Vaccine injury

A vaccine injury is an injury caused by vaccination. Historically, allegations of vaccine injuries have come in waves, and have been closely related to litigation, and publicity surrounding that litigation.

Allegations of vaccine injuries in recent decades have appeared in litigation in the United States, and in the United Kingdom. Numerous legislative bills have been introduced in the United States to shield pharmaceutical companies from liabilities stemming from vaccine injury claims. Globally, billions of dollars have been paid out to the families of alleged victims, and potential cumulative liability many times that amount has been estimated.

Suspected and recognized vaccine injury
Some adverse events following vaccination, as with all pharmaceutical interventions, are widely recognized as very rare events. Nearly 5,000 U.S. families of autistic children have lodged claims for compensation from a federal fund, saying that their health problems were caused by common childhood vaccines. Large scientific studies have found no association, and no autism claim has been paid from the fund so far.

In 1998, concerns arising from allegations of a possible link between MMR vaccines and autistic spectrum disorders arose after the publication of a controversial paper, by Dr. Andrew Wakefield, et al, in the Lancet. This described an alleged novel inflammatory bowel disease, later named autistic enterocolitis by Wakefield. The interpretation of this link, however, was later retracted. Others, including Bernard Rimland, had earlier expressed concerns about a possible relationship between vaccines and an increase in autism diagnoses.

VICP
In 1988, the National Vaccine Injury Compensation Program (VICP) went into effect to compensate individuals and families of individuals who have been injured by covered childhood vaccines. The VICP was adopted in response to an earlier scare over the pertussis portion of the DPT vaccine. 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. It uses a no-fault alternative dispute resolution system for resolving vaccine injury claims. Funding for claims of harm after 1988 comes from a patient fee of 75 cents per vaccination. 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 proof standard is the civil-law preponderance of the evidence, showing that causation was more likely than not. Claims that are denied can be pursued in regular lawsuits, though this is rare. Some claimants are having some luck suing thimerosal makers instead of vaccine makers, filing class-action suits, or demanding monitoring for vaccinated children who do not show signs of autism.

The VICP covers all vaccines listed on the Vaccine Injury Table maintained by the Secretary of Health and Human Services. From 1988 until 2007-08-31, 5,222 claims relating to autism, and 2,816 non-autism claims, were made to the VICP. 893 of these claims, all non-autism-related, were compensated, with 1,154 non-autism and 327 autism claims dismissed; awards (including attorney's fees) totaled $806 million. 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.

NCVIA
In 1988, the National Childhood Vaccine Injury Act (NCVIA) was enacted "to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals thought to be injured by childhood vaccines." This followed extensive litigation against vaccine manufacturers, most of whom withdrew from production on grounds that the cost of lawsuits outweighed any profit in making them. The VICP is administered jointly by the U.S. Department of Health and Human Services (HHS), the U.S. Court of Federal Claims, and the U.S. Department of Justice (DOJ). As of February, 2003, 3,482 vaccine victims have received compensation totaling over $1.4 billion.

For vaccine injuries ruled to have been sustained after its enactment, the NCVIA allows 'reasonable compensation' for past and future unreimbursable medical, custodial care, and rehabilitation costs, lost earnings, reasonable legal fees, and places a cap of $250,000 for actual and projected pain, suffering and emotional distress. The HHS is represented by the DOJ in hearings before a "special master", who makes initial decision for compensation under the VICP. A special master is appointed by the judges of the Court. Decisions can be appealed to the Court, then to the US Court of Appeals for the Federal Circuit, and then to the Supreme Court.

The U.S. Department of Health and Human Services set up a trust fund in 1988 to compensate people damaged by vaccination. By 2007, the fund had paid out $1.8 billion to 1,500 claimants. The vaccines covered by the compensation scheme are those aimed at protecting against diphtheria, tetanus, pertussis (whooping cough), measles, mumps, rubella (German measles), polio, hepatitis B, varicella (chicken pox), Hemophilus influenzae type b, and rotavirus. Pneumococcal vaccine is expected to be covered soon.

VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC).

VAERS is intended to track adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines. The program's success in tracking vaccine injuries has been questioned by some, who allege medical practitioners frequently fail to make reports. Others say that it may overstate possible injuries since many neurological problems in childhood may manifest at around the ages when vaccines are routinely administered.

VSD
The Vaccine Safety Datalink (VSD) is comprised of databases from seeral organizations containing information regarding health outcomes for millions of US citizens and to enhance assessment of vaccine injuries. It was designed to allow for such things as comparisons between vaccinated and unvaccinated populations, and for the identification of possible groups at risk for adverse events.

United Kingdom
In 2003, parents of over 1,000 United Kingdom children diagnosed with autistic spectrum disorders, alleging the MMR vaccine was the culprit, were dealt a major setback by decision by the Legal Services Commission to withdraw legal aid. This followed advice to the commission by the lawyers representing the parents themselves that the lawsuit had no reasonable prospects of success.

VDPS
Under the Vaccine Damage Payment Scheme (VDPS), it is thought that thousands of unsuccessful claims have been made. The maximum payment per claim is currently £100,000. Disabled vaccine injury patients are allowed to file a claim up to the age of 21. The 'disability threshold' before payments are granted is 60%. The scheme covers vaccinations for illnesses such as tetanus, measles, tuberculosis and meningitis C. As of 2005, the British government had paid out £3.5 million to vaccine injury patients since 1997.