D.Md.: AG’s admin. investigative demand for improper purpose and quashed; constitutional right of privacy in medical records

The AG issued a subpoena to a hospital for records of adolescent gender affirming care. The subpoena is quashed. The subject has Art. III standing. There is no allegation of a health care offense to support the subpoena. In addition, the subject has a constitutional right of privacy in their records. In re 2025 Subpoena to Child.’s Nat’l Hosp., 2026 U.S. Dist. LEXIS 10523 (D. Md. Jan. 21, 2026):

The Government fails to place before the court any information, record, or evidence supporting or pertaining to investigation of the Hospital for any “health care offense.” There is no articulated basis to suspect the Hospital of violations of the FDCA or the False Claims Act; and surely none that would call for disclosure of Movant’s records. The Government offers no affidavit (or complaint or whistleblower statement) attesting to grounds for an investigation of the Hospital for FDCA or False Claims Act violation. Instead, the Government offers the Declaration of Lisa Hsiao, Acting Director of DOJ’s Enforcement and Affirmative Litigation Branch. Instead of information based on her personal knowledge pertaining to a proper investigation of the Hospital for FDCA violations, Hsiao’s Declaration consumes 15 pages of her assertions of what the law is—including assertions of the “overriding purpose of the FDCA,” the proper scope of § 3486 affidavits, recitation of how the FDCA is applied, legal definitions of statutory terms, and citation to statutes and case law in support of her description of drug mislabeling and misbranding, and associated harms.

Nothing in the Government’s papers provides even a bare foundation on which to issue the Subpoena requiring adolescent patient medical records. The Government sets forth no basis on which it suspects the Hospital of misbranding or distributing drugs, or any other conduct, as proscribed by the FDCA. The Government’s attestation of its general awareness that (or how) certain drugs are applied to patient care across the national healthcare spectrum is “too indefinite” to demand the Hospital produce the medical records described in the Subpoena. See Morton Salt Co., 338 U.S. at 652-53, supra. The Government seeks to investigate how the Hospital treats its patients; specifically, in the context of gender-affirming patient care. But the FDCA regulates commerce, not patient care. In re Subpoena No. 25-1431-014, Misc Action No. 25-39, 2025 WL 3252648, at *17 (E.D. Pa. Nov. 21, 2025).

The court concludes the Subpoena was not issued for a legitimate governmental purpose, is not limited in scope to any legitimate purpose, and is oppressive in its breadth. In re Subpoena Duces Tecum, 228 F.3d 341, 349 (4th Cir. 2000). Even crediting the Government’s stated FDCA investigatory purpose, such a purpose is at odds with the Subpoena. …

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E. Movants Have a Constitutional Right to Expect Privacy of the Medical Records.

There can be no question that Movants have a constitutionally reasonable expectation of privacy in the highly sensitive medical records subject to the Subpoena. Doe v. Broderick, 225 F.3d 440, 451 (4th Cir. 2000). In view of the court’s determination that the Government lacks a proper investigative purpose, and, specifically, that the Subpoena demands production of information disconnected from a proper § 3486 subpoena related to investigation of suspected FDCA violations by the Hospital, Movants’ interest in maintaining the privacy of their sensitive medical records outweighs any interest of the Government in calling for their production. No proper (never mind compelling) governmental purpose has been demonstrated. Payne v. Taslimi, 998 F.3d 648 (4th Cir. 2021).