Что изменилось

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.

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

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.

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.”

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).

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

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.

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).

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 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 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”).

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)).

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).

“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]

“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.

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.

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.

“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.

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.

## 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.

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/presidentthose identified as male at birth look more feminine.” United States v. Skrmetti, 605 U.S. 495, 581 (2025) (Sotomayor, J., dissenting).

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 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 genderaffirming 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 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

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.”

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]fflabel’ 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,

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

## 4. Subpoena Breadth

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 genderaffirming 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

The subpoenas also chill the provision of genderaffirming 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 “genderaffirming 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.

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 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.

The majority abdicates this core judicial duty. In the name of executive power, and based on a “fundamental misunderstanding about the authority of the [DOJ],” the majority “thwart[s]” Congress’s clear limitations on the HIPAA subpoena power, sanctions agency abuse of court process, and abandons our role in maintaining the separation of powers. LaSalle, 437 U.S. at 317 n.18; Shell Oil Co., 466 U.S. at 65; see Morrison v. Olson, 487 U.S. 654, 693 (1988) (quoting Buckley v. Valeo, 424 U.S. 1, 122 (1976)) (“[T]he system of separated powers and checks and balances established in the Constitution was regarded by the Framers as ‘a self-executing safeguard against the encroachment or aggrandizement of one branch at the expense of the other.’”); 1 B. Montesquieu, The Spirit of the Laws 161 (Thomas Nugent transl., J. Prichard ed. 1914) (“To prevent this abuse, it is necessary from the very nature of things that power should be a check to power.”).

The majority’s primary rejoinder is that the President’s policy goal of ending gender-affirming care is not itself improper. True, the President may adopt a policy position on gender-affirming care, even if that position is unsupported by scientific evidence. 10 But that is not the legal question before us. That the President can voice policy opposition to gender-affirming care does not mean that the DOJ can weaponize its statutorily constrained subpoena authority as a tool to put health care providers out of business. The crux of the majority’s confusion lies here. It uses one word to refer to two distinct ideas. As QueerDoc’s

The majority claims that the President’s Article II removal power, Trump v. Slaughter, No. 25-332, 609 U.S. ____, 2026 WL 1855612, at *6 (U.S. June 29, 2026), eliminates the “division between DOJ and the President.” Majority 49. This odd position reveals a “fundamental misunderstanding about the authority of the [DOJ].” LaSalle, 437 U.S. at 317 n.18. Because the individuals within the Executive Branch are legally distinct, whether an executive official’s action is lawful depends on who takes the action. For example, where an executive agency has the power to conduct formal adjudications, the President cannot himself legally wield that authority. Myers v. United States, 272 U.S. 52, 135 (1926) (explaining that notwithstanding Article II, there are duties the President “cannot in a particular case properly influence or control”). Or order an agency adjudicator to rule against a specific party. Portland Audubon Soc. v. Endangered Species Comm., 984 F.2d 1534, 1545 (9th Cir. 1993) (“[S]trongly disagree[ing]” with the argument that the “President’s broader policy role” permits such influence). Nor are executive agency officials entitled to presidential immunity for official acts. Harlow v. Fitzgerald, 457 U.S. 800, 809 (1982) (concluding it would be “untenable to hold absolute immunity an incident of the office of every Presidential subordinate”). In other words, the President is not an agency, Franklin v. Massachusetts, 505 U.S. 788, 796 (1992), and an agency is not legally synonymous with the presidency.

The majority claims I “never explain[]” why DOJ may not issue a subpoena for the purpose of ending genderaffirming care, if the President may voice policy opposition to such care. Majority 50. I will repeat myself for the majority’s benefit: the law Congress enacted does not allow DOJ to issue a subpoena in order to harass a practitioner or to put a provider out of business, and our precedent prohibits agencies from pursuing bad faith, pretextual investigations. See Powell, 379 U.S. at 58. As judges, our duty is to follow the law, not ignore it.

This misses the mark. In isolation, an agency’s consistency with presidential priorities is not dispositive of whether it acted in good faith. This case is not about whether DOJ may investigate a regulated industry if the President has voiced policy opposition to that industry. No one contends such an industry is immune from investigation. Nor did the district court quash the subpoena because it was merely consistent with the President’s priorities. Instead, the district court quashed the subpoena because it found extensive evidence, see supra Section III.A, satisfying QueerDoc’s burden, that DOJ’s stated, statutorily authorized purpose for its investigation was not in fact its “honest[]” objective. LaSalle, 437 U.S. at 316.

DOJ officials’ public statements put my colleagues in a bind. To rule in favor of the government, the majority is forced to hold that the district court erred in considering statements by agency officials in determining whether the subpoena was issued for a pretextual reason. But the “dispositive question” is whether the agency acted in bad faith—and bad faith turns on intent. LaSalle, 437 U.S. at 317 n.19. Accordingly, district courts must “inquire into the underlying reasons” motivating an administrative subpoena. Powell, 379 U.S. at 58; Goldman, 637 F.2d at 666. Statements by officials about DOJ’s objectives provide strong evidence of institutional purpose. See Arlington Heights, 429 U.S. at 266, 268 (evaluating motive “demands” consideration of “evidence of intent as may be available,” including “contemporary statements by members of the decisionmaking body”); Gertner, 65 F.3d at 969–70; Mullin, 146 S. Ct. at 2138–39. It is blackletter law that across varied contexts, to “evaluat[e] purpose,” courts routinely and “regularly take into account the statements of governmental officials.” Freedom From Religion Found., Inc. v. Chino Valley Unified Sch. Dist. Bd. of Educ., 896 F.3d 1132, 1149 (9th Cir. 2018).

The majority also argues that the district court disregarded the presumption of regularity in finding DOJ acted in bad faith. True, courts presume that government officials “properly discharge[] 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, 15 (1926)). But there is “[n]o doubt” that the presumption “is subject to be rebutted.” R.H. Stearns Co. v. United States, 291 U.S. 54, 63 (1934). That is, the presumption applies “in the absence of clear evidence to the contrary.” Cruz, 146 F.4th at 739 (quoting Chem. Found., Inc., 272 U.S. at 14–15) (emphasis added). As described above, QueerDoc has presented ample evidence “to the contrary.” Id. We need not assume that DOJ is acting in good faith to investigate crimes when it has told us that it is acting with the intent to end an industry.

This ipse dixit reasoning would eliminate judicial review of whether a subpoena was issued for an improper purpose. In practice, a statement by a government official that the agency would follow the law would always defeat a motion to quash, regardless how flagrant the evidence of pretext. But a district court’s role is to serve as an “independent reviewing authority,” not “a ‘rubber stamp’ for agency demands for the production of information.” Wearly v. FTC, 616 F.2d 662, 665 (3d Cir. 1980); Markwood, 48 F.3d at 979. I cannot join the majority in turning “potent” judicial review of institutional bad faith into a hollow formality. Arthur Young & Co., 584 F.2d at 1024 n.39.