Vaccine court

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Vaccine court is the popular term which refers to the Office of Special Masters of the U.S. Court of Federal Claims, which administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the Court of Claims, sitting without a jury. The program was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine. Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared the loss of herd immunity.^[1]

Some parents of children with autism spectrum disorders have attributed the disorders' onset to vaccines, often citing the mercury-based preservative thiomersal as the cause, and have demanded compensation from vaccine makers. However, the medical and scientific communities have consistently found no link between routine childhood vaccines and autism.^[2]

Contents 1 National Childhood Vaccine Injury Act 2 Homeland Security Act 3 Previous rulings 4 Current proceedings 5 References 6 External links

[edit] National Childhood Vaccine Injury Act

The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines.^[3] The VICP was adopted in response to a scare over the pertussis portion of the DPT vaccine.^[1] These claims were later generally discredited, but some U.S. lawsuits against vaccine makers won substantial awards; most makers ceased production, and the last remaining major manufacturer threatened to do so.^[1] The VICP uses a no-fault system for resolving vaccine injury claims.^[1] Compensation covers medical and legal expenses, loss of future earning capacity, and up to $250,000 for pain and suffering; a death benefit of up to $250,000 is also available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims.^[4] Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award, a claimant must show a causal connection; if medical records show a child has one of several listed adverse effects soon after vaccination, the assumption is that it was caused by the vaccine. The burden of proof is the civil-law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare.^[1]

The VICP covers all vaccines listed on the Vaccine Injury Table maintained by the Secretary of Health and Human Services; in 2007 the list included vaccines against diphtheria, tetanus, pertussis (whooping cough), measles, mumps, rubella (German measles), polio, hepatitis B, varicella (chicken pox), Haemophilus influenzae type b, rotavirus, and pneumonia.^[5] From 1988 until 2008-01-08, 5,263 claims relating to autism, and 2,865 non-autism claims, were made to the VICP. 925 of these claims, one autism-related (see Proceedings), were compensated, with 1,158 non-autism and 350 autism claims dismissed; awards (including attorney's fees) totaled $847 million.^[6] The VICP also applies to claims for injuries suffered before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $903 million.^[6]

Filing a claim with the Court of Federal Claims requires a $250 filing fee, which can be waived for those unable to pay. Medical records such as prenatal, birth, pre-vaccination, vaccination, and post-vaccination records are strongly suggested, as medical review and claim processing may be delayed without them. Because this is a legal process most people use a lawyer, though this is not required.^[4] By 1999 the average claim took two years to resolve, and 42% of resolved claims were awarded compensation, as compared with 23% for medical malpractice claims through the tort system.^[7] There are legal time limits for filing claims.^{[citation needed]} As with any benefit program, eligibility requirements seem unfair to some applicants.^[7]

Several claimants have attempted to bypass the VICP process, with some successes so far. They have demanded medical monitoring for vaccinated children who do not show signs of autism, and have filed class-action suits on behalf of parents.^[1] In March 2006, the U.S. Fifth Circuit Court of Appeals ruled that plaintiffs suing three manufacturers of thiomersal could bypass the Court of Federal Claims (the 'vaccine court') and litigate in either state or federal court utilizing the ordinary channels for recovery in tort (Holder v. Abbott Laboratories Inc., 444 F.3d 383). The ruling is significant, since this is the first instance where a federal appeals court has held that a suit of this nature may bypass the 'vaccine court'. The 5th circuit court reached its conclusion by first looking to the statutory intent of the 1986 National Childhood Vaccine Injury Act, and determining that the intent of the statute was to protect the financial stability of vaccine manufacturers. In this case, thiomersal was held to be not a vaccine, but merely a preservative; and, as such, its manufacturers could not use the National Childhood Vaccine Injury Act as a defense.

[edit] Homeland Security Act

The Homeland Security Act of 2002 provides another exception to the exclusive jurisdiction of the vaccine court. If smallpox vaccine were to be widely administered by public health authorities in response to a terrorist or other biological warfare attack, persons administering or producing the vaccine would be deemed federal employees and claims would be subject to the Federal Tort Claims Act, in which case claimants would sue the U.S. Government in the U.S. district courts, and would have the burden of proving the defendants' negligence, a much more difficult standard.^[8]

[edit] Previous rulings

A 2005 United States Court of Appeals for the Federal Circuit ruling held that an award should be granted if a petitioner provides either establishes a "Table Injury" or proves "causation in fact" by proving the following three prongs:

1. a medical theory causally connecting the vaccination and the injury;
2. a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and
3. a showing of a proximate temporal relationship between vaccination and injury.^[9]

This ruling held that tetanus vaccine caused a particular case of optic neuritis even though no scientific evidence supported the petitioner's claim.^[10] Other rulings have allowed petitioners to gain awards for claims that the MMR vaccine causes fibromyalgia, that the Hib vaccine causes transverse myelitis, and that the hepatitis B vaccine causes Guillain–Barré syndrome, chronic demyelinating polyneuropathy, and multiple sclerosis.^[10] In the most extreme of these cases, a 2006 petitioner successfully claimed that a hepatitis B vaccine caused her multiple sclerosis despite several studies showing that the vaccine neither causes nor worsens the disease, and despite a conclusion by the Institute of Medicine that evidence favors rejection of a causal relationship.^[10]

In 2008 the federal government agreed to award damages to the family of Hannah Poling, a girl who developed autistic-like symptoms after receiving a series of vaccines in a single day.^[11] The vaccines given were DTaP, Hib, MMR, varicella, and inactivated polio. Two days after vaccination Poling was lethargic, irritable, and feverish, and ten days after vaccination she developed a rash consistent with vaccine-induced varicella (chickenpox). Poling suffered from encephalopathy (brain disease) caused by a mitochondrial enzyme deficit, a mitochondrial disorder, which was diagnosed months after the vaccination; it is not unusual for children with such deficits to develop neurologic signs between their first and second years. Poling had frequent episodes of fever and middle ear infection, which posed a much greater antigenic challenge than the vaccines; due to changes in vaccine formulation, the fourteen vaccines given to young U.S. children now contain fewer immunologic components than the single smallpox dose given a century ago.^[10] There is little scientific research in the area: no scientific studies show whether childhood vaccines can cause or contribute to mitochondrial disease,^[12] and there is no scientific evidence that vaccinations damage the brains of children with mitochondrial disorders.^[13] Although many parents view this ruling as confirming that vaccines cause regressive autism, most children with autism do not seem to have mitochondrial disorders, and the case was conceded without proof of causation.^[14]

[edit] Current proceedings

Currently, nearly 5,000 families are attempting to demonstrate that vaccines can cause autism, despite the medical and scientific consensus that there is no link between vaccines and the onset of autistic symptoms.^[2][15] With the commencement of hearings in the case of Cedillo v. Secretary of Health and Human Services (Case #98-916V), the battle over vaccine injuries moved into the courts. A panel of three 'special masters' heard the first case of the historic Autism Omnibus Proceedings in June 2007, but is not expected to announce any decision for several months.

The lead petitioners, the parents of Michelle Cedillo, claim that Michelle's autism was caused by a vaccine. Theresa and Michael Cedillo contend that thiomersal seriously weakened Michelle's immune system and prevented her body from clearing the measles virus after her vaccination at the age of fifteen months.

George Hastings, Jr., one of the special masters, said "Clearly the story of Michelle's life is a tragic one,"^[16] while pledging to listen carefully to the evidence.

A ruling in favor of the parents could enable thousands of autistic children to receive compensation. If the special masters find for the parents, the remaining individual claims will be heard. Too many successful claims could exhaust the $2 billion fund and could deter parents from vaccinating their children, which could lead to illness or death from the diseases the vaccines prevent.^[17]

[edit] References

[edit] External links

• National Vaccine Injury Compensation Program (VICP)
• Vaccine Program/Office of Special Masters

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