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A Tennessee man has filed a lawsuit against St. Jude Medical over their recalled Riata lead, alleging that the small wire used to connect a defibrillator to his heart failed, requiring him to undergo invasive surgery to remove and replace the lead.
The complaint (PDF) was filed by Walter Glen Grant and his wife, Pamela, in the U.S. District Court for the Middle District of Tennessee in Nashville on August 7.
According to allegations raised in the St. Jude Riata lawsuit, Grant was implanted with one of the defibrillator leads in June 2010 and learned about two years later, in August 2012, that it was failing and had to be replaced. As a result of injuries caused when the recalled defibrillator lead failed, Grant claims that he suffered and will continue to suffer injury, as well as physical, emotional, economic and other damages.
The claim is one of a growing number of product liability lawsuits over the St. Jude Riata lead, which was removed from the market in late 2010 amid reports that suggested the insulation surrounding the leads was prone to fail, resulting in exposed wires inside the body. This could result in unnecessary shocks or cause the defibrillator to fail to deliver a life-saving jolt when needed, often requiring revision surgery to remove the lead once problems are detected.
Grant’s complaint indicates that the company manufactured a defective and dangerous product that never should have been placed on the market, seeking compensatory and punitive damages.
St. Jude Riata Lead Recall
The St. Jude Riata and Riata ST ICD leads are small wires used to connect an implantable cardiac defibrillator (ICD) to the heart. The company decided to suspend sales of the leads more than two years ago, and then issued a warning to doctors in late 2011 about reports of insulation problems.
The FDA determined that the actions constituted a St. Jude Riata recall in December 2011.
Approximately 227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and estimates suggest that approximately 79,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled 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.
The FDA has ordered the company to conduct additional studies on the potential risk of insulation failures and problems with the debrillator leads, including the newer versions sold under the Riata ST Optim and Durata names.