Medical-device maker St. Jude Medical expects to pay about $14.5 million to settle litigation over a discontinued product linked to 22 patient deaths.
The settlement involves Riata-brand wires that connect an implanted defibrillator to the heart. A defibrillator delivers an electric shock to jolt a stopped or erratically beating heart back to its normal rhythm.
St. Jude stopped selling the connectors in late 2010, amid reports wire was breaking through protective insulation, causing malfunctions. The defect can lead to inappropriate shock — or a failure to provide a life-saving jolt of electricity when a patient's heart stops.
"St. Jude Medical has entered into an agreement to settle a majority of our known U.S. lawsuits and claims related to Riata," company spokeswoman Candace Steele Flippin said. "We have resolved approximately 950 cases."
St. Jude admitted no liability and disputes that the wires were at fault.
The company said patient safety is its highest priority and it monitors the Riata leads that are still implanted in about 90,000 patients. The federal Food and Drug Administration doesn't recommend replacement of leads functioning normally.
In the litigation to date, less than one percent of claims involved patient deaths related to Riata, according to the company. That includes claims related to surgeries to remove the leads. St. Jude Medical contends those claims are not device related.