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Guidant’s heart defibrillator may be smaller than a pack of cigarettes, but its purpose appeared to be essential to sustaining life: If it detected irregular heart rhythm, the device shocked it back to the correct beating. Those receiving it previously experienced a heart attack, had at least one episode of rapid heart beating, or were at risk for both.
In 2005, Guidant voluntarily recalled its defibrillator. At the time, the manufacturer found that up to 50,000 of the devices could be flawed. In response, Guidant issued a statement saying more than half of them (28,900) could be replaced and the remaining 21,000 could be reprogrammed to reduce short circuiting.
By this point, two deaths and 45 instances of failure were associated with the heart defibrillator. The FDA, in turn, told recipients to speak with their doctors but did not recommend either replacement or removal. 63,000 implanted devices covering seven models had been recalled.
Nevertheless, even with the voluntary recall in 2005, Guidant had a history of keeping its products on the market after the first reported death – a 21-year-old college student whose device short-circuited while he mountain-biked. Even after the redesign in 2002, the manufacturer still sold the defective Prizm 2DR without informing physicians of the newer, improved model.
The second death, occurring in 2004, concerned the Contak Renewal defibrillator.
Later Recalls and Legal Issues
Boston Scientific purchased Guidant in 2006 for $28.4 billion. However, even with a new company overseeing production, a recall occurred in 2010. Boston Scientific allegedly had not received federal approval for its new manufacturing process and, in return, stopped sales and removed all field inventory for seven models of Implantable Cardiax Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).
For this recall, 73,000 products were found to have faulty capacitors that depleted batteries quicker or were associated with short circuiting, issues with the magnetic switch, or computer memory. Since its introduction, 13 deaths have been linked to the Guidant heart defibrillator.
Guidant continued to be less than forthright concerning product information, and in 2011, this behavior resulted in a U.S. Justice Department lawsuit filed against Guidant and Boston Scientific Corp. Allegedly, Medicare had wrongly paid for patient devices Guidant knew were faulty, and as a result, Medicare approximately 2,000 false or fraudulent claims. The case filed in Minnesota federal court sought to recover some of the healthcare expenses.
A federal judge ordered Guidant, on related criminal charges, to pay $296 million in criminal penalties and ordered three years of probation. Guidant had pleaded guilty to two misdemeanor violations: filing a false report to the FDA and failing to inform the FDA about changes made to the defibrillator.
Filing a Claim
Trantolo & Trantolo’s experienced product liability lawyers have been taking on claims concerning Guidant heart defibrillators. Having a defective medical device implanted, even after reprogramming, feels like your life is constantly on the line – especially when the manufacturer has a history of covering up or being less than direct with information.