The U.S. Supreme Court on Monday allowed a Philadelphia woman to sue Pfizer Inc. and its Irvine-based unit, Shiley Inc., over a heart valve that she had removed.
The court's decision is likely to prompt others to proceed with efforts to recover more than they could have received through a class-action settlement with the two companies, attorneys said.
The court, issuing its decision without comment, refused to consider the pharmaceutical giant's argument that Nina Michael of Philadelphia couldn't sue because federal regulators had approved Pfizer's marketing of the valve.
More than 80,000 of the valves were implanted worldwide between 1978 and 1986 before being pulled off the market. Hundreds of deaths have been linked to the failure of a tiny strut in the valve, attorneys said.
Pfizer and Shiley agreed to pay $215 million in damages three years ago to settle a class-action lawsuit, but Michael opted out of the settlement and filed her own lawsuit in 1993.
A brief filed by Pfizer in the Supreme Court case indicates at least 13 other similar cases are pending in state and federal courts around the country, including eight in California state courts. Five of the California cases involve plaintiffs, like Michael, whose valves hadn't malfunctioned but were surgically replaced.
Plaintiffs' lawyers said state and federal judges hearing related cases aren't required to heed the Supreme Court's decision, but they added that it bolsters these cases because the court didn't review Pfizer's key legal objection to the suits.
"Beautiful. You've made my day," Irvine attorney James Capretz said Monday when informed of the ruling. He represents five plaintiffs in cases against Pfizer and Shiley.
Morton Wapner, a Philadelphia lawyer who represents Michael, added that he'll press ahead with both Michael's case and another in New Jersey he had put on hold until the Supreme Court decided.
Her lawsuit initially was dismissed by a federal judge in Philadelphia. Last February, however, the 3rd U.S. Circuit Court of Appeals in Philadelphia reinstated Michael's claims that the defendants allegedly breached their product's warranty and made fraudulent claims of the product's benefit to the medical community. Another Pfizer unit, Hospital Products Group Inc., is also named as a defendant.
In a related action, Shiley and Pfizer agreed last year to pay the federal government $10.75 million to settle accusations that they made false claims about the valves Shiley made from 1979 to 1986. Shiley did not admit wrongdoing.
In 1992, Pfizer's Shiley division sold most of its heart-valve manufacturing operations to Sorin Bio-Medical Inc., an Irvine unit of Fiat SpA of Turin, Italy. Shiley now employs fewer than 40 workers, who handle claims of heart-valve litigants and related activities, according to a Pfizer spokesman.