On the recordMarch 9, 1995
I rise in clear opposition to an amendment which will ultimately have the effect of immunizing manufacturers of defective products who happen to obtain FDA approval. This amendment would provide a complete defense to liability for any drug or medical device that received premarket approval from the FDA. In other words, if the FDA for whatever reason allows a defective product on the market, the victims would not be able to sue at all. Even if both the manufacturer and the FDA have evidence of the dangers of a product but permitted it to be marketed anyway, the innocent, injured victim would be left without any opportunity for compensation whatsoever.
Source
govinfo.gov




