WASHINGTON _ Former FDA Chief Counsel RichardCooper told the Senate Judiciary Committee onWednesday that it makes "common sense and goodpublic policy" for Congress to include the so-called"FDA defense" in pending product liability legislation.
The rationale for the defense, which is supported by drugand medical device manufacturers, is that because FDAreviews and approves a medical product, then the productshould be exempt from punitive damages awards.
Cooper argued that the FDA defense is "limited in scope"because it does not affect liability in compensatorydamages. Also, if a drug maker withholds informationfrom the FDA that was material and relevant to theperformance of the product, then the punitive damagesdefense is not available.
Janice Toran, assistant general council for G.D. Searle &Co., said the FDA defense against punitive damageswould "help to make product liability litigation morerational and predictable. It would also be an importantstep toward removing the chilling effect of the presentsystem _ an effect that forces manufacturers to withdrawsome products from the market and convinces researchersto avoid certain kinds of important research anddevelopment of needed pharmaceutical products." _Michele L. Robinson
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