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St. Jude Medical has agreed to pay $64.3 million to settle lawsuits filed by consumers and shareholders over problems with Riata defibrillator leads, which were recalled amid reports that the insulation may fail.
In a recent press release, the manufacturer indicated that it has reached agreements to settle about 950 St. Jude Riata injury lawsuits for about $14.75 million, leaving only a handful of claims unresolved.
In addition, a class action lawsuit brought on behalf of shareholders over the company’s third-quarter 2009 results is settling for $50 million, resolving claims that St. Jude provided false information by failing to reveal that it knew the Riata leads had 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 is estimated that nearly 80,000 of the leads remain 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.
Nearly 1,000 patients who received the recalled wires pursued St. Judge Riata lawsuits, alleging that the manufacturer sold a defective and dangerous medical device and failed to disclose the risk of early failure.
Unlike many mass litigation cases involving medical devices or drugs, the St. Jude cases have not been consolidated as part of an MDL, or multidistrict litigation. This has led to conflicting rulings regarding preemption, with some courts finding that the cases are barred, because the device was approved by the FDA.