Medical device manufacturers are held to a high standard. The products they produce are expected to work properly. When their products are defective or fail, the results can be catastrophic to patients.
This week, the U.S. Department of Justice joined a civil lawsuit against Boston Scientific Corporation and Guidant, one of its subsidiaries, alleging the company wrongfully sold faulty medical devices to the Medicare program. The government is intervening in a previously filed suit by a patient who was implanted with a Guidant implantable defibrillator device in 2002.
Implantable defibrillators are battery-powered devices implanted in patients who are at risk for sudden death from heart problems. In the event a patient experiences a heart arrhythmia, or irregular heartbeat, the devices are designed to correct the arrhythmia by shocking the heart with a jolt of electricity. According to the lawsuits, Guidant knew as early as 2002 that its defibrillators might not deliver the jolts of electricity when needed, but it did not act quickly enough to correct the problem.
According to the government, the flawed defibrillators are responsible for 13 known deaths and possibly more. Guidant did not issue a recall of the defibrillators until 2005, nearly three years after it allegedly became aware of the problems with its defibrillators. Although Guidant eventually fixed the problems with its defibrillators, the company is accused of selling defective devices it still had in stock.
Recently, Guidant pleaded guilty to criminal charges for withholding information from the U.S. Food and Drug Administration and failing to inform regulators of catastrophic failures in its devices. As a result of the guilty plea, Guidant was sentenced to three years of probation and was ordered to pay $296 million in penalties.
Minnesota Public Radio, "US sues Boston Scientific, alleging false claims by Guidant unit," Martin Moylan, 1/28/2011
The Wall Street Journal, "US Justice Department Files Civil Lawsuit Over Guidant Defibrillators," Brent Kendall, 1/27/2011