Law Report: Court ruling against whooping cough claim

Queen’s Bench Division Loveday v Renton and another Before Mr Justice Stuart-Smith March 29 and 30 1988. In an action claiming damages for brain damage alleged to have been caused by whooping cough (pertussis) vaccination the plaintiffs failed on a preliminary issue to show on the balance of probabilities that the vaccine was capable of causing brain damage.

THE FACTS

The plaintiff, Susan Jacqueline Loveday, now aged 17, claimed damages against Dr George Renton for permanent brain damage after the administering of whooping cough vaccine in 1970 and 1971. The judge heard a preliminary issue as to whether pertussis vaccine could cause permanent brain damage in young children. Depending on the outcome of the present case there were 200 other cases waiting to come to trial.

THE DECISION

Mr Justice Stuart-Smith said that the burden of proof rested on the plaintiff to show on a balance of probability that it was more likely than not that the vaccine could cause permanent brain damage.

Medical and expert opinion was deeply divided on the issue. The question had to be determined on all the evidence in the case, which was preimarily the oral evidence of witnesses, tested in cross-examination. But the question was not answered by showing that there was a respectable and responsible body of medical opinion that the vaccine, albeit rarely, caused permanent brain damage, or that that view might be more likely than the contrary.

The opinion of others not called to give evidence was not admissible to prove the truth of the opinion. The works of learned and qualified authors formed part of the general corpus of medical and scientific learning on the subject and could be relied on and adopted by suitably qualified expert witnesses who might have their opinions tested in the light of that literature.

Similarly the contra-indications against the vaccine published from time to time in this country by the DHSS and similar bodies in other countries could not be relied upon as though it was evidence of qualified experts not called as witnesses, that the vaccine in fact caused brain damage.

Reports of cases in the case series, or by clinicians of encephalopathy (inflammation of the brain), resulting in some cases in brain damage or death (where the onset of the illness occurred shortly after vaccination) raised the hypothesis that the vaccination might cause brain damage or death. It did not prove the hypothesis nor raise a prima facie case.

What it did establish was that encephalopathy resulting occasionally in permanent brain damage or death did sometimes occur in close temporal proximity to pertussis vaccination. The hypothesis appeared to be that the vaccine might cause that condition where the conset of symptoms occurred within about 72 hours, more usually 24 hours. That was the overwhelming effect of the evidence called on both sides.

There were potential areas where evidence could be sought that might establish a causal link between permanent brain damage and pertussis vaccine. There was no evidence of an indentifiable clinical syndrome which was specific to pertussis vaccine nor a specific pathology which was peculiar to cases of death following the vaccine. Nor was there animal experimentation showing that encephalopathy leading to permanent brain damage occurred within 72 hours of injection of pertussis vaccine.

The plaintiff’s case was that it was only children who were in some way vulnerable who were affected by the vaccine. The vulnerabilities referred to might explain why such events occasionally occurred in close temporal association with this and indeed other vaccinations as well, but it did not show that any brain damage or epilepsy that ultimately resulted was due to the vaccine as opposed to the underlying pathology.

In the last analysis it seemed that if pertussis vaccine could on very rare occasions cause permanent brain damage in some children it must do so because of some vulnerability or susceptibility on the part of the child. That did not help to establish the hypothesis.

His Lordship had come to the clear conclusion that the plaintiff had failed to satisfy him on the balance of probability that pertussis vaccine could cause permanent brain damage in young children. It was possible that it did; the contrary could not be proved. But in the result the plaintiff’s claim must fail.

His Lordship said that even if he had found in favour of the plaintiff on the preliminary issue any plaintiff would face insuperable difficulties in establishing negligence on the part of the doctor or nurse in administering the vaccine. Such a claim would have to be based on the grounds that the vaccination had been given in spite of certain contraindications.

Appearances: Stanley Brodie QC and Jacqueline Beech instructed by Teacher Stern & Selby for the plaintiff; Nicholas Underhill instructed by Hempsons for the doctor; Anthony Machin QC and Michael Spencer instructed by Davies Arnold & Cooper for the Wellcome Foundation who were joined as defendants.

Heroin brain damage rising

The number of victims of heroin-induced brain damage, who are sometimes left blind, paralysed or incontinent, has increased dramatically in recent years, figures show.

Many are left unable to care for themselves, but they are forgotten statistics, ignored amid the publicity surrounding drug deaths and drug-related crime.

Others make significant recoveries and the signs of their brain damage might be subtle. Occasionally they might encounter memory difficulties, behavior problems or decision-making difficulties.

Some need just a couple of weeks of rehabilitation, the more severely injured more than six months. And others are simply too acutely ill to be sent to rehabilitation programs.

Before the 1990s, heroin-related brain damage was a phenomenon rarely seen by the Melbourne rehabilitation medicine specialists, Dr David Burke and Dr Barry Rawicki.

Now, heroin overdose has replaced injury as the major cause of brain damage requiring treatment at the Royal Talbot Rehabilitation Centre’s acquired brain injury unit in Kew, where Dr Burke is a consultant.

Dr Burke, a rehabilitation specialist for nearly 35 years, said he was saddened and disturbed by the growing toll.

“In the past two years it’s been a new disease process for us, and it seems to be very much on the increase, because particularly in the past six months it’s been very busy,” Dr Burke said. Last year at least 11 patients with brain damage from a heroin overdose were referred to Royal Talbot. In 1997, the unit treated five patients suffering brain damage from a heroin overdose and in 1996, none at all. Two young men are still waiting for a bed in the 12-bed unit.

Last month The Age revealed that up to 10,000 patients were treated in Victorian hospitals each year for drug overdoses. Generally, the victims of heroin-related brain damage are aged between the late teens and early 30s. Most are men, some destined to spend the rest of their days in a nursing home.

Dr Burke said the victims came from all groups in society. Some were long-term drug users, some had a drug habit and psychiatric illness, some were possibly drug peddlers and users and others were probably just experimenting, he said.

Often the drug overdose patients rehabilitating in the brain injury unit at Royal Talbot are isolated people, estranged from families and lacking social supports. But others are simply from middle-class Melbourne.

The role of heroin and other drugs in brain injury is also about to be examined in a Melbourne study. The research, by the director of rehabilitation medicine at the Epworth Hospital, Associate Professor John Olver, and other researchers, will investigate how many people who suffer brain injury from road and other accident trauma had drugs or alcohol in their system.

Professor Olver said it was hoped the research would give doctors a better understanding of how to rehabilitate these patients.

Look Health: Whooping cough – to vaccinate or not? / The risks of whooping cough and vaccination

THE DECISION whether or not to immunise a child against whooping cough is one of the most agonising that parents have to take. On the one hand frightening stories about babies brain-damaged by the vaccine deter them from accepting immunisation, while on the other doctors and health visitors press it on them.

Doubts about the overall benefits of whooping cough vaccine were widely held a few years ago by doctors, but now the expert committee which advises the Department of Health has pronounced it to be a good thing and most doctors accept this advice. So GPs and clinics are now putting pressure on parents to accept the vaccine. But worried parents are still asking the following questions:

What are the risks of brain damage from the vaccine and the disease?

An important British research project, the National Child Encephalopathy Study, found that one child suffered permanent brain damage following immunisation for every 100,000 children receiving a complete course of three injections. The risk for a completely normal, healthy child might be less.

However, assumptions are built into the calculation of this one in 100,000 risk which, according to critics such as Professor Gordon Stewart, formerly of Glasgow university, raise serious doubts. To obtain this estimate, doctors searched hospital records for children who had suffered fits which indicated brain damage. They then looked to see if the fits started immediately after immunisation.

The estimate of risk is not comprehensive because the doctors counted only children who had fits lasting more than half an hour. Some children can suffer brain damage after having fits lasting less than half an hour, but these children were overlooked. Nor were children counted if they had suffered brain damage but had never been admitted to hospital – some 20% of brain damaged children may come into this category.

Alternative methods of calculating risk of permanent brain damage following whooping cough immunisation put the figure at one in 50,000 children immunised. These estimates are even less precise, but in the absence of a definitive figure cannot be ignored.

There are other imponderables. Some children may suffer lesser degrees of brain damages which are not recognized at the time but may show up later as slow learning or minor problems of control over movement. These are too difficult to identify and so cannot be included in the estimate of risk.

On the other side of the equation, whooping cough itself can cause damage to the brain that may be permanent. If no one was immunised, the incidence of this brain damage caused by the disease itself might be similar to the incidence of brain damage resulting from vaccination. This is the assumption made by an American team that calculated risks and benefits. If this is the case, then these two risks cancel each other out, leaving no compelling reason for or against immunisation on this count alone.

What is the chance of a child dying from whooping cough and can this be prevented by vaccination?

Treatment of whooping cough has improved greatly over the years, with the introduction of antibiotic drugs that prevent pneumonia and as a result of improvement in intensive care. There were only 46 deaths between 1976 and 1981, when only 42% of children were immunised and the incidence of disease was high. This compares with 82 deaths during 1970-75, when 76% of children were immunised and there was less disease. So contrary to expectation, deaths have continued to decline even when the disease has increased in prevalance.

Better immunisation could prevent only about half of these deaths, because more than 50% of the children who die are under three months old – an age at which they could not have been immunised. It may be urged that fewer of these infants would die if there was a higher number of immunised children in the population, so reducing circulation of infection. However, children who have been immunised often get a mild infection which can still cause the full disease when passed to someone who is not immunised. Whooping cough immunisation helps to prevent the disease, but it is much less effective in preventing infection.

So fuller immunisation of the population against whooping cough would save at most four deaths a year. Death is a small risk – comparable to the estimated risk of getting brain damage from the vaccine – so it is not a compelling reason to accept immunisation.

What is whooping cough like as an illness and what are the chances of getting it if a child is not vaccinated?

Whooping cough can be mild, but it can also be a very distressing disease both for the children who get it and for the parents who care for them. The children have bouts of coughing which often culminate in vomiting or blue attacks. A child may have as many as 50 of these attacks in 24 hours. Parents find them most distressing because they often feel that their child will die.

In one study of children who were eventually admitted to St George’s hospital, parents were found to have been woken at least five times every night for an average of 24 nights before the child was admitted to hospital. Some were woken 10 or 15 times a night and others never slept. The illness lasted an average of three months and generally imposed a great stress on marriages. These, however, are extreme cases – most children have more mild disease.

Reduction of the risk of serious illness which requires hospitalisation is the main benefit of immunisation against whooping cough. A child who is not immunised is six times more likely to get whooping cough than one who is. If the immunised child gets the disease, it is likely to be milder.

Does whooping cough cause any serious permanent damage to a child’s lungs?

A survey undertaken by doctors at St George’s Hospital, London, has found that whooping cough is unlikely to cause any permanent breathing problems.

Some children should not be immunised against whooping cough because the risk of side effects is higher for them. How do I know if my child comes into this category?

The circumstances in which immunisation should not be given are set out in a booklet, Immunisation against Infectious Disease, which is provided to all clinic doctors (see panel). However, an investigation by Professor David Hull of Nottingham university, has found there is considerable uncertainty in interpreting this official advice. Hull gave a group of doctors and health visitors 22 theoretical cases and asked them to advise for or against immunisation – in few cases was there substantial agreement. For example, about two thirds advised against immunisation for a premature baby who had been on artificial ventilation and about one third was in favour.

Should we immunise our child?

Official advice in Britain is a categorical yes. Calculation of the economic benefit of whooping cough vaccine has been made by experts at the US Centers for Disease Control in Atlanta, using mainly British data. They suggest that for every pound spent on immunisation, pounds 11 is saved in the cost of medical treatment. In fact, the economic benefits might be greater because this does not take account of loss of earnings. An 11-1 benefit is obviously a handsome pay-off for government, but this calculation can only be undertaken if assumptions are made which beg the very questions at issue.

For parents who sense these uncertainties, an 11-1 pay-off does not necessarily promise a big enough margin of benefit. The risks of the disease are not the same for everybody. A healthy, well-nourished child with his or her own bedroom is at much less risk of getting the disease, or of getting it badly, than a child living on a poor diet or sharing a bedroom with brothers or sisters. Nevertheless every child is potentially vulnerable. And each parent is different in his or her capacity to survive without sleep night after night. These are considerations which only parents themselves can bring to bear on the decision.

Official advice

A child should not be immunised against whooping cough if:

Suffering from a feverish illness or before having fully recovered from a feverish illness.

The child has had a severe local or general reaction to a preceding dose of vaccine.

The child has a history of damage or irritation to the brain or has suffered from fits or convulsions.

The child suffers from allergy (this may be a reason not to immunise, but opinion differs).

If the child suffers from a disease of the nervous system, has a nervous defect, or there is epilepsy in the immediate family, then the risk from immunisation may be higher, but the risk of damage from the disease may also be higher. Doctors are told to assess the balance of risk and benefit in such cases but it is not clear how this can be done.

Abstracted from official Health Departments’ advice

Harefield sued over brain damage

MATTHEW POYNTER was such a lively, happy baby that the management of Harefield hospital in west London chose to feature him in a promotional video to raise funds. Matthew, then just one year old, was filmed to the strains of the pop star Sting singing Every Breath You Take.

His parents treasure that video. It is the only one that exists of Matthew when he was a normal child. Not long after it was made he was given a new heart by Sir Magdi Yacoub, the world-renowned surgeon. He came out of the operation irreversibly brain-damaged.

The Poynters are not claiming anyone was medically negligent but that Yacoub and his team at Harefield failed to tell them of the risk of brain damage associated with the particular difficulties of open-heart surgery. In April they will seek damages in the High Court. They claim doctors did not warn them because surgical staff had already decided to go ahead with the operation. Yacoub’s team, they allege, was fully aware of their fears and unease about the surgery.

It is understood that Harefield hospital has conceded that its doctors did not warn them in advance. It argues there was no need to do so because the surgical team was better placed than the parents to judge what was best for Matthew.

His mother and father insist that if they had known of the risk they would not have allowed the operation to go ahead and would rather their son had died with dignity.

“Many people will find it difficult to understand,” said Kevin Poynter, an osteopath from Biggleswade, Bedfordshire. “We love Matthew and we knew that without the transplant he would die. But the way he was going was peaceful. We were told the transplant would only give a few more months or years. This was the choice: a high-tech death delayed for a while or a quiet passing away. If they had told us about any risk of brain damage we would have said no to the operation.”

Tom Osborne, the family’s solicitor, said the courts should back the right of parents to decide the fate of their child. “If the parent is responsible, it must be their decision to let a child live or die. This is life-threatening surgery. If the child survives but is brain-damaged there are consequences for the whole family. This family was not given enough information to make an informed decision.” He said he would call on expert witnesses to confirm that the risk of brain damage in heart surgery is well known and that patients are usually informed.

Matthew was born a healthy child. When he was eight months old he caught a virus that infected the muscle of his heart. At first he did not seem ill, but he had a cold which would not go away and his mother suspected something was wrong. Their GP referred them to the local hospital, where they were introduced to the idea that Matthew could be fatally ill and that his only option was a heart transplant.

“The doctor told us that in all likelihood he was going to die,” said Kevin Poynter. “Then they talked about transplant but right away I said no. No way.”

The Poynters were soon sent on to Harefield and their son was put into the surgical care of Yacoub. However, they continued to refuse to consider a transplant.

“I have always had reservations about transplants,” said Linda Poynter. “I don’t believe in life at any cost. The quality of life is more important than the quantity.”

She alleges that none of the doctors was prepared to discuss these concerns. “I just wanted to talk to somebody, but none of Yacoub’s doctors talked to us as much as we felt they should. I kept thinking, ‘When is Yacoub going to talk to us about this? He never did. I think we wanted to convince ourselves that we would be doing the right thing by agreeing to the transplant.”

The Poynters allege that one member of the transplant unit’s staff told them that if they continued to refuse the treatment, the hospital would obtain a court order.

Despite the parents’ reluc tance, Matthew was put on the transplant list. When a donor heart became available, they agreed to the operation. “We were told Matthew was going to die anyway, that the operation would extend his life for a few months. We could not deny him that extra time,” said Kevin Poynter.

The Poynters allege they were warned there was a risk that the operation might kill him but not that he could be brain-damaged as a result.

The operation itself was deeply traumatic. His mother carried Matthew down to the operating theatre where he was taken from her by a nurse. “It is imprinted in my mind for ever, his looking over the shoulder of the nurse and reaching out for us, screaming,” she said.

After the operation, Linda Poynter approached Yacoub as he was leaving the theatre. “He just said he was very sorry. I immediately thought Matthew must have died. He said that he was worried about organ damage. I thought he would come and explain what he meant. But we never saw him again.” Several months later it was confirmed that Matthew would not recover from the brain damage and would need lifelong nursing care. Now aged 10, he is incapable of doing anything for himself. He can move his head a little, can see bright lights and laugh and cry. But he cannot communicate in any other way and is constantly curled by body spasm into a ball.

The Poynters decided to sue the hospital when they were told by other doctors that they should have been told of the risk of brain damage.

In 1992, five years after Matthew’s operation, Rose Fleet, then eight years old, underwent heart surgery at Harefield and she, too, emerged with severe brain damage. Her parents have been granted legal aid to claim damages against the hospital. Polly Fleet, Rose’s mother, said last week she had not been told of possible brain damage.

Yacoub spoke to the family nine days after the operation. “He was adamant that everything had gone well and he could not understand the brain damage,” Fleet said. “If I had been told there was a risk of such severe brain damage, I would have said no. I would rather she had died the happy, chatty girl I remember. I was denied the right to make that decision.”

Doctors testify brain damage came from blows

A DOCTOR from Britain has told the High Court in Dublin that he considered a Co Dublin man, who is claiming he was beaten violently by gardai, had sustained brain damage from “day one” of the injury artd it was irreversible.

Dr Michael Abdul, head of the Solihull Pain Relief and Sports Injury Clinic, and an authority on head and brain injuries, said Mr Derek Fairbrother had been referred to him, and he saw Mr Fairbrother seven times during June and July 1988, and once on October 2nd this year.

Mr Fairbrother (28), Mays Cross, The Ward, Co Dublin, is suing the State for damages, claiming he was violently beaten by a number of gardai on June 12th, 1988, and suffered brain damage. The defence denies the claim and says that in striking him the gardai acted in self-defence and used no unnecessary force.

Dr Abdul told the court that his clinical finding was that he was confident Mr Fairbrother’s story was genuine. When Dr Abdul saw him in June 1988, Mr Fairbrother had lacerations on the back of his head. He complained of recurrent severe headaches and stiffness in the neck region. He did not speak much and was withdrawn and detached.

Dr Abdul said that he came to the conclusion that Mr Fairbrother was not really recovering. “In reality, I think this man has sustained brain damage from day one of the injury and it is irreversible.”

When he saw him again in October this year, Mr Fairbrother was worse. He had no sense of time and when he asked him how old he was, the patient replied that he was 24 years of age, which was his age when the incident happened. The doctor said that Mr Fairbrother was out of control, he could not look after his son, did not look after his personal hygiene, did not clean or wash, lost his way, would never be independent and could not have friends.

“The brain damage is totally linked to the injury he sustained on June 12th, 1988. I’m 99.9 per cent sure that it is definitely genuine. There is no evidence so far that he was faking,) Dr Abdul said.

Dr Arnold Orwil, a consultant psychiatrist, saw Mr Fairbrother in Britain in June 1988 and again in October this year. He said that Mr Fairbrother . behaved more like a child in many ways than a grown man. He said looking at the whole history of the case and Mr Fairbrother’s reactions, all suggested that hehad brain damage. When asked in court what the likely cause of the brain damage was, Dr Orwil replied: “Blow” to the head.”

Another witness, Dr Michael Timms, a senior psychologist on the National Rehabilitation Board, Dublin, said that he had assessed Mr Fairbrother four times since August 1988. He said that he gave Mr Fairbrother test’ for intellectual and memory function. The patient performed at a much lower level in the memory test than in the intellectual test One would expect some discrepancy between the two areas, but not so great a difference.

“Psvcholoeists take that kind of discrepancy as being indicative of brain damage,” he told the court.

A Birmingham professor of neurology, Professor Adrian Williams, said that when he recently examined Mr Fairbrother, it seemed he had lost intellectual skills in a very profound way. Professor Williams said he also concluded that Mr Fairbrother’s depression was very severe.

Mr Kevin Haugh SC, for the State, in cross-examination, asked Professor Williams whether, if Mr Fairbrother was feigning his symptoms, this would suggest a subtle form of thinking and a high level of function. Professor Williams said that was the first suggestion he had heard that Mr Fairbrother was feigning his symptoms. He would have had to be “pretty on the ball” to fool a battery of medical experts.

Mr Haugh said there would be evidence that the Garda doctor thought Mr Fairbrother was feigning his symptoms in Finglas Garda station on the night of the incident. Mr Fairbrother went down on the floor, started thrashing around, rubbed his hands on the floor and took dirt off the floor which he put on his face. Professor Williams said that if Mr Fairbrother was confused he could behave in very bizarre ways.

Ms Denise Gillen said she had known Mr Derek Fairbrother since she was 16 and they had lived together for the last four years.

There was no comparison between Derek now and what he was like before the incident.

The hearing continues today.