Suit Targets Irvine Maker of Discontinued Heart Valve

Baxter Edwards, an artificial heart-valve maker headquartered in Irvine, has been hit with a $2.5-billion class-action suit by a New Orleans man whose 6-month-old heart valve is one of the models that Baxter Edwards discontinued in May because of malfunctions.

The company, a subsidiary of Baxter International, canceled production and sales of its primary line of mechanical heart valves, the Edwards Duromedics Aortic Bileaflet Valve Model 3160 and Mitral Bileaflet Valve Model 9160, after reports of six deaths attributed to malfunctions of these devices. About 20,000 of the valves have been used worldwide.

The company has requested physicians to carefully monitor the condition of patients who have already received one of the valves. Company officials have also asked that health care professionals return an estimated 6,000 valves that have not been used yet.

A Baxter Edwards spokesman said production was halted until the exact cause of the malfunctions can be determined.

Walter Schneggenburger, chief of the federal Food and Drug Administration’s Santa Ana office, said the FDA has received reports of 12 valves malfunctioning, resulting in six deaths.

In his suit filed Tuesday in New Orleans, Gene Earl Willett, 58, claims that news of the problems associated with the device has caused him much “stress and pain” and interrupted his daily life style. Willett received a Model 3160 valve during open-heart and triple bypass surgery in January. Although Willett is not claiming that his implant has malfunctioned, his attorney, David Oestreicher, said that “the prospect of secondary surgery frightens him enough.”

Oestreicher said that he finds it “inconceivable that both Edwards and the FDA were unaware of the difficulties posed by these products. They’ve been well aware of these problems for some time now.” The attorney said both organizations are “dragging their feet” and have not moved quickly enough to discover why some valves are malfunctioning.

“The heart valves are a ticking time bomb,” Oestreicher said. “More than 20,000 men, women and children depend upon these objects for their lives.”

Baxter Edwards and the FDA refused to comment on Willett’s suit or on Oestreicher’s allegations of negligence.

But Les Jacobson, a spokesman for Baxter International, said that it would be “premature” to believe that all of the valves are defective because of the “performance of six to 12. We aren’t sure exactly why those valves malfunctioned, but we’re going to find the exact cause,” Jacobson added.

He said he knows of no other heart-valve suits against Baxter Edwards.