The first St. Jude Riata bellwether trial is scheduled for February 3, 2015, according to court documents. The patients chosen for the case allege that the Riata defibrillator leads are defective.
In one case, a patient died and the others allege injuries following a heart procedure that was allegedly caused by the Riata’s defects. A Scheduling Order filed on January 24, 2014 in the U.S. District Court for the Central District of California, Southern Division indicates the plaintiffs chosen for the bellwether cases; a pre-trial conference date is set for January 12, 2015 and discovery will remain open until October 21, 2014.
According to a Joint Status Conference report dated February 24, 2014, the St. Jude Riata defibrillator leads are allegedly defective due to their tendency to fracture and malfunction. In fact, the Riata Implantable Cardioverter Defibrillator (ICD) Lead was recalled on November 28, 2011 over premature erosion of the insulation that surrounds the electrical conductor wires. This is known as insulation failure. Also, according to a U.S. Food and Drug Administration (FDA) Safety Communication, the Riata devices deliver an electrical current to an implanted cardiac defibrillator. If the lead fails, serious consequences may occur.
The plaintiffs chosen for the bellwether include a man implanted with the Riata lead in 2004. In 2012, his doctor advised him that the wire was failing and that the device lead required replacement. The lead was removed through a laser abstraction on June 18, 2012. The patient alleges that he suffered injuries due to the defective lead, such as damages associated with multiple fluoroscopy procedures, extrusion of the conductor, compromised lead insulation, increased lead impedance, and electrical abnormalities.
The other case involves a woman bringing the suit on behalf of her now-deceased husband who received a Riata lead on December 13, 2005. The man suffered cardiopulmonary arrest and died on September 6, 2011. The injury and death have been alleged due to the failure of his Riata lead. After he died, the Riata lead was found to be abraded; the abrasion is being blamed on his death.
The FDA Safety Communication indicates that, according to St. Jude Medical, as of 2011, some 79,000 Riata leads remained implanted in United States patients.
The Riata was removed from the market in 2010 following reports of defects and high failure rates, which, as well as emerging lawsuits, allege that the Riata’s conductive ends break free. When this happens, the device either delivers excessive shocks, insufficient shocks, or shocks at the wrong time. The problem stems from the Riata’s exposed ends, which have been linked with internal injury reports that include reports of lacerations. An inferior Riata lead housing was blamed for many of the reported defects and was ultimately changed to a silicone material, called Optim, and released as the Durata lead.
In one case cited in a prior The Wall Street Journal report, a 55-year-old plaintiff said she received a number of shocks in a 25-minute period while she was laying on her bed. She underwent surgery to have the faulty lead removed and her physicians said the explanted Riata revealed faulty wiring.