COLUMN ONE : For Export: A Double Standard? : Heart valves the FDA banned as risky were legally sold abroad. The medical industry argues the U.S. shouldn’t impose its regulations on others.

Every time her heart beats, Constance A. Cooper hears the tiny clicks of two mechanical valves implanted there. Every time she hears those clicks, she fears it will be the last.

“There is no moment when you don’t hear those clicks, no night when you go to bed without thinking about it,” Cooper said. “You wake up every night and you just want to hear those clicks perfectly. You just hope you’re going to wake up in the morning.”

Cooper’s fear is well-grounded: At least 246 people worldwide have died following fractures of similar heart valves. So she filed a civil lawsuit last year in Los Angeles against the manufacturer, Shiley Inc. of Irvine, a subsidiary of the pharmaceutical giant Pfizer Inc.

The suit was settled Monday when Shiley paid Cooper an undisclosed sum. The company had settled many lawsuits involving broken valves, but this was the first time that Shiley has settled a suit involving a valve that had not broken.

But Connie Cooper’s situation is special, even in the deadly annals of the Shiley heart valves. Her case has contributed to charges that the federal Food and Drug Administration is doing an inadequate job of protecting the public, and it has raised questions about whether the United States should impose its generally strict standards on foreign customers of U.S. pharmaceutical companies.

The 50-year-old Cooper is Canadian, and one of the valves in her heart was among 4,000 implanted in foreigners after the U.S. Food and Drug Administration prohibited Shiley from selling the device in this country but allowed its export to other countries.

Critics argue that the law that permitted Shiley to export its 70-degree heart valve--a measure of the valve’s opening--creates a double standard. Although medical devices sold here must undergo rigorous clinical testing, even the most critical products may be exported without tests.

Hearing Scheduled

A congressional subcommittee, chaired by the influential Rep. John D. Dingell (D-Mich.), has tentatively scheduled a hearing for February or March to explore the FDA’s regulation of Shiley’s heart valves and whether tighter export rules are warranted.

“It is a double standard that will, over time, come back to haunt us, as it did with the 70-degree valve,” said Dr. Sidney M. Wolfe, director of Ralph Nader’s Public Citizen Health Research Group in Washington.

The medical-device industry, which will sell an estimated $4.3-billion worth of products abroad this year, responds that the United States should not impose its standards on other nations.

“There is a recognition that all countries have their own standards by which they regulate anything, whether it is food and drug products, airline safety or automobile driving,” said Stephen D. Terman, an attorney with the Health Industry Manufacturers Assn., the industry trade group in Washington. “The fact that a product is not up to the standards of one country should not deprive another country of a product if its standards are different.”

Shiley declined to comment on the Cooper case, but company spokesman Robert J. Fauteux issued the following statement concerning export of the 70-degree valve:

“Valves were exported to modern, industrialized countries with sophisticated health care systems and individual regulations and customs. Shiley made every effort and believes it successfully complied with the responsibilities imposed upon it by each foreign country which authorized Shiley to import the 70-degree . . . valve.”

The congressional inquiry into export regulations and the Shiley heart valve is one of several problems now confronting the FDA, which is responsible for ensuring the safety of drugs, foods and cosmetics as well as medical devices.

In the last decade, the agency’s staff has been cut from 8,000 to about 7,500 and the FDA has been beset by criticism that its regulation has broken down. Frank E. Young resigned as the commissioner last month as a result of the agency’s troubles, symbolized by the convictions of three agency officials in an unfolding scandal over the cozy relationship between the FDA and generic drug makers.

Monitoring Faulted

The chief of the General Accounting Office, an investigative arm of Congress, warned last month that inadequate monitoring of medical devices by the FDA is endangering the American public.

“We are concerned about the large number of devices that reach the market after only a relatively cursory review,” Charles A. Bowsher told a House subcommittee.

A spokeswoman for the FDA challenged Bowsher’s contentions and said the agency acts “promptly and aggressively” to protect the public.

The FDA regulates the more than 1,700 types of medical devices available in the United States as well as those manufactured here for export. The products include almost everything, except drugs, used by health-care professionals to diagnose and treat illness.

To ensure the safety and effectiveness of devices sold in the United States, the agency requires clinical tests and reviews of devices before they may be sold and monitors the performance of devices once they are in general use.

Last month’s GAO report criticized both the agency’s thoroughness in testing and its system for monitoring reports of problems with devices already on the market in the United States. The FDA came under similar criticism in the mid-1980s for its failure to move faster in urging the removal of Shiley’s 60-degree heart valve from the U.S. market after fractures began to occur.

The number of deaths ultimately attributed to malfunctions of the Shiley valves is unknown. The FDA has received reports of 181 deaths involving failures of the far more widely distributed 60-degree valve and 65 involving the 70-degree version.

But Wolfe estimates that at least 480 persons have died, and an FDA spokeswoman acknowledged that there are gaps in the reporting of deaths involving 70-degree valves because they have all occurred outside the United States.

The 60-degree valve was the predecessor to the 70-degree valve, which was never sold in the United States. The original valve, called the Bjork-Shiley 60-degree convexo-concave valve, was developed by the Irvine company and a pioneering Swedish heart surgeon, Viking O. Bjork, who now lives in Palm Springs.

The FDA approved the 60-degree valve for sale in the United States in April, 1979, after clinical tests and a review. It also approved the valve for export, and it became the world’s most widely used mechanical valve to replace diseased or damaged human heart valves.

Soon after the 60-degree valves were sold, a small fraction of them began to break. When that happened, the heart could no longer pump blood effectively, and the consequence was death in two out of every three cases.

Blame quickly focused on the welds that joined two components of the valve together, and Bjork later wrote in a medical journal that the welding had caused difficulties. Shiley voluntarily recalled various versions and sizes of the 60-degree valve in 1980, 1982, 1983 and 1985.

Shiley told the FDA that it had corrected the problem with each recall. The FDA also tolerated the fractures because Shiley had presented data to the agency that maintained its valve was better than other types at preventing the formation of blood clots, an infrequent but often fatal side effect of mechanical heart valves.

According to an analysis by the FDA, the agency later determined that Shiley’s claims of correcting the fracture problem were “often unfounded” and that the valve was no better in reducing clotting than some other types available.

Shiley ended production of the 60-degree valves in 1986 after 81,791 of them had been implanted worldwide. The FDA said the valves were subject to a “pattern of rare but persistent . . . fractures.”

Shiley had developed the 70-degree version in 1980, as an improvement upon the 60-degree valve.

FDA documents show that Shiley sought approval to sell the 70-degree valve in the United States as a variation of the 60-degree valve and a solution to the fracture problem. The FDA rejected that request but, in 1980, gave Shiley permission to export the 70-degree valve. Shiley shipped 5,600 to 15 countries, and 4,000 of them are known to have been used.

The first 70-degree valves were produced by remilling 60-degree valves to create a 70-degree opening, according to a study by Swedish surgeons published this year and FDA documents.

Problems Developed

The 70-degree valve soon developed its own fracture problems. The most failure-prone valves appeared to be a subgroup of 521 large-size 70-degree valves that were among those created by remilling 60-degree devices.

The failure rate for this group is more than seven times higher than for the 60-degree valve or the later versions of the 70-degree, said the study by Bjork and two other surgeons.

The study concluded that these remilled valves have “a major risk for mechanical failure” from fractures. According to the study, a person with a large 70-degree valve has one chance in eight of a valve fracture over a seven-year period.

The rate is so high that the surgeons recommended removing the large, remilled 70-degree valves from some of those who had received them, even though one person in 20 dies as a result of replacement surgery. The 60-degree valve’s fracture rate is lower, and doctors do not recommend its removal.

It was one of the high-risk remilled 70-degree valves that was implanted in Connie Cooper during five hours of surgery on May 25, 1982, at Toronto General Hospital. Cooper, who had had open-heart surgery twice before to replace damaged valves, also received a 60-degree Shiley valve at the same time.

She knew nothing then of the standard for exports in the United States, or that the 60-degree valve in her heart had been tested clinically but the 70-degree valve had not.

“I felt very safe,” Cooper recalled in an interview. “My doctor said it was the best valve for me and I told him to do whatever he thought was best.”

Under a 1976 law, the FDA grants an export certificate for a medical device if no negative information about the product exists and the receiving country says it has no objection to the device and no law against it. Few countries, however, have the evaluation capacity and strict standards of the United States.

“Some Western European countries have stricter standards than we do, and some Third World countries will take anything,” said Terman of the manufacturers trade group.

Officials Confused

Investigators from Dingell’s subcommittee found that officials in some countries became confused about the significance of an FDA export certificate.

The Dutch, for instance, had no standards regulating mechanical heart valves. So when Shiley sought Dutch approval to export the 70-degree valve to the Netherlands in 1981, the government responded that it had no regulations for the devices and therefore no legal objections to importing them, according to a government letter obtained by The Times.

However, Dutch officials told the congressional investigators recently that they had been surprised to learn that the Shiley 70-degree valve was not sold in the United States. The Dutch also said that they did not learn the valve had been recalled until 1985, two years after the FDA revoked Shiley’s export license. Even then, the information came not from the FDA but from a newspaper article.

On Jan. 11, 1983, the FDA suspended Shiley’s right to export the 70-degree valves after reports of five valve fractures in Sweden and two in Australia. Five months later, the FDA revoked Shiley’s export certificate, and the company recalled the valves that had not been implanted. By that time, 4,000 of the devices were already in patients, including Cooper.

Shiley has been sued more than 200 times in connection with the heart valves. According to Wolfe, 50 to 60 of the suits involving broken valves have been settled for as much as $1 million. No case has gone to trial and, as part of every settlement, Shiley insists that no one disclose the amount of money.

Beginning last year, recipients of valves that have not broken began to file suits in Orange County against Shiley. The suits claimed that the recipients lived in fear of sudden death from a valve fracture and many of those suing are foreigners with the 70-degree valve.

According to lawyers who have sued Shiley, the company maintained that it would not settle a case in which a valve had not fractured. But that position changed with the Cooper case.

Cooper learned of the problems with one of her Shiley valves in March of 1988 when a doctor at Toronto General told her that the 70-degree valve in her heart had a high failure rate. He recommended that she consider surgery to have it removed.

But when Cooper explained that she had undergone heart surgery three times and one of her natural valves also had a leak, he said she should not be a candidate for replacement surgery because her odds of surviving another heart operation were too slim.

“You think this can’t possibly be true when somebody tells you you are living with a time bomb in your heart,” said Cooper. “You think, ‘My God, how can I live with this?’ ”

Her attorney, Vance C. Simonds Jr. of the Irvine firm of Capretz & Kasdan, said Cooper’s emotional stress and the fact that she cannot have replacement surgery were substantial factors in the settlement.

“Connie has a long history of medical problems,” said Simonds. “This is the first man-made problem. She has overcome all the others. This one she can’t overcome. It will always be with her.”

Cooper said she thinks of the valve in her heart every day. She often dreams that it has broken and she is dying. But she said she has one overriding fear.

“I have two grandchildren and I love baby-sitting for them,” she said. “I just pray to God that it doesn’t happen when I’m baby-sitting the little ones.”