Home > Expert Insights > Government Accountability Office Report on Vaccine Injury Compensation

Government Accountability Office Report on Vaccine Injury Compensation

This guest post has been written by Dr. Dorit Reiss, Professor of Law at the University of California Hastings College of Law in San Francisco, CA.  Dr. Reiss contributes to various articles, blogs and law journals, utilizing her legal expertise to examine the social policies of immunization.  This particular post is a continuation of her analysis of the National Vaccine Injury Compensation Program.

Government Accountability Office Report:  “VACCINE INJURY COMPENSATION: Most Claims Took Multiple Years and Many Were Settled through Negotiation” November, 2014 GAO-15-142

Side-Nav-one-third-VICP

The Government Accountability Office (GAO) is a Congressional agency that investigates the actions of other agencies, with a special emphasis on use of funds (though that is not the only thing they look at).

Sometime in late 2013 or 2014, Congressman Darrell Issa, Chairman of the Committee on Oversight and Government Reform in the House of Representatives, asked the GAO to examine the Vaccine Injury Compensation Program (VICP). In November 2014, the GAO issued its report, GAO-15-142 (hereinafter “the report”).

As explained in the opening letter to Chairman Issa: 

This report examines (1) how long it has taken to adjudicate VICP claims and how claims have been adjudicated, (2) the changes to the vaccine injury table and in the types of claims filed, (3) how the balance of and spending from the trust fund have changed, and (4) available information on petitioner experience with VICP and how HHS has informed the public of the availability of VICP.

The first section of the report describes the Vaccine Injury Compensation Program. Under the Childhood Vaccine Injury Compensation Act of 1986, individuals seeking compensation for vaccine injuries need to first file claim with the program (42 U.S.C. § 300aa-11). Bruesewitz v. Wyeth, 131 S.Ct. 1068, 1072 (2011) further clarified that design defect claims – but not manufacturing or warning defects – are preempted by the program and that individuals cannot bring suit in state courts at all, even after going through the program. Claims must be filed within a certain time period (three years for most claims, 42 U.S.C. § 300aa-16) and need to demonstrate the injury was related to the vaccine. Causation can be shown by demonstrating the injury is one of those mentioned in the table of injuries within the time frame indicated, which then creates a presumption according to the three-prong test set out in Althen v. Secretary of Health and Human Services, 418 F.3d 1274, 1278 (2005)  The report describes the process, and the possible ways compensation can be awarded: by concession, where the Department of Health and Human Services (HHS) finds petitioner is entitled to compensation, by settlement (which is not an admission the vaccine caused the injury), or by a contested decision in favor of petitioner (the report, p. 7).

The law requires HHS to include information about the program in the Vaccine Information Sheet given to parents before vaccinating and “to undertake reasonable efforts to inform the public of the availability of the program” (the report, p. 9).

Findings: Lengths of Claims and Types of Decisions

The report found that the average length of adjudicating a claim since 1999 was 5.5 years (range 2 days to over 14 years). Claims since 2009 were more likely to be resolved much more quickly (with an average of 1.6 years). Part of the explanation is the Omnibus Autism Proceeding, which led to some claims being put on hold. Petitioners complain about delays,  however officials attribute much of the delay to the time needed for petitioners to get a case together for initial review, or gather documents about compensation. There are other stages in the process that can lead to delay such as consulting experts or needing more information.

Since 2006, most claims compensated were decided by settlement (about 80%; about 10% were conceded, about 10% decided). Reasons for settlement include a desire to resolve the case quickly and efficiently.

The report discusses the Autism Omnibus Proceeding – more information on that can be found on the Vaccinate Your Baby website here.

In conclusion, some proceedings took a long time, but the program’s processing times improved over time. Many of the delays are related to the need to get more information, often from – but not limited to – petitioners. The program appears willing to give petitioners ample time to provide needed information. Most cases in recent years settle.

Findings: Changes to Table of Injuries

Six vaccines were added to the table since 1999 with no table injuries assigned to them. Claims relating to those vaccines are handled as off-table injuries, without the presumption of causation. Two pre-1999 vaccines also had no injuries, so at this point, out of sixteen covered vaccines, eight have no table injuries.

HHS said it’s working on proposed rules to add injuries. In July 2013, HHS proposed to add intussusception as a table injury for the rotavirus vaccine. HHS also said it’s considering opening rulemaking to add table injuries for the influenza, hemophilus influenza type b conjugate, varicella, pneumococcal conjugate, hepatitis A, meningococcal, and human papillomavirus vaccines. Many cases for injuries that are not yet added, but are under consideration have, in the meantime, been conceded or settled.  Such an example is that of Guillain-Barré Syndrome (GBS) as a possible injury from the influenza vaccine.

Most cases since 2005 were off-table claims with no presumption of causation. There has also been an increase in claims brought by adults – especially for the influenza vaccine (29% of claims brought since 1999).

In other words, HHS is working on changing the table.

Note: While it is important for HHS to add injuries to the table that science shows are associated with vaccines, it is just as important to refrain from adding injuries that are not supported by scientific evidence,  and to remove injuries that science now shows are not associated with the vaccine. For example, although there is evidence associating GBS with the 1976 swine flu/H1N1 vaccine, there is no good evidence showing the annual influenza vaccine causes GBS, and actually some evidence to the contrary.  Similarly, while it used to be believed that the DTP and MMR vaccines caused encephalitis or encephalopathy, there really is no good evidence for that in the case of MMR, and an abundance of evidence against it for DTP (Offit 2010). The table was designed to reflect injuries that science associates with the vaccines. Those are the ones that should be on it.

I hope scientists will look out for HHS’ rulemaking and provide appropriate input. I also hope that as part of updating the table, HHS will consider removing injuries that should not be on it.

Findings: Changes to Balance of and Spending of Trust Fund

The balance of the trust fund has increased, even though spending on disbursement to HRSA, DOJ, and USCFC has also increased, as has total compensation to petitioners and the number of claims compensated.  According to the Office of Special Masters, the increase in payments is due to the addition of the influenza vaccine which, in 2005, began to be administered to many more people each year than childhood vaccines are.  The payment to lawyers was stable until 2007 and then started going up.

Findings: Petitioner Experience and Informing Public of VICP

The report highlights that information about petitioner experience is very limited and mostly anecdotal. There was an HRSA voluntary survey with a very low response rate, and some stakeholder comments submitted, but the report highlights that they are not representative.

Some petitioners felt the program imposed too much burden, and described it as “traumatic”.  In contrast, another stakeholder said that the program handles vaccine injuries “efficiently and fairly.”

Many petitioners felt compensation was inadequate, though more than half were satisfied with the method of award payment.

Many petitioners felt the process was adversarial. However, assessing whether the process is adversarial based on feeling is problematic. After all, one of the goals of an adjudicatory process is to examine claims with the purpose of compensating deserving claims, but not compensating those that do not meet the criteria. About half felt finding an attorney was difficult and the other half felt it was easy.

Given that, few adjudicatory processes will feel “friendly” – especially if you are required to provide proof. If a parent is distressed and tired from dealing with a disabled child, the process may feel even more taxing. This impression alone is not enough to view the process as overly adversarial. More objective criteria are needed.

HHS also acknowledged ongoing criticism for not promoting public awareness of the program. After contracting out, a national marketing and outreach plan was completed in November 2010. HHS also had a 2014 outreach plan and said its activities were in progress. These included reviewing the VICP booklets to use plain language and make them more user-friendly, reviewing and upgrading the VICP website to improve navigation, developing VICP message points for target audiences and slides about the program to be used in speeches and other presentations by HRSA staff, and requesting federal websites to provide information on the program and to link to the VICP website. In its outreach plan for fiscal year 2015, the agency is targeting health care providers, parents and expectant parents, adults aged 50 years and older to include Spanish-speaking older adults, and civil litigation and health attorneys, with the goal of informing target audiences of the availability of the program. (The report, p. 32)

The report highlighted the importance of increasing public awareness.  However, it’s important that we put the awareness issue in perspective.

How many readers know of the tax court? How many of you heard of the Commodity Futures Trading Commission, which has the authority to adjudicate and enforce issues related to future markets? How many of those who are not immigrants know of the Board of Immigration Appeals? How many of you would know how to appeal a social security disability benefits determination?

Most of us know very little about administrative adjudicatory mechanisms we have not had contact with or need for.  And many of us have limited knowledge about the ins and outs of the regular court system.

The American administrative state is big and complex, and it has a lot of parts that most people do not find out about unless they need to. I teach administrative law, and I still constantly discover new parts. The fact that most people do not know about VICP is neither surprising, nor sinister.

Information about VICP is actually more easily accessible than for most other administrative tribunals. The Vaccine Information Sheet that federal law requires providers to give to parents before vaccinating includes information about it. Googling “suing for vaccine injury” brings up links to HRSA and to a Wikipedia article about Vaccine Court.

More awareness, especially by providers, could be a good thing, but the program is certainly not hidden or buried.

Conclusion:

The report’s conclusion highlights changes in the program. For example, most claims now are off-table injuries, and it’s not clear how adding injuries to the table will mean that more claims settle. The report highlights that addressing one criticism – the statute of limitations – requires statutory change and points out the importance of increasing awareness.

But while the GAO report suggests areas where change is either in progress or needed, it’s hardly a condemnation of the program. It highlights a program that is not perfect, but is mostly working.  And it indicates that the department in charge – HHS – is aware of the challenges and is working on areas that need improvement. If anyone hoped that examination by the GAO would lead to aggressive condemnation of VICP, they are going to be disappointed. There is no evidence of corruption in the report; there is no evidence of systematic mistreatment of petitioners; problems – like delays – are addressed and explained, and generally, the report does not suggest that VICP requires a dramatic overhaul.

 Offit, P. A. (2010). Deadly Choices: How the Anti-Vaccine Movement Threatens Us All. New York, Basic Books.
  1. reissd
    December 13, 2014 at 12:11 pm
  2. December 21, 2014 at 5:16 pm

    Wonderful website you have here but I was wanting to know if
    you knew of any user discussion forums that cover the same topics
    discussed here? I’d really love to be a part of online community where I can get opinions from other
    experienced individuals that share the same interest. If you have any recommendations, please
    let me know. Kudos!

    Like

  3. December 31, 2014 at 1:45 am

    Great article.

    Like

  4. December 21, 2016 at 12:37 pm

    “How many readers know of the tax court?”
    You’re kidding me…. you’re going to compare taxes, trade, immigration to disability and death due to forced science upon our bodies??

    “How many of you would know how to appeal a social security disability benefits determination?”
    Ohhh… and I have to say that the SS department does an f’d up job in informing their beneficiaries about their benefits – their representatives sound like THEY are in their death beds…. they give you the run around for days and erroneous information.

    “Most of us know very little about administrative adjudicatory mechanisms we have not had contact with or need for.  And many of us have limited knowledge about the ins and outs of the regular court system.’
    Yes… and how absolutely sad that is…. and when we go looking for answers – those “experts” still misinform us or don’t have them!!

    And WHAT does all that have to do with being informed of the very medical procedures that are measured by “benefits versus risks”? …risks which are not being properly monitored once the vaccine is accepted by the FDA because they are assumed safe overall…. risks of which only 10% are being actually reported by medical professionals, never mind that patients do not know there IS a place to report them… or that the symptoms their child IS experiencing are IN FACT adverse reactions to the vaccine – but which their pediatricians poo-poo for years… making parents feel as if they are hysterical or complainers or incompetent to observe and discern problems.

    Moreover, many of the more severe results of vaccine damage do not appear until many years later when the child is able to express himself or uses skills like reading and communication that is not needed when younger – and there is no protocol to monitor these after receiving vaccines, the results are assumed within only a few months versus years – which is due to the ASSUMPTION that vaccines do not cause any known damage – but that “known” have NEVER been investigated purposefully. And the vaccine injury program caps the years to a mere 3 years since the vaccine or under. Most injured find out about the program too late. WHY?

    Because of the pervasive apathy and dismissiveness Pediatricians have for their patient’s claims – based on the belief given by their mentors and teachers that vaccines have been fully tested and are safe.

    Doctors are NOT educated on the mechanisms of vaccines in medical school. Students ASSUME that whatever they are taught to do is full-proof – they are being taught by the “elites of science”, right? Why an 18, 19 year old ask questions?. They do not go over the science of vaccines (unless you take up immunology or similar). It’s like being taught there is a God – no child actually knows that, they learn it, it is faith. But science is not religion – is it. Should we submit on faith alone? Should we experience science spiritually?….Then it would not be science – would it.

    I was never given the “benefits versus risks” speech or pamphlet, and when I reported the adverse effects I was told they were “normal” and “nothing to worry about.” Even the severely adverse reactions such as screaming and fainting and not sleeping for 6 years since the vaccine.

    There are major flaws to her “assessment” because there are major flaws to the surveillance and
    management of post-vaccination.

    Like

  5. December 21, 2016 at 12:57 pm

    OH… a word on the FDA….. the FDA does NOT perform clinical tests/studies on vaccines…. they do NOT perform or monitor ANY study. Go to their website and look that up.

    The vaccine manufacturer fills out an FDA application. The FDA hands them the requirements. The manufacturer finds and hires the laboratory and staff to conduct clinical trials/studies (How self serving is that? To hand pick and hire your own people who will conduct the test of and that will approve your own chocolate…lol…. a product that will earn me millions and billions of dollars and those staff in partnership with me…. ha!)

    They repeat the tests over and over again and tweak them over and over again, until they get the positive results they want and match the requirements.
    They submit this positive result to the FDA – they do not have to submit any of their failed attempts that show a repeated problem with the science or vaccine.

    The FDA may or may not sample a vaccine during production to test its integrity (not that it will function or damage).

    It’s approved for injecting millions of infants and children, and in cases, pregnant women and adults.

    Like

  6. December 21, 2016 at 1:11 pm

    A. The comparison between vaccine court and other adjudicative forums was to highlight that the lack of knowledge about vaccine court is not the result of anything being hidden and is by no means unusual in the administrative state. There are just a lot of administrative agencies that are not well known outside those who directly need them. It’s just the reality of a big administrative state with a lot of parts.

    B. I’m not sure how informed consent is relevant here. NVICP is not the body that’s supposed to handle informed consent, and that was in now way part of the topic here. I think your claims are incorrect, but since they’re off topic, I don’t want to derail the discussion.

    C. Tens of thousands of studies of vaccine safety exist. Literally. Here is a recent review: Margaret A. Maglione, et al., Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review, 134 PEDIATRICS 1(2014).

    We don’t depend on reporting alone, and they show clearly that serious harms from vaccines happen, but very rarely. So the claim that they’re not studied or known – including things that allegedly develop years later – is simply mistaken.

    D. I’m not sure why you’d connect something to vaccines if it happened year later and studies don’t support the claim. Assuming everything bad is because of vaccines does not have a good basis.

    Like

  7. December 21, 2016 at 1:14 pm

    The FDA does not conduct safety studies, but monitors them. As to them being tweaked – to remind you, most vaccines fail safety testing and never make it to market. So the claim is unconvincing.

    All results of clinical trials are public. They don’t have to publish them in peer reviewed, but if they want to get the vaccine to market they certainly have to provide the FDA with all the data.

    Even if we ignore the extensive post-market monitoring systems, there is a lot of monitoring during the licensing process.

    And this, too, has nothing to do with the topic of this post.

    Like

  8. Lawrence
    December 21, 2016 at 2:05 pm

    Depending on the data you look at, for every 1 vaccine that is approved, 4 – 5 of them don’t.

    If the process worked as you believe that it does, then every single vaccine would be approved, every single time – instead, we see a process that is extremely rigorous and can take a decade or more to go through the entire approval process.

    Even after approval, vaccine safety is tracked by multiple surveillance systems – both active and passive, by multiple organizations around the world.

    Like

  9. Lawrence
    December 21, 2016 at 2:09 pm

    https://www.cdc.gov/vaccines/basics/test-approve.html

    Again, there is a very robust process in place…anti-vaxers just don’t what to understand it.

    Like

  10. JFP
    December 22, 2016 at 2:18 pm

    “That’s a $210 check I just received from our vaccine lawyer. It’s to reimburse our initial expenses back in 1999 when our vaccine claim was filed. 17 years later, our claim is denied in a final appeal. No words. This is a huge punch to the gut.
    Healthy baby, 9 weeks old, receives 2 month immunizations and dies 2-3 hours later.
    And the claim is denied.”
    ~ Shared with permission from one of our members from Texans for Vaccine Choice

    “Thanks to the National Childhood Vaccine Injury Act of 1986, you can’t directly sue a vaccine manufacturer for injury or death caused by a vaccine. In case you did not know about this, read that again. Let it really sink in. Vaccine manufacturers have no liability. In other words, there are no checks and balances in place to encourage a safe product.
    Instead, to be compensated for injury or death, you must go through Vaccine Court, which is not really a court at all. It is a secret, closed-doors, hellishly-frustrating, drawn-out process for the injured parties, and rarely results in any form of compensation. If compensation is given, it is not even taken from the vaccine manufacturers’ pockets – but rather from the taxpayers. When someone buys a vaccine, a portion of the amount they pay goes into a fund. This fund is what is dipped into on the rare occurrence someone is paid for injury or death due to vaccines. In other words, the taxpayer pays, NOT the vaccine manufacturer.”

    Like

  11. Lawrence
    December 22, 2016 at 2:47 pm

    So secret that it has its own website which is published and distributed to millions of Americans every year who get vaccinated.

    So secret that all decisions of the Court are published in the public domain, unless specified by the plaintiffs.

    So secret that we know each and every detail of the program and its administration.

    So secret, that it is not secret at all……

    And no, the tax is paid directly by the manufactuers.

    Given your lack of even the most basic understanding of the program, no wonder you aren’t taken seriously.

    Like

  12. December 22, 2016 at 3:24 pm

    It’s always sad when a baby died. But if a family could not meet VICP’s lower burden of showing causation, it’s very unlikely the death was, in fact, caused by the vaccine. It’s impossible to say more without the details of the case, of course. But to remind you, VICP is not a support program for bereaved parents. It’s a program to compensate things shown according likely caused by a vaccine, according to criteria less stringent than the regular courts.

    The points about secrecy and the tax were already addressed by Lawrence. Let me add that:
    A. Liability protections are not absolute.
    B. The claim of no checks and balances is simply false. There are multiple mechanisms in place to assure a safe product. Tort liability isn’t the end all of that, nor necessarily a very good mechanism for achieving that.

    Like

  1. December 27, 2014 at 4:42 pm
  2. January 11, 2015 at 12:01 pm

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