vaccinejustice

Swine flu vaccine remains on the news agenda around the world

An article in England in the Daily Mail on 2nd April, features the case of a little boy with narcolepsy after swine flu vaccine

This follows similar incidents in Ireland, reported here and some concern in Australia

Meanwhile the Chief Medical Officer of Finland has said that swine flu vaccines for children are “possibly a mistake”

And the Government of Finland has been reported as offering GlaxoSmithKline a contractual indemnity against product liability claims arising from swine flu vaccine. GSK has done similar deals with other countries, including the UK.

Meanwhile in the UK, the Medicines Healthcare Regulatory Authority says it knows of 32 cases of deaths reported to it after swine flu vaccine but the MHRA says that the vaccine is not responsible for any of those deaths

I’ve been consulted recently by a client whose partner had the flu vaccine last Autumn.

Until this person received the vaccine they were fit and healthy. Then within about 48 hours of vaccination they fell ill. Initially the symptoms were a cough, feeling tired and sleepy and being sick. Their condition steadily worsened and they began fitting and losing consciousness. Eventually MRI scan diagnosed ADEM (acute disseminated encephalomyelitis). Despite all attempts to treat this unfortunately the person tragically died.

Is there a link between the vaccine and ADEM? The Department of health’s Green Book says

“The following adverse events have been reported very rarely after seasonal influenza vaccination over the past 30 years but no causal association has been established: neuralgia, paraesthesiae, convulsions and transient thrombocytopenia, vasculitis with transient renal involvement and neurological disorders such as encephalomyelitis.”

GSK’s product safety datasheet for their vaccine says this

“Adverse reactions reported from post marketing surveillance

Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders:

Transient thrombocytopenia, transient Lymphadenopathy

Immune system disorders:

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders:

Neuralgia, paraesthesia, febril convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome”

So………GSK disclose that there have been reports of ADEM after their flu vaccine.

The Department of Health acknowledge this but say that causation has not yet been established.

They don’t however say that causation has been disproven.

So……was the ADEM caused or triggered by the vaccination?

The Consumer Protection Act 1987 (“CPA”) came into force in England and Wales with effect from 1st March 1988.

The Act provides that the manufacturer of a defective product will be liable to pay compensatory damages for injury loss and damaged caused, without the need for the consumer to prove the manufacturer was negligent.

A product is defective within the meaning of the Act if it is not as safe as consumers generally are entitled to expect.

So if a consumer suffers a serious permanent injury caused by a vaccine they may have a claim under the Act. They will have to prove that the vaccine caused the injury. This is no small difficulty as the pharmaceutical manufacturer is likely to dispute this.

If they can prove causation however, the consumer will also have to show that the vaccine was “defective” within the meaning of the Act. This point has never been tested in England and Wales.

Does a consumer have the right to expect a vaccine to be absolutely safe – i.e. risk free?

Is what the consumer was warned about relevant? For example, if the consumer was told that the vaccine would only have mild temporary effects but it caused serious permanent injury, is the vaccine defective?

Or must a reasonable consumer expect there to be a small risk of very severe permanent injury even though she or he had not been advised of this and was totally unaware? These interesting issues will be decided by a court in due course – subject of course to the ability of a consumer to bring a claim.

The fact no claims at all of this nature have reached trial since the CPA came into force illustrates the lack of access to justice in England and Wales. If consumers have rights under CPA, they may effectively be unable to exercise them. The legal aid scheme has been repeatedly cut in recent years to the point where consumers are now unable to exercise their legal rights and the rule of law has been undermined.

The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert advisory committee that advises Ministers on matters relating to the provision of vaccination and immunisation services.

 The Health Protection (Vaccination) Regulations 2009 came into force from 1st April 2009 and require the Secretary of State for health to implement the recommendations of the JCVI provided that the recommendation must:-

(a) relate to new provision for vaccination under a national vaccination programme or to changes to existing provision under such a programme;
(b) be made by the JCVI (and not therefore a sub-committee of the JCVI);
(c) be in response to a question referred to the JCVI by the Secretary of State;
(d) be based on an assessment which demonstrates cost-effectiveness; and
(e) not relate to vaccination in respect of travel or occupational health.

It is surprising that the Regulations require the recommendation to be cost-effective but make no stipulation as to any requirements for consumer safety

The latest declaration of interests of members of the committee can be reviewed here

The 2009 Regulations mean that the Secretary of State is no longer responsible for setting the national vaccination programme in the UK and cannot be accountable to Parliament for it. Responsibility for this now lies with the members of the JCVI

The purpose of this group of Members of Parliament is to:

“To support and advise individuals, families and organised groups campaigning for assistance for vaccine damaged people”

Details of the membership and officers of the group are available here

The group is planning to lobby the government soon about reform of the Vaccine Damage Payment Act 1979.

Russell Brown MP became Chair of the Group after Ian Stewart MP left Parliament in the May 2010 general election.

The UK Parliament has provided a compensation scheme for victims of vaccine injury in the Vaccine Damage Payment Act 1979.

But the scheme is badly flawed. Here are 4 compelling reasons why it needs to be reformed.

1. To qualify for compensation, the victim must be assessed as 60% permanently disabled for life. So if you are only 59.9% permanently disabled, you get nothing. It is wrong and unfair that you can suffer a 59.9% permanent disability, which will very substantially affect your whole life, and get no support at all. If you establish that you have suffered permanent disability, there is no need for any minumum level of disability to qualify.

2. If the adverse reaction results in death, but the victim is less than 2 years old, nothing can be awarded to the parents. Death is surely the most serious and tragic outcome. The logic for this is unclear. Why should a child on their second birthday be more deserving of compensation than the day before? Are babies not human or of no value to their parents? I can’t see how this provision can be objectively justified.

3. If the Applicant is found to be 60%+ permanently disabled caused by vaccination, the compensation payable is only a lump sum of £120,000. This is plainly insufficient. The cost at market rates to provide a 24 hour a day care package for a seriously disabled person is approx £250,000 per annum. So the award can provide about 6 months care for someone who might have 80 years further life expectancy. Presumably the remaining 79 years 6 months care responsibility is supposed to fall on their family. That amounts to a contribution of 1/160 towards the requirement fo care, with nothing for loss of earnings, aids, rehabilitation, mobility, accomodation. Given that the number of awards are less than 2 a year on average, there is no reason why awards cannot be fully compensatory.

4. There are significantly anomalies in the coverage provided by the Act. For example the swine flu vaccine is covered, but the annual flu vaccine is not. Hepatitis vaccines and travel vaccines (such as Yellow Fever) are not covered. Adults receiving vaccines are generally not covered, unless they are. The logic of why adults are generally exluded but some adults are excluded is unclear. If you are an adult who received the rubella vaccine you are covered but if you are an adult who received the measles vaccine you are not covered. A fair and comprehensive scheme would cover all vaccines received in the UK, but the present scheme does not.