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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.