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A BILL TO BE ENTITLED
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AN ACT
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relating to manufacturer disclosure requirements and liability for |
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experimental drugs and devices. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter E, Chapter 431, Health and Safety |
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Code, is amended by adding Section 431.118 to read as follows: |
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Sec. 431.118. EXPERIMENTAL DRUG OR DEVICE DISCLOSURE |
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REQUIREMENTS; LIABILITY. (a) In this section, "experimental drug |
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or device" means a drug or device that: |
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(1) is experimental or investigational; or |
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(2) has been approved by the United States Food and |
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Drug Administration for emergency use. |
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(b) A manufacturer of an experimental drug or device shall |
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provide to a purchaser of the drug or device a disclosure form that |
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provides a consumer all information reasonably necessary for the |
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consumer to make an informed decision on whether to use the drug or |
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device, including possible adverse health effects of the drug or |
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device, in a clear and coherent summary. |
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(c) A purchaser of an experimental drug or device shall |
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provide the disclosure form described by Subsection (b) to a person |
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to whom the purchaser sells the drug or device. A health care |
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provider or retailer providing or selling the drug or device to a |
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consumer: |
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(1) shall provide the disclosure form in person to the |
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consumer; and |
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(2) may provide or sell the drug or device to the |
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consumer only if a person capable of providing informed consent for |
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the ultimate consumer of the drug or device signs the disclosure. |
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(d) A consumer who receives an experimental drug or device |
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in violation of this section may bring an action against the |
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manufacturer of the drug or device for damages arising from an |
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adverse effect of the drug or device. |
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(e) A prevailing claimant in an action brought under |
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Subsection (d) may recover: |
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(1) compensatory damages, including damages for |
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physical and emotional pain and suffering; |
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(2) exemplary damages; and |
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(3) reasonable attorney's fees and costs incurred in |
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bringing the action. |
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SECTION 2. Section 431.118, Health and Safety Code, as |
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added by this Act, applies only to a cause of action that accrues on |
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or after the effective date of this Act. |
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SECTION 3. This Act takes effect September 1, 2025. |