Boston Scientific Defibrillator Suits will Proceed to Trial
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LLFClerk LLFClerkJune 18, 2007 9:25 AMBoston Scientific is currently involved in 1,600 product-liability lawsuits related to claims involving the Model 1861 defibrillator. The issue concerns a flaw that could cause the Model 1861 defibrillator not to produce a life-saving jolt. Guidant Corp. (purchased by Boston Scientific in 2006) discovered this flaw in 2002, but did not warn patients until the recall in 2005. This flaw proved fatal for three patients.
Patients who had the Model 1861 defibrillators removed after the 2005 recall are now suing Boston Scientific for "emotional distress and punitive damages and for failing to warn them of the flaw." The company argued that the plaintiffs could not sue them since their individual devices were not faulty.
The court did not accept those arguments, however, stating that the company was still liable even though the patients elected to remove the defibrillator before it could possibly malfunction. The lawsuits will thus proceed to trial. Boston Scientific stated that they are confident in their arguments, but they expect to pay at least $732 million in legal costs and damages as a result of the cases.
The Food and Drug Administration recalled these devices
Recall of Certain Guidant Defibrillators
Source: Boston Scientific/Guidant Recall: Questions & Answers, FDA Questions and Answers, April 10, 2007.Boston Scientific/Guidant is recalling certain Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices can cause the batteries to deplete sooner than expected.
The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135).
Patients with one of the recalled devices should contact their physicians about what steps to take next.
For further information on injuries, please see our section detailing drugs, medical devices, and implants.