Bill > HB3455

This bill introduces new requirements for manufacturers of experimental drugs and devices in Texas, mandating comprehensive disclosure and informed consent procedures. The legislation defines experimental drugs or devices as those that are investigational or approved for emergency use by the FDA, and requires manufacturers to provide a clear, detailed disclosure form to purchasers that outlines potential adverse health effects. Health care providers and retailers must personally provide this disclosure form and obtain signed consent from someone capable of providing informed consent for the ultimate consumer. The bill also establishes legal recourse for consumers, allowing them to sue manufacturers for damages if they receive an experimental drug or device in violation of these requirements. If successful in such a lawsuit, consumers can recover compensatory damages (including physical and emotional pain and suffering), exemplary damages, and reasonable attorney's fees. The new law will take effect on September 1, 2025, and will only apply to causes of action that accrue on or after that date, providing clarity about its prospective application.

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https://capitol.texas.gov/BillLookup/History.aspx?LegSess=89R&Bill=HB3455