Texas Civil Practice & Remedies Code - Section 82.007. Medicines
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Texas Laws > Civil Practice & Remedies Code > Texas Civil Practice & Remedies Code - Section 82.007. Medicines
§ 82.007. MEDICINES. (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.
Added by Acts 2003, 78th Leg., ch. 204, § 5.02, eff. Sept. 1,
2003.
Section: 81.010 82.001 82.002 82.003 82.004 82.005 82.006 82.007 82.008 83.001 84.001 84.002 84.003 84.004 84.005
Last modified: August 11, 2007
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