The Fear That a Heart Valve Will Break Prompts Unusual Kind of Suits : Health: About 400 patients sue Irvine’s Shiley Inc. not because their life-sustaining devices failed, but because of anxiety that they will.

The artificial heart valve clicks 60 times a minute. Some patients find the mechanical heartbeat soothing--audible proof that their lifesaving valve is working.

But to John Civatte, who was implanted with a potentially defective Shiley heart valve in 1986--just nine months before the manufacturer pulled the device from the market--the ticking sounds like a time bomb.

“Imagine if you had a piece of dynamite strapped to your chest, you didn’t know how long the fuse was, and you didn’t know if the fuse was lit,” the 31-year-old salesman said. “Could you be comfortable?”

Bill Wallace said he has nightmares in which his valve stops ticking. Wallace, 40, of Chino, said he began having anxiety attacks last summer after his cardiologist called to inform him that his valve was the type that has been blamed for more than 250 deaths.

The good news, said the cardiologist, was that the risk of his valve breaking was tiny--less than 1% per year, according to the manufacturer, Shiley Inc. of Irvine. The bad news was that two-thirds of such fractures are fatal.

Wallace’s wife asked the doctor if there were any early-warning symptoms.

“Unfortunately, there aren’t,” the doctor said. “The only symptom is instant death.”

Civatte and Wallace are among about 400 people with Shiley valves who are suing the Irvine-based manufacturer for fraud and emotional distress, not because their valves have failed but because they must live with the fear that they might.

The massive product liability case, expected to come to trial in Orange County Superior Court this year, poses a novel legal and ethical question: Is a person implanted with a lifesaving but potentially flawed device entitled to compensation even if he or she has not suffered physical harm?

Other states have rejected such claims, but a California appeals court ruled in 1990 that Shiley patients could sue if they could prove fraud by the manufacturer. That ruling could have wider implications for other product liability suits. It raises the possibility, for example, that women with Dow Corning silicone breast implants who have not suffered health problems but want the implants removed might seek damages.

Unlike breast implants, however, the risk of surgery to replace heart valves--even potentially faulty ones--have until recently been deemed unacceptably high. Mortality during open-heart surgery averages between 3% and 5%.

Shiley said that is much higher than the risk of valve failure, which it said is about 0.07% per year. Implant patients are more likely to die of complications, heart disease or other causes, Shiley spokesman Robert Fauteux said.

For years, plaintiffs’ attorneys have complained that Shiley has grossly understated the risk of valve fracture. A study in this month’s British medical journal the Lancet indicates a higher rate of fracture than most studies have shown.

The study of 2,303 Dutch patients with Shiley valves found that the incidence of fractures over an eight-year period was four to eight times higher than Shiley’s estimates. For the first time, researchers concluded that patients with some types of valves should consider replacement surgery.

Shiley and its parent, Pfizer Inc. of New York, are still reviewing the Lancet data, but Fauteux said the firm’s independent medical panel has seen a preliminary version of the Dutch study and does not recommend that U.S. patients have new operations.

“We think that (patients) need to recognize that all medical devices and medical products have risks as well as benefits. That includes the valves they have that are saving their lives,” Fauteux said. “The important thing is that they put the various risks they face into some perspective that makes those risks commensurate with reality.

“It’s not that we’re not sympathetic,” Fauteux added. “It’s just that we think they ought to achieve a realistic understanding of the risks by talking with their doctor.”

“We never, ever said that people who have Shiley heart valves haven’t had an improvement in their condition,” said Minneapolis attorney Bruce A. Finzen, whose firm represents about 370 patients with intact valves who are suing Shiley. “But there are other valves out there that would make them feel just as good, and would not expose them to the risk of fracture.”

But some patients say they can no longer trust Shiley, feel betrayed by their doctors and are considering having their valves removed even against medical advice.

“I feel like I’ve got something in my heart that could break right now or break on the way home--today, tomorrow or a year from now,” Wallace said. “Sometimes I think it might be better for me to take the chance and live a worry-free life.

“I’ve tried to block it out, but I just can’t. I get on a freeway, and traffic gets stopped, and I think, ‘What am I going to do if I have a problem right now and I can’t get off the freeway?’ ”

One of the few U.S. cardiac surgeons who has removed functioning Shiley valves from healthy patients is Dr. Cecil Vaughn of Phoenix.

“I did it after a lot of soul-searching and review of the data,” Vaughn said. He performed successful replacement surgery on three patients who told him that they could no longer bear to live with the device. All three survived.

Vaughn tells his patients that the risk of death during such surgery is about 5%. He believes that if patients understand the risks, the choice should be theirs. As the toll of fracture deaths mounts, and more data about Shiley valves becomes available, Vaughn said, some cardiologists are also beginning to reconsider.

“If I had it in my chest, I’d have it out,” Vaughn said.

The Shiley heart valve saga began when several valves fractured even before the federal Food and Drug Administration approved the valve for sale in 1979. The devices were recalled three times before they were removed from the market in 1986, after about 86,000 valves had been implanted in patients worldwide.

Since then, Shiley has been lambasted by the FDA and a congressional committee, sued repeatedly, accused of misleading regulators, submitting confusing or even fraudulent data, and ignoring or concealing manufacturing defects. The company has denied all wrongdoing.

Last fall, Pfizer sold all of Shiley’s assets, leaving the company only to handle the litigation and conduct research to try to discover a method for predicting valve fractures. At the moment, no such method exists.

For years, Pfizer has reached out-of-court settlements with patients whose valves have broken, or their survivors. But with two exceptions, the company has refused to settle “fear of fracture” suits.

In an about-face, last month the company announced a proposal under which it would spend up to $205 million to settle the hundreds of anxiety lawsuits. But the three major law firms that are handling the anxiety cases are recommending that their clients reject the offer. So has the head of a support group for Shiley patients.

They say that the settlement offer--$2,000 to $4,000 per patient--would not even cover psychological counseling to deal with patient anxiety, let alone the $40,000 to $60,000 cost of replacement surgery for those who desire it. One Miami law firm is demanding $100,000 for each of its 250 “fear of fracture” clients.

Wallace and Civatte said they will reject Pfizer’s offer and take their chances with a jury.

“To me, $4,000 is a piddly amount for having to live with the anxiety of possibly dying,” Wallace said. He also cannot understand why Shiley did not withdraw the valve from the market sooner.

“They took seven years--seven years--before they recalled the product,” he said. “I’m angry that they let it go on so long.”

“When these valves were implanted in us, we were told it would improve the quality of our lives, but we don’t feel that we’re living a quality life,” said Elaine Levenson, who organized the patient group. Levenson was also cool to Pfizer’s offer to spend $75 million for research at Shiley’s Heart Valve Research Center in Irvine.

“We’ve got a Shiley valve in us that could fracture at any time,” she said. “Why would we trust Shiley to do the research?”

While they wait for their cases to come to trial, Wallace and Civatte said they struggle daily not only with fear but also with feelings of anger and betrayal.

Civatte must travel on the job. When he checks into a hotel, he said, the first thing he does is scout out the nearest medical transport helicopter. “The further I get from a trauma center, the less I sleep at night,” he said. And he worries that if his valve failed, he might not have time to summon help.

“My valve is in the aortic position,” he explained. “If it fractured, I would feel like a drowning man. My lungs would fill with fluid . . . I would be unconscious in three, maybe four minutes.

“Can Shiley tell me how to increase my chances of survival in the unlikely event of a valve failure?” he asked. “Nobody can.”

Civatte began seeing a psychiatrist after several trips to the emergency room with symptoms that seemed terrifyingly similar to a valve fracture but turned out to be an anxiety attack.

The counseling, he said, “made me realize that my fear was real.” He also takes an anti-anxiety drug.

“Can someone please tell me how to live a normal life?” he asked. “That’s the question that we all want answered.”

History of Shiley Heart Valves

1969--Dr. Viking O. Bjork, a Swedish surgeon, implants the first Bjork-Shiley heart valve at Karolinska Hospital in Stockholm.

April, 1979--Pfizer Inc. acquires Shiley along with the new Bjork-Shiley 60-degree Convexo-Concave heart valve, which has just received Food and Drug Administration approval for marketing in the United States.

February, 1980--First of four voluntary recalls after reports of strut fractures on several valves; subsequent recalls occur in 1982, 1983 and 1985.

April, 1984--Shiley begins new inspection procedures. Since then, none of the approximately 8,100 60-degree heart valves manufactured have reported strut fractures.

September, 1984--Despite assertions by Public Citizen and even Shiley’s own admissions that the 60-degree valve may be failing, the FDA reiterates that its benefits outweigh the risks.

January, 1990--Latest figures indicate that of the 86,000 valves implanted worldwide, 391 reported strut fractures. A California appellate court rules that patients whose valves have not fractured can sue for emotional distress if they show that Shiley fraudulently withheld information about problems with the valves.

February, 1990--The state appellate court rules that heart valve recipients may sue Shiley for fraud even if their own heart mechanisms have not malfunctioned, provided that plaintiffs prove that the company acted in a fraudulent and deceitful manner.

December, 1991--Pfizer announces its intention to sell most of the product lines of trouble-plagued Shiley; the company will retain the Shiley Heart Valve Research Center as well as legal responsibilities for defective heart valves.

January, 1992--Pfizer announces a proposal to spend up to $205 million to settle hundreds of lawsuits arising from its valves, which have been blamed for more than 250 deaths; reaction from plaintiffs’ attorneys was chilly. They said that would net only about $2,000 to $4,000 each for their clients.

Researched by DALLAS M. JACKSON / Los Angeles Times