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Riegel v. Medtronic: A Victory for Patients and Device Manufacturers in the US

March/April 2008
RAJ Devices
In December 2007 the US Supreme Court heard oral argument in Riegel v Medtronic, Inc, to determine whether, if a Class III medical device has been approved for sale by the Food and Drug Administration via its premarket approval process, that approval precludes patients from bringing lawsuits against the manufacturer based on claims that the device was not safe and effective despite complying with the FDA’s conditions of approval.
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