Science: Medical advances under threat from patients who sue

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The Independent Online
`Mother sues over breast implants that left baby ill' said the weekend headlines about a British case. But scientists and doctors from the US say fears of lawsuits are leading health companies to shy away from providing new, useful technologies. Who loses? You, the patient - especially if you are female. Charles Arthur, Science Editor, investigates.

American scientists and doctors are worried that lawsuits over medical equipment are killing off potentially useful technologies in the US - and that the same trend could follow here.

Their biggest objections are that the lawsuits, and sometimes decisions that follow, are based on "junk science" which does not stand up to scientific scrutiny. Yet manufacturers fight shy of them because they don't want to end up with huge legal bills.

At risk, they say, are not just silicone breast implants, but also contraceptive pills, drugs for children, and even essential items such as pacemakers.

"It's a serious issue," said Cheston Berlin, a paediatrician at Penn State University's medical school, who complains that pharmaceuticals companies are so scared of lawsuits that 80 per cent of drugs in the US don't have any labelling advice for doctors on what dosage children should receive. The result: if anything goes wrong, the doctor gets sued.

Elizabeth Connell, an emeritus professor at Emrie University school of medicine, said: "There is a frenzy of litigation in the US over medical issues. It's the worst thing that's ever happened in the history of medicine for women in the US."

As a result, she said: "We have lost intra-uterine [contraceptive] devices, almost lost breast implants, and companies working on womens' reproductive health issues have dropped from 20 to three. There used to be 14 companies working on female contraceptives: now there are just two." The reduction is not caused by mergers or business failure: "They just shut down their whole reproductive health divisions and went into fields where there was less litigation."

Last weekend, many newspapers carried a story saying that Mary Bowler, from North Walsham in Norfolk, had been granted legal aid to sue Dow Corning, which makes silicone breast implants. Ms Bowler claims her baby Danielle was harmed during the three days she was breast-fed because, Ms Bowler claims, the implants were deteriorating and leaked into the breast milk.

However, contrary to the reports, the legal aid will only cover the cost of seeking expert opinion, to see whether "there are reasonable prospects of success" if the case goes ahead.

It is still a long way from the courts. According to some American scientists, it should never get there. Ms Bowler's solicitor has declined to comment.

Dr Wendy Epstein, who has investigated the field of silicone-related legal cases closely, says that large-scale epidemiological studies have always shown that there is no difference in the amount of autoimmune disease in women with or without silicone implants, and "emphatically" no demonstrable effects on children of mothers with implants. Certainly, some mothers with implants have shown no worries about breastfeeding - the highest- profile of whom is probably the celebrity Pamela Anderson Lee, proud owner of both a breast-fed baby and a surgically-enhanced bust.

But a 1994 US study apparently showed that four of 11 children breast- fed by mothers with implants had illness and low weight gain. Dr Epstein charges that the figures were distorted by only including ill children in the studies only after identifying them. That seriously distorts the statistics, and means they are not a useful guide to the effects - if any - of implants.