Bill Text: TX HB4027 | 2015-2016 | 84th Legislature | Introduced
Bill Title: Relating to products liability action related to a pharmaceutical product.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2015-03-23 - Referred to Judiciary & Civil Jurisprudence [HB4027 Detail]
Download: Texas-2015-HB4027-Introduced.html
By: Blanco | H.B. No. 4027 |
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rel | ||
ating to products liability action related to a pharmaceutical | ||
product. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Section 82.007, Civil Practice and Remedies | ||
Code, is amended to read as follows: | ||
Sec. 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, | ||
such as a failure of the manufacturer to place notice to the United | ||
States Food and Drug Administration of a potential safety signal, | ||
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 relevant [ |
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information that was material [ |
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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. | ||
(6) the defendant, before or after pre-market approval | ||
or licensing of the product, failed to report any adverse event (or | ||
adverse experience), adverse drug reaction or unexpected adverse | ||
drug reaction for the product as defined by the United States Food | ||
and Drug Administration. | ||
(7) the United States Food and Drug Administration | ||
adds or amends a boxed warning as defined by USC §201.57(c)(1). | ||
(c) The claimant is entitled to reasonable discovery on any | ||
rebuttable presumption before a dispositive motion under (a). | ||
SECTION 2. This Act takes effect September 1, 2015. |