The US Supreme Court ruled in February of 2008 that once the FDA approves a "medical device" an "injured patient has no right to sue the manufacturer to seek compensation for harm caused by design defects, failure to warn of the device's risks, or other flaws in the labeling". The case is Riegel v. Medtronic. The consumer group Public Citizen is pushing Congress for legislation-Medical Device Safety Act-to "correct this wrong". The group PC believes patients should have "access to the courts" if they are harmed by medical devices.
(Source: "Medical Device Bill Would Restore Ability to Sue for Harm" bu Rick Claypool. Public Citizen News May/June 2009
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