A federal judge has approved the settlement of a class-action lawsuit in which the makers of an allegedly defective artificial heart valve agreed to pay up to $215-million in damages.
The lawsuit was filed on behalf of 51,000 recipients of the Bjork-Shiley Convexco-Concave Valve. It alleged that New York-based Pfizer Inc. and its subsidiary, Shiley Inc., knew heart valves sold from 1979 to 1986 could fracture, possibly causing death.
William Steere Jr., Pfizer's chairman and chief executive officer, said the company still believed complaints about the valve lack merit but agreed to the settlement to end the court battle.
"Our primary concern has always been and will continue to be with the welfare of people with Shiley C-C heart valves," Steere said in a statement.
Cincinnati lawyer Stan Chesley, who negotiated for the valve recipients, said Wednesday the plaintiffs were pleased. "We think this is an important precedent for how future mass litigation will be resolved," he said.
Pfizer said the valve was implanted in nearly 86,000 people worldwide. It had been blamed for about 300 deaths that resulted from strut fracture, or the breakage of a wire that makes a disk inside the valve open and close.
Under the settlement approved by U.S. District Judge Arthur Spiegel, Pfizer must provide $75-million for any needed valve replacement surgeries and for research to identify recipients of valves that may be at risk of fracturing.
Each valve recipient also will receive a minimum payment of $2,500 from the fund.
Pfizer will pay $90-million to $140-million for recipients' medical consultations.
The settlement also guarantees an immediate cash payment to a recipient if the heart valve fractures. The amount will be based on the recipient's income, marital status and number of dependents.