HB3455 - Relating to manufacturer disclosure requirements and liability for experimental drugs and devices.

  89R14542 SCL-D     By: Shofner H.B. No. 3455       A BILL TO BE ENTITLED   AN ACT   relating to manufacturer disclosure requirements and liability for   experimental drugs and devices.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Subchapter E, Chapter 431, Health and Safety   Code, is amended by adding Section 431.118 to read as follows:           Sec.   431.118.     EXPERIMENTAL DRUG OR DEVICE DISCLOSURE   REQUIREMENTS; LIABILITY. (a) In this section, "experimental drug   or device" means a drug or device that:                 (1)  is experimental or investigational; or                 (2)     has been approved by the United States Food and   Drug Administration for emergency use.           (b)     A manufacturer of an experimental drug or device shall   provide to a purchaser of the drug or device a disclosure form that   provides a consumer all information reasonably necessary for the   consumer to make an informed decision on whether to use the drug or   device, including possible adverse health effects of the drug or   device, in a clear and coherent summary.           (c)     A purchaser of an experimental drug or device shall   provide the disclosure form described by Subsection (b) to a person   to whom the purchaser sells the drug or device. A health care   provider or retailer providing or selling the drug or device to a   consumer:                 (1)     shall provide the disclosure form in person to the   consumer; and                 (2)     may provide or sell the drug or device to the   consumer only if a person capable of providing informed consent for   the ultimate consumer of the drug or device signs the disclosure.           (d)     A consumer who receives an experimental drug or device   in violation of this section may bring an action against the   manufacturer of the drug or device for damages arising from an   adverse effect of the drug or device.           (e)     A prevailing claimant in an action brought under   Subsection (d) may recover:                 (1)     compensatory damages, including damages for   physical and emotional pain and suffering;                 (2)  exemplary damages; and                 (3)     reasonable attorney's fees and costs incurred in   bringing the action.          SECTION 2.  Section 431.118, Health and Safety Code, as   added by this Act, applies only to a cause of action that accrues on   or after the effective date of this Act.          SECTION 3.  This Act takes effect September 1, 2025.