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Capitol Health Call
July 8, 2009

Medical Device Bill

JAMA. 2009;302(2):136. doi:10.1001/jama.2009.938

Bills working their way through Congress would give patients the right to sue manufacturers for injuries incurred from medical devices approved by the Food and Drug Administration (FDA).

The intent of the bills, the Medical Device Safety Act of 2009 (HR 1346 and S 540 [http://thomas.loc.gov]), is to overturn a 2008 Supreme Court ruling (Riegel vs Medtronic). The ruling held that FDA approval of a device prevents a person injured by that device from suing the manufacturer in a state court.

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