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CASE 0:11-cv-00022-DWF -AJB Document 45 Filed 01/27/11 Page 17 of 35A. Guidant Continued To Sell Defective Devices That It Expected WouldFail67. After the implementation of the April 2002 Change Order, there were twodistinct Prizm 2 device populations being implanted by physicians into patients: (1) deviceswith the arcing defect that had been manufactured before the April 2002 Change Order and(2) devices manufactured after that manufacturing corrective action.68. Guidant expected that the defective device population would continue toexperience arcing events that would potentially put patients’ lives at risk. In contrast,Guidant did not anticipate any arcing events in the post-Change Order device population.69. On May 20, 2002, in order to track future arcing events internally, Guidantopened Trend Report TR 02019, titled “Feedthrough Wire to Backfill Tube Short.” Thetrend report distinguished between devices made before the corrective action and those madeafterwards. Guidant anticipated that the former population of devices likely would continueto experience arcing but the latter population would not.70. In a June 2002 Health Risk Assessment (“HRA”) that Guidant performed forthe Prizm 2 arcing defect, Guidant concluded that injury to a patient stemming from an arcingevent would be “life-threatening” because “unanticipated deaths could reasonably beexpected to occur[.]” (emphasis added). The HRA further concluded that there were nomitigation factors for this risk and that the risk affected the entire pre-fix Prizm 2 patientpopulation. Guidant did not disclose this assessment to physicians or to the FDA.17