By: Blanco H.B. No. 4027
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 ยง201.57(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.