§ 82.007.Medicines

Title 4. Liability in Tort · Chapter 82. Products Liability · Last amended 2003 · Last verified August 29, 2026

In one sentenceSection 82.007 presumes a pharmaceutical defendant not liable for inadequate warnings where the FDA approved them, rebuttable on five specific showings.

Full Text of § 82.007

Text sizeJump to: (a) (b)

(a)In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if:

(1)the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended; or

(2)the warnings provided were those stated in monographs developed by the United States Food and Drug Administration for pharmaceutical products that may be distributed without an approved new drug application.

(b)The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that:

(1)the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant's injury;

(2)the pharmaceutical product was sold or prescribed in the United States by the defendant after the effective date of an order of the United States Food and Drug Administration to remove the product from the market or to withdraw its approval of the product; (3)(A) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;

(B)the product was used as recommended, promoted, or advertised; and

(C)the claimant's injury was causally related to the recommended, promoted, or advertised use of the product; (4)(A) the defendant prescribed the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;

(B)the product was used as prescribed; and

(C)the claimant's injury was causally related to the prescribed use of the product; or

(5)the defendant, before or after pre-market approval or licensing of the product, engaged in conduct that would constitute a violation of 18 U.S.C. Section 201 and that conduct caused the warnings or instructions approved for the product by the United States Food and Drug Administration to be inadequate.

End

Plain-English Summary

The pharmaceutical warnings presumption, added in 2003, and it makes failure-to-warn claims against drug makers difficult in Texas.

In an action alleging injury from a failure to provide adequate warnings or information about a pharmaceutical product, there is a rebuttable presumption that the defendants — including a health care provider, manufacturer, distributor, and prescriber — are not liable if the warnings that accompanied the product were those approved by the Food and Drug Administration, or those stated in FDA monographs for products distributable without an approved new drug application.

The presumption covers everyone in the chain, from the manufacturer to the prescribing physician.

Five routes rebut it, and each targets a failure of the FDA process itself:

the defendant withheld from or misrepresented to the FDA required information that was material and causally related to the injury; the product was sold or prescribed after an FDA order to remove it from the market or withdraw approval; the defendant recommended, promoted, or advertised the product for an unapproved indication, it was used as promoted, and the injury was causally related; the defendant prescribed it for an unapproved indication, it was used as prescribed, and the injury was causally related; or the defendant engaged in conduct constituting bribery of a public official that caused the approved warnings to be inadequate.

The logic is consistent throughout. The presumption rests on the FDA having reviewed and approved the warning, so it is rebutted by showing that review was corrupted, disregarded, or bypassed — by concealment, by continued sale after withdrawal, by off-label promotion, or by bribery.

The compliance-with-standards section expressly does not extend to products covered here, so this is the exclusive presumption for pharmaceuticals.

Frequently Asked Questions

Can I sue a drug company for inadequate warnings in Texas?

There is a rebuttable presumption that defendants are not liable where the warnings were those the FDA approved. You must rebut it on one of five statutory grounds.

How is the presumption rebutted?

By showing the defendant withheld or misrepresented required information to the FDA, sold the product after a withdrawal order, promoted or prescribed it for an unapproved indication with a causal link to the injury, or bribed an official so the approved warnings were inadequate.

Who does the presumption protect?

All the defendants, including the health care provider, manufacturer, distributor, and prescriber.

Does the general compliance presumption also apply?

No. The compliance-with-government-standards section does not extend to products covered by this one.

Amendment History

Added by Acts 2003, 78th Leg., ch. 204, Sec. 5.02, eff. Sept. 1, 2003.

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