Vaccine Court




Congressional Oversight

Congress passed legislation was passed in 1986 and the program died that same year. It would be 13 years before congress would be informed about progress either through the United States General Accounting Office (GAO), would be updated about the NVICP. The GOA report was given to congress December of 1999 titled “Vaccine Injury Compensation: Program Challenged to Settle Claims Quickly and Easily.” By law the office of GAO is required to review trust funds and their viability to meet future claims.

The gist of the report was the ability to settle claims in an efficient and timely manner. The goal for deciding cases and settlements was 1 year. That goal was never reached, the average case and settlement went from 2 years and by the 1990s 3-5 years and many claim took over five years. One of the reasons why all the cases took longer was the backlog of older claims dealing with the Hepatitis B vaccine that had to be filed by January 31, 1991. There were so many claims this caused a huge backlog and slowed down the whole process.

The GAO reported there were 4,245 claimed filed prior to October 1, 1988. The claims were labeled, “pre-act” petitions with the price tag of $745,000,00 in compensation rewards and petitioner attorney fees.

As I read through the history of medicine I see time and time again where dangerous practices and medicine are allowed to stay on the market and cause more injury and death than they prevent. After October 1, 1988 the vaccine injury trust was funded by $0.75 excise tax on each antigen component of a vaccine that was sold. The measles, mumps, and rubella (MMR) vaccine would cost us $2.23 in excise taxes per dose. When you think about how many doses are given for all newborns that’s a lot of money to manage.

Adjudicating, that is dealing with claims was taking many years to settle. The GAO proceeded to investigate the problem citing the HHS Secretary absolute authority over the changes of the Vaccine Injury Table. The changing in the Vaccine Injury Table and the complete authority of the HHS Secretary was causing confusion and backlogs in settlements.

Barbara Loe Fisher in testimony September 28th 1999 in the House Subcommittee on Criminal Justice, Drug Policy, and Human Resources reported: “The principle reason why the Vaccine Injury compensation has become highly adversarial and is turning away 3 out of 4 claimants is that the Department of Health and Human Services (DHHs), with the assistance of the Department of Justice (DOJ), has wielded its discretionary authority to all but eliminate a just list of compensable events in the Vaccine Injury Table, thereby destroying the guiding tenet of presumption. This action by DHHS constitutes the most egregious violation of the spirit and intent of the law and, in effect, is a fatal compromise of its integrity.”

What is troubling is the parents who worked with congress in developing the law gave the HHS Secretary broad discretionary authority to alter the Vaccine Injury Table to “Add” events and expand the table over time. What happened was just the opposite, the Secretary has his/her discretionary power and flexibility to remove compensable events from the Table sanctioned by congress. The refinement process as attorney’s for the injured have stated, “The secretary’s arbitrary and definition of the medically recognized definition of “Encephalopathy” is so restrictive that it is believed by petitioners’ counsels across this country that they will never again see an injury to a child that falls within the definition’s narrow confines.”

HHS Secretary Donna Shalala removed Residual Seizure Disorder (RSD) from the vaccine trust fund table. In 1195 RSD was removed from the table relating to pertussis and tetanus vaccines and in 1997, RSD was removed from the table relating to the MMR Vaccines.(1995-1997)

Another major change was the definition of brain injury (encephalopathy). The HHS secretary using her overreaching authority used the Institute of Medicines (IOM) report stating that evidence was inadequate to accept or reject a causal relationship between vaccine and residual disorder. Another troubling fact was and still is additional vaccines added to the table by the HHS secretary have no specific table injuries or have the immediate onset of anaphylactic shock as the only listed table injury. Most petitions filed today are off-table injuries, which takes years and a lot of money for petitioners to litigate.

The HHS Secretaries office has published its reasoning for revisions to the Vaccine Injury Table in the Federal Register. However, it has not published an overall method of a how it came to these decisions through applying the criteria it uses in combination with the IOM findings.

The secretary of the HHS has the authority to interpret the intent of congress and is its own rule making authority when linking vaccines to the table injures. Parent advocates and other concerned people would interpret the rule making authorized granted to HHS as directing the secretary to make data definitive when available but the benefit of the doubt must remain with the petitioner.

This has decision to interpret inconclusive data from the IOM on Residual Seizure Disorder as absolute prof that no causal relationship exists has brought increased scrutiny. The IOM has found that existing scientific evidence felt that there was a causal relationship between tetanus vaccines and brachial neuritis and the HHS secretary added this to the Vaccine Injury table. Rather vexing the IOM found a similar relationship between tetanus and Polio vaccine and Gullain-Barre Syndrome (GBS). This was not added to the vaccine table.

The IOM found evidence lacking and rejected a causal relationship between vaccines and Residual Seizure Disorder and this was not added to the Vaccine Injury Table. This also happened when reviewing evidence of the MMR and encephalopathy , which remained on the Vaccine Table List.

The reports I’ve been reading the HHS secretary hasn’t created a Vaccine Injury table for the Trivalent influenza vaccine and the Quadrivalent Influenza vaccine. In 2013 of quarterly meeting the ACCV approved a new addition to the Vaccine Injury table for Influenza vaccines Guillain Barre Syndrome. The HHS secretary hasn’t approved the addition to the table. Most of the petitions filed through the program since 2013 have been influenza vaccine injuries with Guillain-Barre syndrome as the common injury.

Seven years before the Department of Health and Human Services inspector general filed a report with the HHS secretary criticizing how the program was managed and the large number of petitioned filed as well as how the petitions were reviewed. In his report the Inspector General cited: As of August 1991, 58 percent of the cases that the HHS internal medical staff recommended not to be compensated were overturned by the special masters and compensated. Two major factors accounted for the reversal, the lack of corroboration of evidence and interpretations of the Vaccine Injury Table.

As of 2014 there is $3.42 billion for the vaccine trust fund. Since the beginning of excise taxes the vaccine trust has receive more funds than it has paid out. Damages include, attorney fees, administrative costs, everyone involved gets paid except for those who are injured! The excise tax of .75 per dose has been the most common income reported for the vaccine trust fund. Since the program began the US treasury collects the excise tax from vaccine manufactures and transfers, withhold a 25 percent to the vaccine injury trust fund. This is provided for in section 9602(b) of the Internal Revenue Code for the management of trust funds. The US General Fund has taken $.19 cents out of the $.75 exists tax for every dose sold.

The Vaccine trust only takes in $.56 cents instead of the $.75 cents promoted to the public. This isn’t the only government departments dipping into the vaccine trust fund.

Each year congress dips into the vaccine fund through apportion and gives the funds to the HHS, DOJ, and the court for their administration of the program. Health Resources and Service Administration (HRSA), a part of HHS also gets a cut, the largest cut of all out of the trust fund because they handle the paying out of damages and attorney fees. There has been an increasing difference in cost of administration over the last decade with the majority of the funds going towards salaries, wages, and administrative costs of the trust fund.

Concerned parent groups and attorneys have been examining the monthly and yearly trust fund budget reports published on the US Treasury website. One report from March 2000 to congress for the Vaccine Injury Trust fund reported “current annual appropriation levels to reimburse agencies from the VIT for administrative expenses cost the trust fund $9.6 million to meet agency needs.

The HHS administrators, DOJ, and the US court of Federal Claims helped adjudicate injury claims in the beginning the agencies would go over their budgets given to them through the Vaccine Injury Trust Fund.

From 1996 to 1999, the trust fund paid out from $7.8 million to $9.4 million for administration costs are increasing by 3 to 11 percent every year.

This is the point of this article. Many concerned lawyers, journalist, and parent groups have filed FOIA requests for the balance sheet reports of the vaccine trust fund because of the yearly increasing administrative costs.

The trust fund isn’t a private bank for these agencies to balance their budgets. Journalist have requested reports on how much money is being spent per petition on DOJ attorney fees, outside contracted medical expert fees and costs, and internal medical reviews have stated this information is legal privilege and disclosing this information would reveal their strategy when prosecuting claims. The public should be informed of the compensable damage awards, attorney fees, costs for each petition for the final decision of each petition.

Also the HRSA has refused to respond to FOIA requests from concerned parties regarding contracts, document, funding of IOM reports used by the HHS Secretary regarding potential changes to the Table and DOJ attorney prosecuting petitions in the program.

Because of this secretive behavior the members of the Advisory Commission on childhood Vaccines that the VIT is paying for research studies, which would be a violation of federal laws. The VIT is not established to fund vaccine research studies.

There has been arguments going on between government divisions, vaccine manufacturers, and concerned parents groups what to do with the large vaccine trust fund. Manufactures want to cut the excise tax and the other side, the concerned parents, want increased research and funding in vaccine related projects. I can’t find what the governmental bodies that make so much money from the vaccine trust fund state, but I am pretty sure they don’t want the excise taxes cut, which would impact their ever increasing administrative budgets.

After I finished crawling through numerous reports and articles it is obvious to me congress needs to request a more in-depth independent audit of the vaccine trust fund. It looks like the vaccine trust fund has turned into a feeding trough for a bunch of pigs.

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History Of Vaccine Series Part 1

History Of Vaccine Series Part 2

Photos from Pixabay

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VACCINE INJURY TRUST FUND: Revenue Exceeds Current Need for Paying ClaimsHEHS-00-67: Published: Mar 31, 2000. Publicly Released: Mar 31, 2000

THE VACCINE INJURY COMPENSATION PROGRAM: ADDRESSING NEEDS AND IMPROVING PRACTICES

The National Vaccine Injury Compensation Program: A Program Evaluation [Redacted Version]

26 U.S. Code § 9602 - Management of Trust Funds

Vaccine Injury Compensation Reports - 75X8175

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