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Products liability defendant presumed to not be liable for injury

In Texas, products liability covers pharmaceutical drugs as well as manufactured items. A Texas statute specifically addresses who may be sued in a drug-related product liability action based on a failure to provide adequate warnings, available defenses against such a lawsuit, and how a plaintiff may overcome those defenses.

Who may be sued?

Texas law identifies drug manufacturers, distributors, health care providers and individuals who prescribe allegedly defective pharmaceutical products. These defendants may be sued individually or collectively, as the facts may warrant.

Presumption of non-liability

In a failure to warn lawsuit, defendants are armed with a rebuttable presumption that they are not liable for any accusations based on this theory. If the product has complied with applicable U.S. Food and Drug Administration information and warning requirements, the presumption may be difficult to overcome.

Overcoming the presumption of non-liability

  • The presumption of non-liability is just that: a presumption. It is not conclusive, and a plaintiff can overcome it in a number of ways, including:
  • The withholding from or misrepresentation to the FDA by the defendant of material information about the product, and that withholding or misrepresentation caused the plaintiff's injury;
  • The product was still being sold or prescribed in the United States after the FDA has withdrawn its support for the product or ordered it off the market;
  • The defendant advertised, recommended or promoted the product for something that the FDA did not approve, and the plaintiff was harmed by using the product in the way that it was advertised, recommended or promoted;
  • A defendant prescribed the product for use not approved by the FDA, and the plaintiff was injured by using the product as prescribed;
  • During the pre-market approval or licensing of the product, the defendant engaged in conduct that federal law considers to be bribery in exchange for inadequate product warnings or instructions.

In a pharmaceutical products liability action, overcoming the presumption of non-liability involves fact-specific questions for each individual case and should be considered with the assistance of qualified legal counsel.

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