HBA-ATS H.B. 2243 76(R) BILL ANALYSIS Office of House Bill AnalysisH.B. 2243 By: Goodman Civil Practices 4/4/1999 Introduced BACKGROUND AND PURPOSE States are not uniform in their treatment of exemplary damages in medical products liability cases. Depending on applicable state law, exemplary damages can be quite significant. Exemplary damages usually exceed compensatory damages because they are awarded to punish the wrongdoer. Because of their punitive nature, many states, including Texas, limit the amount that may be recovered. Some courts reason that the cap insures that punitive damages assessed are reasonably related to damages suffered. H.B. 2243 prohibits the award of exemplary damages in a products liability action against a manufacturer or seller of a drug that caused the claimant's harm if the drug was subject to premarket approval, and subsequently approved, by the federal Food and Drug Administration (FDA) for its safety, performance, packaging, or labeling, or if the drug is generally recognized as safe and effective under conditions established by the FDA and applicable federal regulations, including packaging and labeling regulations. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that this bill does not expressly delegate any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Chapter 41, Civil Practice and Remedies Code, by adding Section 41.014, as follows: Sec. 41.014. COMPLIANCE WITH GOVERNMENT STANDARDS FOR DRUG SAFETY. (a) Defines "drug," "manufacturer," "products liability action," and "seller." (b) Prohibits the award of exemplary damages in a products liability action against a manufacturer or seller of a drug that caused the claimant's harm if the drug was subject to premarket approval, and subsequently approved, by the federal Food and Drug Administration (FDA) for its safety, performance, packaging, or labeling, or if the drug is generally recognized as safe and effective under conditions established by the FDA and applicable federal regulations, including packaging and labeling regulations. (c) Sets forth that Subsection (b) does not apply to a drug manufacturer if the claimant proves, by clear and convincing evidence, that the manufacturer, before or after premarket approval of the drug, intentionally or wrongfully withheld from or misrepresented to the FDA information about the drug required to be submitted to the FDA under applicable federal law and which is material and relevant to the harm suffered by the claimant, or that the manufacturer, before or after premarket approval of the drug, made an illegal payment to an FDA official or employee to secure or maintain approval of the drug. SECTION 2.Effective date: September 1, 1999. Makes application of this Act prospective. SECTION 3.Emergency clause.