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National Vaccine Injury Program Needs Modernizing

March 8, 2022, 9:00 AM

In an effort to modernize the critically endangered National Vaccine Injury Compensation Program (VICP), the Vaccine Injury Modernization Act of 2021 (H.R. 3655) was introduced by the bipartisan team of Rep. Lloyd Doggett (D-Texas) and Rep. Fred Upton (R-Mich.) on June 1, 2021, with the support of public health officials.

The VICP needs increased resources to respond to a caseload that has seen enormous growth over the past decade, even without injuries related to the Covid-19 vaccine, which are currently excluded from the program.

Covid-19 vaccine injuries are covered exclusively by the Countermeasures Injury Compensation Program (CICP) established for vaccines and medications, etc. used in response to public health emergencies and national security threats. Unlike the VICP, the CICP is not a legal process, and Congress should add Covid-19 vaccines to VICP. Here’s why.

‘Vaccine Court’s’ Growing Caseload

The National Childhood Vaccine Injury Act of 1986 established the VICP—a no-fault compensation program where vaccine-injured parties may file a claim for compensation for suffering injury or death as a result of the administration of certain vaccines. Congress intended that the VICP provide individuals (petitioners) a swift, flexible, and non-adversarial alternative to often costly and lengthy traditional civil tort litigation. You cannot file a lawsuit against a manufacturer or administrator of a covered vaccine without going through this program first.

All covered vaccine claims in the U.S. are managed and adjudicated by eight special masters in the Office of Special Masters, also known as the vaccine court, within the U.S. Court of Federal Claims. They act as fact finders and determine the types of proceedings necessary for presenting the relevant evidence and ultimately weighing the evidence to render a final, enforceable decision.

The VICP’s covered vaccines have increased significantly since the inception of the program in 1986. The original program covered six vaccines, while the current program covers 16 vaccines. With the inclusion of the flu shot, the overall number of cases being filed with the VICP annually has increased at an overwhelming rate, solely because more individuals are eligible to file, not because vaccines became less safe.

In fiscal year 2011, just 386 petitions were filed. The numbers increased to 1,120 in FY 2016, and in FY 2021 the number of cases filed was 2,060. Currently, there are approximately 4,000 open cases in the vaccine court.

Despite this enormous increase, the number of special masters still remains limited to eight.

Severe Inefficiencies, Long Waits

While the Office of Special Masters has been operating valiantly under these circumstances, severe inefficiencies exist, which continue to delay adjudication and the speedy delivery of justice to injured petitioners. The two- to three-year waiting times for scheduling a hearing, resulting from the overwhelmed system, and the insufficient number of overworked special masters adjudicating the VICP claims, results in devastating difficulties to petitioners.

When the long wait for decisions in a backlogged system deprives a child of potentially life-changing treatment, justice delayed is indeed justice denied. Even in cases where causation is presumed, the time necessary to conclude has dramatically increased as well.

The VICP has reached a critical point. Congress has acted to promote a strong universal immunization program. Essential to supporting a strong universal immunization program is maintaining a vibrant safety net for those individuals who are harmed by immunizations. That safety net is in danger of failing. Not because vaccines are less safe, but because Congress has failed to update the VICP’s infrastructure while allowing caseloads to increase.

The Vaccine Injury Compensation Modernization Act and the Vaccine Access Improvement Act (H.R. 3656)—introduced at the same time in an effort to streamline the cumbersome process by which new vaccines are added to the VICP— seek to modernize the program to reflect today’s realities.

The single most important part of these legislative efforts is reducing delay by increasing the number of special masters. H.R. 3655 also seeks to bring compensation caps in line with inflation, as well as increasing the statute of limitations by two years and reducing the bureaucratic delay for allowing compensation to those who receive new vaccines.

Unfortunately, H.R. 3655 has been languishing in the House Committee on Energy and Commerce where it has not been marked up and allowed to move forward, all the while vaccine-injured adults and children wait years for their compensation.

Which brings us to Covid-19 vaccines.

Congress Must Include Covid-19 Vaccines in the Vaccine Injury Program

Covid-19 vaccines were produced in response to a pandemic. As such, they are covered exclusively under the CICP. This means a person cannot sue a Covid-19 vaccine manufacturer and must go through the CICP.

Unlike, the VICP, the CICP is not a legal process. Those injured by the Covid-19 vaccines are not entitled to counsel. They have no right of appeal. There are no pain and suffering damages, substantial limits exist on actual economic damages, and a drastic one-year (from the date of vaccination) statute of limitations applies by which a claim must be filed.

Of the thousands of claims submitted to the CICP, only 29 claims have been compensated. As of Feb. 1, 2022, there were more than 3,700 claims filed alleging injury or death from Covid-19 vaccines.

Based on its history, compensation for these claims will be few and far between. The CICP gives vaccine-injured people little more than the right to file and lose.

Congress must act quickly to include the Covid-19 vaccines in the VICP so those people who did the right thing to protect themselves, their families, and their communities by getting vaccinated have a legitimate opportunity for compensation if they prove their case.

Further, Congress must ensure that the VICP and its stakeholders, including the Office of Special Masters, the Department of Health & Human Services, and the Justice Department have the resources, staff, and infrastructure to properly administer this critical public health program.

It is well past time to bring this 34-year-old program up to date and for Congress to keep the promise of the VICP.

This article does not necessarily reflect the opinion of The Bureau of National Affairs, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

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Author Information

Renée J. Gentry is the director of the Vaccine Injury Litigation Clinic at the George Washington University Law School where she is a professorial lecturer in law. She is a leading expert on vaccine injury litigation in the VICP.