Canadian Sues Over Heart Valve

Shiley Inc. of Irvine was sued for product liability and negligence Thursday by a Canadian man who claims that a heart valve made by the firm fractured in his body 11 months ago and nearly killed him.

Shiley announced earlier this month that it is conducting a worldwide recall of the valve and two others like it because of a mechanical defect that has caused 14 deaths since 1982.

Bob Curtis, president of Shiley, declined to comment on the suit Thursday.

A number of suits have been filed against Shiley alleging damage from failed heart valves. Curtis said he did not know how many suits have been filed but that 21 valves manufactured by the pharmaceutical firm between March and June of 1982 have fractured and caused “approximately 14 deaths.”

Most Recent Suit

The most recent civil suit was filed Thursday in Orange County Superior Court by an Irvine law firm representing Glen Wallace, 27, of Ontario.

Wallace, whose own heart valve was destroyed in a 1977 car accident, underwent three open-heart surgeries before a 29-millimeter Bjork-Shiley 60-degree Convexo-Concave heart valve was surgically implanted on Sept. 8, 1982, his attorneys said.

On the morning of Nov. 15, 1984, Wallace awoke with chest pains and breathing difficulty and “nearly died” en route to a hospital, Vance Simonds, one of his attorneys, said Friday.

In his suit, Wallace claims he suffered shock and “massive pulmonary edema” when the valve broke. Another artificial valve, made by a different manufacturer, was implanted to replace the Shiley device in Wallace’s fifth open-heart surgery. During that operation, the suit states, part of the faulty valve that broke off and traveled to his stomach was removed; another part of the device remains lodged in an artery near his hip.

Third Recall

Wallace’s suit alleges that Shiley knew its valve was “defective” and “unsafe” at the time it was sold.

The most recent Shiley recall is the third since the company, a division of Pfizer Inc., opened in 1969. Similar valves were recalled in 1975 and 1983.

Shiley agreed to recall its 29-, 31- and 33-millimeter valves after negotiations with the U.S. Food and Drug Administration earlier this month.

Wallace’s valve was recalled, but not until July of 1983, about 10 months after it was implanted.

He is seeking general, punitive and exemplary damages, but his suit mentions no sums.