On August 1, 2025, 16 state attorneys general filed a complaint in federal court in Massachusetts against the US administration seeking a declaratory judgment that President Trump’s January 28, 2025 Executive Order 14187, "Protecting Children from Chemical and Surgical Mutilation” violates states’ rights under the Tenth Amendment to the US Constitution, exceeds statutory authority, and violates the federal Administrative Procedures Act.
The EO directs the Secretary of the Department of Health and Human Services (HHS) to withdraw prior guidance regarding gender-affirming care and, in consultation with the Attorney General, issue new guidance aimed at protecting whistleblowers in this context. The state suit follows US Department of Justice (DOJ) enforcement, driven by the EO, against members of the medical community—including hospitals and healthcare professionals (HCPs), pharmaceutical manufacturers and distributors, and continuing medical education providers—that are involved in gender-affirming care for minors.
In an April 22, 2025, internal Memorandum for Select Component Heads titled “Preventing the Mutilation of American Children,” the Attorney General stated that she was putting “medical practitioners, hospitals, and clinics” on notice that, on her watch, the DOJ intended to act decisively to “hold accountable those who mutilate [children] under the guise of care.” The Memo also promised to “investigate and hold accountable medical providers and pharmaceutical companies that mislead the public about the long-term side effects of chemical and surgical mutilations.”
The Memo’s directive to the DOJ’s criminal and civil divisions to aggressively pursue enforcement actions against members of the medical community includes the investigation of alleged violations of the federal False Claims Act (FCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), Medicare and Medicaid billing guidelines, and certain criminal statutes related to the provision of drugs and medical services to minors, including but not limited to puberty blockers, sex hormones, and gender-affirming surgical procedures.
The Memo is consistent with the US Administration’s use of enforcement tools like the FCA to, as noted in our February 24, 2025 LawFlash, implement its domestic policy agenda beyond focusing on more typical forms of fraud, waste, and abuse in healthcare. To be sure, the life sciences and healthcare sectors have begun to feel the effects of such enforcement measures. In the approximately three months since the release of the Memo, the DOJ appears to have fully embraced the Attorney General’s instructions and, as discussed below, has begun aggressively investigating in accordance with the Memo’s directives.
Congress, demonstrating close coordination with executive branch priorities, set the stage by holding an April 2025 hearing ahead of the Memo’s issuance. The hearing by the House Judiciary Subcommittee on the Constitution and Limited Government put forth medical professional witnesses who came forward regarding a children’s hospital performing gender-affirming procedures on minors contrary to the same hospital’s public statements as to its practices. Further, several pieces of legislation related to gender-affirming care have been introduced in the 119th Congress.
These developments, including the declaratory judgment action filed on August 1 by Massachusetts, New York, California, Connecticut, Illinois, Delaware, Hawaii, Maine, Maryland, Michigan, Nevada, New Jersey, New Mexico, Rhode Island, Wisconsin, and Josh Shapiro, in his capacity as Governor of the Commonwealth of Pennsylvania, create significant uncertainty for hospitals, health systems, clinics, physicians, and other healthcare entities (HCEs) and HCPs. They also increase the enforcement risk faced by pharmaceutical companies that sell drugs furnished by HCPs and HCEs for gender-affirming care.
Hospitals, Doctors, and Other Healthcare Entities and Professionals
The Attorney General’s Memo instructs federal prosecutors to conduct criminal investigations of “all suspected cases of [female genital mutilation]—under the banner of so-called ‘gender affirming care’ or otherwise—and to prosecute” all such cases to the fullest extent of the law, thus zeroing in on the conduct of hospitals, health systems, clinics, physicians, and other HCEs and HCPs. The Memo observes that it is a felony to perform, attempt to perform, or conspire to perform female genital mutilation on any person under the age of 18, which carries a maximum prison sentence of 10 years per count.
The Memo also instructs the DOJ Civil Division’s Fraud Section to “pursue investigations under the False Claims Act of false claims submitted to federal health care programs for any non-covered services related to radical gender experimentation.” Examples of such non-covered services that would generate false claims include but are not limited to “physicians prescribing puberty blockers to a child for an illegitimate reason (e.g., gender dysphoria) but reporting a legitimate purpose (i.e., early onset puberty)” on the claim submitted for reimbursement to the government, and “hospitals performing surgical procedures to remove or modify a child’s sex organs while billing Medicaid for an entirely different procedure.”
The Memo notes that “[f]alsely billing the government for the chemical or surgical mutilation of a child is a violation of the False Claims Act and is subject to treble damages and severe penalties.” HCPs also are put on notice that they will be held accountable for misleading “the public about the long-term side effects of chemical and surgical mutilations.”
Pharmaceutical Manufacturers and Distributors, Field Sales Representatives, … and CME Providers
Pharmaceutical manufacturers and distributors and even continuing medical education (CME) providers are also within focus. The Memo states that, in parallel with HCPs, the DOJ “will investigate and hold accountable … pharmaceutical companies that mislead the public about the long-term side effects of chemical … mutilations.” The DOJ Civil Division’s Consumer Protection Branch, which is being consolidated into the Criminal Division and historically has been tasked with FFDCA enforcement, is directed to investigate violations of the FFDCA by pharmaceutical manufacturers and distributors “engaged in misbranding by making false claims about the on- or off-label use of puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition.’”
Of particular note is the Memo’s observation that “[e]ven if otherwise truthful, the promotion of off-label uses of hormones—including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses—run afoul to the FDA’s prohibitions on misbranding and mislabeling”.
Encouraging False Claims Act Whistleblowers
Consistent with other recent DOJ FCA initiatives, the Memo explicitly solicits FCA relators to come forward by notifying “the public that [DOJ] is eager to work with qui tam whistleblowers with any knowledge of any such [FCA] violations.” As an additional enticement to incentivize whistleblower activity, the Memo notes that “[i]n 2024 alone, qui tam relators received a $344 million share won by the [DOJ].”
In response to the Memo’s directives, the Assistant Attorney General of the Civil Division in a July 11, 2025, memorandum to Civil Division Employees instructed them “to use all available resources to prioritize investigations of doctors, hospitals, pharmaceutical companies, and other appropriate entities.” This directive was quickly followed by an announcement that DOJ had issued more than 20 subpoenas to doctors and clinics allegedly involved in “performing transgender medical procedures on children.” The DOJ’s press release related to the subpoenas stated that the underlying investigations involved “healthcare fraud, false statements, and more.”
And the DOJ is not the only federal government agency that has sought information related to gender-affirming care. On May 28, 2025, the Administrator of the Centers for Medicare and Medicaid Services (CMS) wrote to various HCEs to request they provide information on their medical interventions for gender dysphoria in children in order to meet CMS’s obligations to ensure baseline quality standards at institutions participating in the Medicare and Medicaid programs.
CMS requested that the institutions that received the letter respond within 30 days regarding, among other things, policies and procedures with respect to the adequacy of informed consent protocols for children with gender dysphoria and how they are capable of providing such consent; information on any adverse events related to medical interventions for gender dysphoria in children; and complete financial data regarding “all pediatric sex trait modifications” performed at the institution reimbursed in whole or in part by the federal government.
These requests make clear that the public messaging from DOJ and agencies like CMS is more than politically motivated talking points, and that the federal government’s regulatory, investigative, and enforcement activities should be taken seriously.
Although there now is little doubt as to the seriousness with which DOJ and other federal agencies will pursue enforcement actions given the recent subpoenas and other information requests, the legal bases for such actions remain unclear. As noted above, the Memo describes a doctor prescribing puberty blockers to a child “for an illegitimate reason (e.g., gender dysphoria)” but then submitting a claim for reimbursement to the government that identifies “a legitimate purpose (i.e., early onset puberty)” as an example of a false claim.
But the Memo also describes how the Biden administration announced public support for gender-affirming care. The Memo in particular highlights how the former Assistant Secretary of Health at HHS “promoted gender-reassignment surgeries and hormone replacement for the treatment of gender dysphoria in minors…” The prior administration’s documented and public support of the treatments and services that the current US Administration has identified as potentially fraudulent seemingly presents a challenge to federal prosecutors in satisfying the legal elements of a FCA violation. It will be difficult in particular for the DOJ or a FCA whistleblower to adequately allege that any misrepresentation about the services provided, even if false or misleading, would have been material to the government’s decision to pay for the services at the time a claim is submitted for reimbursement.
Because there has not been case law developed under either the FCA or the FFDCA with respect to gender-affirming care, DOJ’s enforcement steps are in uncharted waters. But the expense, pressure, interruption to operations, and organizational distraction associated with a government investigation are quite real. And it is possible that other potential consequences associated with such an investigation—for example, the threat of losing federal funding—may ultimately be the DOJ’s most efficient tool to potentially extract settlements from and policy changes at the targets of its gender affirming care investigations.
Moreover, the Attorney General announced that, as part of the effort “prioritize children’s health over ideology,” she is launching the Attorney General’s Coalition Against Child Mutilation through which the DOJ “will partner with state attorneys general to identify leads, share intelligence, and build cases against hospitals and practitioners” that violate federal or state laws prohibiting female genital mutilation and other related practices. The Memo promises that the DOJ will support state-level prosecution of HCPs who violate such state laws and cites as an example the Vulnerable Child Compassion and Protection Act in Alabama, which makes it a felony for doctors to “treat children with puberty blockers or hormones to affirm a gender identity inconsistent with biological sex.”
In addition to Alabama, some states, such as Missouri, have actively sought to prohibit the conduct described in the Memo since as early as 2023 by defining the provision of such services as an allegedly “deceptive” practice under that state’s consumer protection laws. On the other hand, other state attorneys general, including Massachusetts, New York, California, and Rhode Island, have filed lawsuits and amicus briefs seeking to protect access to this same care. And the August 1, 2025, declaratory judgement action filed in federal district court in Massachusetts alleges that the EO has had a chilling effect on HCPs providing gender-affirming care that is lawful and protected in those states.
As we have seen in the context of multiple, hot-button issues since January, this suit highlights the tension between federal and state laws and actions and presents a significant challenge to members of the medical community seeking to find a way to comply with competing laws and interests. The fault line on policy falls directly along party lines with red states supporting the administration’s EO and implementing orders while blue states oppose. As we have noted both as to the 2024 elections (in our November 6, 2024 LawFlash) and in the past (in our November 10, 2020 blog post), the arguments made here by blue state attorneys general are consistent with the actions taken by red state attorneys general to block executive actions undertaken by Democratic administrations.
The Memo instructs the DOJ’s Office of Legislative Affairs (OLA) to draft legislation creating a private right of action “for children and parents of children whose health body parts have been damaged by medical professionals through chemical and surgical mutilation.” The private right of action will have an expansive statute of limitations and apply retroactively to ensure that no one “providing such ‘treatment’ will escape liability.” The Memo also directs OLA to draft legislation amending existing criminal law to “enhance protections for children whose healthy body parts have been damaged by medical professionals practicing chemical and surgical mutilation.” The Attorney General states that she also will work with state legislatures to pass similar legislation at the state level.
Members of the medical community, including pharmaceutical manufacturers and distributors, associated in any way with the care continuum surrounding gender-affirming care are probable targets of DOJ and other federal and state law enforcement agencies. Although there are likely strong defenses to certain of these enforcement actions, the investigations alone are costly and may be linked to reputational and operational consequences. Members of the medical community should be prepared to engage outside counsel and swiftly and strategically respond to any request for information related to such practices. HCEs and HCPs in particular should consider closely evaluating clinical practice protocols and compliance policies and procedures associated with gender-affirming care and reviewing any prior submission of possibly related claims for reimbursement to government healthcare payors in preparation for, and potentially to get out in front of, any potential investigation by DOJ, CMS, FDA, or HHS OIG. Pharmaceutical companies should consider proactively monitoring promotion of medical treatments known to be prescribed off-label by HCPs for gender-affirming care.
Given the pending state attorney general litigation coupled with the partisan divide, HCEs, HCPs, and pharmaceutical manufacturers may find it difficult to straddle conflicting laws and guidance and may themselves need to litigate to establish clarity.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors or lawyers in our FDA and Healthcare and FCA & Qui Tam Litigation practices.