Ben Hills reports

The publicity pictures in the company magazine are just what you would expect of a high-tech plant in California’s mega-wealthy Orange County – workers in pristine masks and gowns, decontamination chambers, microscopes, micrometers, and a maze of other precision scientific equipment.

But, behind the scenes, every day was party-time at Shiley Inc’s factory in Irvine, according to statements by former employees. None of his fellow workers “took their job seriously, and we all enjoyed it”, recalls a welder named Harvey Hilman. One man came to work with a refrigerator full of beer in his van which they drank during breaks – Hilman says the pace was such that he became an alcoholic during the five years he worked for Shiley. Some smoked dope or snorted cocaine on the job.

“Workers were frequently smashed for much of the time,” says another Shiley employee, Wayne Runnells, who recalls once finding a workmate who had passed out at the wheel of his car and driven it into a wall.

Even sober, it was not everyone’s idea of an ideal workforce. Many skilled staff had walked out during an industrial dispute, and were replaced – according to Larry Hamilton, who was Shiley’s quality control manager from 1980/1984 – by illegal immigrants hired “straight off the streets”, many of them Vietnamese and South Americans who did not speak English.

They were given “absolutely no training”, before being put to work without adequate supervision, Hamilton says. “Everything (at Shiley) seemed to be done the easiest, fastest and cheapest way possible.”

It would have been a scandal even on a Motown assembly line. But Shiley was not making cars; it was making gadgets on which people’s lives depended – artificial heart valves in which the minutest flaw could mean instant death. As Larry Hamilton puts it: “A crack is a killer.”

Today, 18 years after those workers turned out the first cumbersomely named Bjork-Shiley Convexco/Concave heart valve, about 1,000 people are believed to have died as a result of defects in the device that was supposed to save their lives, and tens of thousands more live in daily fear that they could be next. It has turned out to be one of the greatest man-made disasters in medical history.

When “Arthur Kelly” (his real name has been suppressed by the courts), a 30-year-old North Shore accountant, woke up one day in 1982 feeling short of breath and generally out of sorts, a Sydney specialist diagnosed a congenitally defective heart valve.

Twenty years earlier, little could have been done – Kelly would have died. But in the 1960s, biotechnology companies developed artificial valves to do the heart’s work, with only a faint “click” 72 times a minute to remind the patient that he was being kept alive by a piece of metal and plastic about the size of a 20-cent coin.

By 1979, Don Shiley, a Californian entrepreneur who had started manufacturing heart-valves in his garage 15 years earlier, had become one of the leaders in the field. Teaming up with a Swedish cardiologist, Professor Viking Bjork, he developed a series of increasingly sophisticated artificial valves, culminating in the Bjork-Shiley Convexco/Concave model, which was claimed to be the best in the world and rapidly came to dominate the market.

Over the seven years until it was finally withdrawn, 86,000 of these valves were stitched into the hearts of patients – about half of them in the United States, and the rest in a dozen other countries, from Europe to Canada, Africa and Australasia. Don Shiley moved production from his garage to the Irvine factory, which eventually employed 1,000 people and had sales of $50 million a year.

It was this valve that Kelly’s cardiac surgeon decided to use, partly because he had read of its superior performance, partly because it was cheaper – at about $1,500 – than some of its rivals. The delicate operation, which usually takes three or four hours, was performed at Royal North Shore Hospital. Kelly recovered well and went back to his family “cured”.

In fact, there were several things about the valve that Kelly’s doctor, Dr Donald Ross, one of Australia’s leading cardiothoracic surgeons, did not know. For a start, the company had suppressed the fact that almost since it began testing the new design in 1978 it had been aware that a tiny metal “strut” on which the valve’s carbon disc pivoted could fracture, causing instant death.

The second fact of which Australian cardiac surgeons (at one stage, 35 were fitting Bjork-Shiley valves at 11 different hospitals in five States) were unaware was that one of the valve designs, a modification of the original valve which allowed it to open wider, had never been approved by government regulatory authorities.

The United States watchdog Food and Drug Administration refused to license this so-called “70-degree” version of the valve, “because of lack of clinical data” – although it did allow some 4,000 of them to be exported to countries including Australia. Australia, at that stage, did not test or regulate medical devices – it was not until a public uproar about the faulty heart valves that such products began to be monitored.

In 1985, the then Federal Health Minister, Dr Neal Blewett, told Parliament: “It was a matter of grave concern to the Government when it became apparent that there was an inadequate regime for supervising medical devices. It appears that at least five people died in this country as a result of faulty artificial heart valves.”

A few months after he operated on Kelly, Ross was shocked when two of his patients who had also received the Bjork-Shiley implant died on the same day after their valves failed. He returned the valves to Shiley, but the company said there was no metallurgical or manufacturing problem, and suggested that the valves might have been damaged at the hospital.

In fact, evidence from former Shiley employees, filed with the Federal Court in Sydney in support of a compensation claim by Kelly’s family, shows that a failure in the welding of the valve strut is the more likely cause. That, and shoddy workmanship caused by drink, drugs and relentless pressure from Shiley management to increase production.

Witnesses describe how defective valves rejected and thrown into “million-dollar barrels” were recovered, rewelded, had cracks polished out, had their identification numbers changed and paperwork falsified. Hamilton says that for two years he performed a spot audit on 25 of the 700 valves a week which were going out of the Irvine factory, and found one quarter of them had a defect.

As report after report of the fatal failure of its valves came to light, the company established a pattern of minimising the danger. In a series of “Dear Doctor” letters, Shiley insisted there was “an extremely low risk of failure” and that the risks of replacing the valves were greater than the risk of leaving them in place – the operation kills as many as one patient in 20.

In fact, according to a 1990 report of a US House of Representatives committee titled “The Bjork-Shiley Heart Valve – Earn As You Learn” the company was well aware of the potential dangers long before Kelly’s operation. The evidence is in a series of damning telex exchanges between Shiley and Bjork obtained by the committee.

As early as December 1980, Shiley telexed Bjork: “We would prefer you not to publish the data relative to strut fractures. We expect a few more, and until the problem has been solved we do not feel comfortable.”

By March 1982, Bjork telexed Shiley’s company president with news of another valve failure, commenting: “It is evidence (sic) by now that the manufacture of the prosthetic valve is not acceptable. Dear friends, I am serious.” Later, the professor said that to continue to sell the more dangerous “70-degree” valve was “tantamount to murder”.

In April 1982, Bjork stopped implanting the valves that bore his name, and plaintively wrote: “Well, I suppose I should take the blame for not calling Uppsala (hospital) to warn of the valves. But where to stop? Was it up to me to call all the clinics in Europe and the rest of the world also? No, I think that was the manufacturer’s duty.”

If Shiley had listened to Bjork, the lives of Arthur Kelly and hundreds of other people around the world might have been spared. In 1990, eight years after it was implanted, Kelly’s heart valve shattered. He died at 38, leaving a pregnant widow with two children.

By June of 1989, Shiley knew of 70 deaths due to the failure of its heart valve. By 1991 the toll was up to 300, and this may be a gross underestimate, because no records were kept of where each of the 86,000 valves went, and many deaths may have been put down to “natural causes”.

In Australia, recipients of about 100 of the 900 valves that were imported are still untraced. Of those who have been located, 20 have had operations to replace their valves with a safer brand, and in 14 cases the valve had already broken apart. It is believed that as well as Kelly, at least nine other people have died.

It was calculated earlier this year, using research by Ron Brookmeyer, a biostatistician at Johns Hopkins University, that 1,454 valves had failed in the 19 years since Shiley first put them on the market, resulting in 968 deaths. There were then still 40,000 people walking around with Bjork-Shiley heart valves in their chests, so no-one is game even to guess at the final toll.

In 1992, Shiley and the company which took it over in 1979, the $13 billion-a-year-turnover US pharmaceutical giant Pfizer, was forced to settle a massive class-action lawsuit by establishing a $600 million fund to pay for medical care for surviving valve implant patients, compensate families of the dead, and research diagnostic techniques to predict which valves may be about to fail.

A Pfizer/Shiley spokesman said this week that the company had been unable to agree on “fair compensation” for Kelly’s relatives, and would fight the case “vigorously”. He said the company “regretted” the fact that some valves had failed, but reassured people with Bjork-Shiley C/C implants that “the risk is very small, and in the great majority of cases (the valves) will save and extend the lives of recipients”.

There have been promising results in predicting which valves may fail, using a “super X-ray” known as high resolution cineradiography. According to a report in the New England Journal of Medicine, a Michigan hospital detected five hair-line fractures in time to allow replacement and the saving of patients’ lives.

The bad news for more than 300 Australians who fear they may have time-bombs ticking away in their hearts is that the test is not available here, apparently because the machinery costs several million dollars.

Publishing Info

Pub: Sydney Morning Herald
Pub date: Saturday 23 August 1997
Edition: Late
Section: News And Features
Sub section: News Review Page: 41
Word count: 1594
Classification: Health/Complaints & Malpractice Health/Body/Artificial Parts Company/Pfizer
Geographic area: Australia USA
Graphic: How the valve works – and fails
1. The Shiley production line
2. The Bjork-Shiley C/C valve, as shown in a company magazine.