Courts’ Rare Quash Of DOJ Subpoenas Has Lessons For Cos.

These rulings are significant for the healthcare industry and other industries facing political scrutiny.

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, 2025, 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, the False Claims Act, 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 Title 18 of the U.S. Code, Section 3486, to more than 20 healthcare providers.

Section 3486 grants the DOJ broad authority to issue administrative subpoenas — often called Health Insurance Portability and Accountability Act subpoenas — for documents in any investigation involving a federal healthcare offense.

However, the DOJ’s subpoena power is not unlimited. In U.S. v. Powell, the U.S. Supreme Court held in 1964 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.[1]

Boston Children’s Hospital, The Children’s Hospital of Philadelphia and telehealth provider QueerDoc PLLC 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 entities 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 healthcare 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, the scope was vastly overbroad and unduly burdensome, and the requests raised serious HIPAA and constitutional privacy concerns.

The government argued that it satisfied Powell by showing statutory authority under Section 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, courts owe substantial deference to the DOJ’s investigative decisions, and any privacy or burden concerns could be addressed through protective orders, deidentification or narrowing of the requests.

BCH and QueerDoc: Motion to Quash Granted in Full

In In re: Administrative Subpoena No. 25-1431-019, the U.S. District Court for the District of Massachusetts granted BCH’s motion to quash in full last September. Then, in late October, the U.S. District Court for the Western District of Washington did the same in QueerDoc v. DOJ.

U.S. District Judge Myong Joun in Massachusetts, and U.S. District Judge Jamal Whitehead in the Western District of Washington, both acknowledged the deference typically afforded to the government’s investigative subpoenas.

But under Powell and U.S. Courts of Appeals for the First and Ninth Circuit precedent, as Judge Joun explained, 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.”

Both judges rejected the government’s argument that the subpoena was issued for a proper purpose based solely on the attorney general’s direction to the DOJ’s Civil Division to “undertake appropriate investigation” into violations of the FCA or FDCA through the provision of gender-affirming care. According to both 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 court in QueerDoc also emphasized the Trump “[a]dministration’s explicit agenda,” while the BCH court pointed to ”[n]umerous statements by the Administration, executive orders, and memorandums, [that] detail the Administration’s goal of ending [gender-affirming care].”

Judge Joun noted that the administration’s public statements, combined with the lack of “an iota of suspicion that BCH [was] actually engag[ed] 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 make a showing of proper purpose, but even if it had, the providers successfully showed that the subpoenas were improperly motivated and issued solely in bad faith.

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

In its Nov. 21 ruling in In Re: Subpoena No. 25-1431-014, the U.S. District Court for 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, U.S. District Judge Mark Kearney held that the DOJ lacked authority under Section 3486 to compel minors’ identities and treatment files given their attenuated relevance to any articulated federal healthcare 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 healthcare 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 “agree[d] 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 U.S. Court of Appeals for the 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 outsize 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.

DOJ’s Subpoena Power Not Unlimited

These decisions underscore that, while agency subpoena standards are deferential, courts are likely to 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: (1) the mismatch between asserted FDCA and FCA theories and the recipients’ operations; (2) the extraordinary breadth and intrusiveness of demands for minors’ identities and complete medical charts; and (3) extensive record evidence that the administration 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 appeals of all three rulings. 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.

Administrative Subpoena Authority Across Industries

While the BCH, QueerDoc and CHOP decisions arose in the healthcare context, the legal principles articulated by these courts may have implications for organizations across multiple industries. The DOJ and other federal agencies possess broad administrative subpoena authority under numerous statutory schemes, and the current administration’s policy priorities suggest that entities in other industries may also face heightened investigative scrutiny.

The civil investigative demand is the primary mechanism government agencies use to investigate allegations of fraud and other potential violations in healthcare and other regulated industries. These rulings therefore have particular relevance for sectors such as government contracting, education and nonprofits that receive federal funds and may be subject to the FCA.

Executive orders and agency directives have signaled an intent to use CID authority to examine diversity, equity and inclusion programs in government contracting, education and healthcare. Similarly, nonprofit and advocacy organizations focused on immigration, voting rights, healthcare access or environmental issues may face investigative inquiries pursuant to directives addressing potential violations of federal law.

For organizations in these industries that believe a CID may exceed its statutory authorization or reflect improper political animus, the BCH, QueerDoc and CHOP decisions offer a framework for evaluating and navigating potential challenges.

Key Takeaways

As these appeals proceed, companies and organizations 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.

Beyond the healthcare sector, organizations across industries should internalize the core lessons from these decisions: the requirements of proper purpose, relevance and procedural compliance.

Industries facing government scrutiny should remember that public statements and official pronouncements matter. Organizations that believe they are being targeted should document and preserve evidence of government officials’ statements that may reveal improper motive.

The scope of the demand is also crucial, and overbroad requests for virtually unlimited categories of documents or records with attenuated relevance are vulnerable to challenge.

Organizations should also scrutinize the statute invoked by the government and assess whether the demands exceed its boundaries. For example, a subpoena premised on investigating federal healthcare offenses under Section 3486 may not authorize demands for records concerning lawful medical practice governed by state law, just as a CID issued under the FCA may not extend to categories of documents unrelated to any plausible theory of government fraud.

Finally, remember that privacy interests carry significant weight, particularly where the records sought involve minors, medical treatment or other highly sensitive personal information.

These recent decisions demonstrate that courts are prepared to scrutinize purpose, cabin statutory authority, and acknowledge the profound privacy and operational burdens at stake when sensitive records are demanded en masse under the banner of a legitimate government inquiry.

Companies in the healthcare industry and other heavily regulated industries should continue to monitor developments in the BCH and QueerDoc appeals and related litigation.

Originally published by Law360.