NVIC Vaccine News

Federal Government Poised to Expand Vaccine Injury Table

By Theresa K. Wrangham
Published May 09, 2012 in Government

On March 8, 2011, the federal Advisory Commission on Childhood Vaccines (ACCV) unanimously passed recommendations made by the Institute of Medicine (IOM) Report Task Force on Updating the Vaccine Injury Table (VIT), which was created under the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) as a guide for special masters evaluating federal vaccine injury compensation claims. The VIT has not been substantially updated since 1997, even though the Centers for Disease Control has added nine more vaccines to the recommended childhood vaccination schedule since then. 

Congress Gave Pharma Liability Shield

After major pharmaceutical companies threatened to leave the U.S. without childhood vaccines unless they were shielded from vaccine injury lawsuits, the U.S. Congress passed the 1986 law giving major pharmaceutical companies a partial liability shield. The law also shielded pediatricians and all vaccine providers from civil liability for vaccine injuries and deaths.
Co-founders of the National Vaccine Information Center (NVIC) were successful in inserting vaccine safety provisions in the 1986 law, as well as protecting the right of vaccine injured plaintiffs to sue if it could be proven the company could have made a vaccine safer. However, in 2011 the U.S. Supreme Court completely removed all liability from pharmaceutical corporations making and selling vaccines in the U.S.– even it could be proven the vaccine could have been made less harmful.

Vaccine Injury Compensation Was Supposed to Be Expedited

The purpose of including a Vaccine Injury Table of Compensable Events in the 1986 law was to list specific clinical symptoms and injuries on the Table to facilitate administrative procedures for the special masters to allow the awarding of expedited compensation by acknowledging there was enough evidence to argue for vaccine injury in the absence of a more biologically plausible explanation. Vaccine injury claims filed for an “on the Table” injury were to be awarded quick and unopposed compensation, while “off the Table” injuries would have to be argued by plaintiff’s lawyers, who are opposed by Department of Justice lawyers representing the Secretary of Health and Human Services, in front of a special master in the D.C. Court of Claims to essentially “prove” causation, much like a civil court trial.  

Highly Adversarial “Off Table” Claims Process

Since the mid-1990’s, most vaccine injury compensation claims have been filed for “off the Table” injuries because the VIT has not been updated to include symptoms and injuries for new vaccines. This has resulted in fewer vaccine injury claims being awarded through a non-adversarial, expedited administrative process and most claims being vigorously opposed by the Departments of Justice and DHHS in a hotly contested, argumentative process that involves huge expenses incurred by families to obtain expert testimony to prove vaccine injury occurred.
“The federal compensation claims process has become notorious for being adversarial, traumatic, lengthy, expensive,” said NVIC co-founder and president, Barbara Loe Fisher, who called the system “a failed experiment in tort reform in a 2008 presentation to ACCV. “Two out of three plaintiffs seeking federal compensation being turned away empty handed,” she said, “and that is not what parents of vaccine injured children were promised by Congress in 1986.”

ACCV Recommendations Based on 2011 IOM Report

The ACCV’s recommendations were based on the landmark report by the Institute of Medicine – Adverse Effects of Vaccines: Evidence and Causality - published in August 2011. Below are the ACCV’s unanimous recommended compensable event additions to the VIT, which are based on the IOM Task Force report.
I attended the meeting via telephone and webinar and was impressed by the thoroughness and thought put into the ACCV’s discussion and recommendations. They were inclusive of the IOM’s findings when formalizing them into recommendations which, hopefully, will lead to an expansion of the VIT so more vaccine injured plaintiffs can receive non-adversarial, expedited federal compensation.
The ACCV is also planning to take up streamlining the existing VIT to clarify definitions of clinical symptoms and injuries to facilitate the compensation process.

IOM Report Points Out Vaccine Safety Science Gaps

When I made personal public comment during the ACCV meeting, I said that, while this proposed expansion to the VIT is welcome, there is cause for concern because IOM could not determine whether 85% of reported adverse events associated with eight routinely used vaccines were or were not causally related to those vaccines. The IOM Committee of experts making the report in 2011 was hampered by the lack of quality vaccine safety research, just as previous IOM Committees were hampered. I called on the ACCV to fulfill their charge to not only help facilitate the compensation of vaccine injuries but also to prevent vaccine injuries and recommended that DHHS fund independent research to close acknowledged vaccine safety research gaps so more vaccine injuries would be recognized and compensated.

DHHS Official Wants Vaccine Injury Trust Funds for Research

Geoffrey Evans, M.D., Director, Division of Vaccine Injury Compensation, and the ACCV Executive Secretary, noted that recommendations to fund research had been discussed in previous years by the ACCV and indicated that the sticking point was how to fund the research. He went on to suggest taking money from the Vaccine Injury Trust Fund, which was created to fund awards to the vaccine injured, and using it for vaccine research (presumably research conducted by federal health officials).  ACCV’s Vaccine Injury Attorney Representative Ed Krause pointed out that only an act of Congress could divert compensation funds for research and added that it was not incumbent upon the ACCV to provide funding solutions in their recommendations for ongoing research. 
For myself, I cannot help but wonder how long trust funds would last under Dr. Evans scenario or what kind of research would be done if it was left in the hands of the same federal officials already fighting almost every vaccine injury claim in order to deny vaccine injury awards to two out of three plaintiffs. I believe that much needed ongoing research is likely to reveal that the VIT must be substantially expanded to keep pace with the ever expanding number of vaccines recommended in the U.S. DHHS has billions of dollars available for research that could be re-directed from new vaccine research to research evaluating the safety of existing vaccines. Funds that Congress intended to be used to compensate vaccine injuries must continue to be used for that purpose.

Public Engagement and Comment Period on Expansion of VIT

Next steps in the expansion of the VIT will include the ACCV creating a public engagement and comment period for the proposed expansion. The timeline for public engagement has not yet been determined. NVIC will keep NVIC Vaccine E-newsletter readers informed of the timeline as it unfolds and strongly encourages participation in the public engagement process.   
The ACCV will meet again on June 14 and 15, 2012. The meeting is open to the public and the agenda and meeting materials are generally made available 2-3 weeks in advance and will be posted here.  Transcripts and materials for previous meetings can be found here.

Autism Rates Rising Sharply, CDC Reports, Los Angeles Times, Mar 30 2012 
Vaccine Could Stop Nicotine From Reaching the Brain, Technology Review, May 1, 2012 
Unspeakable Outrages Around the CountryFood Freedom News, May 5, 2012 

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13 Responses to "Federal Government Poised to Expand Vaccine Injury Table"
Commenter Name
Christina Waldman
Posted: 5/10/2012 12:57:57 PM
What is your case citation for saying in 2011 the US Supreme Court removed all liability from vaccine manufacturers, even if it could be proven a safer vaccine could have been made? Please give me all you've got.
Commenter Name
Posted: 5/10/2012 3:21:26 PM
So, what about the anthrax vaccine? it has caused more long term problems than all these vaccines together! the vaers data is starting to show there are effects that happen longterm after the injections. unlike the other vaccinations, we were forced to take these. ill stop here because im just peeing in the wind.
Commenter Name
Katie Beecher
Posted: 5/10/2012 7:19:41 PM
Excellent article with excellent points, as usual. I especially liked that Barbara was able to expose the desire of Dr. Evans' to use Vaccine Trust funds for research, which would be improper. The ACCV has been making their own rules for far too long and this needs to stop.
Commenter Name
Theresa Wrangham
Posted: 5/11/2012 11:05:08 AM
Christina - Here is the link to an article Barbara wrote in March 2011 on the U.S. Supreme Court decision that I referenced in the article - http://www.nvic.org/nvic-vaccine-news/march-2011/no-pharma-liability--no-vaccine-mandates-.aspx. Will include it as a hyperlink in the article. Thanks! James - The IOM was not asked to review Anthrax vaccine in the report I referenced. The purpose of my reference to IOM was to illustrate how the ACCV came to approve expansion of the Vaccine Injury Table. As I noted in this article, there is no comfort for consumers in the most recent IOM report, as 85% of the adverse events reported for the vaccines under review there was a lack of quality research. Such has been the case in previous IOM reviews on vaccines. I certainly agree with you that there is a need for such research, and NVIC has on several occasions called for this independent research to be done. Katie - Thanks for the compliment. While Barbara did not write this article, certainly I have had the benefit of her expertise. It should be pointed out that Dr. Evans is not a member of the ACCV. Dr. Evans is a federal employee and the executive secretary for the ACCV. He supports the ACCV from an administrative perspective. The most recent actions of the ACCV in proposing to expand the Vaccine Injury Table are welcome and needed. It is also important to understand that federal advisory committees like the ACCV are committees comprised of experts in a given area that are charged with offering recommendations/advice to the federal government. Recommendations given by these committees are not in themselves legally binding and are for the consideration of the federal government. Many thanks for your comments! Theresa Wrangham NVIC Executive Director
Commenter Name
Posted: 5/29/2012 7:26:46 PM
Are there provisions for fetuses that died, became stillborn after the mom was injected with thiomersol containing flu shots that we know can not last even 1 solitary year? Is this shot included in the 9 shots added since 1997?
Commenter Name
Posted: 7/4/2012 12:21:11 PM
Whoa, whoa, whoa Are you arguing the point that those folks that do not fall in the high need cerogaty should not have access to it? I believe the free clinic was intended to serve that audience, but it was left to each person to fill out the form truthfully. And we all know what happens when individuals are left to govern themselves Or, are you still trying to argue that it's tough see a mass of people gather for a government hand out?And how is this different than when the Governor calls a State of Emergency for an unruly forest fire which allows the government (state and federal, right?) to step in and provide resources and money to help put it out?At any rate, I think we do agree that if the vaccine was distributed better everyone could get it just like they do with the seasonal vaccine (their doctor, Raley's, Walgreen's, their employer, etc.).
Commenter Name
Seattle Chiropractor
Posted: 8/28/2012 5:28:03 PM
The funds need to go directly to families injured by these vaccines. Parents are forced to vaccinate their children in order for them to go to school. When children (or anyone else) are injured by something the government has forced upon them they need to be justly compensated. The government acts like an insurance company, denying anyone they can. What happened to a "government of the people, by the people, for the people"?
Commenter Name
Matthew Bennett
Posted: 10/10/2012 3:20:15 PM
The problem I have is that one hour after I received the Anthrax vaccine I developed fatigue and a headache. I thought nothing of it cause they told me that those side affects are common. Well four days later I developed severe abdominal pain and the doctors thought I had appendicitis. I had CT scans done and everything was normal. So I mentioned I just received the vaccine for an upcoming deployment and that I had got sick in November 2004 after 30 days of receiving the Anthrax vaccine. They pulled my medical records from then and the doctor didn't know what I had do to the fact I got better in a couple of weeks. I have been sick now since 14 April 2011. I have developed seronegative undifferentiated spondyloarthropathy, which has been shown to be triggered by the vaccine. The article(s) that goes in to detail about the safety of the Anthrax vaccine is called Safety of anthrax vaccine: A review by the Anthrax Vaccine Expert Committee (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) and Safety of anthrax vaccine: An expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). This articles mention the possiblity of aggravating/trigger my condition. This reports are old but they still show the possibility exist. I have also developed migraines, photodermatits, severe abdominal pain, joint pain and tremors. When we first thought I was dealing with an adverse reaction to the vaccine I applied for benefits through Countermeasures Injury Compensation Program (CICP). I was denied benefits do to the fact that none of my conditions are listed on the injury table. I am in the process of appealing this decision. The question I have, " Is there even a injury table for the Anthrax vaccine?". When we ask for one everyone tells us there isn't one. I have accepted the fact that I have this conditions but what I haven't is the fact the vaccine didn't trigger my conditions. I have worked with the Vaccine Healthcare Center throughout this whole process. I just wish there was a better way to dealing with this process. I guess the worse part about this is my condition is progressing way faster then it normally does. My local doctors believe it's because of the vaccine. If there is a way to proof this then please let me know.
Commenter Name
Posted: 2/25/2013 8:57:57 AM
I was also denied under CICP in the death of my son after he received the 2009 H1N1 vaccine, because I did not prove scientifically and medically that his death was caused by the vaccine. My son was healthy, he had his yearly checkups, he was not obese, he had no prior medical issues, his death was caused by "myocarditis caused by a recent viral infection." The medial examiner said it could have been caused by the flu he had in Oct 2009, he did NOT have the flu in Oct, 2009, he had Flumist vaccine. I have tried to find out what is going on with our reconsideration letter but there is zero transparency in this department no one has been able to tell me the current status of our claim.
Commenter Name
Posted: 7/31/2013 2:23:57 PM
I don't understand how it is not mandatory for all babies to not be screened at birth for SCID. This is a serious issue and causes lots of problems when getting live vaccinations later and having reactions to them. Testing should be mandatory all over. This could save a lot of SCID children from getting sick, pain and suffering and unnecessary medical bills!!!
Commenter Name
Thomas Southerland
Posted: 11/17/2014 1:46:18 PM
The anthrax vaccine will make some people sick. I finally became service connected with the VA after 12 year battle. The government knows it. They will never admit it. It gave me RA an degenerative joint disease. Almost killed me with blood infections.
Commenter Name
Posted: 1/31/2015 12:22:33 PM
Interesting article.It has been 20 years since my own vaccine injury (hep b),and 12 years since doctors harrassed me to vaccinate my children. In light of the measles outbreak I once again started reading up on vaccines. I am no fool to have expected 100% safe and effective vaccines all these years later,but what I see is so very sad. More vaccines.More denial of adverse events.Families going through hell to get compensated.And people trying to tap the money that should only go to those who suffered as a result of vaccinations. In all these years we could not accept the fact that vaccines injure and kill even though doctors state just that.So sad for people who vaccinate,suffer an injury,and then are told no way was it the vaccine.Doctors never admit it was a reaction,and send you on your way to suffer alone. Why can't we support people when vaccines harm? Are we afraid it will cause a panic,and everyone will refuse to vaccinate? I think it would have the opposite effect.You know things could go wrong,but you also know your doctor and government will help you.I don't think things will ever change,but you keep talking.Keep sharing with those who vaccinate,because when things go wrong they have no one to turn too. No one believes them.
Commenter Name
Posted: 1/12/2016 1:02:12 PM
Lacking any protection why then does the government get to demand what we as parents choose to have injected into our children? I am battling the school regarding the varicella vaccine. After one of my daughters sufferedvtremendously, I believe I have the right to safe guard my children my now 21 year old daughter received this vaccine at age 11. Within a week she had shingles. She now suffers from shingles regularly. I refuse to ever inject any of my children with it. Where are the rights of my daughter who not only had a reaction but has a life altering problem that there is no fix for?
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