STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS — (Senate – March 05, 2009)

“Moreover, there is very little FDA oversight once a device reaches doctors and patients. In fact, even the best designed and most reliable clinical studies by their very nature cannot duplicate all aspects and hazards of everyday use. Moreover, while manufacturers are supposed to report defects and injuries, the FDA has admitted that there is ‘severe underreporting” of defects and injuries.

Given the FDA’s limitations, it is crucial that an individual have a right to seek redress. When defective medical devices reach the market, whether or not approved by the FDA, patients are often injured. Those injured are often left temporarily unable to work or to enjoy normal lives, and in many cases never fully recover. State tort law provides the only relief for patients injured by defective medical devices and should not be foreclosed.

Not only does access to State court mean that a person injured can receive fair compensation, but there are other advantages. Such suits aid in exposing dangers and serve as a catalyst to address their consequences. Through discovery, litigation can help uncover previously unavailable information on adverse effects of products that might not have been caught during the regulatory system. Litigants can demand documents and information on product risks that might not have been shared with the FDA. In this way, the public as a whole is alerted to dangers in medical products…”

http://thomas.loc.gov/cgi-bin/query/F?r111:9:./temp/~r111RtwMfs:e199102:

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