Heavy Criminal Penalty for Boston Scientific's Guidant Division

Reports say Boston Scientific's Guidant Unit is set to pay a criminal penalty for failing to announce safety information about its implantable heart defibrillators. The devices were reportedly linked to the deaths of 13 people when they short circuited, reports say.

A settlement with the Department of justice and Boston Scientific was rejected by a U.S. District Judge in April, citing concerns from doctors and patients. The judge has approved a new settlement that still allows the $296 million fine, but also penalizes Boston Scientific with a three-year probation, reports say.

According to the charges, Boston Scientific concealed information from the FDA concerning catastrophic short-circuiting failures, even though they had found fault with one of the products as early as 2002, reports say.

Safety alerts were finally issued in June of 2005, reports say. But the recalls, according the FDA, should have been the more serious Class I recalls, which suggest the device should be recalled due to potential death or serious health risks, reports say.

Boston Scientific is now required to create quarterly reports to the U.S. Probation Office related to safety issues. They are also subject to unannounced inspections. The probation, along with the $296 million penalty is believed to be the largest criminal penalty ever imposed in a medical device suit.

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