Colorado Judge Quashes DOJ Gender-Related Care Subpoena

On January 5, 2026, District of Colorado Magistrate Judge Cyrus Chung issued a recommendation that the district court grant a motion to quash a Department of Justice (DOJ) administrative subpoena that sought records about the provision of gender-related care by Children’s Hospital Colorado (Children’s) in In re: Department of Justice Administrative Subpoena No. 25-1431-030, U.S. District Court for the District of Colorado, No. 1:25-mc-00063. The court concluded that the DOJ had failed to carry its “light” burden, noting that no other courts that had considered the more than 20 similar subpoenas issued by DOJ had ruled in the DOJ’s favor.  

Background

The DOJ issued a subpoena to Children’s on July 14, 2025, seeking records related to “gender-related” care, and, in declarations to the court, stated it was investigating potential FDCA violations relating to the off-label promotion or unlawful dispensing of puberty blockers and cross-sex hormones to minors. Children’s and the DOJ successfully negotiated to narrow some of the requests but could not agree on others—most importantly, the DOJ’s request for patient records and the records of employees of Children’s TRUE Center for Gender Diversity (“TRUE Center”). The DOJ, for example, rejected a compromise of de-identifying patient records. In response, Children’s filed a motion to quash.

This litigation took place amidst signals from the Administration that it intends to use various law enforcement tools against gender-affirming care, including Section 5 of the Federal Trade Commission Act and the False Claims Act. Late last year, the Department of Health and Human Services (HHS) also proposed three rules that would prohibit the provision and coverage of gender-affirming care (described as “sex-rejecting procedures”) for minors enrolled in Medicare and Medicaid, indicating, in part, the government’s intention to expand its efforts against gender-affirming care to the payor space.  

Analysis

The court found that the government could not show that the subpoena was appropriately limited in scope, as the government’s supporting affidavit did not explain its investigation or how the subpoena was “right-sized for it.” The court also found that the government failed to show the relevance of the requested records to its investigation. While the FDCA prohibits the promotion of approved drugs for unapproved (i.e., off-label) uses, it does not prohibit doctors from prescribing drugs for off-label uses. The court therefore determined that the personal health data requested by the government could not be relevant to an investigation of off-label drug promotion. 

While these findings would have been enough for the court to quash the subpoena, the court added scathing language to articulate a finding that the government abused the court’s process. An abuse of process occurs when the government issues a subpoena for improper or illegitimate purposes and in bad faith. The court found that the government did just that, as the ostensible purpose of the subpoena (the investigation of off-label drug promotion) did not match its actual purpose (ending gender-affirming care). To support its conclusion, the  court pointed to the government’s own statements; specifically, Executive Orders (“EO”) 14168 (“Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government”) and 14187 (“Protecting Children from Chemical and Surgical Mutilation”) and to a memorandum issued by Attorney General Pam Bondi in response to both EOs, which stated that the ultimate goal of the DOJ’s investigation was to end gender-affirming care.

The court also pointed to the government’s unwillingness to negotiate its requests for patient data or data about TRUE Center employees (including those employees not in position to witness any off-label use), and the government’s own statements about ending gender-affirming care, to support the court’s ultimate conclusion that “the government’s aim is not actually to investigate FDCA violations, but to use the FDCA as a smokescreen for its true objective of pressuring pediatric hospitals into ending gender-affirming care through commencing vague, suspicionless ‘investigations.’”

Takeaways

Companies, health care systems, and payors navigating a changing regulatory landscape and shifting DOJ enforcement priorities should continue to act carefully and thoughtfully when engaging with the government. While any litigation can be risky, however, companies should not discount the option to use the courts to protect their rights.