Facing allegations that the company knowingly sold defective heart devices to health care facilities, which were then implanted into Medicare patients, Boston Scientific Corporation, along with its subsidiaries, Guidant LLC, Guidant Sales LLC, and Cardiac Pacemakers Inc., will pay $30 million to settle a lawsuit filed by a private citizen on behalf of the U.S. Government.
The devices that were alleged to have been defective were the Prizm 2 and the Renewal 1 and 2. The devices were designed to detect a patient’s heart entering an irregular rhythm and thus placing them at risk for cardiac arrest. To correct the patient’s heart beat, the device would issue an electrical pulse to shock it back to a normal rhythm. However, according to the government’s complaint in this case, these devices were susceptible to arcing. The electrical pulse from the device would come back from the heart to the device and render the device useless.
“These cardiac devices are relied on by patients to potentially save their lives,” commented Christopher Paulos, an attorney with the Levin, Papantonio law firm who practices in the areas of qui tam or whistleblower law. “Unfortunately, Guidant has shown that it will put its own profits ahead of the safety of the patients that it is supposed to serve.”
As early as 2002, reports and complaints of the defectiveness of the Guidant devices were coming in. It wasn’t until 2005, after an article was published by the New York Times that the corporation admitted the device was defective and engaged in a recall. It wasn’t until February of 2010 that Guidant pleaded guilty to criminally misleading the FDA and failing to pursue a label change for its devices.
The current lawsuit, United States ex rel. Allen v. Guidant LLC et al., was filed under the qui tam provisions of the False Claims Act by James Allen after he had received one of Guidant’s defective devices. As part of the provisions of the False Claims Act individuals with knowledge of entities filing false claims for payment by the government may bring suit on behalf of the government and, potentially, receive a share of any money recovered. For his involvement, Allen will receive $2.25 million of the $30 million settlement.
“The False Claims Act is one of the most effective laws on the books for combating corruption and fraud against the government,” Mr. Paulos continued. “It is only fitting that these individuals, who proceed with litigation under the very real threat of both public and private retaliation, are compensated for their brave efforts.”