James Allen, who received a defective pacemaker manufactured by Guidant LLC decided to blow the whistle on the company revealing information that two lines of implantable defibrillators were sold even though the company knew they were defective.
Boston Scientific and its subsidiaries Guidant LLC , Guidant Sales LLC and Cardiac Pacemakers Inc. will pay $30 million to settle allegations that for three years, Guidant knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients.
Mr. Allen shall receive $2.25 million as his reward for revealing the false claims, pursuant to The False Claims Act, a whistleblower law allowing for individuals to reveal fraud on the government and obtain a percentage of what the government recovers.
The devices as issue are implantable devices used in patients at risk of cardiac arrest due to an irregular heartbeat. The government alleged that two lines of the devices known as Prizm 2 and Renewal 1 and 2 contained a defect that resulted in “arcing”. This happens with the device detects the irregular heartbeat and delivers a shock but instead of the current traveling to the heart, it “arcs” back into the device. This results in a short circuit rendering the device ineffective. The allegations were that the company continued to sell the device even though it knew of the defects.
In addition the government said that the company took steps to hide the problems from patients, doctors and the FDA.