Amend CSHB 4 as follows:                                                     
	On pages 545 and 546 of the packet, strike Sec. 82.009 and 
substitute a new Sec. 82.009 to read as follows:
	Sec. 82.009. COMPLIANCE WITH GOVERNMENT STANDARDS.                      
	(a) In a products liability action brought against a product 
manufacturer, distributor, or seller, in which the claimant alleges 
that an injury was caused by some aspect of the formulation, 
labeling, or design of a product, it is an affirmative defense to 
the claimant's allegation that the product's formula, labeling, or 
design complied with mandatory safety standards or regulations 
adopted and promulgated by the federal government, or an agency of 
the federal government, that were applicable to the product at the 
time of the manufacture, and that governed the particular product 
risk alleged by the claimant to have caused harm.  Once the product 
manufacturer, distributor, or seller presents evidence to support 
this affirmative defense, the claimant may overcome the affirmative 
defense by establishing by a preponderance of the evidence that:
		(1) the mandatory federal safety standards or 
regulations applicable to the product were inadequate to protect 
the public from unreasonable risks of injury or damage;
		(2) the manufacturer, before or after marketing the 
product, withheld from or misrepresented to the government or 
agency information that was relevant to the performance of the 
product and was causally related to the claimant's injury;
		(3) Congress included a "savings" provision, intending 
to permit state common law to apply to the field being regulated;
		(4) with respect to the manufacturer of a motor vehicle, 
or a component of a motor vehicle, after the product was sold and 
before the alleged injury occurred, that the manufacturer failed to 
provide the federal government, or the governing agency of the 
federal government, with all incidents of which the manufacturer 
receives actual or constructive notice which involve fatalities or 
serious injuries which are alleged to have been caused by a possible 
defect in such manufacturer's motor vehicle or motor vehicle 
equipment; or
		(5) with respect to the manufacture of a tire, that the 
manufacturer failed to comply with the obligations set forth in the 
Transportation Recall Enhancement, Accountability, and 
Documentation (TREAD) Act.
	(b) In a products liability action brought against a product 
manufacturer, distributor, or seller, in which the claimant alleges 
that an injury was caused by some aspect of the formulation, 
labeling, or design of a product, it is an affirmative defense to 
the claimant's allegation that the product was subject to 
pre-market licensing or approval by the federal government or an 
agency of the federal government, that the manufacturer complied 
with all of the government's or agency's procedures and 
requirements with respect to pre-market licensing or approval, and 
that, after full consideration of the product's risk and benefits, 
was approved or licensed for sale by the government or agency.  Once 
the product manufacturer, distributor, or seller presents evidence 
to support this affirmative defense, the claimant may overcome the 
affirmative defense by establishing by a preponderance of the 
evidence that:
		(1) the standards or procedures used in the particular 
pre-market approval or licensing process were inadequate to protect 
the public from unreasonable risks of injury or damage;
		(2) the manufacturer, before or after pre-market 
approval or licensing of the product, withheld from or 
misrepresented to the government or agency information that was 
relevant to the performance of the product and was causally related 
to the claimant's injury;
		(3) Congress included a "savings" provision, intending 
to permit state common law to apply to the field being regulated; or
		(4) with respect to the manufacturer of a drug or 
medical device, after the product was sold and before the alleged 
injury occurred, that the manufacturer failed to provide the 
federal government, or the governing agency of the federal 
government, with all incidents of which the manufacturer receives 
actual or constructive notice which involve fatalities or serious 
injuries which are alleged to have been caused by a possible defect 
in such manufacturer's product.
	(c) The affirmative defense created in sections (a) and (b) 
does not exist if the claimant demonstrates that the product has 
been withdrawn from the market.
	(d) The affirmative defense created in sections (a) and (b) 
does not exist if the claimant demonstrates that the product 
manufacturer acted with gross neglect or malice.
	(e) This section does not extend to manufacturing flaws or 
defects even though the product manufacturer has complied with all 
quality control and manufacturing practices mandated by the state 
or federal governments or agencies.