St. Jude Heart Defibrillator Wire Lawsuits Filed Over Recalled Riata Leads

More than two dozen people filed a product liability lawsuit last week alleging that serious injuries or deaths were caused by problems with St. Jude Riata heart defibrillator wires, which were removed from the market more than two years ago amid reports that the insulation may fail.

Complaints were filed against St. Jude Medical by more than 30 people last Thursday, in California Superior Court in Los Angelos and in the U.S. District Court for the Central District of California.

The lawsuits allege that manufacturing defects with the St. Jude Riata allowed the small wire used to connect an implantable cardiac defibrillator (ICD) to the heart to become exposed inside the body, poking through the insulating material. The complaints join a number of similar St. Jude Riata lawsuits that are already pending in courts throughout the United States.

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A St. Jude Riata lead recall was issued in December 2011, after the manufacturer sent several warning letters to doctors about reports of problems with the insulation surrounding the wire, which can become worn and allow the heart defibrillator wires to become externalized.

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 agency also indicated at that time that it was ordering St. Jude 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.

A recent study published in the medical journal Heart Rhythm found that about 11% of St. Jude Riata leads suffer insulation failure after five years.


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