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News-At-A-Glance: Patient Files Whistleblower Suit Costing a Device Manufacturer $30 Million:

by | Feb 23, 2015 | Essential, Lab Compliance Advisor

A manufacturer of heart pacemakers continued to sell devices it knew were defective; hid the defects from patients, doctors, and the Food and Drug Administration; and misled physicians about the problems. Boston Scientific Corp. and its subsidiaries, Guidant LLC, Guidant Sales LLC, and Cardiac Pacemakers Inc. (Guidant), paid $30 million to settle allegations that it sold the defective devices from 2002 through 2005 that were implanted into patients, thereby risking their lives if the defective device failed. The devices, cardiac pacemakers, had a defect that could cause them to short-circuit when activated by an irregular heartbeat and render them ineffective. According to the government complaint, Guidant corrected the problem but rather than recall the defective devices it continued to sell them until its stock was depleted. The whistleblower, James Allen, a patient who received one of the defective devices, will get a $2.25 million share of the settlement.

A manufacturer of heart pacemakers continued to sell devices it knew were defective; hid the defects from patients, doctors, and the Food and Drug Administration; and misled physicians about the problems. Boston Scientific Corp. and its subsidiaries, Guidant LLC, Guidant Sales LLC, and Cardiac Pacemakers Inc. (Guidant), paid $30 million to settle allegations that it sold the defective devices from 2002 through 2005 that were implanted into patients, thereby risking their lives if the defective device failed. The devices, cardiac pacemakers, had a defect that could cause them to short-circuit when activated by an irregular heartbeat and render them ineffective. According to the government complaint, Guidant corrected the problem but rather than recall the defective devices it continued to sell them until its stock was depleted. The whistleblower, James Allen, a patient who received one of the defective devices, will get a $2.25 million share of the settlement.

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