Lawsuit Over Guidant Heart Devices Filed by DOJ

Federal prosecutors have filed a lawsuit against Boston Scientific Corp. and their Guidant subsidiary, alleging that Guidant heart devices that the manufacturer knew were defective were sold to patients, defrauding the U.S. health system. 

The Guidant heart device Medicare fraud lawsuit was filed this week in the U.S. District Court for the District of Minnesota by the U.S. Department of Justice (DOJ).

The complaint comes just after a federal judge accepted a guilty plea and $296 million settlement from Guidant over charges by the DOJ that it attempted to keep the FDA from knowing about heart defibrillator problems which are believed to have caused severe injury and death.

According to the DOJ, Guidant sold the Ventak Prizm 2 and the Renewal 1 and 2 implantable cardioverter defibrillators (ICDs) with the knowledge that they were defective and subject to malfunctions. The devices send electric pulses to the recipients heart when they detect an irregular heartbeat. However, the Guidant defibrillators could suffer an electric arc that would short-circuit the devices, leaving them unable to provide life-saving rhythm corrections when the patient needs it.

The DOJ says that by asking for Medicare reimbursements for patients who received the ICDs, Guidant was perpetrating fraud against the government. According to the DOJ, Guidant knew about problems with the devices as early as April 2002, corrected the problem, hid the changes from the FDA and doctors, and then continued to sell off the older stock of the defective devices.

The defective heart implants were not revealed publicly until a 2005 investigative report by the New York Times, which led to Guidant announcing a defibrillator recall. A year later the company was acquired by Boston Scientific.

The DOJ is joining a whistleblower lawsuit brought by James Allen, a recipient of one of the defective defibrillators. Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

On January 12, 2011, U.S. District Judge Donovan Frank accepted a $296 million settlement and guilty plea from Guidant, as well as a three-year probation sentence where the company would be under increased federal scrutiny. Judge Frank had originally rejected the settlement until the probation was added, saying that it was too lenient for a case where people had lost their lives.

“Patients with serious heart conditions who depend on these devices should not have to second-guess whether they are safe and effective,” said Assistant Attorney General Tony West in the DOJ press release. “When a medical device manufacturer conceals problems with its products, as is alleged here, not only is taxpayer money wasted, but lives are put at risk.”