Few issues are as currently controversial as gender affirming care. For some people, the incongruence between gender identity and sex assigned at birth can cause clinically significant distress, recognized as “gender dysphoria” by the American Psychological Association. Treatment can come in various forms, such as social transitioning or medical intervention, which might include chemical treatments or surgery.

There is no doubt where the Trump administration stands on the controversy. Eight days into his second term, the President issued an Executive Order (EO) that sought to end such medical treatment. The Department of Justice (DOJ) followed up with memoranda (DOJ Memos) that set forth how, with certain interpretations of existing law, including the Food, Drug, and Cosmetics Act (FDCA), the EO goal would be achieved. The EO and DOJ Memos refer to gender affirming care as “mutilation.”

In Massachusetts v. Trump, 2026 WL 1584837 (D. Mass. June 3, 2026), fifteen states, the Governor of Pennsylvania, and the District of Columbia sued the President, the then United States Attorney General (AG), and the DOJ challenging the EO and the DOJ Memos. Most of those states had enacted laws mandating insurance for gender affirming care and shielding patients and providers from criminal and civil liability for the provision of such care. The plaintiffs alleged that the EO and DOJ Memos were arbitrary and capricious under the Administrative Procedure Act (APA), and contrary to constitutional right, power, or privilege under the Tenth Amendment. The plaintiffs sought a declaratory judgment.

The defendants moved to dismiss the action, arguing that the plaintiffs lacked standing, that the Memos were not final agency actions, that those Memos announced policies committed to agency discretion by law, and that the claims failed under the Tenth Amendment. The court denied the government’s motion to dismiss. Thus, the federal government lost this initial skirmish involving the off-label use-related showdown over gender affirming care.

Standing

The standing issue arose in the context of the government’s motion under Rule 12(b)(1) challenging the court’s subject matter jurisdiction. Jurisdictional matters come first, so standing led off the festivities. The court held that the plaintiffs had standing to challenge, inter alia, the government’s novel interpretations of the FDCA. The government was not merely articulating enforcement policies, but announced a new interpretation of the FDCA. For example, the EO prioritized investigations and actions against “deception” of consumers about the “long-term side effects of chemical and surgical mutilation.” In one of the Memos, the AG directed investigations of any violations of the FDCA by “manufacturers and distributors engaged in misbranding by making false claims about the on- of off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition.’” We have discussed the government’s novel attack on off-label use here and here. Those earlier matters took place in the context of subpoenas, whereas this case is a direct challenge to the entire underlying policy.

The government’s EO and DOJ memoranda assert that healthcare providers’ statements regarding gender dysphoria treatments are false claims prosecutable under the FDCA, regardless of whether they are made in conjunction with on- or off-label uses of medication. The federal government has never before made it illegal for healthcare providers to consult with their patients about, and prescribe medication for, treatment of a recognized medical condition.

The court held that the plaintiffs had established an injury in fact. First, the plaintiffs had a legitimate fear of future prosecution (which establishes standing under the APA) because the risk of prosecution here was readily apparent in the record, since the government has already initiated enforcement actions. Second, the plaintiff governments also alleged direct harm that confers standing. Healthcare facilities in the states were expending significant time and resources responding to patient questions, the Memos prompted many facilities to limit the provision of gender affirming care to adolescents, and the delay of such healthcare would lead to more expensive care down the road. Where plaintiffs challenge an FDCA interpretation that would prohibit their conduct, the injury can be traced to the government’s actions. The court also held that the plaintiffs had standing to seek a declaratory judgment and to vindicate their rights under the Tenth Amendment (more on the latter momentarily).

Final Agency Action

The Memos are “rules” under the APA because they announce a new interpretation of statutes. They also “bind and direct inferior employees.” Further, the government’s own statements, which direct enforcement, establish the finality of its actions. There has never been anything remotely clever or subtle about anything the Trump Administration has said or done. Call it transparency or something else, but the Administration’s bluster certainly has the effect of making things easier for the courts. Indeed, the court reasoned that “[b]ased upon the government’s inflammatory rhetoric … and the Memos’ pronounced goals, the purpose of the Memos is to intimidate and harass.” Mission accomplished.

Agency Discretion

Under APA section 701(a)(2), a plaintiff may not obtain judicial review for an agency action “committed to agency discretion by law.” But the Memos’ announce statutory interpretation that would “provide clear standards for enforcement.” The defendants’ “actions are not committed to agency interpretation by law.” Again, lack of subtlety has a price.

The Tenth Amendment

The Tenth Amendment provides: “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the People.” To put it mildly, “Tenth Amendment jurisprudence ‘has traveled an unsteady path.’” But it is now well established that the Tenth Amendment is violated when the federal government acts in excess of its statutory authority in an area traditionally reserved to the states. Medical practice is an area traditionally reserved for the states. Interestingly, the court supported this proposition by citing the recent SCOTUS Skrmetti case, which permitted a state to limit gender affirming care. Turnabout is fair play. Or something like that. The federal government’s FDCA interpretations directly conflict with the plaintiff states’ laws concerning the same type of medical procedures. “Accordingly, Plaintiffs have stated a claim under the Tenth Amendment.”