Utah Bar Journal

Before a lawsuit may be filed against a vaccine manufacturer, federal law requires the submission of a claim under the National Vaccine Injury Compensation Program (the Program). See 42 U.S.C. §§ 300aa‑1 et seq. The Program was created by the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660). It is a no-fault system that provides an efficient forum for individuals to be compensated for vaccine-related injuries directly from a federally-established fund instead of vaccine manufacturers.

The Program provides some basic protection for vaccine manufacturers by compensating those relatively few individuals injured by vaccines while allowing the manufacturers to maximize their energies on new and current vaccine development for the betterment of society as a whole. The Program involves three distinct federal government offices:

• The U.S. Department of Health and Human Services – the respondent in all vaccine injury claims and the “guardian” of the vaccine fund;
• The U.S. Department of Justice – the legal counsel for the respondent; and
• The U.S. Court of Federal Claims – the court that receives the petition and decides if the claim will be paid.

In general, a vaccine injury claim must be filed within three years after the first symptom of the vaccine injury. See 42 U.S.C. § 300aa-16(a). A vaccine related death claim must be filed within two years of death and within four years after the first symptom of the injury from which the death occurred. See 42 U.S.C. § 300aa-16(a)(3).

A vaccine claim begins with the filing of a petition with the U.S. Court of Federal Claims in Washington, D.C. All vaccine cases are filed electronically and are assigned to a special master who makes all factual and legal findings in the case. There are no juries in the Program. Once a vaccine petition is filed, there are two phases of the claim: Entitlement and Damages.

In the Entitlement phase, the special master receives evidence to determine if, by a preponderance of evidence, the vaccine injuries claimed were caused in-fact by the vaccine. See 42 U.S.C. § 300aa-13(a). If the injuries are determined to have been caused by the vaccine, entitlement is awarded. If not, entitlement is denied and no award of damages is reached.

Under the Program some vaccine injuries, such as anaphylactic shock, are presumed to have been caused in-fact by a vaccine if they occurred within a certain timeframe from the administration of the vaccine. As a result, the Program has established a vaccine table for injuries that have a legal presumption of causation. See 42 U.S.C. § 300aa-14.3 This is commonly referred to as a “Table Injury.” It is not fatal to your case if your vaccine or injury is not listed on the table. It only means that there is no presumption of causation and that you will need to prove causation in-fact through expert opinion. Expert opinion is then required to determine the causal connection between the vaccine and the alleged vaccine injuries. Similar to traditional litigation, the special master will also encourage settlement discussions between the parties before an entitlement decision is rendered.

After the petition is submitted, the Department of Justice will file a report with the court, typically with expert opinion disputing causation, among other defenses. This is referred to as a Rule 4 report. See Rule 4, Vaccine Rules of the United State Court of Federal Claims. The special master then renders a decision on entitlement. Only after a decision of entitlement is granted does the court move on to the next phase – Damages.

In the Damages phase, the court receives evidence concerning the damages related to the vaccine injury and decides the amount of damages to award. For vaccine injury cases, there is no cap on the amount of damages that can be awarded. However, punitive damage awards are prohibited and there is no collateral source rule under the Program. See 42 U.S.C. § 300aa-15. For example, if your client has health insurance coverage for past medical expenses related to the vaccine injury, the Program will not compensate any expenses that those collateral sources will cover, whether past or future expenses. The court will only award past and future nonreimbursable medical, custodial care, and rehabilitation costs, and related expenses. In vaccine related death cases, the award is capped at $250,000 under the Program.

Because the Program is a no-fault system, each year approximately 60% of the petitions for entitlement are granted.4 The average damages award in 2007 was approximately $1,000,000. Under federal law, attorneys are prohibited from taking a contingent fee on the damages awarded to the petitioner under the Program. See 42 U.S.C. § 300aa-15(e). Instead, the Court will make a separate award of attorney’s fees and costs based on a reasonable hourly rate considering the experience of the attorney, the actual time incurred, and the difficulty of the matter. This requires that attorneys keep extremely detailed and accurate time logs. Additionally, as long as the claim was made in good faith with an appropriate factual basis, attorneys may still receive an award of attorneys fees even if entitlement is denied. In 2007, the average award of costs and attorneys fees was about $50,000 for compensated claims.5 The average attorneys fees award for non-compensated claims was about $26,000.6 Costs are reimbursed to the attorney as long as the incurred costs are related to the prosecution of the vaccine claim.

Even after winning entitlement and receiving an award of damages, you may still elect to decline the damages award, leave the Program, and file suit against the vaccine manufacturer under the traditional tort system. See 42 U.S.C. § 300aa-21. An election to take the award completes your journey through the Program and precludes a suit against the vaccine manufacturer. If you decline the award and withdraw from the Program, you are no longer bound by the restrictions of the Program. For example, you may now enter into a contingency fee agreement with your client.

In addition to the general procedures mentioned above, there are a few things every attorney litigating vaccine cases should know that differ from the traditional tort process:

First, vaccine cases can take a very long time to complete, longer than the traditional tort process. Even if a case settles before experts are retained, it may take over three years to receive any funds. More complicated or disputed cases can take five to seven years or more to resolve. Additionally, if the client were to die before the vaccine injury claim is completed in the Program, the $250,000 cap would then apply to the claim and limit the damages award.

Second, discovery is “front-loaded.” Most, if not all, of the fact discovery is completed before the petition is even filed with the court. In vaccine cases, the client’s past medical records are the most critical records to both parties. As such, the Program requires the submission of complete medical records of the injured party at the same time the petition is filed. The records submitted are more extensive than in traditional medical malpractice litigation. In most cases, even if the injury occurred later in life, production is required of virtually every medical record in existence since the birth of the injured party, including pre-natal medical records.7 If a record cannot be located, an affidavit is required from the records custodian accounting for its absence. Incomplete records and the acquisition of medical records are the main reasons these cases take such an excruciatingly long time to prosecute under the Program.

Third, locating experts familiar with the Program is difficult. Not only is it difficult to locate immunology experts who are unbiased toward lawyers and will actually be willing to opine to causation of a vaccine injury, but it is also difficult to find life care planners that are familiar with what the Program will and will not compensate. These difficulties increase both the cost and complexity of vaccine cases.

As even the most seasoned personal injury attorneys are often not familiar with the intricacies of the Program, it is important for attorneys practicing personal injury litigation to at least be familiar with the basic procedures of the Program so as to properly advise their clients and evaluate their potential claims under the Program.

1. See MSNBC, Court investigates vaccine link to autism, at http://www.msnbc.msn.com/id/19168291 (last modified June 11, 2007).

2. Currently, autism-related vaccine cases are treated and categorized differently in the National Vaccine Injury Compensation Program. This article is a general primer on non-autism vaccine claims. See U.S. Court of Federal Claims, Autism Update, at http://www.uscfc.uscourts.gov/sites/default/files/autism/autism_7_08_08.pdf (last visited July 20, 2008).

3. See U.S Department of Health and Human Services, Vaccine Table, at http://www.hrsa.gov/vaccinecompensation/table.htm (last visited July 20, 2008).

4. See U.S Department of Health and Human Services, Statistics Reports, at http://www.hrsa.gov/vaccinecompensation/statistics_report.htm (last visited July 20, 2008).

5. See id.

6. See id.

7. See U.S Department of Health and Human Services, Filing a Claim with the VICP, at
http://www.hrsa.gov/vaccinecompensation/filing_claim.htm (last visited July 20, 2008).