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Stanley, Fiona --- "Impact of medical litigation" [1996] ALRCRefJl 2; (1996) 69 Australian Law Reform Commission Reform Journal 11


ALRC Reform 69

LITIGATION OR SCIENCE
what's driving medical decision making?

Cervical cancer
Vaccination
The New Obstetrics
Debendox
Conclusion

Is the legal system stifling medical research? Although litigation is meant to deter negligence and compensate its victims, Professor Fiona Stanley, argues that marked increases in court actions and awards and the misuse of forensic science is making it more difficult to apply the findings of public health and medical research for the public good. In this article she discusses four examples of unhealthy litigation.

Professor Fiona Stanley is an eminent epidemiologist and Director of the TVW Telethon Institute for Child Health Research in Perth and Professor of Paediatrics, University of Western Australian. In 1996 she was made a Companion of the General Division of the Order of Australia.

Cervical cancer

Cervical cancer is the seventh commonest cancer in Australia in women, with 1700 new cases per year. It is preceded over a period of years by a spectrum of asymptomatic abnormalities graded as 1, 2, or 3. Only a proportion of women with these lesions - even grade 3, the most severe - will progress to invasive cancer, but those with any of these lesions are at high risk of getting cancer eventually.

Screening healthy women without symptoms by taking a smear from the cervix and looking at the cells so obtained to assess their precursor status, was introduced in Australia and many other developed countries in the mid-1960s. It attempts to identify these abnormalities in women who have no symptoms and thus give them and their doctors an idea of their risk status.

It is important to understand that these screening tests are not diagnostic of cancer, although some women call them cancer tests, and even some doctors do not seem to understand that the majority of women who have abnormalities on the paper smear will not get cancer and that some women who have no abnormalities will get cancer.

But it gets even more difficult. The tests themselves are not 100% accurate in terms of the detection of abnormalities. Some report abnormal cells when they are not really abnormal - false positives - and some report normal cells when the woman really has an abnormality - a false negative. Those with false positives will have additional unnecessary and sometimes invasive investigations to rule out cancer. Those with false negatives will be falsely reassured that they are not at high risk. It is when these latter women develop rapidly progressive cancer that they feel cheated by the system.

Recent litigation has involved women who have claimed that their cancers were not picked up by the screening process. These situations are tragic but it is not a failure of the screening program and it is not negligence on the part of the laboratory. It is expected as part of a normal screening activity. These women were the unfortunate few, the very rare cases, the false negatives which occur in any screening program.

The effects of this litigation have been negative in the following ways. Firstly, a marked increase in referrals for slightly abnormal smears. Secondly, major increases to the costs of the program - more repeat tests, more doctors' examinations, more colcoscopies, more biopsies and so on. Thirdly, fewer women coming for screening, having been put off by the program because of the adverse publicity which is usually damaging to the service and the profession whether they are found eventually liable or not. Fourthly, trained people leaving gynaecology or pathology as they do not like being sued. And lastly, encouragement to search for new technologies or tests which may bring very small gains in terms of increased accuracy but with considerable increases in costs.

It's not beyond the realms of possibility that the increased costs of cervical cancer screening programs could result in them being abandoned. If this community wishes to allow women and their lawyers to sue and be awarded huge damages, then we'll have to accept that there will be more women dying from this disease.

Vaccination

The most cost effective public health measure after the provision of fresh water and sanitation, is vaccination. The success stories of smallpox, polio and measles are legends in the history of international public health. AIDS has made the public even more aware of how wonderful the solution of a vaccine would be. However, most developed countries have in the past, or are still now, facing major problems with their childhood vaccination participation rates, and in the USA and Australia it has been called a shambles.

Why? The sources of this reversal have been vaccine liability which has lead to exorbitant costs or loss of supply of vaccines as the companies decide that the costs and risks of litigation are too extreme and they decide not to make vaccines any more; followed by the belief of certain groups, and an increasing number of parents, that vaccines cause major problems such as brain damage, cot deaths, AIDS, Chronic Fatigue Syndrome and allergies.

Not only are none of these allegations borne out by rigorous scientific study but the damage and death from the disease itself, and the power of vaccines to virtually eradicate them appears to have been ignored.

Whooping cough epidemics are currently sweeping the eastern seaboard of Australia where vaccination levels have fallen so low that less than 50% of our children are vaccinated. In one eastern state in 1990, there were 143 cases of whooping cough. In 1994 there were 1940 cases, with 290 children hospitalised and 7 cases of brain damage from whooping cough.

The story of brain damage and whooping cough vaccine is a tragic one. Again, decisions made by the courts have done public health a major disservice, by dealing with vaccine injury in an irregular and unpredictable manner. I also feel angry that we as doctors did little to counter the highly emotive and very well publicised cases of so-called vaccine brain damage. We could have done so by showing dying and brain-damaged children with whooping cough on television and publicising the statistics which demonstrated what some parents found out too late, that the disease is far, far worse then the vaccine.

In the 1970s in the United Kingdom, and in the early 1980s in the USA, there were suggestions from parents of children with neurological disabilities that the vaccine may have been responsible for their child's condition, as they had noticed fits after the vaccine and the children did not recover.

Many children with disabilities are not diagnosed or even noticed to be abnormal until about 6 to 12 months of age. Thus it was easy to demonstrate coincidence of the exposure - the vaccination - to the problem.

A documentary on television in the United Kingdom in 1974 showed 36 such children who it was claimed had been brain-damaged, had encephalopathy as it's called, over the previous twelve years. The parents demanded and eventually were granted vaccine damage payments, and the Vaccine Injury Compensation Act was introduced in the United Kingdom in 1979. In the meantime there was a dramatic fall in immunisation rate in the United Kingdom, falling from 80% in early 1974 - enough to give protection to the community - to about 30% in 1975. Then followed the worst outbreak of whooping cough since vaccination became available - 5000 children were hospitalised, 2000 cases of pneumonia, 83 cases of encephalopathy, and 28 deaths.

If you feel litigation is the way to go, the parents of those children should have sued the television station who ran the documentary.

In the USA, following the first law suit in 1978 for $10million, there was a dramatic increase in vaccine brain-damage suits, particularly following the widespread media coverage of still-unproven scientifically adverse vaccine effects. In 1984, 73suits were filed with an average of $46million per claim, rising to 255 suits in 1986, averaging $16million per suit. Over the same time period, not unexpectedly, the cost of the whooping cough vaccine rose from 15cents a vaccine to $8.50 per dose.

Two of the major companies making vaccines, Wyeth and Lederle, pulled out leaving Connaught the only US supplier of whooping cough vaccine.

In 1987 the US Childhood Vaccination Injury Compensation Act was passed, following determined lobbying by such organisations as the American College of paediatrics and the American Public Health Association. Parents must go through this system first before they are allowed to pursue a legal route. They forfeit any compensation from this system once they have chosen to sue.

Well, does whooping cough vaccine cause brain damage? The very well-funded National Encephalopathy study was conducted in the United Kingdom. All cases of encephalopathy over a two-year period - over a thousand children - were compared in terms of their vaccination status, with over 2000 control children without encephalopathy.

The final analyses, summarised beautifully by the judge in the class action suit in the United Kingdom, demonstrated that vaccination actually protects against encephalopathy rather than causes it.

Many thousands of cases, hundreds of deaths and complications later, and following numerous court cases worth millions of dollars, with science hardly having a look-in, science eventually did win. How can we stop this happening again and again?

The New Obstetrics

In 1975, the New Obstetrics began. Their promises were not backed up by any research findings but by a growing belief that most of the cases of cerebral palsy in childhood were due to birth asphyxia - that is lack of oxygen going to the brain at birth. New machines were said to accurately diagnose birth asphyxia by electronically monitoring the baby's heart rate during labour. One can only speculate how this belief arose as most data over the last 100 years suggests that only a very small percentage of children with disabilities had birth asphyxia.

I am sure that those obstetricians rue the day they made these rash promises. The new obstetrics relied on improved methods of detecting foetal distress, and then responding by delivering the baby by caesarean section if distress was noted. Babies in poor condition at birth were resuscitated. These birth interventions were much more invasive than anything done to mother or child up until that time. The aims were to reduce death and prevent brain damage.

From the late 1970s there was a dramatic increase in the number and amount claimed per suit, as parents sued their obstetricians for negligence if their child was diagnosed as having cerebral palsy, irrespective of the real cause of that child's condition. The effects have been devastating for obstetrics and for obstetricians. Litigation has driven up the cost of care, particularly in the USA, but also now in Australia and in the United Kingdom. In Australia, insurance premiums for obstetricians have risen from $50 per annum in 1975 to $25000 per annum in 1995. In the USA where some individual cerebral palsy settlements have been as high as a hundred-million, insurance premiums are over $100000 per annum.

Hospitals have also been hit. One hospital in South Australia has been forced to close because of the payout in one case. Pregnant women and their families and society have also paid a price. Obstetricians are leaving obstetrics, general practitioners have decided against doing GP obstetrics, and midwives - once a cheaper option for mothers - now have to get malpractice insurance and have raised their fees too.

Some rural general practitioners do too few deliveries to even cover the costs of their premiums, and as a backdrop to this sad and sorry tale, lawyers continue to advertise to encourage parents to sue.

All evidence to date suggests that litigation has increased the obstetric intervention rate in the face of no evidence to demonstrate the effectiveness of either electronic foetal monitoring or caesarean section to reduce cerebral palsy or birth asphyxia. Obstetricians are ignoring science because of fear and exposure in the courts and are practicing what is called 'defensive obstetrics'.

Well does intrapartum asphyxia cause cerebral palsy? And can obstetric care, aimed at diagnosing and tracing such asphyxia, reduce the occurrence of cerebral palsy? My own group in Perth have contributed to this international debate because we have data on all cerebral palsy cases. Thus, for the total population, we have accurate cerebral palsy rates from 1956 to 1990, and the capacity to conduct case control studies to investigate trends and causes.

In spite of dramatic increases in the use of foetal monitoring, 0% in 1970 to well over 50% of birth in 1990, and caesarean sections: 4% in 1970 to over 20% of all deliveries in 1990, the occurrence of cerebral palsy in Western Australia actually rose over the same time period. The message was clear: widespread use of aggressive obstetric interventions has not reduced the occurrence of cerebral palsy as promised by the practitioners of the 1970s.

For obstetric care in labour to reduce the occurrence of cerebral palsy, birth asphyxia or other intrapartum problems must cause a significant proportion. And secondly, obstetric care must be able to avoid the problem. Neither of these seem to be true. The most damaging aspect is the reliance on the electronic foetal monitor. This was introduced by enthusiasts who did not evaluate it. The science has now been done. The main effect is a rise in intervention rates, but no reduction in cerebral palsy.

What is even more embarrassing for the obstetricians is the considerable observer variability in interpreting the electronic traces. There was only 22% agreement to do a caesarean section or not in one study of 50 traces by four experienced obstetricians. Six months later, 21% of the same traces were interpreted differently by the same obstetricians.

With such poor levels of agreement, how can expert witness get up in court to say with confidence that the tracing was indicative of incipient encephalopathy? Or that by not doing a section, that a clinician failed in their duty to the standard of their colleagues?

What is amazing to me is that the courts are still relying on these traces as the mainstay of evidence in cerebral palsy litigation and that doctors are using monitors more than ever because not using one is a reason for parents to sue. It is acknowledged that we cannot diagnose asphyxia in the human foetus, either before or during delivery. Research suggests now that most cerebral palsy cannot be prevented. No individual case of cerebral palsy can, in my opinion, be attributed with confidence to a birth asphyxial episode. It is even less scientific to say that a different level of care may have changed the outcome. Expert witnesses in cerebral palsy litigation have done enormous damage to their profession, pushed by lawyers who only have to prove it is possible that the brain damage of a severely handicapped child was damaged during the birth process.

Parents, who are promised perfection in a world where realistic expectations of pregnancy outcomes and the limitations of medical care are never fully explained, continue to seek someone to blame for the tragic problems in their child.

Debendox

Debendox was a drug given to pregnant women to prevent severe nausea and vomiting in pregnancy. Such symptoms are very common in pregnancy and can be very debilitating. Thus it was prescribed commonly. About 30% of pregnant women in Australia may have been on the drug. Birth defects also occur frequently - that's 12-and-a-half-thousand every year in Australia - of all Australian births have a major abnormality. Thus it is relatively easy to collect a series of exposed cases and suggest a relationship. This was done by a Canadian physician in 1969.

The importance of going public with such information is to obtain a group of control children without birth defects, to ascertain the level of exposure in them. Alternatively, one could compare the occurrence of birth defects between two large cohorts of pregnant women - one on Debendox and one who had not been on Debendox. Only then can we estimate a relative risk of exposure in relation to birth defects. This was done again and again and again and showed no association. But this information did not influence the courts nor the media.

As soon as the first case went to court in Florida in the late 1970s, the then Australian obstetrician researcher, William McBride, suggested that the association was causal based on animal and human data. Until animal data in a key experiment was eventually shown to be fraudulent by the ABC's Norman Swan, McBride was used extensively by lawyers in the USA and Australia as an expert witness for the plaintiffs. His human data never had a control group.

Juries of non-epidemiologists were influenced by clever lawyers for the plaintiff. The tragedy of a disabled child is the emotive factor which seems to influence many juries in favour of the plaintiff. The presentation of good scientific evidence against Debendox being a teratogen (a teratogen is a chemical causing a birth defect) did not appear to influence them. Thirty trials over thirteen years from 1700 suits, with many being settled out of court, resulted initially in a 30% success rate for the plaintiffs, one as recently as 1991.

The effects of this litigation were that women believed that Debendox was a teratogen and they stopped taking it. The costs of litigation were not being met by the falling sales of the drug, and eventually, in spite of no evidence of teratogenicity, Merrell Dow stopped making the drug and took it off the market.

There is now no good safe drug for use in pregnancy nausea. Women are too scared to take anything else, so they just go on suffering or into hospital for intravenous fluid replacement, and no drug company is ever likely to make or market another drug, given the Debendox fiasco. So who won?

The lawyers were the only winners as eventually most of the court cases were thrown out on appeal. The families of affected children lost everything as well. Litigation spawned over forty research studies, so that the safety of Debendox has been proved conclusively and some what unnecessarily, over and over again. It was the translation of science into evidence that was particularly flawed.

Conclusion

Well, has litigation served anyone well? Who are the winners and who are the losers in these fiascos? The community and medical care are the losers. Doctors cannot avoid litigation by practising defensively, as litigation is illogical and unpredictable. There is no evidence that increasing litigation has resulted in better obstetric care, fewer cases of brain damage following vaccines, fewer birth defects, or better and cheaper screening programs to prevent cancer. Litigation has had the reverse effects.

Can we change the legal system, and if we could, how would we? There are two general responses: one that I support is to avoid the courts altogether as occurred with the Vaccine Compensation Acts in the United Kingdom and the USA. The other way is to improve the way in which the courts handle evidence so that science is better converted into evidence that can be assimilated by judge and/or jury alike. In all Australian States except Victoria and New South Wales, I believe that juries are no longer used and civil cases are tried by a judge alone.

I support the idea of compensation, not no-fault compensation but compensation without proof of fault. The concept of fast-tracking compensation outside the court system for those inevitable, but unpredictable, very rare and non-negligent cases of adverse consequences of public health interventions has been implemented overseas. Such compensation would be quick, fair and helpful and should be introduced immediately. People need to debate how it should be funded - possibly by an additional levy on Medicare, similar to motor vehicle insurance.

The courts could then be reserved for those cases where negligence was provable. Mediation, structured settlements, capping payments and statutes of limitation have all been suggested, along with changes to improve the evidence from expert witnesses such as court-appointed witnesses rather than ones appointed for the plaintiff or the defence, peer reviewing of witnesses and - what I want to really support - scientifically conducted consensus statements.

I suggest using rigorous overviews such as the Cochrane Collaboration, which is an international activity trying to get a consensus on what are the effects of medical care and what therefore would be best practice, or considered best practice, based on an unbiased scientific overview. It's not a doctor-initiated study or a plaintiff-initiated one. It's an unbiased assessment of the effects of medical care. If we used such activities to decide on the standards of care rather than a biased witness, I think the situation would improve.

Rigorous randomised trials of new techniques, new drugs, screening tests, should be mandatory. The possibly devastating consequences of not doing so must be widely disseminated amongst doctors and health policy makers. And what about the medical profession? We must ensure that scientific proof of effectiveness in the practice of medicine in Australia is used. Every way of encouraging doctors to use evidence to guide their practice must be investigated. In Brecht's play, Galileo said 'the aim of science is not to open the door to everlasting wisdom, but to set a limit on everlasting error'.



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