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The Measles Mumps Rubella (MMR) vaccine

Alexander Harris are representing 43 clients who believe they have been damaged as a result of the MMR/MR
Their conditions include:


If you would like the MMR/MR team to assess your enquiry, please complete the online enquiry form, or telephone 08700 77 88 77

Related news article
Approved Judgement: Some Legal Aid Appeals Successful

 

Archived information

Measles Mumps Rubella (MMR) vaccine was introduced in the UK in 1988. It superseded single vaccines against measles and rubella which had been available for a number of years previously. Mumps vaccine had never been widely used as a single vaccine. Since this time there has been a concerted programme of vaccination with the trivalent MMR vaccine on a very large scale. It has been estimated that something in the region of 1 million vaccinations are administered annually.

Legal interest was first sparked in 1990 when a concerned mother approached Richard Barr after her son had developed meningitis shortly after having received the MMR vaccine. Richard investigated and established that the vaccine had indeed caused her son's illness. Fortunately for this family it was further established that there would be no long-term consequences as a result of the meningitis. This case left those involved with many questions with regard to the vaccines and their safety.

In September 1992 the Department of Health stopped using two of the three brands of the vaccine which were then available. These were: Pluserix and Immravax. At this time a group of parents whose children had suffered severe injury after being vaccinated contacted Richard. These parents believed that their children had suffered brain damage and other injuries as a result of receiving the vaccine. Among the conditions suffered by the children at this time were autism or autistic spectrum disorders.

After Richard had been contacted by several hundred families (who complained that their children had become autistic) a clear pattern began to emerge; children who were developing well (both physically and intellectually) before the vaccine, a regression after vaccination often accompanied by other symptoms and a gradual decline into autism. Before he joined Alexander Harris (early in 1999), Richard Barr had been working on the MMR cases for some time. After joining Alexander Harris Richard headed the Science Team investigating the cases and working with a team of Solicitors, paralegals and three Scientists.

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The Vaccines

The MMR vaccines were first introduced to the UK in October 1988 as part of a campaign to reduce childhood illness. They are a triple vaccine, using the mumps, measles and rubella live viruses. Until September 14th 1992 there were three types of MMR vaccine available:

IMMRAVAX - Manufactured by Aventis Pasteur MSD Ltd (formerly Merieux UK Ltd)
PLUSERIX-MMR - Manufactured by SmithKline Beecham Plc
MMR ll - Manufactured by Merck & Co Inc (formerly Merck Sharpe and Dohme)

Pluserix-MMR and Immravax vaccines contain the Urabe strain of mumps vaccine virus; MMR ll vaccine contains the Jeryl Lynn strain of mumps vaccine virus.

In September 1992 the Chief Medical Officer announced, "changes in supply". From that moment onwards only MMR ll would be available. Both Immravax and Pluserix have subsequently been withdrawn in this country. This change was brought about following reports of viral meningitis caused by the mumps vaccine virus in some children who had received either Immravax or Pluserix. The rate of incidence of meningitis with the Jeryl Lynn strain was considered much lower.

In fact TRIVIRIX an MMR vaccine containing the Urabe strain of the virus was suspended in Canada about 6 months before the introduction of MMR vaccines in the UK in October 1988 due to the same safety concerns, yet vaccines containing the same strain of virus (Urabe) were not only introduced into this country as part of the MMR campaign; they were not withdrawn in the UK until 1992.

In the autumn of 1994 it was announced that the Government feared an epidemic of measles and that it aimed to vaccinate all children between the ages of 5 and 16 with the Measles/Rubella vaccine. The two brands, which were used in this campaign, were produced by the same manufacturer as the two brands of the MMR vaccine that had been withdrawn. We are handling a number of claims arising from this vaccination campaign. Because the children were older when vaccinated, the pattern of injury is different. For instance there are virtually no cases of autism arising from this campaign, but many children suffer from very serious bowel problems.

More recently Priorix, manufactured by SmithKline Beecham Plc, was introduced to the UK in 1997 as a new version of MMR. This vaccine contains the Jeryl Lynn strain of the mumps virus.

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The Claimants

Prior to the withdrawal of Legal Aid there were approximately 1,600 children who had been granted legal aid and whose parents believed that they had been damaged as a result of the vaccines. Many, although by no means all of these, had issued court proceedings and joined the group litigation.

They were divided into groups:-
The MMR Vaccine claimants - children who were all typically vaccinated at a young age (usually around 15 months) with the MMR vaccine.
The MR vaccine claimants - children who were vaccinated with the mumps/rubella vaccine in the widely publicised campaign in the autumn of 1994 to vaccinate 7million children. By definition these are older children aged between 5 and 16 years.

In some cases, children had not only been given the MMR but had then been vaccinated once more with the MR in the 1994 campaign.

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Our Investigations

During the litigation a range of side effects were reported to us following children being vaccinated with the MMR and MR vaccines. These included autism, bowel problems, juvenile rheumatoid arthritis, epilepsy, brain damage, meningitis, encephalopathy, encephalitis, deafness in one or both ears, multiple sclerosis, optic neuritis, Guillain Barré Syndrome and also behavioural and learning problems in the older children.

Many children suffered more than one side effect, the multiple distress of inflammatory bowel disease coupled with autism being one such instance.

Side effects from vaccines are widely recognised, though fortunately most are mild and transient. It is also recognised that there can be serious long-term adverse effects from vaccines.

It is important to stress that parents tell us that their children, who were fit and well before being vaccinated and were developing normally in every way, are now chronically ill and many now are seriously mentally or physically disabled.

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The Legal Case

The MMR Litigation was halted following public funding (legal aid) being withdrawn in September 2003. An appeal was made by the claimants' lawyers against the Legal Services Commission's decision, and a Funding Review Committee (FRC) was subsequently convened to look at the decision to withdraw funding. This Committee upheld the decision of the LSC. Since this time the lawyers for the claimants have appealed the decision of the FRC. On 27th February 2004 this Judicial Review challenge to the withdrawal of public funding was unsuccessful. A further appeal of this decision was considered by our Judicial Review Counsel but having read and carefully considered the judgment, they reached the view that an appeal would be unlikely to succeed and that further public funding would not be justified. This came as a bitter disappointment to all involved. For many this could mark the end of their cases for compensation. The Court case still exists but without legal aid the Claimants are placed in enormous difficulty trying to pursue their claims further. The Defendant drug companies have obtained orders from the Court requiring Claimants to give an indication of whether they wish to proceed with or abandon their claims by 14th May 2004 - even though by then many Claimants may not know whether their own individual legal aid certificate is to be discharged or not. There will be another court hearing on 26th July 2004 when the Court will review the position and how the cases should proceed thereafter.

Consumer Protection rather than negligence
The cases were brought under the Consumer Protection Act 1987 ("CPA") which makes manufacturers legally responsible for unsafe products. It was agreed that this was the best route to take rather than suing for negligence (see below). However the CPA has a downside. It imposes a strict 10-year time limit during which proceedings have to be started at the Court office. This time limit is not extendable even for a child who lacks mental capacity (for example due to brain damage). Once the time limit has expired there is no longer any chance of bringing a case under the CPA. Unfortunately it is not even clear when the 10-year time limit begins to run. It may run from when the batch of vaccine is supplied and we know that the MMR has a shelf life of 2 years; or it may run from when the individual injection is prepared for use.

The real drawback of the Consumer Protection Act time limits is that we were forced to start court proceedings before we had the necessary evidence to prove the cases. We had no choice here, because if we had not started proceedings the right to sue under this Act would have been lost. But it did mean that we were involved in a race to get the science into a state where it could prove the cases in time for a trial.

If it had not been for this time limit, we would have had and used the time to get the cases ready for trial BEFORE issuing proceedings. As it was, every step we took had to be disclosed to the defendants. This made the task doubly difficult.

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Negligence

If a case is brought under the quite separate law of negligence then different considerations apply. Manufacturers are not responsible for damage caused simply because they distributed an unsafe product. Rather they are only responsible if it can be shown that they were at fault in the design, production, supply and/or monitoring of the drug. It is generally more difficult to prove fault than to prove that a product is unsafe.

In either case it is necessary to show that the vaccine caused or contributed to the injury. And there was the problem - because the LSC were unconvinced that if the cases went to court in the near future we would win on the causation argument. If we didn't win on causation, questions of negligence would never arise.

In negligence however more generous time limits apply. For adults who are injured, cases have to be started at the Court office within 3 years of damage occurring or the injured person having knowledge of who was responsible for what happened whichever is the later (the exact definition of date of knowledge is complex so we have only paraphrased it here). For children the time limit is within 3 years of their 18th birthday i.e. by the time they reach 21. For people who are not capable of managing their affairs due to some mental impairment the time limit may never operate at all and someone can start a case for them at any time (this could well be the case for many autistic or otherwise brain damaged children). This is in stark contrast to the strict 10-year non-extendable CPA time limit.

As the cases started were brought under the CPA, it remains a possibility that fresh proceedings could be brought at a later date for negligence if sufficient evidence could be gathered together.

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How were the cases being funded?

Alexander Harris had a contract with the Legal Services Commission that provided funding to carry out both generic and individual work on the MMR cases. Generic work is the work that is undertaken for the benefit of the group action as a whole and includes investigation of the lead cases, scientific research, liasing with medical experts and preparing the overall case for trial.

In theory the litigation could go on without legal aid. The reality is however that without public funding it would be nigh on impossible to fully prepare the case for a long trial. One estimate puts the cost of paying for the work from now until the conclusion of trial on the Claimants' side alone at £10million. In addition the nearly inevitable rule in litigation in this country is that the losing party pays the winners legal costs as well as their own. By having legal aid Claimants (and their litigation friends) have some degree of protection against being ordered by the Court to pay the Defendants' legal costs if the case were to go to court and not win. Without legal aid no such protection exists. The homes of the families involved would be at risk. It is not going to be possible to obtain insurance against the risk of losing to cover such a possibility. The pharmaceutical companies may well spend far more than £10million between now and the end of any trial.

The MMR/MR litigation was always going to be hard fought. Experience has borne that out. Without a team of lawyers and experts with major financial backing (such as legal aid), the chances of winning are, at best, greatly reduced. The worst outcome would be to take a badly prepared case to Court and fight it weakly because of lack of preparation, backup and resources. The pharmaceutical companies have, in comparison, unlimited resources and the fight would be a very unequal one. Suppose the Judge then found on the evidence he heard that MMR/MR did not cause ASD or IBD. As a result not only the lead cases, but also the children who are waiting in the wings (whose cases have been issued and stayed pending the lead cases being heard), could well find themselves barred from bringing a claim at a later date - even if evidence emerged in the meantime which helped them or even proved the link with the vaccine. That would be a further disaster.

We know that some parents of children with ASD and/or IBD wish to continue without legal representation. We wish them well but it will be a very unequal struggle. Other parents have children with conditions other than ASD or IBD. We have given them advice as to the extent to which they are affected by the LSC decision on ASD and IBD. The problems they face are somewhat different, as the case so far has focused on ASD and IBD. Again we wish them well. We expect that work is underway in different parts of the world to look even more closely at whether there are links between MMR/MR vaccines and ASD, IBD and various other conditions. The problem is that we do not know when such work may be completed and results may come too late to be of use in the litigation. The Claimants will no longer be able to afford to pay for expensive research to be done by experts for the purpose of the Court proceedings.

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Conclusion

On 23rd June 2004 Master Ungley, at a hearing at the Royal Courts of Justice, refused to approve the ending (by a procedure known as "discontinuance") of a number of cases against Merck & Co. The cases, affecting some 48 Claimants, were those where litigation friends had agreed to stop their child's claim against Merck and in addition had promised never to sue Merck again over MMR whether in the UK or anywhere else in the world. In exchange Merck were to agree not to try to make any claim for legal costs against either the Claimant or the litigation friend. A number of the families had been very concerned indeed following correspondence from Merck's lawyers that they would try to make a claim for costs against them despite the fact that having legal aid usually protects claimants against costs claims.

Master Ungley decided that while the litigation friend might be reassured by the terms of such an arrangement, it was not in the interests of the child claimant never to be able to sue again. Accordingly he refused to approve those conditions.

The Court considered this issue further when the case was heard before the Honourable Mr Justice Keith at the case management conference (CMC) at the RCJ on Monday 26th July 2004 at 10.30am.

The Legal Services Commission refused our request for legal aid to provide representation for the Claimants at the hearing. Alexander Harris and one member of Counsel therefore attended the CMC, on a pro bono basis, to try to help those parents who wanted to discontinue their case without accepting Merck's terms never to sue again anywhere in the world.

MMR/MR claimants who have issued proceedings can obtain a copy of the court order made on the 30th July 2004 either on application to Caroline Moore at Lovells or from the court office.

According to the Legal Services Commission, all of the individual legal aid certificates have now been discharged. A number of families are appealing the discharge of legal aid. The indications are that any such appeals will be heard in or around September 2004.

No-one is more sorry than we are that this state of affairs has arisen. It has always seemed to us that the vital question that needed answering was whether or not MMR causes autism. That question remains unanswered. That cannot be satisfactory to the public at large let alone to our clients.

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