Queerdoc, Pllc v. DOJ - United States Department of Justice

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

QUEERDOC, PLLC, No. 25-7384

D.C. No.

Plaintiff - Appellee,

2:25-mc-00042-

JNW

v.

DOJ - UNITED STATES

DEPARTMENT OF JUSTICE, OPINION

Defendant - Appellant.

Appeal from the United States District Court

for the Western District of Washington

Jamal N. Whitehead, District Judge, Presiding

Argued and Submitted March 6, 2026

Seattle, Washington

Filed August 14, 2026

Before: Richard A. Paez, Carlos T. Bea, and Daniel A.

Bress, Circuit Judges.

Opinion by Judge Bea;

Dissent by Judge Paez

2 QUEERDOC, PLLC V. USDOJ

SUMMARY *

Administrative Subpoena

The panel reversed the district court’s order quashing in

its entirety an administrative subpoena issued by the United

States Department of Justice (DOJ) to QueerDoc pursuant to

the Health Insurance Portability and Accountability Act

(HIPAA), which authorizes the Attorney General or his

designee to issue a subpoena in any investigation of a federal

health care offense, and remanded for further proceedings.

QueerDoc is a telehealth provider of gender affirming

care that treats patients, including minors, who suffer from

gender dysphoria. Patients of QueerDoc may be diagnosed

with gender dysphoria and prescribed puberty blockers and

cross-sex hormones.

Following President Trump signing Executive Order

14,168, which declared that the United States “recognize[s]

two sexes, male and female,” and that “[t]hese sexes are not

changeable[,]” and Executive Order 14,187, which declared

that the federal government would not “fund, sponsor,

promote, assist, or support the so-called ‘transition’ of a

child from one sex to another[,]” DOJ issued an

administrative subpoena to QueerDoc ordering QueerDoc to

produce various documents necessary for the investigation

of potential violations of federal health care laws. The

district court quashed the subpoena in its entirety, finding the

subpoena unenforceable because DOJ had issued it for an

*

This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

QUEERDOC, PLLC V. USDOJ 3

“improper purpose”: to achieve the President’s policy

objective of “eliminating gender-affirming care.”

The panel held that DOJ issued the administrative

subpoena pursuant to statutory authority because 1) HIPAA

permits investigations for potential violations of the Federal

Food, Drug, and Cosmetic Act’s misbranding prohibitions;

2) DOJ complied with HIPAA’s procedural requirements;

and 3) the subpoena requests were relevant to an authorized

investigation under HIPAA.

The panel next held that QueerDoc did not meet its heavy

burden of showing that the subpoena was issued for an

improper purpose. Consistent with the presumption of

regularity and the high standard required to quash an

administrative subpoena on improper purpose grounds, the

Executive Branch’s public opposition to “gender-affirming

care” is insufficient to show that an agency within the

Executive Branch issued an otherwise permissible HIPAA

subpoena in bad faith. The President may direct DOJ to

exercise its statutory authority in a manner that aligns with

his broader policy goals.

Because the district court decided only that the subpoena

was motivated by an improper purpose and did not rule on

QueerDoc’s arguments that DOJ’s subpoena is overbroad

and poses an undue burden, the panel remanded for the

district court to consider those issues the first instance.

Dissenting, Judge Paez wrote that the district court’s

finding that DOJ issued the subpoena to QueerDoc in bad

faith was not clearly erroneous. Considering the information

properly before the district court at the time it rendered its

decision, the government failed to satisfy its prima facie

burden of showing the information subpoenaed was relevant

and material to its purported investigatory purpose. Even if

4 QUEERDOC, PLLC V. USDOJ

the government satisfied its prima facie burden, the district

court’s decision to quash the subpoena should be affirmed

because ample evidence supports its finding that the

subpoena was issued in bad faith.

COUNSEL

Paula Ramer (argued) and Marcus A. Asner, Arnold &

Porter Kaye Scholer LLP, New York, New York; Taylor B.

Graham, Arnold & Porter Kaye Scholer LLP, Denver,

Colorado; Benjamin C. Mizer and Samuel D. Kleinman,

Arnold & Porter Kaye Scholer LLP, Washington, D.C.;

Jaclyn Machometa, Arnold & Porter Kaye Scholer LLP,

Boston, Massachusetts; Jonathan P. Hawley, David B.

Robbins, and Harry H. Schneider Jr., Ashurst Perkins Coie

LLP, Seattle, Washington; Adrien Leavitt and La Rond

Baker, American Civil Liberties Union of Washington,

Seattle, Washington; David B. Robbins, Perkins Coie LLP,

Seattle, Washington; for Plaintiff-Appellee.

Sarah Welch (argued) and Bradley Hinshelwood, Attorneys;

Abigail Stout, Counsel to the Assistant Attorney General;

Yaakov M. Roth, Principal Deputy Assistant Attorney

General; Civil Division; Brett A. Shumate, Assistant

Attorney General; United States Department of Justice,

Washington, D.C.; for Defendant-Appellant.

Kohsei Ugumori, Attorney, Office of Immigration

Litigation, Civil Division, United States Department of

Justice, Washington, D.C.; Miriam Rosenbaum and Wendy

R. Weiser, Brennan Center for Justice at NYU School of

Law, New York, New York; Joseph Gaeta, Brennan Center

for Justice at NYU School of Law, Providence, Rhode

QUEERDOC, PLLC V. USDOJ 5

Island; Jonah M. Knobler, Caitlin Ross, Bharath Palle, and

Gregory L. Diskant, Patterson Belknap Webb & Tyler LLP,

New York, New York; for Amici Curiae Former U.S.

Department of Justice Attorneys.

David M. Zinn, Christopher N. Manning, Dana B. Kinel,

Patrick C. Hynds, and Amy M. Saharia, Williams &

Connolly LLP, Washington, D.C.; Jeffrey B. Coopersmith,

Corr Cronin LLP, Seattle, Washington; for Amicus Curiae

Seattle Children's Hospital.

Lauryn K. Fraas, Assistant Attorney General; William D.

McGinty and Cristina Sepe, Deputy Solicitors General;

Nicholas W. Brown, Washington Attorney General; Office

of the Washington Attorney General, Olympia, Washington;

Adam M. Cambier, Morgan Carmen, and Jak Kundl,

Assistant Attorneys General; Allyson Slater, Director,

Reproductive Justice Unit; Andrea J. Campbell,

Massachusetts Attorney General; Office of the

Massachusetts Attorney General, Boston, Massachusetts;

Rob Bonta, California Attorney General, Office of the

California Attorney General, Oakland, California; William

Tong, Connecticut Attorney General, Office of the

Connecticut Attorney General, Hartford, Connecticut;

Kristin K. Mayes, Arizona Attorney General, Office of the

Arizona Attorney General, Phoenix, Arizona; Philip J.

Weiser, Colorado Attorney General, Office of the Colorado

Attorney General, Denver, Colorado; Brian L. Schwalb,

District of Columbia Attorney General, Office of the District

of Columbia Attorney General, Washington, D.C.; Kathleen

Jennings, Delaware Attorney General, Office of the

Delaware Attorney General, Wilmington, Delaware;

Kwame Raoul, Illinois Attorney General, Office of the

Illinois Attorney General, Chicago, Illinois; Aaron M. Frey,

Maine Attorney General, Office of the Maine Attorney

6 QUEERDOC, PLLC V. USDOJ

General, Augusta, Maine; Anthony G. Brown, Maryland

Attorney General, Office of the Maryland Attorney General,

Baltimore, Maryland; Dana Nessel, Michigan Attorney

General, Office of the Michigan Attorney General, Lansing,

Michigan; Keith Ellison, Minnesota Attorney General,

Office of the Minnesota Attorney General, St. Paul,

Minnesota; Aaron D. Ford, Nevada Attorney General, Office

of the Nevada Attorney General, Carson City, Nevada;

Jennifer Davenport, Acting New Jersey Attorney General;

Office of the New Jersey Attorney General, Newark, New

Jersey; Raúl Torrez, New Mexico Attorney General, Office

of the New Mexico Attorney General, Santa Fe, New

Mexico; Letitia James, New York Attorney General, Office

of the New York Attorney General, New York, New York;

Dan Rayfield, Oregon Attorney General, Office of the

Oregon Attorney General, Salem, Oregon; Peter F. Neronha,

Rhode Island Attorney General, Office of the Rhode Island

Attorney General, Providence, Rhode Island; Charity R.

Clark, Vermont Attorney General, Office of the Vermont

Attorney General, Montpelier, Vermont; Joshua L. Kaul,

Wisconsin Attorney General, Office of the Wisconsin

Attorney General, Madison, Wisconsin; for Amici Curiae

Washington, Massachusetts, Arizona, California, Colorado,

Connecticut, Delaware, District of Columbia, Illinois,

Maine, Maryland, Michigan, Minnesota, Nevada, New

Jersey, New Mexico, New York, Oregon, Rhode Island,

Vermont, and Wisconsin.

Amy Whelan, National Center For LGBTQ Rights,

Sacramento, California; Jennifer L. Levi and Donovan C.

Bendana, GLBTQ Legal Advocates & Defenders, Boston,

Massachusetts; for Amici Curiae National Center for

LGBTQ Rights, National Center for Youth Law, and

GLBTQ Legal Advocates & Defenders.

QUEERDOC, PLLC V. USDOJ 7

Joel McElvain and Alethea A. Swift, Democracy Forward

Foundation, Washington, D.C., for Amicus Curiae

American Academy of Pediatrics.

Karen L. Loewy, Lambda Legal Defense & Education Fund

Inc., Washington, D.C.; Omar Gonzalez-Pagan, Lambda

Legal Defense & Education Fund Inc., New York, New

York; Morgan Walker, Lambda Legal Defense & Education

Fund Inc., Dallas, Texas; A.D. Lewis, Lambda Legal

Defense & Education Fund Inc., Los Angeles, California; for

Amicus Curiae Lambda Legal Defense & Education Fund

Inc.

OPINION

BEA, Circuit Judge:

As part of an ongoing investigation into potential

violations of federal health care laws, the United States

Department of Justice (DOJ) issued an administrative

subpoena to QueerDoc pursuant to the Health Insurance

Portability and Accountability Act (HIPAA). QueerDoc is

an online medical clinic that treats patients, including

minors, who suffer from gender dysphoria. An interested

patient, after an introductory meeting and the completion of

some online forms, can have a “medical visit” that consists

of a videoconference with a licensed medical professional.

After this virtual appointment, a patient may be diagnosed

with gender dysphoria and prescribed puberty blockers and

cross-sex hormones.

8 QUEERDOC, PLLC V. USDOJ

QueerDoc commenced this action by filing a motion to

quash the subpoena in federal district court. The parties did

not dispute that DOJ had statutory authority to issue the

subpoena. However, the district court found the subpoena

unenforceable because DOJ had issued it for an “improper

purpose”: to achieve the President’s policy objective of

“eliminating gender-affirming care.” The district court thus

quashed the subpoena in its entirety.

We hold that QueerDoc has not met its heavy burden of

showing that the subpoena was issued for an improper

purpose. Consistent with the presumption of regularity and

the high standard required to quash an administrative

subpoena on improper purpose grounds, the Executive

Branch’s public opposition to “gender-affirming care” is

insufficient to show that an agency within the Executive

Branch issued an otherwise permissible HIPAA subpoena in

bad faith. The President may direct DOJ to exercise its

statutory authority in a manner that aligns with his broader

policy goals. Accordingly, we reverse the district court’s

order quashing the subpoena in its entirety and remand for

further proceedings.

I

A

The Health Insurance Portability and Accountability Act

of 1996 (HIPAA) authorizes the Attorney General

or his designee to issue a subpoena in “any investigation

of . . . a Federal health care offense.” 18 U.S.C.

§ 3486(a)(1)(A)(i)(I). “Federal health care offense,” defined

at 18 U.S.C. § 24(a), includes any prohibited acts under the

Federal Food, Drug, and Cosmetic Act (FDCA) and related

conspiracies. See 21 U.S.C. § 331.

QUEERDOC, PLLC V. USDOJ 9

The FDCA outlaws the introduction into interstate

commerce of “any new drug” unless the Food and Drug

Administration (FDA) has approved a new drug application

(NDA) for that drug. 21 U.S.C. §§ 331(d), 355(a). The

NDA must demonstrate that a drug is safe and effective for

a certain range of uses; the FDA approves the drug only for

those specified uses. Id. § 352(f); 21 C.F.R. § 201.5. The

FDA also approves the drug’s labeling, which specifies the

approved uses and provides directions for administering the

drug in accordance with those uses. 21 C.F.R. §§ 201.5,

201.55–201.57. Manufacturing, promoting, or labeling a

drug for non-FDA-approved uses, known as “off-label

uses,” may violate the FDCA’s prohibition on misbranding.

See 21 U.S.C. §§ 352(a), (f), 355(a).

QueerDoc operates in this highly regulated industry.

QueerDoc holds itself out as a “telehealth provider of gender

affirming care” that offers services to patients, including

minors, in ten states. A person who lives in one of these

states and believes that he may suffer from gender dysphoria

can go to QueerDoc’s public website and register for

a free fifteen-minute consultation regarding potential

treatment plans. See QueerDoc, Telemedicine Services,

https://perma.cc/EQW5-C7WT; QueerDoc, Youth Gender

Care, https://perma.cc/23UZ-7YWE. Assuming the

prospective patient wishes to proceed, he will upload various

medical records and consent forms to QueerDoc’s online

“patient portal” and will then have an hour-long medical

visit by videoconference with one of QueerDoc’s licensed

medical professionals. See QueerDoc, Telemedicine

Services. After the visit, the doctor may render a diagnosis

(here, of gender dysphoria), refer the patient to another clinic

for testing or further treatment, and prescribe drugs for the

patient. See QueerDoc, Telemedicine Services; QueerDoc,

10 QUEERDOC, PLLC V. USDOJ

Youth Gender Care; QueerDoc, Our Pricing,

https://perma.cc/FZ7E-MTT2.

The drugs that QueerDoc prescribes to its patients fall

within one of two categories: “puberty blockers” and “cross-

sex hormones.” The term “puberty blockers” refers to a set

of prescription drugs that block the natural production of sex

hormones, thereby suppressing the effects of normal

puberty in an adolescent’s body. Report, U.S. Dep’t of

Health and Human Services, Treatment for Pediatric

Gender Dysphoria: Review of Evidence and Best Practices

(“HHS Report”) at 116–17 (Nov. 19, 2025),

https://perma.cc/ZMA3-YPQ2. The term “cross-sex

hormones” refers to a set of prescription drugs intended to

alter a person’s secondary sexual characteristics so that they

resemble those of the opposite sex (e.g., estrogen for males;

testosterone for females). Id. at 123. Neither puberty

blockers nor cross-sex hormones have been approved by the

FDA for the purpose of treating gender dysphoria. 1 All use

of these drugs to treat gender dysphoria is “off-label.”

1

The FDA has approved puberty blockers for other uses, including the

treatment of central precocious puberty (CPP), a condition in which the

pituitary gland is activated prematurely, sometimes during infancy or

early childhood. See HHS Report, supra, at 115–16. CPP is associated

with many “negative health outcomes,” including decreased adult height.

Id. Thus, puberty blockers are approved to treat CPP in youths but not

to treat gender dysphoria. Moreover, because puberty blockers are

administered to CPP patients differently from the way they are

administered to patients with gender dysphoria, the side effects of the

latter treatment are unknown. See United States v. Skrmetti, 605 U.S.

495, 533 (2025) (Thomas, J., concurring) (“To treat precocious puberty,

puberty blockers are administered until the age appropriate for puberty;

to treat gender dysphoria, however, puberty blockers are administered to

stop puberty throughout the years it would normally occur.”).

QUEERDOC, PLLC V. USDOJ 11

Although QueerDoc prescribes puberty blockers and

cross-sex hormones, it does not manufacture or distribute

these drugs. In addition to providing medical services,

QueerDoc operates a public website that informs readers

about various matters pertaining to “gender-affirming care.”

For example, two of QueerDoc’s webpages provide written

and visual instructions for injecting cross-sex hormones into

one’s own body. QueerDoc, Tips for Less Painful Injections,

https://perma.cc/6TC5-T84R; QueerDoc, Self-Injections,

https://perma.cc/3UTA-QKEQ. Other webpages provide

links to pharmacies from which a person may obtain

puberty blockers and cross-sex hormones and advise

the reader on how to submit insurance claims for these drugs.

QueerDoc, Pharmacy Options, https://perma.cc/XLL9-

9286; QueerDoc, Insurance Dictionary,

https://perma.cc/PRC8-KVKT. On another webpage,

QueerDoc claims that the effects of puberty blockers are

“completely reversible.” QueerDoc, Youth Gender Care,

https://perma.cc/23UZ-7YWE.

It is generally understood that the FDCA does not

regulate core aspects of medical practice, such as a doctor’s

choice of which drug to prescribe to a patient. See, e.g., U.S.

Food and Drug Admin., Legal Status of Approved Labeling

for Prescription Drugs; Prescribing for Uses Unapproved

by the Food and Drug Administration, 37 Fed. Reg. 16,503,

16,504 (Aug. 15, 1972) (“Congress did not intend the [FDA]

to regulate or interfere with the practice of medicine.”).

State law and professional standards of practice regulate a

doctor’s ability to prescribe drugs for off-label uses. The

FDCA, in contrast, regulates the labeling and branding of

drugs and their distribution into the national market.

As relevant here, the FDCA prohibits the “misbranding”

of a drug. 21 U.S.C. §§ 331(a)–(b), 352. One way to

12 QUEERDOC, PLLC V. USDOJ

“misbrand” a drug is to publish false or misleading labeling

of that drug. Id. § 352(a). Under the FDCA, “labeling”

includes all “labels and other written, printed, or graphic

matter (1) upon any article or any of its containers or

wrappers, or (2) accompanying such article.” Id. § 321(m).

A piece of “labeling” may “accompany” a drug even if it is

physically separated from the drug’s container. See Kordel

v. United States, 335 U.S. 345, 350 (1948) (“No physical

attachment . . . is necessary.”). The FDA has given

“labeling” a broad definition that includes virtually any

“printed, audio, or visual matter descriptive of a drug.” 21

C.F.R. § 202.1(l)(2).

The off-label use of puberty blockers and cross-sex

hormones to treat minors with gender dysphoria is the

subject of “fierce scientific and policy debates,” United

States v. Skrmetti, 605 U.S. 495, 525 (2025), and reflects a

“deep conflict over human nature.” State v. Loe, 692 S.W.3d

215, 239 (Tex. 2024) (Blacklock, J., concurring). The

Trump Administration has taken one side of this dispute. On

January 20, 2025, President Trump signed Executive Order

14,168 (EO 14,168), which declared that the United States

“recognize[s] two sexes, male and female,” and “[t]hese

sexes are not changeable.” Exec. Order No. 14,168, 90 Fed.

Reg. 8615, § 2 (Jan. 20, 2025). On January 28, 2025,

President Trump signed Executive Order 14,187 (EO

14,187), which declared that the federal government would

not “fund, sponsor, promote, assist, or support the so-called

‘transition’ of a child from one sex to another.” Exec. Order

14,187, 90 Fed. Reg. 8771, § 1 (Jan. 28, 2025). Section 8(c)

of EO 14,187 directed DOJ to “prioritize investigations” into

“violations of the [FDCA] by any entity that may be

misleading the public about long-term side effects of

chemical and surgical mutilation.” Id. § 8(c). Section 11(b)

QUEERDOC, PLLC V. USDOJ 13

provided that EO 14,187 “shall be implemented consistent

with applicable law.” Id. § 11(b).

On April 22, 2025, then-Attorney General Pamela Bondi

circulated to all DOJ employees a memorandum (the “Bondi

Memo”) to implement § 8(c) of EO 14,187. To that end, the

Bondi Memo directed the Consumer Protection Branch, an

office within the Civil Division of DOJ, to conduct

“appropriate investigations of any violations of the [FDCA]

by manufacturers and distributors engaged in misbranding

by making false claims about the on- or off-label use of

puberty blockers, sex hormones, or any other drug used to

facilitate a child’s so-called ‘gender transition.’” The Bondi

Memo took the position that “the promotion of off-label uses

of hormones . . . run[s] afoul of the FDA’s prohibitions on

misbranding and mislabeling.” The Bondi Memo stated a

goal: to “bring [gender-affirming care] to an end.”

On June 11, 2025, Brett Shumate, Assistant Attorney

General for the Civil Division, circulated to all Civil

Division employees a memorandum (the “Shumate Memo”)

that further refined the directives in EO 14,168, EO 14,187,

and the Bondi Memo. Relevant here, the Shumate Memo

directed the Civil Division to “prioritize investigations of

doctors, hospitals, pharmaceutical companies, and other

appropriate entities” for “possible violations of the

[FDCA].”

B

1

On June 11, 2025, Assistant Attorney General Shumate

served QueerDoc with the present subpoena. The subpoena

14 QUEERDOC, PLLC V. USDOJ

ordered QueerDoc to produce, no later than July 9, 2025, the

following documents:

Request 1: Personnel files for

(i) QueerDoc executives;

(ii) QueerDoc employees or

contractors who are

authorized to prescribe

medications or perform

medical evaluations; and

(iii) QueerDoc employees

or contractors who are

engaged in billing activities.

Requests 2–6: Documents relating to

billing, coding, and

reimbursement practices in

the provision of “gender-

related care” to minors,

including billing records,

insurance claims, internal

protocols, and training

materials.

Requests 7–9: Communications between

QueerDoc and drug

manufacturers, salespeople,

and pharmacies relating to

the use of puberty blockers

and hormones in minors for

the purpose of “gender-

related care.”

Request 10: Records of sponsorships

or contracts between

QUEERDOC, PLLC V. USDOJ 15

QueerDoc and any

manufacturer of puberty

blockers or hormones or any

pharmacy that distributes

these drugs.

Requests 11–13: Patient records for any

patient who was prescribed

puberty blockers or

hormone therapy, including

medical records describing

the basis for the

prescription. For minor

patients who were

prescribed puberty blockers,

documents relating to

informed consent, patient

intake, and parental

authorization, including

disclosures about off-label

use of puberty blockers and

the associated risks.

Requests 14–15: Records of communications

between QueerDoc and

drug manufacturers,

pharmacies, or government

agencies relating to

the safety of puberty

blockers and hormones in

the treatment of minors.

Documents relating to

any adverse effects or

“unfavorable

consequence[s]” of

16 QUEERDOC, PLLC V. USDOJ

“gender-related care” in

minor patients.

The subpoena stated that production of the documents

was “necessary in the performance of the responsibility of

the [DOJ] to investigate Federal health care offenses as

defined in 18 U.S.C. § 24(a).”

On June 26, 2025, QueerDoc’s counsel and three DOJ

attorneys met by videoconference to discuss the subpoena.

QueerDoc’s counsel asked about the basis for DOJ’s

investigation of QueerDoc. One DOJ attorney referred to

the directives contained in EO 14,168, EO 14,187, and the

Bondi Memo, and explained that his office had been “tasked

with investigating potential violations of the [FDCA],” but

did not offer specific reasons for investigating QueerDoc

other than its prominence as a provider of “gender-affirming

care.” DOJ stated that although it would require QueerDoc

to begin production by July 9, it did not expect that

production would be completed by that date.

2

On July 8, 2025, QueerDoc filed a motion to quash the

subpoena in the United States District Court for the Western

District of Washington pursuant to 18 U.S.C. § 3486(a)(5).

See Motion to Quash Subpoena, No. 2:25-mc-00042-JNW

(W.D. Wash., July 8, 2025), ECF Doc. 1. QueerDoc did not

claim that DOJ lacked statutory authority to issue this

subpoena. See id. at 9. QueerDoc instead argued that the

subpoena was unenforceable, irrespective of statutory

authority, because DOJ had issued it for an “improper

purpose.” Id. at 6–9. Alternatively, QueerDoc argued that

the subpoena was invalid because its document requests

QUEERDOC, PLLC V. USDOJ 17

were “overbroad” and compliance with them would be

“unduly burdensome.” Id. at 9–12.

QueerDoc asserted that the “improper purpose” for this

subpoena originated “[a]t the highest levels of government.”

Id. at 8. QueerDoc argued that the “true purpose” of § 8(c)

of EO 14,187 was to “downsize or eliminate all gender-

affirming care.” Id. at 7 (emphasis in original) (internal

quotation marks omitted). QueerDoc contended that

because DOJ issued the subpoena to implement § 8(c) of EO

14,187, it had issued the subpoena to achieve the same goal

as the Administration: to “end” the provision of gender-

affirming care. Id. at 4, 8. Because “[e]nding gender

affirming care” was not a “valid” purpose of a HIPAA

subpoena, QueerDoc argued, this subpoena should be

quashed. Id. at 6–9. QueerDoc did not contend that any of

DOJ’s investigators harbored illicit motives. Rather,

QueerDoc asserted that the Administration’s directives and

public statements themselves were sufficient proof of

improper purpose. Id. at 8–9 (“The Court can—and

should—find improper purpose and bad faith from [the

Administration’s] statements alone.”).

DOJ filed a response arguing that the Administration’s

“position as to gender-related medical treatments for

minors” was not a valid reason to quash the subpoena. DOJ

emphasized that a court’s duty in a subpoena-enforcement

proceeding is to ensure that the investigating agency has

acted pursuant to statutory authority. Because it was

undisputed that HIPAA authorized DOJ to issue the

subpoena, DOJ argued that the district court should enforce

it. See 18 U.S.C. § 3486(c).

Two months after filing its response, and one month

before the district court issued its order quashing the

18 QUEERDOC, PLLC V. USDOJ

subpoena, DOJ tried to supplement the record with a

declaration from Allan Gordus, the Assistant Director of the

Consumer Protection Branch (the “Gordus Declaration”).

The Gordus Declaration explained DOJ’s reasons for

believing that QueerDoc may be engaged in the

“misbranding” of puberty blockers and cross-sex hormones

through false or misleading labeling. DOJ attempted to file

the Gordus Declaration pursuant to a local rule that permits

a party to “add an additional document in support of a

previous filing.” W.D. Wash. Loc. Civ. R. 7(m).

3

On October 27, 2025, the district court quashed the

subpoena in its entirety on the ground that DOJ had issued it

for an “improper purpose.” QueerDoc, PLLC v. U.S. Dep’t

of Just., 807 F. Supp. 3d 1295, 1301–04 (W.D. Wash. 2025).

The district court first analyzed the Administration’s general

policy on “gender-affirming care.” See id. at 1302–03.

Based on EO 14,168, EO 14,187, the Bondi Memo, the

Shumate Memo, and public statements from the

Administration, the district court found that “the

Administration’s explicit agenda” was to “downsize or

eliminate all gender-affirming care.” Id. at 1303 (internal

quotation marks omitted). The district court concluded that

this “agenda” was improper because its objective—“the

elimination of medical care that Washington and other states

explicitly protect”—was one that “the Administration

cannot accomplish . . . .” Id. at 1301. The district court then

imputed that improper purpose to DOJ’s investigation of

QueerDoc: Because DOJ “implemented [the

Administration’s] directives through [the issuance of]

administrative subpoenas,” the district court concluded that

DOJ issued the subpoena to QueerDoc for an “improper

purpose.” Id. at 1302–04.

QUEERDOC, PLLC V. USDOJ 19

The district court also noted that the “mismatch”

between QueerDoc’s business activities and the stated

purpose of the investigation demonstrated the subpoena’s

“pretextual nature.” Id. at 1303. While acknowledging that

“the government need not justify its decision to open an

investigation” in the typical case, the district court subjected

DOJ’s reasoning to a “more muscular review.” Id. at 1302.

Turning to the sufficiency of DOJ’s explanation, the district

court found that DOJ’s “inability to articulate why it is

investigating QueerDoc” “confirm[ed]” that the subpoena

was issued for the improper purpose of ending “gender-

affirming care.” Id. at 1303.

Because the district court quashed the subpoena in its

entirety on improper purpose grounds, it did not reach

QueerDoc’s arguments regarding overbreadth and undue

burden. Id. at 1304. The district court also suggested that

DOJ had issued the subpoena under its valid HIPAA

authority, although QueerDoc had not raised the issue of

statutory authority in its motion to quash. See QueerDoc,

807 F. Supp. 3d at 1301 n.1. Finally, the district court struck

the Gordus Declaration on the ground that it did not comply

with Local Civil Rule 7(m). See id. at 1303 n.2. The district

court noted that it would have quashed the subpoena even if

it had considered the Gordus Declaration, which, in the

court’s view, “further demonstrate[d] the pretextual nature

of the subpoena.” Id.

This appeal followed.

II

We have jurisdiction pursuant to 28 U.S.C. § 1291. In

re Subpoena Duces Tecum, 228 F.3d 341, 346–47 (4th Cir.

2000) (orders enforcing or quashing administrative

subpoenas are “final” because “there is no ongoing judicial

20 QUEERDOC, PLLC V. USDOJ

proceeding that would be delayed by an appeal.”); see

Cobbledick v. United States, 309 U.S. 323, 330 (1940)

(proceedings to enforce administrative subpoenas are “self-

contained, so far as the judiciary is concerned[.]”).

We review the district court’s order quashing an

administrative subpoena for abuse of discretion. McLane

Co. v. EEOC, 581 U.S. 72, 75 (2017). We will uphold the

district court’s findings of fact unless they are “illogical,

implausible, or without support in inferences that may be

drawn from the record.” United States v. Hinkson, 585 F.3d

1247, 1263 (9th Cir. 2009) (en banc). However, “the District

Court’s latitude does not extend to legal issues about what

counts as an illicit motive,” United States v. Clarke, 573 U.S.

248, 256 (2014), and we review such legal issues de novo.

Hinkson, 585 F.3d at 1261–62.

III

We begin by describing a federal court’s authority to

enforce or quash an administrative subpoena before

explaining why the district court exceeded its authority in

this case.

A

An administrative agency’s authority to issue subpoenas

is created by statute. Peters v. United States, 853 F.2d 692,

696 (9th Cir. 1988). Just as Congress delegated to agencies

the power to execute federal law in particular domains,

Congress delegated to certain agencies the “power[] of

original inquiry” to fulfill their statutory mandates. United

States v. Morton Salt Co., 338 U.S. 632, 642 (1950). As part

of this scheme, Congress made federal courts the exclusive

bodies that could enforce, modify, or quash administrative

subpoenas. In re Nat’l Sec. Letter, 33 F.4th 1058, 1063 (9th

QUEERDOC, PLLC V. USDOJ 21

Cir. 2022) (“[W]hile an agency may issue a subpoena

without prior judicial approval, it must invoke the aid of a

federal court to enforce it.”). The scope of a court’s inquiry

during a subpoena-enforcement proceeding, however, is

“strictly limited.” FTC v. Texaco, Inc., 555 F.2d 862, 871–

72 (D.C. Cir. 1977) (en banc). If enforcing a subpoena

entailed rigorous, trial-like proceedings, “the investigative

process [w]ould be completely disrupted,” agencies would

be “diverted from their legitimate duties,” and the “injection

of collateral issues . . . would make the investigation

interminable.” Hannah v. Larche, 363 U.S. 420, 443 (1960).

Hence, these proceedings are “summary in nature.” United

States v. Stuart, 489 U.S. 353, 369 (1989).

The court’s primary role is to ensure that the agency does

not act “arbitrarily or in excess of [its] statutory authority.”

Okla. Press Publ’g Co. v. Walling, 327 U.S. 186, 216 (1946).

The agency bears the initial burden of showing that

(1) Congress empowered the agency to issue investigatory

subpoenas; (2) the agency followed applicable procedures;

and (3) the subpoena sought evidence that could be relevant

and material to a statutorily authorized investigation. United

States v. Golden Valley Elec. Ass’n, 689 F.3d 1108, 1113

(9th Cir. 2012). An affidavit in which the investigating

official declares a legitimate basis for the subpoena is

sufficient to establish the agency’s prima facie case for

enforcement. FDIC v. Garner, 126 F.3d 1138, 1143 (9th

Cir. 1997). Once the agency has established its prima facie

case, the recipient is left with “few defenses” against

enforcement. United States v. Derr, 968 F.2d 943, 945 (9th

Cir. 1992).

One defense is that enforcement of the subpoena would

be an “abusive use of the court’s process” because, although

the subpoena was authorized by statute, the agency issued it

22 QUEERDOC, PLLC V. USDOJ

for an “improper purpose” or in bad faith. United States v.

Powell, 379 U.S. 48, 51, 58 (1964). An “abuse of process”

would occur if a court enforced an administrative subpoena

that the agency had “issued for an improper purpose, such as

to harass [the recipient] or to put pressure on him to settle a

collateral dispute, or for any other purpose reflecting on the

good faith of the particular investigation.” Id. at 58. A party

that seeks to quash a subpoena on this basis bears a “heavy”

burden to produce “specific facts and evidence to support his

allegations of bad faith or improper purpose.” United States

v. Jose, 131 F.3d 1325, 1328 (9th Cir. 1997) (en banc)

(citation and internal quotation marks omitted).

A federal court has the inherent power to ensure that its

process is not abused by a government that acts from illicit

motives. See Powell, 379 U.S. at 58 (“It is the court’s

process which is invoked to enforce the [subpoena], and a

court may not permit its process to be abused.”). The

authority to quash an administrative subpoena when its

enforcement would abuse the court’s process derives from

this inherent power. SEC v. ESM Gov’t Sec., Inc., 645 F.2d

310, 317 (5th Cir. Unit A 1981) (“The equitable powers of

the courts of the United States . . . over their own process, to

prevent abuse, oppression and injustice, are inherent. . . .

The Supreme Court’s directive[] in Powell . . . leave[s] no

doubt that this power may be properly invoked in cases

involving the enforcement of administrative subpoenas.”);

see also Chapman v. Maren Elwood Coll., 225 F.2d 230, 234

(9th Cir. 1955) (explaining that a subpoena-enforcement

proceeding is “equitable in character”). The prohibition

against bad-faith subpoenas is also grounded in the Fourth

Amendment’s requirement that a subpoena be reasonable.

Golden Valley, 689 F.3d at 1113. Whether the authority

QUEERDOC, PLLC V. USDOJ 23

rests on our inherent equitable power or on the Fourth

Amendment, the inquiry remains the same.

The doctrine of “improper purpose” arose from the use

of civil tax summonses by the Internal Revenue Service

(IRS). In the term before it decided United States v. Powell,

the Supreme Court noted that the recipient of an IRS civil

tax summons could raise the defense that the IRS had issued

the summons “for the improper purpose of obtaining

evidence for use in a criminal prosecution.” Reisman v.

Caplin, 375 U.S. 440, 449 (1964). This defense came from

the text of the Internal Revenue Code, which enumerated

four valid purposes of a civil tax summons. See id. at 442

n.1. Moreover, there was a separate concern that if the IRS

used its civil summons authority to obtain information to be

used later in a criminal investigation, it would circumvent

rules of criminal procedure intended to protect the rights of

defendants. See United States v. LaSalle Nat’l Bank, 437

U.S. 298, 312 (1978). Therefore, the Supreme Court held

that the IRS could not issue a civil summons if there was a

“pending criminal charge” or if the IRS was conducting “an

investigation solely for criminal purposes.” Donaldson v.

United States, 400 U.S. 517, 533 (1971). The Supreme

Court later added that the IRS could not use its civil

summons authority in “bad faith,” which would occur if the

IRS issued a summons to investigate potential tax violations

after the IRS had referred those violations to DOJ for

criminal prosecution. LaSalle, 437 U.S. at 311–13, 316.

Although the leading cases on “improper purpose” and

“bad faith” involve the use of IRS civil tax summonses in

connection with criminal investigations, the doctrine also

applies to extreme cases of official misconduct. For

example, it is improper to issue a subpoena solely for the

benefit of a private party, rather than for a public-regarding

24 QUEERDOC, PLLC V. USDOJ

purpose. See United States v. Cortese, 614 F.2d 914, 921

(3d Cir. 1980) (if a private informant was “pursuing its own

business purpose by giving the IRS data,” and the “entire

motivation” for the IRS investigation was this private party’s

information, an improper purpose may exist). An agency

investigator may not issue a subpoena to satisfy a “personal

vendetta.” EEOC v. First Ala. Bank of Birmingham, 440 F.

Supp. 1381, 1385 (N.D. Ala. 1977), aff’d, 611 F.2d 132 (5th

Cir. 1980). Nor may a member of Congress direct an agency

to pursue a “patently frivolous” investigation. See SEC v.

Wheeling-Pittsburgh Steel Corp., 648 F.2d 118, 127–30 (3d

Cir. 1981) (en banc); but see United States v. Am. Target

Advert., Inc., 257 F.3d 348, 355 (4th Cir. 2001) (“[Recipient]

has demonstrated a fair degree of hostility directed toward it

by Senator Pryor. But that is not enough.”). Finally, a court

may not enforce a subpoena based on evidence that the

agency obtained through “fraud, deceit, or trickery,” for

when an agency “invokes the power of a court to gather the

fruits of its deception . . . there is an abuse of process.”

ESM, 645 F.2d at 316–17.

There is no exhaustive list of “improper purposes.”

LaSalle, 437 U.S. at 318 n.20 (“Future cases may well reveal

the need to prevent other forms of agency abuse

of . . . judicial process.”). As a corollary to a court’s inherent

authority to police the integrity of its processes, a court may

recognize and proscribe novel “improper purposes” in the

first instance. See Wheeling-Pittsburgh, 648 F.2d at 124

(“[Just] because the Supreme Court has never confronted

allegations like the ones before us does not mean that the

federal judiciary is powerless to structure relief . . . .”). But

a court’s exercise of this inherent authority must accord with

the thick set of legal principles that limit judicial review of

administrative subpoenas. Cf. Armstrong v. Exceptional

QUEERDOC, PLLC V. USDOJ 25

Child Care Ctr., Inc., 575 U.S. 320, 327–28 (2015) (“‘Courts

of equity can no more disregard statutory and constitutional

requirements and provisions than can courts of law.’”)

(quoting Hedges v. Dixon Cnty., 150 U.S. 182, 192 (1893)).

Our court has long respected those principles of judicial

restraint. Applying them to the present case, we hold that

the district court erred in finding that DOJ had issued the

subpoena for an improper purpose.

B

We first turn to the requirement that DOJ issue an

administrative subpoena pursuant to statutory authority. We

conclude that DOJ did so here.

1

To establish its statutory authority, DOJ had to

demonstrate the following: (1) Congress granted DOJ the

authority to issue investigatory subpoenas; (2) DOJ followed

the relevant procedural requirements; and (3) the evidence

sought by the subpoena was relevant and material to a

statutorily authorized investigation. Golden Valley, 689

F.3d at 1113. It satisfied each requirement.

First, Congress authorized DOJ to issue investigative

subpoenas under HIPAA. 18 U.S.C. § 3486(a)(1)(A)–(B)

(“In any investigation of . . . a Federal health care

offense . . . the Attorney General . . . may issue in writing

and cause to be served a subpoena requiring the

production . . . of any records or other things relevant to the

investigation . . . .”); see also id. § 24(a). Because HIPAA

permits investigations for potential violations of the FDCA’s

misbranding prohibitions, DOJ properly issued its subpoena

under HIPAA. See 21 U.S.C. §§ 331(a)–(c), 352(a), (f).

26 QUEERDOC, PLLC V. USDOJ

Second, DOJ complied with HIPAA’s procedural

requirements. See 18 U.S.C. §§ 3486(a)–(b). The

subpoena’s fifteen document requests and definitions

adequately “describe[d] the objects” that QueerDoc was

required to produce. Id. § 3486(a)(2). The subpoena

“prescribe[d] a return date,” required production at a

location within 500 miles of where QueerDoc was served

with the subpoena, was signed by the Attorney General’s

designee, and was served on QueerDoc’s registered agent.

Id. § 3486(a)–(b).

Third, the subpoena requests were relevant to an

authorized investigation under HIPAA. 18 U.S.C.

§ 3486(a)(1)(B)(i). The question of an administrative

subpoena’s relevance is not one of evidentiary relevance.

Doe v. United States, 253 F.3d 256, 266 (6th Cir. 2001)

(analyzing a HIPAA subpoena). Instead, “[r]elevancy is

determined in terms of the investigation,” Golden Valley,

689 F.3d at 1113, and an agency “may define the boundary

of its investigation quite generally,” CFPB v. Accrediting

Council for Indep. Colls. & Schs. (ACICS), 854 F.3d 683,

690 (D.C. Cir. 2017) (citation and internal quotation marks

omitted). A HIPAA subpoena must be enforced unless the

“evidence sought by the subpoena is plainly incompetent or

irrelevant to any lawful purpose of the agency.” EEOC v.

Karuk Tribe Hous. Auth., 260 F.3d 1071, 1076 (9th Cir.

2001) (citation, alterations, and internal quotation marks

omitted).

DOJ’s subpoena to QueerDoc clears this low bar. As

DOJ explained in its briefing and in the Gordus Declaration,

QueerDoc may itself be misbranding drugs in violation of

QUEERDOC, PLLC V. USDOJ 27

the FDCA. 2 Further, QueerDoc may possess information

relevant to DOJ’s broader investigation of manufacturers

and distributors. See Opening Brief for Appellant 32–38;

Reply Brief for Appellant 6–8; ER 62–73.

As the Gordus Declaration explains, DOJ has questions

about whether QueerDoc is engaged in the misbranding of

puberty blockers and cross-sex hormones. See ER 62–73.

2

In the district court, after briefing on QueerDoc’s motion to quash was

complete, QueerDoc filed a notice of supplemental authority concerning

a recent district court decision that quashed an administrative subpoena.

QueerDoc’s filing indicated, among other things, that quashal had been

proper in that separate case because the government had not filed any

affidavits to show its proper purpose for issuing the subpoena, which

sought information about a hospital’s provision of gender-affirming care.

In response to QueerDoc’s filing, DOJ sought leave to file the Gordus

Declaration. DOJ explained that “[b]ecause QueerDoc supplemented its

original filing with additional authority to suggest the government issued

the administrative subpoena for an improper purpose and may need ‘an

affidavit[] or other evidence to show proper purpose,’ the United States

asks this Court to permit the filing” of the Gordus Declaration. The

Gordus Declaration did no more than expand upon DOJ’s previously

stated positions in response to QueerDoc’s assertion that DOJ had to

provide further information to justify the subpoena. The district court

struck the Gordus Declaration. QueerDoc, 807 F. Supp. 3d at 1303 n.2.

But it did so after imposing a “more muscular review” of DOJ’s asserted

purpose, id. at 1302, a standard that cannot be reconciled with our case

law, which establishes that judicial review of an administrative subpoena

is “quite narrow.” Golden Valley, 689 F.3d at 1113 (citation omitted).

Having imposed an improperly high standard, the district court should

have permitted DOJ to meet that standard. Moreover, the district court

itself considered the effect of the Gordus Declaration on the merits of the

case, finding that the declaration “further demonstrate[d] the pretextual

nature of the subpoena.” QueerDoc, 807 F. Supp. 3d at 1303 n.2. Even

if the district court did not err in striking the Gordus Declaration, we

exercise our discretion to consider it. QueerDoc has long had notice of

the declaration and an opportunity to respond to it, and the declaration

merely expands on DOJ’s previously stated positions.

28 QUEERDOC, PLLC V. USDOJ

QueerDoc’s webpages promote the off-label use of these

drugs, instruct users how to administer them, tell users where

to obtain them, and claim that any effects are “completely

reversible.” QueerDoc, Self-Injections; QueerDoc,

Pharmacy Options; QueerDoc, Youth Gender Care.

According to DOJ, these statements may qualify as

“labeling” of puberty blockers and cross-sex hormones

under the FDA’s broad definition of that term. See 21 C.F.R.

§ 202.1(l)(2). DOJ further maintains that promotion of a

drug for off-label uses may violate the FDCA if that

promotion constitutes “false or misleading” “labeling” of

that drug. 21 U.S.C. §§ 331(a), 352(a). Finally, QueerDoc’s

website suggests that it may be engaged in fraudulent billing

practices. See QueerDoc, Pharmacy Options (“We usually

order prescriptions under the diagnosis of ‘endocrine

disorder’ not ‘gender dysphoria[.]’”). 3

Under this theory of the investigation, the personnel files

and training materials sought in Request 1 are relevant

because they may help DOJ identify the individuals

responsible for any unlawful billing, prescribing, or labeling

practices. Requests 2 through 6, which seek records of

billing, coding, and reimbursement practices, are relevant to

determining whether QueerDoc disguised treatment for

gender dysphoria as treatment for another illness, which

could demonstrate an “intent to defraud or mislead” under

21 U.S.C. § 333(a)(2). Requests 14 and 15, which seek

communications with drug manufacturers and distributors

about possible adverse effects of these drugs, are relevant to

3

Endocrine disorders are conditions caused by imbalances in hormone

levels or by the body’s inability properly to utilize hormones. Common

types include diabetes, thyroid diseases, and pituitary or adrenal

disorders. Such disorders appear to be quite different from “gender

dysphoria.”

QUEERDOC, PLLC V. USDOJ 29

establishing conspiracy as well as intent and knowledge

regarding the potential falsity of QueerDoc’s statements.

Further, the subpoena requests may be relevant because they

could help DOJ determine whether QueerDoc’s conduct

falls within DOJ’s regulatory jurisdiction. Fed. Mar.

Comm’n v. Port of Seattle, 521 F.2d 431, 434 (9th Cir. 1975)

(“[An] agency has the power to obtain the facts requisite to

determining whether it has jurisdiction over the matter

sought to be investigated.”).

Other requests are relevant not because they concern

QueerDoc’s own potential FDCA violations, but because

they seek information that QueerDoc may possess about

other actors in DOJ’s broader FDCA investigation, such as

manufacturers and distributors of puberty blockers and

cross-sex hormones. Drug manufacturers and distributors

may violate the FDCA by shipping drugs into interstate

commerce with the intent that they be used for an off-label

purpose. See 21 U.S.C. §§ 352(a), (f)(1), 355(a).

Communications between manufacturers and QueerDoc

might produce evidence of a manufacturer’s “knowledge”

that puberty blockers are “offered or used” for an off-label

purpose. 21 C.F.R. § 201.128. Promotional materials or

communications with sales representatives may also be

valuable evidence. See, e.g., Press Release, U.S. Dep’t of

Justice, Genzyme Corporation to Pay $32.5 Million to

Resolve Criminal Liability Relating to Seprafilm (Sep. 3,

2015), https://perma.cc/2V3Y-9SDG (conduct of “sales

representatives” and distribution of “promotional material”

relevant to misbranding charges under the FDCA). Requests

7 through 10, which seek records of communications with

manufacturers and sales representatives regarding the use of

puberty blockers or hormones, are thus relevant to an

authorized HIPAA investigation. Requests 11 through 13,

30 QUEERDOC, PLLC V. USDOJ

which seek patient records, may produce evidence about the

scale of any misconduct and about whether QueerDoc or

another party concealed the risks or failed to warn about the

potential adverse effects of “gender-affirming care.”

Applying a greater degree of scrutiny to the relevance of

each subpoena request would undermine Congress’s

decision to empower DOJ to investigate potential violations

of federal health care laws. See 18 U.S.C. § 3486(a)(1).

DOJ cannot know what information it may need to prove an

eventual violation or which entities it may wish to prosecute.

That is why it has the power to investigate. Hence, “[t]he

initial determination of what information is reasonably

relevant is left to the investigating agency.” In re Gimbel,

77 F.3d 593, 601 (2d Cir. 1996). We defer to the agency’s

assessment of relevance and intervene only in the extreme

case in which a subpoena seeks information that is “plainly

incompetent or irrelevant to any lawful purpose” of the

agency. Port of Seattle, 521 F.2d at 434 (quoting Endicott

Johnson Corp. v. Perkins, 317 U.S. 501, 509 (1943)). To

require any higher quantum of proof would be illogical. It

would tell an agency that it must prove what, at this stage,

the agency can do no more than suspect.

DOJ met its slight burden of demonstrating relevance, as

the district court suggested. QueerDoc, 807 F. Supp. 3d at

1301 n.1 (concluding that the subpoena “calls for the

production of documents relevant to an investigation” under

HIPAA). We therefore hold that DOJ issued the subpoena

pursuant to statutory authority.

2

The counterarguments raised by QueerDoc and the

dissent are unavailing. The gravamen of these arguments is

that DOJ’s investigation exceeds the substantive reach of the

QUEERDOC, PLLC V. USDOJ 31

FDCA. See Brief for Appellee 43–52; Dissent 62–64, 75–

77. Such arguments are premature at this stage in the

proceedings, so they do not support quashing the subpoena.

a

“[C]ourts must enforce administrative subpoenas unless

‘the evidence sought by the subpoena is plainly incompetent

or irrelevant to any lawful purpose of the agency.’” Karuk

Tribe, 260 F.3d at 1076 (brackets and internal quotation

marks omitted) (quoting Port of Seattle, 521 F.2d at 433–

34). “Although a party may not avoid an administrative

subpoena on the ground that it has a valid defense to a

potential subsequent lawsuit, such a challenge may, in

limited circumstances, be mounted when the defense raised

is ‘jurisdictional’ in nature—i.e., when the agency lacks

jurisdiction over the subject of the investigation.” Id. at

1076–77. However, at the subpoena-enforcement stage, any

“factual challenges based on a lack of statutory ‘coverage’

are clearly not permitted.” Id. at 1077 (citation omitted).

QueerDoc argues that DOJ’s investigation is infirm for

several reasons: (1) the statements on its website do not

constitute “labeling” under the FDCA; (2) the FDCA does

not regulate the act of prescribing drugs for off-label uses;

(3) applying the FDCA’s “misbranding” prohibition to

QueerDoc’s statements on its website would violate its First

Amendment right to freedom of speech; and (4) interpreting

the FDCA to reach the prescribing of drugs for an off-label

use would violate principles of federalism. These arguments

all raise potential defenses to liability under the FDCA and

are therefore unripe for decision at this early point in the

investigation, when DOJ has not initiated any enforcement

action against QueerDoc. Karuk Tribe, 260 F.3d at 1076;

see also EEOC v. Shell Oil Co., 466 U.S. 54, 72 n.26 (1984)

32 QUEERDOC, PLLC V. USDOJ

(“[A]ny effort by the court to assess the likelihood that the

[commission] would be able to prove the claims made in the

charge would be reversible error.”).

The contrary approach urged by QueerDoc and our

dissenting colleague would require us to decide thorny

questions of statutory and constitutional law at this

preliminary stage in the proceedings. For instance, if an

online medical clinic prescribes a drug to its patients and

publishes articles on its website that instruct the public about

using that drug, do those articles constitute “labeling” of the

drug under the FDCA? See Brief for Appellee 43–45;

Dissent 76–77. Such “novel and complex” questions are

“especially ill-suited to a premature and absolute

pronouncement” at the subpoena-enforcement stage. EEOC

v. Mar. Autowash, Inc., 820 F.3d 662, 667 (4th Cir. 2016)

(Wilkinson, J.). Although these defenses may prevail if

QueerDoc raises them in a later enforcement action, it is

uncertain whether DOJ will ever bring such an action. A

claim that depends on “contingent future events that may not

occur as anticipated, or indeed may not occur at all” is “not

ripe for adjudication.” Texas v. United States, 523 U.S. 296,

300 (1998) (citations omitted).

b

We also reject the argument that the subpoena amounts

to an unauthorized “fishing expedition.” Brief for Appellee

52–55; see Dissent 63–64. Relying on our decision in Peters

v. United States, QueerDoc contends that DOJ may not use

a HIPAA subpoena to obtain information about third parties.

853 F.2d 692 (9th Cir. 1988). Thus, according to QueerDoc,

the subpoena requests that seek information about drug

manufacturers and distributors are statutorily invalid

because they do not relate to an investigation of QueerDoc

QUEERDOC, PLLC V. USDOJ 33

itself. But QueerDoc overreads Peters. That decision did

not establish a general prohibition against administrative

subpoenas that sought information about persons other than

the subpoena’s recipient. Indeed, such a rule would

contradict the recognized principle that an agency need not

“charge first and investigate later.” Reich v. Mont. Sulphur

& Chem. Co., 32 F.3d 440, 444 (9th Cir. 1994). Since

Peters, we have upheld subpoenas that sought information

about unidentified targets. See, e.g., Golden Valley, 689

F.3d at 1115.

Rather, Peters involved a subpoena that was

unenforceable because it furthered a “general investigation

of unnamed individuals” and was therefore too indefinite.

See 853 F.2d at 699–700. The subpoena in Peters did not

specify which laws the agency suspected were being violated

and did not name the parties under investigation. See id. at

694–96. Indefinite subpoenas, like the one in Peters, remain

subject to quashal. But we are not faced with an “indefinite”

subpoena here. DOJ’s subpoena sought specific records

(communications, billing, coding, and reimbursement

practices) for specific patients (minors) for specific drugs

(puberty blockers and cross-sex hormones) from a specific

entity (QueerDoc) for an investigation of a specific set of

FDCA violations (misbranding). Moreover, unlike the

subpoena recipient in Peters, QueerDoc operates its business

in the highly integrated pharmaceutical industry. DOJ must

have some flexibility in subpoenaing downstream actors in

such a complex supply chain to effectuate its investigation.

See Texaco, 555 F.2d at 877 (“[A] wide range of

investigation is necessary and appropriate where, as here,

multifaceted activities are involved, and the precise

character of possible violations cannot be known in

advance.”).

34 QUEERDOC, PLLC V. USDOJ

C

Because DOJ established its prima facie case for

enforcement of the subpoena, QueerDoc bore a “heavy”

burden to produce “specific facts and evidence to support

[its] allegations of bad faith or improper purpose.” Jose, 131

F.3d at 1328 (citation and internal quotation marks omitted).

The district court found that QueerDoc had discharged its

heavy burden. That was an error.

It is undisputed that the Administration opposes the

provision of “gender-affirming care” to minors. See

Opening Brief for Appellant 3 (“The President has serious

moral and policy objections to the practice of subjecting

minors to these interventions[.]”). Those views are not

“improper.” As QueerDoc’s counsel conceded at oral

argument, the President may have moral and political

objections to gender-affirming care, wish to end it, and take

steps to achieve that goal consistent with law. See Oral

Argument at 18:18–18:52, QueerDoc, PLLC v. U.S. Dep’t of

Just. (No. 25-7384), https://perma.cc/4NRE-Z3CT. 4

4

The full exchange from oral argument is below:

COUNSEL: These subpoenas were issued as part

of the Administration’s larger effort to

end gender-affirming care.

JUDGE BEA: Is that an improper motive for the

Executive? To end gender-affirming

care?

COUNSEL: Your Honor, the Executive issued an

Executive Order stating that they

wanted to “end” gender-affirming

care, calling it a “stain on the nation’s

history.” That, in and of itself, is not

improper—

QUEERDOC, PLLC V. USDOJ 35

The district court nonetheless inferred an improper

purpose for DOJ’s investigation because of the

Administration’s policy views and enforcement priorities.

QueerDoc presented no evidence of any other improper

purpose to the district court, such as a desire to benefit one

of QueerDoc’s market competitors or to settle some

collateral dispute. See Motion to Quash, supra, at 8. On

appeal, QueerDoc maintains that “the government’s

statements . . . alone” demonstrate improper purpose. Brief

for Appellee 32. But there is nothing improper about a

President having policy preferences and directing the

Executive Branch to enforce federal law in a manner

consistent with those preferences. Because QueerDoc

provided no additional evidence of improper purpose and the

district court overread the government’s public statements in

finding an improper purpose, we reverse.

1

First, the Administration’s policy views and objectives

were not themselves “improper.”

The use of puberty blockers and cross-sex hormones on

minors is the subject of “fierce scientific and policy

debates.” Skrmetti, 605 U.S. at 525. Many states have

codified protections for “gender-affirming care.” See Brief

for State of Washington et al. as Amici Curiae 6–7 & n.8.

These protections reflect the view of many leading medical

associations that “hormones and puberty blockers are

‘appropriate and medically necessary’ to treat gender

dysphoria.” Skrmetti, 605 U.S. at 582 (Sotomayor, J.,

JUDGE BEA: —not an improper motive, right?

COUNSEL: Certainly. The Administration can

have that as a policy goal and can take

steps to achieve that policy goal.

36 QUEERDOC, PLLC V. USDOJ

dissenting). In contrast, more than 20 states have banned or

limited the provision of sex-transition treatments to minors.

Id. at 504–05 (majority). Similarly, health authorities in

many developed nations have limited the use of these

treatments for minors, citing a lack of evidence supporting

their efficacy. See id.; see also Pamela Paul, As Kids, They

Thought They Were Trans. They No Longer Do., N.Y. TIMES

(Feb. 2, 2024), https://perma.cc/VG68-Q79G (“[In] Sweden,

Norway, France, the Netherlands and Britain . . . medical

professionals have recognized that early research on medical

interventions for childhood gender dysphoria was either

faulty or incomplete.”). The efficacy and long-term risks of

these treatments are uncertain. 5 The off-label use of puberty

blockers to treat gender dysphoria may adversely affect a

minor patient’s bone density, brain development, and

fertility; the off-label use of cross-sex hormones may harm a

5

In March 2026, Finnish researchers published a study based on data

from 2,100 Finns who sought care from a gender clinic between 1996

and 2019 before they reached age 23. See S.-M. Ruuska, K. Tuisku, T.

Holttinen, and R. Kaltiala, Psychiatric Morbidity Among Adolescents

and Young Adults Who Contacted Specialised Gender Identity Services

in Finland in 1996–2019, 115 Acta Paediatrica 1545, 1545–53 (2026).

The study found that among these youths—who showed sufficient signs

of gender dysphoria to seek care from a gender clinic—those who

underwent a medical gender transition were much more likely to seek

specialist psychiatric care later. See id. at 1545 (“Among adolescents

who underwent medical gender-reassignment, psychiatric morbidity

increased markedly.”). Among males in that group, 10 percent had

sought specialist psychiatric care before treatment, whereas 61 percent

did so after treatment. Id. Among females, the proportion rose from 22

percent to 55 percent. Id. As this study demonstrates, there is some

disagreement among professionals as to whether gender-affirming care

necessarily “improves mental health outcomes and reduces suicide risk

in transgender youth.” Brief for American Academy of Pediatrics as

Amicus Curiae 8–11.

QUEERDOC, PLLC V. USDOJ 37

patient’s sexual organs and increase his risk of cancer. See

Skrmetti, 605 U.S. at 534–35 (Thomas, J., concurring).

The district court found that the Administration sought

to “eliminate all gender-affirming care.” QueerDoc, 807 F.

Supp. 3d at 1303 (internal quotation marks and citation

omitted). Although the subpoena here was validly based on

an investigation of health care law violations, the goal of

ending “gender-affirming care” is not in and of itself an

“improper” policy objective. It is not so irrational or

arbitrary as to be ultra vires. The Administration is entitled

to adopt a position on either side of this “ongoing debate

among medical experts,” Skrmetti, 605 U.S. at 523, and to

pursue policies consistent with that position. A district court

has no warrant to override the President’s judgment on a

disputed matter of public policy. It is for the American

people, through the democratic process, to decide whether a

President’s views on such topics and the policies that result

from those views are “improper.”

The district court nevertheless concluded, with little

explanation, that the President’s opposition to “gender-

affirming care” was an improper objective. See QueerDoc,

807 F. Supp. 3d at 1301. The district court noted that

“[a]lmost every court and medical organization to address

the issue has recognized the benefit of providing gender

affirming care to individuals suffering from gender

dysphoria” and that “[s]everal states have codified

protections for gender-affirming care.” Id. (simplified). But

the President is entitled to a contrary view in an unsettled

scientific debate. Further, the Administration’s policy need

not be justified on “scientific” grounds alone. The

Administration may also consider ethical and philosophical

perspectives regarding the relationship between gender

identity and biological sex. See Skrmetti, 605 U.S. at 540

38 QUEERDOC, PLLC V. USDOJ

(Thomas, J., concurring) (“Setting aside whether sex-

transition treatments for children are effective, States may

legitimately question whether they are ethical.” (emphases

in original)); Loe, 692 S.W.3d at 239 (Blacklock, J.,

concurring) (explaining that the debate around gender-

affirming care for minors is not just a scientific question but

also “one of philosophy, morality, even religion.”).

Second, the Administration’s directives to DOJ to carry

out this policy did not render DOJ’s subpoena “improper.”

DOJ’s actions are “entitled to a presumption of

regularity.” Citizens to Preserve Overton Park, Inc. v.

Volpe, 401 U.S. 402, 415 (1971). This “long-standing”

principle holds that “in the absence of clear evidence to the

contrary,” a court presumes that government officials

“properly discharged their official duties.” Cruz v. Bondi,

146 F.4th 730, 739 (9th Cir. 2025) (quoting United States v.

Chem. Found., Inc., 272 U.S. 1, 14–15 (1926)). Yet the

district court inferred from the Administration’s general

opposition to gender-affirming care, along with its directives

to DOJ to issue subpoenas to providers of such care, that

DOJ had “issue[d] [the] subpoena not to investigate legal

violations but to intimidate and coerce [QueerDoc] into

abandoning lawful medical care.” QueerDoc, 807 F. Supp.

3d at 1299 (emphasis in original). In doing so, the district

court improperly disregarded the presumption of regularity.

Executive Order 14,187 directed DOJ to “prioritize

investigations” into entities that may be “misleading the

public about long-term side effects” of gender-affirming

care. 90 Fed. Reg. 8771, § 8(c). The Order also stated that

it “shall be implemented consistent with applicable law.” Id.

§ 11(b). The Bondi Memo directed DOJ to conduct only

“appropriate investigations” of potential FDCA violations.

QUEERDOC, PLLC V. USDOJ 39

To the extent that the directives ordered DOJ to end “gender-

affirming care,” they ordered DOJ to pursue that goal within

the bounds of the law. They did not order DOJ to act ultra

vires.

According to QueerDoc’s declaration, DOJ’s attorneys

stated that they were investigating QueerDoc because of the

directives contained in EO 14,168, EO 14,187, and the

Bondi Memo. But the fact that DOJ acted pursuant to these

high-level directives is not evidence that DOJ acted with an

improper purpose, since a court has no warrant to presume

that an agency carried out lawful directives in an unlawful

manner. See Ross and Morrison v. Reed, 14 U.S. 482, 486

(1816) (“It is a general principle to presume that public

officers act correctly until the contrary be shown.”).

Likewise, although DOJ officials did not give QueerDoc a

detailed justification for their investigation, they provided

QueerDoc with notice that their investigation related to

possible FDCA violations. That answer did not demonstrate

that DOJ was proceeding improperly. DOJ was not

obligated to divulge confidential information about its

investigation to QueerDoc, which was itself a subject of the

investigation. See United States v. Whispering Oaks

Residential Care Facility, LLC, 673 F.3d 813, 818 (8th Cir.

2012) (involving a HIPAA subpoena) (“[Recipient] cites no

legal authority for requiring the Government to justify its

administrative subpoenas by revealing the identity of any

informants, the information those informants may have

provided, or any other facts revealing the motives behind a

lawful investigation.”). Even the district court recognized

this principle when it explained that “the government need

not justify its decision to open an investigation.” QueerDoc,

807 F. Supp. 3d at 1302.

40 QUEERDOC, PLLC V. USDOJ

The district court should not have inferred DOJ’s bad

faith from political advocacy statements made by

government officials. Cf. Mullin v. Doe, No. 25-1083, 609

U.S. ____, 2026 WL 1825840, at *12 (U.S. June 25, 2026)

(“Political discourse by prominent public figures is

increasingly couched in terms that would have scandalized

the public just a short time ago. . . . But whatever one may

think of the cited statements, they are insufficient to show

that the [government acted out of animus].”). Given our

narrow review of administrative subpoenas and the heavy

burden required to demonstrate an improper purpose, these

public statements—coupled with important qualifying

language and the presumption of regularity—cannot taint an

otherwise valid government investigation. See Golden

Valley, 689 F.3d at 1113; Jose, 131 F.3d at 1328. And

QueerDoc presented no evidence of impropriety besides the

Administration’s public statements and directives. For

instance, QueerDoc proffered no evidence that DOJ acted on

behalf of one of QueerDoc’s market competitors, that DOJ

pursued a “claim it knows it cannot win” merely to satisfy

an ill-disposed senator, or that one of DOJ’s investigators

issued the subpoena merely to settle a “personal vendetta”

against QueerDoc. See, e.g., Cortese, 614 F.2d at 921;

Wheeling-Pittsburgh, 648 F.2d at 127; First Ala. Bank of

Birmingham, 440 F. Supp. at 1385.

In sum, QueerDoc did not provide “specific evidence of

improper intent,” Garner, 126 F.3d at 1146, and therefore

failed to carry its “heavy” burden to demonstrate that DOJ

issued the subpoena for an improper purpose. Jose, 131 F.3d

at 1328.

QUEERDOC, PLLC V. USDOJ 41

2

The district court’s finding of improper purpose was

erroneous. Equally misguided, however, was the district

court’s intrusion upon the President’s core constitutional

power to set law enforcement priorities and to order his

subordinate officers to carry out these enforcement

priorities.

To fulfill the President’s duty to “take Care that the Laws

be faithfully executed,” U.S. Const. art. II, § 3, “the

Executive Branch must prioritize its enforcement efforts.”

United States v. Texas, 599 U.S. 670, 679 (2023). The

Executive Branch lacks the resources to investigate every

potential violator of every law and must adapt its

enforcement priorities to the “ever-shifting public-safety and

public-welfare needs of the American people.” Id. at 680.

The Constitution therefore vests in the President the

“‘exclusive authority and absolute discretion’ to decide

which crimes to investigate and prosecute.” Trump v. United

States, 603 U.S. 593, 620 (2024) (quoting United States v.

Nixon, 418 U.S. 683, 693 (1974)). Further, although the

Constitution vests the entirety of the executive power in the

President, U.S. Const. art. II, § 1, “the President alone and

unaided could not execute the laws . . . [h]e must execute

them by the assistance of subordinates.” Myers v. United

States, 272 U.S. 52, 117 (1926). “[B]y virtue of the general

grant to him of the executive power,” the President may

exercise “administrative control” over executive officers,

which includes the power to “supervise” executive officers

and “guide their construction of the statutes under which

they act.” Id. at 135.

Here, the President established the Executive Branch’s

general policy of enforcing the FDCA against providers of

42 QUEERDOC, PLLC V. USDOJ

gender-affirming care in § 8(c) of EO 14,187. Subsequently,

his subordinates implemented this policy at increasing levels

of specificity through the Bondi Memo, the Shumate Memo,

and, ultimately, the investigation of QueerDoc. Indeed,

DOJ’s attorneys told QueerDoc that this investigation

proceeded because of the President’s executive orders, the

Bondi Memo, and the Shumate Memo. This sequence

reflects the ordinary operation of the Executive Branch. The

President sets broad policy that his subordinates

implement at increasingly specific levels down the

organizational hierarchy. See Trump v. Slaughter, No. 25-

332, 609 U.S. ____, 2026 WL 1855612, at *7 (U.S. June 29,

2026) (“The Constitution . . . establish[ed] a hierarchy—a

‘Chief Magistrate’ with whom the buck stops, and below

him various ‘assistants or deputies’ who ‘derive their offices

from his appointment’ and remain ‘subject to his

superintendence.’” (quoting The Federalist No. 72, p. 436

(C. Rossiter ed. 1961) (A. Hamilton))).

Yet the district court found that the Administration’s

opposition to the general practice of gender-affirming care

made any investigation that advanced this policy

“pretextual” and “improper.” QueerDoc, 807 F. Supp. 3d at

1303. The district court’s reasoning would require

subordinate executive officers either to act independently of

and contrary to the President’s policies or to refrain from

acting altogether. Either course would undermine the

President. Such reasoning would lead to a disordered

government, in which the President could neither

“supervise” executive officers nor “guide their construction

of the statutes under which they act.” Myers, 272 U.S. at

117, 135.

Further, if a President’s stated policy views are evidence

of improper purpose, as the district court held, the

QUEERDOC, PLLC V. USDOJ 43

administration of the federal government would crumble.

Every President has law enforcement priorities, just as every

President has signature policies (often, the former are

components of the latter). Consider a hypothetical that the

parties raised in their briefs: A President opposes online

sports gambling platforms because he believes that they

foster addiction and cause financial ruin, thereby harming

the public welfare. This President uses his bully pulpit to

advocate for comprehensive legislation that bans these

platforms, but as the legislative process grinds along, he also

uses existing tools of federal law to hold these platforms

accountable. Would it be “improper” for an IRS agent to

issue an otherwise valid civil tax summons to a gambling

company? Would the FTC be unable to investigate that

company for allegedly misleading gambling

advertisements? The district court’s reasoning, which

contains no limiting principle, would deem such actions

improper. That approach enables the federal judiciary to

intrude on some of the President’s fundamental prerogatives:

his decisions about which policies to advance, how to

allocate scarce law-enforcement resources, and how to

articulate his policies to the public. That approach is clearly

wrong and underscores the magnitude of the district court’s

error.

3

None of the counterarguments raised by the dissent,

QueerDoc, the court below, or QueerDoc’s amici gives us

any reason to believe that an improper purpose exists here.

a

We reject the contention that DOJ’s allegedly “post hoc”

attempts to justify the subpoena illustrate the improper

purpose for which it was issued. Brief for Appellee 37; Brief

44 QUEERDOC, PLLC V. USDOJ

for Former DOJ Attorneys as Amici Curiae 17–23; Dissent

73–78.

This argument invokes the “foundational principle of

administrative law,” which holds “that a court may uphold

agency action only on the grounds that the agency invoked

when it took the action.” Michigan v. EPA, 576 U.S. 743,

758 (2015) (citing SEC v. Chenery Corp., 318 U.S. 80, 87

(1943)). But the rule against “post hoc justifications” does

not apply in this case because DOJ’s investigatory purpose

as to QueerDoc has remained constant throughout: to

investigate potential violations of the FDCA’s misbranding

provisions. Indeed, from EO 14,187 to the Shumate Memo,

the government has consistently stated that its investigation

involved possible “violations of the [FDCA] by any entity

that may be misleading the public about long-term side

effects of chemical and surgical mutilation,” 90 Fed. Reg.

8771, § 8(c), including “doctors, hospitals, pharmaceutical

companies, and other appropriate entities,” ER 55–56

(Shumate Memo).

Moreover, an agency investigation is dynamic. The

agency’s reasons for issuing a subpoena to a party may

change as its investigators acquire new information.

Requiring an agency to justify itself at the outset and to

adhere to that justification throughout the investigation

would frustrate the agency’s investigatory function. United

States v. Tan, 16 F.4th 1346, 1352 (9th Cir. 2021)

(“[Requiring] specificity ahead of time could hinder the

investigation by . . . foreclosing the pursuit of new, relevant

avenues of inquiry that come to light . . . .”). So, absent a

clear statutory mandate, we do not require agencies to

“charge first and investigate later.” Reich, 32 F.3d at 444;

see also EPA v. Alyeska Pipeline Serv. Co., 836 F.2d 443,

447 (9th Cir. 1988), overruled on other grounds by McLane,

QUEERDOC, PLLC V. USDOJ 45

581 U.S. at 80–81 (“EPA need not allege that it has a

suspicion or has knowledge of any facts indicating that the

law has been violated.”).

HIPAA imposes no such mandate on DOJ. See 18

U.S.C. § 3486(a). HIPAA authorizes DOJ to issue

investigative subpoenas to enforce a limited set of laws and

to do so in accordance with specified procedures, but it does

not require DOJ to issue a formal charge against a suspected

wrongdoer as a predicate to exercising this power. See id.

§§ 24(a), 3486. Congress included a pre-investigation

charging requirement in other statutes, such as Title VII,

which permits the EEOC to issue an investigatory subpoena

only after a “sworn charge of discrimination” has been filed.

Univ. of Penn. v. EEOC, 493 U.S. 182, 190 (1990). The

absence of such a requirement under HIPAA reflects

Congress’s judgment about the proper balance between

efficient agency investigations and the risk of governmental

abuse in federal health care investigations. We have no

warrant to amend HIPAA to add restrictions on DOJ’s

investigatory power. Cf. Vermont Yankee Nuclear Power

Corp. v. NRDC, 435 U.S. 519, 549 (1978) (“The court

should . . . not stray beyond the judicial province . . . to

impose upon the agency its own notion of which procedures

are ‘best’ or most likely to further some vague, undefined

public good.”).

b

We also reject the contention that the purported breadth

of the subpoena and its alleged incongruence (“mismatch”)

with DOJ’s FDCA theory of investigation were probative of

the agency’s bad faith. QueerDoc, 807 F. Supp. 3d at 1303–

04; Brief for Appellee 35; Dissent 80–85.

46 QUEERDOC, PLLC V. USDOJ

To the extent that any overbreadth or mismatch could

help establish improper purpose in the abstract, these

considerations do not support the district court’s improper

purpose determination in this case. There was no mismatch

between the government’s investigation and QueerDoc’s

activities. Hence, DOJ made out its prima facie case that the

subpoena was statutorily authorized. See Golden Valley, 689

F.3d at 1113, 1115. QueerDoc need not be a manufacturer

or distributor to receive the HIPAA subpoena at issue here.

As DOJ explained in the Gordus Declaration, certain

statements on QueerDoc’s website may themselves violate

the FDCA’s misbranding provisions. See 21 U.S.C.

§ 352(a). Given the labyrinthine supply chains in the

pharmaceutical industry and the corresponding complexity

of federal health care investigations, DOJ must have the

flexibility to seek information from ancillary entities, such

as QueerDoc, that may possess relevant information that

could help establish FDCA misbranding violations by

upstream entities such as manufacturers and distributors.

Nor does the breadth of the subpoena’s production

requests suggest bad faith in this case. As explained above,

the subpoena seeks information relevant to potential FDCA

misbranding violations. That relevance is sufficient to

establish DOJ’s prima facie case for enforcing the subpoena.

The dissent’s principal concern is with the subpoena’s

requests for patient information, which make up only three

of the fifteen document requests. See Dissent 80–82. But

even if the subpoena is overbroad—an issue the district court

did not reach and the parties briefed only minimally—the

proper remedy would be to narrow it, not to quash it in its

entirety, as the district court did here. See Morton Salt, 338

U.S. at 653–54; In re Subpoena Duces Tecum, 228 F.3d at

349.

QUEERDOC, PLLC V. USDOJ 47

c

We reject the argument, advanced by QueerDoc and its

amici, that the Administration’s policy was improper

because it conflicts with Washington state law, which

authorizes the provision of “gender-affirming care” to

minors. See Brief for Appellee 42 (“DOJ issued this

subpoena to end medical care that is lawful under the laws

of numerous states.”); see also Brief for Former DOJ

Attorneys as Amici Curiae 19–20; Brief for State of

Washington et al. as Amici Curiae 4–13. Whether an activity

is authorized by state law is irrelevant to determining the

lawful authority for a federal investigation, because federal

law is supreme. U.S. Const. art. VI, cl. 2. The State of

Washington cannot shield a resident company from having

to comply with federal law.

QueerDoc and its amici might be understood to argue

that DOJ’s interference with lawful state activities suggests

that DOJ exceeded its authority under the FDCA. Under this

view, an interpretation of the FDCA that permits DOJ to

encroach upon the practice of medicine might exceed

Congress’s enumerated powers. Whatever the merits of

such arguments, they are “defense[s] to a potential

subsequent lawsuit” and are thus premature at the subpoena-

enforcement stage. Karuk Tribe, 260 F.3d at 1077–78

(citing Endicott Johnson, 317 U.S. at 509). Further, those

arguments likely have no bearing on the “improper purpose”

inquiry, which is distinct from the question of statutory

authority. See Miccosukee Tribe of Indians of Fla. v. United

States, 698 F.3d 1326, 1331–32 (11th Cir. 2012)

(distinguishing a subpoena’s “underlying validity” from

whether the subpoena was issued for an improper purpose);

Mazurek v. United States, 271 F.3d 226, 231 (5th Cir. 2001)

(“Mazurek incorrectly conflates his challenge to [the

48 QUEERDOC, PLLC V. USDOJ

agency’s statutory authority] and the alleged illegitimacy of

the [agency’s] investigation.”).

d

We respectfully disagree with our dissenting colleague,

who contends that we must be “highly deferential” to the

district court’s “factual determination” that DOJ issued the

subpoena for an improper purpose. Dissent 66. The issue

here is not one of fact. The district court conducted no

evidentiary hearings and took no testimony. Instead, the

district court relied on the Administration’s public

statements to infer an improper purpose on the part of DOJ.

That did not amount to fact-finding but rather the drawing of

legal conclusions from undisputed facts.

There is no dispute that the current Administration has a

policy objective of ending gender-affirming care. See

Opening Brief for Appellant 27 (“It is certainly uncontested

that the President, the Attorney General, and others in the

administration have expressed strong moral, ethical, and

policy opposition to [gender-affirming care.]”). However,

the questions before us on appeal are whether the Executive

Branch’s public-facing statements reflecting a general

policy objective can establish an improper purpose, and

further, whether the Executive Branch’s policy statements

can undermine an otherwise valid subpoena. It is simply of

no moment that the district court found that DOJ acted for

the purpose of ending gender-affirming care, because that

finding was based on several misapprehensions about “what

counts as an illicit motive” of the government, which are

“legal issues” that we review de novo. Clarke, 573 U.S. at

256. For two reasons, the dissent errs in its resolution of

these legal issues.

QUEERDOC, PLLC V. USDOJ 49

First, as discussed above, the Administration’s general

policy objective of ending gender-affirming care in a manner

consistent with existing law is not an “improper purpose.”

See supra Part III(C)(1). It bears repeating that not even

QueerDoc’s counsel contends that this policy goal was

improper. See supra note 4; Oral Argument at 18:18–18:52.

Indeed, the dissent appears to concede this point,

acknowledging that “the President may adopt a policy

position on gender-affirming care[.]” Dissent 89. If this

policy objective of the Executive Branch was proper, then it

was proper for DOJ, as an agency within the Executive

Branch, to use its authority under HIPAA to carry out this

broader policy.

To avoid the difficult argument that the President’s

policy views were themselves “improper,” the dissent

attempts to distinguish DOJ’s reasons for acting from the

President’s general policy positions. See, e.g., Dissent 89

(“That the President can voice policy opposition to gender

affirming care does not mean that the DOJ can weaponize

its statutorily constrained subpoena authority . . . .”

(emphases in original)). But as a conceptual matter, the

dissent’s proffered division between DOJ and the President

is misguided. The Constitution vests the entirety of the

executive power in the President. U.S. Const. art. II, § 1.

DOJ, as an agency within the Executive Branch, thus

exercises no executive power except that which the President

has delegated to it. See Slaughter, 609 U.S. at ____, 2026

WL 1855612, at *21 (recognizing that “these officers

exercise the President’s power, not their own, and thus must

be responsible to him” (emphasis in original)). The

President’s control over DOJ must be especially great, as

DOJ is charged with the “investigation and prosecution of

crimes,” which “is a quintessentially executive function.”

50 QUEERDOC, PLLC V. USDOJ

Morrison v. Olson, 487 U.S. 654, 706 (1988) (Scalia, J.,

dissenting). As the dissent concedes, the President’s policy

objective of ending gender-affirming care, consistent with

applicable law, was not itself unlawful. See Dissent 89, 91.

The dissent never explains why DOJ may not then act to

achieve that policy objective pursuant to its investigatory

authority under HIPAA.

Second, as explained above, nothing prevents DOJ from

issuing an otherwise valid subpoena that is consistent with

the President’s policy agenda. Congress empowered DOJ to

investigate violations of the health care laws. It is not the

case that DOJ is unable to investigate an area simply because

the President or other high-ranking officials have voiced

policy opinions on the topic. With essentially no

explanation, the district court deemed illegitimate the

Administration’s policy objections to gender-affirming care

and then inferred that the subpoena to QueerDoc was based

on this illegitimate purpose. That legal conclusion was

incorrect. Regulated entities routinely receive subpoenas

from government agencies that request information.

QueerDoc, which operates in the highly regulated

pharmaceutical industry, is no exception. We are hard-

pressed to imagine that the dissent would conduct such an

intrusive review of the government’s purpose for issuing this

subpoena but for the fact that this case involves gender-

affirming care.

In a final effort to justify the district court’s finding of

improper purpose, the dissent argues that it is improper for

DOJ to issue an administrative subpoena for the purpose of

putting the subpoena’s recipient out of business. See Dissent

89 (arguing that DOJ cannot “weaponize its statutorily

constrained subpoena authority as a tool to put health care

providers out of business.”). But the fear that the costs of

QUEERDOC, PLLC V. USDOJ 51

compliance will force a party to shutter its business

implicates the question of undue burden, not of improper

purpose. QueerDoc has an interest in continuing to operate

its business. That interest is adequately protected by the

“undue burden” restriction on an agency’s subpoena power,

under which a court may modify the terms of a subpoena if

“compliance threatens to unduly disrupt or seriously hinder

normal operations of [the recipient’s] business.” Texaco,

555 F.2d at 882.

Lastly, we respectfully disagree with the dissent’s

suggestion that our decision undermines the separation of

powers by rendering judicial review of administrative

subpoenas “a hollow formality.” See Dissent 95. Our

decision lays down no novel principle. It reflects a

straightforward application of our well-established law

regarding the enforcement of agency subpoenas. The

agency still bears the initial burden of demonstrating that it

has issued a subpoena pursuant to statutory authority. See

supra Part III(B). Even if the agency discharges this burden,

a recipient remains protected against having to comply with

unduly burdensome or overbroad subpoenas. See infra Part

IV. Nor do we narrow or amend the legal standards that

govern a court’s “improper purpose” inquiry. See, e.g.,

Golden Valley, 689 F.3d at 1113. We hold only that

QueerDoc did not meet its “heavy” burden to demonstrate

improper purpose in this case. Jose, 131 F.3d at 1328. 6

6

That longstanding, uncontroversial standard, which the dissent

mentions once, is not fairly described as “hollow.” Dissent 67, 95. Nor

does it permit the so-called “potent” judicial review in the way that the

dissent envisions it. Dissent 86, 88, 95 (citing SEC v. Arthur Young &

Co., 584 F.2d 1018, 1024 n.39 (D.C. Cir. 1978)). In Arthur Young, the

D.C. Circuit explained in a footnote that “while the court’s role in

subpoena enforcement is narrow, within its confines it is potent.” 584

52 QUEERDOC, PLLC V. USDOJ

At bottom, the dissent’s argument rests on the

supposition that the Administration’s policy goal of ending

gender-affirming care through the enforcement of existing

federal law was improper, so any subpoena issued in that

area is invalid even if it validly seeks to investigate potential

violations of the health care laws. We cannot agree with a

position that is so at odds with our circuit precedent, with the

proper role of the federal judiciary within our constitutional

system, and indeed with QueerDoc’s own representations at

oral argument. See supra note 4. It would be a stunning

expansion of the judicial power to hold that the little-used

authority to quash otherwise valid subpoenas in their entirety

when they are issued for an “improper purpose”—an

authority meant to police fraud on the court and other

extreme abuses of official power—allows a federal court to

strike down statutorily authorized subpoenas merely because

the agency issued those subpoenas in service of a general

policy that a judge deems “improper.”

IV

Because the district court decided only that the subpoena

was motivated by an improper purpose, it did not rule on

F.2d at 1024 n.39 (internal citation omitted). That statement merely

reflects the principle that courts retain the “duty not to rubber-stamp [an

agency’s subpoenas], but to adjudge their legitimacy.” ACICS, 854 F.3d

at 689. It does not permit the dissent’s sweeping judicial review, for in

most cases, “‘when the information sought falls within the purview of

the regulatory agency’s authority,’ judicial review of an administrative

subpoena typically results in enforcement.” Id. (quoting FEC v.

Machinists Non-Partisan Pol. League, 655 F.2d 380, 385–86 (D.C. Cir.

1981)). Nor does the judicial review that courts exercise in this context

detract from a subpoena recipient’s “heavy” burden to show an improper

purpose. See id. (recognizing that “[i]n extraordinary circumstances, a

court also may inquire into allegations that an agency is using an

administrative subpoena for an improper purpose” (emphasis added)).

QUEERDOC, PLLC V. USDOJ 53

QueerDoc’s arguments that DOJ’s subpoena is overbroad

and poses an undue burden. We do not resolve these issues

today. Instead, we remand them for the district court to

consider in the first instance. But we offer the following

guidance on remand.

First, the parties are expected to cooperate on remand to

narrow or resolve any potential disagreements about the

scope of discovery. Before the district court may grant relief

from an overbroad or unduly burdensome subpoena,

QueerDoc must make a “reasonable effort to reach [an]

accommodation with the government.” Morton Salt, 338

U.S. at 653; see also In re Subpoena Duces Tecum, 228 F.3d

at 349 (“[B]efore a court will conclude that a subpoena is

‘arbitrarily excessive,’ it may expect the person served ‘to

have made reasonable efforts . . . to obtain reasonable

conditions’ from the government.” (quoting Morton Salt,

338 U.S. at 653)); Doe, 253 F.3d at 268–69 (rejecting undue

burden claim in part because the recipient “made no attempt

to reach a reasonable accommodation with the

government.”).

Second, because DOJ’s subpoena requests information

that is relevant to an authorized HIPAA investigation, any

determinations by the district court that limit the scope of

DOJ’s discovery will require proper legal and evidentiary

support. See Texaco, 555 F.2d at 882 (“The burden of

showing that the request is unreasonable . . . is not easily met

where, as here, the agency inquiry is pursuant to a lawful

purpose and the requested documents are relevant to that

purpose.”).

Because undue burden is evaluated and remedied on a

request-by-request basis, QueerDoc must explain why

compliance with each request would be burdensome.

54 QUEERDOC, PLLC V. USDOJ

QueerDoc’s evidence of undue burden must consist of more

than bare conclusory declarations. See FTC v. Shaffner, 626

F.2d 32, 38 (7th Cir. 1980) (rejecting undue burden when

recipient made only the “conclusory allegation that

compliance with the subpoena would ‘severely interfere,

disrupt and temporarily terminate [recipient’s] legal

practice.’”). Rather, QueerDoc must provide objective and

specific evidence, such as “the number of files involved, the

number of estimated work hours required to effect

compliance, [or] the estimated costs of compliance.” Id.

A subpoena request that requires production of a large

volume of documents or a high proportion of the recipient’s

records does not necessarily constitute an undue burden.

See, e.g., Garner, 126 F.3d at 1145–46 (upholding a

subpoena that required production of over one million

documents); NLRB v. G.H.R. Energy Corp., 707 F.2d 110,

114 (5th Cir. 1982) (“[T]he production of thousands of

documents is also insufficient to establish

burdensomeness.”); Walsh v. Alight Sols., LLC, 44 F.4th

716, 726–27 (7th Cir. 2022) (“[L]arge production requests

are not necessarily unduly burdensome.”); NLRB v. Carolina

Food Processors, 81 F.3d 507, 513 (4th Cir. 1996) (similar).

Nor does a subpoena impose an undue burden just because

compliance will be time- and resource-intensive. See EEOC

v. Citicorp Diners Club, Inc., 985 F.2d 1036, 1040 (10th Cir.

1993) (upholding a subpoena for which compliance required

“two full-time employees working approximately six

months”).

Finally, the district court may entertain any objections

specific to DOJ’s requests for patient medical records if

QueerDoc argues that compliance with these requests would

raise concerns about patient privacy. The district court and

the parties should also consider whether protective orders or

QUEERDOC, PLLC V. USDOJ 55

other devices should be used to ameliorate any concerns

about privacy.

* * *

For the foregoing reasons, the district court erred in

quashing the subpoena on the basis that it was issued for an

“improper purpose.” We reverse the district court’s order

quashing the subpoena and remand for further proceedings

consistent with the above guidance.

REVERSED AND REMANDED.

PAEZ, Circuit Judge, dissenting:

As I see this case, the narrow question we must decide is

whether the district court’s finding that the Department of

Justice (“DOJ”) issued the subpoena to QueerDoc in bad

faith was clearly erroneous. It was not. DOJ submitted

essentially nothing in opposition to the motion to quash the

subpoena. There is, however, a mountain of evidence that

corroborates that DOJ used the threat of criminal

investigation to pressure health care providers to stop

offering gender-affirming care. The record amply supports

the district court’s finding that DOJ issued the subpoena as

pretext for its real goal of eliminating gender-affirming care,

not in good faith investigation of potential violations of the

Federal Food, Drug, and Cosmetic Act (“FDCA”).

In evading our highly deferential standard of review and

the extensive record evidence to the contrary, the majority

manufactures legal errors that will require federal courts to

rubber stamp investigations initiated by the DOJ to harass

opponents and chill disfavored causes, so long as the

investigation serves the President’s policy priorities. But the

56 QUEERDOC, PLLC V. USDOJ

President’s authority to voice a policy position is far broader

than the DOJ’s statutorily constrained authority to issue

subpoenas. Because the law does not permit the DOJ to

initiate sham investigations—even if the President says to do

so—I dissent.

I.

We review a district court’s decision to quash an

administrative subpoena for abuse of discretion. McLane

Co. v. EEOC, 581 U.S. 72, 75 (2017). Whether the district

court identified the correct legal rule is reviewed de novo.

United States v. Hinkson, 585 F.3d 1247, 1261–62 (9th Cir.

2009). Part of the legal rule includes “what counts as an

illicit motive.” United States v. Clarke, 573 U.S. 248, 256

(2014).

But the agency’s actual purpose in issuing a subpoena is

a factual question subject to deferential clear error review.

Ponsford v. United States, 771 F.2d 1305, 1307–08 (9th Cir.

1985). 1 Evaluating motive and purpose are “the ‘kind of

fact-intensive, close calls’ better suited to resolution by the

district court than the court of appeals.” McLane, 581 U.S.

at 81 (citations omitted). We may not reverse because we

“would have weighed the evidence differently” had we “s[at]

as the trier of fact” or because there was some “evidence to

contradict this view.” Anderson v. Bessemer City, 470 U.S.

564, 574 (1985); United States v. Ritchie, 15 F.3d 592, 599

(6th Cir. 1994). Unless the district court’s finding was

“illogical, implausible, or without support in inferences that

1

Accord United States v. Gertner, 65 F.3d 963, 970 (1st Cir. 1995); La

Mura v. United States, 765 F.2d 974, 981 (11th Cir. 1985); Groder v.

United States, 816 F.2d 139, 145 (4th Cir. 1987); United States v.

Ritchie, 15 F.3d 592, 599 (6th Cir. 1994); United States v. Krauth, 769

F.2d 473, 478 (8th Cir. 1985).

QUEERDOC, PLLC V. USDOJ 57

may be drawn from the record,” we must affirm. Hinkson,

585 F.3d at 1262.

The majority’s suggestion that the district court’s finding

of DOJ’s purpose in issuing the subpoena “is not one of fact”

because the “district court relied solely on a cold record” is

misguided. Majority 48; Crittenden v. Chappell, 804 F.3d

998, 1006 (9th Cir. 2015). We review factual findings for

clear error “even when the district court’s findings do not

rest on credibility determinations, but are based instead on

physical or documentary evidence or inferences from other

facts.” Anderson, 470 U.S. at 574.

“We may affirm a district court’s judgment on any

ground supported by the record, whether or not the decision

of the district court relied on the same grounds.” Atel Fin.

Corp. v. Quaker Coal Co., 321 F.3d 924, 926 (9th Cir. 2003).

II.

An administrative agency seeking to enforce a subpoena

bears the burden of establishing that (1) Congress has

granted the agency the authority to investigate; (2) the

agency has followed the procedural requirements; and

(3) the evidence sought is relevant and material to the

investigation. United States v. Golden Valley Elec. Ass’n,

689 F.3d 1108, 1113 (9th Cir. 2012). If the government

establishes its prima facie case, the burden shifts to the

recipient to challenge the subpoena on “any appropriate

grounds.” United States v. Jose, 131 F.3d 1325, 1328 (9th

Cir. 1997) (en banc) (quoting Reisman v. Caplin, 375 U.S.

440, 449 (1964)).

The government fails on both fronts. I first address how

the government failed to satisfy its prima facie burden to

enforce the subpoena against QueerDoc. Even if it did,

58 QUEERDOC, PLLC V. USDOJ

QueerDoc has nonetheless satisfied its burden to quash the

subpoena because it was issued for an improper purpose.

Finally, I respond to the majority’s contrary conclusions,

which ignore the role of Congress in authorizing agency

action and erroneously conflate the “purpose” of the

President with the “purpose” of a subpoena.

A.

I start with the government’s prima facie burden. An

affidavit or declaration from the investigating agency

explaining the purpose of the investigation may be sufficient

to satisfy the agency’s prima facie burden. FDIC v. Garner,

126 F.3d 1138, 1143 (9th Cir. 1997). Despite the majority’s

near-dispositive reliance on the declaration from Allan

Gordus (“Gordus Declaration”), that declaration was not

properly before the district court when it ruled on the motion

to quash.

After QueerDoc moved to quash the subpoena, DOJ

declined to submit any affidavit attesting to its investigatory

purpose. While the motion was pending in the district court,

multiple district courts granted analogous motions to quash.

See In re Admin. Subpoena No. 25-1431-019, 800 F. Supp.

3d 229, 239 (D. Mass. 2025); In re Subpoena Duces

Tecum No. 25-1431-016, 2025 WL 3562151, at *12–13

(W.D. Wash. Sept. 3, 2025). Before the district court ruled

on the motion, DOJ filed a “praecipe” requesting leave to

file the Gordus Declaration attesting to the purpose of the

investigation. The district court granted QueerDoc’s motion

to strike the Gordus Declaration pursuant to the court’s local

rules. QueerDoc, PLLC v. U.S. Dep’t of Just., 807 F. Supp.

3d 1295, 1303 n.2 (W.D. Wash. 2025); see W.D. Wash. Loc.

Civ. R. 7(m). The government does not now contend that

the district court abused its discretion in striking the Gordus

QUEERDOC, PLLC V. USDOJ 59

Declaration, Bias v. Moynihan, 508 F.3d 1212, 1223 (9th

Cir. 2007), and we therefore may not substantively consider

whether the Declaration satisfied the government’s prima

facie burden.

Pursuant to the Western District of Washington’s Local

Rule 7(m), “Praecipe,” “[p]arties are expected to file

accurate, complete documents, and the failure to do so may

result in the court’s refusal to consider later filed corrections

or additions to the record.” W.D. Wash. Loc. Civ. R. 7(m).

A court may grant an exception where a party: (1) identifies

an “error” in a filed document and seeks permission through

a praecipe to file a “corrected document,” or (2) seeks to file

an additional document “in support of a previous filing,” and

“set[s] forth why the document was not included with the

original filing and reference[s] the original filing by docket

number” in the praecipe. Id. The district court struck the

Gordus Declaration, explaining that under Rule 7(m), “a

praecipe serves a narrow function: to correct clerical errors

or, in limited circumstances, to add documents inadvertently

omitted from an original filing,” and is “not a vehicle for

submitting new evidence or supplementing legal arguments

after briefing has closed.” 2 QueerDoc, 807 F. Supp. 3d at

1303 n.2.

District courts “have broad discretion in interpreting and

applying their local rules.” Delange v. Dutra Const. Co.,

183 F.3d 916, 919 n.2 (9th Cir. 1999) (quoting Miranda v.

Southern Pac. Transp., 710 F.2d 516, 521 (9th Cir. 1983)).

“Only in rare cases will we question the exercise of

2

As explained in Section III.A.2, the Gordus Declaration did not merely

expand upon the government’s prior positions, as the majority contends.

Rather, the Gordus Declaration proffered investigatory theories,

justifications, and facts not previously presented to the district court.

60 QUEERDOC, PLLC V. USDOJ

discretion in connection with the application of local rules.”

Ghazali v. Moran, 46 F.3d 52, 53 (9th Cir. 1995) (quoting

United States v. Warren, 601 F.2d 471, 474 (9th Cir. 1979)).

Neither the majority nor the government offer any

persuasive reason for why this is a “rare case[]” in which the

district court’s application of its own local rules was an

abuse of its “broad” discretion. Id.; Delange, 183 F.3d at

919 n.2 (quoting Miranda, 710 F.2d at 521).

Instead, the majority strains to rationalize its

consideration of the Gordus Declaration, perhaps

recognizing that without the Declaration, the government did

not provide the district court with any evidence to satisfy its

“burden.” Crystal v. United States, 172 F.3d 1141, 1144 (9th

Cir. 1999). Each disingenuous justification falls short.

First, the majority reasons, the government was not on

notice that it had the burden to establish the purpose of the

investigation until another district court quashed an

analogous subpoena. See In re Admin. Subpoena No. 25-

1431-019, 800 F. Supp. 3d 229. But we have long held that

the government bears the “burden” of establishing that “the

investigation will be conducted for a legitimate purpose” and

that “the material being sought is relevant to that purpose,”

a burden that “may be satisfied by a declaration from the

investigating agent.” Crystal, 172 F.3d at 1143–44; United

States v. Dynavac, Inc., 6 F.3d 1407, 1414 (9th Cir. 1993).

Next, the majority contends that the district court

imposed an “improperly high standard” and should have

allowed the government to satisfy that standard by filing the

Declaration. Majority 27 n.2. Not so. The district court

simply recognized that improper purpose analysis requires

“more muscular review” than whether the government

satisfied its prima facie burden, rejecting the government’s

QUEERDOC, PLLC V. USDOJ 61

argument that courts may not consider whether the

government acted in bad faith. QueerDoc, 807 F. Supp. 3d

at 1302. The majority appears to agree with the district court

that the improper purpose inquiry is at least more intrusive

than the “slight burden of demonstrating relevance.”

Majority 30. In context, the district court’s decision to

impose greater scrutiny on the government’s purpose,

compared to the issue of relevance, is not inconsistent with

our prior description that such scrutiny is, overall, “narrow.”

Golden Valley, 689 F.3d at 1113 (citation omitted).

Finally, the majority claims we have discretion to

consider the Declaration “[e]ven if the district court did not

err in striking [it].” Majority 27 n.2. The majority distorts

the doctrine of forfeiture to reach its preferred result. We

may have discretion to consider the antecedent question of

whether the district court abused its discretion

notwithstanding the government’s failure to raise this issue

on appeal. See, e.g., Williams v. Gerber Prods. Co., 552

F.3d 934, 940 n.5 (9th Cir. 2008). But we do not have

discretion to consider the Declaration itself absent a

determination that the district court abused its discretion in

striking it.

The Federal Rules of Appellate Procedure enable circuit

courts to review stricken filings to determine whether the

district court’s decision to strike was erroneous. Fed. R.

App. P. 10(a)(1). But we may not rely upon correctly

stricken materials to upset a district court’s ruling. Our

review is “confined to the record that was properly before

62 QUEERDOC, PLLC V. USDOJ

the district court when it made its decision.” 3 Rios-Jimenez

v. Principi, 520 F.3d 31, 39 (1st Cir. 2008) (emphasis

added); see also Chelf v. Prudential Ins. Co. of Am., 31 F.4th

459, 464 n.2 (6th Cir. 2022) (rejecting request to review

documents on appeal that the district court “declined to

consider”).

This makes sense. Our job is to determine whether the

district court erred based on the record appropriately before

it at the time it rendered its decision. For example, if a

district court properly excluded declarations on summary

judgment, we could not rely upon the stricken declarations

to find a genuine dispute of material fact and reverse the

district court’s decision granting summary judgment. See

Milczak v. Gen. Motors, LLC, 102 F.4th 772, 781 (6th Cir.

2024). Likewise, if a district court properly excluded

inadmissible evidence, we could not invoke that evidence as

grounds for overturning the district court’s decision. To do

so would subvert our system of review.

B.

With the scope of the record clarified, this becomes an

easy case. Considering the information properly before the

district court at the time it rendered its decision, the

government failed to satisfy its prima facie burden of

3

Here, the district court docket literally reads:

STRICKEN GOVERNMENT'S PRAECIPE TO FILE

ADDITIONAL DOCUMENT, filed by Defendant

United States Department of Justice. (Attachments: #

1 Declaration of Government Attorney Allan Gordus,

# 2 Exhibit 1 to Declaration of Allan Gordus, # 3

Exhibit 2 to Declaration of Allan Gordus, # 4 Exhibit

2 to Declaration of Allan Gordus (Folder 2), # 5

Exhibit 2 to Declaration of Allan Gordus (Folder 3)).

QUEERDOC, PLLC V. USDOJ 63

showing the information subpoenaed was relevant and

material to its purported investigatory purpose. See Reich v.

Montana Sulphur & Chem. Co., 32 F.3d 440, 447 (9th Cir.

1994) (explaining that the agency must show “that the

documents it requests are relevant to the purpose of an

authorized investigation”). Although the government’s

burden to establish relevance is “not great,” United States v.

Goldman, 637 F.2d 664, 667 (9th Cir. 1980), the agency may

not engage in a “fishing expedition.” Peters v. United States,

853 F.2d 692, 697 (9th Cir. 1988) (citation omitted); In re

Subpoena Duces Tecum, 228 F.3d 341, 349 (4th Cir. 2000).

That is, the government must establish a “realistic

expectation rather than an idle hope that something may be

discovered.” Goldman, 637 F.2d at 667 (quoting United

States v. Harrington, 388 F.2d 520, 524 (2d Cir. 1969)).

The government did not file any affidavits attesting to

the relevance of its expansive production demands in

responding to QueerDoc’s motion to quash. See Garner,

126 F.3d at 1143. DOJ arguably offered one justification,

stating that its requests for information about billing and

coding “relate to how [QueerDoc’s] providers billed for

medical services to prescribe or deliver, inter alia, the

pharmaceuticals in question.” This purported justification,

echoed by the majority, is insufficient to satisfy the

government’s prima facie burden. The FDCA regulates

“misbranding” and “adulteration,” not billing or coding. See

21 U.S.C. § 331(b). As the majority acknowledges, the

FDCA does not regulate “a doctor’s ability to prescribe

drugs.” Majority 11. Moreover, QueerDoc does not submit

claims to “health care benefit program[s].” See 18 U.S.C.

§ 24(a)(2).

Nor did the June 11, 2025 memorandum issued by

Assistant Attorney General for the Civil Division Brett

64 QUEERDOC, PLLC V. USDOJ

Shumate (“Shumate Memo”) satisfy the government’s prima

facie burden under the FDCA. The Shumate Memo directed

FDCA investigations into “pharmaceutical companies that

manufacture drugs used in connection with so-called gender

transition and (2) dealers such as online pharmacies

suspected of illegally selling such drugs.” But QueerDoc is

neither a drug manufacturer nor a pharmacy.

In sum, DOJ failed to satisfy its prima facie burden of

establishing that the records subpoenaed were material and

“relevant to the purpose of an authorized [FDCA]

investigation.” Reich, 32 F.3d at 447. At most, DOJ’s

sweeping demands for QueerDoc’s records established only

an “idle hope” of uncovering information relevant to its

stated investigatory purpose. Goldman, 637 F.2d at 667

(citation omitted).

Given DOJ’s failure to carry its burden, I would affirm

the district court’s quashal on this alternative ground. See

Perfect 10, Inc. v. Visa Int’l Serv. Ass’n, 494 F.3d 788, 794

(9th Cir. 2007).

III.

Even assuming the government satisfied its prima facie

burden, the district court’s decision to quash the subpoena

should be affirmed because ample evidence supports its

finding that the subpoena was issued in bad faith.

“Subpoena enforcement power is not limitless.” FTC v.

Ken Roberts Co., 276 F.3d 583, 586 (D.C. Cir. 2001). A

court may not enforce an administrative subpoena where it

“would be an abusive use of the court’s process.” United

States v. Powell, 379 U.S. 48, 51 (1964). “Such an abuse

would take place if the [subpoena] had been issued for an

improper purpose,” including “harass[ment],” “pressur[ing]

QUEERDOC, PLLC V. USDOJ 65

[the recipient] to settle a collateral dispute,” or “any other

purpose reflecting on the good faith of the particular

investigation.” Id. at 58.

“The authority of an administrative agency to issue

subpoenas for investigatory purposes is created solely by

statute.” United States ex rel. Richards v. De Leon

Guerrero, 4 F.3d 749, 753 (9th Cir. 1993) (quoting Peters,

853 F.2d at 696); United States v. LaSalle Nat. Bank, 437

U.S. 298, 316 n.18. Because an agency’s subpoena power is

authorized by statute, the issuance of a subpoena for a

purpose other than the purpose authorized by Congress is

improper. The Health Insurance Portability and

Accountability Act of 1996 (“HIPAA”), 18 U.S.C.

§ 3486(a)(1)(A)(i)(I), authorizes subpoenas solely to

investigate a “[f]ederal health care offense,” which requires

that a violation or conspiracy of the FDCA “relates to a

health care benefit program.” 18 U.S.C. § 24(a)(2). Neither

the government nor the majority argues that all gender-

affirming care violates the FDCA, so ending gender-

affirming care cannot be an authorized investigative

purpose. The “dispositive question” is whether the record

shows that DOJ issued the subpoena in “honest[]” and “good

faith” “pursuit of the congressionally authorized purpose[]”

of investigating a federal health care offense. LaSalle, 437

U.S. at 316, 317 n. 19.

Importantly, a determination that the government

satisfied its prima facie burden does not obviate the improper

purpose inquiry. These are separate analytic steps. See infra

Section III.A.4. When the government establishes that the

information sought is relevant to an investigation into

plausible federal health care offenses, but the subject of the

subpoena establishes that this purpose was merely a pretext

66 QUEERDOC, PLLC V. USDOJ

for a different, impermissible goal, the district court may

properly quash the subpoena.

Our inquiry at this stage is highly deferential. An

agency’s motive or purpose in issuing a subpoena is

quintessentially a factual determination made by the district

court and reviewed on appeal for clear error. Thus, if the

district court’s finding that DOJ issued the subpoena to

“harass” QueerDoc or to “pressure” it to “settle a collateral

dispute” (to put QueerDoc out of business or otherwise end

its provision of gender-affirming care) is logical, plausible,

and supported by the record, we must affirm. 4 Powell, 379

U.S. at 58; Hinkson, 585 F.3d at 1262. It plainly is.

A.

The record supports the district court’s determination

that it was “presented . . . with an explanation for agency

action” that was “incongruent with what the record reveals

about the agency’s priorities.” Dep’t of Com. v. New York,

588 U.S. 752, 785 (2019).

The burden of establishing improper purpose through

“specific facts and evidence” of improper intent is generally

4

Even if the issuance of a subpoena to end gender-affirming care did not

squarely fall within the Powell examples, that does not foreclose an

improper purpose. On this point, the majority and I are on common

ground. “[A] court may recognize and proscribe novel ‘improper

purposes.’” Majority 24; LaSalle, 437 U.S. at 317 n.19 (explaining that

Powell contains “examples” of improper purposes but is not an

“exclusive statement about the meaning” of improper purpose); SEC v.

Wheeling-Pittsburgh Steel Corp., 648 F.2d 118, 124 (3d Cir. 1981) (en

banc) (“[B]ecause the Supreme Court has never confronted allegations

like the ones before us does not mean that the federal judiciary is

powerless to structure relief when necessary.”). An “unusual”

unauthorized purpose is still improper. Wheeling-Pittsburgh Steel

Corp., 648 F.2d at 125.

QUEERDOC, PLLC V. USDOJ 67

“heavy,” in no small part because DOJ investigations are

confidential. Jose, 131 F.3d at 1328 (citation and internal

quotation marks omitted); LaSalle, 437 U.S. at 316; U.S.

Dept. Just., Justice Manual § 1-7.100; id. § 1-7.400. Those

under investigation can ordinarily only speculate about an

agency’s motives, and speculation is insufficient to establish

bad faith. See, e.g., SEC v. McGoff, 647 F. 2d 185, 193–94

(D.C. Cir. 1981); Adamowicz v. United States, 531 F.3d 151,

160 (2d Cir. 2008); United States v. Am. Target Advert., Inc.,

257 F.3d 348, 355 (4th Cir. 2001). Consider the cases

invoked by the majority. In Jose, the recipient made “only a

bald assertion that he ‘feel[s] that the underlying reason’”

was improper and provided “no facts or evidence to support

this allegation.” 131 F.3d at 1328. Likewise, in Garner, the

subpoena recipients failed to make “any specific allegations

of bad faith or improper purpose.” 126 F.3d at 1146. To the

extent subpoena recipients obtain evidence of improper

purpose, it is often limited to an individual employee’s

motivation, which does not amount to institutional bad faith.

See, e.g., United States v. Markwood, 48 F.3d 969, 984 (6th

Cir. 1995). By contrast, because DOJ initiated a remarkably

public investigation, as described infra Section III.A.3, and

announced its purpose, QueerDoc presents substantial

evidence of DOJ’s “institutional posture.” LaSalle, 437 U.S.

at 316.

Specifically, the government’s (1) own statements of

purpose, (2) shifting post-hoc rationalizations, (3) deviation

from longstanding prosecutorial norms, and (4) intrusive

informational demands provide ample support for the district

court’s finding that the “specific facts and evidence” in the

record show DOJ “issued the subpoena first and searched for

a justification second.” Jose, 131 F.3d at 1328 (citation and

internal quotation marks omitted); QueerDoc, 807 F. Supp.

68 QUEERDOC, PLLC V. USDOJ

3d at 1303. When confronted with the motion to quash, the

district court properly considered the full record and

determined that QueerDoc satisfied its burden to establish

bad faith. Jose, 131 F.3d at 1328. The question on appeal is

not how we would weigh the evidence de novo, but rather,

whether the district court’s finding was clearly erroneous.

Anderson, 470 U.S. at 574.

I address each category of evidence in turn.

1. Statements of Purpose

An agency’s “self-proclaimed practice” that deviates

from the purported purpose of an investigation provides

evidence of “pretext.” Gertner, 65 F.3d at 969–70.

Remarkably, the government repeatedly announced that it

was investigating QueerDoc to end the provision of services

that facilitate gender-affirming care. 5 The district court took

the government at its word. We should have done the same.

5

Gender-affirming care includes “any single or combination of a

number of social, psychological, behavio[]ral or medical (including

hormonal treatment or surgery) interventions designed to support and

affirm an individual’s gender identity.” World Health Org., Gender

Incongruence and Transgender Health in the ICD,

https://www.who.int/standards/classifications/frequently-asked-

questions/gender-incongruence-and-transgender-health-in-the-icd

[https://perma.cc/9KV3-QQWC]. The Administration has described

gender-affirming care as care that supports the “so-called ‘transition’ of

a child from one sex to another,” and characterized such care as entailing

“chemical and surgical mutilation.” Exec. Order 14,187, 90 Fed. Reg.

8771, §§ 1–2 (Jan. 28, 2025).

This case involves a subset of gender-affirming care. Specifically,

QueerDoc is a telehealth provider that prescribes puberty blockers and

hormones to treat gender dysphoria. Puberty blockers stop the

production of sex hormones, thereby delaying puberty, and hormones

“help adolescents identified as female at birth look more masculine and

QUEERDOC, PLLC V. USDOJ 69

To be clear, at no point did the government claim that the

mere provision of gender-affirming care constituted the

relevant federal health care offense. Rather, the government

first said that it wanted to end gender-affirming care, and

then came up with possible ancillary federal health care

offenses to investigate. If gender-affirming care is not itself

a crime, and DOJ’s purpose is to end gender-affirming care,

then it must be the case that in issuing a subpoena to

QueerDoc, DOJ was motivated by more than a proper law

enforcement purpose.

On January 28, 2025, President Trump issued Executive

Order 14,187, “Protecting Children from Chemical and

Surgical Mutilation.” Exec. Order 14,187, 90 Fed. Reg.

8771, § 1 (Jan. 28, 2025). The EO accuses medical

providers of gender-affirming care of “maiming and

sterilizing” children or engaging in “mutilation,” and states

that “[t]his dangerous trend will be a stain on our Nation’s

history, and it must end.” Id. §§ 1–2. The EO directed the

Attorney General to “prioritize enforcement of protections

against female genital mutilation” and to “take appropriate

action to end . . . violations of the Food, Drug, and Cosmetic

Act by any entity that may be misleading the public about

long-term side effects of chemical and surgical mutilation.”

Id. §§ 8(a), (c). On February 3, 2025, the White House

stated that the “intended effect” of the EO was to “downsize

or eliminate” gender-affirming care. White House,

President Trump is Delivering on His Commitment to

Protect Our Kids (Feb. 3, 2025),

https://www.whitehouse.gov/releases/2025/02/president-

those identified as male at birth look more feminine.” United States v.

Skrmetti, 605 U.S. 495, 581 (2025) (Sotomayor, J., dissenting).

70 QUEERDOC, PLLC V. USDOJ

trump-is-delivering-on-his-commitment-to-protect-our-

kids/ [https://perma.cc/9MSG-M6CL].

On April 22, 2025, then-Attorney General Pamela Bondi

issued a memorandum (“Bondi Memo”), titled “Preventing

the Mutilation of American Children.” Bondi claimed a

“radical ideological agenda . . . teaches children to deny

biological reality” and described as “barbaric [the] practice

of surgically and chemically maiming and sterilizing

children.” She promised to “act decisively to protect our

children and hold accountable those who mutilate them

under the guise of care.” Accordingly, she directed the

investigation of (1) “manufacturers and distributors engaged

in misbranding by making false claims about the on- or off-

label use of puberty blockers, sex hormones, or any other

drug used to facilitate a child’s so-called ‘gender

transition,’” and (2) “false claims submitted to federal health

care programs for any non-covered services related to radical

gender experimentation.” Bondi promised that “the

Department of Justice will bring these practices [gender-

affirming care] to an end.”

On June 11, 2025, on his first day in office, Assistant

Attorney General Brett Shumate of the Civil Division issued

a memorandum reiterating the Attorney General’s promises

to “hold accountable those who mutilate” children and to

“pursue investigations” related “to radical gender

experimentation.” The Memo stated that “[t]he Civil

Division will use all available resources to prioritize

investigations of doctors, hospitals, [and] pharmaceutical

companies” that “advance the Administration’s policy

objectives,” including pursuing “violations of the Food,

Drug, and Cosmetic Act and other laws by

(1) pharmaceutical companies that manufacture drugs used

in connection with so-called gender transition and

QUEERDOC, PLLC V. USDOJ 71

(2) dealers such as online pharmacies suspected of illegally

selling such drugs.” The memorandum reiterated that DOJ

would “aggressively pursue claims under the False Claims

Act against health care providers that bill the federal

government for impermissible services.”

The same day, Assistant Attorney General Shumate

served QueerDoc with a criminal administrative subpoena

under HIPAA, 18 U.S.C. § 3486(a)(1)(A)(i)(I).

On July 8, 2025, QueerDoc filed a motion to seal the

district court’s docket. The next day, DOJ issued a public

announcement that it had “sent more than 20 subpoenas to

doctors and clinics involved in performing transgender

medical procedures on children,” and promised that

“[m]edical professionals and organizations that mutilated

children in the service of a warped ideology will be

held accountable by this Department of Justice.” U.S. Dept.

Just., Department of Justice Subpoenas Doctors and

Clinics Involved in Performing Transgender Medical

Procedures on Children (July 9, 2025),

https://www.justice.gov/opa/pr/department-justice-

subpoenas-doctors-and-clinics-involved-performing-

transgender-medical [https://perma.cc/S5YJ-QRY7].

That same day, at a Federal Trade Commission

workshop titled “The Dangers of ‘Gender-Affirming Care’

for Minors,” then-Chief of Staff Chad Mizelle stated

that DOJ’s goal was to “take down this multi-billion

dollar industry,” and that “[w]e are using all of the tools at

the Department of Justice” to do so. Fed. Trade

Comm’n, The Dangers of “Gender-Affirming Care”

for Minors at 49 (Jul. 9, 2025),

https://www.ftc.gov/system/files/ftc_gov/pdf/FTC-The-

Dangers-of-Gender-Affirming-Care-for-Minors-

72 QUEERDOC, PLLC V. USDOJ

Transcript.pdf [https://perma.cc/47J5-VQRZ]. In response

to a participant’s statement that investigations of false

diagnosis codes might “stop [gender-affirming care] even in

blue states,” Deputy Assistant Attorney General Jordan

Campbell said DOJ was “[w]orking on it.” Id. at 29.

On July 25, 2025, the White House issued a statement

lauding that President Trump had “delivered” on his promise

to “end” gender-affirming care, and listing health systems

that stopped providing such care following his Executive

Orders. White House, President Trump Promised to End

Child Sexual Mutilation – and He Delivered (July 25, 2025),

https://www.whitehouse.gov/releases/2025/07/president-

trump-promised-to-end-child-sexual-mutilation-and-he-

delivered/ [https://perma.cc/8KK8-PXMD].

The district court properly concluded that these

statements provided strong evidence of an improper

“institutional posture.” LaSalle, 437 U.S. at 316. The

majority argues that whether statements by agency officials

can establish bad faith is a legal question subject to de novo

review. But this legal question has already been answered.

Officials’ statements are probative evidence of institutional

motive. See Vill. of Arlington Heights v. Metro. Hous. Dev.

Corp., 429 U.S. 252, 266, 268 (1977) (explaining that

evaluating motive “demands” consideration of

“circumstantial and direct evidence of intent,” including

“contemporary statements by members of the

decisionmaking body”); Gertner, 65 F.3d at 969–70 (finding

that “several public statements” by the agency contributed to

a “sufficient evidentiary” showing of bad faith); Mullin v.

Doe, 146 S. Ct. 2121, 2138–39 (2026) (applying Arlington

Heights to consider whether statements by the President and

the Secretary of Homeland Security established racial

animus). The district court correctly concluded that these

QUEERDOC, PLLC V. USDOJ 73

statements provide strong circumstantial evidence that DOJ

issued the subpoena to pressure QueerDoc to “settle a

collateral dispute”—that is, to end its provision of gender-

affirming care or shut down its business. Powell, 379 U.S.

at 58.

2. Shifting Justifications

DOJ’s shifting rationalizations support the district

court’s finding that the subpoena was not “honestly” issued

in pursuit of a federal health care investigation. LaSalle, 437

U.S. at 316; see Washington v. Garrett, 10 F.3d 1421, 1434

(9th Cir. 1993) (explaining that “different

justifications . . . suggest the possibility that . . . the official

reasons [were not] the true reason[s]”); EEOC v. Ethan

Allen, Inc., 44 F.3d 116, 120 (2d Cir. 1994) (recognizing that

a reasonable juror could find explanations “pretextual,

developed over time to counter the evidence”). The record

contradicts the majority’s claim that DOJ’s theory of liability

“has remained constant.” Majority 44.

Initially, DOJ stated only that it had initiated the

investigation pursuant to the Executive Orders and the Bondi

Memo. The Bondi Memo asserted that “manufacturers and

distributors” of medications could be engaged in

“misbranding” under the FDCA by making “false claims

about the on or off-label use” of gender affirming drugs. But

QueerDoc is neither a manufacturer nor distributor of drugs.

The Shumate Memo stated that DOJ would pursue FDCA

investigations into “pharmaceutical companies” that

manufacture hormones and puberty blockers and “dealers

such as online pharmacies” that sell such drugs. By contrast,

with respect to providers, the Shumate Memo said only that

DOJ would pursue “claims under the False Claims Act” for

those “that bill the federal government for impermissible

74 QUEERDOC, PLLC V. USDOJ

services.” But DOJ did not issue the subpoena to pursue a

False Claims Act investigation, and QueerDoc “does not

participate in federal insurance programs or submit

insurance claims.” QueerDoc, 807 F. Supp. 3d at 1298.

When QueerDoc asked if “specific concerns” prompted

DOJ’s investigation, a DOJ attorney offered only that

QueerDoc was being investigated because it was a

“prominent” provider of gender-affirming care: “[T]hat’s

the extent of it.” See Gertner, 65 F.3d at 970 (finding that a

“generic affidavit, devoid of particularization, suggests that

the [agency] never really suspected the [subpoena recipient]

of any questionable activity”). Nevertheless, DOJ attorneys

were instructed to make “frequent and extensive reports” to

“senior leadership.” That is, despite the absence of

particular information prompting the investigation, it was

apparently an agency priority.

QueerDoc filed a motion to quash the subpoena on July

8, 2025. DOJ did not file any affidavits regarding

investigatory purpose with its responsive briefing. In

September 2025, district courts in Massachusetts and

Washington quashed analogous DOJ subpoenas on

relevance and improper purpose grounds. See In re Admin.

Subpoena No. 25-1431-019, 800 F. Supp. 3d at 239; In re

Subpoena Duces Tecum No. 25-1431-016, 2025 WL

3562151, at *12–13. 6

6

At least seven courts have quashed, recommended quashal, or modified

these subpoenas. See In re Admin. Subpoena No. 25-1431-019, 800 F.

Supp. 3d at 239; In re Subpoena Duces Tecum No. 25-1431-016, 2025

WL 3562151, at *12–13; In re DOJ Admin. Subpoena No. 25-1431-030,

2026 WL 33398, at *11 (D. Colo. Jan. 5, 2026); In re Children’s Nat’l

Hosp., 2026 WL 160792, at *9 (D. Md. Jan. 21, 2026); In re Subpoena

No. 25-1431-014, 810 F. Supp. 3d 555, 580 (E.D. Pa. 2025); In re 2025

QUEERDOC, PLLC V. USDOJ 75

The government then pivoted. On September 26,

2025—two months after the close of briefing—the

government filed a declaration offering new justifications

for its investigation. The Gordus Declaration posited that

(1) any evidence of fraudulent billing could establish intent

under the FDCA (not the False Claims Act), and (2) that

QueerDoc could be liable for misbranding under the FDCA

for “caus[ing] the distribution of” an “approved drug for an

unapproved use” or for having “false and misleading”

information on its website that “may legally qualify as drug

labeling under the FDCA.”

On appeal, DOJ again tries motley legal theories on for

size. For one, DOJ avers, the QueerDoc subpoena may

instead aid in investigating potential FDCA violations by

unnamed manufacturers and distributors. Why, then, would

DOJ’s press release announce only the issuance of

subpoenas to “doctors and clinics” that “mutilated children,”

not to manufacturers or distributors—if the latter are the

ones suspected of violating the law? U.S. Dept. Just.,

Department of Justice Subpoenas Doctors and Clinics

Involved in Performing Transgender Medical Procedures on

Children (July 9, 2025). And how are children’s names,

dates of birth, social security numbers and addresses relevant

to this purpose?

Alternatively, DOJ contends, it may be investigating

purportedly fraudulent billing statements. But the FDCA

regulates “misbranding” and “adulteration.” See 21 U.S.C.

UPMC Subpoena, 2025 WL 3724705, at *3 (W.D. Pa. Dec. 24, 2025);

In re Admin. Subpoena 25 1431 032 to R.I. Hosp., 2026 WL 1392565, at

*10 (D.R.I. May 14, 2026). The “uniformity of judicial expression in

the district courts is significant and impressive.” McComb v. Hunt

Foods, Inc., 167 F.2d 905, 908 (9th Cir. 1948).

76 QUEERDOC, PLLC V. USDOJ

§§ 331(a)–(c). It does not regulate billing or coding. This

rationale provides no help to the majority.

Finally, DOJ suggests that QueerDoc itself may be liable

for misbranding under the FDCA. The government

acknowledges that the FDCA only “regulates the

development, manufacturing, and distribution of drugs.” It

“does not go further by regulating a doctor’s practice of

medicine,” which is reserved to the states. Ass’n of Am.

Physicians & Surgeons v. FDA, 13 F.4th 531, 534 (6th Cir.

2021); United States v. Skrmetti, 605 U.S. 495, 524 (2025)

(explaining that states retain “wide discretion” to regulate

“areas where there is medical and scientific uncertainty”

(citation omitted)). This includes a provider’s decision to

prescribe medication for off-label uses. See Buckman Co. v.

Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (‘“[O]ff-

label’ usage . . . is an accepted and necessary corollary of the

FDA’s mission to regulate in this area without directly

interfering with the practice of medicine.”); 21 U.S.C. § 396

(“Nothing in this chapter shall be construed to limit . . . the

authority of a health care practitioner to prescribe or

administer any legally marketed device to a patient.”).

Notwithstanding these principles, DOJ argues that

QueerDoc’s webpage describing puberty blockers as

“reversible” may constitute false or misleading “labeling” of

a drug, and subject QueerDoc to liability for “misbranding”

under the FDCA. 21 U.S.C. §§ 331(a)–(b), 352(a). And the

majority adds a new proposal for the government to add to

its “labeling” theory: Perhaps webpages that provide

patients guidance for self-administering injections,

informational graphics depicting cartoon unicorns, and

“tips” to facilitate “less ouch” injections, such as purchasing

“calming aromatherapy” and “[h]olding a pet or emotional

support animal,” constitute “labeling” of a drug. QueerDoc,

QUEERDOC, PLLC V. USDOJ 77

Less Ouch! Tips for Less Painful Injections,

https://queerdoc.com/tips-for-less-painful-injections/

[https://perma.cc/6TC5-T84R]; QueerDoc, Self-Injections,

https://queerdoc.com/self-injections/

[https://perma.cc/3UTA-QKEQ]. But to constitute

“labeling” of a drug, written material must appear “upon any

[drug] or any of its containers or wrappers,” or

“accompany[]” the drug. See 21 U.S.C. § 321(m).

The theory that a health care provider’s website is

“labeling” that “accompan[ies]” a drug is not persuasive. Id.

QueerDoc’s website is not “distributed to consumers as part

of an integrated distribution program.” Alberty Food Prods.

Co. v. United States, 185 F.2d 321, 325 (9th Cir. 1950)

(concluding newspaper advertisements did not accompany a

drug). Nor does it share “a common origin” with a drug.

Kordel v. United States, 335 U.S. 345, 348 (1948). At its

core, this theory is not credible because QueerDoc’s website

relates to the provision of medical care (which is reserved to

the states), not to the commercial manufacturing or

distribution of drugs (which is covered by the FDCA). 7

*

To the majority, it does not matter that DOJ’s

investigatory targets and justifications changed after issuing

7

While a party “may not avoid an administrative subpoena on the

ground that it has a valid defense to a potential subsequent lawsuit,” that

does not “mean that under no circumstances may the court inquire into

the underlying reasons for the examination.” EEOC v. Karuk Tribe

Hous. Auth., 260 F.3d 1071, 1076–77 (9th Cir. 2001); Powell, 379 U.S.

at 58. Rather, the “specific sequence of events” preceding and following

the issuance of the subpoena, including the government’s shifting and

thin theories of liability, may provide “circumstantial . . . evidence” of

bad faith. Arlington Heights, 429 U.S. at 266–67.

78 QUEERDOC, PLLC V. USDOJ

the subpoena, because “an agency investigation is dynamic.”

Majority 44. It certainly matters. A fundamental principle

of administrative law is that courts may not uphold agency

actions based on “post hoc rationalizations,” theories

developed to “defend[] in court the agency’s acts.” FTC v.

Atl. Richfield Co., 567 F.2d 96, 100 (D.C. Cir. 1977);

Gonzalez v. Reno, 212 F.3d 1338, 1350 (11th Cir. 2000);

Burlington Truck Lines, Inc. v. United States, 371 U.S. 156,

168 (1962). The majority does just that by adopting

investigative theories first articulated in the properly stricken

Gordus Declaration—all while bafflingly claiming that the

“government’s investigatory purpose has remained

constant.” Majority 44.

Even if we could ignore this “foundational principle of

administrative law,” Michigan v. EPA, 576 U.S. 743, 758

(2015), DOJ does not claim that it has “acquire[d] new

information” that caused it to change investigatory targets,

legal theories, and justifications. Majority 44. In law, as in

life, “the simplest explanation is generally the best.” Apache

Stronghold v. United States, 101 F.4th 1036, 1082 (9th Cir.

2024) (en banc) (Bea, J., concurring in part and dissenting in

part). Here, the record suggests that after multiple courts

quashed DOJ’s subpoenas as having been issued to

intimidate providers of gender-affirming care, DOJ adopted

new post-hoc rationalizations to “counter the evidence” and

save its improper investigation. Ethan Allen, Inc., 44 F.3d

at 120.

3. Deviation from Prosecutorial Norms

DOJ’s approach to this investigation runs counter to

longstanding agency policies and norms that prioritize

confidentiality. “Departures from the normal procedural

QUEERDOC, PLLC V. USDOJ 79

sequence” provide “circumstantial . . . evidence” of bad

faith. Arlington Heights, 429 U.S. at 266–67.

The day after QueerDoc filed a motion to seal

proceedings to protect the integrity of the investigation and

the “safety of the providers associated with QueerDoc [and]

their patients,” DOJ publicly announced that it had issued

subpoenas to more than twenty providers of gender-

affirming care. U.S. Dept. Just., Department of Justice

Subpoenas Doctors and Clinics Involved in Performing

Transgender Medical Procedures on Children (July 9,

2025).

This represents a significant departure from agency

norms that prioritize confidentiality. The DOJ’s

investigative work “involves non-public, sensitive matters.”

Justice Manual, § 1-7.100. DOJ’s manual explains that it

generally “will not confirm the existence of or otherwise

comment about ongoing investigations,” or “comment on

[their] nature or progress before charges are publicly filed.”

Id. at §§ 1-7.100, 7.400. This norm makes sense. When

investigatory subjects and witnesses are put on notice of an

ongoing investigation, it becomes more difficult to obtain

the evidence necessary to identify and prosecute violations

of the law. See Brief for Former U.S. DOJ Attorneys as

Amicus Curiae 29. In addition to potentially “jeopardiz[ing]

an investigation,” publicizing an investigation also risks

“put[ting] a witness or law enforcement officer in

danger; . . . prejudic[ing] the rights of a defendant; or

unfairly damag[ing] the reputation of a person.” Justice

Manual § 1-7.100. Confidentiality thus promotes effective

enforcement of the law.

DOJ abandoned these longstanding norms in this case.

DOJ did not wait for “charges [to be] publicly filed” to

80 QUEERDOC, PLLC V. USDOJ

disclose the existence and nature of its investigation. Id. § 1-

7.400. Instead, just a month after serving a subpoena on

QueerDoc, DOJ publicly announced its investigations into

providers of gender-affirming care—and opposed

QueerDoc’s motion to seal the district court’s docket. DOJ’s

departure from confidentiality norms key to an

investigation’s success (in DOJ’s own telling) provides

circumstantial evidence that its goal was not to “honestly”

pursue potential FDCA violations. LaSalle, 437 U.S. at 316.

4. Subpoena Breadth

The subpoena’s expansive scope supports the district

court’s finding that the government acted in bad faith. See

Media Matters for Am. v. FTC, No. 25-5302, 2025 WL

2988966, at *7 (D.C. Cir. Oct. 23, 2025) (holding that the

“broad scope” of a civil investigative demand provides

“relevant evidence of pretext”). While the government’s

demand for intrusive identifying information bears little on

its purported purpose of investigating federal health care

offenses, it effectively serves the goal of intimidating

patients and providers.

The subpoena requires disclosure of thousands of

intrusive patient and employee records. 8 Requests 11 and 12

seek patient data and records for every patient prescribed

8

The subpoena ordered QueerDoc to produce fifteen categories of

documents, including “[c]omplete personnel files for each employee,

contractor, or affiliate,” “[a]ll documents . . . concerning the use

of . . . diagnosis codes,” “[a]ll communications with public or private

health care benefit programs or plans regarding” coding, “[a]ny training

materials . . . relating to billing or coding practices for gender-related

care,” “[a]ll documents relating to contracts” with manufacturers or

pharmacies of puberty blockers or hormones, and “[a]ll documents

relating to any adverse event . . . in a minor patient with regard to

gender-related care.”

QUEERDOC, PLLC V. USDOJ 81

puberty blockers or hormone therapy, including

“[d]ocuments sufficient to identify each patient.” QueerDoc

must produce patients’ “name[s], date[s] of birth, social

security number[s], address[es], and parent/guardian

information.” On appeal, the government doubles down on

its “need” for patients’ identifying information, but it is

unclear what information would not be obtainable from

anonymized records. Indeed, a district court recently found

that DOJ has agreed to anonymized data in several

jurisdictions. In re Admin. Subpoena 25 1431 032 to R.I.

Hosp., 2026 WL 1392565, at *3.

So too, the subpoena seeks identifying information on

QueerDoc’s adult patients, although DOJ claims it is only

investigating the provision of gender-affirming care to

minors. See United States v. Henry, 491 F.2d 702, 705 (6th

Cir. 1974) (finding pretext determination “buttressed by” the

subpoena’s demand of records that “could not apply” to the

stated investigatory purpose but “could be useful” for the

improper purpose).

In contrast to legitimate law enforcement, it is obvious

how DOJ’s intrusive demands “could be useful” to the

improper purpose of eliminating gender-affirming care.

Henry, 491 F.2d at 705. For one, disclosure of patients’

names and personally identifying information intimidates

current patients and deters prospective patients from seeking

care. Patients may choose to forgo care rather than risk

public intolerance, hostility, or violence. Access to gender-

affirming care “can be a question of life or death,” as

untreated gender dysphoria can cause “depression, eating

disorders, substance abuse, self-harm, and suicidality.” 9

9

The majority identifies a recent Finnish study, not briefed by the parties

and not raised by amici curiae, and suggests that its findings evince

82 QUEERDOC, PLLC V. USDOJ

Skrmetti, 605 U.S. at 581 (Sotomayor, J., dissenting) (citing

E. Coleman et al., Standards of Care for the Health of

Transgender and Gender Diverse People, Version 8, 23 Int’l

J. Transgender Health S1, S62 (2022)).

The subpoenas also chill the provision of gender-

affirming care by intimidating providers who offer such

care. The financial cost of litigation and the operational

burden of compliance with expansive production demands

may put providers out of business. See United States v.

Samuels, Kramer & Co., 712 F.2d 1342, 1347–48 (9th Cir.

1983) (requiring an evidentiary hearing on improper purpose

in light of evidence government may have issued subpoena

in part to “close [recipient’s business] down”). And the

professional disagreement with previous research finding that “gender-

affirming care improves mental health outcomes and reduces suicide risk

in transgender youth.” Majority 36 n.5; see Brief for American Academy

of Pediatrics as Amicus Curiae 8–11 (canvassing research). As a

threshold matter, it is not our role to parse the merits of quantitative

research neither raised before the district court nor briefed on appeal.

Assuming we were tasked with evaluating this study, since the study’s

publication, wide-ranging critiques have emerged about its

methodology. Among the notable critiques, a group of professors wrote

that the data “cannot be used to draw conclusions about mental health

after [gender-affirming care], nor can they be used to compare those who

accessed [gender-affirming care] and those who did not,” and requested

a reanalysis and re-review of the data based on the study’s

“misrepresentation of data, misrepresentation of findings, and

inappropriate controls.” E. Kale Edmiston et al., Concerns Regarding

Data Modelling and Interpretation in Ruuska et al., Acta Paediatrica:

Reader’s Forum 1–2 (May 30, 2026), https://doi.org/10.1111/apa.70617.

Likewise, based on the study’s alleged methodological flaws, an open

letter signed by nearly fifty academics, researchers, practitioners, and

advocates urged “prompt editorial reconsideration” of the study to

“ensure scientific soundness.” See David R. Banos et al., Letter of

Concern About Ruuska et al. From 4 April 2026, Acta Paediatrica:

Reader’s Forum 1–4 (May 22, 2026), https://doi.org/10.1111/apa.70620.

QUEERDOC, PLLC V. USDOJ 83

industry-wide threat of criminal investigation pressures

providers to stop offering such care, even if they are not yet

investigatory targets. Unsurprisingly, these threats have

proven effective at achieving the “intended effect” of

chilling gender-affirming care. President Trump is

Delivering on His Commitment to Protect Our Kids (Feb. 3,

2025). Since the Executive Orders, “more than 40 hospitals

nationwide have paused or ceased to offer some type of

gender-affirming care” to minors. Theresa Gaffney, Amid

Federal Pressure, More Hospitals Stop Gender-Affirming

Care for Minors, STAT News (Feb. 5, 2026),

https://www.statnews.com/2026/02/05/hospitals-stop-

gender-care-minors-trump-administration-pressure/

[https://perma.cc/UD9V-LBV3].

This case is no different. Dr. Crystal Beal, Chief

Executive Officer of QueerDoc, attested that “full

compliance” with the subpoena, including reviewing and

producing patient records, personnel files, and other

documents, and ensuring conformity with state privacy laws,

would “seriously threaten QueerDoc’s ability to remain in

business.” QueerDoc is a small telehealth provider. Apart

from Dr. Beal, QueerDoc has only one other employee.

Because QueerDoc does not have an information technology

department to manage document production, Dr. Beal would

have to hire a discovery vendor. QueerDoc would also have

to “invest additional resources into legal resources.” And

Dr. Beal would have to shift from “providing healthcare

services to patients” to “managing document productions.”

*

The majority responds that the subpoena’s expansive

scope does not show bad faith, because the information

sought may be relevant to DOJ’s investigation. But a

84 QUEERDOC, PLLC V. USDOJ

subpoena recipient may move to quash a subpoena either

because the information is irrelevant to the purported

investigation or because the subpoena was issued for an

improper purpose. See Crystal, 172 F.3d at 1144 (describing

the “burden” shift after “the government has established the

Powell elements”). That is, a subpoena recipient who moves

to quash a subpoena may prevail by establishing that the

information sought is irrelevant, notwithstanding the

agency’s demonstrated good faith. Or a subpoena recipient

may show that a subpoena was issued in bad faith, although

it clears the prima facie relevance bar. See Gertner, 65 F.3d

at 968–71 (affirming improper purpose determination

notwithstanding a sufficient relevance showing).

The majority similarly reasons that “fear that the costs of

compliance will force a party to shutter its business

implicates the question of undue burden, not of improper

purpose.” Majority 50–51. QueerDoc could certainly seek

to narrow the subpoena because compliance would unduly

burden its business operations. But this simply presents a

different question from whether the subpoena was issued for

the purpose of putting QueerDoc out of business—and under

our precedent, warrants a different remedy. That is, a

subpoena recipient may obtain an order narrowing a

subpoena because compliance would be unduly

burdensome, although the agency issued the subpoena in

good faith pursuit of its statutorily authorized purpose. Or a

district court may properly quash a subpoena on improper

purpose grounds after finding that the agency issued the

subpoena for the purpose of shutting down a business,

regardless of whether the subpoena in fact imposed a legally

sufficient undue burden. See Samuels, Kramer & Co., 712

F.2d at 1347–48.

QUEERDOC, PLLC V. USDOJ 85

Thus, even assuming the government carried its prima

facie burden, the district court did not err in concluding that

the subpoena’s intrusive and expansive scope supported its

bad faith finding.

**

The district court’s finding that DOJ issued the subpoena

to chill QueerDoc’s provision of gender-affirming care is

logical, plausible, and supported by the record, which is all

that clear error review requires. Hinkson, 585 F.3d at 1262.

The majority should have ended its inquiry here.

IV.

The district court’s finding that DOJ acted for the

purpose of ending gender-affirming care was not “based on

several [legal] misapprehensions.” Majority 48. The

majority invents purported legal errors based on the

misguided view that courts are powerless to constrain

agency overreach if doing so would “intrude” on the

President’s policy priorities. This misunderstands the

relationship between the executive, judicial, and legislative

branches in the investigative subpoena context. “Subpoena

enforcement power is not limitless.” Ken Roberts Co., 276

F.3d at 586. Agencies must operate within the bounds of the

law enacted by Congress, and courts have a “duty not to

rubber-stamp” administrative subpoenas “but to adjudge

their legitimacy.” CFPB v. Accrediting Council for Indep.

Colls & Schs., 854 F.3d 683, 689 (D.C. Cir. 2017). The

district court’s decision respects this balance of powers. The

majority’s opinion undermines it.

86 QUEERDOC, PLLC V. USDOJ

A.

The checks and balances built into the § 3486 subpoena

authority constrain executive power. True, the Executive

Branch has “discretion” to prioritize “legal actions against

defendants who violate the law.” TransUnion LLC v.

Ramirez, 594 U.S. 413, 429 (2021). But the administrative

subpoena power is not a discretionary executive function; it

is a congressionally authorized power, limited by statute and

subject to judicial review that is “narrow,” but “potent.”

SEC v. Arthur Young & Co., 584 F.2d 1018, 1024 n.39 (D.C.

Cir. 1978). Where Congress has provided authority to issue

subpoenas for a particular purpose, neither the President nor

the DOJ has the authority to stray from that purpose.

First, “[t]he authority of an administrative agency to

issue subpoenas for investigatory purposes is created solely

by statute.” United States ex rel. Richards, 4 F.3d at 753

(quoting Peters, 853 F.2d at 696); LaSalle, 437 U.S. at 317

n.18. Rather than sanction “unconstrained investigative

authority,” Congress, in the context of this case, authorized

the use of subpoenas solely for the purpose of investigating

“[f]ederal health care offense[s].” EEOC v. Shell Oil Co.,

466 U.S. 54, 65 (1984); 18 U.S.C. § 3486(a)(1)(A)(i)(I).

Thus, our task is simply to determine whether the district

court’s finding that DOJ issued the subpoena for a purpose

not authorized by Congress was clearly erroneous. LaSalle,

437 U.S. at 317 n.18. Again, the district court had ample

evidence to conclude that when DOJ issued its subpoena, it

did so not for the purpose of investigating a crime, but to run

QueerDoc out of business.

In an apparent effort to avoid the clear error standard of

review for factual findings, the majority recasts the issue

before us as “what counts as an illicit motive,” a legal

QUEERDOC, PLLC V. USDOJ 87

question subject to de novo review. Clarke, 573 U.S. at 256.

But the “illicit motive[s]” at issue in this case are well-

established. Id. Because DOJ “does not enjoy inherent

authority to summon production of the private papers of

citizens” and may “exercise only that authority granted by

Congress,” the issuance of a subpoena for a purpose other

than its statutorily authorized purpose is improper. LaSalle,

437 U.S. at 317 n.18. That is, if DOJ issued the subpoena

not in “honest[]” and “good faith” investigation of a federal

health care offense, as § 3486 requires, but to “harass”

QueerDoc or to “pressure” it to “settle a collateral dispute”

(to shut down its business or end its provision of gender-

affirming care), it acted pursuant to an improper purpose. Id.

at 316, 317 n. 19; Powell, 379 U.S. at 58. The district court

thus applied the “correct legal standard.” Clarke, 573 U.S.

at 256.

Second, federal courts have a duty to ensure agencies do

not exceed their statutory authority in issuing subpoenas.

Agencies are expected to pursue “earnest and eager action”

in enforcement proceedings. United States v. Morton Salt

Co., 338 U.S. 632, 640 (1950). But “judicial review is

provided” to protect against “harsh and overzealous action”

or “mistaken or arbitrary orders.” Id.

“[W]hile the courts’ role in subpoena enforcement may

be a strictly limited one, it is neither minor nor ministerial.”

Ken Roberts Co., 276 F.3d at 587 (citation and internal

quotation marks omitted). In subpoena enforcement

proceedings, courts may review only whether the agency

satisfied its prima facie burden, and if so, whether the

subpoena recipient satisfied its burden to show the subpoena

was issued in bad faith, poses an undue burden, or is

overbroad. See Golden Valley Elec. Ass’n, 689 F.3d at 1113.

These are “narrow” inquiries; but “the court’s role . . . within

88 QUEERDOC, PLLC V. USDOJ

its confines [] is potent.” Arthur Young & Co., 584 F.2d at

1024 n.39. That is, district courts have a duty to carefully

weigh evidence suggesting an investigation is pretextual,

rather than simply accepting at face value an agency’s claim

that it acted in good faith. The district court properly

examined a “narrow” question—whether the subpoena was

issued in bad faith—and engaged in “potent” review within

its confines, examining all relevant evidence of DOJ’s intent.

Id.

Potent review of

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