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According to allegations raised in a wrongful death lawsuit filed against Abbott Laboratories and it’s St. Jude Medical subsidiary, a Georgia man suffered fatal injuries in an auto accident, after problems with a St. Jude defibrillator caused his heart device to fail.
The complaint (PDF) was filed by Wendy Sharp in the U.S. District Court for the Northern District of Georgia, on behalf of herself and the estate of Milton Sharp, her husband.
Prior to his death, Sharp had a St. Jude implantable cardiac defibrillator (ICD), which included a Riata defibrillator lead and Fortify generators, both of which have been recalled due to serious design defects that may cause the defibrillator to fail when needed to deliver a life-saving jolt to the heart.
As a result of the high risk associated with replacing the device and lead wires, Sharp was one of thousands of individuals nationwide who had the recalled defibrillator left in their body, since there were no current signs of problems. However, on August 23, 2015, Sharp experienced a cardiac arrhythmia while operating a motor vehicle, the lawsuit indicates.
“At that time, his ICD failed to administer an appropriate shock to his heart, which would have corrected the arrhythmia,” the lawsuit notes. “The ICD failed to convert the arrhythmia because friction between the external insulation on the Riata lead and the ICD exposed the wires inside the lead, causing the ICD to malfunction when it attempted to administer the shock.”
As a result of the St. Jude defibrillator failure, the lawsuit indicates that Sharp drove off the road and was involved in an auto accident. He was pronounced dead on arrival at a nearby hospital. He was 68 years old.
St. Jude ICD problems
St. Jude Riata leads are small wires used to connect implantable cardiac defibrillators (ICDs) to the heart. They are designed to monitor the heart rhythms and deliver electric shocks if needed to restore normal heart beats.
About 227,000 of the lead wires were sold worldwide before the manufacturer acknowledged that the insulation surrounding the wire may be prone to decay and erode, leaving exposed wires inside patients. This has caused many users to experience unnecessary shocks, or for the defibrillator to fail.
In late 2010, St. Jude removed the leads from the market amid reports of insulation failure, and a warning letter was sent to doctors about the risk of problems in late 2011, which the FDA classified as a St. Jude Riata recall. However, it was estimated that nearly 80,000 of the leads remained active in patients in the United States, as the process of attempting to remove the lead is risky and doctors often recommend keeping the defective lead in place unless there is evidence that it has failed.
In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.
Several hundred patients who received the recalled wires are pursuing St. Judge Riata lawsuits, alleging that the manufacturer sold a defective and dangerous medical device and failed to disclose the risk of early failure.