Wednesday, 19 January 2011

Boston Scientific Unit to Pay $296 Million in Detective Cardiac Device Penalties

Guidant, a subsidiary of Boston Scientific will pay $296 million as part of a criminal sentence for failure to reveal defects in its cardiac defibrillators. Those devices have been linked by prosecutors to at least 13 deaths, including that of a 21-year-old man, whose device failed to restore normal rhythm while he was mountain biking.

California pharmaceutical liability attorneys are not unfamiliar with the Guidant scandal broke out in 2005, when cardiac specialists at the Minneapolis Heart Institute went public with allegations that the company was concealing defective devices. According to the heart specialist, the 21-year-old man died when his heart device failed to function properly. According to prosecutors, Guidant had been aware of these defects at least since 2002, but failed to make it public in spite of calls from cardiologists.

The company has been under investigation since 2005, when it recalled at least three types of the implantable cardiac defibrillators. The devices are designed to emit an electric shock when it notices a slowing cardiac rhythm. However, these devices had a defect that caused the devices to short-circuit, causing malfunctioning of the device.

The devices were sold under the names Ventak Prizm 2 DR, Contak Renewal and Contak Renewal 2. Prosecutors allege that the flaws in these devices caused at least 13 deaths, including one last year. In all these cases, Guidant was aware of the defective devices, but failed to make these public. According to prosecutors, at least 153 defective Renewal cardiac defibrillators were implanted in American patients even after the company found that they were defective. At least 200 more devices were implanted outside of the United States.

The $296 million in penalties that Guidant will now pay include fines of nearly $254 million, as well forfeiture of about $42 million to the government because it sold the Renewal cardiac devices without making the problem public.

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