Shiley Agrees to Settle Heart Valve Suit a Week Before Scheduled Trial

One week before trial, Shiley Inc. of Irvine settled a $2-million claim of a man whose artificial heart valve broke apart inside his chest.

Glen Wallace was “moribund” when doctors revived him and replaced the device, marketed as the Bjork-Shiley convexo-concave heart valve, but not before he had suffered severe physical and emotional damage, according to his lawsuit.

The terms of the settlement were not disclosed. Wallace, 29, was “very satisfied” with the result, his lawyer, Vance C. Simonds Jr., said.

Shiley attorney Frank C. Rothrock confirmed the settlement but declined to discuss any terms.

The firm ended all production of the convexo-concave valves last November. The valve has been blamed for at least 125 deaths, according to the Food and Drug Administration.

Makes 3 Other Valves

“The valves have saved and prolonged thousands of lives,” said Rothrock. “Shiley continues to make three other types of heart valves.”

Wallace lives in Oshawa, Ontario, a suburb of Toronto. His heart was permanently damaged in an auto accident in 1977. The open-heart surgery needed to implant the Shiley valve was the fourth Wallace had undergone, Simonds said.

Two years after the implant, in 1982, a metal valve strut broke while Wallace slept.

“He wakes up and what he feels is the equivalent of an anvil on his chest. He knows that something’s wrong, but he doesn’t know what it is,” Simonds said.

Wallace was taken to a local hospital. Doctors decided to send him to specialists at another hospital in Toronto. Bad weather paralyzed helicopter flights, so Wallace made the trip by ambulance.

“He’s got this enormous pressure on his chest because the blood isn’t passing from one (heart) chamber to the other; it’s backing up,” Simonds said. “He was described as moribund on arrival--which is as close to death without death as you can possibly be.”

“So for three hours, this guy is wondering if this breath is gonna be his last. I can’t imagine greater torture for anyone to go through than not knowing whether you’re going to survive the next minute,” Simonds said.

Wallace suffered a mild stroke from reduced flow of blood, short-term memory loss, an inability to concentrate and what Simonds called “loss of life”--undetermined damage to his life expectancy.

Severe emotional damage resulted as well. Wallace was depressed amd suicidal, Simonds said.

The Bjork-Shiley 60- and 70-degree convexo-concave valves were used to replace a human heart valve that has been damaged or diseased.

Welded Strut Blamed

The valve has a tilting disc that opens and closes to control the flow of blood. Two metal struts hold the disc in place, one made from the same piece of metal as the ring of the valve, the other welded on.

The welded strut is alleged to be the “culprit,” according to Simonds. The strut has sometimes fractured where it is welded, and that’s allegedly what happened to Wallace.

When the strut cracks or breaks, the disc usually floats free and the valve stops working. The metal strut from the Shiley valve remains in Wallace’s hip, where it traveled after breaking loose. It will not be removed, Simonds said.

Wallace is now living with his parents, who were described by Simonds as “working class.”

“He’d like to start his own business, settle down and start a family,” Simonds said.