Title: An act relating to products liability.

Brief Description: Changing provisions regarding products liability actions.

Sponsors: Senators Brandland, T. Sheldon, Stevens and Murray.

Brief History:

Committee Activity: Judiciary: 2/6/04 [DP, DNP].

SENATE COMMITTEE ON JUDICIARY

Majority Report: Do pass.Signed by Senators McCaslin, Chair; Esser, Vice Chair; Brandland, Hargrove and Haugen.

Minority Report: Do not pass.
   Signed by Senator Thibaudeau.

Staff: Aldo Melchiori (786-7439)

Background: Each drug sold in this country comes equipped with the product insert. Each insert is reproduced in a book published each year entitled the Physicians Desk Reference (PDR). The product insert and its corresponding documentation in the PDR contain a number of sections pertaining to the listed drug. These include a description of each drug; its clinical pharmacology; its indications and usage; its contraindications; warnings; precautions; drug abuse and dependence; over dosage; dosage and administration information; and how it is supplied. It is required by federal law that this information accompany the products as they are distributed.

Summary of Bill: In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, the defendant is not liable if the warnings or information that accompanied the product were those required by the United States Food and Drug Administration for a product approved pursuant to the federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the warnings provided were those set forth in monographs developed by the United States Food and Drug Administration for pharmaceutical products that may be distributed without an approved new drug application.

Appropriation: None.

Fiscal Note: Not requested.

Effective Date: Ninety days after adjournment of session in which bill is passed.

Testimony For: This bill would help bring uniformity in product liability claims. An affirmative defense does not offer the same degree of protection as this bill provides. Claims, other than for failure to warn, are not affected by this bill.

Testimony Against: This is an immunity bill for the drug industry. Eight products have been recalled by the FDA in the past year for dangerous effects, even though the labels complied with the law. The FDA has inadequate resources to test and provide adequate warnings.

Testified: PRO: Cliff Webster, Pharmaceutical Research and Manufacturer's Assoc.; CON: Larry Shannon, WSTLA.