St. Jude Medical Inc. has agreed to pay up to $14.25 million to settle about 950 claims from patients that their Riata defibrillator leads were prematurely degrading.
St. Jude, a global heart-device maker based in Little Canada, pulled its Riata and Riata ST silicone-only leads off the market in 2010 after reports of defects surfaced. More than 227,000 Riata leads had been distributed worldwide at the time, though many were removed in follow-up surgeries.
Leads are thin wires that carry electric shocks from an implanted defibrillator to restore normal heart rhythm.
The U.S. Food and Drug Administration said in 2011 that such leads are supposed to last for at least a decade, but the insulation protecting some Riata leads was degrading in as little as four years.
Degraded insulation can cause the defibrillator to deliver inappropriate shocks or no shocks, resulting in serious adverse events, including death.
St. Jude disclosed in 2011 that it had reports of two patient deaths and one serious injury related to the malfunctioning Riata leads.
Hundreds of legal claims were filed and threatened to be filed by patients.
On Thursday, the company announced in a securities filing that on Dec. 17 it resolved the claims that stemmed from 70 lawsuits, many representing multiple plaintiffs. Three lawsuits in the United States and one class-action case in Canada remain pending.
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