National Vaccine Injury Compensation Program: FAQ
What is the National Vaccine Injury Compensation Program (VICP)?
The National Childhood Vaccine Injury Act of 1986 (the Act) established the VICP. The VICP went into effect in October 1988 and is a Federal "no-fault" system designed to compensate individuals, or families of individuals, who have been injured by childhood vaccines, whether administered in the private or public sector.
What vaccines are covered?
Diphtheria, tetanus, pertussis (DTP, DTaP, DT, TT, or Td), measles, mumps, rubella (MMR or any components), and polio (OPV or IPV). Effective August 6, 1997, hepatitis B, Haemophilus influenza type b, and varicella vaccines were added for coverage under the VICP. Rotavirus vaccine was added for coverage under the VICP, effective October 22, 1998. On May 22, 2001, the Secretary published a notice in the Federal Register announcing the addition of pneumococcal conjugate vaccines to the Vaccine Injury Table under Category XIII with an effective date of December 18, 1999. (66 Fed. Reg. 28166-01 May 22, 2001)). The Secretary plans to include pneumococccal conjugate vaccines as a separate and distinct category on the Vaccine Injury Table through the rulemaking process, in order to comply with legal requirements. For the purpose of potential petitioners filing claims concerning pneumococcal conjugate vaccines, however, this category of vaccines is now covered by the VICP (under the Table's broad Category III). Eight years' retroactive coverage is provided for vaccine-related adverse events associated with any vaccine newly added for coverage under the VICP.
How are new vaccines added for coverage under the VICP?
On March 24, 1997, a final rule was published which, in part, provided for the "automatic" addition of future vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration to children. However, Congress will still need to set an appropriate excise tax on any new vaccines recommended by CDC before those vaccines are effectively covered under the VICP. Under the current statutory language, 8 years' retroactive coverage will be provided for those claiming injury or death resulting from a vaccine newly added to the VICP.
Who may file a claim?
Any injured individual or a parent, legal guardian, or trustee of an injured child or an incapacitated person may file a claim. A claim may be made for any injury or death thought to be a result of a covered vaccine. These injuries may include, but are not limited to: anaphylaxis, paralytic polio, and encephalopathy.
What is the time frame in which to file a claim?
For injuries 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.
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.
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 U.S. Court of Federal Claims (the Court).
How is the VICP funded?
Funding of vaccine claims depends on the date of vaccination:
a. For vaccines administered prior to October 1, 1988, awards are compensated from Federal tax dollars allocated by Congress at $110 million per year.
b. For vaccines administered on or after October 1, 1988, awards are paid from the Vaccine Injury Compensation Trust Fund, funded from an excise tax on every dose of covered vaccine that is purchased.
How does the VICP work?
The VICP is administered jointly by the Court, the Department of Health and Human Services (HHS), and the Department of Justice (DOJ). The process is as follows:
a. An individual claiming injury from a vaccine files a petition for compensation with the Court;
b. A physician at the Division of Vaccine Injury Compensation, HHS, reviews each petition to determine whether it meets the criteria for compensation. This recommendation is provided to the Court through a report filed by the DOJ, although it is not binding.
c. The HHS position is represented by an attorney from the DOJ in hearings before a "special master" who makes the initial decision for compensation under the Program. A special master is an attorney appointed by the judges of the Court.
d. Decisions may be appealed to the Court, then to the Federal Circuit Court of Appeals.
How is eligibility for compensation determined?
There are three means to qualify for compensation:
a. A petitioner must show that an injury found on the Vaccine Injury Table occurred; or
b. A petitioner must prove that the vaccine caused the condition; or
c. A petitioner must prove that the vaccine significantly aggravated a pre-existing condition.
The Vaccine Injury Table 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." It is much easier to demonstrate a "Table Injury" than to prove that the vaccine caused the condition, and most claims allege that a Table Injury occurred. Compensation is not awarded, however, if the Court determines that the injury or death was due to a cause unrelated to the vaccine, even if it was a Table Injury.
In contrast to civil liability suits, hearings to determine eligibility under the VICP usually last only 1 or 2 days. A case found eligible for compensation is scheduled for a hearing to assess the amount of compensation. Most claims found to be noncompensable receive awards for attorney's fees and costs.
What is the amount of an award under the VICP?
Awards to the estate in a vaccine-related death are limited to $250,000 plus attorney's fees and costs. Awards to individuals with an injury judged to be vaccine-related have averaged $824,463 although this amount typically represents the cost of an annuity that pays out significantly more over the life of the petitioner. There is no limitation as such on the amount of an award in a vaccine-related injury; however, the law does contain certain restrictions.
How does the VICP protect vaccine administrators and vaccine manufacturers?
a. For vaccine administrators and manufacturers: The Act requires that vaccine injury claims involving covered vaccines given on or after October 1, 1988, must first be filed with the VICP before civil litigation through the tort system can be pursued. If a petitioner accepts an award under the VICP, the claim cannot be brought subsequently to the tort system.
b. For vaccine manufacturers: In addition to the above, the legislation sets new, more restrictive standards for actions alleging injury from these covered vaccines in cases that are brought to the tort system.
Under what circumstances may a vaccine administrator or manufacturer be sued?
a. If the petition has been judged non-compensable or dismissed under the VICP, or
b. If the award granted by the VICP is otherwise rejected by the petitioner, or
c. If the vaccine is not covered under the VICP.
Have there been changes to the Vaccine Injury Table?
On March 10, 1995, a modified Vaccine Injury Table (and the accompanying Qualifications and Aids to Interpretation) became effective for all claims filed on or after that date. Significant changes include the addition of chronic arthritis under vaccines containing rubella (e.g., MMR,MR, R vaccines), and the removal of Residual Seizure Disorder and Hypotonic-Hyporesponsive Episode (HHE) under the DTP vaccine. The definition of Encephalopathy was clarified in the Qualifications and Aids to Interpretation.
On March 24, 1997, further modifications to the Vaccine Injury Table took effect that include addition of brachial neuritis and removal of encephalopathy for tetanus-containing vaccines, addition of thrombocytopenia and vaccine-strain measles virus infection, removal of residual seizure disorder for measles-containing vaccines, and addition of vaccine-strain poliovirus infection for live polio virus vaccine. Modifications also include the addition of three new vaccines: hepatitis B, Haemophilus influenzae type b, and varicella. Coverage for the three new vaccines went into effect August 6, 1997. The Rule also provides for "automatic " addition of future vaccines recommended by CDC for routine administration to children, although injuries for such vaccines will be specified only after additional rulemaking. All other Table changes become effective for all claims filed on or after March 24.
Rotavirus vaccine was added for coverage, effective October 22, 1998. On May 22, 2001, the Secretary published a notice in the Federal Register announcing the addition of pneumococcal conjugate vaccines to the Vaccine Injury Table under Category XIII with an effective date of December 18, 1999. (66 Fed. Reg. 28166-01 (May 22, 2001)). Category XIII is the general category reserved for new vaccines that qualify for coverage under the VICP. Because this category is general, it does not specifically include reference to pneumococcal conjugate vaccines. The Secretary plans on including pneumococcal conjugate vaccines as a separate and distinct category on the Vaccine Injury Table through the rulemaking process, in order to comply with legal requirements. For the purpose of potential petitioners filing claims concerning pneumococcal conjugate vaccines, however, this category of vaccines is now covered by the VICP (under the Table's broad Category XIII).
What documentation are vaccine administrators required to keep?
The National Childhood Vaccine Injury Act requires that the date of administration; vaccine manufacturer; lot number; and name, address, and title of the health care provider be recorded in the patient's permanent medical record.
What adverse events are health care providers required to report?
The Vaccine Adverse Events Reporting System (VAERS), operated by the Food and Drug Administration (FDA) and the CDC, should be notified of any adverse event by completing a VAERS reporting form. The following events are required to be reported:
a. Any event set forth in the Vaccine Injury Table that occurs within the time period specified, or within 7 days if that is longer.
b. Any contraindicating event listed in the manufacturer's package insert.
In addition, VAERS accepts all reports by any interested party of real or suspected adverse events occurring after the administration of any vaccine.
The VAERS form may be obtained by calling 1-800-822-7967.
Please note: Submitting a reporting form to VAERS is not the same as filing a claim under the VICP as they are two separate programs.
If I believe that the thimerosal (mercury) in a vaccine caused an injury or death, can I file a claim with the VICP?
For vaccines covered under the VICP, individuals alleging that the thimerosal in a vaccine caused an injury or death must first file a claim with the VICP before any civil litigation can be pursued according to section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33(5)), a "vaccine-related injury or death" eligible for compensation under the VICP does not include an injury or death associated with an adulterant or contaminant intentionally added to a vaccine. Components, such as thimerosal, that are added to microorganisms to create vaccines cannot and should not be considered adulterants or contaminants. Instead, preservatives and components such as thimerosal should be considered one of several elements that comprise vaccines. The VICP has presented this argument to the Office of the Special Masters, United States Court of Federal Claims, however, the Court has not yet ruled on this issue.
Because thimerosal is not an adulterant to or a contaminant of vaccines, individuals who have claims relating to thimerosal in vaccines covered under the VICP are not statutorily barred from filing claims with the VICP. Thus, the Department believes individuals interested in filing such a claim must first file the claim with the VICP before pursuing any other civil litigation.
Should I contact an attorney if a family member has been harmed by a vaccine?
Perhaps. It may be important for you to contact an attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case that is worth pursuing. Keep in mind however that there may be time limits (Statute of Limitations) which affect your ability to sue.
How much does an attorney evaluation cost in these types of cases?
Nothing! Attorneys associated with InjuryBoard.com will evaluate your case free of charge. If a participating attorney agrees to handle your case, you will owe no fees or other costs unless that attorney recovers money for you.
How do I submit my case for a free evaluation?
Simply click on the free Ask an Attorney button and complete the online intake form. An attorney will evaluate your case and respond to you via email. zzzzzzzz
-- Article Courtesy of InjuryBoard.com
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