Rare Rebuke: Federal Courts Significantly Limit DOJ Subpoenas to Gender Affirming Care Providers

Courts are generally deferential to agency processes and seldom quash the DOJ’s investigative subpoenas. Yet, three judges independently found the DOJ’s asserted rationale lacking, its demands overbroad, and its use of subpoena power inconsistent with statutory limits and good-faith investigative practice.

The Backdrop: A Nationwide Subpoena Campaign Under Section 3486

Following public statements and executive orders calling for the end of gender‑affirming care, the DOJ announced on June 11, that it would “use all available resources” to prioritize investigations of doctors, hospitals, and other providers into possible violations of the Food, Drug, and Cosmetic Act (FDCA), the False Claims Act (FCA), and other laws arising from conduct relating to drugs used in gender-related treatments of minors and alleged fraud involving diagnosis codes. Shortly thereafter, the DOJ issued subpoenas pursuant to 18 U.S.C. § 3486 to more than 20 health care providers.

Section 3486 grants the DOJ broad authority to issue administrative subpoenas (often called the Health Insurance Portability and Accountability Act (HIPAA) subpoenas) for documents in any investigation involving a federal health care offense. However, the DOJ’s subpoena power is not unlimited. In United States v. Powell, 379 U.S. 48 (1964), the US Supreme Court held that a government subpoena is enforceable only if (1) it is issued for a congressionally authorized purpose, (2) the information sought is relevant to that purpose, (3) the information sought is not already in the government’s possession, and (4) the government has complied with required administrative steps.

Boston Children’s Hospital (BCH), Children’s Hospital of Philadelphia (CHOP), and QueerDoc, a telehealth provider, received substantially identical HIPAA subpoenas demanding sweeping categories of material, including confidential personnel files, communications with manufacturers, extensive billing and coding materials, and — most notably — highly sensitive patient-identifying information and full medical records for minors prescribed puberty blockers or hormones.

All three challenged the subpoenas in federal court, arguing that the subpoenas were motivated by an improper purpose — namely, to chill or “end” lawful (and in BCH’s case, state-protected) gender-affirming care rather than to investigate a defined federal health care offense. They further argued that the sweeping demands for minors’ identities, full clinical charts, and staff personnel files were not relevant to any articulated FDCA or FCA theory, that the scope was vastly overbroad and unduly burdensome, and that the requests raised serious HIPAA and constitutional privacy concerns.

The government argued that it satisfied Powell by showing statutory authority under 18 U.S.C. § 3486, procedural regularity, and facial relevance to potential misbranding/off-label and false-claims theories. It also emphasized that probable cause is not required at the investigative stage, that courts owe substantial deference to the DOJ’s investigative decisions, and that any privacy or burden concerns could be addressed through protective orders, de-identification, or narrowing of the requests.

BCH and QueerDoc: Motion to Quash Granted in Full

The federal courts in Massachusetts and Washington granted BCH’s (Massachusetts) and QueerDoc’s (Washington) motions to quash in full. Judge Myong Joun of the Massachusetts District Court and Judge Jamal Whitehead of the Western District Court of Washington both acknowledged the deference typically afforded to the government’s investigative subpoenas. But under Powell and First and Ninth Circuit precedent, the courts must initially “assess whether the Government has made its prima facie showing of proper purpose, and then whether [the movant] has shown that the subpoena was issued for an improper purpose.”

Judge Joun and Judge Whitehead both rejected the government’s argument that the subpoena was issued for a proper purpose based solely on the Attorney General’s direction to the Civil Division to “undertake appropriate investigation” into violations of the FCA or FDCA through the provision of gender affirming care. According to the courts, the government’s logic “would preclude any form of judicial review as the Government’s self-proclaimed say-so would always be sufficient to defeat a motion to quash.”

The courts also emphasized the Trump Administration’s “explicit agenda,” including “[n]umerous statements by the Administration, executive orders, and memorandums, [that] detail the Administration’s goal of ending [gender affirming care].” For the BCH subpoena, Judge Joun noted that the Administration’s public statements, coupled with the lack of “an iota of suspicion” that BCH was actually engaged in unlawful conduct, and the government’s “astonishingly broad” and “virtually unlimited” request for documents and information made it “abundantly clear that the true purpose of issuing the subpoena is to interfere with the Commonwealth of Massachusetts’ right to protect [gender affirming care] within its borders, to harass and intimidate BCH to stop providing such care, and to dissuade patients from seeking such care.”

For the QueerDoc subpoena, Judge Whitehead emphasized that the “mismatch between the DOJ’s stated investigation and QueerDoc’s actual operations further reveal[ed] the subpoena’s pretextual nature.” QueerDoc neither manufactures drugs nor bills federal programs. This, according to the court, “suggests that DOJ issued the subpoena first and searched for a justification second. No legitimate investigation would demand thousands of patient records from an entity that cannot, by definition, commit the violations being investigated.”

Both courts found that the government failed to establish a prima facie showing of proper purpose, but even if it had, the providers had “demonstrated that the subpoena was issued for an improper purpose, motivated only by bad faith.”

CHOP: Subpoena Limited, Patient-Identity and Clinical Demands Quashed

Judge Mark Kearney of the Eastern District of Pennsylvania also granted CHOP’s motion as to the most intrusive requests — those seeking the identities of minors receiving gender-affirming care and their treatment files. First, the court held that the DOJ lacked authority under Section 3486 to compel minors’ identities and treatment files given their attenuated relevance to any articulated “federal health care offense” and the absence of record evidence tying the subpoena’s broad demands to legitimate FDCA or FCA investigations. The court emphasized that the FDCA regulates drug labeling and distribution, not the practice of medicine, and that off‑label prescribing is lawful under state regulation. Therefore, patient‑specific clinical records and consent materials do not bear on manufacturer misbranding or claims issues. Judge Kearney rejected the government’s argument that clinical documents can qualify as “false or misleading labeling” under the FDCA because health care providers are a part of the “chain of distribution” of drugs. The court stated that “[a]ccepting this interpretation would transform every act of treatment into a potential federal offense.”

The court also expressly noted the BCH and QueerDoc outcomes and agreed with Judge Joun that “the connection between child-patient-identifying information and potential fraudulent billing codes or unlawful off-label promotion is tenuous at best and cannot shoulder the weight of compelled disclosure of a child’s medical files.” Instead, the “children’s records concern lawful medical practice governed by Pennsylvania law” and the DOJ “lacks statutory authority for a rambling exploration of the Hospital’s files to learn the names and medical treatment of children.”

Second, even if such demands were authorized, the court held that Third Circuit precedent requires balancing an individual’s Constitutional right to privacy against the DOJ’s investigative needs. The court found that “the scale weighs in favor of protecting the privacy of children’s identities and treatment in an investigation into whether medical professionals are using false billing codes or misbranding the puberty blockers and hormone therapy.”

In particular, the court found that the type of records sought, and the information contained in such records, “fall at the highest end of intimate and personal spectrum.” In light of the president and attorney general’s claim that gender affirming care is “a stain on our Nation’s history” and the result of “a warped ideology,” the court also found an outsized risk that patients and their families could be exposed to “stigma, harassment, and social injury” if these types of identifying records were disclosed without the patient’s consent. The Administration’s public statements also factored into the court’s analysis that nonconsensual disclosure could irreparably harm the patient-doctor relationship and that statutory safeguards were inadequate to prevent broader dissemination.

The DOJ’s Subpoena Power Is Not Unlimited

These decisions underscore that, while agency subpoena standards are deferential, courts will intervene where the record reflects bad faith, improper purpose, overbreadth untethered to an authorized objective, or an attempt to transform Section 3486 into a roving mandate over state‑regulated clinical care. Across these opinions, three themes overcame the usual deference: the mismatch between asserted FDCA/FCA theories and the recipients’ operations; the extraordinary breadth and intrusiveness of demands for minors’ identities and complete medical charts; and extensive record evidence that the executive sought, not to investigate discrete offenses, but to achieve policy ends — “ending” gender‑affirming care — through investigatory pressure.

Another common thread likely to continue is the DOJ’s vigorous defense of its subpoena authority. The DOJ has noticed an appeal of the BCH and QueerDoc ruling. The government also continues to defend the subpoena program in district court filings and public statements, signaling that appellate courts will likely be asked to clarify the permissible scope of section 3486 subpoenas where policy animus, medical privacy, and state-protected care intersect.

Key Takeaways

As these appeals proceed, providers and health systems confronted with a similar process should promptly assess the subpoena’s scope, preserve objections, and consider moving to quash or limit on the grounds recognized in BCH, QueerDoc, and CHOP. The emerging record shows that courts are prepared to scrutinize purpose, cabin statutory authority, and acknowledge the profound privacy and operational burdens at stake when patient identities and clinical records are demanded en masse under the banner of a health care offense inquiry.