As reported by Cardiovascular Business, California Federal Judge James V. Selna earlier this year denied St. Jude’s motion to dismiss five cases in which manufacturing defects that caused their Riata leads to fail were alleged. According to the judge, plaintiffs had met their burden of showing a plausible association between the injuries alleged and the allegedly defective St. Jude leads. He also found that the claims were not preempted by federal law. Preemption is a legal concept that a number of medical device makers have used in liability lawsuits that have been filed over devices that have received FDA approval.
Riata and Riata ST ICD leads are prone to high-voltage failures, which appear to be caused by insulation defects that lead to short circuits between high-voltage components. A phenomenon known as “externalized conductors” occurs when conductor cables wear through the silicone insulation from inside out, ending up outside the lead’s body. According to the American College of Cardiology research, inappropriate shocks were common and high voltage cable insulation abrasion also occurred. JACC concluded that Riata leads may have more widespread damage than can be detected by fluoroscopic exam.