FDA Subpoena Battle: Rhode Island Hospital Challenges HIPAA Order Over Gender Dysphoria Drug Prescriptions

The U.S. Food and Drug Administration (FDA) has initiated an investigation into medical facilities that prescribe "off-label" drugs to minors diagnosed with gender dysphoria. The FDA has not yet determined whether these drugs are safe or effective for treating gender dysphoria.

Timeline of Legal Proceedings

Initial Subpoena and Court Enforcement

In July 2025, the Assistant Attorney General issued a HIPAA subpoena to Rhode Island Hospital (affiliated with Brown University Health) to verify whether patients received misbranded drugs. Rhode Island Hospital refused to comply with the subpoena.

On April 30, 2026, the U.S. Department of Justice (DOJ) filed a petition in the U.S. District Court for the Northern District of Texas (NDTX) to enforce the subpoena. Chief Judge Reed O'Connor granted the government's petition the same day, ordering Rhode Island Hospital to produce all requested records within 14 days.

Rhode Island Hospital’s Appeal and Emergency Motion

On May 6, 2026, Rhode Island Hospital filed a notice of appeal with the U.S. Court of Appeals for the Fifth Circuit and an emergency motion to stay the enforcement order. The hospital argued, among other points, that the venue in NDTX was improper.

The government countered that venue was proper because the investigation was actively being conducted in the Northern District of Texas. On May 12, 2026, Judge O'Connor denied the emergency stay motion, ruling that venue was indeed proper under Title 18 U.S.C. § 3486(c).

Judge O'Connor’s Venue Ruling

"Second, RIH argues that this Court is not the proper venue to adjudicate the Government's petition. Title 18 U.S.C. § 3486(c) permits enforcement of an administrative subpoena in 'any court of the United States within the jurisdiction of which the investigation is carried on or of which the subpoenaed person is an inhabitant, or in which he carries on business or may be found.'

According to the Declaration from the Acting Director of the Enforcement and Affirmative Litigation Branch, there is substantial operational and decision-making control of the investigation being exercised at the U.S. Attorney's Office in the Northern District of Texas, along with several subjects and potential targets of the investigation located therein. The record therefore reflects that the investigation is being carried on in the Northern District of Texas and the Government's enforcement petition was properly brought in this Court. Accordingly, RIH has failed to show a likelihood of success on the merits as to its venue challenge."

The court also noted that the government had presented ex parte information supporting its choice of venue, which was sealed due to the sensitive nature of the details. The Fifth Circuit has previously upheld such rulings, as seen in In re Grand Jury Subpoena, 419 F.3d 329 (5th Cir. 2005).

Parallel Legal Action in Rhode Island

While the Texas litigation unfolded, a separate legal track began on the East Coast. On May 4, 2026—even before Rhode Island Hospital filed its emergency motion in Texas—the Child Advocate for the State of Rhode Island (a non-profit organization) filed an emergency motion in the U.S. District Court for the District of Rhode Island. The motion sought to block the enforcement of the subpoena, arguing that it violated state laws and patient privacy protections.

This parallel action adds another layer of complexity to the legal battle over the subpoena and the broader debate surrounding the prescription of off-label drugs to minors with gender dysphoria.