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.