Riata® Heart Lead Failure
You have had heart surgery, and had a defibrillator implanted five years ago. While watching your son play football, suddenly you feel a jolt in your chest. Then you feel it again, and the third jolt knocks you unconscious. This is exactly what happened to high school football coach Greg Jessee, in October 2011 as profiled in a 2012 article in the New York Times.
Connecting the defibrillator to Mr. Jessee’s heart were leads, or wires, manufactured by St. Jude Medical, Inc. headquartered in St. Paul, Minnesota. These leads marketed under the brand names Riata, and Riata ST, have recently come under scrutiny of the U.S. Food and Drug Administration (FDA) and others, due to premature failure of the leads. In Mr. Jessee’s case, the insulation surrounding the conductors had eroded, or worn off, allowing the conductors to migrate, externalizing the bare wires to internal tissue.
In another case, Robert Loiseau, of Southampton, Pennsylvania, was required in 2012, to replace leads implanted in 2007, requiring invasive chest surgery. During surgery, doctors found that the leads had fractured and would not have been functional if his heart had required it. By this time, St. Jude had discontinued marketing the defective heart leads in 2010, and the FDA had recalled them in 2011. He has now retained attorneys and is suing St. Jude Medical, Inc. for failure to warn of the dangers of the product.
Due to the location of these leads, and the fact that they carry electrical current from an implantable cardioverter defibrillator (ICD), usually mounted in soft tissue beneath the collar bone, into the heart cavity, it requires invasive surgery to remove and replace.
The probability of failure of this product increases the longer the leads are installed. Doctors have been asked by the FDA to contact any patient that has had the Riata product installed. Lawsuits against Riata ICD lead manufacturer, St. Jude Medical, Inc., are mounting. If you had an Implantable Cardioverter Defibrillator (ICD) installed we would be interested in speaking with you to determine if you have a potential case. Please call our firm at (702) 444-4444, or complete our online Free Consultation Form.
History of Riata Products
St. Jude Medical, began marketing the Riata model lead in 2002, and in 2005 introduced the Riata ST. By the time the company stopped marketing the leads in 2010, about 227,000 units had been sold worldwide. It is estimated that approximately 80,000 are still in use in the United States.
It has been reported that doctors began communicating insulation erosion to St. Jude, as early as 2006. In spite of the reports, St. Jude tracked the product’s failures for several years, while continuing to market them.
Media and Regulatory Attention
The FDA expects ICD leads to last at least 10 years before failure. In the case of these products, the FDA has tracked significant failure rates in as little as 4 years after implantation.
In 2010, St. Jude Medical sent a letter to doctors advising them that the silicone insulation of the Riata leads could erode, allowing the wires to protrude or externalize. This lead malfunction in itself could cause abnormal sensing, or pacing of the ICD, causing it to either deliver too much current, or no shock at all, circumstances that can cause serious adverse events, including death.
Then in 2011, St. Jude sent another letter to doctors, which the FDA treated as a Class 1 recall, which is their most stringent product recall, and has issued recommendations under which leads should be extracted and replaced.
In March 2012, an article appeared in the journal, Heart Rhythm, looked at the FDA Manufacturers and User Facility Device Experience database, and reported at minimum 22 deaths related to malfunctioning Riata leads.
A study performed by the Department of Clinical Electrophysiology at the Erasmus Medical Center in the Netherlands, reviewed all patients who had the products implanted at the Center. Their findings were published on the National Center for Biotechnology Information (NCBI) website. This study also confirmed high failure rate associated with the Riata family of ICD leads.
Riata® and Riata ST® are registered trademarks of St. Jude Medical, Inc., and are used here only to identify the product in question.
This law firm is not associated with, sponsored by, or affiliated with the St. Jude Medical, Inc., or the U. S. Food and Drug Administration (FDA)