Shofner Bill Requires A Signed Risk Form For Experimental Drugs

The text as introduced · 373 words

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.