Defective medical device lawyers at Pintas & Mullins Law Firm report that Boston Scientific recently agreed to pay the federal government $30 million to resolve allegations that it knowingly sold defective heart devices. The devices were implanted between 2002 and 2005 under Guidant and Cardiac Pacemakers labels.
The Department of Justice alleged that, as a result of Boston Scientific’s fraud, thousands of Medicare patients were implanted with defective devices and purposefully subject to a high risk of injury. Patients who rely on cardiac defibrillators have severe, life-threatening medical conditions, such as irregular heartbeats, and should not have to worry that their pacemakers will not work when their life depends on it.
The devices at issue – the Prizm 2 and Renewal 1 and 2 – were manufactured by Guidant, which Boston Scientific purchased in 2006. They are implantable defibrillators surgically inserted into patients” chests to detect irregular heartbeats. When a cardiac arrhythmia is sensed, the device sends out an electrical pulse to the heart, which shocks it back to a normal rhythm.
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According to the suit, the Prizm and Renewal devices would detect an irregular heartbeat and send out a shock as needed, however, the electrical current would arch back to the device itself instead of to the heart. This is known as “arching,” and can cause the device to short circuit, rendering it ineffective. The Department of Justice claims Guidant knew the Prizm was faulty as early as April 2002, and the Renewal as early as November 2003.
The company claims it took immediate action to correct the defects, though it continued selling the remaining stock of the remaining “arching” devices. The government also claimed that Guidant took several measures to conceal the potential defects from health care professionals, the FDA and patients. Rather than truthfully informing them of the defects, Guidant issued intentionally misleading alerts to physicians regarding the scope and severity of the faulty products. Guidant failed to completely disclose the issue to patients and the FDA until May 2005, and only after being contacted by reporters at the New York Times.
Guidant issued a national recall of the Prizm and Renewal devices that year, and quickly came under fire for failing to notify patients. By 2005, at least two patients died from the arching defect, and 45 other patients had to undergo surgery for failed defibrillators. Guidant promised to replace nearly 29,000 of the recalled devices. An additional 21,000 devices were able to be fixed with external programming.
The recall affected the following models: the Contak Renewal and Renewal 2, Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICDs. Total, 63,000 devices were recalled, 50,000 of which had already been implanted in patients.
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One of these patients was Joshua Oukrop, a 21-year-old college student from Minnesota. He was born with a genetic heart disease that caused cardiac arrhythmias, and was implanted with a defective Guidant defibrillator. He died in March 2005, four months before the recall and three years after Guidant knew of the defects, while he was mountain biking. He was implanted with the Prizm 2, which short-circuited and failed.
Minnesota’s Attorney General stated that Guidant clearly placed profits over patient safety in its conduct. He noted that he would continue to investigate the defective cardiac defibrillators and take appropriate action against Guidant. The company pleaded guilty in 2010 to misleading the FDA and failing to submit label changes. The current $30 million lawsuit was filed one year later when a whistleblower who was implanted with a faulty device sued on behalf of the government.
Medical device recall lawyers at Pintas & Mullins Law Firm have recovered millions of dollars on behalf of victims injured by faulty devices like the Prizm and Renewal defibrillators. Our team of recall attorneys ensures that our clients receive maximum compensation for injuries and losses, and are currently reviewing cases of defective medical devices from patients in all 50 states.