Last month, the federal government intervened and settled a qui tam action for $30 million, alleging that Boston Scientific and its subsidiary Guidant knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients.
The qui tam action was particularly noteworthy, for the relator was a Medicare patient who had received one of the allegedly defective medical devices. In the end, the patient-relator received a $2.2 million share of the government’s recovery.
In addition to the $30 million civil recovery, the federal government received over $296 million from Guidant, in 2010, when the company pleaded guilty to criminal charges of misleading the FDA and failing to submit a labeling change to the FDA relating to the defective devices.
The devices at issue were implantable defibrillators, which are used in patients at risk of cardiac arrest due to an irregular heartbeat. The devices are surgically implanted into patients’ chests, and when the devices detect an irregular heartbeat, they send an electrical pulse to the heart to “shock” it back to its normal rhythm. According to the allegations in the government’s complaint-in-intervention, the 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 the current traveling to the heart, the current “arcs” back to the device itself. This causes the device to short circuit, rendering the device ineffective.
According to the allegations in the 2010 criminal information and the government complaint-in-intervention, Guidant learned as early as April 2002 that its Prizm device was defective, and as early as November 2003 that the Renewal 1 and 2 were similarly defective. The government further alleged that the company fixed the defects, but it continued selling its remaining stock of the old, defective versions of the devices. Moreover, the government alleged that, as Guidant learned about the cause of the defect, it took steps to hide the problem from patients, physicians, and the FDA.
More information for whistleblowers is located at the Nolan Auerbach & White website.