St. Jude Medical put aside $15 million to privately settle about 950 claims and other disputes over its Riata and Riata ST leads, the company reported in a filing with the Securities and Exchange Commission.
The company announced in its Feb. 26 10-K report that it had entered into an agreement for filed and unfiled claims with representatives of patients who were implanted with Riata and Riata ST silicone defibrillation leads as well as claimants who had not yet started litigation. The FDA recalled 8 French and 7 French Riata implantable cardioverter-defibrillator leads in 2011 because of insulation defects leading to externalization of conductors.
According to the filing, some patients filing claims alleged injuries from the revision or removal of leads as well as other complications. It claimed most cited no specific injuries. Of those who sought recovery for implantation or removal of leads, most wanted compensatory damages as well as other demands. It added that “several” sought punitive damages.
St. Jude Medical reported that it entered into the settlement on Dec. 17, 2014 and that it had set aside a $15 million fund in the fourth quarter of 2014 to cover approximately 950 claims. Eligible claimants have until March 16 to release their claims and participate in the settlement.
It added that it believed the settlement fund was sufficient but it “is not able to estimate a possible loss or range of loss at this time.”