Sponsors (4)
The bill shifts liability for emergency medical countermeasures back toward ordinary tort law—strengthening victims' ability to sue and increasing oversight—but raises litigation risk that could increase costs and slow development or distribution of countermeasures during emergencies.
Patients and people harmed by medical countermeasures retain and gain clearer ability to sue in state or federal court for injuries, preserving access to judicial compensation and due-process rights.
All Americans benefit from increased congressional and judicial scrutiny of liability shields used during public health emergencies, increasing accountability for harms and oversight of government immunity decisions.
Manufacturers and distributors face clearer legal accountability incentives, which may encourage safer product design, distribution practices, and greater attention to patient safety.
Manufacturers, distributors, hospitals, and healthcare providers face increased litigation risk and potential liability costs, which can raise health care and consumer prices and deter investment in new vaccines, treatments, and devices.
Greater liability exposure could deter rapid development, production, or distribution of emergency countermeasures, reducing availability or slowing responses during public-health crises.
Patients seeking compensation could face longer, more uncertain, or more burdensome paths if administrative compensation programs or unobligated funds are reduced, and rescinded funds could delay payments to claimants.
Based on analysis of 6 sections of legislative text.
Repeals the PREP Act immunity and related fund, restoring individuals’ ability to sue over harms from emergency drugs, devices, biologics, and countermeasures (for pending or new claims).
Repeals the PREP Act liability shield and a related fund, removing the federal statutory immunity that protected manufacturers, distributors, and administrators of medical countermeasures during public-health emergencies. It preserves individuals’ ability to sue in state or federal court for injuries related to drugs, devices, biologics, and covered countermeasures, and applies to cases pending at enactment or started afterward. The bill rescinds unobligated balances in the related Covered Countermeasure Process Fund, updates statutory cross-references, and includes standard severability language. It is narrowly focused on undoing the statutory immunity regime for emergency countermeasures while preserving private civil remedies going forward.
Official title: To repeal sections 319F-3 and 319F-4 of the Public Health Service Act, and for other purposes.
Introduced July 15, 2025 by Thomas Massie · Last progress July 15, 2025