If you have an irregular heartbeat, an implantable cardioverter-defibrillator (ICD) is supposed to be a lifesaving technology. However, defective leads—the wires that carry charge from the ICD to the heart—can undermine the effectiveness of the device and may lead to unnecessary shocks, resulting in pain, debilitation, additional surgeries, and early death. St. Jude Medical is a leading manufacturer of ICD leads, and it turns out that two of their most successful lead models may be defective, and some charge that the company is concealing the full extent of the defect.
If you have been hurt or lost a loved one due to a defect in a St. Jude Medical ICD lead, you may be able to receive compensation for the injury or loss. To learn about your rights, please call 1-877-567-7732 or email a lawyer in your area for a free case evaluation.
The Defibrillator Lead Defect
An implantable cardiverter-defibrillator (ICD) works to regulate the heart by providing stimulating shocks when the heart’s rhythm deviates from a predetermined pattern. However there have been a number of cases recently when defects have caused the ICD to issue numerous unnecessary shocks. Most often these shocks are due to defective leads.
St. Jude Medical has manufactured numerous models of ICD leads, and two of their most popular models, the Riata and Riata II, which have been implanted in nearly 130,000 people, have recently been shown to bedefective medical devices. According to reports from St. Jude and independent researchers, the primary defect is that the leads can wear themselves free of their insulation. Once the wires become exposed, they are prone to short-circuiting high-voltage components, leading to excessive, unnecessary shocks. Research has shown that these shocks, even when therapeutically delivered, may increase a person’s risk of death. An article in Heart Rhythm stated that a person receiving any shock from an ICD was at a 55% elevated risk of death, and attributed a portion of that risk to the damage done to the heart by the shock.
How Common a Defect?
Initial reports of the defect claimed that it was very rare, occurring in only 0.47% of leads, but imaging of patients with the leads shows much higher rates of exposed leads. One study showed 15% of leads were defective with exposed wires, while others have showed failure rates as high as 30%. Studies suggest that the failure rates increase over time.
A study in Heart Rhythm analyzing the FDA’s database of adverse events associated with medical devices showed that 22 deaths were known to be associated with shocks from St. Jude Medical leads, four times more than those associated with a competitor’s leads. Critics have accused St. Jude of trying to downplay the problem and said that doctors should have been given more warning about the defect.
St. Jude Medical defends its stance on the defective leads, claiming it has been open about its leads, and claiming that the apparent frequency of defects in their leads compared to competitors’ is because they are more open about reporting defects than competitors. St. Jude stopped selling these leads in 2010 and claim that its successor leads, called Durata, are free from the defect.
Compensation for Injury and Loss
If you have been hurt or lost a loved one due to a defective ICD lead manufactured by St. Jude or another manufacturer, you may be able to receive compensation. It is important for victims of this type of defect to step forward—your claim can help us understand the magnitude of the problem and determine whether St. Jude Medical and allied doctors are concealing the full extent of this problem.
To learn more about your legal rights and options, please contact a local defective products lawyer for more information.