The U.S. Department of Justice has filed a civil lawsuit against Boston Scientific Corp. and its Guidant unit, alleging that company officials knowingly sold implantable heart devices with a potentially life-threatening defect.
In its complaint filed Thursday in federal court in Minnesota, the government claims that Guidant corrected the flaw in its defibrillators but then kept selling the remaining defective models it had in stock.
The civil suit follows Guidant’s recent agreement to pay the government $296 million in fines and forfeiture fees to settle criminal charges that it misled the Food and Drug Administration about changes it had made to its defibrillators. Prosecutors said the criminal penalty, approved by a judge this month, was the largest ever against a medical device company.
Implantable defibrillators are supposed to detect irregular heartbeats and shock the heart back to a normal rhythm. But instead of delivering a life-saving jolt, some of the Guidant defibrillators had the potential to short-circuit, causing the device to fail. The suit cites two “failure events” in which patients died of cardiac arrest after their defibrillators short-circuited.
In the civil complaint, the government is now seeking damages against Guidant for continuing to sell defective versions “even after the company took corrective manufacturing action to remedy the defect and even though devices without a known defect were available.”
The government alleges that the company also failed to issue a formal recall for the faulty devices already in use at hospitals, a move that would have forced Guidant to alert the FDA. In addition, the government says Guidant hid the issue from patients, doctors and even its own sales force while the company continued to file for Medicare reimbursements for defective implants.
The False Claims Act would allow the government to recover triple the amount of damages it suffered in paying for Guidant’s devices through Medicare. The government says the company allowed about 2,000 false or fraudulent claims to be submitted.
Problems with the devices were discovered by Guidant, government lawyers say, beginning in 2002, four years before the company was acquired by Boston Scientific. In a news release, Boston Scientific expressed disappointment that “the Federal Government, after reaching a criminal resolution with Guidant LLC, has chosen to seek additional money in a civil lawsuit.”
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