Producer of Heart Valves Hit by 79 Suits

Shiley Inc., a medical products manufacturer in Irvine, is the target of 79 new lawsuits filed on behalf of patients who received a type of mechanical heart valve that the company once made.

The lawsuits, filed Friday in Orange County Superior Court on behalf of patients who received Bjork-Shiley convexo-concave valves, claim that the implants were defective and have caused serious injuries and deaths. The company, which introduced the valves in 1979, stopped making them in October, 1986, following reports of malfunctions.

Shiley officials could not be reached for comment Monday. Neither could Joseph Dunn, a Newport Beach lawyer who filed the 79 suits.

According to the lawsuits, more than 80,000 valves implanted to date have broken. The Food & Drug Administration has said that more than 100 deaths have resulted.

Before last week’s filings, Shiley already had been hit with more than 200 lawsuits brought by patients who received the valves or their families. Of those lawsuits, 30 to 40 have resulted in out-of-court settlements, according to the Public Citizens Health Research Group, which since 1984 has acted as a clearinghouse for plaintiff attorneys doing battle with Shiley.

Shiley was founded as a heart valve manufacturing firm in 1966 and is a subsidiary of Pfizer Inc., a New York pharmaceutical firm. The parent company also is named as a defendant in the 79 new suits.

Shiley no longer sells any heart valves in the United States. It discontinued its line of spherical disk heart valves--the last model it sold in America--in December. A month earlier, it stopped manufacturing and distributing organic tissue heart valves both in the United States and abroad.

Although the company is seeking government approval to begin selling a new mechanical valve in the United States, some industry analysts have predicted that Shiley will find it difficult to recapture its lost market share.