Government Accountability Office Report on Vaccine Injury Compensation
Dec 09, 2014

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

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.

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