A motion to dismiss five cases alleging that manufacturing defects caused St. Jude Medical’s Riata defibrillator leads to fail was denied last month by Federal Judge James V. Selna. Selna ruled that the plaintiffs had met the burden of showing a plausible connection between their injuries and the alleged defective St. Jude defibrillator leads and also wrote that federal law did not preempt their claims.
St. Jude Medical recalled Riata and Riata ST leads In November 2011. The leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor and, if necessary, correct heart rhythms. The leads were recalled because of premature erosion of the insulation around the electrical conductor wires. This is a Class I recall, which the FDA reserves for situations in which there is a reasonable probability that the device will cause serious adverse health consequences or death.
The Food and Drug Administration (FDA) explains that insulation failure may cause the ICD lead to malfunction, causing abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death. Lawsuits brought against St. Jude Medical allege that the defective leads caused painful and unnecessary shocks or failed to provide a necessary shock, and, further, that some patients needed additional surgery to remove or repair defective leads. Reports to St. Jude Medical associated with the removal of a Riata lead include two patient deaths and one serious injury.
According to the FDA, approximately 79,000 Riata leads remained implanted in patients in the United States, and the agency has expressed concern that “Riata and Riata ST leads that show insulation abnormalities on imaging may be at greater risk of future electrical failure.”
The affected model numbers are 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).