Heart Patient Sues Shiley, Claims Fraud : Courts: The man says that his valve, removed in October, had begun to break. Shiley officials said they have not seen the suit and could not comment.

A New Jersey man whose Shiley heart valve was removed six months ago filed suit against the manufacturer Thursday after learning that the device had already begun to fracture at the time of his surgery.

Stuart John Davis, 35, of Pennsville, N.J., filed suit in U.S. District Court in Los Angeles against Shiley Inc. of Irvine and its parent company, Pfizer Inc. of New York. The suit also names Grindley Manufacturing Inc., which built some of the valve parts.

The suit, which seeks unspecified damages, claims that Davis was living in “clear and present danger” before the surgery to remove the device and could have died had it not been removed. It accuses Shiley of negligence and fraud and claims that Davis has suffered severe emotional distress.

Researchers who studied the valve removed from Davis’ chest in October told him 12 days ago that a strut holding the device together had broken before the operation, Davis said in a telephone interview from his home.

The lawsuit contends that the valve “could have severely injured or killed” Davis “at any moment had it not been replaced in open-heart surgery.”

When he was told of the fracture, Davis said: “I was in shock. I always had this gut feeling that something was wrong. . . . When you are told something was wrong and what could happen, you just thank God for being with you.”

Shiley officials said they had not seen the suit and that they normally do not comment on individual cases.

Davis, who suffers from a congenital heart disease, had a Bjork-Shiley convexo-concave heart valve implanted in 1982. The U.S. Food and Drug Administration has since received reports of 350 fractures among 82,000 valves implanted in people worldwide.

The valves were taken off the market in 1986, but not before there were several hundred deaths reported and hundreds of lawsuits filed against Shiley, accusing the company either of wrongful death or injury, or the emotional distress accompanying the fear that a valve would break.

Earlier this month, the FDA asked Shiley to inform doctors and patients that some of its heart valves are more likely to break than was previously thought. The FDA said that the risk of valve failure may be great enough that patients might want to consider taking the risk of open-heart surgery to replace the artificial valves.

Shiley officials continue to maintain that there is a greater risk in replacing the valve during open-heart surgery than in leaving it in place.

“There is a mortality rate in the operation,” Davis said, “but I thought: ‘You have to weigh the risks in the long term.’ I wasn’t willing to live with that. I wanted it out.”

Davis, an insurance salesman, said that he spent about $70,000 on the October surgery and on other costs of being hospitalized. His insurance company refused to pay, he said, and he had to take out a loan to cover the medical costs and other expenses.

“I have been financially ruined,” Davis said. “It has financially devastated myself and my family.”

The suit was filed by the Irvine law firm of Capretz & Kasdan, which has more than 200 suits pending by heart valve recipients seeking damages for emotional distress, although those recipients’ valves have apparently not fractured.

The law firm also filed a suit Thursday in U.S. District Court in Los Angeles on behalf of Yvette E. Lemire, who survived emergency open-heart surgery when her valve fractured on last May.