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.