Bill not drafted by TLC or Senate E&E.

      Line and page numbers may not match official copy.

      By Goodman                                      H.B. No. 3285

                                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.

 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.

 1-8     (a)  Exemplary damages may not be awarded against a manufacturer or

 1-9     seller of a drug that caused the claimant's harm if:

1-10                 (1)  the drug was subject to premarket approval by the

1-11     federal Food and Drug Administration with respect to the safety of

1-12     the formulation or performance of the drug or the adequacy of the

1-13     packaging or labeling of the drug and the drug was approved by the

1-14     federal Food and Drug Administration; or

1-15                 (2)  the drug is generally recognized as safe and

1-16     effective pursuant to conditions established by the federal Food

1-17     and Drug Administration and applicable regulations, including

1-18     packaging and labeling regulations.

1-19           (b)  Subsection (a) does not apply to a manufacturer of a

1-20     drug if the claimant proves by clear and convincing evidence that

1-21     the manufacturer, before or after premarket approval of the drug:

1-22                 (1)  intentionally or wrongfully withheld from or

1-23     misrepresented to the federal Food and Drug Administration

1-24     information concerning the drug required to be submitted under the

 2-1     Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et

 2-2     seq.) or Section 351 of the Public Health Service Act (42 U.S.C.

 2-3     Section 262) that is material and relevant to the harm suffered by

 2-4     the claimant; or

 2-5                 (2)  made an illegal payment to an official or employee

 2-6     of the federal Food and Drug Administration for the purpose of

 2-7     securing or maintaining approval of the drug.

 2-8           (c)  In this section, "drug" has the meaning assigned by

 2-9     Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21

2-10     U.S.C. Section 321(g)(1)).

2-11           SECTION 2.  This Act takes effect September 1, 1997, and

2-12     applies only to an action commenced on or after that date.  An

2-13     action commenced before the effective date of this Act is governed

2-14     by the law in effect immediately before that date, and that law is

2-15     continued in effect for that purpose.

2-16           SECTION 3.  The importance of this legislation and the

2-17     crowded condition of the calendars in both houses create an

2-18     emergency and an imperative public necessity that the

2-19     constitutional rule requiring bills to be read on three several

2-20     days in each house be suspended, and this rule is hereby suspended.