DOJ Subpoena Seeks Health Information of Hospital Patients Receiving Gender-Affirming Care: Will Judge Grant Motion to Quash?

On June 12, 2025, the Children’s Hospital of Philadelphia (“CHOP”) received a subpoena issued by the Department of Justice (“DOJ”) requesting highly sensitive patient health and procedure information related to gender-affirming care.

These subpoenas, issued to multiple hospitals, doctors, and clinics, were directly related to the Trump Administration’s January 28, 2025, Executive Order entitled, “Protecting Children from Chemical and Surgical Mutilation” (“EO 14187”).  The subpoena to CHOP has resulted in recent court activity over its purpose and enforceability. 

E.O. 14187, and the directives that followed, are designed to discourage, if not end, gender-affirming care involving surgery and medication, and to bring enforcement action against those who perform “sex-trait modification procedures.” As EBG reported in July, this has been a policy priority of the Administration from Day One—with a concerted effort across multiple federal agencies.

The subpoena issued to CHOP featured broad requests for information regarding the identities and personal health information of minor patients who received gender-affirming care, information about their parents, health care provider information, and billing records. The request extended to patient communications, clinical determinations, medical records, and documentation related to informed consent.

There have been many developments in the U.S. District Court for the Eastern District of Pennsylvania challenging the subpoena’s legality. CHOP patients and their parents, for instance, have filed a Motion to Quash, asserting that the subpoena “violates the privacy rights of patients and their parents” and that it was issued for an improper purpose. In response, the United States has filed a brief opposing the motion, along with a DOJ declaration purporting to validate its actions—highlighting the government’s “nationwide investigation into, among other things, whether off-label promotion and/or unlawful dispensing of puberty blockers and cross-sex hormones for use by children suffering from gender dysphoria violated federal law, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et seq. (“FDCA”).” The declaration provides information about the Administration’s playbook that may have been suspected previously but is now part of a public record. 

The FDCA-focused initiative reflects Administration priorities outlined in EO 14817 and reiterated in a DOJ Civil Division Enforcement Priorities memorandum published on June 11, 2025. In these publications, the message is clear: the DOJ will attempt to “use all available resources” to investigate any “appropriate entities” for violations of the FDCA, and to “aggressively pursue” violations of the federal False Claims Act (“FCA”). Here, we discuss two legal challenges to the subpoena, one brought by CHOP, In Re: Subpoena No. 25-1431-014, Docket No. 2:25-mc-00039, and the above-referenced one brought by CHOP patients and their parents, In Re: Subpoena No. 25-1431-014, No. 2:25-mc-00054.

Procedural History

July 8, 2025: CHOP’s Motion to Limit Subpoena

CHOP has filed a Motion to Limit the Subpoena in No. 2:25-mc-00039, seeking to exclude the following requests for the health information of its patients, including patients who sought treatment for gender dysphoria:

• Request 11: “[d]ocuments sufficient to identify each patient (by name, date of birth, social security number, address, and parent/guardian information) who was prescribed puberty blockers or hormone therapy”;
• Request 12: “documents relating to the clinical indications, diagnoses, or assessments that formed the basis for prescribing puberty blockers or hormone therapy” (for each patient identified in Request 11);
• Request 13: “[a]ll documents relating to informed consent, patient intake, and parent or guardian authorization for minor patients identified in [Request 11], including any disclosures about off-label use (e., uses not approved by the U.S. Food and Drug Administration) and potential risks”; and
• “Any and all other Requests enumerated in the Subpoena…to the extent that [they] call for the production of health information of CHOP patients.”

September 22, 2025: Memorandum of Law in Support of Motion to Quash

In a separate action, CHOP patients and parents filed their Motion to Quash, and an accompanying Memorandum, in No. 2:25-mc-00054, objecting to the same requests.

October 6, 2025: Memorandum in Opposition to the Motion to Quash

The DOJ has filed a Memorandum in Opposition to the Motion to Quash in No. 2:25-mc-00054, asserting that “[t]he subpoena properly seeks evidence of adulterated, misbranded, and unapproved new drug violations of the FDCA.” The DOJ makes a number of procedural and substantive arguments, including that the U.S. attorney general is authorized under the Health Insurance Portability and Accountability Act (“HIPAA”) to investigate health care offenses.

Hsaio Declaration

The DOJ’s October 6 Memorandum includes a declaration from Acting Director Lisa Hsiao of the DOJ’s Enforcement and Affirmative Litigation Branch (“Enforcement Section”) asserting that the Enforcement Section is authorized to undertake appropriate investigations of FDCA violations relating to the on-or off-label use by manufacturers and distributors of drugs, including puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition’ (citing to an Attorney General Memorandum of April 22, 2025 previously discussed by EBG).

October 8, 2025: Reply in Support of Motion to Quash Subpoena

CHOP’s patients and their parents have countered that “the subpoena and the underlying investigation is an “extraordinary attempt to use the FDCA to regulate, and indeed criminalize, the practice of medicine.” Their brief points out that gender-affirming care is legal in Pennsylvania—as are doctors’ off-label prescriptions, administration, and use of puberty blockers and sex hormones for gender-affirming care. They also dispute other procedural and substantive arguments made by the DOJ.

October 20, 2025: CHOP’s Supplemental Brief in Support of Motion to Limit the Subpoena

CHOP, for its part, contends that the Hsiao Declaration is “unreliable” and that the FDA does not regulate physicians’ off-label prescriptions. They point out what the FDCA expressly states: “Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” Too, the hospital argues, the FDA does not regulate the practice of medicine: “DOJ repeatedly obscures and confuses the differences between the legal obligations of manufacturers related to the approval, labeling, branding, and distribution of drugs with the doctors who prescribe approved drugs for off-label purposes, who the DOJ targets through the Subpoena.”

October 28, 2025: Amicus Brief

Pennsylvania Governor Josh Shapiro, along with the attorneys general of 14 states and the District of Columbia, have filed an amicus brief in No. 25-mc-00039—also arguing that enforcement of the subpoena issued to CHOP would 1) harm privacy rights; 2) interfere with states’ authority to regulate the practice of medicine; and 3) further an “unprecedented” interpretation of the FDCA that “jeopardizes entire fields of medicine.” Like the hospital, amici contend that off-label use of approved drugs where medically appropriate is lawful and that “DOJ wrongly sweeps off-label prescribing and dispensing into the FDCA’s prohibitions concerning distribution and promotion of unapproved drugs.”  

In early November, the government filed its response to CHOP’s supplemental brief as well as to  the amicus brief.

Takeaways

On October 27, 2025, the U.S. District Court for the District of Washington granted a motion to quash a DOJ subpoena in yet another case brought by a small telehealth provider offering gender-affirming care in 10 states, including Washington, QueerDoc PLLC v. U.S. Department of Justice, 2025 WL 3013568 (W.D. Wash. Oct. 27, 2025). The plaintiff in that case describes itself as “a healthcare provider that prescribes medications, not a manufacturer or distributor of pharmaceutical products[.]” The court denied a motion to seal, “because, despite legitimate safety concerns, transparency in judicial proceedings remains paramount when challenging executive power.” Yet it agreed that “DOJ issued the subpoena for an improper purpose”—pointing out that Requests 11 through 13 “demand a staggering amount of personal health data” that “have little to do with investigating violations of FDCA or FCA.” This, and a similar case in Massachusetts, may be a predictor of things to come.

Nonetheless, through the DOJ’s memos and directives, prosecutors are being urged to target entities that are manufacturing, distributing, or prescribing drugs used in gender-affirming care, especially if drugs are being used “off-label” – i.e., not for their FDA-approved use. Therefore, investigative risks are heightened for clinicians, the institutions where care is provided, and the pharmaceutical industry.  DOJ, FDA, the Federal Trade Commission, and other federal agencies are advancing a theme that clinicians and drug manufacturers are cynically exploiting vulnerable children and their parents for profit purposes by selling products and therapies that lack scientific support. If you have questions regarding gender-affirming care, or the potential intersection with the FDCA and government investigations, please reach out to the authors.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.