To Sally Walker, doubled up in agony in the doctor’s surgery, the words were as bad as a death sentence: “The gynaecologist told me he would have to operate to remove my (fallopian) tubes. I had f—-d up my life and would never have babies. I just ran out of there in hysterics.” That was in 1979 when Walker, then 22, thought she had her whole life ahead of her – a home, marriage, a family. Instead, at 40, she now lives alone in the Queensland resort town of Noosa, her fiance having abruptly called off the wedding when he learnt she could not have children.
The cause of Walker’s infertility, she believes, was a plastic gadget about the size of a snapper fishing hook bound around with copper wire and attached to a plastic tail. The Gravigard, or “Copper-7″ as it was nicknamed, was once the world’s most popular intra-uterine contraceptive device (IUD). Twenty years later, it stands accused of wrecking the reproductive systems of thousands of women.
Sally Walker is one of about 300 of these women in Australia who are pinning their hopes of compensation for their suffering – and revenge against the company they claim lied about the device and failed to warn them of the dangers – on a marathon case which is drawing to a conclusion in the NSW Supreme Court.
It is already the longest, the most complex, the most bitterly contested and the most expensive case anyone can remember. The writs were filed 10 years ago, the hearing – involving teams of lawyers led by $3,500-a-day QCs – has run for 113 days, and testimony from experts flown in from around the world takes up 7,300 pages of transcript and 13 linear metres of scientific reports.
The trial has cost the defendants alone more than $20 million, the women’s lawyer, Dr Peter Cashman, estimates – a figure lawyers for the manufacturers say is “mere speculation”.
In the dock is the drug company that manufactured the Copper-7, G. D. Searle, of Skokie, Illinois, which is now called the Nutrasweet Company and is part of the huge Monsanto chemical conglomerate worth more than $US8 billion ($10 billion). Ten years after Searle, overwhelmed with lawsuits, took the device off the market in the United States, it maintains there is nothing wrong with the product.
In the witness box have been nine women, from NSW, Victoria, Queensland and Western Australia, who were fitted with the Copper-7 between 1974 and 1985. Their medical histories are a horror story – four lifethreatening ectopic pregnancies (where the foetus lodges in the fallopian tube), one septic abortion, and eight contracted infections which led to infertility or impaired fertility.
As well as compensation for their injuries, the women are seeking $1 million each in “exemplary damages” from Searle, a rarely invoked sanction in which the judge is asked to financially punish the company for “knowingly and wilfully placing (the victims’) health and wellbeing at risk for commercial gain”.
The promotional material conjures up a bizarre image of a New Age car salesman. Using a picture of the armless Venus de Milo, Searle’s salesmen were told to sell the Copper-7 to doctors with this sales-pitch: “For the ‘feminine metal’ a new role – birth control. To alchemists, copper was associated with Venus, the goddess of beauty and love, probably because of the ancient use of copper in mirrors … the symbol long shared by copper and the planet Venus / becoming the symbol for feminity.”
This was 1975, not long after Searle had launched the Copper-7 in Australia with unprecedented hype. There were advertisements in all the medical journals, lengthy articles in women’s magazines, a “Sister Searle” telephone hotline. A company in New Jersey was even licensed to produce Copper-7 earrings and necklaces.
It was, said Searle, “the first IUD breakthrough. It provides a high level of efficacy without the side-effects associated with other IUDs.” The company told the Food and Drug Administration, the US regulatory watchdog, that its clinical trials indicated the device “approaches the ideal contraceptive”.
That certainly is what Lynette Hutchings was told when she went to her gynaecologist in 1978 to have one fitted. She had read about the Copper-7 in a magazine – and the doctor told her it was a safe and effective contraceptive, even when she developed infections and had to be treated with antibiotics.
She had the device removed two years later, when she and her husband tried to start a family. Three times she became pregnant, and three times it was ectopic – on the last occasion it ruptured, causing peritonitis, and Hutchings was “knocking on the pearly gates” before blood transfusions and emergency surgery saved her life.
Despite having both her fallopian tubes removed and her abdomen covered by scars from the operations, she did not give up trying to become a mother. Three times Hutchings went on the IVF program and received frozen embryo transplants, and three years in a row they failed.
By now it was 1990 and Hutchings, who works as a doctor’s secretary near Newcastle, was approaching 40, the cut-off age for the IVF program. “I was just devastated when I finally realised I was never going to have a child,” she said. “My marriage broke up over it.”
Extraordinarily, it was not until last January, when she read about the trial in a newspaper, that Hutchings realised that her Copper-7 might have been to blame and contacted the lawyers.
* * *
For half a million Australian women such as Lynette Hutchings who had the Copper-7 fitted, it seemed like the right product at the right time. The sexual revolution unleashed by the Swinging Sixties was gathering pace, but worldwide women were beginning to worry about the safety of oral contraceptives.
Sally Walker chose the Copper-7 because friends had told her she would put on weight with the pill, and she had heard that it might be linked with cancer.
The curious thing is that, even now, there is no satisfactory scientific explanation of how IUDs work. Their origin is said to have been the ancient Bedouin practice of inserting small stones in the uteri of their camels to prevent them becoming pregnant when on long journeys in the desert.
In more modern times, the German physician Ernst Graefenberg* invented a gold or silver ring which became popular with flappers* in the 1930s. By the 1970s, there were already half a dozen loops, leaves and squiggly bits of metal and plastic being inserted into wombs – and already the alarm bells were ringing about potentially lethal side-effects.
One of the more telling pieces of evidence produced in the Sydney trial was the transcript of a meeting of the Population Council – an influential international birthcontrol forum – in New York in 1962. An expert, Dr Christopher Teitze, said: “The greatest obstacle to the widespread adoption of IUCDs* is the almost unanimous opposition of the medical profession. Therefore our first objective must be to convince our colleagues outside of this room that intra-uterine contraception is a respectable medical procedure and not the devil’s work.”
IF ANY further warning was needed, it was provided by the catastrophe of the Dalkon Shield, an IUD launched in the early 1970s by the A. H. Robbins company. By the time it was withdrawn in 1974 (just three months after the Copper-7 was launched), it had killed and injured thousands of women worldwide: the company filed for protective bankruptcy and has set aside $US2.5 billion to compensate the victims and their next-of-kin.
Searle, the women’s counsel argue, ignored these generic risks associated with IUDs. In 1971 it bought the rights to the Copper-7 from one Jaime Zipper, a Chilean doctor, and prepared to market it before it had completed the clinical trials necessary to show that it was safe and effective. According to testimony in one US case, early tests on monkeys had shown “premalignant transformation” of cells, indicating the device might be linked to cancer.
The plaintiffs’ evidence is that Searle’s subsequent human trials had serious deficiencies. Many of the women fitted with the Copper-7 were simply “lost” to follow-up – these included women attending clinics in countries such as Taiwan and Thailand, and in the US the entire cast of a travelling production of the musical No No Nanette. Evidence of infection and pregnancy had been minimised, and the data “massaged” to win approval for the product.
Far from IUDs “approaching the ideal contraceptive”, as the company claimed, Professor Janet Daling, one of America’s leading epidemiologists, testified that the risk of ectopic pregnancy was increased two or three times in women using IUDs, and the risk of pelvic inflammatory disease (described by another witness as “the most important thing, next to cancer, that (can) happen in a woman’s pelvis”) was four times higher.
Nineteen different international studies showed the risk of infertility in women using the Copper-7 and other IUDs was increased by an average of 40 per cent. In 1985, two studies for the US Government indicated that as many as 88,000 American women may never be able to have children because of IUD-induced damage to their reproductive systems.
The problem, the plaintiffs argue, was the polypropylene “tail” of the Copper-7, whose surface degraded, forming a “swamp” where germs might breed. They say it was a problem well known to Searle by the late 1970s, when an internal memo described a microscopic scan of one tail-string in these words: “To be brief and descriptive – it looks like a dog’s breakfast after the rats have been at it. The surface is rough and irregular, and the ends of the copper wire look like a medieval weapon.”
But, reassured by Searle’s data, country after country allowed the Copper-7 to go on sale. After the US, it was sold in Europe, Japan, Australasia and parts of Asia. A total of 10 million women in 40 countries were fitted with it.
In Australia, the watchdog on new drugs and medical devices is the Australian Drug Evaluation Committee (ADEC) of the National Health and Medical Research Council, the country’s peak medical bureaucracy. The testimony provides a sorry commentary on the failure of the system to adequately scrutinise products such as the Copper-7.
In the case of a small version of the Copper-7 designed for women who had never had children, there was evidence given that Searle had withheld data on infection and “alarmingly high pregnancy rates”. This model, the “miniGravigard”, was in fact never approved for use in the US.
The evidence of Dr Brewster Ashley, a former secretary of ADEC, was if anything even more damning.
Question: Do you or do you not have the opinion that this was misleading in the sense of lying, cheating, fraud … or simply an area where honest minds approaching the same problem might reasonably come to opposite conclusions?
Which is it, doctor?
ANSWer: Well, I don’t think it’s the latter; I think it’s more the former, and I think an examination of the basis for it will reveal why we feel that way.
The evidence shows that even when the alarm bells finally began to ring at ADEC in 1986 (after the Copper-7 had been withdrawn in the US) its response was too little too late. Files were shredded because of a departmental error, directions were not passed on because of a “breakdown in the (Health) Department’s channel of communications”.
When finally concerns began to emerge – through hundreds of damages claims filed in the US – that a potentially lethal product may have been allowed onto the market here, the eminent doctors and scientists who made up ADEC recorded in their minutes “members were agreeable to letting it lie dormant unless/until TDEC (the Therapeutic Devices Evaluation Committee) feels the matter should be reopened”.
The Copper-7 remained on the market in Australia – and 17 other countries – until 1990, five years after it had been withdrawn in the US. Searle finally, reluctantly, withdrew it here, not because it was dangerous but for what it says were commercial reasons: the company had been asked to resubmit its data for a re-evaluation by ADEC, a process it says would have been costly.
But there was no attempt by Searle to recall it or warn the tens of thousands of women still using the Copper-7: “We will not be recalling the product,” a company memo said. “The existing stock will simply be allowed to be depleted.” Searle says a recall was unnecessary because there was nothing wrong with Copper-7.
Dr Barbara Simcock has no idea how many IUDs she has inserted in the course of her long career in family planning. 3,000? 4,000? In the 1970s and 1980s, when she worked as a doctor and later director of the Family Planning Association of NSW, she was a leading apostle of IUDs.
An article by her in the Medical Journal of Australia was used by Searle to “prove” the safety and efficacy of the Copper-7 and she even appeared in an instructional video. In 1977, when a researcher warned that there might be a link between birth deformities and the use of other copper-containing IUDs, she criticised the Herald for publishing the report, saying it was based on only two cases and might “cause a great deal of anxiety and needless worry to women using an IUD”.
For years after the Copper-7 was withdrawn in the US, Simcock says she continued fitting it in women in Australia because “the vast majority of my patients were very happy”. Even today, she is not convinced there was a problem, and attributes some of the blame for any increase in pelvic infection to the women themselves. “With some women there was a higher incidence of promiscuous behaviour – they thought that once an IUD was fitted it was open slather.”
One woman who saw Simcock is Kate Fry, a lecturer in communications from Killara, on Sydney’s North Shore. In 1975, wanting a spell after having two children, Fry sought advice from Simcock at a family planning clinic at the Royal Prince Alfred Hospital.
“Dr Simcock was so enthusiastic about the Copper-7 I agreed to have it fitted. She said it was a wonderful product, it would cause no trouble at all … after 20 years I can still remember the strength of her conviction and see the light in her eyes.” Within a matter of weeks Fry began to feel desperately ill. For a while she put up with it and was treated with antibiotics by another doctor (she had moved). But eventually the pain was so severe she went to the Royal North Shore Hospital where the device was removed a few months after it had been fitted.
As it turned out, Fry suffered no lasting after-effects. “I was so lucky I was aware of what was happening and woke up before any major damage was done … I feel so sorry for all those women who did not,” she said.
Simcock said she had no record or recollection of having treated Fry. She said if a patient had had a problem she should have contacted her immediately.
STUART Clark throws open a door, revealing three young lawyers beavering away in a room crammed almost to the ceiling with yellow lever-arch files. “Look at it all,” he said. “They have thrown everything at us … this case has been a real witch-hunt.”
To Clark, a partner in Clayton Utz, the trial of the Copper-7 is a David and Goliath story – with a twist. David is the $US8 billion multinational Monsanto and its law firm, one of the largest in Australasia, which occupies nine floors of the prestigious* office block at No 1 O’Connell Street; Goliath is represented by the women who believe they were damaged by the Copper-7 and the firm of Cashman and Partners, with four solicitors on staff, which rents one cluttered floor down near Chinatown.
Clark maintains there was “absolutely nothing wrong” with the Copper-7. Indeed, he says that Searle was criticised by the medical profession for withdrawing it. “As a consequence, women suffered … people die as a result of pregnancy; they die as a result of abortion. The mortality and morbidity associated with copper-bearing IUDs are significantly less than that associated with other methods of contraception and pregnancy. There’s a whole risk/benefit (calculation) there that gets ignored in the allegation (that the Copper-7 endangers women’s health).” Clark said thousands of women in the US were persuaded to sue Searle because of the “fat fees” their lawyers hoped to collect, fees that in the US can amount to 40 per cent of damages awards.
Searle took the Copper-7 off the market in the US because it could not get product liability insurance and the only reason the company compensated women who claimed to have been damaged was that it would have been more expensive to go to trial.
OF THE 24 cases that have gone to trial in the US, Searle claims to have won 19. Of the landmark $US8.75 million (about $A11 million) awarded to Esther Kociemba* in 1985 (which included $US7 million in punitive damages because the judge concluded that Searle acted with “wilful indifference” to the woman’s well-being), Clark said the case was appealed and settled for less. He said the thousands of cases that Searle had settled out of court had involved “peanuts”.
“Why pay $4,000 or $5,000 to make the case go away? Because the cost of running the case is horrendous and in America, even if Searle wins, it doesn’t get a cent back.”
Mike Ceresi, the Minneapolis lawyer who represented Kociemba and hundreds of other women who used the Copper-7, retorts that Clark is wrong: “If he is talking about this firm’s cases being settled for $4,000 or $5,000 then … if they will release us from our confidentiality order we will prove it.”
Likewise, there is disagreement about why the case in Australia has dragged on for 10 years and cost millions of dollars. Peter Cashman says the defendants have turned the case into World War III: “It is a multinational company which has spent tens of millions of dollars … throwing every conceivable legal obstacle in their way.”
Clark blames Cashman for the delays, saying he sued the wrong company (Searle changed its corporate identity) and sued on behalf of one woman who did not use a Copper-7.
“Essentially, we got a letter saying, ‘I’ve got all these cases – pay us money or we’ll sue you’,” Clark said. “My surmise is … he expected Searle to just roll over and die. I don’t believe Cashman ever really thought he was going to have to run these cases (until) Searle said, ‘Not liable. Go away’.”
The winner in what has been fought as an increasingly bitter propaganda – as well as legal – battle will be known this year when Justice Vince Bruce in the NSW Supreme Court brings down his findings in a case that has far-reaching implications, not only for the 300 women directly involved, but also for the future of IUDs, for the accountability of large multinationals, and for the effectiveness of Australia’s health regulators.
Pub: Sydney Morning Herald
Pub date: Saturday 4 January 1997
Word count: 2744
Classification: Health/Childbirth/Birth Control Law/Cases Health/Complaints & Malpractice
Geographic area: Australia International
Photography: David Hunt, George Fetting
1. Home alone … Sally Walker was 22 when doctors had no choice but to remove her fallopian tubes.
Caption: Marriage break-up … Lynette Hutchings tried and failed three times to conceive on the IVF program.
2. Kate Fry was in such pain she had to have the Copper-7 removed at Royal North Hospital a few months after it had been inserted … “I was so lucky I was aware of what was happening … I feel so sorry for all those women who did not.”address>