A California federal judge ruled that Riata Lead cases not subject to preemption. A California federal judge just ruled that Riata Lead cases are not subject to preemption; the judge’s order also denies St. Jude’s motion to dismiss. California federal Judge James V. Selna 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, those who brought the case had met their burden of showing a plausible association between the injuries alleged and the allegedly defective St. Jude leads. As for preemption, Judge Selna found that the claims were not preempted by federal law.
Preemption is legal concept that a number of medical device makers have used in liability lawsuits that have been filed over devices that have received U.S. Food and Drug Administration (FDA) approval.
Following reports of defects, high failure rates, and mounting lawsuits
Following reports of defects, high failure rates, and mounting lawsuits, the St. Jude Medical, Inc. Riata Lead was recalled on December 14, 2011 in what the FDA deemed a Class I recall, its most serious designation and involving a situation in which there exists a reasonable probability that the use of, or exposure to, the product being recalled will cause serious adverse health consequences or death.
That recall involved the Riata and the Riata ST Silicone Defibrillation Leads. The Class I recall designation followed an updated a November 28, 2011 Physician Advisory Letter.
At the time of the recall designation, some 79,000 Riata leads and leads in the Riata ST family of silicone leads are actively implanted in United States patients. St. Jude stopped distributing the Riata and Riata ST family of silicone leads in December 2010.
Affected model numbers are: 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).
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. The conductor cables wear through the silicone insulation from inside out, ending up outside the lead’s body, a phenomenon known as “externalized conducters.” Typically, it is the electrical malfunctions that result in death, according to the American College of Cardiology.
As indicated in the Physician Advisory Letter
As indicated in the Physician Advisory Letter, clinical implications of externalized conductors in a Riata defibrillation lead with no electrical anomalies are not fully understood or known.
These externalized conductors may simply appear as a visual observation on an X-ray or fluoroscopy with no related clinical or device-related observations. If the lead’s electrical integrity is compromised, the lead may not deliver appropriate therapy or may deliver inappropriate therapy, which may lead to a serious adverse event or death.
Reports to St. Jude Medical tied to removal of a Riata lead with externalized conductors led to two patient deaths and a serious injury known as effusion requiring thoracotomy. Another patient death and another serious injuries were reported in patients with externalized conductors, but were found not to be due to externalized conductors.
In another case cited by The Wall Street Journal, a 55-year-old woman alleged she received a number of shocks in a 25-minute period while laying on her bed. She underwent surgery to have the faulty lead removed and her physicians said the explanted Riata revealed faulty wiring.