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.