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Michael McGuan v. Endovascular Technologies
Over 7600 patients were implanted with the Ancure Device, and approximately 4400 E-Forms were submitted. Though the E Forms contained check boxes for equipment malfunctions and comments, they did not contain a check box for injuries ...
(New) Medical Device Preemption Scorecard
Summary judgment granted against all claims concerning Ancure endograft system, an investigational device. Riegel applies to IDE devices. This case was appealed to the 6th Division of the California Court of Appeals on March 5, 2009). ...
The Legal Infrastructure of Business: Boston Scientific Still ...
As a result of “knowingly and willfully” concealing information related to Guidant's Ancure Device, the company had agreed to a ten count guilty plea in 2003, which led to an unprecedented $92 million dollar penalty. Aside from the hefty penalty, ... The defense counters that the company did take action upon learning of the product risks, issuing a letter to doctors nine days after it knew of a death related to a malfunctioning device. The letter stated that Guidant “did ...
Allianz Insurance Company, et al. v. Guidant Corporation ...
Soon after the Ancure Device was approved by the FDA, EVT became aware of various malfunctions in the delivery catheter that was used to insert the graft. Some of these malfunctions resulted in the delivery system becoming improperly ...