Defective leads transform the potentially lifesaving implantable cardioverter-defibrillator (ICD) into a lethally defective product. When leads, the wires that carry electricity from the ICD to the heart, are defective, the result may be unnecessary shocks, additional surgery, even premature death. To protect patients with defective leads, it is crucial that information about the defect is publicized to doctors and patients alike so that appropriate action can be taken.
However, some charge that St. Jude Medical concealed the defects in its Riata and Riata II ICD leads. The Riata and Riata II leads are coming under increasing scrutiny after a paper published in the journal Heart Rhythm showed they were associated with four times more fatalities due to lead failure than leads manufactured by a competitor. This study comes after several others showing that the failure rate for Riata and Riata II leads may be much, much higher than reported by St. Jude. Although St. Jude reported that the lead failure rate was 0.47%, imaging of patients who received the leads suggests the rates might be much higher, 15-30%. This had led to charges that St. Jude has been concealing the actual failure rate of the Riata and Riata II leads, which it stopped selling in 2010 and replaced with a new lead designed to address the Riata failures.
We will likely not know if St. Jude has been concealing the incidence of Riata failures until victims come forward with lawsuits that compel the company to reveal internal records. A lawsuit can mean not just compensation for your injury or the loss of a loved one, it can expose potential misconduct that should not be allowed to continue in this type of medical device manufacturer.
To learn more about your legal rights and options after a problem with defective ICD leads, please contact a local personal injury lawyer today.