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§ 148.002.Products Liability Actions Related to Pandemic Emergency

Title 6. Miscellaneous Provisions · Chapter 148. Liability During Pandemic Emergency · Last amended 2021 · Last verified August 29, 2026

In one sentenceSection 148.002 shields designers, makers, sellers and donors of pandemic products from liability absent actual knowledge of a defect or actual malice, plus unreasonable risk of substantial harm.

Full Text of § 148.002

Text sizeJump to: (a) (b) (c) (d)

(a)This section applies only to the following products:
(1)clothing or equipment worn to minimize exposure to hazards of a pandemic disease that cause injury or illness;
(2)medical devices, equipment, and supplies used during a pandemic emergency or to treat individuals infected or suspected to be infected with a pandemic disease, including devices, equipment, and supplies used or modified for an unapproved use to treat or prevent the spread of the disease or used outside of their normal use to treat or prevent the spread of the disease;
(3)drugs, medicines, or vaccines used to treat or prevent the spread of a pandemic disease, including drugs, medicines, or vaccines prescribed, dispensed, or administered for an unapproved use in an attempt to treat or prevent the spread of the disease or used outside of their normal use in an attempt to treat or prevent the spread of the disease;
(4)tests to diagnose or determine immunity to a pandemic disease;
(5)commercial cleaning, sanitizing, or disinfecting supplies used to prevent the spread of a pandemic disease; or
(6)any component of a product described by this subsection.
(b)A person who designs, manufactures, sells, or donates a product described by Subsection (a) during a pandemic emergency is not liable for personal injury, death, or property damage caused by the product unless:
(1)the person:
(A)had actual knowledge of a defect in the product when the product left the person's control; or
(B)acted with actual malice in designing, manufacturing, selling, or donating the product; and
(2)the product presents an unreasonable risk of substantial harm to an individual using or exposed to the product.
(c)A person who designs, manufactures, labels, sells, or donates a product described by Subsection (a) during a pandemic emergency is not liable for personal injury, death, or property damage caused by a failure to warn or provide adequate instructions regarding the use of a product unless:
(1)the person acted with actual malice in failing to warn or provide adequate instructions regarding the use of the product; and
(2)the failure to warn or provide adequate instructions regarding the use of the product presents an unreasonable risk of substantial harm to an individual using or exposed to the product.
(d)A person is not liable for personal injury, death, or property damage caused by or resulting from the person's selection, distribution, or use of a product described by Subsection (a) during a pandemic emergency unless:
(1)the person:
(A)had actual knowledge of a defect in the product when the person selected, distributed, or used the product; or
(B)acted with actual malice in selecting, distributing, or using the product; and
(2)the product presents an unreasonable risk of substantial harm to an individual using or exposed to the product.
End

Plain-English Summary

A products liability shield for six categories of pandemic-related product.

Subsection (a) lists what is covered: protective clothing or equipment; medical devices, equipment and supplies used during the emergency, including those used or modified for an unapproved use; drugs, medicines or vaccines, including those prescribed, dispensed or administered for an unapproved use; tests to diagnose or determine immunity; commercial cleaning, sanitizing or disinfecting supplies; and any component of those products.

The repeated reference to unapproved and off-label use is deliberate. During an emergency, products get used in ways they were never designed or approved for, and ordinary products liability would treat that as the paradigm of a defect claim.

Subsection (b) is the shield, and it requires the claimant to establish both of two things. First, that the person had actual knowledge of a defect when the product left their control, or acted with actual malice. Second, that the product presents an unreasonable risk of substantial harm.

"Actual knowledge" and "actual malice" together displace the whole of ordinary products law — strict liability, design defect, manufacturing defect. Negligence is not enough; the defendant must have known or acted maliciously.

Subsection (c) covers failure to warn separately, and sets an even higher bar: actual malice only, with no actual-knowledge alternative, plus the same unreasonable risk requirement.

Subsection (d) protects the downstream user — a person who selects, distributes, or uses the product — on the same actual knowledge or actual malice standard. That reaches hospitals, employers and schools that supplied protective equipment to others.

Donors are named alongside sellers throughout, which matters because much of what moved during the emergency was donated.

Frequently Asked Questions

Can I sue over defective pandemic protective equipment?

Only by establishing actual knowledge of a defect when the product left the defendant’s control, or actual malice, and that the product presents an unreasonable risk of substantial harm.

Does it cover off-label use?

Yes. The definitions expressly include devices, drugs and vaccines used or modified for an unapproved use.

Is failure to warn treated differently?

Yes, and more strictly. Subsection (c) requires actual malice, with no actual-knowledge alternative.

Does the shield protect a hospital that handed out masks?

Yes. Subsection (d) covers a person who selects, distributes, or uses the product, on the same standard.

Amendment History

  • Added by Acts 2021, 87th Leg., R.S., Ch. 528 (S.B. 6), Sec. 3, eff. June 14, 2021.
Source & verification. Section text is reproduced verbatim from Texas Legislature Online (statutes.capitol.texas.gov). Enacted by the Texas Legislature. Current through May 14, 2026. Last verified August 29, 2026. · Official source