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.