Shiley to Compensate Spouses of Valve Patients : Medicine: The maker of the discontinued heart device sets aside $10 million to offset emotional distress.
Shiley Inc., manufacturer of a potentially defective heart valve, has agreed to set up a $10-million fund to compensate spouses of recipients of the device, the company and a plaintiff’s attorney said Friday.
The new fund, added recently to a proposed settlement awaiting approval by a federal judge in Cincinnati, is designed to compensate husbands and wives of valve recipients and can be used at their discretion, said Robert Fauteux, a spokesman for Shiley Inc. in Irvine.
“It’s another fund that we have set aside, along with a fund for valve recipients, so that we can relieve any of their concerns,” Fauteux said.
About 55,000 patients worldwide have had Shiley’s convexo-concave valves implanted, and the valves have fractured in more than 350 recipients. The fractures--in which a strut holding the device together pulls apart--have caused about 250 deaths. Hundreds of patients with working valves--as well their spouses--have sued Shiley and its parent company, Pfizer Inc. of New York, alleging emotional distress because of anxiety about the device’s safety. Shiley stopped selling the valves in 1986.
U.S. District Judge S. Arthur Spiegel is reviewing the two companies’ offer to pay $75 million for research and valve replacement surgery, and another $80 million to $130 million for physician consultations and anxiety-related medical expenses. Another $300 million would be set aside for patient or survivor claims.
Until recently, however, the offer did not include a fund for spouses. The amount given to each spouse will be based on how many decide to join the settlement offer, said James Capretz, an Irvine lawyer representing 314 valve recipients and 207 spouses. He said one estimate placed it at $1,000 for each spouse.
The spouses’ lives have been changed, Capretz said. “In many cases, the implantees won’t travel anywhere. Their outlook on life is different. That has an impact on a spouse’s life.”
The lawsuits filed by Capretz’s clients are expected to come to trial in Orange County Superior Court in Santa Ana later this year unless the recipients decide to accept the offer. Capretz said he doubts that 24 of his clients who are California residents will drop their emotional-distress suits, even if the settlement offer is approved.
His other clients, including 235 in other states and 55 outside the United States, could be limited by a recent state Supreme Court decision. In June, the justices let stand a lower court ruling that out-of-state residents could be prevented from pursuing their cases in California.
