MMR Vaccine Damage cases

News February 2001

The purpose of this newsletter is to bring you up to date with progress on the cases and to describe the main processes that will be involved in the next few months. It will also discuss some of the main issues that have been in the news recently and clarify some points which may have been of concern to you.

The Progress of the MMR Litigation

As you are aware from our previous newsletters, all cases in which damages are claimed for injury and consequential loss caused by the MMR vaccine have now been formed into a group action. A Judge has been appointed to manage the progress of the litigation. His name is Mr Justice Bell.

At the last hearing in July 2000 Mr Justice Bell decided that the MMR Litigation should proceed by examining eight cases in detail where the Claimant's allege that bowel symptoms and autism were caused by the vaccine.

Eight illustrative cases have now been chosen and a detailed statement of case has been served for those eight cases. The Defendants are strongly contesting these claims and will shortly be serving their Defence.

These particular eight children are undergoing extensive medical examinations and testing by medical experts instructed on behalf of both parties.

On 13th March 2001 there will be another hearing – a "case management conference". This is a procedural hearing where the Court considers the practicalities of how to manage the litigation. The Court will decide what the next steps should be. It is likely a timetable will be fixed for the exchange of documents, witness statements and expert reports.

At some stage in the future there will be a trial to determine an important preliminary issue. For example, the Court may decide the question "Does the MMR vaccine cause inflammatory bowel disease and/or brain damage?" The Court's decision on this issue would have implications for the whole group.

We will keep you informed of further progress in future newsletters on this website.

Recent Media Coverage

The controversy over the MMR vaccine has been much reported recently in the media. We have had a lot of press interest in the subject and this has produced yet more enquiries from concerned parents. The numbers of cases contained in the group continue to increase. The group currently exceeds 2,000 in number and it is not yet known how many will finally join the group action.

You will no doubt have seen news coverage of a study from Finland which was reported in the media to prove once and for all that the MMR vaccine is safe. The paper referred to was "Serious Adverse Events After MMR Vaccination During A 14 Year Prospective Follow Up" published in the Paediatric Infectious Disease Journal (2000)

It was widely reported that this study followed up 1.8 million children over a 14 year period and that not a single case of autism and inflammatory bowel disease was found.

A closer look at the paper however suggests that the study was not as conclusive as much of the media reports might have indicated.

The study was in fact based on the vaccination of 1.8 million individuals, not all children. It included armed forces personnel, health service workers and older children. Autism appears to occur in children who have been damaged at a particular age when they are vulnerable. Older children and adults do not develop autism.

Strangely, the research has stated that "No case of inflammatory bowel disease or autism was detected during this long follow up study comprising 3 million vaccine doses". One of the experts has estimated that among the 1.8 million vaccinees, based on average incidence, there would have been as many as 2,500 cases of autism – possibly more. How then did the researchers did not find any cases of autism?

The reason is that the study was not of 1.8 million people but only 169. The study only followed up 169 cases where family doctors or local physicians had sent in a report that they thought an adverse reaction was connected to the MMR vaccine.

It is widely accepted that the reporting of these adverse events using this kind of passive surveillance system is not adequate to show safety of a pharmaceutical product. This is because only the side effects that are expected will be reported by doctors and there can be huge under reporting. Even the authors of the paper acknowledge the shortcomings of this system. Further it is clear that side effects were only thought to be important if they were of a particular type and they occurred within a short time of vaccination. One of the symptoms that was discarded as a possible adverse effect was gastrointestinal disturbance (diarrhoea) which of course could have been a symptom of the development of inflammatory bowel disease. Given the follow up only considered the medical records of 169 cases, it is not particularly surprising that no cases of autism were found within this group.

The paper therefore does little to clarify the issue of whether the MMR vaccine causes inflammatory bowel disease and autism. The research was partly funded by Merck, one of the pharmaceutical companies which makes the MMR vaccine.

Paper On Safety Trials Leading To The Introduction Of MMR

Dr Wakefield, from The Royal Free Hospital, and Dr Montgomery, at The Karolinska Institute in Sweden, wrote a paper which was published on 21st January 2001 which looked at the amount and extent of safety trials undertaken prior to the introduction of MMR on a wide scale. These trials were predominately carried out in the USA, where MMR was introduced in the 1970's, and further trials were conducted in the UK prior to the MMR vaccine being introduced here in 1988.

As you will probably have heard in the media, the paper was peer reviewed by scientists and doctors who themselves have worked in an advisory capacity to committees giving approval and licenses to MMR vaccines, and who now have added their criticisms of the safety trials.

The rising incidence of autism

A paper has been published in the British Medical Journal this month written by Kaye J A et al. This paper looks at the rising incidence of autism over time. It reports that the incidence of newly diagnosed autism increased seven-fold from 1988 to 1999. It concludes that as incidence of autism increased during the years of 1998 to 1993, but as the vaccine coverage remained steady at over 95% during this period, there was evidence against correlation between the two. This is because if the vaccine exposure was linked to autism then the rate of autism should have risen to a set point and they evened out as exposure remained constant, not continued to rise.

However, it has never been suggested that all cases of autism are linked to the MMR vaccination and the level of possible MMR induced autism could well have evened out and cases of autism from other exposures may well be causing the rest of the rise and hiding the MMR numbers. The study was again used to "disprove" the connection between MMR and autism but clearly this conclusion cannot safely be drawn from it. The study was carried out by the Boston Collaborative Drug Surveillance Programme which is in part supported by grants from a number of the world's largest pharmaceutical corporations.

Idiopathic Thrombocytopenic Purpura (ITP).

The government's Public Health Laboratory Service announced this month that a causal association exists between the MMR vaccine and a rare condition known as idiopathic thrombocytopenic purpura (ITP). The research is published in the journal Archives of Disease in Childhood.

ITP is an autoimmune illness in which the body attacks itself and destroys the platelets within the blood.

Although ITP can lead to removal of the spleen and/or death this is extremely rare and ITP is usually treated with drugs.

Victims generally feel tired, feverish and develop a purple rash, which can turn black and spread over the body. The platelet count also becomes exceedingly low and spontaneous bleeding from the nose, gums and gastrointestinal tract can be seen.

The study calculated that two out of every three cases of ITP that occurred 6 weeks after immunisation were caused by the MMR and 1 in every 22,300 vaccinations will result in admission to hospital to ITP.

We would like very much to hear from any parent who has a child who has been diagnosed with ITP or any other rare autoimmune condition.

Continuing Medical Investigations

Medical research is continuing on the mechanisms of damage caused by the vaccine. Some children with gastrointestinal symptoms have had small samples of tissue removed from the bowel for testing. The hypothesis is that a longstanding chronic infection of the bowel by the measles virus leads to inflammation of the bowel. This in turn might lead to a gut that is "leaky", allowing peptides (chemicals from the digestive process) to get into the blood stream and then into the brain. The possibility is that if this happens at a vulnerable age, the child can suffer brain damage and become autistic.

The biopsy tissue samples are being tested and so far show that the measles virus from the MMR vaccine is capable of producing a chronic infection and inflammation. Genetic sequencing of the measles virus found in bowel tissue samples has apparently shown the source of the virus to be the vaccine rather than a wild infection. This work is continuing.

Although only the autism/inflammatory bowel disease cases are currently proceeding in the group litigation, there are other cases such as encephalitis, epilepsy and sensory neural deafness, which still remain within the group. Usually, in these cases, a strong temporal link exists between the vaccine and the onset of symptoms. In those cases we have to look closely at the facts of each case and in due course it may be possible to offer tests that will help gather evidence for these cases.

Individual Cases

For each individual case, we start off by obtaining a Legal Aid Certificate to cover the costs of investigating the case. Once Legal Aid has been obtained, we then obtain all the relevant medical records. We will then arrange to come and see you to take a detailed statement from you regarding the case. We will try to secure and preserve all important evidence relating to your child's individual case.

In all cases we have to continuously review the merits of each individual case. It is in the interests of all members of the group that weak cases are not encouraged. We may decide to instruct a barrister to consider your individual case and advise as whether there is a realistic prospect of success.

We will ensure that proceedings are issued on each case before the expiry of ten years from the date the vaccine was given. This preserves the right to bring the claim under the Consumer Protection Act 1987.

Once these steps are taken there may be significant periods when you don't hear much from us. The reason for this is that in a group action we have to manage the work we do and this may involve periods of inactivity on an individual case.

We will keep you updated by future newsletters as to the further progress of the group litigation and will keep you informed of any significant advances in the medical and scientific research on the issue.

If you have any queries or concerns regarding your child's case then please do not hesitate to contact the person who has conduct of your case.

The members of our team are :-

If you want any further information about the MMR Vaccine damage litigation please do not hesitate to contact us

In preparing the above, Hodge Jones & Allen have relied on information supplied by Alexander Harris, who have conduct of the generic issues of the MMR litigation on behalf of Claimants.