Guidant Faces 2nd Legal Battle Over Faulty Devices

Shortly after wrapping up a criminal case surrounding several of the company's faulty defibrillators, the government has filed a related civil lawsuit.

About two weeks after the end of one legal battle involving several defibrillators manufactured by Boston Scientific Corporation's Guidant subsidiary, the government has filed a related lawsuit against the company.

In a complaint filed Thursday, the U.S. Justice Department alleges that Guidant, LLC, knowingly sold several defective models of implantable cardioverter defibrillators-the Ventak Prizm 2 and Contak Renewal 1 and 2.

Boston Scientific, which acquired Guidant in 2006, is based in Natick, Massachusetts, but Guidant's cardiac rhythm management division-which produced the faulty defibrillators-is headquartered in Arden Hills.

According to the lawsuit, Guidant learned as early as April 2002 and November 2003, respectively, that the devices contained a potentially life-threatening defect. Even after Guidant took corrective action to fix the defects, it continued to sell the defective versions of the devices.

As information about the cause and nature of the defects worked its way up to top company executives, Guidant took steps to hide the defibrillator problems from patients, doctors, and the U.S. Food and Drug Administration (FDA), according to the suit. Instead of disclosing the problem, Guidant allegedly issued a misleading memo to doctors that misinformed them about the nature of the defect.

According to the government, Guidant didn't fully disclose the device problems to doctors and the FDA until May 2005 when a reporter contacted someone at the company. The company allegedly recalled the devices shortly after a front-page article about the defects appeared in The New York Times.

The government's lawsuit builds upon a whistleblower lawsuit filed in 2008 by James Allen, who allegedly received one of the faulty devices.

Earlier this month, a federal judge signed off on a plea agreement that calls for a $296 million payment from Guidant and three years of probation for the company. That plea agreement resulted from Justice Department allegations that Guidant concealed information from the FDA regarding “catastrophic failures” in the same Ventak Prizm and Contak Renewal devices at the center of the just-filed lawsuit.

Boston Scientific issued a brief response to the Thursday lawsuit indicating that it had hoped the recent resolution marked the end of the legal battle surrounding the faulty defibrillators: “The company is disappointed that the federal government, after reaching a criminal resolution with Guidant, LLC, has chosen to seek additional money in a civil lawsuit. However, the company believes that the ultimate resolution of this matter should not have a significant financial impact.”