In mid-October, it was reported that Boston Scientific has agreed to pay the federal government in excess of $30 million in an attempt to resolve accusations that the medical manufacturing conglomerate sold defective surgical devices. The defective products were implanted in heart patients between 2002 and 2005 under the labels "Guidant Pacemakers" and "Cardiac Pacemakers."

The United States Dept. of Justice (USDoJ) claims that due in part to Boston Scientific's fraudulent practices, thousands of people were implanted with the defective heart defibrillators and subjected to high risks of life-threatening injuries. The Guidant Pacemaker models in question were the Renewal 1, Renewal 2, and Prizm 2. The mechanical heart devices were implanted into the chests of patients to detect heart murmurs and irregular beats. If an arrhythmia was recognized by the device, it retaliated with an electric pulse that shocked the heart back into its regular rhythm. 

The federal lawsuit claims that the Renewal 1, Renewal 2, and Prizm 2 heart devices did in fact recognize the arrhythmia, but would fail to send the impulse to the heart. Instead, the shock would bounce back to the defibrillator and never reach the heart. In physics, this is known as "arching," and it can cause electrical devices to short circuit and die. The USDoJ insists that Guidant, which was bought by Boston Scientific in 2006, knew the Prizm defibrillator was defective as early as April of 2002 and that the Renewal systems malfunctioned as early as November of 2003.

Boston Scientific claims that Guidant fixed the problem as soon as it was reported; however, the USDoJ says that they continued to sell the remaining unrecalled devices to surgeons and their patients. The federal government adds that Guidant attempted to hide the potential problems its products could have from the United States Food and Drug Administration, as well as hospital administrators, surgeons, physicians, and patients. It was not until May of 2005 that Guidant began revealing the full scope of its product's problems to patients and doctors, and only after they had been contacted several times by journalists from the New York Times.

Source: Justice.gov, "Boston Scientific and Subsidiaries to Pay $30 Million for Guidant's Sale of Defective Heart Devices for Use in Medicare Patients" 17 October 2013