A federal judge ruled that five product liability claims against St. Jude Medical over its Riata defibrillator leads can move forward.
Judge James V. Selna of the U.S. District Court for Central California denied a motion by St. Paul, Minn.-based St. Jude to dismiss five cases involving patients implanted with Riata leads that claimed the manufacturer failed to warn of problems with the leads. The judge previously had allowed claims of injuries and defects to move forward but ruled the plaintiffs did not sufficiently argue the failure-to-warn claims.
Selna recently determined the previous deficiencies had been addressed and denied St. Jude’s motion to dismiss. The judge also granted some motions to strike and denied others.
In 2011, the FDA issued a Class 1 recall of Riata and Riata ST silicone defibrillation leads due to the potential risk of serious injury or death if affected devices malfunction. The recall affected Riata (8Fr) models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592; and Riata ST (7Fr) models 7000, 7001, 7002, 7010, 7011, 7040, 7041 and 7042.
The recall also raised concerns about St. Jude’s Durata leads, which share some design features with the Riata leads but have a proprietary Optim coating designed to prevent insulation abrasion. The FDA is requiring St. Jude to conduct three-year post-market surveillance studies on its Riata and Riata ST leads, as well as its QuickFlex LV CRT leads, QuickSite LV CRT leads, Riata ST Optim and Durata implantable cardioverter-defibrillator leads.