By Goodman                                            H.B. No. 2243
         76R6521 MI-F                           
                                A BILL TO BE ENTITLED
 1-1                                   AN ACT
 1-2     relating to compliance with government standards as a defense to an
 1-3     award of exemplary damages in certain products liability actions.
 1-4           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
 1-5           SECTION 1.  Chapter 41, Civil Practice and Remedies Code, is
 1-6     amended by adding Section 41.014 to read as follows:
 1-7           Sec. 41.014.  COMPLIANCE WITH GOVERNMENT STANDARDS FOR DRUG
 1-8     SAFETY.  (a)  In this section:
 1-9                 (1)  "Drug" has the meaning assigned by Section
1-10     201(g)(1) of the  Federal Food, Drug, and Cosmetic Act (21 U.S.C.
1-11     Section 321(g)(1)), as amended;
1-12                 (2)  "Products liability action," "manufacturer," and
1-13     "seller" have the meanings assigned by Section  82.001.
1-14           (b)  Exemplary damages may not be awarded in a products
1-15     liability action against a manufacturer or seller of a drug that
1-16     caused the claimant's harm if:
1-17                 (1)  the drug was subject to premarket approval by the
1-18     federal Food and Drug Administration with respect to the safety of
1-19     the formulation or performance of the drug or the adequacy of the
1-20     packaging or labeling of the drug, and the drug was approved by the
1-21     federal Food and Drug Administration; or
1-22                 (2)  the drug is generally recognized as safe and
1-23     effective under conditions established by the federal Food and Drug
1-24     Administration and applicable federal regulations, including
 2-1     packaging and labeling regulations.
 2-2           (c)  Subsection (b) does not apply to a manufacturer of a
 2-3     drug if the claimant proves by clear and convincing evidence that
 2-4     the manufacturer, before or after premarket approval of the drug:
 2-5                 (1)  intentionally or wrongfully withheld from or
 2-6     misrepresented to the federal Food and Drug Administration
 2-7     information concerning the drug that is:
 2-8                       (A)  required to be submitted to the federal Food
 2-9     and Drug Administration under the Federal Food, Drug, and Cosmetic
2-10     Act (21  U.S.C. Section 301 et seq.), as amended, or under Section
2-11     351 of the federal Public Health Service Act (42 U.S.C. Section
2-12     262), as amended; and
2-13                       (B)  is material and relevant to the harm
2-14     suffered by the claimant; or
2-15                 (2)  made an illegal payment to an official or employee
2-16     of the federal Food and Drug Administration for the purpose of
2-17     securing or maintaining approval of the drug.
2-18           SECTION 2.  This Act takes effect September 1, 1999, and
2-19     applies only to a civil action commenced on or after that date.  An
2-20     action commenced before September 1, 1999, is governed by the law
2-21     in effect immediately before that date, and that law is continued
2-22     in effect for that purpose.
2-23           SECTION 3.  The importance of this legislation and the
2-24     crowded condition of the calendars in both houses create an
2-25     emergency and an imperative public necessity that the
2-26     constitutional rule requiring bills to be read on three several
2-27     days in each house be suspended, and this rule is hereby suspended.