| |
| |
|
|
A BILL TO BE ENTITLED
|
|
|
AN ACT
|
|
|
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 [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. |
|
|
(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. |