Childhood Vaccine Injury Act

Definition

The Childhood Vaccine Injury Act established a federal program for compensating victims of vaccine-related injuries or death.

Purpose

During the early 1980s childhood immunization programs fell into chaos. Vaccine manufacturers and healthcare providers were overwhelmed with liability lawsuits from parents who believed that their children had been harmed by the DTP vaccine , which protects against diphtheria, tetanus , and pertussis ( whooping cough ). Companies that developed and produced vaccines halted or threatened to halt production and serious vaccine shortages developed. Childhood immunization rates fell.

To address this problem, physicians, public health agencies, the pharmaceutical industry, government representatives, and the parent-founded and -operated National Vaccine Information Center called for a no-fault alternative to litigation for resolving vaccine injury claims.

In response the U.S. Congress passed the Childhood Vaccine Injury Act of 1986 (PL 99-660). The purpose of the act was to do the following:

• establish the National Vaccine Injury Compensation Program (VICP) as a no-fault alternative to suits against vaccine manufacturers and healthcare providers
• provide victims with an accessible and efficient means of obtaining compensation
• reduce the costs of litigation
• ensure adequate supplies of vaccine
• stabilize the cost of vaccines
• help prevent vaccine injuries through education and a vaccine adverse event reporting system (VAERS)
• create incentives for developing safer vaccines

The Childhood Vaccine Injury Act was part of an initiative to immunize all children against potentially life-threatening diseases. The act was amended several times after its original passage.

Description

In addition to establishing the VICP, the Childhood Vaccine Injury Act requires that vaccination records be included in a patient's permanent medical record and that they include the following:

• date of vaccine administration
• vaccine manufacturer and lot number
• name, address, and title of the healthcare provider

The act also requires that doctors report all adverse events occurring within 30 days of vaccination to the VAERS. About 12,000 vaccine-related adverse reactions are reported annually; however, it is estimated that less than 10 percent of doctors file such reports.

The Vaccine Injury Compensation Program (VICP)

The VICP took effect on October 1, 1988. The program is administered jointly by the Division of Vaccine Injury Compensation within the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS), by the U.S. Court of Federal Claims, and by the U.S. Department of Justice (DOJ). A nine-member Advisory Commission on Childhood Vaccines oversees the VICP. This commission performs the following services:

• recommends improvements to the program
• proposes changes to the Vaccine Injury Table that specifies qualifying vaccines and injuries or deaths
• proposes legislation
• proposes new, safer vaccines for inclusion in the VICP
• collects information about vaccine-related injuries from federal, state, and local immunization programs
• revises vaccine information statements
• revises adverse reaction reporting requirements

Vaccine Injury Table

The VICP applies to all vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDC) for routine administration to children. However, to qualify for compensation, the petitioner must prove one of the following:

• that an injury occurred that is specified in the Vaccine Injury Table
• that a vaccine significantly aggravated a pre-existing condition
• that a vaccine caused a condition

As of August 26, 2002, the Vaccine Injury Table included the following vaccines:

• DTP for diphtheria, tetanus, and pertussis, as well as other tetanus- and pertussis-containing vaccines
• MMR for measles, mumps , and rubella (German measles), as well as other measles- and rubella-containing vaccines
• OPV and IPV for polio , including cases in which polio was contracted from a child vaccinated with OPV
• hepatitis B
• Hib conjugate vaccines for haemophilus influenzae type B that causes meningitis
• varicella (chickenpox)
• pneumococcal conjugate vaccines
• live, oral, rhesus-based rotavirus vaccines for gastroenteritis , administered on or before August 26, 2002 (This vaccine was administered routinely only between October 1, 1998 and October 15, 1999.)
• new vaccines

These vaccines are covered regardless of whether they were administered individually or in combination or whether they were administered by public or private healthcare providers. When a new vaccine is added to the Vaccine Injury Table, coverage is retroactive for eight years. When the CDC recommends a new vaccine for routine administration to children, it may be automatically added to the table. Claims can be filed for other vaccines; however, the claimant must prove that the injury was caused by the vaccine. Since this can be very difficult to prove, most VICP claims fall within the Vaccine Injury Table.

The Vaccine Injury Table contains guidelines for evaluating whether the injury or death was vaccine-related. For example, a claim that a child's seizures were triggered by a vaccine must include proof that the child's first seizure occurred within three days of the vaccine administration.

Furthermore, claims for vaccine-related injuries are only valid if the effects continued for at least six months following the vaccination or resulted in hospitalization or surgical intervention. The claim must be filed within 36 months of the appearance of the first symptoms. Claims for vaccine-related deaths must be filed within 24 months of the death or within 48 months of the onset of the injury that caused the death.

VICP procedures

Claims must be filed through the VICP before civil litigation can be pursued. Claims can be filed by the injured individual or by a parent, legal guardian, or trustee on behalf of a child or incapacitated victim. The procedural steps are as follows:

• A claimant files a petition for compensation with the U.S. Court of Federal Claims in Washington, DC, and with the secretary of HHS, along with a $150-filing fee.
• A physician from within the Division of Vaccine Injury Compensation reviews the petition and makes a recommendation.
• The physician's recommendation is included in a report filed with the court by the DOJ.
• Hearings are held before a "special master," an attorney appointed by the court judges; a DOJ attorney represents the HHS position; hearings usually last one or two days.
• The special master decides whether the claimant should be compensated.
• A hearing determines the amount of compensation.
• Decisions may be appealed first to a judge of the court, then to the Federal Circuit Court of Appeals, and finally to the Supreme Court.

Although claimants are not required to be represented by an attorney, most petitioners find that they need one. The law provides for compensation for reasonable attorney fees and costs, regardless of the outcome of the claim. An attorney filing a VICP petition must be a member of the bar of the U.S. Court of Federal Claims.

When the victim is a child, the following medical records must accompany the original petition to the court and the HHS secretary:

• all prenatal and birth records and newborn hospital records
• all medical records prior to and including vaccination records
• all post-injury hospital/emergency treatment records
• all post-injury outpatient records
• the VAERS form, if available
• long-term records, including school records, reports, and evaluations, and educational and psychological testing results
• police/ambulance records
• death and autopsy records

Compensation

Compensation for a vaccine-related injury may include the following:

• past and future non-reimbursable medical and custodial care and rehabilitation costs
• a maximum of $250,000 for pain , suffering, and emotional distress
• lost earnings or potential lost earnings
• reasonable attorney's fees and costs

Compensation for approved claims have averaged $824,462. The highest compensation award was for $9.13 million. Compensation for a vaccine-related death is limited to $250,000 for the deceased's estate plus attorney's fees and costs. Compensation is paid from the Vaccine Injury Compensation Trust Fund that is funded by a 75-cent excise tax on every purchased dose of a covered vaccine.

Petitions cannot be filed under VICP if a civil action for damages related to a vaccine injury is pending or if damages have been awarded by a court or in a settlement against the manufacturer or vaccine administrator. Civil litigation cannot be pursued if the petitioner accepts an award under the VICP.

Victims may file a civil suit against a vaccine manufacturer or the vaccine administrator given the following:

• The VICP petition is dismissed or ruled non-compensable.
• The VICP compensation offer is rejected by the claimant.
• The vaccine is not covered by VICP.

Common problems

Some lawyers and parents argue that there are serious problems with the VICP. They claim the following:

• The VICP is much too complicated and time-consuming.
• Victims are not necessarily able to recover damages.
• The VICP does not consider the emotional and psychological effects of a vaccine-related injury on the child's family .
• The VICP greatly underestimates the amount of legal work required for a reasonable chance of a successful claim.
• There is no real difference between the VICP and civil litigation except that the defendant is the U.S. Government rather than the vaccine manufacturer.
• The death-benefit limit of $250,000 does not take into account instances in which prolonged hospitalization preceded death.
• The death-benefit limit does not take into account an adult, family wage earner with a vaccine-related injury or death resulting from exposure to a newly-vaccinated child. (However, a claimant affected by the death benefit limitation may file a civil suit.)

Parental concerns

Outcomes

Between 1988 and 2004, 6,506 petitions were filed with the VICP, of which 4,246 were claims for autism resulting from the mercury-containing vaccine preservative thimerosal. Between 1989 and 2004, 140 of the thimerosal claims were dismissed and the rest of these claims were found to be not compensable. Of the nonautism/thimerosal claims, 916 were dismissed and 680 were compensated. Between 1990 and 2004, the government paid out over $588 million in compensation, fees, and costs for 676 claims. Nearly $10 million were paid out for attorney fees.

The VCIP has been credited with helping to stabilize the American vaccine market by providing the following services:

• providing a faster and easier method for resolving claims
• providing liability protection to vaccine manufacturers and healthcare providers
• encouraging research and development of new, safer vaccines

See also Chickenpox vaccine ; Hepatitis B vaccine ; .

Resources

PERIODICALS

Bridges, Sarah. "A Child's Severe Reaction to a Vaccine Alters Life." Washington Post August 3, 2003: W12.

"Pediatrics Information Center Urges Parents to Vaccinate Safely." Health & Medicine Week September 24, 2001: 9.

ORGANIZATIONS

National Vaccine Information Center. 421-E Church St., Vienna, VA 22180. Web site: http://www.909shot.com.

National Vaccine Injury Compensation Program. Health Resources and Services Administration, U.S. Department of Health and Human Services , Parklawn Building, Room 16C–17, 5600 Fishers Lane, Rockville, MD 20857. Web site: http://www.hrsa.gov/osp/vicp/vicp.html.

WEB SITES

"Commonly Asked Questions about the National Vaccine Injury Compensation Program." Health Resources and Services Administration, Office of Special Programs , December 18, 2002. Available online at http://www.hrsa.gov/osp/vicp/qanda.htm (accessed December 8, 2004).

"National Vaccine Injury Compensation Program Fact Sheet." Health Resources and Services Administration, Office of Special Programs , November 2002. Available online at http://www.hrsa.gov/osp/vicp/fact_sheet.htm (accessed December 8, 2004).

"National Vaccine Injury Compensation Program: Special Programs Bureau." Health Resources and Services Administration , November 2002. Available online at http://www.hrsa.gov/osp/vicp/dvicprog.htm (accessed December 8, 2004).

"Post-1988 Monthly Statistics Report." National Vaccine Injury Compensation Program , August, 13, 2004. Available online at http://www.hrsa.gov/osp/vicp/monthly_stats_post.htm (accessed December 8, 2004).

"The Vaccine Injury Compensation Program." National Vaccine Information Center . Available online at http://www.909shot.com/Issues/Comp_Summary.htm (accessed December 8, 2004).

Margaret Alic, PhD