NATIONAL VACCINE INJURY COMPENSATION PROGRAM FACT SHEET

Background

In the early 1980s, reports of harmful side effects following the DTP (diphtheria, tetanus, pertussis) vaccine posed major liability concerns for vaccine companies and health care providers, and caused many to question the safety of the DTP vaccine. Parents began filing many more lawsuits against vaccine companies and health care providers. Vaccination rates among children began to fall and many companies that develop and produce vaccines decided to leave the marketplace, creating significant vaccine shortages and a real threat to the Nation's health.

The dilemma facing the nation was so great that Congress decided to act. A coalition of physicians, public health organizations, leaders of industry, government representatives and private citizens developed the idea of a no-fault alternative to the tort system for resolving vaccine injury claims. Lawmakers passed the National Childhood Vaccine Injury Act of 1986 (P. L.99-660), which established the National Vaccine Injury Compensation Program (VICP).

The VICP is administered jointly by the U.S. Department of Health and Human Services (HHS), the U.S. Court of Federal Claims (the Court), and the U.S. Department of Justice (DOJ). The VICP is located in the Division of Vaccine Injury Compensation, Health Resources and Services Administration, HHS.

Overview

Congress created the VICP 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. The VICP, which went into effect on October 1, 1988, is a no-fault alternative to the traditional tort system for resolving vaccine injury claims, whether the vaccine is administered in the public or private sector. Since its inception, the VICP has been a key component in stabilizing the U.S. vaccine market by providing liability protection to both vaccine companies and health care providers, by encouraging research and development of new and safer vaccines, and by providing for a more streamlined and "less adversarial" alternative to the traditional tort system for resolving claims. The VICP covers all vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children. The vaccines currently covered include: diphtheria, tetanus, pertussis (DTP, DTaP, DT, TT or Td), measles, mumps, rubella (MMR or any components), polio (OPV or IPV), hepatitis B, haemophilus influenza type b (Hib), varicella, rotavirus, and pneumococcal conjugate.

The 9-member Advisory Commission on Childhood Vaccines (ACCV) provides oversight of the VICP. Members recommend ways to improve the VICP, including changing the Vaccine Injury Table, proposing legislation, covering new and safer childhood vaccines, gathering information about vaccine-related injuries from Federal, State, and local immunization programs, and revising vaccine information statement and adverse reaction reporting requirements.

The Vaccine Injury Table

There are three means of qualifying for compensation: 1) a petitioner must show that an injury listed on the Vaccine Injury Table (the Table) occurred; 2) a petitioner must prove that the vaccine significantly aggravated a pre existing condition; or 3) a petitioner must prove that the vaccine caused the condition.

The Table (see page 3) lists specific injuries or conditions and the time frames in which they must occur after vaccine administration. The Table is a legal mechanism for defining complex medical conditions and allows a statutory "presumption of causation." The Table serves as the basis for presumptions of causation for vaccines covered under the VICP. It is much easier to demonstrate a Table injury than to prove that the vaccine caused the condition. However, if an adverse event is not listed on the Table, an individual may still file a claim but must prove that the vaccine did "in fact" cause the alleged injury. Compensation may not be awarded if the Court determines that the injury or death was due to an alternative cause unrelated to the vaccine, even if a Table injury is demonstrated.

Filing a Claim

An individual claiming a vaccine-related injury or death files a petition for compensation with the Court, and is often represented by an attorney (which is not a requirement). The Secretary of HHS is named as the Respondent. The time for filing claims for injuries resulting from vaccines administered prior to October 1, 1988, has expired. Any claims filed for that time period are subject to dismissal by the Court. For injuries or deaths resulting from a vaccine administered on or after October 1, 1988, the following restrictions apply:

a. In the case of an injury, the claim must be filed within 36 months after the first symptoms appeared. The effects of the injury must have lasted at least 6 months after the vaccine administration, or the injury must have resulted in inpatient hospitalization and surgical intervention.
b. In the case of a death, the claim must be filed within 24 months of the death, and within 48 months after the onset of the vaccine-related injury from which the death occurred.

An HHS physician reviews each petition to determine whether it meets the medical criteria for compensation. This recommendation is provided to the Court through a Responden's report filed by the DOJ. The HHS position is presented by an attorney from the DOJ in hearings before a "special master" who makes the decision for compensation under the VICP. A special master is an attorney appointed by the judges of the Court. Decisions may be appealed to the Court, then to the Federal Circuit Court of Appeals, and eventually to the U.S. Supreme Court.

If a case is found eligible for compensation, the amount of the award is usually negotiated between the DOJ and the petitioner's attorneys. If the attorneys can't agree, the case is scheduled for a hearing for the special master to assess the amount of compensation. Compensable claims, and even most claims found to be non-compensable, are awarded reimbursement for attorney's fees and costs. A petitioner may file a claim in civil court against the vaccine company and/or the vaccine administrator only after first filing a claim under the VICP and then rejecting the decision of the Court.

Contact Information

For further information regarding the VICP:

National Vaccine Injury Compensation Program
Parklawn Building
5600 Fishers Lane
Room 8A-46
Rockville, Maryland 20857
800-338-2382

For information on the Rules of the Court, including requirements for filing a petition:

Clerk, U.S. Court of Federal Claims
717 Madison Place, N.W.
Washington, D.C. 20005
202-219-9657

Vaccine Injury Table (Effective August 26,2002)
 

*Time intervals for immunocompetent/immunodeficient individuals who receive OPV. Contact cases have no time limit.
**No condition has been identified requiring inclusion on the Vaccine Injury Table; and therefore, compensation for alleged injuries must be pursued on a causation in fact basis.

Last updated: July 29, 2002