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By: Irvin Jackson | Published: April 17th, 2013
A Washington man has filed a class action lawsuit against St. Jude Medical on behalf of individuals who were implanted with Riata or Riata ST defibrillator leads, which have been recalled from the market due to problems with the insulation that may allow the small wires to become exposed inside the body.
The complaint (PDF) was filed in U.S. District Court for the Western District of Washington on April 12. The lawsuit was brought by K Sean O’Neil and his wife S.L. O’Neil, seeking class action status to include claims for all Washington state residents who received the ICD leads.
The St. Jude Riata and Riata ST ICD leads are small wires used to connect an implantable cardiac defibrillator (ICD) to the heart. The leads were removed from the market more than two years ago amid reports of insulation problems, which can cause individuals to experience unnecessary shocks or cause the ICD to fail to deliver a life saving jolt when needed.
According to the St. Jude Riata class action lawsuit the manufacturer should pay for medical, surgical and incidental expenses of anyone in the state who was implanted with a recalled Riata lead. Because of the risks associated with removing the lead wires, individuals now must have Riata leads checked regularly to see if the insulation has failed, possibly placing their health at risk. The lawsuit also calls for punitive damages to be levied against the medical device manufacturer.
O’Neil’s Riata lead had to be surgically removed in October 2012, after he began suffering electrical shocks, according to the complaint, which says that the ICD lead was defective.
St. Jude Riata Defibrillator Lead Recall
After discontinuing the ICD leads in late 2010, the FDA issued a St. Jude Riata recall in December 2011. The action was taken in response to several warning letters sent by St. Jude 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 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.
A growing number of individual St. Jude Riata lead lawsuits have been filed throughout the country by individuals who have experienced problems. However, this class action lawsuit for St. Jude Riata lead recipients seeks compensation for medical monitoring and other damages caused, even if the lead has not malfunctioned.
A recent study published in the medical journal Heart Rhythm suggested that about 11% of the St Jude Riata leads may suffer insulation failure after five years.