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Summer 2003-06 Vaccine injury compensation program provides relief without fault

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Number 52
Summer 2003

Vaccine injury compensation program provides relief without fault

The National Vaccine Injury Compensation Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 through 300aa-34.

The Vaccine Act became effective October 1, 1988. It establishes the Vaccine Program as a no-fault compensation scheme whereby persons allegedly suffering injury or death as a result of the administration of certain compulsory childhood vaccines may petition the federal government for monetary damages. Congress intended that the Vaccine Program provide individuals a swift, flexible, and less adversarial alternative to the often costly and lengthy civil arena of traditional tort litigation.

Special masters

All vaccine claims are managed and adjudicated by the congressionally-created Office of Special Masters, which currently consists of one chief special master and five associate special masters, appointed to serve for four-year terms. The Office of Special Masters is established within the U.S. Court of Federal Claims, which appoints and removes the special masters, and to which the special masters' decisions are appealed.

A special master has two primary functions:

case management, which involves overseeing the collection of information and setting time frames for its submission; and

decision making, which involves determining the types of proceedings necessary for presenting the relevant evidence and ultimately weighing the evidence in rendering a final, enforceable decision.

In each case, the special master actively and frequently interacts with the parties-generally through counsel representing petitioner and a Department of Justice attorney representing the Secretary of Health and Human Services-to ensure that the case progresses effectively and efficiently. The parties are also given several opportunities early on in the case to ask questions, raise concerns, discuss generally how the system works, and, if appropriate, learn the special master's tentative conclusions and findings. Throughout the entire process, the special masters make every effort to balance Congress's vision of streamlined proceedings with the parties' right to a fair opportunity to present their cases.

The special masters' rules, orders, and other published communications, such as the special masters' Guidelines for Practice Under the National Vaccine Injury Compensation Program, likewise evoke a philosophy of guidance, cooperative effort, informality, and reasonable speed in presenting and deciding the case.

National Vaccine Injury Compensation Program

In the United States, the National Vaccine Injury Compensation Program, which went into effect in 1988, handles compensation. The injured person, a parent, legal guardian or trustee may file a claim. A physician with the Department of Health and Human Services looks at the claim and a recommendation is made to the court through a report filed by the Department of Justice, although it is not binding. The court makes a decision, which can be appealed. The Department of Health and Human Services and the Department of Justice administer the program.

As of July 3, 2000, 5,836 petitions had been filed under the act. The majority of those (about 70%) involved the DPT vaccine or parts of it. A claim may be filed for any injury or death thought to be the result of a covered vaccine. To get an idea of the number of children immunized, in 1998 79% of children had received four doses of DPT or the newer version DTaP, three polio vaccinations, one measles, mumps and rubella (MMR) vaccination and three Haemophilus influenzae type b (Hib) vaccinations. There were 18.9 million children under the age of five in the United States in 1998, according to the U.S. Census Bureau.

National Vaccine Information Center

The program is something the National Vaccine Information Center supported. Parents who believe their children suffered vaccine reactions formed the center.

The group encourages parents to make informed consents about vaccination, but it does not officially say it advises people to avoid vaccinations.

Thimerosal

Another safety issue that concerns some is the presence of thimerosal-a mercury derivative-in some vaccines. "Thimerosal is a derivative of ethylmercury and has been used as an additive to biologics and vaccines since the 1930s because it is effective in killing bacteria and in preventing bacterial contamination, particularly in opened multi-dose containers," according to a joint statement from the American Academy of Family Physicians, the American Academy of Pediatrics, the Advisory Committee on Immunization Practices and the United States Public Health Service.

The national medical community set a goal in July of 1999 to remove thimerosal from vaccines. Studies of the health effects of exposure to thimerosal are continuing, but preliminary results don't show evidence of increased risk. According to the Centers for Disease Control and Prevention (CDC), the mercury exposure from vaccines is well within the safety margins included in any guideline established by federal agencies, and there is no evidence that children have been harmed by the amount of mercury found in vaccines.

The medical groups project that with more vaccines now being offered without thimerosal, the United States could have completed the transition by the first quarter of 2001.

Acellular pertussis vaccine

Another change the National Vaccine Information Center celebrated was the licensing in 1996 of an acellular pertussis vaccine, a new version of the DPT vaccine that has a different pertussis component. Most children now receive the acellular (the DTaP) version instead of the (DPT) whole cell version. According to the CDC, most experts believe mild to serious reactions to the vaccine--such as fussiness, fever or seizure-will be much less likely to happen with the DTaP. Severe reactions, such as breathing difficulty or coma, will be more rare.

Compensation

Compensation is divided into two parts:

1- Injuries or deaths prior to October 1, 1988 (no matter how long ago the injury occurred):

A citizen may choose to pursue a lawsuit unrestricted.

A citizen could have filed a claim in the compensation system by January 31, 1991

If the claim was not filed by 1/31/91, the statute of limitations has run out.

2- Injuries or deaths occurring after October 1, 1988:

A citizen is required to apply for federal compensation prior to pursuing a lawsuit.

The system will offer to pay up to $250,000 for a vaccine associated death.

The system will offer to pay for all past and future unreimbursed medical expenses, custodial and nursing home care; up to $250,000 pain and suffering; and loss of earned income.

If a citizen rejects the award or is turned down, a lawsuit may be filed.

Claims must be filed within 24 months of a death and 36 months of an injury.

Restrictions may apply to lawsuits.

The system is funded by a surcharge on each dose of vaccine sold.

VICP

On October 1, 1988, the National Vaccine Injury Compensation Program (VICP), Subtitle 2 of Title XXI of the Public Health Service Act, became effective. The VICP is a Federal "no-fault" system designed to compensate individuals, or families of individuals, who have been injured by childhood vaccines. Vaccines currently covered under the VICP are: diphtheria, tetanus, pertussis, (DTP, DTaP, DT, TT, or Td), measles, mumps, rubella (MMR or any components), polio (OPV or IPV), hepatitis B, Haemophilus influenzae type b, varicella (chicken pox), rotavirus and pneumococcal conjugate whether administered individually or in combination.

Effective as of August 26, 2002, the Secretary added vaccines containing live, oral, rhesus-based rotavirus as a separate category to the Vaccine Injury Table (Table), with an associated injury of intussusception. Prior to this date, the Table already contained the general category of rotavirus vaccines, with no associated Table injuries. The new Table injury of intussusception applies to all cases in which the injury occurred within 30 days of the administration of the vaccine, provided that the rotavirus vaccine was administered on or before August 26, 2002. Eight years' retroactive coverage is provided for vaccines and vaccine-related adverse events newly added for coverage under the VICP.

A claim may be made for any injury or death thought to be the result of a covered vaccine. Claims may be filed by the injured individual; or a parent, legal guardian, or trustee may file on behalf of a child or an incapacitated person. Compensable injuries are either those listed in the Vaccine Injury Table, which is found in the Code of Federal Regulations, Section 2114 of the Act, or those which petitioners can demonstrate were caused by the vaccine.

Administration

The VICP is administered jointly by the Department of Health and Human Services, the U.S. Court of Federal Claims and the Department of Justice.

First, an individual claiming injury or death from a vaccine files a petition for compensation with the court and with the Secretary of HHS. Next, a physician at the Division of Vaccine Injury Compensation, HHS, reviews the petition to determine whether it meets the medical criteria for compensation and makes a recommendation on compensability. This recommendation is provided to the court through a report filed by DOJ, although it is not binding. The HHS position is represented by an attorney from DOJ in hearings before a "special master" who makes the initial decision for compensation under the VICP. A special master is an attorney appointed by the judges of the court. Decisions may be appealed to a judge of the court, then to the Federal Circuit Court of Appeals, and then to the Supreme Court.

No petition may be filed under the VICP if a civil action is pending for damages related to the vaccine injury, or if damages were awarded by a court or in a settlement of a civil action against the vaccine manufacturer or administrator.

Attorney representation

It is not a requirement to have attorney representation during this process; however, because the rules of the court are very specific and must be strictly followed, many petitioners have made the decision to have an attorney represent them. The Act provides for the payment of reasonable attorneys' fees and costs, regardless of the court's decision on compensability, providing the case is brought in good faith and there is a reasonable basis for the claim. An attorney who files a petition must be admitted to the U.S. Court of Federal Claims Bar.

Vaccine-related injury

A victim of a vaccine-related injury is entitled to receive:

reasonable compensation for past and future unreimbursable medical, custodial care and rehabilitation costs;

$250,000 cap for actual and projected pain and suffering, emotional distress;

lost earnings;

reasonable attorneys' fees and costs.

The deadline for filing is 36 months after the first symptoms appeared.

Vaccine-related death

A victim of a vaccine-related death is entitled to receive:

$250,000 for the estate of the deceased;

reasonable attorneys' fees and costs.

The deadline for filing is 24 months of death and 48 months after the onset of the vaccine-related injury from which the death occurred.

Necessary medical records

The Act specifies certain medical records that must be provided with petitions filed under the VICP. However, the VICP has set forth in greater detail the materials needed to complete the medical review of each claim. If relevant records on this list are not provided with the petition, the medical review, and therefore, processing of the claim, may be delayed. n


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