MIAMI -- A class-action lawsuit filed Monday accused the Pfizer Inc., the medical products giant, of knowingly distributing defective heart valves, alleging the flawed implants caused up to 350 deaths in the last 12 years.
The suit, filed in U.S. District Court in Miami, names Pfizer and two of its subsidiaries, Pfizer Hospital Products Group Inc. of New York City and Shiley Inc. of Irvine, Calif.
The suit said the outflow strut on the metal alloy valves was prone to fracture, enabling blood to flow unimpeded and causing heart failure.
Ervin Gonzalez, attorney for the plaintiffs, said nearly 55,000 of the valves were implanted until the Food and Drug Administration forced their removal from the market in the mid-1980s.
Of those, 450 valve failures were reported worldwide, leading to the deaths of 350, Gonzalez said.
The suit was filed on behalf of Florida residents who received either of two heart valves manufactured by Shiley between 1979 and 1983. The attorney said there could be as many as 1,000 such people in Florida.
The suit did not specify a dollar amount for damage payments sought. But Gonzalez said damages could run into the hundreds of thousands of dollars for each plaintiff.
Pfizer bought Shiley in March 1979.
One of the heart valves in question, the Bjork-Shiley Convexo-Concave valve, was developed by Shiley in 1976 and introduced to the market in April 1979.
The suit alleges the FDA approved it even though the outflow strut had fractured during tests and clinical trials.
'There were repeated failures in the lab. Shiley was aware of this and was told this and the executives decided to market the valves anyway,' Gonzalez said.
Pfizer and Shiley distributed the first version of the valve until the FDA forced them to recall the valves from the market in 1986.
In 1980, the suit said, a second version of the Bjork-Shiley valve was designed, manufactured and distributed by Pfizer and Shiley to other countries.
The second valve never received FDA approval for marketing in the United States, and the FDA withdrew export approval in 1983, the suit said.
The suit alleges that Pfizer and Shiley did nothing to insure the safety of the potential recipients and never adequately attempted to notify recipients of either version about the problems.
'The tragic aspect of this situation is that the operation to fit the valve is practically irreversible,' Gonzalez said.
'It's impossible to determine whether or not a valve will fracture until it occurs, but the operation to replace the valve is considered too dangerous to be worth the risk.'
While he had not seen the lawsuit, a Pfizer spokesman said it appeared to be similar to one filed by the same attorneys in January in federal court in Los Angeles.
In that case, the judge denied the plaintiffs' request to certify a worldwide class on behalf of valve recipients and their spouses, said the spokesman, Tony Biesada.
'When Pfizer and Shiley advised the (Los Angeles) federal judge that they would file a motion for summary judgment to dismiss the complaint, the plaintiffs asked for permission to discontinue the action in order to re-file their claims in state court.
'In the Florida case, it appears the class is limited to Florida residents rather than worldwide,' Biesada said.
He said Pfizer had not been notified of any other class-action suits representing heart valve recipients in other states.
