The U.S. Department of Justice recently announced a structural change that should be on the radar of in-house counsel in the healthcare sector.
In late September, DOJ closed its long-running Consumer Protection Branch and launched its replacement – the Civil Division’s Enforcement & Affirmative Litigation Branch.
While the new unit will continue much of the prior branch’s work, its expanded structure and stated priorities point to a broader mission and a potentially more assertive enforcement approach with implications for healthcare organizations.
According to DOJ’s September 25 press release, the new branch’s mission is to safeguard public health and safety through proactive enforcement and high impact affirmative litigation.
On the enforcement side, DOJ will continue to pursue cases under long-standing statutes, including the Controlled Substances Act, the Federal Food, Drug, and Cosmetic Act, the Consumer Product Safety Act, the Federal Trade Commission Act, the Children’s Online Privacy Protection Act, and the Restore Online Shoppers’ Confidence Act.
For healthcare counsel, this translates to:
- continued scrutiny of clinical and marketing claims for pharmaceuticals, dietary supplements, medical devices, and health services;
- enforcement actions targeting patient data privacy in apps and digital platforms; and
- vigilance over safety hazards in medical products and equipment.
Hospitals, clinics, manufacturers, distributors, and telehealth providers should be prepared for investigations and regulatory activity in these areas.
The branch’s second function – affirmative litigation – represents the most significant structural change. This unit is tasked with filing lawsuits against public and private actors alleged to interfere with or obstruct federal policies.
In practice, this could mean litigation driven by broader policy priorities that directly touch healthcare.
DOJ has indicated this may include:
- targeting deceptive health-related marketing by large technology or healthcare companies;
- pursuing false or misleading product claims associated with gender transition procedures,
- combating the importation of defective medical goods, and
- challenging entities perceived as opposing federal health or safety initiatives.
This authority expands potential exposure beyond traditional consumer protection cases to include policy-related disputes that align with administration priorities.
For healthcare counsel, the key takeaway is that while the core statutes remain the same, DOJ’s enforcement lens has widened considerably.
Exposure no longer stops at traditional consumer protection matters; it now reaches into federal litigation tied to broader policy objectives.
This shift calls for a fresh, proactive review of risk areas. Marketing and promotional content should be vetted for compliance and substantiation under FDA and FTC standards.
Privacy and data‑handling practices, particularly those involving minors, warrant close scrutiny to ensure they meet evolving regulatory expectations.
Product safety protocols, including recall readiness and rigorous due diligence for imported goods, should be strengthened.
Counsel should also evaluate whether business operations or public positions could be perceived as conflicting with current federal health priorities, as such misalignment may now carry heightened enforcement risk.
In short, this is more than a rebranding: it is a shift toward a dual enforcement strategy that combines traditional consumer protection with proactive litigation designed to advance federal policy goals, and healthcare organizations will need to account for both in their compliance and risk management planning.
Author: Samantha Gerencir, Foley & Lardner
