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Boston Scientific settles defective heart device allegation for $30M

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Boston Scientific settles defective heart device allegation for $30M

Boston Scientific Corp. has agreed to pay $30 million to settle allegations that a subsidiary it acquired after the fact had, between 2002 and 2005, knowingly sold defective heart devices that were implanted into Medicare patients to health care facilities, the U.S. Department of Justice said.

A patient who had received one of the defective devices will receive $2.25 million as part of the resolution under the whistle-blower provisions of the False Claims Act, the department said Thursday.

The devices at issue in the settlement reached with Natick, Mass.-based Boston Scientific and its subsidiaries — Guidant L.L.C., Guidant Sales L.L.C. and Cardiac Pacemakers Inc., a Guidant unit — are implantable defibrillators, which are used in patients at risk of cardiac arrest because of an irregular heartbeat. Boston Scientific acquired Guidant, a medical device manufacturer, in 2006.

The government charged that two lines of implantable cardiac devices manufactured and sold by Guidant contained a defect that resulted in “arcing.” Arcing occurs when the device detects the irregular heartbeat and delivers a shock, but instead of current traveling to the heart, the current arcs back to the device itself, causing it to short circuit and rendering it ineffective.

The Justice Department alleged that Guidant learned as early as April 2002 that one line of the devices was defective, and as early as November 2003 that the second line was ineffective as well. It said although Guidant took corrective action to fix the devices, it continued to sell its remaining stock of old, defective versions of the devices.

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It also charged that when it learned about the cause of the defect, it took steps to hide the problem from patients, doctors and the U.S. Food and Drug Administration and issued a misleading communication to doctors about the issue.

Guidant pleaded guilty in February 2010 to criminal charges of misleading the FDA and failing to submit a labeling change to the FDA relating to the defective devices, the Department of Justice said.

Patient James Allen, who had filed a lawsuit under the False Claims Act's whistle-blower provisions in Minnesota and was joined in the litigation by the government in 2011, will receive the $2.25 million. Under the act, private citizens — or relators — can sue on behalf of the government and share in any recovery.

The Department of Justice said that except for the conduct admitted in connection with the criminal plea, there has been no determination of liability.

Commenting on the settlement, John R. Marti, acting U.S. Attorney for the District of Minnesota, said in a statement, “The United States is fortunate that innovative health care companies regularly develop and market remarkable medical devices that improve patients' lives.

“But in this case, Guidant valued profits more than patient safety by selling defective cardiac defibrillators. This office, along with several other components within the U.S. Department of Justice, will continue to vigorously investigate and take appropriate action against health care companies that place public safety at risk.”

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Boston Scientific said in a statement, “While the company continues to deny the allegations made in the complaint, it felt it was in the best interests of all parties to settle this matter and avoid further protracted litigation.

“Of note, the models at issue were sold between April 2002 and April 2005 and were subject to voluntary recalls in June 2005. Boston Scientific acquired Guidant in 2006 and did not design, manufacture or sell the devices involved in this case.”