbidden or

required.” FCC v. Fox TV Stations, Inc., 567 U.S. 239,

23

253 (2012). To that end, “[s]trict enforcement” of the

FCA’s scienter element “helps to ensure that innocent

mistakes made in the absence of binding interpretive

guidance are not converted into FCA liability, thereby

avoiding the potential due process problems posed by

‘penalizing a private party for violating a rule without

first providing adequate notice of the substance of the

rule.’” United States ex rel. Purcell v. MWI Corp., 807

F.3d 281, 287 (D.C. Cir. 2015) (citation omitted).

This case places those problems in stark relief.

Lilly carefully made reasonable assumptions about

the law, including whether service fees paid by Lilly to

drug wholesalers altered the “price paid to the

manufacturer” by the wholesaler. 42 U.S.C. § 1396r8(k)(1)(A); see Pet.9. The statute is “susceptible to

multiple interpretations” in this regard. United States

ex rel. Streck v. Allergan, Inc., 746 F. App’x 101, 108

(3d Cir. 2018). And Lilly was always above board with

its interpretation. The company repeatedly explained

to the government its reasonable assumptions—in

2005, 2008, 2011, and 2013—and the government

never raised any concerns. See Pet.10-11. On the

contrary, the government described the approach used

by Lilly and other pharmaceutical companies as

“generally consistent with Federal requirements”

after auditing those methodologies. Pet.App.43.

Imposing penalties in these circumstances raises

serious due process concerns. Ambiguities abound in

the law for any number of reasons. See Kisor v. Wilkie,

588 U.S. 558, 566 (2019). As a result, companies that

do business with the government must regularly make

interpretive choices. Those choices can be difficult.

But when a company openly seeks to engage with

24

regulators and shares its interpretive choice, a later

nine-figure judgment for fraud is in no way consistent

with the Constitution’s commitment to fair notice.

The government appears to recognize this too. In

Schutte, it conceded that when defendants have

“laid . . . out” their position to regulators, “there

wouldn’t [be] anything deceitful.” Oral Arg. Tr. 36-37,

No. 21-1326 (U.S. Apr. 18, 2023). Yet in this case, the

government and relator collectively stand to extract

nearly $200 million from a company that pled for

clarity from the government, explicitly told the

government what it was doing, and received no

objection.

In short, the decision below creates an impossible

bind. Companies cannot avoid complex and unclear

regulatory schemes. The administrative state “wields

vast power and touches almost every aspect of daily

life,” Free Enter. Fund, 561 U.S. at 499, and FCA

liability spreads as far as the government’s work.

Here, the regulator refused to provide guidance and

directed parties to make “reasonable assumptions”

when faced with ambiguity. That is what Lilly did.

But an unaccountable relator wielded the FCA’s qui

tam provisions to punish Lilly—on behalf of the

government—for doing exactly what the government

had instructed Lilly to do. That cannot be the law.

25

CONCLUSION

The Court should grant certiorari.

Respectfully submitted,

MICHAEL H. MCGINLEY

BRIAN A. KULP

DECHERT LLP

Cira Centre

2929 Arch Street

Philadelphia, PA 19104

ANDREW R. VARCOE

MARIEL A. BROOKINS

U.S. CHAMBER

LITIGATION CENTER

1615 H Street, NW

Washington, DC 20062

STEVEN A. ENGEL

Counsel of Record

DECHERT LLP

1900 K Street, NW

Washington, DC 20006

(202) 261-3369

steven.engel@dechert.com

Counsel for Amicus Curiae

April 27, 2026