Last month, the U.S. Food and Drug Administration (FDA) posted a statement concerning people with implanted St. Jude Riata or Riata ST Silicone Endocardial Defibrillation Leads. Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. ICD’s can detect life-threatening heart rhythms and deliver an electrical shock from the ICD through the lead to the heart. ICD leads typically have layers of insulation to protect electrical conductor wires inside the lead.
Riata’s manufacturer, St. Jude Medical, Inc., recalled these leads on November 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure, or externalization. St. Jude Medical stopped selling these leads in late 2010 but more than 227,000 Riata leads had already been distributed worldwide. According to St. Jude Medical, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the U.S.
Many factors contribute to the lifespan of an ICD lead, including the age and activity level of the patient. On average, an ICD lead is expected to last more than ten years. The FDA is aware of an increase in reported Riata insulation failures, beginning approximately four years after implantation. Insulation failure may cause some of the electrical conductors inside Riata leads to move within (migrate), or move entirely outside (externalize), the outer lead insulation. These changes may be detectable on X-rays or fluoroscopic imaging.
Lead insulation failure may cause the ICD lead to malfunction. ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or lack of any shock therapy, which could result in serious adverse events, including death.
The recalled model numbers include the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
In addition to the FDA Safety Communication for Riata and Riata ST Silicone Endocardial Defibrillation Leads, the agency also required St. Jude Medical to conduct post-market surveillance studies on QuickFlex LV CRT leads, QuickSite LV CRT leads, Riata ST Optim and Durata ICD leads.
St. Jude Medical voluntarily recalled and stopped selling its QuickSite and QuickFlex LV CRT Leads on April 3, 2012. The FDA classified this as a Class II recall.
On January 9, 2014, Federal Judge James V. Selna denied St. Jude’s Motion to Dismiss five cases alleging manufacturing defects causing St. Jude Riata Leads to fail. The Honorable James V. Selna ruled in the case of In Re St. Jude Medical Device Litigation, SACV 13-393 JVS (AN) that Plaintiffs had met their burden of showing a plausible connection between the injuries they suffered and the alleged defective St. Jude leads under the Twombly/lqbal pleading standard. Judge Selna also held that Plaintiffs stated claims parallel to federal requirements or premised upon violations of FDA regulations, and were therefore not preempted by federal law.
For more information about defective St. Jude Medical Riata or Riata ST defibrillators, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).