St. Jude Medical Inc. now faces lawsuits against its Riata® and Riata ST® silicone-coated defibrillator leads. In November 2011, St. Jude recalled the Riata family’s leads because abrasion often caused the silicon coating on the lead wires to prematurely erode. This “insulation failure” resulted in serious problems for the patients, including device malfunction, short circuiting, and death.
St. Jude Riata Leads
The recalled Riata lead connects a patient’s heart to an implantable cardioverter defibrillator (ICD) device. The integrated system is inserted into a patient’s heart to monitor the activity there. If the ICD detects abnormal rhythms, it sends an electric shock through the lead into the heart to restore normal activity. Insulation covers the lead and protects the conducting wires.
However, the Riata lead is prone to premature insulation erosion, which causes the exposure of the wires or their migration inside the device. This insulation failure results in complications, such as:
- Delivery of inappropriate shocks
- Abnormal sensing or pacing
- Complete failure of shock feature
- The need for surgical removal and replacement
Globally, St. Jude has sold more than 227,000 Riata leads, and an estimated 79,000 are still implanted in U.S. patients as of 2011. The lead failure rate is potentially as high as thirty-three percent, according to one third-party study.
St. Jude Lead Recall: What You Need to Know
An ICD lead has an average lifespan of 10 years — the Riata defibrilator demonstrated failures within four years of implantation. St. Jude knew there was the potential for Riata lead insulation failure — but it continued to sell the product. In 2010, St. Jude warned doctors in a letter about the potential for Riata lead insulation failure. On Nov. 28, 2011, it recalled Riata leads, but many thousands of the leads were already implanted in patients.
The Riata warranty stipulates that doctors must replace the Riata leads with a newer-generation St. Jude lead, called the Durata®. However, the Durata leads have a design similar to those of the Riata. There is some evidence that Durata leads may pose risks and complications similar to Riata. The Durata is being closely watched by the U.S. Food and Drug Administration.
But there are other problems for patients who want to surgically remove defective Riata leads. Often, the lead binds with scar tissue on the walls of veins and the heart. To free the lead, doctors must slide a sheath over the wires and scrape the scar tissue away. This procedure may result in tearing of the heart wall due to embedment or wire fraying which may leave tiny pieces of lead wire in the vein. It may also result in a patient dying during the surgical removal process.
File a Riata Lawsuit Today
If you or a loved one suffered an injury because of a St. Jude Riata or Riata ST lead, you may be entitled to compensation. Contact a medical device lawyer today for a free legal consultation and to see if a Riata lead lawsuit is appropriate for you. Sokolove Law has more than 40 years of experience helping those who have been harmed by dangerous medical devices. Our attorneys know who to talk to, where to find answers, and what steps you need to take.