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NORFOLK, England-Medical product liability litigation may increase in the United Kingdom if a new strategy for seeking compensation for alleged victims of pharmaceutical products proves successful.
U.K. lawyers plan to use European Union-based product liability legislation to seek compensation for alleged victims of pharmaceutical products. Although lawyers have researched numerous complaints, no lawsuits have been filed yet.
Historically, U.K. compensation law has required proof of negligence. But, the Consumer Protection Act 1987, which became effective in 1988, enacted E.U. product liability legislation and introduced no-fault product liability law.
Using the 8-year-old Consumer Protection Act, a U.K. law firm plans to seek compensation for dozens, perhaps hundreds, of children who claim they were injured by the U.K. government's childhood immunization program, in particular the measles, mumps and rubella vaccine.
Under the Consumer Protection Act, anyone injured by a defect in a product is entitled to compensation from the manufacturer. It is not necessary to show that the manufacturer was negligent.
No vaccine case has yet proved medical negligence in the United Kingdom, lawyers say. However, Dawbarns, a King's Lynn, Norfolk-based law firm, said that using the product liability law may prove a more successful strategy.
Successful litigation could set precedents for medical product liability suits in the United Kingdom.
"Very few cases have yet been decided by English courts on the Consumer Protection Act, so no court guidelines have yet been laid down," the law firm said in a fact sheet on the legislation.
Dawbarns said it believes the law can be applied to pharmaceutical products. The act imposes new and higher standards on manufacturers to explain risks and give clear instructions for use, according to the law firm.
"Even though many pharmaceutical products have side effects, they would not necessarily be regarded as being unsafe," particularly if the side effects are less severe than the untreated condition, Dawbarns said. But, "if a product causes a long-lasting injury, which was not warned about, that must raise the distinct possibility that it was unsafe."
Parents who claim their children have suffered complications or even died as a result of inoculation argue they were insufficiently warned about possible side effects.
"Parents are informed of the minor reactions such as fevers and rashes but not of any serious problems," said Jackie Fletcher, who lives near Warrington, Cheshire. She believes her 4-year-old son suffers from epilepsy, an impaired immune system, poor communication skills and learning difficulties as a result of the MMR vaccine.
Ms. Fletcher set up Justice Awareness and Basis Support, a support group for parents, in December 1992.
Since then, she has been contacted by 500 families who believe their children have been injured through inoculation. She said those numbers discredit the government's claim that risk of serious damage from vaccines is "very rare."
Dawbarns and Nottingham-based law firm Freeth Cartwright were given a contract by the Legal Aid Board in September 1994 to coordinate and investigate the MMR complaints. The Legal Aid Board is a government-funded organization that subsidizes some legal actions.
MMR vaccinations are given to British children between the ages of 1 and 2 years under a government-sponsored program. The vast majority of children receiving the vaccine.
Until September 1992, three types of MMR vaccines, manufactured by Merieux U.K. Ltd., SmithKline Beecham P.L.C. and Wellcome P.L.C., were available in the United Kingdom. The government withdrew two of the vaccines after reports of "mild transient caused by the mumps vaccine in some children," the government's chief medical officer said in a statement.
Dawbarns questions why it took the government so long to act against the vaccines when one of the vaccines had been withdrawn in Canada as early as May 1990. In Japan, all MMR vaccines have been withdrawn, the law firm noted.
Since September 1992, MMR II-distributed by Wellcome, which since has merged with Glaxo-has been used to vaccinate children in the United Kingdom. Although there are allegations that this vaccine is also causing problems, a lawyer for London-based Glaxo Wellcome P.L.C. said she was unaware of any suits filed against the company as a result of the allegations.
However, Dawbarns is pursuing 70 cases with "several hundred in the pipeline," said Dawbarns researcher Kirsten Lamb. So far no lawsuits have been filed.
Strong evidence is needed to obtain legal aid, she said. For example, "there must be a clear reaction to the vaccine within a specified number of days for each vaccine."
Many of the alleged MMR victims had seizures within days of being inoculated and lost powers of speech and mobility within weeks, she said.
The British government established a state-funded unit responsible for compensating victims of immunizations in 1979. To receive a one-time payment of 30,000 ($46,500) from the Vaccine Damage Pay Unit, victims must prove that they are 80% disabled directly as a result of a vaccine. Since the fund began, 879 payments have been made from 3,711 claims.