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US bill to shield drug companies from product liability

BMJ 2005; 330 doi: (Published 06 January 2005) Cite this as: BMJ 2005;330:62
  1. Jeanne Lenzer
  1. New York

US federal legislation that could shield drug companies from product liability lawsuits will be reintroduced in the Senate within two months, says Jack Finn, spokesperson for Senator John Ensign of Nevada state.

Senator Ensign sponsored an earlier version of the planned bill (S11) that would prohibit product liability awards for drugs or medical devices that “comply with Food and Drug Administration standards.”

The provision, known as the “FDA compliance” or “pre-emption” defence, does not apply if FDA officials were bribed or if the manufacturer withheld information about product safety.

Proponents of the legislation say that …

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