"Compensating Vaccine Injuries: Are Reforms Needed?"

Mr. Chairman and other members of this Subcommittee, I am very pleased to be with you today to talk about a subject that is very near and dear to me. Before I begin, let me enter my father's name, Ralph Shoemaker, into the Congressional Record. My father passed away on September 11th as I was preparing my testimony for this occasion, and my remembrances of him were constantly on my mind as I wrote this testimony.

I often tell people that I represent "saints" - the parents of children who have been profoundly injured as the result of vaccinations. But I want you to understand that I am NOT (and I repeat, NOT) against vaccinations. It is important that you understand where I am coming from in this regard. You see, my parents are also saints - not because they put up with me, but because they also raised a handicapped child and helped her to become a fulfilled, beautiful person. The year I was born, one of my sisters, who was then nine, contracted polio. She has lived her life in a wheelchair because vaccines to protect her against that dread disease had not yet been developed. So now, as Paul Harvey would say, you know the rest of my story and one of the reasons why I am so committed to the development of safe and effective vaccines designed to protect us against serious diseases.

In a very real sense, I feel that I am here today testifying on behalf of the United States government - or at least that part of the government which is "of the people, by the people and for the people." Abraham Lincoln once said,

It is as much the duty of government to render prompt justice against itself, in favor of its citizens, as it is to administer the same, between private individuals.

As a lawyer, it is my job to represent the best interests of my clients in one of the greatest legal systems in the world. For over twenty years, I have been involved in representing children and adults who have been seriously injured as the result of the receipt of vaccinations.

Prior to the enactment of the National Vaccine Compensation Program, injured parties were left to proceed in civil suits against vaccine manufacturers and administrators of vaccines. This litigation was time consuming and expensive, the results were mixed, and, while there were large judgments for some, with large attorney's fees, there were many who were unsuccessful in their quest for needed compensation. (Those whose claims failed most likely today rely on another government program, Medicaid.) Manufacturers were concerned enough about potential liability so that some felt the supplies of vaccines were threatened. It was obvious to many people that, although the risks of serious reactions to vaccinations are small, such injuries are nevertheless devastating to the victims and their families, and they needed a fair and compassionate method of compensation. At a "Symposium on Public Concerns of Immunization" held at Georgetown University on October 25-26, 1978, Dr. Leroy B. Walters set the context for the program that was to follow:

Consider the following metaphor drawn from military service: Mass immunization programs are a significant element in the war on infectious disease. In mandatory immunization programs a system of conscription is employed to recruit soldiers for this anti-disease campaign. As it happens, most of the recruits in the war on infectious diseases are children. In most cases, participation in the war on infectious diseases is beneficial to the young soldiers themselves. However, at least part of the rationale for conscription is that the pediatric warriors will protect other children and the population as a whole against the onslaughts of infectious disease . . . As in all wars, some soldiers are injured. The number of child-soldiers and their contacts who are actually wounded in this war is small, almost infinitesimal. Yet service-connected disabilities do occur. . .

At present, the draftees who are injured in the war on infectious disease are in effect told by the conscripting authorities, 'Thank you for your contribution to the war effort, and best of success in coping with your disability.'

This analogy to the military veteran is particularly appropriate for our discussions today, and I will be referring back to that analogy, so please keep it in mind. The National Vaccine Injury Compensation Act was passed by Congress in 1986 to provide a no-fault compensation program for those individuals who are unfortunately injured by the very vaccines that are designed to protect them and to protect society. The program was supposed to be a non-litigious, compassionate program which would err on the side of over-compensating rather than under-compensating these unfortunate victims. In practice, the program has become a litigious, expensive process where it is becoming more and more difficult to prevail.

Claimants under the program have two ways of prevailing. First of all, they can try to demonstrate that their claim falls within a "Table of Injuries" that was created by Congress and which, if one were to fit under the table, creates a presumption that the vaccine caused the injury. The burden then shifts to the Respondent to prove, if they want to or can, that the injury was in fact caused by something else instead of the vaccine. The second way that a claimant can prevail is to prove that the vaccine did, in fact, cause the injuries that are being complained of. I will discuss the standard of proof for these types of cases in a moment.

In addition to providing petitioners a presumptive Table of Injuries, Congress also gave the Secretary of Health and Human Services the power to change the Table. This included the power to add newly-developed vaccines to the Table and to provide new presumptions for the injuries. In late 1994, the Secretary of Health and Human Services ("HHS") proposed certain changes to the Table of Injuries. These regulations became effective on March 10, 1995, and they have effectively devastated the Program. Please review my footnote here about this subject. Practically speaking, the Table of Injuries, which, in my opinion and the opinion of others, should have been expanded, was instead reduced to a meaningless concept. If anything, the Table of Injuries has almost made it more difficult to prove causation in cases that do not fit it precisely.

The other method of proving causation is supposed to be similar to the method of proving causation in a traditional civil trial. In legal language, that means that the claimant is supposed to demonstrate by a preponderance of the evidence that, more likely than not, the injury was in fact caused by the vaccine. In my experience, the standards of proof that claimants in this program have been held to have been higher than what is typically adequate in front of a jury. The statistics speak for themselves, and it is obvious to me that proving causation in these cases has become an onerous proposition, where we are erring on the side of under-compensation. I would ask that you read carefully my footnote at this point about what I call "the uneven playing field." It is a description of the many difficulties faced by Petitioners in this program.

The Department of Justice has taken the position repeatedly in these claims that this program is not a compensation program, but rather a "waiver of the doctrine of sovereign immunity" where the government is allowing itself to be sued and therefore the statute must be narrowly construed against the claimants. This is the attitude that is behind the HHS proposal to include genetic anomalies and structural lesions as being evidence of alternate causes of injury. It is important that you understand this concept. If you punch someone who is a hemophiliac and they bleed to death, or if you punch someone with a cardiac condition and they have a heart attack, you cannot say that you are not liable for the death or the heart attack because of the person's preexisting condition. This is what we refer to as the "eggshell" principle, where you take your victims as you find them, and you are responsible for the outcomes of your actions. Obviously, when some children are injured by vaccines, it is because of their genetics and/or prior sensitizations that have predisposed them to react in the way they do. If this were not the case, then either all children would have a reaction or none of them would. The government is trying to convince you to take the position that because some kids are susceptible to injury from vaccination, they should therefor be barred from recovery under this no-fault compensation program. That position is absurd, and I urge you not to adopt it.


This is one of those moments when I would ask you to reflect back on the military analogy which I raised earlier. My first proposal to Congress is that you change the burden of proof in these vaccine claims by putting into the statute the exact same language that is used in 38 U.S.C. sec. 5107 for military veterans claiming injuries and seeking benefits.

(a) Except when otherwise provided by the Secretary in accordance with the provisions of this title, a person who submits a claim for benefits under a law administered by the Secretary shall have the burden of submitting evidence sufficient to justify a belief by a fair and impartial individual that the claim is well grounded. The Secretary shall assist such a claimant in developing the facts pertinent to the claim. Such assistance shall include requesting information as described in section 5106 of this title.

(b) When, after consideration of all evidence and material of record in a case before the Department with respect to benefits under laws administered by the Secretary, there is an approximate balance of positive and negative evidence regarding the merits of an issue material to the determination of the matter, the benefit of the doubt in resolving each such issue shall be given to the claimant. Nothing in this subsection shall be construed as shifting from the claimant to the Secretary the burden specified in subsection (a) of this section.

Id. (Emphasis added).

In my humble opinion, this is the one most important change that you can make to improve this program and start us on the road to realizing its potential as an alternate dispute resolution system.


The second most important issue that I feel needs to be dealt with involves the Statute of Limitations for filing claims. In that regard, the Department of Health and Human Services has forwarded a proposal that would increase the Statute of Limitations from 3 years to 6 years, and I applaud them for at least putting forth this modest proposal. IT DOES NOT GO FAR ENOUGH! Most states have provisions which toll (or stop) the running of the statute of limitations while the injured party is a minor. Most states have provisions which toll the statute of limitations while an injured party is incompetent (and many of the victims of vaccine injuries are incompetent under those definitions). Many states have what are called discovery rules, which allow for someone to file within several years of when they first knew or should have known that their injuries were caused by the vaccine. I would encourage you to read my footnote at this point which describes numerous situations that I have experienced and which are simply wrong. This footnote also discusses my specific proposals for change.


One of the most critical needs that petitioners have in these claims is the benefit of highly qualified trial attorneys. This is particularly true because of the highly litigious nature of the program and the fact that the government has the capability of recruiting highly qualified experts and paying them promptly for their services. Unfortunately, because of the extremely low hourly rates that are being awarded to attorneys and the fact that we often wait for years to be paid and to be reimbursed for expenses incurred in connection with the claim, many top-notch litigators have been driven out of the program or refuse to participate. A well-qualified, experienced litigator has to be either very dedicated or very stupid (or both) to stay involved in this system as it currently exists. My proposal to Congress is simple. I would suggest that each Petitioner be given the opportunity to petition for fees and expenses on three separate occasions in addition to their final petition at the end of the claim process. The petitioners should not be limited, as the HHS proposal suggests, to one petition for only interim costs after an entitlement hearing. The petitioners and their counsel should be allowed to select the times when they apply for these reimbursements. Anything short of this will result in a situation where the victims who are most in need will not be able to move their claims forward successfully because they cannot afford to advance the costs, and attorneys in the program no longer have the resources to advance such costs.

I do not have the time to talk about all of my proposals, but please review them carefully, and I would be happy to answer specific questions about them.



    1. Reinstate the table of injuries as originally created by Congress (as to the vaccines originally included) and remove the Secretary's power to change the table in such a way as to make it more difficult to receive compensation;
    2. Reject the proposal for adding further defenses regarding alternate causes, such as genetic abnormalities and structural lesions;
    3. Make it clear that this is a generous compensation program; this is NOT a waiver of sovereign immunity, but rather a welfare program which should be broadly construed so as to achieve its remedial purposes;
    4. Change the burden of proof to reflect the standard used for Veterans' cases;
    5. Change the statute of limitations to six years, but add a discovery rule such as is employed in other FTCA cases;
    6. Toll the statute of limitations during minority and during periods of disability due to mental incompetence;
    7. Allow Petitioners to apply for interim fees and expenses at least three times prior to the final petition for fees and costs;
    8. Allow interest to be paid on past damages from the date incurred, and allow post-judgment interest.
    9. Reject the proposed language of the Secretary concerning the basis for calculating projected lost earnings. It is simply a way of reducing the amount of damages that will be paid to victims;
    10. Do allow compensation for family counseling expenses and expenses of establishing a guardianship, but also allow compensation for the costs of creating and administering special needs trusts; and
  1. In all the changes that are made, remember that there are some victims whose claims would have been successful had these changes been in place when their claims were dismissed. Please give consideration to allowing those individuals a time period - two years perhaps - within which to reinstate their claims.


Let me just say, in conclusion, that this program should not be used to demonstrate whether vaccines are safe or dangerous. Those people who point to the failures of victims who are seeking compensation as evidence that vaccines are safe SHOULD BE ASHAMED OF THEMSELVES. Those people who point to the victims who are awarded compensation and use this as evidence that vaccines are dangerous SHOULD LIKEWISE BE ASHAMED OF THEMSELVES.

This program has been successful in many ways:

Manufacturers are happy and vaccine supplies are plentiful;

Doctors who administer vaccines are happy and no longer threatened with lawsuits;

The federal bureaucracy is happy that they have a system in place that can be firmly controlled.

The people who are largely dissatisfied with this program are the very people it was designed to help - the rare, but unfortunate victims. Again, read the articles attached to my statement, and you will see what I mean.

The sponsors of this program should want to see it fixed. Those who want to help our pediatric warriors cope with their disabilities should want to see it fixed. Those who champion tort reform should want to see it fixed. If it is not fixed, I can assure you that the "hawks" among my profession are sitting on the sidelines ready to pick up the pieces and move us back into the tort arena. If this program is not fixed, I will be one of them.

Thank you!